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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, Inc. (Nasdaq: HUMA) will hold its 2022 annual meeting of shareholders virtually on June 9, 2022, at 7:30 AM ET. The record date for eligible voters is April 18, 2022. Humacyte is focused on developing a platform for universally implantable bioengineered human tissues, with an emphasis on human acellular vessels (HAVs). These vessels are in late-stage clinical trials for vascular applications, receiving FDA's Regenerative Medicine Advanced Therapy designation, and are prioritized for vascular trauma by the U.S. Secretary of Defense.
Humacyte, Inc. (HUMA) reported financial results for Q4 and the year ending December 31, 2021, showing a revenue increase to $177,000 in Q4 from $124,000 year-over-year. The company is advancing its Human Acellular Vessel (HAV) clinical trials, with 50 patients enrolled in a Phase 2/3 trial for vascular trauma. Expected BLA filings for HAV in 2022/2023 and a strong financial position with cash of $225.5 million highlight growth potential. Notable partnerships, including with Fresenius Medical Care, support its market strategy.
Humacyte, Inc. (Nasdaq: HUMA) will release its financial results for Q4 and full year 2021 on March 29, 2022, at 8:00 a.m. ET. The call will provide an update on their bioengineered human tissue platform and ongoing clinical trials. The company focuses on developing acellular human tissues for medical applications, including vascular trauma and chronic conditions. Their human acellular vessel (HAV) technology has received FDA's Regenerative Medicine Advanced Therapy designation and is in late-stage trials.
Humacyte, Inc. (Nasdaq: HUMA), a biotechnology company, announced its participation in two upcoming investor conferences in March 2022. Laura Niklason, CEO, and Dale Sander, CFO, will represent the company. They will present at Cowen’s 42nd Annual Health Care Conference on March 8 at 2:10 p.m. EST and Oppenheimer’s 32nd Annual Healthcare Conference on March 16 at 12:40 p.m. EDT. Both presentations will be accessible for replay for 30 days. Humacyte is known for developing bioengineered human tissues aimed at improving patient outcomes.
Humacyte has published five-year data from a Phase 2 trial of its Human Acellular Vessel (HAV), demonstrating its potential as a durable, safe option for vascular access in long-term hemodialysis patients. The study showed a 58.2% patency rate at five years, significantly higher than the historical 30% for arteriovenous fistulas. No infections were reported, indicating strong safety and tolerability. Humacyte is currently conducting a Phase 3 trial involving up to 240 patients to further evaluate HAV's usability compared to traditional fistulas.
Humacyte, a biotechnology company listed on Nasdaq: HUMA, will have its CEO Laura Niklason and CFO Dale Sander participating in a virtual fireside chat at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 15, 2022, at 9 a.m. EST. This event highlights Humacyte's innovative work in developing universally implantable bioengineered human tissues and organs, particularly its human acellular vessels, currently undergoing late-stage clinical trials for various medical applications.
Humacyte, Inc. (Nasdaq: HUMA) presented outcomes from eight compassionate use cases of its Human Acellular Vessel (HAV) at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society. The HAVs demonstrated efficacy in maintaining patency and resisting infection in patients with critical limb ischemia and vascular trauma, who had no suitable alternative treatment options. Five bypasses remained patent after follow-ups from four to 20 months. The HAV is engineered to be an off-the-shelf solution for vascular repair, currently under FDA evaluation.
Humacyte, Inc. (Nasdaq: HUMA) announced promising results from its preclinical study on the 3.5mm Human Acellular Vessel (HAV) for coronary artery bypass grafting (CABG), presented at Advanced Therapies Week 2022. The study showed that the HAVs maintained patency and supported host-cell remodeling in a non-human primate model over six months. This advancement could eliminate the need for vein harvesting, which is critically important in CABG procedures. Humacyte aims to further assess safety and efficacy to facilitate future clinical trials.
Humacyte, Inc. (Nasdaq: HUMA) announced that the results of its first compassionate use cases of the Human Acellular Vessel (HAV) will be presented at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society on January 28, 2022. The study reports outcomes from eight patients with critical limb ischemia who underwent HAV implantation, providing new insights into limb salvage options. The HAVs are in late-stage trials for various vascular applications, emphasizing their significance for patients with limited treatment alternatives.
Humacyte (Nasdaq: HUMA) has announced pivotal preclinical results for its Human Acellular Vessel™ (HAV) in coronary artery bypass grafting (CABG), to be presented at the Advanced Therapies Week conference on January 28, 2022. The HAVs are designed to address the significant need for viable vascular substitutes, especially in patients lacking suitable autologous veins. Over 350,000 CABG surgeries occur annually in the U.S. alone, indicating a substantial market opportunity. This development represents a critical milestone in advancing small-diameter HAVs for CABG procedures.
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