A startup to stop hemorrhagic shock and treat cardiac and other critical illnesses has a new infusion of capital on its road to the first tests in humans.
Perfusion Medical this fall was awarded a $2.9 million grant from the Defense Health Agency. The Small Business Innovation Research (SBIR) funding will enable the company to complete pre-clinical studies and submit an Investigational New Drug (IND) application to the FDA for its drug candidate, called PM-208 (developed under the name PEG-20k). The solution was invented by a team led by Martin J. Mangino, Ph.D., a professor of surgery, physiology and biophysics in the Department of Surgery at the VCU School of Medicine.
“Getting the IND approval is a critical next step to studying how our drug works in human beings,” says Gerard Eldering, Perfusion’s chief executive. “Our aggressive goal is to be performing the first clinical trials on humans, and do these studies at VCU, in 12 months.”
Perfusion’s PM-208 can open the smallest blood vessels in the body, the capillaries, after a patient experiences shock from losing blood. When the drug is administered intravenously after substantial blood loss, it prevents the all-too-common “reflow problem” when cells swell with water and prevent blood transfusions from doing their job. PM-208 applications could include war zones, ICU units, cardiac care centers, and mass casualty scenarios. (Former Virginia Governor and U.S. Senator for Virginia Mark R. Warner visited Perfusion and Mangino’s lab earlier this year)
In addition to hemorrhagic shock, research suggests PM-208’s biological mechanism of action could help patients experiencing other clinical events including cardiac illness, critical illness, sepsis and vascular disease.
VCU is a subcontractor on the SBIR award, and is positioned to conduct studies and analysis of PM-208. Initial clinical studies would prove out the drug’s safety, while later studies would demonstrate the effectiveness of the drug on actual patients experiencing shock. The shock therapeutics market has estimated annual revenue of over $4 billion, Perfusion says. Several companies are developing therapeutics for cell ischemia, but those products target symptoms of cell ischemia, while PM-208 treats the root cause.
The Defense Health Agency is a joint, integrated combat support agency enabling the U.S. Army, Navy, Air Force, and Space Force medical services to provide a medically ready force and ready medical force to Combatant Commands in both peacetime and wartime.
Earlier this year, Perfusion received two grants from U.S. Air Force’s venture capital and innovation arm, AFWERX. VCU has also received more than $12 million from the U.S. Army over the past decade to develop PM-208, and Perfusion has raised more than $1 million in private funds to bring the drug to
“Our goal is to see this used worldwide, both in pre-hospital and in-hospital settings, and for a wide range of conditions,” Eldering says. “PM-208 has a truly impactful and broad market that will save lives, and we are working hard to get it into the hands of healthcare professionals who can make that happen."