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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 (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.
Humacyte, Inc. (Nasdaq: HUMA) 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 has been accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The presentation, titled "Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access," will be delivered by Dr. Mohamad A. Hussain on October 26, 2024, in San Diego. Humacyte plans to provide additional details from the presentation in a future press release. The ATEV is still an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company, has announced a $30.0 million registered direct offering of common stock and warrants. The company will sell 5,681,820 shares of common stock and warrants to purchase an equal number of shares. The warrants are divided into two tranches, both with an exercise price of $5.28 per share, expiring at different intervals. The purchase price for one share and one warrant is set at $5.28. The offering is expected to close around October 7, 2024, subject to customary conditions. EF Hutton is acting as the exclusive placement agent for this offering, which is being made under a previously filed and effective shelf registration statement.
Humacyte (Nasdaq: HUMA) has announced a virtual Key Opinion Leader (KOL) event scheduled for September 30, 2024 at 8:00 AM ET. The event will focus on case studies evaluating Humacyte's acellular tissue engineered vessel (ATEV) product candidate for vascular trauma treatment.
Featured speakers include Dr. Charles Fox and Dr. Rishi Kundi from the University of Maryland School of Medicine, and Dr. YingWei Lum from Johns Hopkins School of Medicine. They will discuss the unmet medical needs and current treatment landscape for urgent arterial repair after extremity vascular trauma.
The event will highlight case studies from a Phase 3 trial conducted in the United States and Israel, as well as treatments of warfighters under a humanitarian program in Ukraine. Humacyte's ATEV is described as an investigational, first-in-class bioengineered human tissue designed as a universally implantable vascular conduit for arterial replacement and repair.
Humacyte (Nasdaq: HUMA) announced the allowance of a U.S. Patent for its BioVascular Pancreas (BVP) product candidate, designed to treat type 1 diabetes. The patent covers the BVP's design and composition, which uses Humacyte's acellular tissue engineered vessel (ATEV™) to deliver insulin-producing islets inside the body. Positive preclinical results support the BVP's potential:
1. Stem cell-derived islets restored normal blood sugar in diabetic mice
2. Successful BVP implantation in non-human primates showed islet survival and continued insulin production for three months
With 1.45 million Americans living with type 1 diabetes and 64,000 new diagnoses annually, the BVP could potentially overcome current hurdles in islet implantation for diabetic patients.
Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology company, has announced its participation in two upcoming investor conferences in September 2024. The company, which focuses on developing universally implantable, bioengineered human tissue at commercial scale, will be represented by Laura Niklason, M.D., Ph.D., Founder, President, and CEO, and Dale Sander, CFO.
The conferences are:
- H.C. Wainwright 26th Annual Global Investment Conference on Tuesday, September 11, 2024, from 8:30 - 9 AM ET
- Cantor Global Healthcare Conference on Wednesday, September 18, 2024, from 9:10 - 9:40 AM ET
Both events will feature company presentations, with webcasts available for interested parties to view online.
Humacyte (Nasdaq: HUMA) presented positive long-term results from a humanitarian program in Ukraine using their investigational acellular tissue engineered vessel (ATEV) to treat vascular injuries. The study, known as the 'V017 trial', showed high rates of patency and avoidance of amputation and infection in severe wartime injuries.
Key findings include:
- 12-month primary and secondary patency rates of 87.1%
- Zero instances of ATEV infections, amputations, or deaths
- Mean follow-up duration of 357.9 days
- Only one event of ATEV thrombosis after month six
- No reports of ATEV aneurysm or pseudo-aneurysm
The ATEV is designed as an off-the-shelf, universally implantable vascular conduit for arterial replacement, repair, and hemodialysis access. It is still investigational and not yet approved for sale by the FDA or other regulatory agencies.
BioAesthetics has appointed Dr. Juliana Blum as its new Chief Executive Officer, effective August 12, 2024. Dr. Blum, co-founder and former EVP of Corporate Development at Humacyte (NASDAQ: HUMA), brings 20 years of experience in biotech development and commercialization. Her expertise includes global regulatory affairs, CMC development, and manufacturing scale-up.
BioAesthetics, a biotechnology company focused on biomaterials advancements, is developing the NACgraft™ biologic matrix, an acellular tissue graft for nipple regeneration in breast reconstruction patients. The company is also working on a drug-eluting graft technology for soft tissue reconstruction. Dr. Blum's appointment is seen as a strategic move to guide the company's products towards clinical trials and commercialization.
Humacyte (Nasdaq: HUMA) reported Q2 2024 financial results and business updates. Key highlights include:
1. FDA requires additional time to review ATEV™ BLA for vascular trauma treatment.
2. Positive topline results from Phase 3 trial of ATEV in hemodialysis access, showing superior functional patency over standard care.
3. ATEV received third RMAT designation from FDA for advanced peripheral artery disease.
4. Q2 2024 financial results: No revenue, R&D expenses $23.8M, G&A expenses $5.7M, net loss $56.7M.
5. Cash and cash equivalents of $93.6M as of June 30, 2024.
The company remains confident in ATEV's approvability for vascular trauma treatment despite the FDA review extension.
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