Paragonix Technologies Inc. And Essential Pharmaceuticals, Announce A Product Supply Agreement For Custodiol HTK Organ Preservation Solution For Use With The Sherpapak Cardiac Transport System And Sherpapak Kidney Transport System

BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. (Paragonix) and Essential Pharmaceuticals, LLC (Essential) today announced a Product Supply Agreement, wherein Essential agreed to supply Custodiol® HTK Organ Preservation Solution for use with the SherpaPak™ Cardiac Transport System and the SherpaPak™ Kidney Transport System. Sherpa Pak™ ^1,2 combines innovative cooling technology with a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for implantation.

“Innovative ColdStorage Of Donor Organs Using The Paragonix SherpaPak™ Devices”

Bill Edelman, CEO and Chairman, for Paragonix commented, “Following our recent launch of the portfolio SherpaPak™ at the 2016 American Transplant Congress, we are pleased to announce the Supply Agreement with Essential Pharmaceuticals. The ability to kit SherpaPak™ with Custodiol® HTK³ enables streamlined hospital acquisition logistics when stocking organ preservation technologies. We are looking forward to broadly introducing the SherpaPak™ Organ Transport Systems to the clinical community following strong market support we experienced during 2016 American Transplant Congress. Recent market feedback studies suggest continuing demand for this important technology. The Paragonix Sherpa Pak™ devices for kidney and heart preservation are an important step in improving donor organ transportation. We believe that improving the utilization of donated organs is critical to patients in end-stage organ failure who are desperate for this precious commodity.”

Allan Weber, CEO, for Essential commented, “Essential is proud to supply Custodiol® HTK for use with the SherpaPak™. SherpaPak™ promises to bring a level of control and consistency much needed in the organ transplant market. Improved donor organ management is necessary to increase the supply of donor organs, which SherpaPak™ and Custodiol® provide.”

Previous Announcements
Paragonix previously announced on June 6, 2016, Presentation of the SherpaPak™ Cardiac Transport System during the 2016 American Transplant Congress June 11 - 15, 2016 in Boston, MA.

Paragonix previously announced on July 23, 2015, Publication of “Innovative ColdStorage Of Donor Organs Using The Paragonix SherpaPak™ Devices”⁴

Paragonix previously announced on February 9, 2015, Innovative Tracking Technology For Real-Time, National Location Tracking of Donor Organs

Paragonix previously announced on December 2, 2014, clearance of two 510(k) Premarket Notifications by the US Food and Drug Administration, allowing the Paragonix Sherpa Pak Transport Systems to be combined and distributed with any FDA-cleared, commercially-available preservation solution.

Paragonix previously announced on Nov 17, 2014, Receipt of ISO 13485:2003 Certification for the Paragonix Sherpa Organ Storage and Transport Systems

Paragonix previously announced on Nov 3, 2014, filing of two 510(k) FDA Pre-Market Notifications to combine the Paragonix Sherpa Pak Cardiac and Kidney Transport Systems with any effective organ preservation solution currently marketed under 510(k) Pre-market Clearance

Paragonix previously announced on Oct 27, 2014, joining of David D’Alessandro, MD, as Medical Director for Paragonix

About Essential Pharmaceuticals, LCC
Established in 2006, Essential Pharmaceuticals, LCC, is based in Ewing, NJ. In addition to Custodiol® HTK organ preservation solution, Essential Pharmaceuticals provides medical researchers and manufacturers new tools to bring performance, convenience, and control to enhance the advancement of basic research and drug discovery. From the cell to the entire organ, Essential Pharmaceuticals look to advance medical treatments and the research that creates new medical treatments.

About Paragonix Technologies, Inc.
Based in Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix SherpaPak™ and SherpaPerfusion™ Transport Systems, which are novel, single-use organ preservation devices to improve donor organ quality and extend donor organ preservation times. Paragonix SherpaPerfusion^™ 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 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 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 The SherpaPak™ Organ Transport Systems are protected by patents, both issued and pending
² The SherpaPak™ Organ Transport Systems have received FDA 510(k) pre-market clearances
³ Custodial® HTK has received FDA clearances for both kidney and heart preservation
⁴ Heart, Lung and Vessels; 2015;7(3):246-55