CardioKinetix Announces the 500th Parachute Heart Failure Device Implantation July 21, 2016

Menlo Park, Calif. – July 21, 2016— CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that 500 patients have received  the company’s Parachute® Ventricular Partitioning Device for heart failure. Patients have been treated in more than 15 countries, including patients in key international markets where the device is commercially available, and patients enrolled in PARACHUTE IV, the company’s U.S. pivotal trial under investigational device exemption (IDE).

After a heart attack, many patients experience enlargement of the left ventricle. This enlargement causes a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath, fatigue, swelling in the legs, ankles and feet, rapid or irregular heartbeat, and reduced ability to exercise. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment designed to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“Heart failure is a large area of fast-growing unmet need, both clinically and from a health economics perspective,” said Dr. Abraham. “Patients with heart failure suffer from debilitating symptoms and have few effective treatment options, and the results to date in the Parachute studies are very encouraging. It is important for the medical community to collaborate in completing this pivotal study to further the treatment options for heart failure patients.”

“With more than 500 patients now treated with the Parachute device in 15 countries, and a growing body of clinical data supporting the therapy, we feel we have made tremendous progress toward establishing this minimally invasive device as a promising alternative for patients with heart failure,” said Maria Sainz, president and CEO of CardioKinetix.

Clinical data supporting the use of the Parachute device has been published in 35 peer-reviewed journals. Two-year safety and efficacy results from 100 European patients treated with the Parachute device were presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2015.

The company’s U.S. pivotal study, PARACHUTE IV, a large-scale, multi-center, randomized trial, is presently enrolling patients at over 70 treatment centers in the United States. The trial is more than 50% enrolled and is led by three National Principal Investigators, Drs. William Abraham (Ohio State University Medical Center), Marco Costa (Case Western Reserve University), and Leslie Saxon (University of Southern California), leaders in the fields of heart failure, interventional cardiology and electrophysiology, respectively. The trial leadership illustrates the multi-disciplinary approach of the Parachute therapy, common among novel structural heart therapies.

About Heart Failure:

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device:

The Parachute device is designed to offer the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data has demonstrated improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the U.S. (clinicaltrials.gov identifier NCT01614652).

About CardioKinetix Inc.:

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.

For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:

Nicole Osmer

650-454-0504

nicole@nicoleosmer.com

CardioKinetix Announces US Pivotal Trial More Than Half Enrolled January 14, 2016

Menlo Park, Calif. – January 14, 2016— CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that it has enrolled more than half of the subjects in its pivotal United States trial, PARACHUTE IV. The trial is evaluating the innovative Parachute device for the treatment of patients suffering from heart failure, a highly debilitating condition.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath, fatigue, swelling in the legs, ankles and feet, rapid or irregular heartbeat, and reduced ability to exercise. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

Dr. William Abraham from the Ohio State University, Dr. Marco Costa from University Hospitals, Case Western Reserve University, and Dr. Leslie Saxon from the University of Southern California provide physician leadership for the trial. A multidisciplinary approach similar to other novel structural heart therapies is optimal for success. The Parachute Heart Team leverages heart failure, interventional cardiology and electrophysiology experts to identify patients with ischemic etiology and reduced ejection fraction for enrollment.

“As a physician, I am often frustrated that there is not more that I can do for my patients with heart failure following a heart attack to improve debilitating symptoms,” said William Abraham, M.D., professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center. “The Parachute is an innovative device that holds promise as a breakthrough treatment that could transform quality of life for these patients.”

“We are pleased to have reached this milestone in the US trial, and are looking forward to completing the enrollment phase. We are very excited with the interest in our therapy from interventional cardiologists, heart failure specialists and electrophysiologists,” said Maria Sainz, president and CEO of CardioKinetix. “This achievement was accomplished by the strong partnerships with our more than 60 clinical sites.”

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011.  In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the U.S. (clinicaltrials.gov identifier NCT01614652).

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.

For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Announces South Korean Approval 
for the Parachute System for Heart Failure October 13, 2015

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that it has received regulatory approval for the Parachute® System in South Korea by the Korean Ministry of Food and Drug Safety (MFDS).

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“We are pleased to have received approval for the Parachute device, and are excited to introduce the therapy to patients with heart failure in South Korea,” said Maria Sainz, president and CEO of CardioKinetix. “The achievement of this milestone builds upon the technology adoption we are experiencing in the Asia market where we have treated the first 100 patients, completed a Chinese clinical trial, and recently received regulatory approval in Indonesia.”

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011.  In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an IDE study in the U.S. and Canada (clinicaltrials.gov identifier NCT01614652).

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Announces Excellent Results of Chinese Trial Evaluating Parachute Heart Failure Device March 24, 2015

Menlo Park, Calif. and Beijing, China — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced three-month clinical and echocardiographic results of PARACHUTE China, a study of 31 Chinese patients treated consecutively with the company’s Parachute® Ventricular Partitioning Device.

“The results of this study, which met its primary and secondary endpoints, continue to substantiate the safety profile and effectiveness of the Parachute as a viable minimally invasive ventricular partitioning device for patients with ischemic heart failure,” said Gao Runlin, M.D, chief cardiologist at Fu Wai Hospital, Chinese Academy of Medical Sciences, and co-principal investigator of the trial, who presented the results at the China Interventional Therapeutics (CIT) 2015 conference in Beijing. “The very compelling data from these Chinese patients demonstrates the clear promise of this breakthrough technology and is consistent with previous data reported from Europe and the United States.”

The primary endpoint of left ventricular end systolic volume index (LVESVi) reduction as compared to baseline was met by a reduction from 78.2±20.3 ml/m2at baseline to 53.4±17.4 ml/m2 at three-month follow-up, which was found to be highly significant (p < 0.0001). The three-month highlights from the data include:

• Very high procedural success rate of 97 percent
• Secondary Safety Endpoint: Device or Procedure Related MACE rate of 3 percent
• Secondary Efficacy Endpoints Achieved
o NYHA functional class improved from 2.1 to 1.4 (p < 0.001)
o EQ5D VAS Score improved from 64 to 76 (p < 0.01)
• Hemodynamic Improvement
o Ejection Fraction improved from 29.8% to 36.1% (p < 0.0001)
o Wall Motion Severity Index improved from 2.6 to 2.0 (p < 0.0001)
o Stroke Work indexed to End Diastolic Volume improved from 29.4 mmHg to 35.9 mmHg (p < 0.001)

“The PARACHUTE China trial is the fourth trial to demonstrate statistically and clinically meaningful results from our clinical program. The achievement of meeting the primary and secondary endpoints of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device where already more than 50 patients have been treated through clinical trials or special access programs from nine hospitals. The Parachute can address a significant unmet need in the care of heart failure patients in China.”

