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Expanded Access Policy

Humacyte Global, Inc. is a publicly held biotechnology company committed to developing and providing innovative and transformative tissue-engineered products to address significant unmet medical needs and significantly improve the quality of life for patients who require vascular surgery.

Expanded Access refers to the use of investigational therapy outside a clinical trial for potential treatment of a serious condition in a patient. The U.S. Food and Drug Administration has set forth guidelines when considering expanded access. They include:

  • The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling in clinical trials).
  • There is sufficient evidence that the potential benefit to the patient would outweigh the potential risks, based on available safety and efficacy information.
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.

Humacyte has FDA approval and product in market under the licensed name SYMVESS™, an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. Please click here for Full Prescribing Information.

We understand that patients, caregivers, or healthcare professionals may wish to have access to our product candidates before they receive regulatory approval, outside the context of a clinical trial.

At the present time, we are not making our acellular tissue engineered vessel available outside of a clinical trial or Humacyte’s FDA approved product (SYMVESS).

Humacyte may revisit this policy, and any such changes will be posted to this site.

Contact Information
If you have any questions regarding Humacyte’s expanded access policy please contact Humacyte at expandedaccess@humacyte.com.

Revised June 18, 2025

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