Received U.S. Food and Drug Administration (FDA) approval of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma Commenced market launch and first commercial sales of Symvess Budget Impact Model for Symvess published in Journal of Medical Economics IND filing planned in 2025 to support first-in-human clinical study of small-diameter ATEV™ for coronary artery bypass grafting... Read More

DURHAM, N.C., March 26, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2024, on Friday, March 28, 2025. Management will host a webcast and conference call at 8:30 a.m. ET. Title: Humacyte Fourth... Read More

DURHAM, N.C., March 25, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the pricing of an underwritten public offering of 25,000,000 shares of its common stock at a public offering price of $2.00 per share. The aggregate gross proceeds from this offering are expected... Read More

DURHAM, N.C., March 25, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc . (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has commenced an underwritten public offering of its common stock. In addition, Humacyte intends to grant the underwriters an option for a period of 30 days to purchase up to an additional... Read More

Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair Publication of the Budget Impact Model in peer-reviewed journal supports Symvess as a treatment that provides economic value to hospitals and payers DURHAM, N.C., March 10, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing... Read More

SAN DIEGO / Mar 06, 2025 / Business Wire / Trestle Biotherapeutics, Inc., today announced a research collaboration with Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale. Trestle Bio is a preclinical stage company developing bioengineered kidney tissues for patients suffering from end stage renal disease (ESRD).... Read More

DURHAM, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced it will host an in-person and virtual investor event in New York on Thursday, March 6, 2025 at 12:00 PM ET. To register as an in-person or virtual attendee, please click here. The event will... Read More

DURHAM, N.C., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will present at the TD Cowen 45 th Annual Health Care Conference in Boston, MA on Tuesday, March 4, 2025.... Read More

Patent provides coverage into 2040 for key aspects of the bioreactor manufacturing system Symvess, the acellular tissue engineered vessel, is manufactured in this patented system DURHAM, N.C., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the issuance of a... Read More

The FDA has authorized Humacyte to release commercial shipments Positive responses from surgeons and trauma centers to initial sales and marketing outreach 21 hospitals have already initiated the Value Analysis Committee (VAC) approval process DURHAM, N.C., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human... Read More

DURHAM, N.C.and SEATTLE, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, and Pluristyx, Inc. today announced an expanded partnership. Pluristyx makes and sells PluriBank™ iPSC lines as part of their tools, technologies, and services to support the development of cellular... Read More

Plans for filing an IND was agreed with the FDA in a recent meeting Positive preclinical results of the small-diameter ATEV were recently presented at The American Heart Association’s Scientific Sessions 2024 meeting DURHAM, N.C., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that... Read More

Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair Highly experienced sales team onboard and trained in preparation for commercial launch Budget Impact Model supports pricing of Symvess DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally... Read More

SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection Highly experienced sales team already recruited and trained in preparation for commercial launch DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE)... Read More

DURHAM, N.C., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc . (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will participate in a fireside chat presentation at the Piper Sandler 36th Annual Healthcare Conference, in New York,... Read More

DURHAM, N.C., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it will present Phase 3 results from a clinical study comparing efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in patients with end stage... Read More

In two studies the acellular tissue engineered vessel (ATEV) provided benefits in terms of patency, limb salvage, and infection resistance compared to current synthetic graft treatment benchmarks Results were published in a premier peer-reviewed surgical journal sponsored by the American Medical Association DURHAM, N.C., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform... Read More

sdATEVs maintained sustained patency throughout the six-month study sdATEV was observed to recellularize with host cells and remodel to effectively reduce the initial size mismatch between the sdATEV and the animal’s native artery DURHAM, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at... Read More

DURHAM, N.C., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it entered into a securities purchase agreement with an institutional investor to purchase approximately $15.0 million worth of its common stock and warrants to purchase common stock in a... Read More

FDA review of acellular tissue engineered vessel (ATEV™) BLA for the Treatment of Vascular Trauma is ongoing Results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for hemodialysis patients presented at American Society of Nephrology’s Kidney Week 2024 Long-term results from the humanitarian program where the ATEV was used to treat vascular injuries suffered during the Ukraine conflict were... Read More

DURHAM, N.C., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the third quarter ended September 30, 2024, on Friday, November 8, 2024. Management will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates... Read More

ATEV™ demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis access ATEV also showed superior function and patency in female, obese and diabetic patients, subgroups with historically poor outcomes with autogenous fistula procedures DURHAM, N.C., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage... Read More

