Humacyte is proud to announce that the FDA has granted full approval for our Acellular Tissue Engineered Vessel, a first-in-class, universally implantable, bioengineered human vessel for extremity arterial trauma. This approval is a significant milestone in regenerative medicine, offering a new treatment option for patients with severe arterial injuries. Congratulations to our incredible team and partners who made this possible! Read our Press Release Here:?https://lnkd.in/ehm-q6CX See the Prescribing Information, including Boxed Warning:?https://bit.ly/4dl5tuL #Humacyte #FDAApproval #RegenerativeMedicine #Innovation #Biotech #Firstinclass $HUMA
Humacyte
生物技术研究
Durham,NC 13,031 位关注者
Our vision is to be the global leader in engineering regenerative medicine products to save and improve patient lives.
关于我们
Humacyte, Inc. (Nasdaq: HUMA) is proud to announce that in Dec 2024, FDA granted full approval for our Acellular Tissue Engineered Vessel (ATEV), a first-in-class, universally implantable, bioengineered human vessel for extremity arterial trauma. This approval is a significant milestone in regenerative medicine, offering a new treatment option for patients with severe arterial injuries.See the Prescribing Information, including Boxed Warning: https://bit.ly/4dl5tuL This is the first approval in our bioengineered ATEV Platform where we are continuing to investigate use of our lab-grown tissues and organs to improve the lives of patients and transform the practice of medicine. We develop and manufacture acellular tissues that are meant to be universally implantable and remodel with the patient's own cells over time. The goal is to grow spare parts for people. Humacyte’s ATEV is in clinical trials for arteriovenous access for hemodialysis, and peripheral arterial disease. Investigational 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’s ATEV for performing hemodialysis in AV Access was the first indication to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation, and the ATEV technology received priority designation for the treatment of extremity arterial repair by the U.S. Secretary of Defense prior to its FDA approval in Dec 2024 for that purpose. For more information, visit https://Humacyte.com.
- 网站
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https://humacyte.com
Humacyte的外部链接
- 所属行业
- 生物技术研究
- 规模
- 201-500 人
- 总部
- Durham,NC
- 类型
- 上市公司
- 创立
- 2004
- 领域
- Regenerative Medicine、biotechnology和bioengineering
地点
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主要
2525 E NC Highway 54
2525 E Hwy 54
US,NC,Durham,27713
Humacyte员工
动态
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?? Join an upcoming Endpoints webinar this Wednesday, Mar 26th from 12:30-1 PM ET with Laura Niklason, Ph.D., M.D., Founder, President and CEO of Humacyte. She will be speaking with Ryan Cross, a senior science correspondent, about Humacyte's lab-grown blood vessels and the possibilities of building human organs and tissues. ?? She will be the last interview of the session. You don't want to miss this great discussion! See more below and at the registration page here: https://lnkd.in/g--qQNPg
Join me Wednesday, March 26 for Endpoints News' inaugural science-focused event, Endpoints Catalysts, where I'll be interviewing leaders in three of the most exciting areas of life science research right now: CRISPR gene editing, cell atlases + spatial biology, and regenerative medicine. I'll be speaking to GV (Google Ventures) entrepreneur in residence Nicole M. Gaudelli, UPenn scientist Kiran Musunuru and Prime Medicine, Inc. CEO Keith Gottesdiener about the challenges and opportunities in making CRISPR gene editing cures work for everyone that needs them. Ed Lein from the Allen Institute, Michael Angelo from Stanford University, and Jasmine Plummer from St. Jude Children's Research Hospital will join me for a discussion of cell atlases and how the spatial biology techniques that power them will shape the next decade of biology. And finally I will sit down with regenerative medicine pioneer and Humacyte CEO Laura Niklason, MD, PhD to reflect on the decades-long journey that led to her company's recent FDA approval of lab-grown blood vessels and what it will take to build, replace or regenerate more human tissues and organs. Register to watch here: https://lnkd.in/dxCVx4gz
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Humacyte转发了
On March 6th, Humacyte (#HUMA) hosted an in-person and virtual investor event featuring Dr. Michael Curi (Rutgers New Jersey Medical School), and Dr. Sammy Siada (UCSF Fresno), who joined company management to discuss the commercial plans and early market-launch success of Symvess (acellular tissue engineered vessel-tyod) for extremity arterial injury.? ? If you missed the event, you can now access the replay through this link!?https://lnkd.in/e6PY9tBd #HealthcareInnovation #Medtech #LifeSciences #Biotechnology #ExtremityArterialInjury
