Akan Biosciences Announces FDA Acceptance of IND Application for StroMeltm in Osteoarthritis of Knee

GERMANTOWN, Md., Feb. 16, 2021 /PRNewswire/ -- Akan Biosciences, LLC (Akan), a Maryland based, clinical stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for StroMeltm, its lead candidate for the treatment of Osteoarthritis of Knee. The active IND enables Akan to start clinical trials.

StroMeltm is a proprietary adipose-derived Stromal Vascular Fraction (SVF) product. StroMeltm will be frozen and stored allowing multiple administrations with each lot. Although the current IND is for autologous administration, Akan is planning to explore allogeneic applications as well.  

StroMeltm would be a relatively unobtrusive therapy (intra-articular injections) for an indication described by the Arthritis Foundation as "a chronic disease ... with no cure." According to ABC News, medical care for osteoarthritis patients in the United States costs $185.5 billion a year.        

The President of Akan, Dr. Mukesh Kumar, is a veteran of FDA regulated products having taken hundreds of products through FDA. Dr. Kumar commented that "StroMeltm is designed as an off-the-shelf SVF product direly needed by patients in the US. Our proprietary technology will eventually lead to a paradigm shift in the development and manufacturing of affordable cellular therapies." The clinical trial is scheduled to initiate in March 2021.

ABOUT THE COMPANY:  Akan Biosciences, LLC (Akan), a Maryland based, clinical stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics. Akan is focused on advancing next generation therapies for degenerative diseases and injury. Akan is part of the Maryland Tech Council and Biohealth Innovation, Inc..

CONTACT: Paul Burton, 219-243-5889, [email protected]

SOURCE Akan Biosciences