About PARACHUTE China
PARACHUTE China (clinicaltrials.gov/NCT02240940) enrolled NYHA II to ambulatory IV ischemic heart failure patients with ejection fraction 15-40% to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which was analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.
The principal investigator is Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.
About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Completes Enrollment in Chinese Trial of First-of-Its-Kind Parachute Device for Treatment of Heart Failure January 8, 2015

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the completion of enrollment in PARACHUTE China, a multi-center trial to evaluate the minimally invasive Parachute® Ventricular Partitioning Device for the treatment of heart failure.

Results of PARACHUTE China will be presented at the China Interventional Therapeutics (CIT) 2015 conference, which will take place March 19-22 in Beijing, China.

“The completion of enrollment in the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device and commitment to enrolling the trial so efficiently, and we look forward to releasing the results this spring.”

PARACHUTE China (clinicaltrials.gov/ NCT02240940) enrolled NYHA II to ambulatory IV ischemic heart failure patients with ejection fraction 15-40% to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.

The principal investigator is Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.

For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Completes $50 Million Financing and Signs Agreement with Edwards Lifesciences, Including Exclusive Option to Purchase December 9, 2014

Menlo Park, Calif. — CardioKinetix, Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has completed a $50 million financing led by Edwards Lifesciences Corporation, with participation from existing investors U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, and Lexington Private Equity.

CardioKinetix has also entered into an agreement that provides Edwards Lifesciences the right to acquire CardioKinetix based on future regulatory milestones.

This financing provides the company with the capital necessary to complete the PARACHUTE IV randomized pivotal clinical trial of the Parachute® Ventricular Partitioning Device for the treatment of heart failure. Data from the study, which is currently enrolling patients in the United States, will be the basis for the company’s pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA). The financing will also enable CardioKinetix to pursue international market development efforts in key geographies.

“We are very proud of our accomplishments to date, with more than 300 patients treated, four clinical trials completed and 23 publications on the Parachute therapy,” said Maria Sainz, president and CEO of CardioKinetix. “Heart failure remains a huge global clinical and economic challenge for healthcare systems, and Parachute holds the promise to bring needed improvements in mortality, quality of life, and care efficiency to clinical providers. We are pleased to have the support of Edwards Lifesciences and our premier investor syndicate as we further our efforts to complete the PARACHUTE IV trial and bring the Parachute therapy to patients around the world.”

Cooley LLP served as legal counsel to CardioKinetix.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device. Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under limited sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.

Media contact:
Nicole Osmer
650-454-0504
nicole@nicoleosmer.com

[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Initiates Study in China of First-of-Its-Kind Parachute Device for Treatment of Heart Failure October 24, 2014

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the enrollment of the first patients in PARACHUTE China, a multi-center trial to evaluate the minimally invasive Parachute® Ventricular Partitioning Device for the treatment of heart failure.

The first ten patients were treated with the Parachute device in Beijing at Peking University and Fu Wai Hospital, and in Shanghai at Shanghai Tenth People’s Hospital.

Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences, principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in China with my colleagues, where there is a significant need for better treatments for heart failure. I am very proud that the first clinical trial cases were performed last week with such high interest by the study investigators, building upon the early, positive experience with the Parachute by leading cardiovascular centers in China.”

PARACHUTE China (clinicaltrials.gov/ NCT02240940) will enroll NYHA II to ambulatory IV ischemic heart failure patients to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.

“The initiation of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are proud of our efforts to bring the Parachute technology to market on three continents. The initiation of the China trial, along with the active enrollment in our PARACHUTE IV U.S. pivotal trial and the initial commercialization in key European centers under CE Mark, illustrate our commitment to developing the Parachute therapy for heart failure globally.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, with a significant number currently receiving an implantable cardioverter-defibrillator (ICD) and many a cardiac resynchronization therapy device (CRT-D) device. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under limited sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

CardioKinetix Releases One-Year Clinical Data from European Trial Showing Consistent, Compelling Positive Results for Patients Treated with Minimally Invasive Device for Heart Failure September 15, 2014

Analysis from 100 Consecutive Post-Market Patients Presented at TCT and HFSA 2014 Substantiate Potential of Breakthrough Treatment for Heart Failure Patients

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a pooled analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Twelve-month clinical data from PARACHUTE III, a study of 100 post-market European patients with ischemic heart failure treated consecutively between 2011 and 2013, were presented at the 2014 TCT Conference in Washington, D.C., by Ulrich Schäfer, M.D., cardiology director of the Structural Heart Division at the Heart Center at the University Medical Center Hamburg-Eppendorf, and at the 2014 HFSA Conference in Las Vegas, Nev., by William Abraham, M.D., professor of internal medicine and director of the Division of Cardiovascular Medicine at Ohio State University Medical Center.

“The results of this European post-market study continue to substantiate the safety profile and effectiveness of the Parachute as a viable, minimally invasive device technology for patients with heart failure,” said Dr. Abraham. “The very compelling data from these 100 European patients demonstrates the clear promise of this breakthrough technology and is exciting news for the more than 50 active hospitals in the U.S. randomized trial, PARACHUTE IV, which is currently enrolling patients.”

Parachute had a very high procedural success rate of 97 percent (97/100). The twelve-month highlights from the data include:

  • Primary safety endpoint yielded a low 7% rate of device- or procedure-related MACCE
  • Sustained reduction of left ventricle volumes (p < 0.0001) resulting in significant improvements in systolic function and a significant reduction in left atrial volume (p < 0.05) reflected improved diastolic function
  • NYHA functional class improved or maintained in 80 percent of patients
  • Six-minute walk distance improved at follow-up (p < 0.01), with 46 percent of patients walking an additional 20 meters or more
  • Rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 9.5 percent and 26.0 percent, respectively

“The results of this trial add excitement about the Parachute treatment, which offers an option to heart failure patients with a very poor prognosis the promise for improved quality of life and reduced rates of mortality and heart failure hospitalization,” said Dr. Schäfer.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, with a significant number currently receiving an implantable cardioverter-defibrillator (ICD) and approximately one-third receiving a cardiac resynchronization therapy device (CRT-D) device. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:
Barry Templin
650-364-7016
btemplin@cardiokinetix.com

 

CardioKinetix Announces Positive Clinical Data Showing Consistent Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure May 22, 2014

Meta-Analysis Presented at EuroPCR Substantiate Potential of Breakthrough Treatment for Heart Failure Patients; Largest Group Studied to Date

Paris and Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a meta-analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Six-month clinical results from 91 U.S. and European patients with ischemic heart failure were presented at the 2013 EuroPCR Conference in Paris by Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England.