DURHAM, N.C., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it will host a virtual KOL event on Thursday, October 31, 2024 at 8:00 AM ET. To register, click here . The event will feature Charles Keith Ozaki, MD (Brigham and Women’s Hospital), Mohamad Anas... Read More

DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, 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 was accepted for an oral... Read More

DURHAM, N.C., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it entered into a securities purchase agreement with an institutional investor to purchase approximately $30.0 million worth of its common stock and warrants in a registered direct offering. Under... Read More

DURHAM, N.C., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Monday, September 30, 2024 at 8:00 AM ET. To register, click here . The event will feature Charles Fox, MD (University of Maryland School of Medicine), Rishi Kundi... Read More

New U.S. patent covers the design and composition of the BVP Positive results from ongoing preclinical studies support the potential of the BVP to deliver insulin-producing islets as a potential treatment for type 1 diabetes DURHAM, N.C., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at... Read More

DURHAM, N.C., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will represent Humacyte at the following conferences in September. H.C.... Read More

Results presented at the Department of Defense’s Military Health System Research Symposium (MHSRS) In real-world military setting the ATEV was observed to have 12-month patency of 87.1% There were zero instances of infection, amputation or death during the long-term follow-up period despite the severity of the wartime injuries treated DURHAM, N.C., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a... Read More

FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma Reported Positive Topline Results from Phase 3 Trial of ATEV in Hemodialysis Access ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA in Advanced Peripheral Artery Disease Conference call and live webcast at 8:30 a.m. ET today DURHAM, N.C., Aug. 13,... Read More

DURHAM, N.C., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the second quarter ended June 30, 2024, on Tuesday, August 13, 2024. Management will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates from... Read More

2 nd quarter conference call to be held Tuesday, August 13 th , at 8:30 a.m. ET DURHAM, N.C., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic... Read More

ATEV demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis Detailed results to be presented at upcoming medical conferences DURHAM, N.C., July 31, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale,... Read More

DURHAM, N.C., July 16, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company’s Board of Directors. “We are... Read More

SEATTLE / Jul 09, 2024 / Business Wire / Pluristyx, a leading provider of tools, technologies, and services for the development of cellular therapies, is pleased to announce a license agreement with Humacyte, Inc. , a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale. Humacyte has licensed Pluristyx’s clinical-grade PluriBank™ induced Pluripotent... Read More

Third RMAT designation by FDA for ATEV RMAT will expedite development of ATEV in PAD DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced Therapy (RMAT) designation for... Read More

BioVascular Pancreas (BVP) product candidate is under development as a potential treatment for type 1 diabetes Humacyte’s stem cell-derived islets observed to restore normal blood glucose in diabetic mice Non-human primate models of BVP implantation showed islet survival and continued insulin production DURHAM, N.C., June 25, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform... Read More

Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte’s HAV BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage... Read More

DURHAM, N.C., May 30, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference, in New York, NY on Thursday, June 6, 2024. Management will... Read More

DURHAM, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc . (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, Dale Sander, Chief Financial Officer, and B.J. Scheessele, Chief Commercial Officer, will represent Humacyte at the... Read More

Biologics License Application (BLA) for HAV™ Accepted by FDA BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024 Raised approximately $43 million in net proceeds from public offering of common stock Conference call and live webcast at 8:00 a.m. ET today DURHAM, N.C., May 10, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company... Read More

DURHAM, N.C., May 06, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the first quarter ended March 31, 2024, on Friday, May 10, 2024. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update.... Read More

DURHAM, N.C., March 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Thursday, March 28, 2024 at 8:00 AM ET, featuring Timmy Lee, MD, MSPH (University of Alabama at Birmingham) and Prabir Roy-Chaudhury MD, PhD, FRCP (University of... Read More

Biologics License Application (BLA) for HAV™ Accepted by FDA on February 8, 2024 BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024 Raised approximately $43.1 million in net proceeds from public offering of common stock Conference call and live webcast at 8:00 a.m. ET today DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage... Read More

DURHAM, N.C., March 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2023, on Friday, March 22, 2024. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and... Read More

DURHAM, N.C., March 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the TD Cowen 44th Annual Health Care Conference, in Boston,... Read More

DURHAM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced today announced the pricing of an underwritten public offering of 13,400,000 shares of its common stock at a public offering price of $3.00 per share. The aggregate gross proceeds from this offering... Read More

DURHAM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it has commenced an underwritten public offering of its common stock. In addition, Humacyte intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15%... Read More

BLA submission supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a Humanitarian Aid Program to treat wartime trauma injuries in Ukraine The HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks PDUFA date set for August 10, 2024 DURHAM, N.C., Feb. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA),... Read More

BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime trauma injuries in Ukraine The HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform... Read More

DURHAM, N.C., Nov. 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Piper Sandler 35th Annual Healthcare Conference, in New... Read More

Presentations included results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime injuries in Ukraine Results showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks BLA for an indication in vascular trauma planned to be filed with the FDA during the current quarter DURHAM,... Read More

Positive top line results from the V005 Phase 2/3 trial of the Human Acellular Vessel™ (HAV™) in vascular trauma repair BLA for an indication in vascular trauma planned to be filed with the FDA during the current quarter Conference call and live webcast at 4:30 p.m. ET today DURHAM, N.C., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally... Read More

DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the third quarter ended September 30, 2023, on Thursday, November 9, 2023. Management will host a webcast and conference call at 4:30 p.m. ET to provide a corporate and financial... Read More

DURHAM, N.C., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced publication of a preclinical study showing the potential for its investigational small-diameter Human Acellular Vessel™ (HAV™) to treat Tetralogy of Fallot, a heart condition that affects one in every 2,000... Read More

DURHAM, N.C., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Cantor Global Healthcare Conference, in New York, NY on... Read More

DURHAM, N.C., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced it will host an in-person KOL event on Wednesday, September 20, 2023 at 3:00pm ET at The New York EDITION Hotel. The event will feature Michael Curi, MD, MPA (Rutgers New Jersey Medical School) and his... Read More

Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks BLA planned to be filed with FDA in 4 th Quarter 2023 Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology... Read More

DURHAM, N.C., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will host a virtual webinar to announce top line data results from its Phase 2/3 V005 vascular trauma clinical trial. The V005 trial evaluated the HAV, an off-the-shelf, universally implantable bioengineered human... Read More

DURHAM, N.C., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of results from a Food and Drug Administration (FDA)-regulated, investigator-sponsored clinical study conducted at the Mayo Clinic. In the study the investigational HAV is being evaluated... Read More

Clinical outcomes presented at Military Health System Research Symposium (MHSRS) Results will be included in Biologics License Application (BLA) planned for fourth quarter 2023 DURHAM, N.C., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, presented yesterday at MHSRS the... Read More

Completed Enrollment in Phase 2/3 V005 Trial of HAV™ in Vascular Trauma Repair; Top-Line Results on Track for Q3 2023 Results from Vascular Trauma Humanitarian Program in Ukraine Highlighted at 2023 Military Health System Research Symposium Conference call and live webcast at 8:00 a.m. ET today DURHAM, N.C., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company... Read More

DURHAM, N.C., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the second quarter ended June 30, 2023, on Monday, August 14, 2023. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update.... Read More

Results published in Journal of Vascular Surgery – Vascular Science DURHAM, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announces the publication of controlled in vitro studies in the Journal of Vascular Surgery – Vascular Science describing the scientific basis for... Read More

Top-line results planned to be released in third quarter 2023 Trial results are intended to support Biologics License Application (BLA) planned for fourth quarter 2023 DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its... Read More

DURHAM, N.C., June 05, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Jefferies Healthcare... Read More

Human Acellular Vessel™ (HAV™) granted second RMAT designation by the FDA, for Vascular Trauma Completion of enrollment in Phase 3 trial of HAV in Hemodialysis Access in End-Stage Renal Disease Patients Conference call and live webcast at 8:00 a.m. ET today DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable... Read More

$40 million upfront, $20 million upon FDA acceptance of HAV BLA in vascular trauma, $40 million upon FDA approval of HAV in vascular trauma, $50 million upon achievement of certain sales milestones, and $10 million equity option Proceeds to support planned development and commercialization of HAV and earlier-stage product candidates DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA) and Oberland... Read More

First regenerative medicine technology used in battlefield trauma Ukrainian surgeons trained on HAV procedures over video conferencing DURHAM, N.C., May 09, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the publication in The Lancet Regional Health - Europe detailing the... Read More

DURHAM, N.C., May 05, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the first quarter ended March 31, 2023, on Friday, May 12, 2023. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update.... Read More

HAV granted second RMAT designation by the FDA RMAT will support Humacyte’s lead indication in Vascular Trauma DURHAM, N.C., May 04, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, has been recently granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced... Read More

DURHAM, N.C., April 28, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will participate in a company presentation and one-on-one investor meetings... Read More

NEW YORK, N.Y. and DURHAM, N.C., April 27, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology company pioneering the development and manufacturing of off-the-shelf, universally implantable bioengineered human tissues and organ systems, and JDRF International (JDRF), the leading global organization funding type 1 diabetes (T1D) research, today announced a new collaboration to advance the development of... Read More

