HUMACYTE, INC


Associated tags: Fast track (FDA), Buddha's hand, Injury, Patient, HUMA, Tissue, Moyamoya disease, HAV, Medicine, Pharmaceutical industry, Vibration, Defense, Food, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration

Locations: NEW YORK, NY, DURHAM, NC, US, UKRAINE, COLUMBUS, UNITED STATES, NEW YORK CITY

Humacyte to Participate in Fireside Chat at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

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Wednesday, February 9, 2022
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DURHAM, N.C., Feb. 09, 2022 (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., 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 a.m. EST.

Key Points: 
  • DURHAM, N.C., Feb. 09, 2022 (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., 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 a.m. EST.
  • Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs designed to improve the lives of patients and transform the practice of medicine.
  • The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions.
  • Humacytes initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease.

Humacyte Announces Clinical Case Series Demonstrating Potential of Human Acellular Vessel™ (HAV™) to Expand Opportunities for Limb Salvage in Multiple Complex Vascular Reconstruction Scenarios

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Monday, January 31, 2022
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DURHAM, N.C., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced results from the first series of compassionate use cases of Humacyte’s investigational Human Acellular Vessel (HAV) for the treatment of critical limb ischemia and vascular trauma. The HAVs were observed to remain patent and infection free in patients requiring vascular reconstruction, thereby highlighting the potential of the HAV to expand limb salvage options for patients who have exhausted current revascularization conduit options. These results were presented at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society (VESS).

Key Points: 
  • Each of the patients had severe peripheral arterial disease (PAD) or vascular injury requiring vascular reconstruction but lacked other treatment options and were at risk for limb loss.
  • Researchers treating these patients concluded that the HAV may greatly expand opportunities for limb salvage in trauma and urgent vascular reconstruction when patients lack suitable alternative conduits.
  • The HAV is currently being evaluated in late-stage clinical trials in vascular trauma repair, arteriovenous access for hemodialysis, and PAD.
  • Human Acellular Vessels (HAV) are engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement.

Humacyte Announces Preclinical Results of Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting

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Friday, January 28, 2022
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DURHAM, N.C., Jan. 28, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced results from the first preclinical study of the use of Humacyte’s small-diameter (3.5mm) Human Acellular Vessel (HAV) in coronary artery bypass grafting (CABG), which were presented at Advanced Therapies Week. The HAV maintained patency and exhibited host-cell remodeling and regeneration in a non-human primate model.

Key Points: 
  • In the preclinical study, the 3.5mm HAVs were implanted into primates following ligation of the native right coronary artery, and the primates were studied for six months.
  • Coronary artery bypass grafting is one of the most common surgical procedures in the U.S., but it currently requires surgically harvesting a saphenous vein for grafting.
  • Humacyte also presented preclinical data on the 3.5mm HAV in pediatric heart disease at the American Heart Associations Scientific Sessions 2021.
  • Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.

Humacyte Announces Presentation of First Eight Expanded Access Cases Using Human Acellular Vessel™ (HAV) for Treatment of Critical Limb Ischemia at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society

Retrieved on: 
Thursday, January 6, 2022
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The presentation will describe the outcomes of HAV implantation into eight patients for the treatment of critical limb ischemia, under the U.S. Food and Drug Administrations (FDA) Expanded Access Program (EAP).

Key Points: 
  • The presentation will describe the outcomes of HAV implantation into eight patients for the treatment of critical limb ischemia, under the U.S. Food and Drug Administrations (FDA) Expanded Access Program (EAP).
  • The HAV has been used in EAP cases for patients with severe PAD and vascular injury for whom there are limited treatment options.
  • The VESS presentation will highlight eight HAV implantations in patients with PAD or vascular injury who had exhausted other treatment options and would have otherwise faced amputation and limb loss.
  • The Annual Meeting of the VESS brings together internationally recognized, fellowship-trained vascular surgeons, and provides the premiere forum to promote the field of vascular and endovascular surgery through education, advocacy and leadership.

Humacyte Announces Presentation of First Preclinical Results of the HAV™ in Coronary Artery Bypass Grafting at Advanced Therapies Week Conference

Retrieved on: 
Tuesday, January 4, 2022
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The presentation, titled Bioengineering and the Future of Cardiac Surgery, will be made by Alan P. Kypson, M.D., FACS.

Key Points: 
  • The presentation, titled Bioengineering and the Future of Cardiac Surgery, will be made by Alan P. Kypson, M.D., FACS.
  • The presentation by Dr. Kypson will include the results of the use of the HAV in a primate CABG model, including six-month outcomes.
  • We look forward to Dr. Kypsons presentation at the Advanced Therapies Week conference this month.
  • Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.

