January 25, 2021

The Niche

Trusted stem cell blog & resources

Kristin Comella resigns from embattled clinic firm US Stem Cell

Kristin ComellaUS Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1.

I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways.

To me Comella seemed like the driving force behind the company, which is now subject to an injunction after a big federal court loss. It is appealing the ruling, but faces a tough road ahead in my view.

From the new SEC filing:

“Effective September 1, 2019, Kristin Comella resigned as a member of the Board of Directors of the Company and has left her position as Chief Scientific Officer. There were no disagreements by Ms. Comella as to the Company’s operations, policies or practices.”

What’s going on? Why did she resign?

Who’s in charge now? (the current leadership page for USRM doesn’t list Comella any longer).

What will be the company’s focus now moving forward with new leadership and can it keep on going?

Lots of questions, few answers.

I would have predicted that Comella would be along all the way for the continuing battle through the appeal. I see this resignation as suggesting that something else major may be going on with the firm or Comella or both. Whatever that “something” is, it’s probably not good news for them.

It may be interesting now at a kind of end point for the Comella/US Stem relationship for readers to go back to my interview with Comella 4+ years ago when we got some of the first inklings of the direct-to-consumer push by her company, then in a sense still called Bioheart.

More broadly, 2019 continues to be arguably the worst year for unproven stem cell clinics ever. While there are still hundreds of them out there, their future does not look promising in my opinion. The FDA is keeping up its elevated level of actions on clinics. The clinics won’t be able to run Google ads anymore. There are many patient lawsuits. Clinic suppliers are also drawing more attention, criticism, and FDA action too. The FTC has taken action and may take more. State AGs and medical boards are paying more attention.

2020 may be even worse for the clinics and their suppliers. This is all good news for the overall stem cell field and for patients, but there may be more confusion and ups and downs before the dust settles somewhat.

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