“The results of this meta-analysis, which represents the largest group of patients studied to date, are consistent with previous positive findings and continue to substantiate the Parachute treatment as a viable technology – a very exciting prospect for physicians treating patients with heart failure,” said Dr. Thomas. “The Parachute promises to revolutionize the treatment for heart attack survivors whose hearts enlarge over time and subsequently suffer from heart failure symptoms, offering hope for a better qualify of life for many patients.”

Clinical data from 91 patients to reach six-month follow up demonstrates successful delivery and deployment of the Parachute implant, without the occurrence of major adverse cardiac events (MACE) related to the device, in 90 percent (82/91) of patients at six months following treatment. In addition, six months following treatment, 89 percent of patients demonstrated improved or maintained New York Heart Association (NYHA) functional class status. Specifically in the NYHA III subgroup, 27 percent improved two classes. The treatment also demonstrated a reduction in left ventricular volume, with a 20 percent reduction in end diastolic volume and a 23 percent reduction in end systolic volume (p<0.001).

“The results of this meta-analysis along with the recent completion of our post-market safety surveillance trial add to our excitement about the Parachute treatment, which we believe holds the potential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “Enthusiasm about the therapy continues to grow in the clinical community in Europe, where the therapy is available commercially, as well as in the United States, where the device is being studied in a landmark randomized pivotal trial.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors, and H&Q Life Sciences Investors. For more information please visit www.cardiokinetix.com.

 

 

CardioKinetix contact:

Barry Templin

650-364-7016

barry@cardiokinetix.com

 

CardioKinetix Releases One-Year Clinical Data Showing Consistent, Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure April 7, 2014

Analysis from 111 Consecutive Patients Presented at ACC 2014 Substantiate Potential of Breakthrough Treatment for Heart Failure Patients

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a pooled analysis study of the first-of-its-kind catheter-based Parachute® Ventricular Partitioning Device. Twelve-month clinical results from 111 consecutive U.S. and European patients with ischemic heart failure were presented at the 2014 ACC Conference in Washington, D.C., by Philip Adamson, medical director at the Heart Failure Institute at Oklahoma Heart Hospital.

“The results of this pooled analysis, which represents the largest group of patients studied to date, continue to substantiate the Parachute treatment as a viable technology for patients with heart failure,” said Dr. Adamson. “As we analyze the longer time points in this population, we are beginning to observe the durable effects of the Parachute device.”

Parachute proves to be a straightforward technology with a very high procedural success rate of 96 percent (106/111). The twelve-month highlights from the data include:

  • Sustained reduction of left ventricle volumes (p < 0.0001) resulting in significant improvements in systolic function (ejection fraction, contractility index, and stroke work) and a significant reduction in left atrial volume reflected improved diastolic function
  • NYHA functional class improved or maintained in 86 percent of patients
  • Six-minute walk distance improved at follow-up (p < 0.05), with 47 percent of patients walking an additional 20 meters or more
  • Rates of death and the combined endpoint of death and repeat hospitalization for heart failure were 5.7 percent and 21.7 percent, respectively

“The results of this analysis add excitement about the Parachute treatment, which we believe holds the potential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “As we amass more and more data with this technology, enthusiasm and confidence continue to build around the landmark U.S. randomized clinical trial, which is currently enrolling at 45 centers.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device

The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Archer Ventures, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

 

CardioKinetix contact:

Barry Templin

650-364-7016

btemplin@cardiokinetix.com

CardioKinetix Announces First Heart Failure Patients Treated in China with Novel Minimally Invasive Structural Heart Device October 14, 2013

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced a new first with two patients successfully treated this week with the new catheter-based Parachute® Ventricular Partitioning Device in Beijing, China.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“We are very proud that the first Parachute procedure in China was performed here in Beijing. China is currently experiencing a rapid increase in cardiovascular disease leading to a significant unmet need for better treatment options for patients with heart failure,” said Huo Yong, M.D., Director Heart Center and Department of Cardiology PKU-1st Hospital and President Chinese Society of Cardiology in Beijing, China.

“These initial cases in China mark another key milestone in CardioKinetix’s journey to bring Parachute to heart failure patients around the world,” said Maria Sainz, President and CEO of CardioKinetix Inc. “China represents a key strategic opportunity for the company as we further our international expansion.”

The introduction of the Parachute into the Chinese market will add significant experience to the program where the device already has CE Mark in Europe and is currently enrolling in the U.S. pivotal trial, PARACHUTE IV.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Announces First Heart Failure Patients Treated in Asia with Minimally Invasive Structural Heart Device August 29, 2013

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced a new first with four patients successfully treated this week with the novel catheter-based Parachute® Ventricular Partitioning Device in Kuala Lumpur, Malaysia.

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“We are thrilled that the first Parachute procedure in Asia was performed here in Kuala Lumpur. There is a significant unmet need for better treatments for patients with heart failure in Malaysia, where heart disease is a growing public health concern,” said Robaayah Zambahari, M.D., Chief Executive Officer of Institut Jantung Negara (National Heart Institute) in Kuala Lumpur, Malaysia. “Heart failure symptoms have a significant negative impact on quality of life. Surgical treatments for the condition are invasive and typically performed in the later stages of the disease, and medical therapy does not address the underlying structural issues of ischemic heart failure. The Parachute device is an innovative new option that has demonstrated promising results in previous studies.”

“The expansion of the Parachute device into Asia is an important achievement for the company,” said Maria Sainz, President and CEO of CardioKinetix Inc. “Continuing to partner with leading clinicians and heart centers illustrates the promise the Parachute holds to bring a solution for the underserved heart failure patients around the world.”

The introduction of the Parachute into the Asian market will add significant experience to the program where the device already has CE Mark in Europe and is currently enrolling in the U.S. pivotal trial, PARACHUTE IV.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors (NYSE:HQH), and H&Q Life Sciences Investors (NYSE:HQL). For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Announces Successful Parachute Live Case Transmission at 2013 EuroPCR Conference May 24, 2013

Paris and Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the transmission of a live satellite feed of a clinical case using the first-of-its-kind catheter-based Parachute® Device at the annual 2013 EuroPCR Conference in Paris.

