HAV

Humacyte First Quarter 2023 Financial Results and Business Update

Retrieved on: 
Friday, May 12, 2023
Infection, JDRF, Kidney disease, Biologics license application, Surgeon, File, Conference call, AC 25.1309-1, Aneurysm, Survival, Research, Trauma center, Sale, Dialysis, Regenerative medicine, Incidence, Polytetrafluoroethylene, Ischemia, Journal, Publication, Patient, Investment, Level, HUMA, Host, Hemodialysis, BVP, FDA, HAV, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Conference, Food, Safety, Fistula, Pharmaceutical industry, Hospital, Video game, Trauma

DURHAM, N.C., May 12, 2023 (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 first quarter ended March 31, 2023, and highlighted recent corporate accomplishments.

Key Points: 
  • ET today -
    DURHAM, N.C., May 12, 2023 (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 first quarter ended March 31, 2023, and highlighted recent corporate accomplishments.
  • There was no revenue for the first quarter of 2023, compared to $0.2 million for the first quarter of 2022.
  • Research and development expenses were $17.3 million for the first quarter of 2023, compared to $16.3 million for the first quarter of 2022.
  • Net cash used in operations was $18.6 million for the first quarter of 2023 compared to $18.8 million for the first quarter of 2022.

Humacyte and Oberland Capital Announce Funding Arrangement Totaling Up to $160 Million

Retrieved on: 
Friday, May 12, 2023
FDA, HAV, BLA, File, HUMA, Security (finance), 3D printing

DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA) and Oberland Capital Management LLC (Oberland Capital) today announced a $150 million, capped funding arrangement based on future revenues of Humacyte’s Human Acellular Vessel™ (HAV™), as well as a $10 million equity investment option. Funding provided to Humacyte under the arrangement includes:

Key Points: 
  • - $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 -
    DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA) and Oberland Capital Management LLC (Oberland Capital) today announced a $150 million, capped funding arrangement based on future revenues of Humacyte’s Human Acellular Vessel™ (HAV™), as well as a $10 million equity investment option.
  • Funding provided to Humacyte under the arrangement includes:
    Humacyte has also granted an option for Oberland Capital to purchase up to $10 million in common stock priced at the greater of $7.50 per share or the market price per share.
  • “We are very pleased to enter into this funding arrangement with Oberland Capital that extends our cash runway and provides additional resources to support our development and commercialization initiatives, particularly as we move closer to our planned BLA filing,” said Dale Sander, Chief Financial Officer of Humacyte.
  • “We are excited to partner with the team at Oberland Capital and appreciate their extensive experience in the life science industry.”
    Michael Bloom, Partner at Oberland Capital added: “We are excited to enter into this revenue-based funding agreement with Humacyte as it prepares for the launch of its innovative HAV in urgent arterial repair following vascular trauma.

Humacyte Announces Publication in Lancet Regional Health - Europe Presenting Use of Human Acellular Vessel™ (HAV™) to Treat Vascular Injuries in Ukraine

Retrieved on: 
Tuesday, May 9, 2023
Infection, Injury, US Foods, Surgeon, International, Amputation, AC 25.1309-1, Trauma, Trauma center, Sale, Military personnel, Regenerative medicine, Biological engineering, Hospital, Patent, Patient, Level, HUMA, Peripheral artery disease, FDA, HAV, Letter, Buddha's hand, BLA, Food, Pharmaceutical industry, Medical device, Health

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 encouraging experience of Humacyte’s investigational Human Acellular Vessel (HAV) in treating battlefield and other vascular trauma injuries suffered in Ukraine-Russia conflict.

Key Points: 
  • Humacyte’s initial shipment of HAVs arrived in Ukraine in May 2022, in response to requests from surgeons on the frontlines in that country.
  • Additionally, Ukrainian surgeons were virtually trained by video conference to learn the procedures for HAV implantation into patients.
  • Since June 2022, 18 patients (13 at time of publication submission) in Ukraine have been treated with the HAV to repair vascular trauma and thereby prevent amputation.
  • Three patients received the HAV to treat arterial wounds after failure of their initial vascular repairs using vein or synthetic grafts.

