Three Companies Set To Benefit From The 21st Century Cures Act: Who And Why

Caladrius Biosciences Inc (NASDAQ:CLBS)

Finally, Caladrius Biosciences Inc (NASDAQ:CLBS). We’ve done devices, and we’ve done opioid abuse, now let’s move on to another major area of medicines development that Cures aims to bolster: regenerative medicine. Specifically, stem cell treatments. The stem cell space has had a pretty tough time to date, with ethical and political roadblocks often standing in the way of its advance – especially in the US. The promise of the technology that underpins it is undeniable, however, and even against the industry headwinds, a number of companies in the US have pushed forward in the space.

One of these is Caladrius Biosciences Inc (NASDAQ:CLBS). The company operates a cell therapy manufacturing facility through a subsidiary called PCT. Basically, PCT prepares stem cell therapies for other entities, which the latter use to conduct trials during an asset’s early stages of development. It’s a type of CMO, specifically working with stem cells in the development asset space. As such, the more research and development activity that exists in the stem cell space, the more trials will be undertaken, and the more companies will need stem cell CMO’s like PCT to prepare their development batches for them.

The Cures Act has brought into play a system whereby stem cell therapies won’t need to be put to the test in large, phase III studies (the studies that they needed to undergo previously) before getting approval. Instead, a company can apply for approval based on early stage safety tests, and then monitor efficacy post approval as part of a follow-up study. It’s one of the most controversial elements of Cures – there will no doubt be some therapies that get approved based on safety data and later turn out not to work – but for companies like Caladrius Biosciences Inc (NASDAQ:CLBS), this doesn’t really matter; at least not from its PCT CMO perspective, defraying the risks that Cures entails for other stem cell companies proper.

Note: This article is written by David Rich and originally published at Market Exclusive.