Science Translational Medicine Publishes Results That Humacyte’s “Human Acellular Vessels Recellularize and Evolve into Living Blood Vessels following Human Implantation”
The medical journal, Science Translational Medicine, published work demonstrating Humacyte’s human acellular vessels (HAVs) repopulate with the patient’s own cells to form a living vascular tissue. The results suggest that the HAV may be an innovative advancement as a bioengineered vessel that develops characteristics of a living tissue over time.
Humacyte Announces the Initiation of a U.S. Phase II Vascular Trauma clinical trial of HAV
Study evaluates HAV for use in patients undergoing vascular replacement or reconstructive vascular surgery.
Humacyte and Fresenius Medical Care Form Strategic, Global Partnership
Fresenius Medical Care, the world's largest provider of dialysis products and services, and Humacyte, announced a strategic, global partnership and a $150M USD equity investment. The agreement has the potential to make HAV available to more patients worldwide following approval of the product.
Humacyte Closes $75 Million Series C Financing
Humacyte raised $75 million in a Series C preferred stock financing, led by a global consortium of existing private investors and new investors. The funding is expected to support Humacyte’s ongoing HUMANITY study, the company’s pivotal Phase III trial assessing the HAV as a conduit for hemodialysis in patients with end-stage renal disease who are not candidates for fistula placement.
Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HAV® in Vascular Access for Hemodialysis
The U.S. Food and Drug Administration (FDA) has granted Humacyte with the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate the efficient development and expedited review of Humacyte’s HAV for vascular acces to patients in need of life-sustaining hemodialysis. Carved from the model of other FDA expedited programs such as Breakthrough Therapy, the RMAT designation is a new expedited program for regenerative medicine products.
Humacyte Awarded $3.4 Million Contract Award from The U.S. Department of Defense
Humacyte received a Broad Agency Announcement (BAA) contract award of $3.4 million from the United States Department of Defense (DoD). The funding will help support the addition of clinical sites for Humacyte’s Phase II vascular trauma trial in the US. The trial is being conducted to study Humacyte’s investigational human acellular vessel to treat patients with traumatic vascular injuries from violent civilian or military events, such as automobile crashes, industrial accidents, or injuries of war.
Humacyte Receives $14.1 Million Award from California Institute for Regenerative Medicine to Expand Clinical Applications of HAV
Humacyte received a $14.1 million award from the California Institute for Regenerative Medicine (CIRM). Funding will support a new clinical trial comparing the Human Acellular Vessel to arteriovenous fistulas, the standard of care for creating vascular access in patients undergoing hemodialysis. Through this study, Humacyte will investigate HAV as a conduit for hemodialysis in a broader population of patients with End-Stage Renal Disease (ESRD) who require renal replacement therapy.
Humacyte Receives Award from the Medical Technology Enterprise Consortium
Humacyte received approximately $650,000 from the Medical Technology Enterprise Consortium (MTEC). This award will help fund the ongoing development and future commercialization of Humacyte’s bioengineered HAV’s application as a conduit for hemodialysis in patients with End-Stage Renal Disease (ESRD). In addition, Humacyte plans to use MTEC funding to further assess the vessel’s stability and potential application towards civilian and combat-related vascular trauma.
Humacyte wins 2016 CNBC Disruptor Award
In the fourth annual Disruptor 50 list, CNBC features private companies in 15 industries — from aerospace to financial services to cybersecurity to retail — whose innovations are revolutionizing the business landscape. Humacyte is pleased to be included along-side companies like Uber, Airbnb, and 23andMe.
Humacyte Commences U.S. Phase II Arterial Bypass Clinical Trial
In December 2016, Humacyte initiated a U.S. Phase II arterial bypass clinical trial of HAV to test the safety and efficacy as a lower extremity arterial bypass vessel in patients with peripheral arterial disease (PAD). In this non-randomized trial, HAV was surgically implanted in the above-the-knee, femoral-to-popliteal arterial position in the legs of patients who suffer from PAD to improve blood circulation. The study goal is to assess whether the vessel performs in the arterial bypass position, and is usable and suitable for repairing human arterial blood vessels.
