For its 9th birthday, the biotech Entegrion is giving itself a present: a product on the market.
The Research Triangle Park, N.C.-based company struck a licensing deal with a Boston-based medical device company to manufacture and market Entegrion’s Stasilon bandage: a proprietary weave of glass and bamboo fibers that promotes clotting. CTO Joseph DaCorta wouldn’t name the company Beantown partner, but DaCorta did say that the business expects to make an announcement this week.
The milestone for Entegrion comes in the midst of transition. Former CEO Stan Eskridge left, though DaCorta says he remains “a friend to the company.” A search for a new CEO continues.
The Stasilon bandage itself received FDA 510(k) clearance in 2007. Entegrion had been trying to commercialize the product on its own. But those efforts were stymied by the financial markets.
Now, though, Entegrion has raised $1.5 million in financing through debt and other options, according to an SEC filing, money that DaCorta said will keep the company going as it evolves from a company focused on research to one with commercialized products.
“To properly launch a product of that kind, it’s a multimillion dollar effort,” DaCorta said. “It was extremely difficult to raise money in ’09 for anything.”
Blood-clotting bandages are an attractive but increasingly competitive field. Stasilon will compete against a product from Oregon company HemCon Medical Technologies, which has developed a bandage incorporating a compound from shellfish that promotes clotting. HemCon also took a partnership route to commercializing its technology in 2007, signing a four-year distribution agreement with Cardinal Health (NYSE:CAH).
Plus, new competitors are on the horizon. Minnesota’s St. Teresa Medical, for example, is raising money to develop its own blood-clotting bandage. Kalorama Information estimated that the global market for wound care products reached $14 billion in 2009. Wound care includes other products besides wound dressings. According to Kalorama, the top four wound care companies are Johnson & Johnson (NYSE:JNJ), Kinetic Concepts (NYSE:KCI), Hill-Rom (NYSE:HRC) and Smith & Nephew (NYSE:SNN).
Stasilon is the first in a series of new, innovative medical technology products for Entegrion. Resusix, dehydrated human plasma, could be the next in the pipeline. It would offer a shelf-stable alternative to fresh frozen plasma, which poses storage issues and is difficult to use in emergency situations because it must first be thawed. Entegrion expects to file an investigational new drug application with the FDA this summer for Resusix. As clinical work progresses, DaCorta said the company could seek a development partner or pursue other financing options in 2012 or 2013 (Talecris Biotherapeutics (NSDQ:TLCR) – literally down the street from Entegrion’s RTP offices – is a logical match to Entegrion).
Entegrion is also working on Stasix, a biological product derived from blood platelets developed to stop internal bleeding. The freeze-dried hemostatic agent could be quickly rehydrated and in its dry form, would offer a product with greater shelf-life than blood bank platelets stored in liquid form.
Other early-stage technologies would use the blood’s platelets as a drug delivery device. Platelets seek areas of injury and inflammation. Entegrion is developing a way to load drugs onto platelets for targeted drug delivery. An imaging agent could similarly be loaded onto platelets for the purpose of giving clinicians a better view of tumors or vascular conditions.
Entegrion was spun out of the University of North Carolina at Chapel Hill as Hemocellular Therapeutics in 2002 (though UNC shares shares ownership of Stasilon’s intellectual property with East Carolina University).
The company has operated without venture capital backing. Entegrion is financed by individual investors, many of them doctors, and has won more than $10 million in government contracts to develop products including a portable, handheld medical device to quickly assess clotting disorders. The company has avoided venture capital since 2006, when it rejected a $15 million investment from Oxford Bioscience Partners choosing instead to go forward on its own.
The pharmaceutical industry has thousands of drug companies developing new products by managing molecules. Entegrion is one of the specialized few whose work relies on the human body to manufacture the cell-based products that are the foundations for its new treatments.
“There are therapies there, we just have to work with nature,” DaCorta said.
Here’s a roundup of companies announcing new distribution deals and other joint ventures.
- Aspect Imaging launches global distribution
Aspect Imaging today announced five new distributors who will sell and support it’s M2 compact high-performance MRI imaging system across Asia in China, Japan, Taiwan and Korea and in Brazil. These new distributors will help Aspect meet increasing international demand by life science researchers for its M2 imaging system.
- Precision NanoSystems and Alnylam ink delivery pact
Precision NanoSystems Inc. and Alnylam Pharmaceuticals Inc. (NSDQ:ALNY), an RNAi therapeutics company, announced today that the two companies have formed an exclusive collaboration focused on the discovery and development of novel lipid nanoparticles, known as small lipid nanoparticles (sLNPs), using microfluidics technology. Based on their small particle size of approximately 20 nanometers, sLNPs have the potential for broadened biodistribution beyond liver delivery.
- MedicaMetrix enters deal to use Vytex latex for ProstaGlove
Vystar Corp. (OTC:VYST), the creator of Vytex Natural Rubber Latex (NRL), a multi-patented, raw material that contains significantly reduced levels of the antigenic proteins found in natural rubber latex, announces that urological medical device manufacturer MedicaMetrix Inc. signed a Letter of Intent to use Vytex NRL as the material of choice in its ProstaGlove, a diagnostic device currently in clinical trial development for the quantitative, physician office-based measurement of prostate cancer.
- RTI Biologics signs deal with Alphatec Spine for BioCleanse-sterilized spinal grafts
RTI Biologics Inc. (NSDQ:RTIX), a provider of orthopedic and other biologic implants, announced today that it signed an agreement to provide spinal allograft implants to Alphatec Spine Inc. Under the agreement, which is effective immediately and has a three year term with the option to renew, RTI will process allograft implants for use in spine made from assembled cortical allograft.
- GE Healthcare and Steris Corp. Extend Collaboration
GE Healthcare renewed its collaborative relationship with Steris Corp. to continue offering interventional suites optimized with products from both companies. Combining the companies’ leading-edge technologies provides physicians with a unified system for imaging and surgical procedures in integrated and hybrid operating rooms.