This section highlights FDA-related milestones and regulatory updates for drugs developed by Humacyte (HUMA).
Over the past two years, Humacyte has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ATEV™, Human, and V007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ATEV™ - FDA Regulatory Timeline and Events
ATEV™ is a drug developed by Humacyte for the following indication: For the Treatment of Vascular Trauma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATEV™
- Announced Date:
- September 26, 2024
- Indication:
- For the Treatment of Vascular Trauma
Announcement
Humacyte, Inc. announced it will host a virtual KOL event on Monday, September 30, 2024 at 8:00 AM ET. To register, click here.
AI Summary
Humacyte, Inc. announced it will host a virtual KOL event on Monday, September 30, 2024, at 8:00 AM ET. The event will gather leading experts, including Charles Fox, MD, Rishi Kundi, MD, and YingWei Lum, MD, who will discuss the unmet needs and treatment approaches for urgent arterial repair after extremity vascular trauma. They will review detailed case studies that examine Humacyte's acellular tissue engineered vessel (ATEV) product candidate. This innovative, investigational product is designed as a universally implantable vascular conduit for arterial replacement and repair, with insights drawn from a Phase 3 trial conducted in the United States and Israel, as well as a humanitarian program in Ukraine involving warfighters. A live question and answer session will follow the presentations. To join the event, registration is available by clicking the provided link.
Read Announcement- Drug:
- ATEV™
- Announced Date:
- August 27, 2024
- Indication:
- For the Treatment of Vascular Trauma
Announcement
Humacyte, Inc. presented positive long-term results from a humanitarian program conducted in Ukraine under which the investigational acellular tissue engineered vessel (ATEV) was used to treat vascular injuries suffered during the ongoing conflict.
AI Summary
Humacyte, Inc. shared encouraging long-term results from its humanitarian program in Ukraine, where the investigational acellular tissue engineered vessel (ATEV) was used to treat vascular injuries sustained during active conflict. In this program, 16 patients with severe injuries from mine blasts, shrapnel, and high velocity ballistics received the ATEV. The device achieved a 12-month patency rate of 87.1%, meaning that blood flow through the treated vessels remained open. Notably, there were no cases of infection, amputation, or death related to the ATEV during the follow-up period, except for one instance of thrombosis after six months.
These results highlight the potential durability and safety of the ATEV as a readily available, off-the-shelf option for vascular repair in combat settings, offering significant benefits in emergency trauma care by avoiding time-consuming vein harvesting procedures.
Read Announcement- Drug:
- ATEV™
- Announced Date:
- August 9, 2024
- Indication:
- For the Treatment of Vascular Trauma
Announcement
Humacyte, Inc. announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication.
AI Summary
Humacyte, Inc. announced that the U.S. Food and Drug Administration (FDA) has requested more time to finish reviewing its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication. The application was originally submitted in December 2023 and was granted a Priority Review in February 2024, with an expected decision date set for August 10, 2024. However, during the review process—which included facility inspections, clinical site evaluations, and discussions on post-marketing and labeling—the FDA determined that additional time was needed. An FDA representative apologized for the delay, and no new decision date has been provided yet. Humacyte remains confident in the product’s potential, partly due to the positive outcomes seen during the BLA review interactions with the FDA.
Read Announcement
Human Acellular Vessel - FDA Regulatory Timeline and Events
Human Acellular Vessel is a drug developed by Humacyte for the following indication: Coronary Artery Bypass Grafting.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Human Acellular Vessel
- Announced Date:
- July 1, 2024
- Indication:
- Coronary Artery Bypass Grafting
Announcement
Humacyte, Inc. announced that it has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD).
AI Summary
Humacyte, Inc. has been granted the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational Acellular Tissue Engineered Vessel (ATEV) for patients with advanced peripheral artery disease (PAD). This RMAT designation is aimed at speeding up the development and review process of the therapy by enhancing communication with the FDA and potentially allowing for an expedited review of its Biologics License Application (BLA).
