BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that David D’Alessandro, MD, Surgical Director of Clinical Transplantation at Montefiore Einstein Center for Transplantation and Montefiore Medical Center faculty, has joined the Company as Medical Director. Dr. D’Alessandro will support the clinical development of the Paragonix Sherpa Perfusion™ Cardiac Transport System (CTS)1,2. The Sherpa Perfusion™ CTS is intended to be used for either hypothermic static preservation or oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Sherpa Perfusion Cardiac Transport System is up to 4 hours.
Dr. D’Alessandro will also support clinical plans for the Paragonix Sherpa Pak™ Transporter Systems1,3,4,5. The Sherpa Pak™ Transport Systems are indicated for the static hypothermic preservation of organs during transportation and eventual transplantation into a recipient.
William Edelman, Chairman & CEO, for Paragonix commented, “We are delighted to have Dr. D’Alessandro join the Paragonix team. His clinical experience as a cardiothoracic and transplant surgeon at premier institutions combined with his research interests will greatly contribute to pre-clinical and clinical programs at Paragonix."
Dr. D’Alessandro, commented, “Given the tremendous shortage of donor organs, I believe new technologies are needed to improve transplant organ quality and utilization of available, donated organs. The Paragonix Sherpa System is an innovative technology and I look forward to seeing it in the clinic. The Sherpa devices are an important advance in the field of organ preservation. Their simplicity and ease-of-use will allow rapid integration into clinical practice.”
Dr. D’Alessandro’s clinical focus has been on surgical treatments of end stage heart failure including mechanical assistance and heart transplantation. He has a broad experience with all aspects of adult cardiothoracic surgery including on and off pump coronary artery bypass surgery, valve repair and replacement, and the treatment thoracic aneurysms. Additionally, he has extensive experience with the latest generation of mechanical assist devices and is a co-investigator in their ongoing clinical trials. His preclinical research focuses on stem cell therapies for myocardial regeneration and his clinical research focuses on developing methods for improving clinical outcomes in cardiac surgery. Dr. D’Alessandro received his undergraduate degree from Cornell University. He received his medical education at the Columbia University College of Physicians and Surgeons where he was elected to the Alpha Omega Alpha Medical Honor Society. Dr. D’Alessandro completed his residency in General Surgery, a fellowship in Renal Transplantation and a clinical and research fellowship in Cardiothoracic Surgery at the Columbia Presbyterian Medical Center in New York. Before joining the Montefiore Medical Center faculty, Dr. D’Alessandro was on the faculty of the Columbia-Presbyterian Medical Center in New York where he served as a clinical instructor and an active participant in the heart transplantation and mechanical assist device programs, one of the largest such programs in the nation. In addition to numerous publications and scientific presentations, Dr. D'Alessandro was awarded a U.S. patent for a novel cardiac stabilizer with a potential application to beating heart surgery.
Previous Announcements
Paragonix previously announced on July 14, 2014, Filing of a 510(k) Pre-market Notification with the US Food and Drug Administration for the Paragonix Sherpa Perfusion™ Cardiac Transport System
Paragonix previously announced on May 28, 2014, clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System
Paragonix previously announced on February 24, 2014, clearance of a second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System
Paragonix previously announced on January 27, 2014, a presentation discussing the Sherpa Perfusion™ Cardiac Transport System during the 2014 Cutting Edge of Transplantation Meeting
Paragonix previously announced on December 18, 2013, closing of a $1.1M Convertible Debt Financing
Paragonix previously announced on December 17, 2013, filing of a third 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System
Paragonix previously announced on November 18, 2013, the filing of a second 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System
Paragonix previously announced on July 22, 2013, Publication by the ASAIO (American Society for Artificial Internal Organs) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure of Donor Organ Viability"
Paragonix previously announced on June 10, 2013, Presentation of "An Innovative, Novel Hypothermic Storage System For Donor Hearts," discussing the Sherpa Pak™ Cardiac Transport System during the 16th Congress of the European Society for Organ Transplantation held in Vienna, Austria, 8th – 11th September 2013
Paragonix previously announced on February 12, 2013, clearance of a 510(k) pre-marketing notification application with the US Food and Drug Administration for the Paragonix Sherpa™ Pak Cardiac Transport System
Paragonix previously announced on July 16, 2012, award of a Phase I Small Business Innovation Research (SBIR) Grant to support the pre-clinical development of the Paragonix Sherpa™ Cardiac Transport in collaboration with the Transplant Center at Massachusetts General Hospital (Boston).
Paragonix previously announced on June 25, 2012, Appointment of Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC as Chief Medical Officer.
Paragonix previously announced on June 18, 2012, Formation of a Clinical Advisory Board for the Paragonix Sherpa™ Cardiac Transport System.
About the Paragonix Sherpa™ Portfolio of Organ Transport Technologies
Currently, the availability of organs for transplantation is governed by the “ischemic time,” which is the elapsed time from organ donation to recipient implantation. The Paragonix Sherpa™ is designed for use in conjunction with any of currently available organ preservation solutions. Paragonix Sherpa™ is fully disposable, eliminating problems associated with maintenance, device transport and contamination. Paragonix Sherpa™ is intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for implantation. The Sherpa Pak™ CTS is intended for transport of hearts and the Sherpa Pak™ Kidney Transport System is intended for transport of kidneys within the time frame currently considered as routine medical practice. The Sherpa Perfusion™ CTS is intended to be used for hypothermic oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
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 Braintree, Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix Sherpa™, a novel, single-use organ preservation device. Paragonix has exclusively licensed University of Texas Health Science Center San Antonio intellectual property from the Office of Technology Transfer and Commercialization. Paragonix has established a pipeline of donor organ transport devices that addresses the current donor organ shortage by maximizing donor organ utilization and improving donor organ quality throughout the entire United States.
1 Patents issued and pending.
2 Not approved for sale.
3 On February 6, 2013, Paragonix received FDA clearance of a 510(k) Pre-Market Notification for the Paragonix Sherpa Pak™ Cardiac Transport System
4 On February 24, 2014, Paragonix received FDA clearance of a second 510(k) Pre-Market Notification for the Paragonix Sherpa™ Cardiac Transport System
5 On May 28, 2014, Paragonix received FDA clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System
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
