Treatment for
Congestive Heart Failure Symptoms

Company Overview

Company Background

The Company, based in Menlo Park, 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 or myocardial infarction in millions of patients worldwide by improving overall cardiac function.

The goal of the PARACHUTETM clinical trial is to establish the safety and feasibility of placing the PARACHUTETM into the heart, isolating the damaged muscle and improving the heart’s ability to pump. The Company has initial clinical data from a European feasibility trial exhibiting initial safety and effectiveness of using the PARACHUTETM Implant in a specific group of heart failure patients. A second trial approved under an IDE by the US Food and Drug Administration, is actively enrolling patients to support continuation onto a pivotal trial early next year. CardioKinetix has a seasoned industry experienced management team, a strong IP portfolio and a supportive investor group.

Unmet Patient Needs

Following a heart attack (myocardial infarction), an area of the heart tissue becomes permanently damaged. Enlargement of the heart can occur, over time impacting the efficiency of the heart to pump blood (reduces cardiac output). This reduction in cardiac output can lead to heart failure symptoms such as shortness of breath. There are 1.5 million ischemic heart failure patients with moderate to severe heart failure symptoms in the US alone, increasing by 120,000 patients annually. Options for these patients are limited to medical management therapy, a cardiac resynchronization technology (CRT) device for heart failure patients with a specific EKG pattern, and surgical options. Heart failure is a progressive, irreversible disease with many patients ultimately receiving a ventricular assist device and/or being placed on a transplant list. Studies report that Class III heart failure patients have a poor prognosis for recovery or improvement. There is a clear need for a safe, easy to deliver efficacious solution with low morbidity and mortality.

Treatment Options

For most heart failure patients, medical management is the prevailing treatment with more invasive procedures recommended as heart failure progresses. CRT devices represent a $3 billion+ market; however, they are not applicable in many ischemic heart failure patients. Further, symptoms of many heart failure patients treated with CRT continue to deteriorate as the root cause of the disease is not treated by CRT devices.

Management Team

Wes Johnson, President and CEO.

Mr. Johnson has been in various senior management roles in the medical device industry 25 years. He has been involved in two IPOs and other follow-on public offerings as well as the successful sale of two start-up companies. Prior to becoming President and CEO of CardioKinetix in February 2008, Mr. Johnson was General Manager of Abbott Spine, S.A., a division of Abbott Laboratories since September 2005. From June 2003 to September 2005, Mr. Johnson served as Division Vice President, Finance for Abbott Spine. From May 1999 to June 2003, he was Vice President of Operations and Chief Financial Officer for Spinal Concepts. From 1995 until May 1999, Mr. Johnson was Vice-President and CFO of Urologix, Inc, and from 1984 to 1995, Mr. Johnson held various senior management roles with Orthofix, Inc (formerly American Medical Electronics), including Chief Financial Officer. Mr. Johnson holds a B.B.A. in Accounting from Texas A&M University and became a certified public accountant in 1981.

Serjan D. Nikolic, Ph.D., CTO and Director.

Serjan Nikolic co-founded Cardiokinetix with late Brano Radovancevic, MD of Houston, TX and serves as a Director and Chief Technical Officer since its inception. He has more than 10 years experience in the medical device industry and 25 years in the academic medical research at Albert Einstein College of Medicine and Stanford University. Serjan’s previous industry positions include management positions at Neovasys, CardioSynopsys, Advance Closure Systems and Somnus (Acquired by Gyrus) He holds advanced degrees in Biophysics, Biomedical Engineering and Cardiovascular Physiology from Yeshiva University and Albert Einstein College of Medicine in New York City. He is a member of several professional societies including Fellow of American College of Cardiology. Dr. Nikolic is extensively published in cardiovascular field with more than 150 original research papers and publications. He is also a named inventor on numerous US patents.

Gerard Champsaur, MD, FACC – Chief Medical Officer.