The Parachute procedure was performed by Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas’ Hospital in London, England, with assistance from Dr. Hüseyin Ince, Prof. of Medicine, University Hospital Rostock, Germany.

“Patients with ischemic heart failure have few effective options for their debilitating condition,” said Dr. Thomas. “I am always excited to perform the Parachute procedure, and give another patient hope for a better life. The procedure today went smoothly.”

“We are thrilled with the growing level of interest in the Parachute device demonstrated at EuroPCR this year,” said Maria Sainz, president and CEO of CardioKinetix. “Over and over again, we are hearing about the need for new therapies for MI survivors who develop heart failure over time. We believe that the Parachute addresses this unmet need with a technology that not only improves lives but could also reduce healthcare spending in the treatment of patients with heart failure.”

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute® Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device first received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JPMorgan Partners, Panorama Capital, H&Q Healthcare Investors, and H&Q Life Sciences Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:

Barry Templin

650-364-7016

barry@cardiokinetix.com

 

 



[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Initiates Landmark Study of First-of-Its-Kind Treatment for Heart Failure in the United States January 8, 2013

Randomized Multicenter PARACHUTE IV Clinical Trial Will Compare Minimally Invasive Device to Optimal Medical Therapy

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.

PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 500 patients with ischemic heart failure at up to 65 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.

The first implant with the Parachute device was performed by David Mego, M.D., assistant medical director at Arkansas Heart Hospital in Little Rock, Arkansas, who treated a 39-year-old female with NYHA class III heart failure referred by Carl Leding, M.D., director of the Congestive Heart Failure Clinic at Arkansas Heart Hospital.

Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart & Vascular Institute at Case Western Reserve University and co-principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in the United States, where there is a significant need for better treatments for this heart failure patient population.”

“Many patients who have had a heart attack experience an extremely poor quality of life due to the debilitating symptoms of heart failure, including shortness of breath, fatigue, lack of appetite, impaired thinking, and increased heart rate. A classic example is the patient just treated at Arkansas Heart Hospital, where the patient experienced a heart attack less than two years ago and now struggles with simple things like dressing, cooking, or playing outside with her son because of shortness of breath and extreme fatigue,” said William T. Abraham, M.D., the co-principal investigator of the trial and director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center. “In October, three-year data on the initial patients treated with Parachute were presented at the TCT Conference by Dr. Marco Costa. These strong and encouraging results provide confidence to initiate a landmark randomized, pivotal trial where a positive outcome will establish this technology as a primary therapy option for the treatment of ischemic heart failure patients.”

The Parachute device offers the first minimally invasive catheter-based treatment to partition the coronary muscle damaged by a heart attack. The treatment excludes the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“This initiation of the U.S. randomized pivotal study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are excited about the opportunity before us to make a major positive impact for patients with heart failure, and we believe that we have partnered with the right heart failure physicians and interventional cardiologists to enroll this trial quickly.”

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, JP Morgan Partners, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Announces Successful Live Case Transmission at TCT 2012 Conference October 25, 2012

Menlo Park, Calif. and Miami, Fla. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the transmission of a live satellite feed of a clinical case using the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device to an audience of several hundred interventional cardiologists at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2012 Conference in Miami, Fla.

The Parachute procedure was performed by Stefan Verheye, M.D., Ph.D., at the Antwerp Cardiovascular Institute, ZNA Middelheim Hospital, Belgium. The patient was enrolled as part of the PARACHUTE III clinical trial, which is designed to support development of post-market clinical data and allow European physicians to increase their experience with the technology.

“The Parachute procedure went very smoothly,” said Dr. Verheye. “We are excited to participate in the PARACHUTE III trial studying this important new treatment for patients with ischemic heart failure, a debilitating condition with limited effective treatment options.”

“We are very pleased with the level of interest and enthusiasm for the Parachute device and the data presented at TCT this year,” said Maria Sainz, president and CEO of CardioKinetix. “It’s clear that new therapies for patients with ischemic heart failure represent an important unmet clinical need and a very compelling opportunity to improve lives as well as reduce healthcare spending in the treatment of Heart Failure.”

Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas’ Hospital in London, England, presented six-month data from 32 patients treated in a European confirmatory trial. These data demonstrate a New York Heart Association (NYHA) class improvement of nearly half a class from a baseline of 2.5 to 2.1 (p < 0.01). The rate of hospitalization due to worsening heart failure was 12.5 percent at six months, with no incidence of stroke or death, confirming the results from the CE Mark approval data of the device in the U.S and Europe.

Dr. Marco Costa, M.D., Ph.D., professor of medicine, Case Western Reserve University in Cleveland, Ohio, presented three-year data from 31 patients treated in the two trials used for CE Mark approval. Results demonstrate a rate of hospitalization due to worsening heart failure of 29.7 percent at two years and 33.2 percent at three years for patients treated with the Parachute system, with the low rate of cardiac death of 6.5 percent at two years remaining unchanged at three years. These results suggest that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare very favorably with current medical therapy in a similar high-risk patient population.

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-701
barry@cardiokinetix.com



[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Announces Data from Latest European Study of Heart Failure Patients with First-of-Its-Kind Percutaneous Treatment October 24, 2012

Positive Six-Month and Three-Year Results Presented at TCT 2012 Demonstrate Meaningful and Sustained Improvement in Clinical Outcomes for Heart Failure Patients

Menlo Park, Calif.CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device.

Data was shown at two presentations today in Miami at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference.

Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas’ Hospital in London, England, presented six-month data from 32 patients treated in a European confirmatory trial. These data demonstrate a New York Heart Association (NYHA) class improvement of nearly half a class from a baseline of 2.5 to 2.1 (p < 0.01). The rate of hospitalization due to worsening heart failure was 12.5 percent at six months, with no incidence of stroke or death, confirming the results from the feasibility trials.

Dr. Marco Costa, M.D., Ph.D., professor of medicine, Case Western Reserve University in Cleveland, Ohio, presented three-year data from 31 patients treated in feasibility trials from the U.S and Europe. Results demonstrate a rate of hospitalization due to worsening heart failure of 29.7 percent at two years and 33.2 percent at three years for patients treated with the Parachute system, with the low rate of cardiac death of 6.5 percent at two years remaining unchanged at three years. These results suggest that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare very favorably with current medical therapy in a similar high-risk patient population.

