The freeze-dried plasma technique was 1st developed by Vascular Solutions, which was acquired for $1 billion by Teleflex in February.
The 24-patient study is designed to assess safety and tolerability of RePlas freeze-dried plasma. Healthy volunteers will receive increased doses of their own blood plasma that has been processed using the company’s proprietary lyophilization (freeze drying) and packaging techniques.
“We are pleased to be underway with the clinical study of this novel freeze-dried plasma product, which could have valuable applications in the treatment of military trauma as well as trauma care in a wide variety of other settings,” principal investigator Dr. Jose Cancelas said in prepared remarks.
The USAMMDA said that developing a commercially available source of freeze-dried plasma is a top priority, since early administration of plasma is an important step to limiting trauma mortality from uncontrolled bleeding.
In April 2014, Vascular Solutions inked a cooperative R&D program with Vascular Solutions. According to the deal, the USAMMDA provides will support the company’s regulatory and clinical work for RePlas and Vascular Solutions owns all intellectual property and commercial rights.
“We are honored to be working with the U.S. Army on this critical, life-saving product, and it is exciting for us to be entering the clinical development phase of this project 3 years after beginning the collaboration,” Steve Penegor, VP of biological development at Vascular Solutions, said. “The lyophilization of biologic materials is one of our core technical competencies, as we have demonstrated with several successful clinical and commercial endeavors, beginning more than a decade ago with our D-Stat Dry Hemostatic Bandage. Since entering into the development agreement with the U.S. Army in April of 2014, we have made significant strides, including the development of our commercial-scale production equipment in our new, dedicated biologics manufacturing facility.”