Humacyte’s Human Acellular Vessel™ (HAV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Urgent Arterial Repair Following Vascular Trauma

Retrieved on: 
Thursday, May 4, 2023
Infection, Biologics license application, File, Trauma, Trauma center, Sale, Military personnel, Regenerative medicine, Patient, Level, HUMA, FDA, HAV, BLA, Food, Pharmaceutical industry, Medical device

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 Therapy (RMAT) designation for its Human Acellular Vessel (HAV) for urgent arterial repair following extremity vascular trauma. The FDA’s RMAT designation is for breakthrough therapy of regenerative medicine. The designation allows for more interactions with the FDA and expedited development and review of regenerative medicine products within the U.S., including the potential for priority review process for a Biologics License Application (BLA). This is the second RMAT designation granted by the FDA for Humacyte’s HAV, in addition to a previous RMAT granted for arteriovenous (AV) access in hemodialysis.

Key Points: 
  • 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 Therapy (RMAT) designation for its Human Acellular Vessel (HAV) for urgent arterial repair following extremity vascular trauma.
  • The FDA’s RMAT designation is for breakthrough therapy of regenerative medicine.
  • “We are delighted to receive our second RMAT designation from the Food and Drug Administration,” said Dr. Cindy Cao, Chief Regulatory Officer at Humacyte.
  • Humacyte’s HAV is designed to be a universally implantable vascular conduit for use in vascular repair.

Humacyte, JDRF Collaborating to Develop Insulin-Producing Biovascular Pancreas to Treat Type 1 Diabetes

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Thursday, April 27, 2023
Tissue, JDRF, Diabetes, Biotechnology, Survival, Research, Sale, Organization, Criticism of the Food and Drug Administration, Patient, HUMA, BVP, HAV, Food, Disease, Pharmaceutical industry, Medical device, T1D

Humacyte’s BVP is designed to deliver insulin-producing islets using Humacyte’s investigational tissue-engineered blood vessel, the Human Acellular Vessel™ (HAV™).

Key Points: 
  • Humacyte’s BVP is designed to deliver insulin-producing islets using Humacyte’s investigational tissue-engineered blood vessel, the Human Acellular Vessel™ (HAV™).
  • JDRF will provide Humacyte with funding to support the development and testing of the BVP.
  • “We are proud to be collaborating with JDRF, one of the leading organizations in the world focused on T1D research,” said Dr. Laura ​​Niklason, founder and CEO of Humacyte.
  • “Humacyte’s HAV technology, combined with insulin-producing islets, may constitute a groundbreaking development in the treatment of T1D in the future.

Humacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma

Retrieved on: 
Tuesday, April 18, 2023
Infection, Biologics license application, Failure, Amputation, AC 25.1309-1, Aneurysm, Iliac artery, Reperfusion injury, Sale, Military personnel, Incidence, Polytetrafluoroethylene, Ischemia, Journal, Animal, Patient, HUMA, Host, Peripheral artery disease, FDA, HAV, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Medical imaging, Trauma

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 Trauma and Acute Care Surgery comparing the use of its Human Acellular Vessel (HAV) to expanded polytetrafluorethylene (ePTFE) grafts for vascular repair following arterial trauma. In the preclinical study the HAV performed better than ePTFE on multiple indices.

Key Points: 
  • In the preclinical study the HAV performed better than ePTFE on multiple indices.
  • In this comparative preclinical study, 36 pigs were randomly assigned to treatment groups receiving either the HAV or an ePTFE graft to reconstruct a severed iliac artery after vascular trauma.
  • At the conclusion of the study, the HAV and ePTFE implants were removed and histologically evaluated for host cellular response.
  • The publication of this preclinical study comes as Humacyte nears the completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of vascular trauma.

Humacyte Completes Enrollment in Phase 3 Trial of Human Acellular Vessel™ (HAV™) for Hemodialysis Access in End-Stage Renal Disease Patients

Retrieved on: 
Tuesday, April 11, 2023
Infection, Comparison, Kidney disease, ESRD, Catheter, Obesity, Failure, Chronic kidney disease, Dialysis, Survival, Clinical trial, Skin, Fungal infection, Cell, Sale, Fast track (FDA), Regenerative medicine, Patient, Risk, HUMA, Blood, AV, FDA, HAV, Disease, Safety, Fistula, Pharmaceutical industry, Medical device

The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.