The designation supports the advancement of the ATEV as a universally implantable vascular conduit designed for patients who lack usable autologous veins for bypass procedures. With a focus on addressing the serious needs of PAD patients, Humacyte expects that the RMAT status will help bring this innovative treatment to market faster, improving outcomes for individuals with life-threatening vascular conditions.
Read Announcement- Drug:
- Human Acellular Vessel
- Announced Date:
- June 17, 2024
- Estimated Event Date Range:
- October 1, 2024 - October 1, 2024
- Target Action Date:
- October 1, 2024
- Indication:
- Coronary Artery Bypass Grafting
Announcement
Humacyte, Inc. announced that Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte's HAV –
AI Summary
Humacyte, Inc. announced a significant milestone by obtaining four unique ICD-10-PCS codes that will be effective on October 1, 2024. These codes are for procedures that involve replacing arteries in both the upper and lower extremities using Humacyte’s Human Acellular Vessels (HAV). The HAV, also known as the “acellular tissue engineered vessel” (ATEV) based on FDA guidance, is designed for urgent arterial repairs when synthetic grafts are not suitable and the patient’s own veins are not available.
The new ICD-10-PCS codes will help hospitals accurately record these procedures, ensuring proper tracking and support for reimbursement and data collection. This development is a key step in making the HAV technology more accessible for critical vascular repairs, potentially improving patient outcomes through faster, more reliable treatment options.
Read Announcement- Drug:
- Human Acellular Vessel
- Announced Date:
- June 17, 2024
- Indication:
- Coronary Artery Bypass Grafting
Announcement
Humacyte, Inc. announced that, based on guidance from the Food and Drug Administration (FDA), the common (non-brand) name for the HAV will be the "acellular tissue engineered vessel" (ATEV).
AI Summary
Humacyte, Inc. recently announced a key update regarding its bioengineered vascular product. The U.S. Centers for Medicare & Medicaid Services has issued four new ICD-10-PCS codes for procedures replacing arteries in the upper and lower extremities using Humacyte’s HAV. These codes, effective October 1, 2024, will help hospitals and insurers accurately classify and track these innovative procedures.
In a notable development based on guidance from the FDA, Humacyte confirmed that the common (non-brand) name for its HAV will be the “acellular tissue engineered vessel” (ATEV). This new designation highlights the technology behind the off-the-shelf product, designed for urgent arterial repairs in cases where synthetic grafts are not suitable and autologous veins are unavailable. The update marks a significant step forward as Humacyte works to advance its product toward wider clinical use.
Read Announcement
V007 - FDA Regulatory Timeline and Events
V007 is a drug developed by Humacyte for the following indication: For patients with end-stage renal disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- V007
- Announced Date:
- June 9, 2025
- Indication:
- For patients with end-stage renal disease.
Announcement
Humacyte, Inc. announced that the results from its V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting (VAM25), held in New Orleans, LA, on June 6, 2025.
AI Summary
Humacyte, Inc. announced that the results from its V007 Pivotal Phase 3 clinical trial for the acellular tissue engineered vessel (ATEV™) were presented at a plenary session during the Society for Vascular Surgery’s 2025 Annual Meeting in New Orleans, LA, on June 6, 2025. The trial focused on patients with end-stage renal disease who are at high risk for autologous arteriovenous fistula (AVF) maturation failure, such as those with diabetes and obesity.
The study compared ATEV to the standard AVF procedure in hemodialysis patients. Findings showed that ATEV provided better functional patency and minimized the need for additional maturation and revision surgeries, even though some cases of thrombosis and stenosis occurred and were successfully treated. These promising results highlight ATEV’s potential as a safer and more effective option for high-risk patients requiring vascular access for hemodialysis.
Read Announcement- Drug:
- V007
- Announced Date:
- June 2, 2025
- Indication:
- For patients with end-stage renal disease.
