Humacyte Inc - HUMA STOCK NEWS

Humacyte (Nasdaq: HUMA) has been granted U.S. Patent No. 12,195,711 for its 'Drawer System for Cultivating Tissue,' covering key aspects of their bioreactor manufacturing system until 2040. The patent specifically relates to the production of Symvess, their first-in-class bioengineered human tissue designed as a universally implantable vascular conduit.

The company operates an 83,000 square foot bioprocessing facility capable of manufacturing human tissue at commercial scale. Notably, the FDA granted full approval for Symvess on December 19, 2024, for use in adults requiring urgent revascularization due to extremity arterial injury when autologous vein grafts aren't feasible.

Symvess offers an off-the-shelf solution that eliminates the need for harvesting veins from patients during acute trauma. The product is currently undergoing clinical trials for arteriovenous access in hemodialysis and peripheral artery disease, with preclinical development for coronary artery bypass grafts.

Humacyte (HUMA) has launched Symvess, its FDA-approved bioengineered human tissue vascular conduit, for treating extremity arterial injuries. The product received full FDA approval on December 19, 2024, and is now authorized for commercial shipments.

Twenty-one hospitals have initiated the Value Analysis Committee (VAC) approval process, with two already completing their review and approving Symvess purchases. Some hospitals plan to purchase while VAC review is ongoing. The product has shown positive results in clinical studies, including high patency rates and low amputation and infection rates.

According to Humacyte's Budget Impact Model (BIM), Symvess treatment is estimated to be more cost-effective than synthetic grafts, cryopreserved allografts, or xenografts, primarily due to reduced amputation and infection rates.

Humacyte (Nasdaq: HUMA) and Pluristyx have expanded their partnership to advance the development of the BioVascular Pancreas (BVP™), designed to treat insulin-dependent diabetes. Pluristyx will provide gene-edited PluriBank™ iPSC lines with blocked Human Leukocyte Antigen (HLA) markers expression, using their clinical-grade Mad7 gene editing technology.

Humacyte is working to optimize the process of differentiating these immune-evading iPSCs into pancreatic islets for their BVP system, which aims to normalize glucose levels in diabetic patients. The BVP utilizes Humacyte's acellular tissue engineered vessel (ATEV™) as a carrier for insulin-producing islets. The product is currently in pre-clinical development and awaits regulatory approval.

Humacyte (Nasdaq: HUMA) announced plans to file an Investigational New Drug (IND) application with the FDA in 2025 to initiate the first-in-human clinical study of its small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) for coronary artery bypass grafting (CABG). This decision follows a recent meeting with the FDA where agreements were reached.

Currently, only the 6.0mm ATEV configuration has been tested in human trials for vascular trauma repair, hemodialysis AV access, and peripheral artery disease. Preclinical studies of the sdATEV in CABG models have shown promising results, including sustained patency, recellularization, and effective remodeling to reduce size mismatch.

The results were presented at The American Heart Association's Scientific Sessions 2024. Humacyte's CEO, Dr. Laura Niklason, emphasized the potential of sdATEV as an off-the-shelf alternative to native vessel grafts. CABG is performed over 400,000 times annually in the U.S., but current autologous vessel grafts have limitations such as low patency rates and surgical wound infections.

Humacyte's ATEV aims to address these issues by providing an unlimited, off-the-shelf vascular conduit, potentially transforming CABG surgery.

Humacyte (NASDAQ: HUMA) provided updates on the commercial launch of Symvess, their FDA-approved bioengineered vascular conduit for extremity arterial injury. The company has set the price at $29,500 per unit and has assembled a highly experienced sales team of ten members, each with over 15 years of experience in medical device and biotech sales.

The company has developed a Budget Impact Model showing that Symvess treatment costs less than synthetic grafts, cryopreserved allografts, or xenografts, primarily due to reduced amputation and infection rates. Humacyte has submitted an NTAP application to CMS in October 2024, which, if approved, would provide additional reimbursement starting October 1, 2025.

Symvess received FDA approval on December 19, 2024, for use in adults when urgent revascularization is needed and autologous vein graft isn't feasible. The company is currently responding to hospital quotation requests and initiating Value Analysis Committee approval processes.

Humacyte (NASDAQ: HUMA) has received FDA full approval for SYMVESS, a first-in-class bioengineered human tissue designed as a universally implantable vascular conduit for arterial injury treatment. The approval is specifically for use in adults when urgent revascularization is needed to avoid limb loss and autologous vein graft isn't feasible.

Clinical testing demonstrated high patency rates and low amputation and infection rates. SYMVESS offers an off-the-shelf solution, eliminating the need for vein harvesting from trauma patients. The approval was based on positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from Ukraine's wartime injuries treatment.

The company has already recruited and trained a sales team for the commercial launch. SYMVESS received RMAT designation in May 2023, and its BLA submission in December 2023 was granted Priority Review in February 2024.

Humacyte (Nasdaq: HUMA) announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York. Dr. Laura Niklason, the company's Founder, President, and CEO, will engage in a fireside chat presentation on December 5, 2024, at 8:00 a.m. EST at The Lotte New York Palace. The presentation will be accessible via webcast, with a replay available on the company's website. Management will also be available for one-on-one meetings during the conference.

Humacyte (Nasdaq: HUMA) announced it will present Phase 3 results comparing the efficacy and safety of its acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in end-stage renal disease patients. The presentation will be delivered by Dr. Charles Keith Ozaki at the 51st Annual VEITH Symposium in New York on November 23, 2024. Dr. Ozaki is the Vascular Surgery Research Director at Brigham and Women's Hospital and John A. Mannick Professor of Surgery at Harvard Medical School. The ATEV remains an investigational product pending FDA approval.

Humacyte announced the publication of clinical results in JAMA Surgery evaluating their acellular tissue engineered vessel (ATEV) for repairing extremity civilian and military arterial injuries. Two studies demonstrated ATEV's superior performance compared to synthetic grafts, showing 91.5% 30-day secondary patency versus 78.9%, 4.5% amputation rate versus 24.3%, and 0.9% infection rate versus 8.4%. The average follow-up duration was 334.4 days, with no ATEV infections or patient deaths reported after month three. The ATEV is currently under FDA review for vascular trauma indication.