HAV

Humacyte to Host Virtual KOL Event “Hemodialysis Access: A Crossroads of Care,” on March 28, 2024

Retrieved on: 
Tuesday, March 26, 2024
AV, Food, Priority review, FDA, BLA, HAV

In addition, in April 2023 Humacyte completed enrollment in a Phase 3 trial in AV Access comparing the HAV to the current standard of care, autologous arteriovenous fistula.

Key Points: 
  • In addition, in April 2023 Humacyte completed enrollment in a Phase 3 trial in AV Access comparing the HAV to the current standard of care, autologous arteriovenous fistula.
  • Top-line results are planned to be available during 2024.
  • A live question and answer session will follow the formal presentations.
  • A replay will be made available here after the call.

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

Retrieved on: 
Friday, March 22, 2024
Diagnosis, Research, U.S. FDA, Peripheral artery disease, Infection, Patent, Buddha's hand, Evaluation, PAD, Journal, Sale, University, Doctor of Philosophy, Efficacy, Priority review, Regenerative medicine, Clinical trial, Trial of the century, Vascular surgery, HAV, Hospital, Injury, Nationwide Children's Hospital, HUMA, FACS, Amputation, Food, FDA, Defense, BLA, PDUFA, Pharmaceutical industry

DURHAM, N.C., March 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 financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
  • Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
  • The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.

Synopsys Announces New AI-Driven EDA, IP and Systems Design Solutions At SNUG Silicon Valley

Retrieved on: 
Wednesday, March 20, 2024
Cloud, Momentum, CVP, Socs, History, IP, PUF, Microsoft, 4X, Synthetic media, Intel, Webcast, 3D, Software, Ghazi, HAV, Compiler, PPA, Intrinsic and extrinsic properties, RTL, EDA, News, Acquisition, AI, Field-programmable gate array, Architecture, Samsung, AMD, Santa Clara Convention Center, Engineering, UCIe, Stunning, Ecosystem, EP2, SNPS, Generative, TSMC, Video game

SUNNYVALE, Calif., March 20, 2024 /PRNewswire/ -- Today Synopsys, Inc. (Nasdaq: SNPS) kicked off its annual flagship Synopsys User Group (SNUG) conference in Silicon Valley at the Santa Clara Convention Center with a keynote presentation by Synopsys president and CEO Sassine Ghazi. Ghazi discussed the unprecedented innovation opportunities and challenges that technology R&D teams face in this era of pervasive intelligence. He also announced new EDA and IP solutions aimed at maximizing the capabilities of the global technology engineering teams, from silicon to systems, that Synopsys serves.

Key Points: 
  • (Nasdaq: SNPS ) kicked off its annual flagship Synopsys User Group (SNUG) conference in Silicon Valley at the Santa Clara Convention Center with a keynote presentation by Synopsys president and CEO Sassine Ghazi.
  • He also announced new EDA and IP solutions aimed at maximizing the capabilities of the global technology engineering teams, from silicon to systems, that Synopsys serves.
  • The company plans to discuss its growing design IP business during this afternoon's investor meeting, which is co-located with SNUG Silicon Valley.
  • Happening March 20 and 21 in Santa Clara, Calif., SNUG Silicon Valley gathers the global Synopsys design community to discuss technology advancements, challenges, strategic collaborations, and business opportunities.

Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma

Retrieved on: 
Friday, February 9, 2024
MD, FDA, Food, HAV, Injury, Defense, Diagnosis, Sale, Amputation, PDUFA, Peripheral artery disease, Surgeon, Infection, Patient, Priority review, BLA, Regenerative medicine, Doctor of Philosophy, HUMA, Pharmaceutical industry

DURHAM, N.C., Feb. 09, 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 the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.

Key Points: 
  • This targeted PDUFA date is based on the Priority Review grant, which is a mechanism reserved by FDA for products that, if approved, would significantly improve the treatment, diagnosis, or prevention of serious conditions.
  • Priority Review applications have a six-month review time instead of ten months for a standard review.
  • The Priority Review aligns with the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2023 for urgent arterial repair following extremity vascular trauma.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Humacyte Submits Biologics License Application (BLA) to U.S. FDA Seeking Approval of Human Acellular Vessel™ (HAV™) for the Treatment of Vascular Trauma

Retrieved on: 
Tuesday, December 12, 2023
Food, Priority review, Infection, HUMA, Injury, FDA, File, HAV, Tissue, MD, Doctor of Philosophy, Biologics license application, Defense, Amputation, Public law, Patient, Food and Drug Administration, BLA, Pharmaceutical industry

DURHAM, N.C., Dec. 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 that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

Key Points: 
  • The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine.
  • The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.
  • Humacyte has requested Priority Review of the application and, if granted, the review should be completed within six months of the filing acceptance date.
  • In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma.

Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma

Retrieved on: 
Friday, November 17, 2023
Sale, Efficacy, Food, Extremities, BLA, Ernest, Denver Health Medical Center, Risk, Surgeon, Clinical trial, Meta-analysis, Amputation, Constipation, Peripheral artery disease, HAV, Thrombocytopenia, Research, Death, FDA, FACS, Army, HUMA, Standard of care, Infection, File, University, Tachycardia, Vascular surgery, Doctor of Philosophy, Anemia, Evaluation, Common, Biologics license application, Saphenous, Injury, Trial of the century, Pharmaceutical industry, Medical imaging, Medical device, Fever, MD, Patient, Safety

DURHAM, N.C., Nov. 17, 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 presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel (HAV) in the treatment of vascular trauma, as well as results from the treatment of wartime injuries in Ukraine. The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City. Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration (FDA) during the current quarter.

