Asana Medical Inc.’s Preclinical Study Indicates Promising Solution to Treat Ulcerative Colitis

MIAMI LAKES, FL – October 4th, 2016 – Asana Medical, Inc., (“Asana,” the “Company”), a regenerative medicine company focused on development and commercialization of its innovative ExtraCellular Matrix Hydrogel (“ECMH”) technology for the treatment of Inflammatory Bowel Disease (“IBD”), today announced significant positive results from preclinical research conducted in collaboration with the research team of Dr. Stephen Badylak D.V.M., Ph.D., M.D. at the University of Pittsburgh’s McGowan Institute for Regenerative Medicine.

Results of the study were recently published online in the Journal of Crohn’s and Colitis.¹

Asana has a field-limited exclusive license to certain patent rights for this technology from the University of Pittsburgh.

The preclinical design leveraged earlier proof-of-concept studies. The results confirm that ECMH inhibits inflammation and promotes the rapid regeneration of healthy tissue in a rodent model of Ulcerative Colitis (“UC”). Specifically, the use of ECMH established:

• Proof of mucosal regeneration and reduction in inflammation and ulceration;
• Reduction in stool blood and weight loss;
• Restoration of the cell barrier function; and
• Reduction in inflammatory biomarkers

Dr. Badylak, stated; “The study results suggest an alternative to traditional therapies for Inflammatory Bowel Disease. The study shows the ability of ECMH to rapidly transform the inflammatory flares of UC into a healing state in this rodent model. These findings are consistent with the known mechanisms by which ECM provides constructive signals in other body tissues.”

Dr. Badylak led the preclinical study team at McGowan which was sponsored by Asana at the University of Pittsburgh.

“Results from this study suggest a new method of potential treatment for Ulcerative Colitis.” stated Steven Wexner MD, PhD (Hon), Director of the Digestive Disease Center and Chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida and current member of Asana’s Medical Advisory Board and a paid consultant. “Traditional therapy attempts to ameliorate clinical symptoms by reducing inflammation. This approach with ECMH seems to be to try to provide a local scaffold to allow healing”.

“The results from this robust, blinded preclinical study are very exciting. Asana will use the data generated in this study in support of an application to pursue regulatory approval to initiate a First-in-Man clinical trial, expected to start in 2017. Asana will now turn its focus on completion of the preclinical studies, manufacturing, and preparation of the regulatory filings,” stated Dr. Christine V. Sapan, Asana’s CEO.