“With data now at three years, the long-term effect of the Parachute procedure remains highly promising for percutaneous treatment of heart failure patients. Particularly encouraging is the plateauing effect still maintained three years after treatment, which points to a potential slowing in the progression of heart failure,” said Dr. Thomas. “The durability of these results are demonstrated by the six-month results from the latest cohort of data, which are nearly the same as the feasibility results. Since the most recent cases were all done by operators without prior Parachute experience, the adoptability of this technology is very promising.”

“We continue to be very excited about the Parachute device and the promise it holds for addressing a significant unmet need for patients with debilitating ischemic heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “In the next few months we look forward to initiating our U.S. pivotal trial, PARACHUTE IV, and beginning our European launch, two major milestones for our company.”

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-701
barry@cardiokinetix.com



[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Receives CE Mark Approval for Full Range of Sizes for First-of-Its-Kind Percutaneous Treatment for Heart Failure October 23, 2012

Menlo Park, Calif. CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced it has received CE Mark approval for the full size matrix of the company’s Parachute™ Ventricular Partitioning Device for Percutaneous Ventricular Restoration (PVR) therapy.

“The CE Mark approval for the full matrix of sizes of the Parachute implant is an important milestone; it will enable us to provide this innovative treatment to a wide range of heart failure patients in the European Union. We are finalizing our plans for our initial commercial launch in Europe in 2013,” said Maria Sainz, president and CEO of CardioKinetix.

“We have been very encouraged with the results of the Parachute cases at our hospital. Now that the Parachute is available in eight sizes, it addresses a significant unmet need in ischemic heart failure, with the potential to improve the lives of thousands patients with this devastating condition,” said Drs. Jozef Bartunek, Associate Director, and Marc Vanderheyden, Associate Director, from the Cardiovascular Center Aalst, OLV Ziekenhuis, Belgium

The Parachute device has been used in approximately 90 cases to date. Clinical results showing safety and meaningful and sustained low clinical events for patients with ischemic heart failure three years following treatment with the Parachute Ventricular Partitioning Device were presented at the 2012 European Society of Cardiology Conference in Munich in August. New data from patients treated with the Parachute device will be presented this week at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference taking place October 22 – 26 in Miami, Fla.

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-701
barry@cardiokinetix.com


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Chosen as One of FierceMedicalDevices’ “Fierce 15” Medical Device and Diagnostic Companies of 2012 October 2, 2012

Award Presented at AdvaMed 2012: The MedTech Conference

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that the company has been named to the FierceMedicalDevices “Fierce 15” list, designating it as one of the leading medical device and diagnostic companies of 2012.

FierceMedicalDevices editors chose this year’s winners based on their top management teams, notable financial backing, promising technologies and market opportunities. The awards were announced at an event that took place today during AdvaMed 2012: The MedTech Conference in Boston, Mass. CardioKinetix was chosen as one of the Fierce 15 based, in part, on its creativity and innovations in the industry.

“We’ll be paying detailed attention to CardioKinetix, particularly its pivotal study involving nearly 500 patients who will be testing its Parachute device to treat ischemic heart failure. The umbrella-like creation is inventive, delivered through a catheter and inserted into the femoral artery so it partitions off the heart’s damaged portion, restoring its function and shape in the process,” said FierceMedicalDevices Editor Mark Hollmer.

“We are very pleased to be included in the inaugural Fierce15 list of leading medical device and diagnostic companies,” said Maria Sainz, president and CEO of CardioKinetix. “Following our recent presentation of three-year data at the European Society of Cardiology conference, physicians globally have expressed enthusiasm about our innovative device, which has the potential to improve the lives of thousands patients with heart failure.”

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time.
Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About FierceMedicalDevices

An internationally recognized e-newsletter reaching more than 34,000 medical device and diagnostic industry professionals, FierceMedicalDevices provides subscribers with a quick authoritative briefing on the day’s top stories, with a special focus on clinical studies, FDA/EMEA regulations, and post-marketing. A complete list of “Fierce 15″ companies is available online at www.fiercemedicaldevices.com.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Announces Positive Three-Year Clinical Data for First-of-Its-Kind Minimally July 27, 2012

Results Presented at European Society of Cardiology Demonstrate Meaningful and Sustained Improvement in Clinical Outcomes for Heart Failure Patients

Munich, Germany and Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure three years following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device.

Findings were presented today in Munich during the State of the Art – Novel Concepts in Heart Failure Treatments session at the 2012 European Society of Cardiology Conference by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, and professor of medicine, Case Western Reserve University in Cleveland, Ohio.

Data from thirty-one patients treated in the U.S and Europe with the Parachute system demonstrate that the New York Heart Association (NYHA) class improvement observed at one and two years was maintained at three years post treatment (average NYHA class of 2.6 at baseline vs. 1.8 at three years, p<0.0001). The rate of hospitalization due to worsening heart failure was 29.7 percent at two years and 33.2 percent at three years, and the low rate of cardiac death of 6.5 percent at two years remained unchanged at three years, suggesting that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients. These outcomes compare favorably with current medical therapy in a similar high-risk patient population.

“These results are compelling. The sustained improvements in functional capacity and plateauing effect seen in outcomes three years after treatment with the Parachute device are particularly encouraging, showing that we may be able to slow the progression of heart failure – a very exciting prospect,” said William T. Abraham, M.D., director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center.

“We were already very excited about the two-year clinical data presented at the EuroPCR conference earlier this year. The unprecedented three-year results observed in this high-risk population treated with Parachute reinforces our initial enthusiasm and fuels our motivation to start the pivotal large randomized trial later this year,” said Dr. Costa. “In the two first-in-man studies, the Parachute device demonstrated its safety and sustained improvements in symptoms, heart function, and clinical outcomes over three years, pointing to a potential historical turning point in the treatment for post-MI heart failure patients.”

“This innovative device could address a significant unmet need in ischemic heart failure, with the potential to improve the lives of thousands patients with this debilitating condition,” said Maria Sainz, president and CEO of CardioKinetix. “We are focused on completing our real-world European post-market surveillance trial and initiating our U.S. pivotal trial to pursue our plans to bring this therapy to patients suffering from heart failure globally.”

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functioning, damaged heart muscle from the healthy, functional segment to decrease the overall volume of the left ventricle chamber and restore its optimal geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:

Barry Templin

650-364-7016

barry@cardiokinetix.com


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Initiates European Post-Market Trial of First-of-Its-Kind Minimally Invasive Treatment for Heart Failure in Germany June 8, 2012

PARACHUTE III Clinical Trial Will Evaluate Benefits of Therapy in Real-World Setting

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has begun enrollment in PARACHUTE III, a post-market safety surveillance trial, in Germany with the CE Marked Parachute™ Ventricular Partitioning Device.

