Humacyte Inc - HUMA STOCK NEWS

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.

Humacyte presented positive preclinical results for their small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in a non-human primate model of coronary artery bypass grafting. The six-month study showed that sdATEV maintained blood flow, recellularized with host cells, and adapted to match the native artery size. The study involved five baboons where sdATEV was implanted between the aorta and right coronary artery. All implants remained patent throughout the study period. The results are significant as over 400,000 CABG procedures are performed annually in the US, with current options having limitations including potential complications and low patency rates.

Humacyte (Nasdaq: HUMA) has announced a $15.0 million registered direct offering of common stock and warrants. The company will sell 2,808,988 shares of common stock and warrants to purchase an equal number of shares at $5.34 per share. Half of the warrants will expire in 180 days, while the other half will expire in four and a half years from issuance. The offering is expected to close around November 15, 2024. The proceeds will be approximately $15.0 million before expenses.

Humacyte reported Q3 2024 financial results and business updates. The FDA review of their acellular tissue engineered vessel (ATEV) BLA for vascular trauma treatment continues without a specified timeline. The company presented positive results from their V007 Phase 3 clinical trial for hemodialysis access at Kidney Week 2024, showing superior performance over standard treatment. Financial highlights include: no revenue for Q3 2024, R&D expenses of $22.9M, G&A expenses of $7.3M, and a net loss of $39.2M. The company reported $71M in cash and equivalents, with an additional $29.6M raised post-quarter through stock and warrant sales.