Results published in Journal of Trauma and Acute Care Surgery Company also provides update on enrollment progress in Phase 2/3 vascular trauma trial DURHAM, N.C., April 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced the publication of a preclinical study in the Journal of... Read More

DURHAM, N.C., April 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced it has completed enrollment of a Phase 3 trial in hemodialysis access. The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access... Read More

Enrollment Nearing Completion in Human Acellular Vessel™ (HAV™) Phase 2/3 Trial in Vascular Trauma and Phase 3 Trial in Arteriovenous (AV) Access in Hemodialysis Patients Multiple publications and scientific meeting presentations highlighting clinical and preclinical HAV results Conference call and live webcast at 8:00 a.m. ET today DURHAM, N.C., March 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a... Read More

DURHAM, N.C., March 21, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2022, on Friday, March 24, 2023. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and... Read More

DURHAM, N.C., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, and Dale Sander, Chief Financial Officer, will represent Humacyte at the following investor... Read More

HAVs observed to provide long-term perfusion to patients with critical limb ischemia 3D Angiograms show mechanical durability of engineered human blood vessels DURHAM, N.C., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale, today announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov, M.D., Ph.D. and Vasyl... Read More

Lt. General Bruce Green, M.D., USAF-ret. Joins Board of Directors Cindy Cao, Ph.D. Appointed as Chief Regulatory Officer Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced the appointments of two distinguished healthcare professionals to the Company’s Board of Directors and leadership team. Lt. General Bruce Green,... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale, today announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The HAV is designed to offer off-the-shelf availability and resistance to infection, as well as to... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and complex tissue and organ systems at commercial scale, today announced an oral presentation on the Company’s Human Acellular Vessel (HAV) by Todd E. Rasmussen, M.D., FACS, (Col, ret. USAF MC) at the 44 th International Committee on Military Medicine (ICMM) World Congress was given... Read More

Human Acellular Vessels™ (HAVs™) successfully implanted in wounded Ukrainian citizens and reported to be functioning, saving limbs Hosted key opinion leader (KOL) webinar on HAV in the treatment of vascular trauma, featuring Ernest E. Moore, M.D and Gregory A. Magee, M.D. Strengthened Board of Directors with appointment of Diane Seimetz, Ph.D. and leadership team with appointment of Shamik Parikh, M.D. as Chief Medical... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the second quarter ended June 30, 2022, on Friday, August 12, 2022. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title: Humacyte Second Quarter 2022 Financial... Read More

Preclinical model data expected to support development of small diameter HAV to treat patients with coronary artery disease Small-diameter HAV observed to maintain patency and exhibit host-cell remodeling at six months post-implantation in a non-human primate model Results presented at American Heart Association Basic Cardiovascular Sciences Scientific Sessions 2022 Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced that six-month outcomes from a preclinical study of a small diameter Human Acellular Vessel™ (HAV TM ) in coronary artery bypass grafting will be presented at the Basic Cardiovascular Sciences (BCVS) Scientific Sessions taking place in Chicago, IL July 25-28, 2022.... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that it will host a key opinion leader (KOL) webinar on its proprietary Human Acellular Vessels (HAV™) in the treatment of vascular trauma on Thursday, July 14, 2022 at 11:30 a.m. Eastern Time. The webinar will feature presentations from KOLs Ernest... Read More

HAV implanted in nearly 500 patients with more than 1,000 patient-years of follow up to date, for treatment of peripheral arterial disease, arteriovenous access for hemodialysis, and trauma Immediately-available HAV, if approved, would represent significant and innovative advancements for vascular repair and replacement conduits Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Diane Seimetz, Ph.D., to its board of directors. “Diane is an innovator and strategist with extensive experience in the biopharmaceutical industry, and we are delighted to welcome her to the Humacyte board,” said Kathleen Sebelius,... Read More

Successful first two HAV implantations in wounded Ukrainian citizens HAVs were provided under Humacyte’s initiative to assist Ukraine humanitarian medical effort Provides further real-world evidence of the potential of HAV treatment for trauma Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that... Read More

Data indicate HAV does not stimulate increase in panel reactive antibodies, an adaptive immune response correlated with increased risk of implant failure Data presented today in IMPACT session at American Transplant Congress (ATC) 2022 Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today presented data on more... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Dale Sander, Chief Financial Officer, and Heather Prichard, Ph.D., Chief Operating Officer, will deliver a corporate presentation in-person at the H.C. Wainwright Global Investment Conference taking place both virtually and in-person at the... Read More