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

The first implants with CE Marked Parachute devices were done in Heidelberg, Germany by Stefan Hardt, M.D., Department of Cardiology, Heidelberg University Clinic as part of the PARACHUTE III trial, which is designed to evaluate the long-term safety of the Parachute implant in a real-world setting in up to 100 patients with ischemic heart failure at up to 20 centers in Europe. Professor Hardt reported that all patients were treated successfully and discharged without procedure-related complications. A successful case was also performed by Heyder Omran, M.D., Ph.D., Department of Cardiology and internal Medicine, St. Marien-Hospital Abt. Innere Medizin in Bonn, Germany.

“The Parachute implant system represents an important advancement in treatment options for patients with ischemic heart failure,” said Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England, and the principle investigator for the PARACHUTE III study. “These first procedures in the PARACHUTE III trial represent the beginning of the largest clinical data evaluation for this new therapy to date. I am optimistic that the patients treated with the Parachute implant will experience positive results similar to those in prior trials of the device most recently reported during the 2012 EuroPCR meeting.”

CardioKinetix plans to continue expanding its post-marketing trial effort in Europe by adding hospitals in the UK, Spain, Italy, Belgium, Germany, and the Netherlands in coming months. The PARACHUTE III clinical trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About the PARACHUTE III Trial

PARACHUTE III is a dual-arm (Parachute vs. optimal medical therapy), open-label, multi-center trial designed to evaluate the Parachute implant in a real-world setting. The trial will enroll up to 100 patients with ischemic heart failure at up to 20 centers in Europe. The primary endpoint of the trial is procedural- and device-related Major Adverse Cardiac Events (MACE) through 60 months. Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Announces Positive Two-Year Clinical Data for First-of-Its-Kind Minimally Invasive Treatment for Heart Failure May 18, 2012

Results Presented at EuroPCR Demonstrate Meaningful and Sustained Improvement in Clinical Outcomes, Suggesting Breakthrough Treatment for Heart Failure Patients

Paris and Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced two-year clinical results for the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device, a Percutaneous Ventricular Restoration (PVR) therapy for patients with ischemic heart failure. Results were presented today during a Trials, Registries and Late Breaking Science Hot Line session at the 2012 EuroPCR Conference in Paris by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio.

Clinical data from the two first-in-human studies of the Parachute system presented today show meaningful and sustained low clinical events for patients with ischemic heart failure two years following treatment with the device.

Results from 31 treated U.S and European patients demonstrate a near-full New York Heart Association (NYHA) class improvement at two years compared to baseline (2.6 vs. 1.9, p<0.01). In addition, reduction in left ventricular volume was maintained out to two years (p<0.001). Furthermore, the procedure stabilized the remodeling process as demonstrated by no statistical change in post-procedure functional volume over a two-year period (p=0.74). The combined rate of all-cause death and hospitalization due to worsening heart failure was 16.1 percent at one year and 32.3 percent at two years. The rate of cardiac death was 6.5 percent at two years. These outcomes compare favorably with current medical therapy in a similar high-risk patient population.

“Heart failure is such a morbid condition and, in spite of our best efforts, we have so little to offer to our patients. Today we shared unprecedented news for cardiologists and heart failure patients. It is difficult to contain our enthusiasm because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population,” said Dr. Costa. “The sustained and concordant improvements in symptoms, heart function, and clinical outcomes are compelling, with a very acceptable safety profile. If these results are confirmed in the upcoming large randomized trial, the Parachute implant will revolutionize the treatment of patients with ischemic dilated cardiomyopathy, reducing debilitating symptoms and allowing patients with heart failure to live with dignity again.”

“We are extremely pleased with the two-year clinical results from the Parachute implant. This data supports the design of our randomized pivotal trial, in which we anticipate a potential reduction of death and hospitalization due to worsening heart failure on the order of 30 to 50 percent for patients treated with the Parachute system compared to optimal medical therapy,” said William T. Abraham, M.D., director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center. “This innovative device has the potential to bring together two cardiology disciplines – heart failure and interventional cardiology – to address a significant unmet need in heart failure.”

“The presentation of this long-term clinical data is an exciting milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We look forward to gathering additional evidence of the clinical benefits of the Parachute from our European trials as we prepare to start our pivotal trial of the device, which we believe holds the potential to improve the lives of tens of thousands of patients around the world.”

After a heart attack, many patients experience enlargement of the left ventricle of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose heart has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning Device

The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.

CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

 

# # #

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

 


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

Maria Sainz Joins CardioKinetix as President and Chief Executive Officer May 7, 2012

Brings Proven Record of Success in Commercializing Innovative Therapies

Menlo Park, Calif. – CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that Maria Sainz has joined the company as president and chief executive officer. A veteran medical device executive, Maria brings more than 20 years of international experience to the role. Most recently Maria served as general manager of Stryker Neurovascular, which acquired Concentric Medical, Inc. in October 2011 under her leadership as president and CEO.

“We are delighted to welcome Maria to CardioKinetix,” said Casey Tansey, general partner at U.S. Venture Partners and the chairman of the company’s Board of Directors. “She is an exceptional leader with a proven record of success in bringing innovative new therapies to market internationally. I am confident that this strong commercial experience, as well as her commitment to improving quality of life for patients with cardiovascular disease, will serve CardioKinetix well as it moves toward its next stage of growth.”

“CardioKinetix is at an exciting time as we prepare for commercialization of the first-of-its-kind Parachute™ Ventricular Partitioning Device in Europe and begin the randomized pivotal trial of the therapy in the United States,” said Maria. “I feel fortunate to be part of bringing this innovative technology to heart failure patients around the world. There is a significant unmet need for new treatments for these patients, who suffer from debilitating symptoms and are in need of additional options for improving their quality of life.”

Prior to joining Concentric Medical, Ms. Sainz held several senior roles at Guidant Corporation including president of the Cardiac Surgery business; vice president, Global Marketing for Vascular Intervention; and vice president, Intermedics Cardiac Rhythm Management in Europe. Ms. Sainz received an M.A. in Languages from the University Complutense in Madrid, Spain and a Masters in International Management from the American Graduate School of International Management.

Maria will be based at the company’s headquarters in Menlo Park, Calif.

