Asana Medical’s Treatment of IBD Progresses with Execution of Research Agreement with University of Pittsburgh

MIAMI LAKES, FL – September 9, 2015 — Asana Medical, Inc., (“Asana,” the “Company”), an emerging life science company focused on the development and commercialization of its innovative engineered tissue therapy to treat Inflammatory Bowel Disease (“IBD”), has executed a Corporate Research Agreement (“CRA”) with the University of Pittsburgh to develop products based on intellectual property recently licensed from the University. Under the CRA, Asana sponsors research at the University focusing on process and product development for the use of Asana’s Extracellular Matrix-derived hydrogels (“ECMH”) to treat IBD.

Asana Medical will initially target product development for the treatment of Ulcerative Colitis (“UC”), one of the two major forms of IBD.  Asana will then pursue use of this technology to treat Crohn’s Disease, the other major form of IBD.  Worldwide, more than 5 million people are afflicted with UC or Crohn’s Disease.

The Company is working with Stephen F. Badylak, DVM, Ph.D., MD, Deputy Director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh, recognized as a world-class center for its work in Extracellular Matrix (“ECM”) for tissue engineering and regenerative medicine.

“We will be evaluating ECM hydrogel for the treatment of Ulcerative Colitis.  This technology has the potential to provide a novel therapeutic approach that, if effective, could markedly enhance the quality of life for affected patients,” stated Dr. Badylak.

Asana’s lead product ECMH, a hydrogel composed of porcine ECM, will be delivered to the colon, initially in animal models, using existing technologies to build a protective barrier and create a scaffold for natural tissue recovery to occur. Extracellular matrix products have demonstrated efficacy in multiple clinical applications including esophageal repair, hernia repair, pericardial closures, and burn and wound treatments. ECM has been successfully commercialized for over a decade and has demonstrated an excellent safety profile. ECMH offers the promise of a non-pharmacologic, non-surgical treatment for UC.

“Execution of this Corporate Research Agreement is a critical achievement for Asana. The testing Dr. Badylak’s lab will conduct will define our core product, providing the foundation for our regulatory submission in pursuit of our first-in-human clinical trial, planned for next year. Our stakeholders recognize the importance of this research and development agreement with the University of Pittsburgh in realizing Asana’s mission to bring a disruptive technology to IBD patients,” stated Marc Ramer, CEO of Asana Medical, Inc.

Ulcerative Colitis is a disease characterized by recurring episodes of inflammation of the colon lining (mucosa). Typical UC symptoms include pain, chronic diarrhea, bleeding, and urgency to use the restroom. More severe symptoms include malnutrition, stunted growth (in pediatric cases), and a greater risk of colon cancer. There is no known cure for UC. Options to manage the symptoms of UC include 5-ASA (aspirin-like drugs, for mild cases) and systemic corticosteroids and biologics (for moderate to severe cases). While 5-ASA is fairly benign, biologics (immunosuppressing drugs) can lead to severe side effects. Regardless of the treatment option, 20-30% of UC patients are unresponsive to any drugs and have no alternative except to undergo colectomy (removal of the colon), a major surgery that leads to challenging, lifelong lifestyle changes.

Asana will market ECMH to UC patients unresponsive to 5-ASA drugs and be positioned to capture substantial market share from a pharmaceutical/biopharmaceutical-dominated marketplace currently valued at $4 billion and estimated to exceed $6.7 billion per year by 2022.