An Open Letter of Warning to Humacyte CEO, Dr. Laura Niklason — Re: The Potential Danger of Humacyte’s New FDA Approved Vascular Graft to Injured U.S. Military Warfighters and Other Trauma Patients.

Yale University anesthesiologist and CEO of Humacyte, Dr. Laura Niklason, is credited with convincing CBER regulators at FDA to approve Humacytes New vascular device for clinical use on injured US military warfighters and trauma patients, despite serious safety and inferiority concerns relative to the existing standard of care.

Dr. Niklason,

I trust that by now you have read the press coverage regarding concerns about the safety of Humacyte’s new nonstandard vascular grafts as an alternative to standard synthetic grafts for treatment of catastrophic traumatic injuries:

https://www.nytimes.com/2025/03/24/health/fda-artificial-blood-vessel-trauma-humacyte.html

My colleagues and I have had the opportunity to review the clinical trial design and data that your company used to convince FDA’s CBER to move ahead with approving the Humacyte device for use in patients in the trauma setting. Additionally, we’ve had an opportunity to learn about the internal dissent expressed about this approval from several senior FDA scientists, including Dr. Robert Lee.

Dr. Robert Lee, a senior scientist and vascular surgeon at FDA’s CDRH, dissented against the agency’s approval of the Humacyte vascular graft.

It is a very serious safety concern that your company is now marketing a non-standard biologic vascular graft, that may be inferior to the existing, standard, and abundantly available synthetic grafts — based on a questionable clinical trial design and potential inferior outcomes that are inadequately vetted.

It is, therefore, my respectful suggestion that as Humacyte’s CEO, you place an immediate moratorium on the marketing and distribution of this product in the US — and request that FDA convene an unbiased third-party expert committee of vascular surgeons and epidemiologists to transparently evaluate the safety of your product and stringently assess whether your clinical trials were properly conducted. Until and unless Humacyte is able to convincingly prove, to a well-balanced committee of expert vascular surgeons, bioethicists and epidemiologists, that your device is as safe or safer than synthetic vascular grafts, no trauma patients in the US or abroad should be exposed to the possibility of catastrophic harm by this non-standard medical device.

Dr. Niklason, last but not least, it is my understanding that your company’s product is being marketed and has potentially been contracted to be sold to the US Department of Defense, for use on US warfighters in the setting of traumatic battlefield injuries. There is no greater sin in the United States than to expose any patient, but especially members of the United States military fallen to traumatic injuries, to non-standard medical devices, whose clinical outcomes have any chance of being inferior to the existing standards of care.

Dr. Niklason, Humacyte’s CEO, would be well advised to remember the story of Elizabeth Holmes and Theranos — because deploying an inferior and potentially dangerous vascular graft in injured American warfighters and trauma patients would be a far greater sin against US public health than Holmes’ lie about a laboratory diagnostic machine.

Again, it is my respectful suggestion that you hit the market pause button at Humacyte, HARD! And please, don’t forget the cautionary tale about Elizabeth Holmes and Theranos’ unjustified rush to market!

Sincerely,

Hooman Noorchashm MD, PhD.