A Professor of Thoracic and Cardiovascular Surgery at Claude Bernard University in Lyon, France, Dr. Champsaur led the cardiac surgery department of Louis Pradel Hospital, a 450-bed institution devoted exclusively to the treatment of cardio thoracic diseases. A frequent Investigator in Clinical trials, he was an early adopter of new technologies, and as a consultant for Abiomed, Inc., during a sabbatical year, supported the clinical and regulatory efforts leading to the approval (PMA) of the first US ventricular assist device in 1991.

Dr. Champsaur has worked in the Medical Device Industry for over 11 years in both startup companies and large Corporations. He founded Sysflow Medical, Inc., a start-up focused on improving patient outcomes in the Hemodialysis field, and 2 years later became an early member of Epicor Medical, Inc. In charge of the pre-clinical studies, regulatory clinical support, and multi-center prospective clinical trial, he was as Chief Medical Officer and VP, Clinical Affairs, a key member of the success leading to the acquisition by St Jude Medical. He joined the latter shortly after, as VP, Medical Affairs, for the Surgical and subsequently the newly created AF Division, where he led the clinical and regulatory efforts for the first Epicor surgical ablation randomized trial and was a key instrument in the US and International product launch. Attracted by new challenges in the startup environment, he joined the team of Cardiokinetix in July, 07, as Senior VP, clinical Affairs and Chief Medical Officer in charge of the US feasibility and ultimately pivotal trial.

A well-published author of publications pertaining to the surgical therapy of heart failure, congenital and valvular surgery, and research on organ perfusion and endothelial function, he is a Member of the American Association for Thoracic Surgery, the Society of Thoracic Surgeons, the European Association for Thoracic Surgery, the American Heart Association (clinical cardiology and cardiovascular surgery councils) and is a Fellow of the American College of Cardiology.

Bart Balkman, Vice President, Sales and Marketing.

Mr. Balkman joined CardioKinetix in October, 2008. He has 25 years experience in the medical device industry, launching many novel and innovative products into the Cardiology and Neurovascular markets. Mr. Balkman was most recently Vice President at Concentric Medical where he managed the product from clinical trials through product launch to become the first Ischemic Stroke device approved by FDA. His previous work history also includes marketing and sales management positions with Johnson & Johnson, Baxter Edwards, Medtronic, Heart Technology (Acquired by BSC), Microvena (Acquired by ev3), Accumetrics (Acquired by Radiometer). Mr. Balkman holds a B.S. in marketing from Oklahoma State University.

Jim Kermode, Vice President, Research & Development and Operations.

Mr. Kermode has 22 years of experience in medical technology spanning cardiology, orthopedics, gynecology and oncology.  Most recently, he was President of Hantel Technologies, a contract manufacturer specializing in medical product development.  Prior to Hantel, Mr. Kermode was Vice President of Engineering at Acueity, Director of Delivery Systems at MicroHeart (acquired by Boston Scientific) and Project Manager at Gynecare (acquired by Johnson & Johnson).  He holds a Biomedical and Mechanical Engineering dual degree from the University of Southern California and is a named inventor on 17 issued US patents and several pending patent applications.

Rich De Young, Controller.

Mr. De Young joined CardioKinetix in October 2008.  His career spans thirty years as a professional in finance and accounting roles, primarily within the medical device industry.  Most recently, prior to his current role with CardioKinetix, Mr. De Young served as the CFO and Corporate Secretary of BSML, inc.  Prior to that engagement, he served as Vice President of Finance for RITA Medical Systems, Inc.  Prior to his employment with RITA Medical, he was employed with Baxter Healthcare in a series of senior financial roles.  Mr. De Young holds a BA from Carleton College and an MBA from the University of Michigan.  He is also a Certified Public Accountant.

Scientific Advisors

Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

CardioKinetix Board of Directors

  • Casey Tansey – U.S. Venture Partners
  • Rod Ferguson, PhD, JD – JP Morgan (Panorama Capital)
  • Jonathon Osgood – Cutlass Capital
  • Frank Gentile, PhD – H&Q Capital Management LLC
  • Eric Fain, MD – St. Jude Medical
  • Serjan Nikolic, PhD – CardioKinetix Founder
  • Wes Johnson – CardioKinetix CE

 

Company News

Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.