Wounds, Gunshot

– Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair – – Highly experienced sales team onboard and trained in preparation for commercial launch – – Budget Impact Model supports pricing of Symvess – DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced an update of plans for the commercial launch of Symvess (acellular tissue engineered vessel-tyod) for extremity arterial injury. Humacyte is responding to requests for quotations from hospitals and has initiated the Value Analysis Committee approval processes at multiple hospitals as part of the preparation for market launch. The U.S. Food and Drug Administration (FDA) granted a full approval for Symvess on December 19, 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. Shortly after approval, Humacyte provided the final packaging and product batch release information required for FDA review prior to shipment of product. Humacyte currently expects to have authorization to commence product shipment early this quarter and continues to build product supply to support market launch. Humacyte has recruited and trained a highly experienced sales team for the commercial launch of Symvess. All ten sales team members are multi-year President’s Club winners, representing the top 10% of achievers in their prior sales organizations. All sales team members have demonstrated consistent overachievement with average hospital medical device and biotech experience exceeding 15 years. Each sales team member has experience in vascular surgery and/or trauma surgery, and 80% have previous experience selling regenerative therapies. All team members have experience selling clinically differentiated disruptive technologies and premium priced portfolios. Humacyte announced that the price of Symvess will be $29,500 per unit. The Company has developed a Budget Impact Model based on the clinical results supporting the approval of Symvess, and the estimated reduction in clinical complications potentially achievable by treating specific patients with Symvess versus current standard of care. Based on the model, the per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. Major drivers of cost savings associated with Symvess were attributed to reductions in the rate of amputation and vascular conduit infection. Additionally, Humacyte submitted an NTAP (New Technology Add-On Payment) application for Symvess to CMS in October 2024. Humacyte presented the Symvess data at a public Town Hall with the Centers for Medicare and Medicaid Services (CMS) on December 11, 2024. If successful, NTAP reimbursement will start for discharges on October 1, 2025, offering hospitals additional payment to cover a portion of the costs associated with Symvess. “We are very excited to take the major steps in providing healthcare providers a novel alternative for treating patients suffering from extremity arterial injury,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “We are pleased to see interest from multiple hospitals and to have commenced the Value Analysis Committee approval processes. We look forward to the anticipated publication of our Budget Impact Model which highlights the major drivers of cost savings associated with Symvess and complement our strong clinical results.” Symvess, or the ATEV™ (acellular tissue engineered vessel), is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. While harvesting vein from a trauma patient takes valuable surgical time and is not always feasible due to damage to veins or to the limbs, Symvess is available off-the-shelf, and does not require further injuring the patient to obtain vascular repair material. Humacyte’s BLA included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. Symvess was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilized by vascular and trauma surgeons in Level 1 Trauma centers throughout the U.S. and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries. Results from these studies were published in JAMA Surgery on November 20, 2024. In the civilian and military clinical studies, Symvess was observed to have high rates of patency, or blood flow, and low rates of amputation and infection. 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. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Graft Rupture Vascular graft rupture has occurred in patients treated with SYMVESS. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic Failure Anastomotic failure has occurred in patients treated with SYMVESS. In clinical studies of SYMVESS, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis Thrombosis has occurred in patients treated with SYMVESS. In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS. Transmission of Infectious Diseases SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of SYMVESS are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for SYMVESS. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems 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. Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease. 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 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize our ATEV in the United States under the brand name SYMVESS in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, our quarterly report on Form 10-Q for the quarter ended September 30, 2024, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

– SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair – – In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection – – Highly experienced sales team already recruited and trained in preparation for commercial launch – DURHAM, NC, USA I December 19, 2024 I Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has granted a full approval for SYMVESS (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. “We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. SYMVESS has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members.” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “SYMVESS approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of SYMVESS is a transformational event for the Company and our bioengineering technology platform. Even more importantly, we believe SYMVESS provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of SYMVESS, and we have recruited and trained a terrific team to execute on our sales and marketing missions.” “The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world,” said Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 clinical trial. “SYMVESS is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. The Humacyte team has responsibly and scientifically solved a major clinical problem that I believe will reduce the amputation rate for traumatic vascular injury. They should be congratulated on an accomplishment that will undoubtedly advance our specialty to the next level.” “I believe that SYMVESS will revolutionize vascular trauma care and be profoundly beneficial to our patients,” said Rishi Kundi, MD, Surgical Critical Care, Vascular Surgery, University of Maryland Medical System. “From my experience so far, SYMVESS will allow reconstructions that are currently impracticable because of contamination and infection. It will make reconstructions that we now perform with prosthetic or even biologic grafts more successful. I am most excited about the promise that SYMVESS holds for the long-term experience of our patients. I hope that, with SYMVESS, the 19-year-old patient with vascular reconstruction after trauma will no longer spend the six decades after their surgery anticipating disaster, but that their chances for reintervention will be no different than if they had autologous conduit.” SYMVESS, or the ATEV™, is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. While harvesting vein from a trauma patient takes valuable surgical time, SYMVESS is available off-the-shelf, and does not require further injuring the patient to obtain vascular repair material. Humacyte’s BLA included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. SYMVESS was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilized by vascular and trauma surgeons in Level 1 Trauma centers throughout the U.S. and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries. Results from these studies were published in JAMA Surgery on November 20, 2024. In the civilian and military clinical studies, SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection. “Finally, we have an innovative technology for battlefield vascular injuries using a tissue engineered human arterial replacement that can resist infections that are so prevalent in modern combat zones,” added Dr. Fox. “SYMVESS shows promise to reduce amputation rates since an alternative conduit for war injuries is often needed but up until now has not been a good option.” “The FDA approval of SYMVESS will make it the preferred conduit for complex vascular injuries, and particularly those at risk for infection.” said Ernest E. Moore, MD, FACS, Director of Research at the Ernest E. Moore Shock Trauma Center at Denver Health, a clinical investigator in the V005 trial. “I look forward to using SYMVESS in my practice.” Arterial injuries resulting from vascular trauma are common in civilian and military populations, frequently resulting in the loss of life or limb. In civilian populations, trauma injuries are primarily caused by motor vehicle, workplace and sporting accidents, gun violence, mass casualty terrorist attacks, stabbings, blunt trauma, and iatrogenic injuries (injuries caused by medical treatment or examination). Autologous vein, which is harvested from the patient’s body through a separate surgical incision, is the current preferred conduit for arterial repair. However, harvesting of autologous vein is not always feasible due to damage to veins or to the limbs. Harvesting autologous vein is also an invasive procedure that requires additional time and resources, delaying the time from injury to restoration of blood flow for the injured patient. In contrast, SYMVESS may be removed from its packaging and ready for implantation within minutes and does not involve creating additional incisions in already-injured patients. The SYMVESS trauma program was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in May 2023, a Biologic License Application (BLA) was submitted to the FDA in December 2023, and in February 2024 the FDA granted a Priority Review. On August 9, 2024, the FDA informed Humacyte that it needed additional time to complete its review of the BLA, although there were no outstanding pre-approval requirements for SYMVESS as of that date. The FDA completed its review today, granting full approval. 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. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Vascular graft rupture has occurred in patients treated with SYMVESS. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic failure has occurred in patients treated with SYMVESS. In clinical studies of SYMVESS, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis has occurred in patients treated with SYMVESS. In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS. SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of SYMVESS are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information, including Boxed Warning, for SYMVESS. Humacyte filed the BLA with trauma clinical data based upon the accepted statistical analysis plan. These data were also peer reviewed and published in JAMA Surgery on November 20, 2024. In the package insert, the FDA elected to exclude the synthetic graft comparator that was in the statistical analysis plan. The FDA also applied a different imputing methodology for SYMVESS patients who did not have a day 30 assessment. Nine patients without day 30 data were imputed as failures of patency in the package insert, despite the fact that they had favorable patency results at the last assessment. In addition, multiple patients who never underwent an amputation were imputed as failures of limb salvage. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems 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 product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication was approved by the FDA in December 2024. 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 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com . For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. SOURCE: Humacyte

Twenty years ago, Laura Niklason founded a company that sounded like something out of science fiction. The Duke University bioengineer and anesthesiologist was working in the budding field of regenerative medicine, which promised to repair or replace failing body parts with new lab-grown tissues and organs. On Friday, the FDA took that idea closer to reality, approving her company’s first product, a lab-grown blood vessel that can be used by surgeons trying to restore blood flow in a patient with traumatic injury, or in patients who need a coronary bypass. It’s a much-needed win for Durham, NC-based Humacyte, which only had $71 million at the end of September, and its stock $HUMA was up more than 30% on Friday. The company had originally expected an FDA decision in August, but the agency asked for more time to complete its review. The blood vessels will be marketed under the name Symvess. The approval is a milestone for Humacyte, which had developed several iterations of the vessels and the manufacturing process required to grow them consistently, safely, and at scale. And it’s a key moment as well for regenerative medicine, which for decades has struggled to turn its intriguing laboratory science into experimental treatments, much less approved products. Even so, the initial use of Humacyte’s vessels will be narrow. The FDA approved the vessels for “urgent revascularization” following trauma to the limbs, such as from a car accident or gunshot wound when surgeons can’t cut out a patient’s own vein (often from their leg) for use elsewhere in their body. The approval was based on a study of 54 people with limb injuries. Symvess restored blood flow in most patients, with 67% still having blood flow without any other interventions after 30 days. Five patients still required amputations within 30 days, and three more did over the course of the three-year study. Humacyte believes these amputation rates are lower than what’s commonly seen with synthetic blood vessels made of plastic. To make its vessels, Humacyte molds a biodegradable polymer into the size and shape of an artery. It then covers the mold in vascular cells that naturally line blood vessels and grows them in a nutrient-rich bioreactor for about two months, gently stretching them to mimic blood flow from a heartbeat. As a final step, the company strips the pink tubes of all their cells, leaving behind a white matrix of collagen and other structural proteins. This acellular vessel is what gets implanted into patients, whose own vascular cells will often end up reforming a complete blood vessel. The counterintuitive approach is designed to minimize chances of the immune system rejecting the graft. A spokesperson said that Humacyte “has commercialization and manufacturing readiness already in place” and will utilize a salesforce of fewer than 20 people. “There’s only about 200 Level I Trauma Centers in the United States, and they take care of 70 to 80% of these major injuries and tend to be concentrated in metropolitan areas,” Niklason told Endpoints News in an interview in July. Humacyte has not yet said how much the vessels will cost, but has previously suggested they will be more expensive than standard plastic-based vessels. “Like any new premium price product, I think we’ll have a ramp. But I do think that there’s going to be a lot of excitement about this in the surgical community. This is not sort of a slightly modified widget,” Niklason said. The most common safety concerns were vascular graft thrombosis, fever and pain. The treatment also comes with a warning about the blood vessel graft rupturing or leaking, which has happened in some patients. It also carries a warning about infectious disease transmission, although Humacyte also believes its vessels carry a lower risk of infections than plastic ones commonly used by surgeons.