January 21, 2021

The Niche

Trusted stem cell blog & resources


4 min read

Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has to wonder if the FDA letter to Osiris was more like a trick or a treat. My take is that it sure doesn’t seem like a Snickers bar. The …Read More

1 min read

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. Editor’s notes: Pete submitted this to me on Sunday, well before today’s big Osiris news. He must be psychic and very smart! By Pete Shuster I own a company that provides stem and primary cell based assays for basic research and drug discovery, and I also …Read More

1 min read

Stem cell & cellular medicine biotech, Osiris, reported a major success today with its cell-based treatment of Diabetic foot ulcers. The data are about as good as it gets. The company’s Grafix product for the ulcers was three times more effective than the control. A cross-over phase where those given the control were switched to Grafix showed similarly dramatic results. Wounds that won’t heal are a huge health problem in medicine so Osiris’ impressive results have huge implications. I see this also more broadly as …Read More