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

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

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

“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

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

Ince Case publication

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

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

AHJ 1yr PARACHUTE Cohort A + US FIM

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

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

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

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

When implanted in the left ventricle, the Parachute^TM 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 Parachute^TM, 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 Parachute^TM 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 Parachute^TM as we begin our early commercialization efforts in Europe and start our pivotal trial in the United States.”

About the Parachute^TM Ventricular Partitioning Device
The Parachute^TM 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^TM 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^TM 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^TM vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute^TM 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^TM Ventricular Partitioning Device (Parachute^TM). The Parachute^TM 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

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

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

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.