Our ongoing commitment.

Produce Humacyte’s life-sustaining, human, bioengineered HAV designed to become the patient’s own and integrate naturally for patients who need a better clinical alternative for vascular access.

What matters to us.

We are committed to becoming the leader in novel, human acellular matrix products for vascular and non-vascular applications. These products are engineered to be immediately available and can have the potential to improve efficacy, safety, and treatment outcomes in patients with a broad range of disease conditions.

Our goal is to develop and commercialize our products in the U.S., and potentially license commercialization rights in ex-U.S. markets. Our corresponding product development strategy aims for the fastest speed to market by pursuing approval for indications with the greatest chance of clinical success and safety, through well-established regulatory pathways for approval.

Humacyte is a privately-held company that was founded in 2004 by Laura Niklason, MD. PhD., a world leader in tissue engineering, and Chief Executive Officer of Humacyte.

Dr. Niklason co-founded Humacyte along with Drs. Shannon Dahl and Juliana Blum. Humacyte’s research platforms and core technologies are based on the research conducted by Drs. Niklason and Dahl at Duke University, and by Dr. Niklason at the Massachusetts Institute of Technology in the laboratory of Dr. Robert Langer.

Our team of senior management advisors and board of directors have extensive, proven experience in product development, clinical trials, regulatory affairs, business and commercial development, finance, and intellectual property management

See how far we've come.

We’re proud of the steps we’ve taken and the progress we’ve made.

March 27th, 2019

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.

October 25th, 2018

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.

June 11th, 2018

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.

March 9th, 2018

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.

March 20th, 2017

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.

September 29th, 2017

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.

October 2nd, 2017

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.

December 29th, 2016

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.

August 8th, 2016

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.

June 7th, 2016

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.

May 13th, 2016

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.

April 25th, 2016

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.

September 2, 2015

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.

July 23, 2014

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.

June 24, 2014

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).

December 12, 2013

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.

October 4, 2013

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.

June 1, 2013

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.

April 5, 2013

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.

December 1, 2012

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.

March 1, 2012

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.
Read the Article.

Industry Visionaries and Healthcare Executives

Our leadership team is focused on developing a novel platform technology to shape human tissues to be used for hemodialysis and the treatment of vascular diseases.

Laura E. Niklason, MD, PhD

Founder, President & Chief Executive Officer

Douglas L. Blankenship

Chief Financial Officer

Jeffrey H. Lawson, MD, PhD

Chief Surgical Officer

Heather Prichard, PhD

Chief Operating Officer

Juliana L. Blum, PhD

Executive Vice President, Strategic Business Operations and Co-Founder

William Tente, MS

Chief Regulatory Officer

Jack Harvey

Vice President of Commercial Bioprocessing

Sabrina Osborne

Executive Vice President, Business Strategy & People

Scott Weit, PHD

Vice President of Quality

Board of Directors

Brady Dougan

Director of Humacyte since 2005
Former CEO of Credit Suisse

Robert Anderson, MD

Director of Humacyte since 2005
Previously served as an Independent Director to MicroIslet; former Chief of Surgery at Duke University

Carrie S. Cox

Served as Humacyte CEO from 2010 to 2018
Independent Director to Electrocore, Texas Instruments, Celgene and Cardinal Health

Robert Langer, Sc.D.

Director of Humacyte since 2008
Serves on the Board of Moderna, Rubius Therapeutics, PureTech Health, and David H Koch Institute Professor at Massachusetts Institute of Technology

Jeffrey Lawson, MD, PhD

Chief Surgical Officer of Humacyte
Prior to joining Humacyte in 2015, Dr. Lawson served as Professor of Surgery and Vice Chair of the Department of Surgery at Duke University Medical Center

Laura Niklason, MD, Ph.D

Humacyte Founder, President and CEO
Adjunct Professor, Yale University

Dale Sander

Director of Humacyte since 2015
Former CFO of Avita Medical, Juventas Therapeutics, Biolex Therapeutics and Maxim Pharmaceuticals

Kathleen Sebelius

Director of Humacyte since 2015
Former 21st Secretary of the Department of Health and Human Services. Former Governor of Kansas

Max Wallace, JD

Director of Humacyte since 2005
Former CEO of Accelerate Brain Cancer Cure; former CEO of Cogent Neurosciences and Trimeris

Humacyte’s state-of-the–art facilities reflect a continuing commitment to the quality of our products.

Our new state-of-the–art, commercial scale cGMP manufacturing facility is located at 2525 Highway 54 in Durham, NC. The new facility is also home to our Research & Development, Process Development, and Quality Control laboratories, along with our Business, Clinical, and Regulatory operations.

We’re building strong relationships with our growing family of partners.

We’re proud of our partners and honored that they stand with us on our commitment to lifesaving possibilities.

INTERESTED IN PARTNERING WITH US?

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