Welcome to our dedicated page for Humacyte news (Ticker: HUMA), a resource for investors and traders seeking the latest updates and insights on Humacyte stock.
Humacyte, Inc. (Nasdaq: HUMA) is a pioneering biotechnology company focused on developing a disruptive platform that offers universally implantable bioengineered human tissues and organs. These advanced tissue constructs are designed to enhance patient outcomes and revolutionize the field of medicine. The company’s flagship product, the Human Acellular Vessel (HAV), is an investigational bioengineered tissue aiming to address a variety of severe medical conditions, ranging from vascular trauma repair to chronic conditions such as peripheral artery disease (PAD).
Humacyte has made significant strides in its core business, showcasing recent achievements such as the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the HAV. This submission, supported by positive results from both Phase 2/3 clinical trials and humanitarian efforts in Ukraine, brings the company closer to its goal of commercializing HAV for urgent arterial repair. The company's efforts have demonstrated higher patency rates and lower infection and amputation rates compared to synthetic graft benchmarks.
Financially, Humacyte has shown resilience and strategic planning. The company is preparing for a potential Priority Review by the FDA, which could expedite the HAV's market release. In addition, Humacyte has established a solid foundation by securing partnerships and achieving regulatory designations, such as the FDA's Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations.
Humacyte's pipeline extends beyond vascular trauma repair. The company is also exploring applications of HAV in arteriovenous (AV) access for hemodialysis, coronary artery bypass grafts, and pediatric heart surgery. Preclinical success in these areas suggests a broad potential for the HAV across various medical conditions.
For more detailed information and the latest updates, visit www.Humacyte.com.
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.
Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology platform company focused on bioengineered human tissue development, has scheduled its third quarter 2024 financial results release for November 8, 2024. The company will host a conference call and webcast at 8:30 a.m. ET to discuss financial performance and provide updates on its acellular tissue engineered vessel (ATEV) programs. The presentation will be accessible via phone and webcast, with replay available on the company's investor website for 30 days.
Humacyte (HUMA) presented positive Phase 3 clinical trial results for their ATEV (acellular tissue engineered vessel) in arteriovenous access for hemodialysis patients. The trial demonstrated superior performance compared to standard autogenous fistula, with 81.3% functional patency at 6 months versus 66.4%, and 68.3% secondary patency at 12 months versus 62.2%. Notable improvements were seen in high-risk groups: female patients achieved 8.3 vs 5.0 months of dialysis duration, obese patients 7.7 vs 4.5 months, and diabetic patients 7.4 vs 5.5 months. While infection rates were similar between groups, ATEV showed higher thrombosis rates (52.1% vs 9.1%), though 94% of cases were successfully treated.
Humacyte (Nasdaq: HUMA) announced a virtual KOL event scheduled for October 31, 2024, at 8:00 AM ET, focusing on their acellular tissue engineered vessel (ATEV™) for hemodialysis access. The event will feature expert speakers from Brigham and Women's Hospital and the University of Alabama at Birmingham who will discuss the current treatment landscape for arteriovenous (AV) access in hemodialysis patients.
The speakers will present case studies and highlight V007 Phase 3 clinical results comparing ATEV to arteriovenous fistula (AVF) in end-stage kidney disease patients. ATEV is an investigational, first-in-class bioengineered human tissue designed as a universally implantable vascular conduit, pending FDA approval.
FAQ
What is the current stock price of Humacyte (HUMA)?
What is the market cap of Humacyte (HUMA)?
What is the primary focus of Humacyte, Inc.?
What is the Human Acellular Vessel (HAV)?
What recent achievements has Humacyte accomplished?
What makes the HAV different from synthetic grafts?
What regulatory designations has the HAV received?
What are some of the potential applications of the HAV?
How does Humacyte plan to commercialize the HAV?
Where can I find more information about Humacyte?
How is the HAV manufactured?
What are the financial prospects of Humacyte, Inc.?
