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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 currently Professor of Biomedical Engineering and Anesthesia at Yale University. 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.

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Our goal is to develop and commercialize our products in the US, and potentially license commercialization rights in ex-US 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 currently Professor of Biomedical Engineering and Anesthesia at Yale University. 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 HUMACYL®

Study evaluates HUMACYL 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 HUMACYL 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 HUMACYL 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 HUMACYL® 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.

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.

September 29th, 2017

Humacyte Receives $14.1 Million Award from California Institute for Regenerative Medicine to Expand Clinical Applications of HUMACYL

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 HUMACYL as a conduit for hemodialysis in a broader population of patients with End-Stage Renal Disease (ESRD) who require renal replacement therapy.

September 27th, 2017

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.

June 7, 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.

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 HUMACYL 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, HUMACYL 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 HUMACYL

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, HUMACYL.

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 HUMACYL 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, HUMACYL 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 HUMACYL welcomes Humacyte

Humacyte, Inc., has announced that the U.S. Food and Drug Administration (FDA) has designated the HUMACYL 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 ½ Study

US Arterio-Venous Clinical Phase 1/2 Study begins as surgeons at perform first US implant of Humacyte investigational bioengineered blood vessel graft in arm of kidney dialysis patient.

April 26, 2013

Humacyte begins Phase ½ Multi-Center Clinical Trial

US Arterio-Venous Clinical Phase 1/2 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 ½ 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.

    *Theodore Lithgow, PhD serves as our Chief Commercial Officer and is currently transitioning into retirement. Ted will officially retire December 31, 2019.

    Board of Directors

    Carrie S. Cox
    Carrie S. Cox is Executive Chairman of Humacyte, Inc. Ms. Cox joined Humacyte in 2010 and served as Chairman and CEO until January 2018, where she led the company through significant business, clinical, regulatory and operational milestones. Prior to Humacyte, she most recently served as Chairman of Prism Pharmaceuticals, sold to Baxter Corporation in 2011. Ms. Cox was also EVP and President, Global Pharmaceuticals, at Schering-Plough Corporation, from 2003 until its merger with Merck & Co., Inc., in November 2009. She was responsible for the company’s global prescription pharmaceutical business, which generated approximately $16 billion in annual sales, with a five-year CAGR of 22%. Prior to that, Ms. Cox held a similar role as President, Global Prescription Business at Pharmacia Corporation.

    Previously, Ms. Cox served as SVP of Global Business Management at Pharmacia & Upjohn (the predecessor company to Pharmacia), and as VP of Women’s Healthcare at Wyeth-Ayerst. She spent her early career at Sandoz pharmaceuticals (now Novartis) in a variety of commercial roles of increasing responsibility. Ms. Cox currently serves as Chairman of electroCore, Inc.’s Board of Directors, and is on the Boards of Directors of Texas Instruments, Cardinal Health, and Celgene, and she has served as Lead Director for Texas Instruments. Ms. Cox has been named six times to FORTUNE Magazine’s list of the “50 Most Powerful Women in Business” and she was named to “Top 10 Women in Biotech” by Fierce Biotech publications in 2012. Her work has been featured in the Harvard Business Review and in the New York Times bestseller, The Profit Zone. Ms. Cox received her B.S. from Massachusetts College of Pharmacy, and worked for several years in retail and hospital pharmacy.

    Robert Anderson, M.D.
    Cardiac Surgeon, former Chief of Surgery at Duke University, and a Key Opinion leader in cardiovascular surgery

    Brady W. Dougan
    Former CEO of Credit-Suisse

    Robert Langer, Sc.D.
    David Koch Institute Professor at Massachusetts Institute of Technology, and a world leader in tissue engineering and regenerative medicine

    Laura Niklason, M.D., Ph.D.
    Humacyte Founder, Nicholas Greene Professor of Anesthesiology and Professor of Biomedical Engineering, Vice-Chair for Anesthesia at Yale, and world leader in cellular therapies and regenerative medicine.

    Dale A. Sander
    Senior Vice President, Global Accounting Officer at Sutherland Global Services, Inc., Former Chief Financial Officer role at Biolex Therapeutics and leadership positions at life science companies Maxim Pharmaceuticals, Inc., Xytronyx, Inc., and Tactyl Technologies, Inc.

    Honorable Kathleen Sebelius
    Former 21st Secretary of the Department of Health and Human Services (HHS). Former Governor of Kansas, she served two terms as the Kansas insurance commissioner, and four terms in the Kansas Legislature.

    Max Wallace, J.D.
    Former CEO of Cogent Neurosciences, former CEO of Trimeris, and currently heads Accelerate Brain Cancer Cure, a private foundation

    Humacyte’s
    state-of-the–art
    facilities
    reflect a
    continuing
    commitment to the

    quality of our
    products.

    Our new state-of-the–art cGMP manufacturing facility is located at 2525
    Highway 54 in Durham, NC. The new facility will also be home to our R&D and
    administration capabilities.

    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?
    We’d love to hear from you.