Human Acellular Vessels™ (HAVs™) shipped to six hospitals in Ukraine for treatment of civilian and military vascular trauma injuries Strengthened leadership team with appointment of Shamik Parikh M.D., as Chief Medical Officer Multiple scientific meeting presentations and publications highlighting clinical and preclinical HAV data Conference call and live webcast at 8:00 a.m. ET today Humacyte, Inc. (Nasdaq: HUMA), a... Read More

First shipment of HAVs to six Ukrainian hospitals made today Product candidate to be used for civilian and military vascular trauma repair, the HAV’s lead investigational indication Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the launch of an initiative to provide Human Acellular Vessels... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the first quarter ended March 31, 2022, on Friday, May 13, 2022. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title: Humacyte First Quarter 2022 Financial... Read More

Seasoned physician, scientist and life science executive brings expertise in clinical research and development across product life cycle Key appointment as Humacyte advances HAV through multiple late-stage clinical trials in initial vascular applications Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that its 2022 annual meeting of shareholders will be held virtually on Thursday, June 9, 2022, at 7:30 AM eastern time. The record date for those eligible to receive notice of and to vote at the annual meeting is Monday, April 18, 2022. About... Read More

Advancing late-stage clinical and preclinical programs of the Human Acellular Vessel™ (HAV™) and other engineered tissues across several indications Multiple publications and scientific meeting presentations highlighting clinical and preclinical HAV results Conference call and live webcast at 8:00 am ET today Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and full year ended December 31, 2021, on Tuesday, March 29, 2022. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title: Humacyte Fourth... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, and Dale Sander, Chief Financial Officer, will represent Humacyte at the following investor conferences in March. Cowen’s 42nd Annual Health Care Conference (March 7-9, 2022) Format: Virtual... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, and Dale Sander, Chief Financial Officer, will participate in a virtual fireside chat at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Feb. 15, 2022, at 9... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that results from the first series of compassionate use cases of Humacyte’s Human Acellular Vessel TM (HAV) will be presented at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society (VESS) in Snowmass, Colo. at 7:56 a.m.... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the first preclinical results of the use of Humacyte’s Human Acellular Vessel™ (HAV) in coronary artery bypass grafting (CABG) will be presented at the Advanced Therapies Week conference in Miami, Fla. at 9:20 a.m. EST on January 28, 2022. The... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Surgical Key Opinion Leaders (KOLs) Alan P. Kypson, M.D., FACS; Luigi Pascarella, M.D., FACS; and Todd E. Rasmussen, M.D., FACS, (Col, ret. USAF MC), to new advisory positions. In these roles, the KOLs will lend their expertise and... Read More

Vanderbilt University Medical Center patient received the HAV under the U.S. Food and Drug Administration’s (FDA) Expanded Access Program (EAP) in April 2019 After replacement, the patient resumed regular physical activity with no signs of infection of the HAV implant observed Published in Journal of Vascular Surgery: Cases, Innovations and Techniques HAV used in 20 EAP cases to date, for treatment of severe vascular disease... Read More

Patency and host cell remodeling of the HAV were observed in all study implants Preclinical study is one component of Humacyte’s expansion of the testing of the HAV in a broader cardiac bypass surgery application Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced positive results from a preclinical... Read More

Performance of HAVs produced in the LUNA200™ commercial-scale system demonstrated efficacy that is similar to prior HAV performance in dialysis access trials 83% secondary patency observed at 12 months post-implantation Data presented today in keynote presentation at 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021) Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage... Read More

Completed business combination with Alpha Healthcare Acquisition Corp. and raised $242M in proceeds Progressed advanced-stage clinical- and early-stage programs of the human acellular vessel (HAV™) and other engineered tissue platform applications Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, will present at the Credit Suisse 30th Annual Healthcare Conference taking place virtually, on Nov. 10, 2021, at 1 p.m. EST. The webcast will be available for replay for at least 30 days... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that leadership will present new data and additional information on its programs at several scientific events in November 2021. “Humacyte is creating off-the-shelf universally implantable bioengineered human tissues to potentially transform the... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at seven scientific and industry events in October 2021. “We’ve made remarkable progress with our human acellular vessel (HAV) and continue to advance the HAV through multiple late-stage clinical and preclinical... Read More

Patent estate also expanded by the issuance of 23 additional patents in international markets Humacyte now owns or licenses 119 patents covering its proprietary platform Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the issuance of three additional U.S. patents covering its proprietary... Read More

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at five scientific and medical events in September 2021. “We’re pioneering the first engineered off-the-shelf human acellular vessel (HAV) and are wholly committed to realizing the full potential of our HAV across... Read More