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We hope you had a chance to visit with us or see our presentation during OPMED 2025 in San Antonio, Tx. Thank you to the Defense Strategies Institute for hosting OPMED and to all the Department of Defense (DOD) personnel who participate in the conference. We appreciate your engagement and interest in Symvess?, our first-in-class, universally implantable, bioengineered human vessel for urgent extremity arterial replacement and repair. With our recent FDA approval and full civilian and military commercial launch, we are excited about helping you and your teams understand more about this new vascular treatment option and grateful for all your questions.? These conferences are packed with great educational opportunities but often don’t leave enough time to tackle all your questions.??Please Contact Us to help you now. We look forward to continuing the conversations! ?? Contact Us Here:?https://lnkd.in/eZdSFPaK SEE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING at https://bit.ly/4dl5tuL See Full Important Safety Information at https://bit.ly/ATEV_ISI INDICATION SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. BOXED WARNING: GRAFT FAILURE: loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy after acute injury resolution. WARNINGS AND PRECAUTIONS: Vascular Graft Rupture, Anastomotic Failure, and Thrombosis have occurred in patients treated with SYMVESS. SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or agents; none have been reported during clinical testing. ADVERSE REACTIONS: most common (≥3%): thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.? ATEV, Humacyte, and Symvess are trademarks of Humacyte Inc.? ? 2025 Humacyte Global Inc. All Rights Reserved. US-SYM-000210 #Humacyte #OPMED2025 #RegenerativeMedicine #Innovation #Biotech #Firstinclass $HUMA
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The Humacyte team is at OPMED! Stop by booth 302 to see and learn more about Symvess?, a first-in-class, universally implantable, bioengineered human vessel for extremity vascular trauma replacement and repair. With recent FDA Approval and full civilian and military commercial launch our team is ready to meet with you! Learn more about Symvess here:?https://lnkd.in/e2jnB-eg SEE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING at https://bit.ly/4dl5tuL See Full Important Safety Information at https://bit.ly/ATEV_ISI INDICATION SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. BOXED WARNING: GRAFT FAILURE: loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy after acute injury resolution. WARNINGS AND PRECAUTIONS: Vascular Graft Rupture, Anastomotic Failure, and Thrombosis have occurred in patients treated with SYMVESS. SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or agents; none have been reported during clinical testing. ADVERSE REACTIONS: most common (≥3%): thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection. ATEV, Symvess, and Humacyte are registered trademarks of Humacyte Global, Inc?? 2025 Humacyte Global Inc. All Rights Reserved. US-SYM-000210 #Humacyte #OPMED2025??#Innovation #Biotech #Firstinclass $HUMA
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Humacyte转发了
Catch the latest episode of #HealthUncensored with host Dr. Drew on Lifetime Television, airing Monday, March 17th at 7:30 AM ET/PT! This week, we’ll be highlighting: ?? VIVUS LLC – Innovators in Healthcare and treatments. ?? Humacyte – Leaders in Biotechnology. ?? 2San – Pioneers in Global Healthcare Solutions.
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Humacyte转发了
Trestle Biotherapeutics and Humacyte Form Research Collaboration
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Humacyte is proud to announce the publication of our Budget Impact Model (BIM) for the Acellular Tissue Engineered Vessel (ATEV?)?in the Journal of Medical Economics.? For more details, please read the full press release here: https://lnkd.in/e9QhQdpN #Humacyte #HealthcareInnovation #Bioengineering #Biotech
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Humacyte转发了
?? Exciting news in trauma care! ?? Humacyte has received full FDA approval for its Biologics License Application (BLA) for the Acellular Tissue Engineered Vessel (ATEV). The approval is based on data from a clinical study led by Ernest "Gene" Moore, MD, trauma surgeon at Denver Health. With this approval, the ATEV is now ready for clinical use—helping save limbs and lives. It underscores how our learning health system research drives innovative solutions to improve patient outcomes and reduce amputation rates. ?? Congratulations to everyone in our system involved in this transformative work! Share this great news with your networks--and follow us to see how Denver Health research is shaping the future of trauma care. #ResearchInnovation #TraumaCare #DenverHealth #FDAApproval
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Humacyte转发了
Trestle Biotherapeutics is thrilled to announce a research collaboration with the incredibly talented team at Humacyte. This work will be focused on evaluating the potential for technology integration and synergies with Trestle's bioengineered human kidney tissue and Humacyte's acellular tissue engineered vessels, ATEV. This is a fantastic opportunity for our team to work with some of the true pioneers in regenerative medicine. https://lnkd.in/gYXxUrSw