Positive trial results for Osiris’ wound product

Osiris Therapeutics has reported that its wound care drug Grafix demonstrated overwhelming efficacy in a landmark stem cell study for the treatment of diabetic foot ulcers.

Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a flexible, conforming membrane that provides a high quality source of living MSCs and growth factors directly to the site of the wound.

The trial found that 62% patients receiving Grafix had complete wound closure compared to only 21% of patients who received conventional treatment for their wounds – a relative improvement of 191% and the largest ever reported from such a study.

"Today, Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine.

"Diabetic foot ulcers afflict 25% of all diabetics and are responsible for more hospitalizations than any other diabetic complication. With 25 million diabetics in the United States, the cost to our health care system is enormous. Through this rigorous study we have shown that Grafix can heal more patients, in less time, and with fewer complications."

C. Randal Mills, Ph.D., Chief Executive Officer of Osiris.

The positive results of this study pave the way for increased reimbursement from insurers that will boost sales of the therapy. According to Reuters, shares of Osiris jumped to their highest in over six years, doubling the value of the company to approximately $800 million.

"These data are very compelling as we have not had a new cellular therapy for diabetic foot ulcers in over 10 years. Compared to other similarly designed studies, this trial demonstrates, by far, the largest relative improvement in complete wound closure. This is great news for our patients with diabetic foot ulcers that are at such high risk of losing their legs."

Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center.