Editor’s notes: Pete submitted this to me on Sunday, well before today’s big Osiris news. He must be psychic and very smart!
This is the first in a series of guest posts on what folks believe are the best compliant stem cell companies out there. You can submit a potential guest post on this topic to me until August 30.
By Pete Shuster
I own a company that provides stem and primary cell based assays for basic research and drug discovery, and I also lead a “Stem Cell Clinical Trials” group on Linkedin. It is in my best interest to closely follow companies involved in stem cell therapies and regenerative medicine. For the companies I follow, it is clear, given the capital requirements and regulatory oversight, the odds for showing any financial success is <1:10. The odds are even higher against sustained success and long term shareholder returns.
As the best, I have chosen Osiris Therapeutics. They have successfully tilted odds for success in their favor. They are experiencing explosive growth with their existing products Grafix and Ovation (5.3 million up 231% in Q2 2013). These are regulated by the FDA under 21CFR Part 1271, Human Cells, Tissues and Cellular and Tissue-based Products (“HCT/Ps”):
- Grafix is a three-dimensional tissue matrix designed for application directly to acute and chronic wounds, including but not limited to diabetic foot ulcers and burns.
- Ovation is a novel cellular repair matrix designed for use in surgical applications.
They also have a partnership with Genzyme for the development and commercialization of the stem cell based therapies Prochymal and Chondrogen. They are well positioned to gain FDA approval for a variety of indications with large markets:
The reasons for nominating Osiri? 1) They have made solid business decisions to minimize cash burn in developing therapies. 2) They have a market capitalization that accurately reflects company prospects and 3) They have real distribution and direct sales channels that are yielding revenue and will be primed and ready to market these new products as they are released.
Disclosure: The author owns <100 shares of Osiris