Velico® Medical Announces a Further $18.9m BARDA Funding for Spray Dried Alternative to Frozen Plasma

BARDA has extended its Spray Dried Plasma development contract with Velico® Medical through November 2019 providing for an additional $18.9 million. This non-dilutive funding is expected to support the company’s development program through FDA approval to commence Phase I clinical trials.  Spray dried plasma is being developed as an alternative to frozen plasma and is expected to play a life-saving role wherever time to plasma transfusion is critical including pre hospital emergency response, military applications and in mass casualty events.

Beverly, Massachusetts – September 26, 2017 – Velico® Medical, today announced a further $18.9m of funding from the Biomedical Advanced Research and Development Authority (BARDA, US Department of Health and Human Services) for their patented, dried plasma technology. BARDA has exercised its third option under a contract with Velico® which extends through November 2019 and provides for up to approximately $18.9 million of additional funding raising the total value of its commitment to Velico® to $46.5 million.  This phase of the contract supports commercial development of a system, targeted for deployment in blood collection and processing centers in the United States and around the world, which enables spray drying of human plasma for transfusion. Currently the industry norm is to freeze plasma which can take up to 40 minutes or more to defrost and deliver.  Spray dried plasma is expected to be an easy to prepare, easy to use alternative to frozen plasma for all civilian (OR, ER, ICU) and military applications. This includes extending availability outside of the hospital to emergency first responders and for use in mass casualty events

“Despite advances in transfusion medicine and trauma resuscitation, massive blood loss remains a major cause of mortality, both in developed and developing countries. Velico’s® breakthrough technology is poised to improve the survival rate of patients suffering from blood loss, extending the ‘golden hour’ of successful intervention to the pre-hospital setting” says Dr. Mark Popovsky, Velico’s® Chief Medical Officer.

“A dry plasma product is our greatest need right now, from field military operations to supporting emergency care in rural America to advancing the life-saving tool kit of Level I trauma centers. Plasma has been shown to have numerous beneficial effects in bleeding patients including stopping bleeding and supporting organ function but it is not currently widely available in the amounts that are needed and this problem is magnified in disaster situations.

Plasma delivered early to a patient makes all the difference. Most hospitals only have three to six units of thawed plasma available. If more is required, then it takes a further 30 minutes or more to thaw – keeping surgeons waiting and putting lives at risk. Velico’s® technology enables plasma on-demand, anywhere. Between 5% and 10% more lives could be saved through early introduction of plasma. Dried plasma has the potential to revolutionize transfusion therapy” said Martin A. Schreiber, M.D., Chief of Trauma, Critical Care and Acute Care Surgery at Oregon Health & Science University.

“We believe that BARDA’s approval of the next phase of the contract reflects recognition of Velico’s® progress and the life-saving potential of this important technology. Our partnership with BARDA has been collaborative, constructive and has resulted in jointly developed solutions to a number of development challenges. We believe this collaboration has and will continue to deliver significant value for both parties as we finalize development and advance toward clinical trials,” stated Bill Skillman, Velico® CEO.

Once commercialized, FrontlineODP™(On Demand Plasma) will be produced by regional blood centers using Velico’s® spray drying system. Blood centers have been producing blood products for decades and will play an integral role in meeting the need for a frozen plasma alternative. Blood centers have the infrastructure, experience, and expertise to provide a sustainable source of dried plasma for local use and for linking to national disaster management channels to support disaster recovery in mass casualty events.

BARDA funding of SpDP is non-dilutive to Velico® Medical shareholders. This work is being performed under contract HHS0100201200005C funded by the Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

About Velico® Medical

Velico® Medical, Inc. is a private, pre-clinical medical technology company focused on applying proprietary technologies to improving the quality, availability and economics of plasma and platelet transfusions. We are developing two separate product candidates that, if approved, are expected to improve patient outcomes and safety and result in a more effective blood delivery system. Our technologies are expected to solve critical unmet needs in transfusing these life-saving blood products and represent opportunities for significant savings for the healthcare delivery system. The technologies underlying our product candidates are the subject of issued and pending patent applications in countries of commercial consequence to us. Our strategy is to develop, commercialize and market single-use disposables for use in processing and storing plasma and platelets, as well as a companion instrument for spray drying plasma.