Paragonix Technologies Inc., Announces Award of a Phase I Small Business Innovation Research (SBIR) Grant to Support the Pre-Clinical Development of the Paragonix Sherpa™ Cardiac Transport System
<0> Paragonix Technologies Inc.Bill Edelman, 781-436-0509Chairman of the Board </0>
Paragonix Technologies Inc., today announced that the National Heart, Blood and Lung Institute has awarded a Phase I Small Business Innovation Research (SBIR) grant to the company to support the pre-clinical development of the Paragonix Sherpa™ Cardiac Transport System. The Phase I SBIR grant is for a six month time period from July to December 2012. Successful completion of the Phase I SBIR grant will enable a SBIR Phase II application for up to $1,000,000.
Lisa Maier, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are thrilled to have been awarded this Phase I SBIR Grant. The milestone for completing the Phase I SBIR addresses the key question of extended donor heart preservation up to 12 hours by the Paragonix Sherpa™ Cardiac Transport System” Dr. Maier continued, “Dr. Madsen has long-standing expertise and experience in heart transplantation and has participated in multiple clinical trials. Dr. Madsen has extensive experience with animal transplant models and, together with the Paragonix Clinical Advisory Board, will be involved in the design of all experimental protocols and interpretation of the results.”
Dr. Madsen commented, “There is a critical need to increase the availability of donor hearts for transplantation in a patient population that is desperate for this lifesaving therapy. I am excited to evaluate the Paragonix Sherpa™ Cardiac Transport System as we pursue the SBIR grant.”
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.
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”) guidelines for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours,, 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 Sherpais fully disposable, eliminating problems associated with maintenance, device transport and contamination.
Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure. With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year, 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. The annual economic burden of treating heart failure exceeds$34.4 billion, over 50% of which is due to the cost of hospitalization. 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 $30,000. 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 transplant. 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 transplantation, maximization of donor organ utilization has enormous potential in cardiac transplantation.
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.
Joren C. Madsen, MD, DPhil, is a Member of the Paragonix Clinical Advisory Board This product is not approved for sale. Patents issued and pending. ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010) J Heart Lung Transplant 2001; 20(2):212. J Am Coll Cardiol 2004; 43(9):1553-1561. 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.” Circulation 2010;121:e46-e215 Circulation 2011;123(8):933-944 Circulation 2007;115(5)