Humacyte Announces the Appointments of Three Surgical and Cardiovascular Opinion Leaders to Advisory Roles

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Friday, December 31, 2021
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Humacytes HAV are engineered off-the-shelf replacement vessels currently being evaluated in advanced-stage clinical trials in vascular trauma, arteriovenous access for hemodialysis and peripheral arterial disease (PAD).

Key Points: 
  • Humacytes HAV are engineered off-the-shelf replacement vessels currently being evaluated in advanced-stage clinical trials in vascular trauma, arteriovenous access for hemodialysis and peripheral arterial disease (PAD).
  • Dr. Kypson is a cardiothoracic surgeon at the University of North Carolina Rex Hospital, in Raleigh, N.C.
  • Dr. Pascarella has authored many publications in peer-reviewed medical journals, with a focus on vascular surgery, aortic disease and medical education.
  • He is also co-inventor of the lifesaving REBOA device, a minimally invasive technique to manage severe hemorrhage and shock.

Humacyte Announces Publication Highlighting the First Use of the Human Acellular Vessel (HAV™) as Arterial Bypass Conduit for Replacement of Infected Prosthetic Graft

Retrieved on: 
Wednesday, December 15, 2021
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DURHAM, N.C., Dec. 15, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that results from a case study of a patient who received the human acellular vessel (HAV) as a replacement for an infected synthetic iliofemoral bypass graft have been published online in the Journal of Vascular Surgery: Cases, Innovations and Techniques (JVSCIT). The manuscript, entitled “Surgical management of an infected external iliac artery interposition graft with a bioengineered human acellular vessel,” reports the first use of the HAV in the treatment of a patient with an infected prosthetic vascular graft, a procedure performed in April 2019 under an expanded access use authorized by the FDA.

Key Points: 
  • We are pleased that the HAV has continued to function in this patient over an extended period of time.
  • The patient received the HAV, following approval of the EAP from the FDA, at the Vanderbilt University Medical Center.
  • Human Acellular Vessels (HAV) are engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement.
  • The forward-looking statements in this press release represent our views as of the date of this press release.

Humacyte Presents Preclinical Results of Small-Diameter HAV™ for Use as a BTT Shunt in Pediatric Heart Disease at American Heart Association’s Scientific Sessions 2021

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Tuesday, November 16, 2021
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DURHAM, N.C., Nov. 16, 2021 (GLOBE NEWSWIRE) -- 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 study of the small-diameter (3.5mm) HAV in a primate model simulating pediatric heart disease were presented at the American Heart Association’s (AHA) Scientific Sessions 2021.

Key Points: 
  • In this initial preclinical study, five non-immunosuppressed juvenile primates were surgically implanted with the 3.5mm diameter HAVs as modified Blalock-Taussig-Thomas shunts (mBTTs).
  • The mBTT shunt operation is used as an initial stage of some pediatric surgical procedures to repair severe congenital heart defects.
  • The presentation was made at the AHA meeting by Humacyte Senior Preclinical Scientist Kevin Nash, Ph.D.
  • Exploring the potential use of the HAV in cardiac surgical procedures represents a logical expansion of Humacytes bioengineered vascular platform.

Humacyte Presents New 12-Month Data from HAVs™ Produced Using Commercial-Scale Manufacturing System

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Monday, November 15, 2021
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Durham, N.C., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that data from a Phase 2 clinical trial of patients receiving the human acellular vessel (HAV) produced using its cutting-edge, large-scale manufacturing systems, known as “LUNA200”, for vascular access in hemodialysis, demonstrated 12-month efficacy that is similar to trials of HAVs produced in the development-scale systems previously used in manufacturing the HAV.

Key Points: 
  • Secondary patency rates of the HAVs produced using the prior, development-scale systems ranged from 82% to 89%.
  • Each modular, automated LUNA200 system, with enhanced process controls, can grow 200 HAVs at a time.
  • The Durham facility is fully operational, and in 2021 the FDA authorized the use of HAVs produced in the LUNA200 system to supply the Companys ongoing clinical trials in the United States.
  • The 12-month data were presented at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021).

Humacyte Reports Third Quarter 2021 Financial Results and Provides Business Highlights

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Friday, November 12, 2021
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DURHAM, N.C., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the third quarter ended September 30, 2021, and highlighted recent corporate accomplishments.

Key Points: 
  • Humacyte has made great strides advancing our bioengineered tissue platform to create novel human acellular tissues and organs.
  • This quarter was marked with significant corporate progress, including the closing of our business combination agreement with Alpha Healthcare and our debut on Nasdaq.
  • This month we will be sharing late-breaking data on the performance of HAVs manufactured with our commercial-scale LUNA200platform.
  • As a result of the Business Combination, the Company received proceeds of $242.4 million net of offering costs, including a $175 million PIPE financing.