Key Points: 
  • The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City.
  • Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.
  • Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial.
  • Common adverse events reported were anemia, vascular graft thrombosis, blood loss anemia, pyrexia, thrombocytopenia, constipation, nausea peripheral edema, and tachycardia.

Humacyte Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, November 9, 2023
Sale, Trauma, Patient, Nationwide Children's Hospital, Research, Conference, Infection, Military personnel, Human, Food, Conference call, Journal, Clinical professor, HUMA, Moyamoya disease, Trial of the century, Extremities, BLA, PAD, Buddha's hand, Amputation, Injury, Saphenous, Chin Na, Patent, Gunshot, Polytetrafluoroethylene, Clinical trial, Peripheral artery disease, Chronic limb threatening ischemia, HAV, Dialysis, FDA, Success, File, Survival, Mayo Clinic, Accident, Hospital, Pharmaceutical industry, Medical device, Tetralogy of Fallot

DURHAM, N.C., Nov. 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 financial results for the third quarter ended September 30, 2023 and highlighted recent corporate accomplishments advancing the investigational, universally implantable Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • In addition, we recently published preclinical results of our small caliber HAV in a juvenile heart disease model.
  • Planned BLA Filing this Quarter – Humacyte plans to file a BLA for the HAV for the treatment of vascular trauma with the FDA during the current quarter.
  • There was no revenue for the third quarter of 2023 and nine months ended September 30, 2023.
  • The decrease in other net expense for the third quarter of 2023 compared to 2022 resulted primarily from an increase in interest income due to rate increases.

Paragon 28 Adds Second Mobile Medical Education Lab Significantly Expanding Upon Wildly Successful Foot and Ankle Surgeon Training Program

Retrieved on: 
Monday, November 13, 2023
Education, Health, Medical Devices, Surgery, Physical Therapy, General Health, Training, Paragon, Foot, City, Surgeon, NYSE, HAV, Multimedia, Entrepreneurship, FNA, Mobile telephony

Paragon 28, Inc. (NYSE: FNA) is pleased to announce the addition of a second trailer to its nationwide mobile lab training program making it even more convenient for the company to facilitate on-site surgeon training and education.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA) is pleased to announce the addition of a second trailer to its nationwide mobile lab training program making it even more convenient for the company to facilitate on-site surgeon training and education.
  • View the full release here: https://www.businesswire.com/news/home/20231113417213/en/
    Paragon 28 Mobile Training Lab (Graphic: Business Wire)
    “We are very excited to add a second lab to our mobile education program and increase our ability to bring education directly to surgeons.
  • The mobile lab program has allowed Paragon 28 to find the most effective venue for medical education to support our growing product portfolio and surgeon customers,” said Albert DaCosta, CEO and Co-Founder of Paragon 28.
  • “The mobile lab program has proven to be a versatile option to showcase P28’s broad and innovative product portfolio which includes new solutions in the growing forefoot, HAV, and hindfoot market segments.”
    To learn more about the Paragon 28 Surgeon Mobile Lab, please visit the following site: Paragon 28 Mobile Lab

National Safety Council Hosts Second Annual Safety Innovation Challenge

Retrieved on: 
Wednesday, October 25, 2023
MSD, Knowledge, DSM-IV codes, United Kingdom, Council, Hand, Trilogy, Innovation, Congress, Construction, Workplace, Safety, Organization, Shoulder, National Safety Council, Injury, NSC, Risk management, World Health Organization, Risk, Hilti, HAV, Amazon, Foreign policy, Motion, Logging, Medical device, Personal protective equipment

NEW ORLEANS, Oct. 25, 2023 /PRNewswire/ -- Continuing its commitment to safety innovation, the National Safety Council convened six leading technology providers from around the globe to showcase their cutting-edge safety solutions during the second annual Safety Innovation Challenge. Hosted in collaboration with Safetytech Accelerator, the challenge builds on the tremendous progress made by the Council's MSD Solutions Lab – a groundbreaking program established in 2021 with funding from Amazon – to help organizations of all sizes prevent musculoskeletal disorders, or MSDs.

Key Points: 
  • NEW ORLEANS, Oct. 25, 2023 /PRNewswire/ -- Continuing its commitment to safety innovation, the National Safety Council convened six leading technology providers from around the globe to showcase their cutting-edge safety solutions during the second annual Safety Innovation Challenge.
  • "Events like the Safety Innovation Challenge are crucial to democratizing knowledge and access to safety technology like ours, and we are proud to participate in this year's challenge to be part of the solution in addressing upper-extremity MSDs."
  • "This is precisely what the National Safety Council annual Safety Innovation Challenge is all about, and we are honored to support their ongoing work to convene the industry's brightest minds and best resources to help organizations implement solutions, assess data and measure progress."
  • The Safety Innovation Challenge is one of several initiatives led by the National Safety Council to achieve its goal of preventing MSDs before they start.

Humacyte Publishes Preclinical Results Showing Human Acellular Vessel™ (HAV™) Patency as Modified Blalock–Taussig–Thomas Shunt in Juvenile Primate Model

Retrieved on: 
Monday, October 16, 2023
Patent, HAV, Buddha's hand, The Journal of Thoracic and Cardiovascular Surgery, Research, Nationwide, CABG, Heart, Tetralogy of Fallot, Hospital, FDA, Nationwide Children's Hospital, Regenerative medicine, National Center for Regenerative Medicine, Tetralogy, HUMA, Peripheral artery disease, Child, Patient, Sale, Pharmaceutical industry, Dentistry

The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled “ Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model, ” describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.

Key Points: 
  • The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled “ Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model, ” describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.
  • The study assessed the HAV’s patency, structure, and blood flow from one week to six months after the implant.
  • This study also demonstrates the successful extension of Humacyte’s manufacturing platform, from the production of 6.0mm vessels to 3.5mm vessels.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.