About the Parachute™ Ventricular Partitioning Device
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Delivered through a catheter inserted in the femoral artery, the small parachute-shaped implant partitions off the damaged portion of the heart, decreasing overall volume and restoring the geometry and function of the heart’s left ventricle. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Wins Edison Award for the Parachute Ventricular Partitioning Device April 27, 2012

Awards Honor Innovation, Creativity and Ingenuity

Menlo Park, CA – CardioKinetix Inc., a pioneer in catheter-based treatments for heart failure, today announced that the first-of-its-kind Parachute™ Ventricular Partitioning Device has received an Edison Award in the Surgical Aid (Medical Device) category, one of the fifteen categories honored annually by the Edison Awards. The distinguished award symbolizes the persistence and excellence personified by Thomas Alva Edison, inspiring America’s drive to remain in the forefront on innovation, creativity and ingenuity in the global economy.

“It’s an honor to be recognized with such a prestigious award recognizing our innovative approach to treating heart failure patients,” said Serjan D. Nikolic, Parachute inventor, co-founder, and chief technology officer of CardioKinetix. “It has been very fulfilling to see the Parachute technology move from initial concept more than 10 years ago to availability today as a new treatment option to patients with heart failure.”

The ballot of nominees for the Edison Awards was judged by more than 3,000 senior business executives and academics from across the nation whose votes acknowledge the winner’s success in meeting the award criteria of Concept, Value, Delivery and Impact. The members of the Edison Awards Steering Committee are senior executives with diverse marketing, scientific, and business backgrounds who monitor the development and successful launch of innovative products each year.

“More than any year, this year’s winners demonstrate the enormous value of teamwork, experimentation, consumer focus and market awareness,” said Tom Stat, chairman of the Edison Awards’ Steering Committee. “It’s exciting to see companies like CardioKinetix continuing Thomas Edison’s legacy of challenging conventional thinking.”

The 2012 Edison Awards are sponsored by Nielson, Discovery Communications, Science Channel, USA Today, CSRware, and applepeak. For more information about the Edison Awards and a list of past winners, visit www.edison awards.com.

About Heart Failure
Approximately 23 million people in the world suffer mild to severe heart failure and 2.4 million new cases of heart failure are diagnosed each year. In the United States, heart failure is responsible for 11 million physician visits annually, and more hospitalizations than all forms of cancer combined.[i] Heart failure is one of the most resource-intensive conditions with direct and indirect costs in the United States estimated at $39.2 billion in 2010.[ii] Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. An estimated 20 to 30 percent of heart failure patients could benefit from percutaneous ventricular restoration therapy with the Parachute.

About the Parachute™ Ventricular Partitioning Device
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Delivered through a catheter inserted in the femoral artery, the small parachute-shaped implant partitions off the damaged portion of the heart, decreasing overall volume and restoring the geometry and function of the heart’s left ventricle. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is a pioneer in catheter-based treatments for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

 


[i] Emoryhealthcare.org

[ii] Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart Disease and Stroke Statistics—2010 Update. A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.* Circulation. 2010;121:e1-e170.

 

CardioKinetix Announces Late Breaking EuroPCR Session Featuring First-of-Its-Kind Minimally Invasive Treatment for Heart Failure April 7, 2012

Two-Year Data on Breakthrough Treatment to be Presented on Friday, May 18

Menlo Park, Calif. — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that clinical trial data from the first-of-its-kind Parachute™ Ventricular Partitioning Device for the treatment of patients with ischemic heart failure will be presented at the 2012 EuroPCR Conference in Paris.

Two-year results from two first-in-human studies of the Parachute system will be presented during a Trials, Registries and Late Breaking Science Hot Line session by Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio.

The session, titled “Percutaneous ventricular restoration therapy in patients with ischemic dilated heart failure: 2-year clinical and echocardiographic outcomes of the first-in-human study of the parachute left ventricle partitioning device” will take place on Friday, May 18 at 9:13 a.m. CET in Room 251.

At 2:10 p.m. CET on Wednesday, May 16, Hüseyin Ince, M.D., Ph.D., professor of Medicine at the University Hospital Rostock in Rostock, Germany, will provide an overview of the Parachute device and Rostock experience during a session titled “Emerging Interventional Technologies for Heart Failure Management” in Room 351.

In addition, two Parachute patient cases will be presented at EuroPCR on Thursday, May 17 in Room 242A:

  • At 9:00 a.m. CET, Guida Silva, M.D., from the Centro Hospitalar de Vila Nova de Gaia in Porto, Portugal will present “Percutaneous ventricular partitioning: a specific solution for a specific problem.”
  • At 9:14 a.m. CET, Dr. Ince will present “Volume reduction therapy for heart failure with a new transcatheter device.”

After a heart attack, many patients experience enlargement of the left ventricle of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose heart has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.[i]

About the Parachute™ Ventricular Partitioning DeviceThe first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation.

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute™ Ventricular Partitioning Device for heart failure. Privately held, the company is backed by SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. For more information please visit www.cardiokinetix.com.

# # #

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

 


[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.

CardioKinetix Demonstrates Positive Results in German Sub-Study using the Parachute™ for Percutaneous Ventricular Restoration Therapy in the Treatment of Ischemic Heart Failure March 8, 2012

Menlo Park, CA — CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the ParachuteTM Ventricular Partitioning Device (ParachuteTM), announced today that a German sub-study from the PARACHUTE Cohort B trial continued to show positive results after heart failure patients were treated with the ParachuteTM. The results were presented today by Dr. Hüseyin Ince, Prof. of Medicine, University Hospital Rostock, Germany, during the 27th annual Interventional Cardiology conference in Snowmass Village, CO.

When implanted in the left ventricle, the ParachuteTM implant partitions damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. The sub-study presented data on eight of the 80 patients to be enrolled in Cohort B of the ongoing PARACHUTE trial. The average patient studied was 62 years of age, had an NYHA class of 2.8, and an ejection fraction (EF) of 28% at baseline.

