A Response to Humacyte CEO’s Press Release of 4/18/2025
Dear Dr. Niklason,
I have read your press release regarding our group’s Citizen Petition to the FDA, which we submitted to the agency following the NYTimes coverage of Dr. Robert Lee’s concerns about the Symvess approval by CBER — and upon review of the publicly available data from FDA on this approval.
It is disturbing to see a well-decorated American healthcare leader and academic innovator, such as yourself, respond with innuendo and personally defamatory characterizations. Especially since the concerns raised are in a Citizen Petition expressing concern to the United States Food and Drug Administration, about a medical product safety and regulatory anomaly that concerns your publicly traded company. Not to mention that the concerns raised by the FDA Citizen Petition are regarding a new and non-standard medical device you are now actively promoting for use in an extremely critical clinical area (i.e. ,traumatic limb salvage) — and even more acutely concerning, because your non-standard vascular device is to be used in critically injured US military personnel and other trauma patients.
To be clear, the Citizen Petition we filed with the FDA is intended to provide the agency with a statutory public mechanism in which to formally respond to serious public concerns raised by the NYTimes and other press outlets about the safety and adequacy of a device approval the agency provided to your public company, Humacyte. As CEO of Humacyte, you should welcome such a thing, because it provides FDA with a formal statutory opportunity to defend its approval and your product! Instead you are doing the opposite, you are engaging in useless innuendo and personally disparaging or defamatory comments about the FDA petitioners. This is a wrong and bad approach as CEO of a publicly traded company.
The rational and ethical response to such public safety concerns, in the United States and in the professional corporate arena you are operating, is not to sling mud and defame the character and competency of the critics. It is rather to behave in a manner that is consistent with your professional standing and aimed at earning public and investor trust in your new product and innovative publicly traded company.
For the record, Dr. Lee has denied the alleged conflicts of interest you have pointed to in your press release. Moreover, our non-profit public advocacy group, HARMS, has no outside affiliations — and neither a financial interest in this public discourse about Symvess, nor in any of Dr. Lee’s personal business dealings. In fact our participation in this filing with the FDA was totally voluntary and done pro bono. Except that, as US public health advocates, we are united with Dr. Lee in defense of public health, transparent FDA regulation of medical products, and medical device safety.
As in my prior e-mail communications with you, I invite you to change your orientation regarding the public criticism your new non-standard vascular bypass conduit is receiving — instead, convince the public that your product is safe and non-inferior to the existing standard arterial conduits used by vascular surgeons. The evidence posed by Dr. Lee and the dissent from other FDA experts are significant and are on the agency’s public record. Humacyte and yourself simply must address them more properly and professionally, as a publicly traded company.
Dr. Niklason, my respectful suggestion to you remains the same as before: 1) place a temporary voluntary moratorium on the marketing and distribution of Symvess for now, 2) voluntarily call for a transparent FDA expert committee re-review of the agency’s Symvess approval, 3) address the concerns about your clinical trial design and the data analysis presented in your JAMA Surgery paper, and to FDA. If all is copacetic with the Symvess approval and the device is truly clinically non-inferior to the existing synthetic vascular conduits, then resume Humacyte’s market activity — and let the vascular and trauma surgeons who will ultimately bear the liability burden of any safety failures, decide if Symvess is the right new standard device for their practices. At the moment, CBER’s approval of Symvess has unjustifiably removed the burden of liability away from Humacyte and placed it on the vascular surgeons who choose to use this non-standard device, and on the patients whose clinical outcomes may be inferior to what is expected from the existing standard conduits.
Respectfully, instead of the ugly press release of 4/18/25, publish scientifically sound analyses of robust data in response to our Citizen Petition on the FDA portal ‘s comments section (Click on the Comments button).
Then allow the FDA to adjudicate this issue and our petition as the agency, the secretary of Health and Human Services and FDA Commissioner see fit. If we are wrong in our criticism and concerns expressed in this public FDA petition, or if FDA chooses to maintain its approval of Symvess irrespective of the serious public safety concerns raised, then Symvess should prevail as a new product in the vascular surgery marketplace.
For the public record, Dr. Peter Marks had a history of presiding over a few shoddy, but high-profile regulatory actions from CBER — but he is now gone. The conduct and apparent laxity of this approval were very likely his doing — perhaps not yours! But if your new non-standard product is truly non-inferior to the existing standard of care conduits, it will withstand our critique of CBER’s approval.
Lastly, please note that none of our safety concerns and critique of the CBER approval are personal. There are no “attacks” on Humacyte, Dr. Niklason — only rational criticism and discourse based on publicly available information from FDA, your analysis published in JAMA Surgery, and reports in the NYTimes and elsewhere about your publicly traded company’s FDA approved medical device. So, I respectfully suggest that you keep your responses clean and not personal, moving forward — in the best interest of Humacyte’s reputation as a safe biotech company, your investors trust, and your own professional reputation as an ethical and well-decorated academic-physician and innovator. Address the safety concerns about the Symvess approval objectively and dispassionately — and if FDA continues to agree that its Symvess approval is justified, leave it to the vascular surgeons and their societies to decide if they will use Symvess as their conduit of choice for traumatic bypass operations. After all with an FDA label like the one Symvess carries, any liability resulting from adverse events associated with the use of this novel, but non-standard conduit, has been trasnferred from Humacyte to the vascular surgeons who will be using it on their unconsentable trauma patients.
Our critique and the public discourse and controversy surrounding this approval are valid and immune to personal inneundo or disparaging personal characterization. Your approach in the press release of 4/18/2025 is likely to discourage investors in your company, because it lacks substance and does nothing to convince the public that Symvess is safe, effective and non-inferior to standard vascular conduits.
I continue to invite you to join us in acting appropriately and professionally - in the best interest of US public health, of patient safety, and of Humacytes investors!
Sincerely,
Hooman Noorchashm MD, PhD.