California Institute for Regenerative Medicine Awards $9.9 Million Grant for the Development of HAV
Humacyte received a grant of nearly $10 million from the California Institute for Regenerative Medicine (CIRM). The grant will help fund a Phase III clinical trial which commenced in May 2016 on Humacyte’s investigational human acellular vessel, HAV.
Humacyte Commences Phase III Clinical Trial of Human Acellular Vessel
On May 13, 2016, Humacyte announced the commencement of a Phase III study of HAV as a conduit for hemodialysis in patients with End-Stage Renal Disease (ESRD) requiring renal replacement therapy and who are not candidates for fistula. In the trial, HAV will be compared to expanded polytetrafluoroethylene (ePTFE) grafts, standard of care for patients not suitable for fistula. The HUMANITY trial will be conducted at approximately 35 sites in the U.S., Europe and Israel with 350 evaluable subjects, making it the largest study of any bioengineered vascular tissue to date.
Humacyte Chief Medical Officer Jeffrey H. Lawson M.D., Ph.D. Elected to Fellowship in the American Surgical Association
Humacyte’s Chief Medical Officer, Jeffrey H. Lawson M.D., Ph.D. has been elected a Fellow of the America Surgical Association. As a premier academic society for surgeons, the American Surgical Association strives to benefit the patient and the profession of surgery by advocating and promoting excellence, innovation, and integrity in science, education and patient care.
New Additions to Humacyte’s Board of Directors
Humacyte was proud to add former U.S. Secretary of Health and Human Services Kathleen Sebelius and healthcare executive Dale A. Sander to our Board of Directors. These new members increased the size of the Humacyte Board to eight directors and set up Humacyte for exciting developments through our next phase of growth.
Humacyte Receives Fast Track Designation for HAV
Humacyte, Inc., has announced that the U.S. Food and Drug Administration (FDA) has designated the HAV development program for vascular access in hemodialysis patients as a Fast Track Development Program.
Humacyte Announces Completion of Enrollment for Studies of Bioengineered Blood Vessel
Humacyte, Inc. has announced the completion of patient enrollment for two multi-center, investigative studies to assess the safety and efficacy of its bioengineered blood vessel in patients with End Stage Renal Disease (ESRD).
Dr. Laura Niklason, M.D., PhD. elected to rank of NAI Fellow
The National Academy of Inventors Fellows Selection Committee announced the election of Dr. Laura Niklason, M.D., PhD., Founder of Humacyte, to the rank of NAI Fellow. NAI Fellows are chosen for having demonstrated a highly prolific spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development, and the welfare of society.
Humacyte enters into long-term manufacturing partnership
Humacyte enters into a long-term strategic manufacturing partnership with AlloSource to create the investigational bioengineered blood vessels being developed for hemodialysis applications.
Humacyte begins US Arterio-Venous Clinical Phase I and Phase II Study
US Arterio-Venous Clinical Phase I and Phase II Study begins as surgeons at perform first US implant of Humacyte investigational bioengineered blood vessel graft in arm of kidney dialysis patient.
Humacyte begins Phase I and Phase II Multi-Center Clinical Trial
US Arterio-Venous Clinical Phase I and Phase II Study begins as surgeons at perform first US implant of Humacyte investigational bioengineered blood vessel graft in arm of kidney dialysis patient.
Poland AV trial affirms Humacyte’s investigational blood vessel safety
EU Safety Committee determined that the trial enrollment of Humacyte investigational bioengineered blood vessel could continue in Poland arterio-venous (AV) vascular access trial.
Humacyte Pilot Study begins in Europe
Phase I and Phase II Multi-Center Pilot Study of the Humacyte investigational bioengineered blood vessel begins in Europe.
Fast Company names Humacyte as one of the “Top 50 World’s Most Innovative Companies”
Fast Company praises Humacyte’s technological advances, highlighting the ability to grow blood vessels from scratch.
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