HUMA Humacyte Inc

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that leadership will present new data and additional information on its programs at several scientific events in November 2021.

“Humacyte is creating off-the-shelf universally implantable bioengineered human tissues to potentially transform the treatment of chronic disease and injuries. We’re pleased to share data on both our late- and early-stage development programs which contribute to our understanding of the broad applicability of our platform,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. “Notably, we will share new data on our LUNA200 commercial-scale manufacturing system, which is our groundbreaking bioengineering platform for producing human tissue at large scale. The advancement of the LUNA200 system supports our efforts toward commercialization of our Human Acellular Vessel (HAV). In addition, we will present the first data from our pre-clinical primate work using a small diameter HAV as a Blalock-Taussig (BT) shunt, to address congenital heart defects.”

The details of the events are as follows:

Mayo Clinic Regenerative Medicine and Surgery SymposiumSession: Advanced Biomanufacturing: Considerations for Biologic TherapeuticsTitle: Innovations in Tissue Engineering - A Promising New Potential for Patients The presentation summarized Humacyte’s ongoing HAV development program in vascular repair, reconstruction and replacement and potential future applications.Location: Virtual webcastDate / time: Friday, Nov. 5, 2021, 9:05-9:20 a.m. MDTPresenter: Juliana Blum, Ph.D., Co-founder and Executive Vice President of Corporate Development, Humacyte

Session: Advanced Biomanufacturing: Considerations for Biologic TherapeuticsTitle: The Human Acellular Vessel (HAV) as a Vascular Implant for Limb Salvage: A Mayo FDA Collaborative Under Expanded Access IND ProvisionsThe presentation highlighted the successful implantation of Humacyte’s HAV to restore blood circulation in the leg of a patient suffering from severe peripheral arterial disease, completed at Mayo Clinic under an expanded access approval by the U.S FDA. Location: Virtual webcastDate / time: Friday, Nov. 5, 2021, 9:20-9:35 a.m. MDTPresenter: Col. Todd E. Rasmussen, M.D., Professor and Senior Associate Consultant, Division of Vascular and Endovascular Surgery, Mayo Clinic

American Heart Association Scientific Sessions 2021Session: Therapeutic Cells, Genes, and Drugs for Cardiovascular TranslationTitle: Evaluation of Tissue Engineered Human Acellular Vessels as a Blalock-Taussig-Thomas Shunt in a Juvenile Primate ModelA presentation of new preclinical data on the development of Humacyte’s small diameter HAV for use as a BTT shunt in pediatric heart disease. Location: Virtual webcast Date / time: Monday, Nov. 15, 2021, 11 a.m. – 12 p.m. ESTPresenter: Kevin Nash, Ph.D., Preclinical Scientist, Humacyte

6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS2021)Session: Keynote—Industry Day Session 3: Innovation from idea to market in regenerative medicine Title: Industrialization of Regenerative MedicineThe one-year safety and efficacy data from the Phase 2 study of Humacyte’s HAVs manufactured using the in-house commercial manufacturing system, LUNA200, will be reported for the first time.Location: Virtual webcastDate / time: Monday, Nov. 15, 2021, 3:30-5 p.m. CET / 10:30-11 a.m. ESTPresenter: Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer, Humacyte

Session: In Vivo Animal Models and Clinical TrialsTitle: Safety, Efficacy, and Immunogenicity Assessment of Humacyte’s Human Acellular Vessel for Dialysis Vascular Access: LUNA SystemAn overview of the Humacyte’s commercial-scale manufacturing system, LUNA200, capable of producing ~40,000 HAVs annually, and data from the Phase 2 study of HAVs manufactured using the LUNA200 system, will be discussed. Location: Virtual webcastDate / time: Wednesday, Nov. 17, 2021, 12 p.m. CET / 7 a.m. ETPresenter: Justin Strader, Senior Process Engineer, Humacyte

About HAVHuman Acellular Vessels (HAV) are engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement – it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. HAV is currently being evaluated in two Phase 3 trials in AV access and a Phase 2/3 trial for vascular trauma, and has been used in more than 460 patient implantations. It is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration, and has also received FDA Fast Track designation.

About HumacyteHumacyte, Inc., (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. Humacyte’s initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Pre-clinical 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 HAVs were the first product to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

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