Healthcare Industry News:  circulatory support 

Devices Cardiology Personnel

 News Release - June 25, 2012

Paragonix Technologies Inc., Announces Appointment of Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC as Chief Medical Officer

Dr. Golding Will Guide Clinical Programs Associated With the Paragonix Sherpa™ Cardiac Transport System

CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--Paragonix Technologies Inc., today announced appointment of Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC, to the position of Chief Medical Officer. Dr. Golding will be responsible for all clinical development activities related to the Paragonix Sherpa™ Cardiac Transport System1,2. Dr. Golding will also immediately assume the position of Chairman for the Paragonix Clinical Advisory Board (CAB). The CAB will meet periodically to assess the development strategies for Paragonix Sherpa™ and advise the company on the state of the cardiac transplantation market.

Lisa Maier, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are thrilled to have Dr. Golding join the Paragonix team as Chief Medical Officer. With experience spanning both cardiac surgery as well as mechanical circulatory support development, Dr. Golding is uniquely suited to advance our development activities as the Paragonix Sherpa™ Cardiac Transport System is prepared for entering the market. We look forward to his contribution as a member of the Paragonix team.”

About Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC

Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC, is on Staff in the Department of Biomedical Engineering at Cleveland Clinic and has a secondary appointment in the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic's main campus. In 1963, Dr. Golding received his medical degree at Sydney University Medical School, Sydney, Australia. From 1972 to 1973, Dr. Golding was a resident at Presbyterian University Hospital, Pittsburgh, PA, where he became chief resident of cardiac surgery. In 1974, he became a fellow in the Department of Thoracic & Cardiac Surgery at Cleveland Clinic. He was the Acting Chairman in the Department of Artificial Organs at Cleveland Clinic from 1989 to 1991 and has been an Adjunct Professor of Surgery at the Cleveland Clinic Lerner College of Medicine since 2004. Dr. Golding initiated the Intraaortic Ballon Pump and the Ventricular Assist Programs at the Cleveland Clinic and was the originator of the CorAide Blood Pump Program. Dr. Golding is an international speaker and was honored as the 2006 Hastings Lecturer at the Annual Conference of the American Society for Artificial Internal Organs. He has authored over 210 peer-reviewed publications and has contributed chapters to medical textbooks in his field. Dr. Golding is a member of the American Association for Advancement of Science, American College of Cardiology, American Heart Association, American Institute for Medical & Biological Engineering, American Medical Association, American Society for Artificial Internal Organs, Royal Australian College of Surgeons, Royal College of Surgeons of Canada, Society of Thoracic Surgeons, and International Society for Rotary Pumps, among others. He has been on editorial boards and acted as reviewer for numerous medical journals, including Artificial Organs, the ASAIO Journal, and the Annals of Thoracic Surgery. Dr. Golding held positions on the ASAIO Project Bionics Committee as well as the AAMI Mechanical circulatory support Systems Committee. He is the project director for the NIH-funded development of a unique Total Artificial Heart blood pump. Dr. Golding holds over 13 patents for numerous cardiac devices.

“I am pleased to be a part of this dynamic young group working on this important area of clinical need. After spending the last decades seeking solutions to cardiac support for end-stage heart failure, I am convinced of the need for technologies that increase cardiac transplant availability. Paragonix's approach is very exciting and I look forward to supporting the development of this important technology.”

Paragonix previously announced on June 18, 2012, formation of a Clinical Advisory Board for the Paragonix Sherpa™ Cardiac Transport.

About the Paragonix Sherpa™ Cardiac Transport System

Currently, the availability of cardiac transplantation is governed by the “ischemic time”, that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation (“ISHLT”) guidelines3 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours4,5, limiting the distance available to transport a donor heart. The Paragonix Sherpa™ combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts. Paragonix Sherpa™ is designed to be used in conjunction with any of the currently available organ preservation solutions. Paragonix Sherpa™ is fully disposable, eliminating problems associated with maintenance, device transport and contamination.

About the Cardiac Transplantation Market

Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure.6 With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year7, there is a persistent need to provide end-stage heart failure support to this expanding population. Estimates of the prevalence of symptomatic HF in the general European population are similar to those in the United States.8 The annual economic burden of treating heart failure exceeds $34.4 billion9, over 50% of which is due to the cost of hospitalization.10 The financial demands associated with transplantation are considerable. The estimated first year costs for heart transplant are $997,700, and subsequent annual costs can easily exceed $30,00011. In the United States, around 30,000 people die annually from end-stage heart disease. As of June 1, 2012, 3,203 patients in the United States are on the waiting list for a heart transplant12. Based on 2011 data, just over 2,300 patients will receive a live-saving transplant each year, which is reflective of the enormous donor heart shortage. These data, however, only seem to represent the tip of the iceberg. Assuming that up to 50,000 people with end-stage heart failure are candidates for transplantation13, maximization of donor organ utilization has enormous potential in cardiac transplantation.

About Paragonix Technologies, Inc.,

Based in Cambridge, Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix Sherpa™ Cardiac Transport System, a novel, single-use organ preservation device to improve donor organ quality and extend donor organ preservation times. Paragonix Sherpa™ combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts. Paragonix has exclusively licensed intellectual property from the Board of Regents of The University of Texas. Paragonix has established a pipeline of donor organ transport devices that address the current donor organ shortage by maximizing donor organ utilization, improving donor organ quality and extending donor organ transport throughout the entire United States.

1 This product is not approved for sale.

2 Patents issued and pending.

3 ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)

4 J Heart Lung Transplant 2001; 20(2):212.

5 J Am Coll Cardiol 2004; 43(9):1553-1561.

6 Datamonitor senior cardiovascular analyst Dr. Sergey Ishin. “Cardiac transplantation continues to be the gold standard for the treatment of end-stage heart failure. However, the number of potential transplants far exceeds the number of donors.” http://about.datamonitor.com/media/archives/314

7 Circulation 2010;121:e46-e215

8 http://about.datamonitor.com/media/archives/314

9 Circulation 2011;123(8):933-944

10 Circulation 2007;115(5)

11 http://www.transplantliving.org

12 http://optn.transplant.hrsa.gov

13 http://www.uptodate.com/contents/heart-transplantation-beyond-the-basics


Source: Paragonix Technologies

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