Humacyte's Symvess offers a significant clinical advance in vascular trauma, with strong efficacy and cost benefits over synthetic grafts and autologous vein grafts. The company targets a $200M-$480M annual revenue opportunity, depending on market penetration and future FDA approvals for expanded indications. Financial risks remain due to high cash burn and potential dilution, but current valuation appears reasonable given future growth prospects and insider buying.
DURHAM, N.C., June 09, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced today that the results from its V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEVâ„¢) 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.
DURHAM, N.C., June 02, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEVâ„¢) 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).
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Biotechnology Industry | Healthcare Sector | Dr. Laura E. Niklason M.D., Ph.D. CEO | NASDAQ (NGS) Exchange | 44486Q103 Cusip |
US Country | 218 Employees | - Last Dividend | - Last Split | 24 Nov 2020 IPO Date |
Humacyte, Inc. is a pioneering healthcare company that specializes in the development and manufacturing of innovative bioengineered human tissues designed for the treatment of various diseases and conditions. The company’s focus is on creating implantable, off-the-shelf tissues that can be used in a wide range of therapeutic areas and anatomic locations. Founded in 2004 and based in Durham, North Carolina, Humacyte leverages its proprietary scientific technology platform to engineer human acellular vessels (HAVs) that, when implanted into patients, are intended not to induce a foreign body response or lead to immune rejection. This technology represents a significant step forward in vascular repair, reconstruction, and replacement, aiming to revolutionize the field of regenerative medicine and improve patient outcomes across multiple treatment areas.
Humacyte is developing HAVs to address the critical need for durable, readily available vascular grafts in the treatment of traumatic injuries. These bioengineered vessels are designed to restore blood flow and facilitate the healing process in patients who have suffered from severe vascular damage.
The company’s HAVs offer a promising solution for patients requiring hemodialysis access. These vessels aim to provide a more reliable and longer-lasting alternative to current arteriovenous fistulas and grafts, potentially reducing complications and improving the quality of life for patients with end-stage renal disease.
For patients suffering from PAD, Humacyte’s HAVs are being developed to improve blood circulation to the limbs. This innovative approach could offer a significant advancement over traditional treatments, potentially avoiding amputations and enhancing patient mobility and comfort.
In the realm of congenital heart disease, Humacyte’s HAVs are investigated as potential solutions to pediatric heart defects. These bioengineered tissues could provide a revolutionary new option for the repair or reconstruction of pediatric vascular structures, offering hope for improved outcomes in young patients.
Humacyte is exploring the use of HAVs in coronary artery bypass grafting, a common procedure to improve blood flow to the heart. The company aims to provide surgeons with a superior alternative to traditional graft materials, potentially reducing the risk of complications and enhancing patient recovery.
Additionally, Humacyte’s technology platform is being utilized for the delivery of cellular therapies, including the transplantation of pancreatic islet cells to treat Type 1 diabetes. This innovative application of HAVs could offer a novel approach to cellular delivery, aiming to improve therapeutic efficacy and patient outcomes.