Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the second quarter ended June 30, 2012.
Highlights and Recent Developments
- Achieved an historic, first approval from Health Canada to market its stem cell drug, Prochymal ( remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children.
- Obtained a second approval for Prochymal in New Zealand, through its medical regulatory agency, Medsafe.
- Attained a transitional pass-through status from the Center for Medicare & Medicaid Services (CMS), with C-Codes being designated for Grafix®. Also, CMS also issued a preliminary positive decision for the assignment of permanent Healthcare Common Procedure Coding System (HCPCS) Q-codes.
- In the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients, reported interim one-year results showing that treatment with Prochymal resulted in a statistically significant reduction in heart failure in patients experiencing first-time acute myocardial infarction.
- Selected by the Biomedical Advanced Research and Development Authority (BARDA) to submit a full proposal for a Broad Agency Announcement (BAA) to fund advanced research and development of countermeasures, specifically for the use of Grafix in mass casualty thermal burn injuries.
- Reported $1.6 million of revenue from the distribution of our Biosurgery products during the second quarter – a 43% increase over the previous quarter.
- Reported cash, receivables and short-term investments of $40.1 million as of June 30, 2012.
“This past quarter was not only memorable, but monumental, for Osiris,” stated C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. “We have set a new benchmark to measure our success, and remain as committed as ever to extending the reach of this remarkable technology. Whether through our Biosurgery or Therapeutics units, we will continue to develop innovative cell therapy solutions for patients in need.”