Key Points: 
  • The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.
  • The Phase 3 trial, labeled V007, is a prospective, multi-center, randomized, comparative study in 240 hemodialysis patients suffering from ESRD in the United States.
  • Enrolled individuals were randomly assigned to either the ​​HAV, or an AV fistula for hemodialysis.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Humacyte Announces Fourth Quarter and Year End 2022 Financial Results and Business Update

Retrieved on: 
Friday, March 24, 2023
Infection, Tissue, CABG, Heart, Insurance, Biologics license application, KOL, Amputation, American Heart Association, Kidney, Conference call, PAD, DRS, Research, Sale, AHA, Facial muscles, Net, Congress, MAC, Patient, Investment, HUMA, Rejection, Peripheral artery disease, AV, FACS, FDA, HAV, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Trauma, BLA, Conference, Food, Pharmaceutical industry, Video game, Cryptocurrency

DURHAM, N.C., March 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 announced financial results for the fourth quarter and year ended December 31, 2022, and highlighted recent corporate accomplishments.

Key Points: 
  • There was no revenue for the fourth quarter of 2022 compared to $177.0 thousand for the fourth quarter of 2021, and revenue was $1.6 million for the year ended December 31, 2022, compared to $1.3 million for the year ended December 31, 2021.
  • Research and development expenses were $15.0 million for the fourth quarter of 2022, compared to $16.3 million for the fourth quarter of 2021, and were $63.3 million for the year ended December 31, 2022, compared to $61.3 million for the year ended December 31, 2021.
  • The decrease for the quarter ended December 31, 2022 compared to the prior-year quarter resulted primarily from a decrease in non-cash stock-based compensation expense.
  • Other net income was $17.1 million for the fourth quarter of 2022, compared to $64.2 million for the fourth quarter of 2021, and was $72.6 million for the year ended December 31, 2022, compared to $54.7 million for the year ended December 31, 2021.

INKIND HOSPITALITY ANNOUNCES $250 MILLION COMMITMENT TO SUPPORT MINORITY-OWNED AND UNDERREPRESENTED RESTAURANT OPERATORS

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Wednesday, March 22, 2023
Heart, James Beard Foundation Award: 2010s, Gastroenteritis, Immigrant Food, Probability, Chopped, Hospitality industry, COVID, CMO, Michelin Guide, MAPP, World Central Kitchen, Franchise, HAV, Bake Squad, Camphor, Ivanović, Restaurant, Denihan Hospitality Group, City, Entrepreneurship, ESG, Policy, City Winery, Food, Management

AUSTIN, Texas, March 22, 2023 /PRNewswire/ -- inKind—the innovative restaurant fintech startup with more than 700 restaurants in its expanding national network—held its inaugural Equity Eats Summit last week at its headquarters in Austin, TX, during which they announced their $250 million commitment to fund underrepresented independent restaurant operators by 2025.

Key Points: 
  • "We created this funding platform to advance systemic change," said inKind CEO Johann Moonesinghe.
  • "While inKind has a proven track record of supporting underserved restaurant operators, there is more we can do to create pathways to financial sustainability, especially around property ownership."
  • In addition to providing vital funding, inKind is also establishing a complementary programmatic component: the Restaurant Operators Alliance.
  • Instead of a funding-only model, inKind recognizes the need to galvanize capital with resources like training, marketing support, and mentorship.

Humacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease

Retrieved on: 
Tuesday, January 24, 2023
Disease, Thrombosis, Journal, Infection, Food, Rest, Chronic kidney disease, HUMA, Quality of life, PAD, Research, Sale, HAV, Patient, Pomeranian Medical University in Szczecin, Amputation, Holm–Bonferroni method, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, General surgery, Tissue, Pain, Pharmaceutical industry

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 announced the publication of “6-Year Outcomes of a Phase 2 Study of Human-Tissue Engineered Blood Vessels for Peripheral Arterial Bypass,” in the Journal of Vascular Surgery – Vascular Science. The publication describes the long-term analysis of the Company’s Phase 2 clinical trial evaluating the bioengineered HAV as a conduit in patients with symptomatic peripheral artery disease (PAD). The researchers concluded that “the infection-resistant, off-the-shelf human acellular vessel could provide a durable alternative conduit in the arterial circuit setting, to restore lower extremity blood supply in patients with peripheral artery disease.”

Key Points: 
  • The publication describes the long-term analysis of the Company’s Phase 2 clinical trial evaluating the bioengineered HAV as a conduit in patients with symptomatic peripheral artery disease (PAD).
  • No patients reported pain at rest or ischemic ulcers on the affected legs.
  • “Key findings of this publication show that the HAV was durable and performed well in a medically complex patient cohort for long-term treatment of PAD.
  • The HAV is an investigational product and has not been approved for sale by the U.S. Food and Drug Administration or any international regulatory agency.