Entegrion’s Blood Tech Runs Deep Through NC Veins

Entegrion blood specialists test a sample of Stasix, the company's freeze-dried battlefield replacement for blood platelets that can have a three-year shelf life. -- Entegrion photo

It’s almost a form of reverse alchemy.

Entegrion doesn’t turn lead into gold, but the Research Triangle Park company found a way to make cash flow stop blood flow. And now it’s even developing better life-saving blood components.

Entegrion is an unusual joint spinout from East Carolina University and the University of North Carolina at Chapel Hill. The company was co-founded in 2002 by Arthur Bode, Ph.D., a now-retired ECU professor; and by Thomas Fischer, Ph.D., who was the scientific director of the Francis Owen Blood Research Laboratory in the Department of Pathology and Laboratory Medicine at UNC.

Neither is still involved with the company, but their legacy is a North Carolina success story.

The North Carolina Biotechnology Center awarded the fledgling firm a $150,000 Small Business Research Loan in 2003, to help it develop what would become a commercially and medically significant product bloodline.

Nearly $284,000 in three NCBiotech Collaborative Funding Grants subsequently went to scientists working on Entegrion technologies at UNC and ECU in 2005, 2006 and 2009.

NCBiotech funding leads to $88 million in defense contracts

The upshot: some $88 million in contracts from various units in the U.S. Department of Defense (DOD) to help Entegrion keep building technologies that can save lives on battlefields by stopping blood loss and/or replacing lost blood components.

The most recent DOD infusion came in October 2014: $7.8 million to help support Entegrion’s work on Stasix, a freeze-dried battlefield replacement for blood platelets that can have a three-year shelf life. Normally these blood particles can’t be used more than a week after they’re drawn from a donor.

As a result of the Stasix contract, Entegrion hired two more employees, bringing the total to nine, with plans to hire one more soon. The company also hires numerous independent contractors to help with various projects.

“The financial assistance provided by NCBiotech early in the development of Stasix was instrumental to securing proof-of-concept data for that technology,” said Entegrion Executive Vice President Richard Martin. “This type of financial support is critical during the start-up period of a life science company, when attracting equity capital is extremely difficult.” 

Executive Chairman Jack Mowell agrees. “Support for the early stage development of promising technologies emerging from research at our universities is important to ensure that these discoveries ultimately become products,” said Mowell. “The example of public/private partnership in North Carolina should serve as a model for successful innovation and economic growth.”

Platelets are needed to stop bleeding

Platelets, small fragments of cells responsible for clotting, are among the four main components of blood. The others include oxygen-carrying red cells, infection-fighting white cells and the plasma that serves as the “river” for liquid transport in the blood stream and carries proteins that help balance coagulation, or clotting.

Platelets gather at the site of an injury and form a scaffold called fibrin that ideally turns into a clot, covering and protecting the wound and preventing more blood from leaking out. Fibrin also forms the initial scaffolding upon which new tissue forms, thus promoting healing.

Entegrion’s first commercial product, Stasilon wound dressing, wasn’t quite as complicated. But it was a unique blend of bamboo and glass fibers in a woven fabric, and won marketing clearance by the U.S. Food and Drug Administration in 2008 for its exceptional ability to help stop bleeding.

Jobs for Beeken BioMedical in Raleigh

Entegrion licensed Stasilon to Beeken BioMedical in 2011. Beeken had just moved its headquarters to Raleigh to be closer to business partners.

Beeken founder, president and CEO Richard Kendall says the company has re-developed the original Stasilon concept, which is now in its fifth generation. Beeken’s cellulosic and silica fiber wound dressing is now knit rather than woven, by Highland Industries. Highland has a mill in Kernersville, though NuStat is currently made at one of its South Carolina plants.  Beeken sells its evolved bandage product as NuStat, primarily targeting the hospital surgical market as an effective, non-stick way to stop bleeding without complicated coatings used by competitors.

Kendall says Beeken, funded entirely from angel investment, has five employees at its Raleigh headquarters, but plans to expand and hire more people in 2015 to sell NuStat to emergency responders, retailers for applications such as home first aid kits and, he hopes, to the military.

“NuStat offers a clear advantage,” says Kendall, “especially in wet environments often encountered by first responders, battlefield medics and even hunters, hikers and other outdoors enthusiasts.”

And UNC continues to receive fees from Entegrion, based on royalties received by Entegrion from Beeken.

Entegrion also licensed its plasma product to Kedrion

In 2013 Entegrion entered a partnership with an Italian company named Kedrion to develop and commercialize Resusix, Entegrion’s spray-dried human plasma that also has far better shelf life and portability than traditional plasma.

Under the deal, Kedrion Melville, a New York-based subsidiary of Kedrion, gained exclusive worldwide rights to commercialize Resusix. Entegrion is collaborating with Kedrion on clinical development of the product, which is pooled from approximately 600 U.S. donors and then treated by Kedrion Melville to remove potential pathogens or impurities. 

“The result is a plasma product with a known profile of proteins as compared to single-donor frozen plasma that may be deficient in one or more proteins, depending on the donor,” says Richard Martin, executive vice president of Entegrion. “It is also safer and more like a drug than a blood bank product.”

Clinical trials are expected to start this year, funded mostly through Entegrion’s DOD contracts. As part of the collaboration, however, Kedrion has also made an undisclosed equity investment in Entegrion.

It all started with early NCBiotech support for technology being spun jointly out of two NC universities. That technology continues to evolve and grow, contributing jobs to North Carolina’s life science economy.

And it continues to build upon NC’s broad military base, using cutting-edge science to battle bloodshed.

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