Endonovo Therapeutics Retains Holland & Knight to File for Orphan Drug Designation

LOS ANGELES, CA--(Marketwired - Feb 11, 2016) - Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"), an innovative biotechnology company developing bioelectronics-based products and therapies for regenerative medicine, announced it has retained Holland & Knight to prepare and file the paperwork necessary to obtain an orphan drug designation for Endonovo's proprietary Cytotronics™ product.

Endonovo is requesting the United States Food and Drug Administration (FDA) grant an orphan drug designation to its next-generation, off-the-shelf treatment for Graft-Versus-Host Disease (GVHD) using Cytotronics™ expanded and ex vivo enhanced stem cells from the human umbilical cord.

Orphan drug designation is granted by the FDA to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The designation provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials. The orphan drug designation also would entitle Endonovo to a seven-year period of marketing exclusivity in the United States for the Company's orphan indication should Endonovo receive FDA approval for the treatment of GVHD. Therapies with orphan drug status are also not subject to a prescription drug user fee for the orphan indication.

Upon the FDA granting Endonovo an orphan drug designation for the treatment of GVHD, the Company intends to demonstrate the safety and effectiveness of our Cytotronics™ product through adequate and well-controlled studies satisfying the FDA's requirements for Premarket Approval.

Alan Collier, President and CEO, commented, this is the first of many steps for Endonovo receiving FDA approval to market its Cytotronics™ product for the treatment of GVHD. Upon Premarket Approval we will expediently engage new studies to further illustrate our technology's capability in treating a wide-array of other conditions with our biologically potent, off-the-shelf, allogeneic treatment where currently human leukocyte antigen (HLA) markers prevent a recipient from obtaining a matching transplant (graft).