Announcement
Humacyte, Inc announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for high-risk patients with end-stage renal disease was accepted for an oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM25).
AI Summary
Humacyte, Inc announced that its abstract on the V007 Pivotal Phase 3 clinical trial was accepted for an oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM25). The study focuses on the acellular tissue engineered vessel (ATEV™) used for arteriovenous access in high-risk patients with end-stage renal disease. The presentation, titled "Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial," will outline how the ATEV™ compares favorably to the traditional arteriovenous fistula for patients undergoing hemodialysis. Dr. Mohamad A. Hussain will present the findings during the plenary session on Friday, June 6, 2025, in New Orleans. This development highlights the potential of bioengineered solutions to improve vascular access and advance treatment options for high-risk patients.Read Announcement
- Drug:
- V007
- Announced Date:
- November 22, 2024
- Indication:
- For patients with end-stage renal disease.
Announcement
Humacyte, announced that it will present Phase 3 results from a clinical study comparing efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in patients with end stage renal disease at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York, NY on November 23, 2024.
AI Summary
Humacyte announced it will present Phase 3 clinical study results at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York on November 23, 2024. The study compares the efficacy and safety of Humacyte’s acellular tissue engineered vessel (ATEV™) with the traditional autologous arteriovenous (AV) fistulas used in patients with end-stage renal disease. This clinical trial aims to evaluate whether the synthetic ATEV™ can provide a reliable alternative for establishing vascular access during dialysis treatments while potentially reducing complications associated with conventional AV fistulas. The upcoming presentation is expected to offer important insights into the performance of the ATEV™, which could lead to improvements in patient outcomes and inform future FDA evaluations of innovative vascular access technologies. The study marks a significant step in addressing unmet needs for end-stage renal disease patients.
Read Announcement- Drug:
- V007
- Announced Date:
- October 8, 2024
- Estimated Event Date Range:
- October 26, 2024 - October 26, 2024
- Target Action Date:
- October 26, 2024
- Indication:
- For patients with end-stage renal disease.
Announcement
Humacyte, Inc. announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024.
AI Summary
Humacyte, Inc. announced that its late-breaking abstract on the V007 Phase 3 clinical trial was accepted for an oral presentation at the American Society of Nephrology’s Kidney Week 2024. The study focuses on the use of Humacyte’s acellular tissue engineered vessel (ATEV™) for arteriovenous access in patients with end-stage renal disease. Titled “Prospective Randomized Trial of Humacyte’s Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access,” the trial compares the performance of ATEV™ to the traditional autologous arteriovenous fistula. The presentation, led by Dr. Mohamad A. Hussain, will take place on October 26, 2024, in San Diego during the High-Impact Clinical Trials session. Humacyte plans to share further details and results from this critical study in a subsequent press release.
Read Announcement- Drug:
- V007
- Announced Date:
- July 31, 2024
- Indication:
- For patients with end-stage renal disease.
Announcement
Humacyte, Inc. announced positive top-line results from the V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) in arteriovenous access for patients with end-stage renal disease. I
AI Summary
Humacyte, Inc. announced positive top-line results from its V007 Phase 3 Clinical Trial evaluating the acellular tissue engineered vessel (ATEV) for hemodialysis access in patients with end-stage renal disease. In this randomized study of 242 patients, the ATEV showed superior performance compared to the autogenous fistula, which is the current standard of care. At six months, 81.3% of patients with the ATEV achieved functional patency, compared to 66.4% with an AV fistula, while at 12 months, 68.3% of ATEV patients maintained secondary patency versus 62.2% with fistulas. These statistically significant results suggest that the ATEV could offer improved vascular access for hemodialysis patients who often face challenges with existing treatment options.
The company plans to share more detailed results, including subgroup findings, at upcoming medical conferences while discussing regulatory pathways with the FDA.
Read Announcement
