410 Medical Gains Military Funding to Develop Rapid Blood Infuser

Durham-based 410 Medical has received up to nearly $2 million in U.S. military funding to develop two new versions of LifeFlow, its medical device for treating life-threatening low blood pressure, shock and sepsis in critically ill patients.

The company received an Air Force AFWERX Phase II SBIR Award of up to $750,000 to develop LifeFlow Ultra, a rapid blood and fluids infuser for use when space, weight and power supply are important factors.

Like the currently marketed LifeFlow PLUS, LifeFlow Ultra will enable healthcare providers to transfuse blood and fluids quickly in soldiers with hemorrhagic shock. 

Ultra will be manually operated, fast and simple to use, but will be significantly lighter and more compact, in order to fit easily in the pack of frontline medical personnel. 

Uncontrolled hemorrhage is the leading cause of preventable battlefield death, with most casualties resulting from severe blood loss prior to arrival at a medical treatment facility.

Initiating blood product resuscitation within minutes of injury dramatically improves survival, and every minute delay in starting blood transfusion increases mortality by 5%, according to 410 Medical.

“We are excited to expand our U.S. military collaboration to fill an identified capability gap by developing an ultra-simple, ultra-compact rapid infuser that easily fits into a medic’s pack and facilitates effective resuscitation closer to the point of injury,” said Galen Robertson, the company’s chief operating officer.

Army contract awarded

Earlier this summer 410 Medical also was awarded a U.S. Army Medical Research and Development Command contract of up to $1.2 million to develop the next-generation LifeFlow, the LifeFlow Advanced Resuscitation System (ARS). LifeFlow ARS will use the same compact, easy-to-use features of LifeFlow PLUS but will be ruggedized for use in austere environments and include advanced features, including automation, designed to improve combat casualty care.

“Significant progress has been made on techniques for achieving better hemostasis (the halt of bleeding) in the field, but none of the current products have focused on rapid, precise and portable methods of blood transfusion,” Robertson said. “We are excited to collaborate with the military to develop a next-generation infuser specifically designed for transfusion in austere environments.”

Final funding amounts for both awards will be tied to technical progress.

LifeFlow in use nationwide

LifeFlow, developed by physician Mark Piehl at WakeMed Health & Hospitals in Raleigh, is 410 Medical’s first product. It received clearance for human use in 2016 from the U.S. Food and Drug Administration.

Since the device’s approval, LifeFlow has been deployed to hospitals and emergency medical services agencies across the United States.

The hand-operated device is used frequently to treat patients with septic shock, trauma and other emergency conditions related to dangerously low blood pressure that can quickly lead to organ failure or death if not treated quickly.

LifeFlow is faster, easier and more efficient than traditional methods of fluid delivery including gravity infusion, IV infusion pumps, pressure bags and manual syringes, 410 says on its website. The device can be readied for use in less than two minutes, can be operated by one hand and can deliver precise amounts of fluid with each squeeze of a trigger.

Early funding from NC Biotech

410 Medical was founded by Piehl and venture capitalist Luke Roush in 2013 to develop innovative products to help emergency clinicians provide better care for critically ill patients. Piehl, who is 410’s chief medical officer, is a pediatric intensivist at WakeMed, where he was medical director of WakeMed Children’s Hospital from 2009 to 2015.

In 2016 the company was awarded a $250,000 Small Business Research Loan by the North Carolina Biotechnology Center. The loan program supports business inception and research critical to developing products, processes or tools with clear commercial potential.

410 Medical raised $3.1 million in financing in 2018 to commercialize LifeFlow. North Carolina investors in the funding round included WakeMed Health & Hospitals and the North Carolina Venture Capital Multiplier Fund, managed by Durham-based Hatteras Venture Partners.

The company lists 18 employees on its website.

410 Medical takes its name from the calculation of a fluid-delivery goal in treating pediatric septic shock.