At three months meaningful improvements were shown in the following critical measurements:

–One full New York Heart Association (NYHA) class improvement (2.8 at baseline vs. 1.6 at 3 months, p < 0.05)
–18% ejection fraction (EF) improvement (28% at baseline vs. 33% at 3 months, p < 0.05)
–62% 6 Minute Walk improvement (305 meters vs. 495 meters, p < 0.05)
–14% reduction in Left Ventricular End-Diastolic Volume (LVEDV) and Left Ventricular End-Systolic Volume (LVESV) reduction (LVEDV: 220 ml at baseline vs. 190 ml at 3 months, p < 0.05; LVESV: 154 ml vs. 132 ml, p < 0.05)
–17% reduction in ProBNP, a diagnostic marker evaluating the severity of heart failure (850 pg/ml at baseline vs. 702 pg/ml at 3 months, p < 0.05)

“After the implant of the ParachuteTM, my heart failure patients showed significant improvement in their symptom scores and quality of life,” said Dr. Hüseyin Ince, “Early studies suggest that by reducing volume and restoring a more normal geometry and function to the left ventricle we can arrest the progression of heart failure, reduce mortality and improve quality of life.”

“We continue to be encouraged by the early clinical results demonstrated by the ParachuteTM implant. In all of our previous studies we have seen similar improvements in treated heart failure patients,” said Thomas Engels, Vice President of Clinical Affairs of CardioKinetix, Inc., “We look forward to collecting additional data on the ParachuteTM as we begin our early commercialization efforts in Europe and start our pivotal trial in the United States.”

About the ParachuteTM Ventricular Partitioning Device
The ParachuteTM is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The ParachuteTM implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The ParachuteTM implant is comprised of a fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial
PARACHUTE is a dual-arm (ParachuteTM vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the ParachuteTM implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.
CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the ParachuteTM Ventricular Partitioning Device (ParachuteTM). The ParachuteTM intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix contact:
Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Receives Expanded CE Mark Approval for World’s First Percutaneous Left Ventricular Partitioning Device, the Parachute™, for Treatment of Ischemic Heart Failure January 30, 2012

Menlo Park, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™), announced today that it has received CE Mark approval for two additional sizes of the Parachute™ implant.

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. In clinical studies to date, the Parachute™ implant has shown to stop the progression of heart failure, reduce mortality, and improve quality of life.

“We are pleased to have received additional CE Mark approvals for the Parachute™ implant, and are enthusiastic about introducing the Parachute™ to treat heart failure patients in the European Union,” said Wes Johnson, President and CEO of CardioKinetix Inc. “These approvals will support our early commercialization efforts in select European markets through our PARACHUTE III clinical trial”.

CE Mark approval for the Parachute™ in Europe was supported by data from both the PARACHUTE clinical trial and PARACHUTE US feasibility trial. To support the development of post market clinical data, the Company is initiating the PARACHUTE III clinical trial. This trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.

About the Parachute™ Ventricular Partitioning Device

The Parachute™ is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The Parachute™ implant is comprised of a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial

PARACHUTE is a dual-arm (Parachute™ vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute™ implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About the PARACHUTE III Trial

PARACHUTE III is a dual-arm (Parachute™ vs. Optical Medical Therapy), open-label, multi-center registry, using CE Marked product, designed to evaluate the Parachute™ implant. The trial will enroll up to 100 patients with ischemic heart failure in up to 20 centers in Europe. The primary endpoint of the trial is procedural and device related Major Adverse Cardiac Events (MACE) through 60 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™). The Parachute™ intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

First Patients in Portugal, Latvia, Slovenia, and the United Kingdom Treated with CardioKinetix’s Parachute Ventricular Partitioning Device January 5, 2012

Menlo Park, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™), announced today that the first patients in Portugal, Latvia, Slovenia and the United Kingdom have been treated with the Parachute™ implant as part of the PARACHUTE clinical trial. Up to 80 patients are currently being enrolled in the second cohort of the PARACHUTE trial in 14 centers across Europe and the Company expects that enrollment will be completed in 2012.

After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle. In clinical studies to date, the Parachute™ has been shown to stop the progression of heart failure, reduce mortality, and improve quality of life.

“The expansion of the PARACHUTE trial into these four new markets, in addition to the Parachute™ implants already completed in Germany and Serbia, will broaden physicians’ exposure to the Parachute™ implant in the European Union,” said Wes Johnson, President and CEO of CardioKinetix Inc. “Enrollments in other key European countries are expected in the coming months. We are pleased with the interest shown in the trial to date and encouraged by the current pace of enrollment”.

About the Parachute™ Ventricular Partitioning Device

The Parachute™ is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The Parachute™ implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

The Parachute™ implant is comprised of a fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.

About the PARACHUTE Trial

PARACHUTE is a dual-arm (Parachute vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute™ implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™). The Parachute™ intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.

CardioKinetix contact:

Barry Templin
650-364-7016
barry@cardiokinetix.com

CardioKinetix Inc. Raises $44 Million in Series E Financing September 20, 2011

MENLO PARK, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the PARACHUTE™ Ventricular Partitioning Device (PARACHUTE™), announced today that it has raised $44 million in a two-tranche Series E financing. The financing was led by new investors SV Life Sciences and New Leaf Venture Partners, who joined existing investors, including U.S. Venture Partners, J.P. Morgan Partners, H&Q Healthcare Investors (NYSE: HQH) and H&Q Life Sciences Investors (NYSE: HQL).

Parachute™, which recently received the CE Mark, is implanted into the left ventricle of the heart in a simple catheter lab procedure and is intended to treat patients with heart failure resulting from a myocardial infarction or heart attack. The Company is currently conducting clinical studies in Europe and the FDA has approved an IDE Pivotal Trial for Parachute™ based on the results from a feasibility study. The Company hopes to continue to demonstrate safety in its clinical studies as well as improve symptoms and function and reduce hospitalization for the millions of patients suffering from heart failure.

In conjunction with the financing, Paul LaViolette, Partner at SV Life Sciences, and Jeani Delagardelle, Managing Director at New Leaf Venture Partners will join CardioKinetix’s Board of Directors.

“This financing provides CardioKinetix the capital necessary to substantially progress the development of our PARACHUTE™ device, including conducting clinical studies to further support the initial commercialization of Parachute™ in Europe and a PMA submission to FDA,” said Wes Johnson, President and CEO of CardioKinetix Inc. “Further, the addition of Paul and Jeani to our Board will supplement the extensive operational and financial expertise available to our management team.”

“We are excited about teaming up with CardioKinetix to help advance an innovative and promising cardiology-friendly treatment for ischemic heart failure patients with limited options,” said Paul LaViolette of SV Life Sciences.

About CardioKinetix Inc.

CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the PARACHUTE™ Ventricular Partitioning Device (PARACHUTE™). The PARACHUTE™ intends to treat heart failure resulting from a heart attack or myocardial infarction in patients worldwide by improving overall cardiac function.

View All Press Releases