Humacyte Announces Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma
Humacyte (HUMA) has launched Symvess, its FDA-approved bioengineered human tissue vascular conduit, for treating extremity arterial injuries. The product received full FDA approval on December 19, 2024, and is now authorized for commercial shipments.
Twenty-one hospitals have initiated the Value Analysis Committee (VAC) approval process, with two already completing their review and approving Symvess purchases. Some hospitals plan to purchase while VAC review is ongoing. The product has shown positive results in clinical studies, including high patency rates and low amputation and infection rates.
According to Humacyte's Budget Impact Model (BIM), Symvess treatment is estimated to be more cost-effective than synthetic grafts, cryopreserved allografts, or xenografts, primarily due to reduced amputation and infection rates.
Humacyte (HUMA) ha lanciato Symvess, il suo condotto vascolare bioingegnerizzato approvato dalla FDA, per il trattamento delle lesioni arteriose agli arti. Il prodotto ha ricevuto l'approvazione completa dalla FDA il 19 dicembre 2024 ed è ora autorizzato per le spedizioni commerciali.
Ventuno ospedali hanno avviato il processo di approvazione del Value Analysis Committee (VAC), con due che hanno già completato la loro revisione e approvato gli acquisti di Symvess. Alcuni ospedali pianificano di acquistare mentre la revisione del VAC è in corso. Il prodotto ha mostrato risultati positivi negli studi clinici, inclusi alti tassi di pervietà e bassi tassi di amputazione e infezione.
Secondo il Budget Impact Model (BIM) di Humacyte, il trattamento con Symvess è stimato essere più conveniente rispetto ai innesti sintetici, agli allograft crioconservati o ai xenograft, principalmente a causa della riduzione dei tassi di amputazione e infezione.
Humacyte (HUMA) ha lanzado Symvess, su conducto vascular humano bioingenierizado aprobado por la FDA, para el tratamiento de lesiones arteriales en las extremidades. El producto recibió la aprobación total de la FDA el 19 de diciembre de 2024 y ahora está autorizado para envíos comerciales.
Veintiún hospitales han iniciado el proceso de aprobación del Value Analysis Committee (VAC), con dos que ya han completado su revisión y aprobado las compras de Symvess. Algunos hospitales planean comprar mientras la revisión del VAC está en curso. El producto ha mostrado resultados positivos en estudios clínicos, incluidos altos índices de permeabilidad y bajos índices de amputación e infección.
Según el Modelo de Impacto Presupuestario (BIM) de Humacyte, el tratamiento con Symvess se estima que es más rentable que los injertos sintéticos, los aloinjertos criopreservados o los xenoinjertos, principalmente debido a la reducción de los índices de amputación e infección.
휴마사이트 (HUMA)는 FDA 승인을 받은 생체공학적 인체 조직 혈관 통로인 Symvess를 출시하여 사지 동맥 손상을 치료합니다. 이 제품은 2024년 12월 19일에 FDA의 전체 승인을 받았으며, 현재 상업적 배송이 허가되었습니다.
21개의 병원이 가치 분석 위원회 (VAC) 승인 프로세스를 시작했으며, 그 중 2개 병원은 이미 검토를 완료하고 Symvess 구매를 승인했습니다. 일부 병원은 VAC 검토가 진행 중인 동안 구매할 계획입니다. 이 제품은 임상 연구에서 높은 개통률과 낮은 절단 및 감염률을 포함한 긍정적인 결과를 보여주었습니다.
휴마사이트의 예산 영향 모델 (BIM)에 따르면, Symvess 치료는 합성 이식편, 냉동 보존 동종 이식편 또는 이종 이식편보다 비용 효율성이 더 높은 것으로 추정되며, 이는 주로 절단 및 감염률 감소 때문입니다.
Humacyte (HUMA) a lancé Symvess, son conduit vasculaire humain bio-ingénierie approuvé par la FDA, pour traiter les blessures artérielles des membres. Le produit a reçu l'approbation complète de la FDA le 19 décembre 2024 et est maintenant autorisé pour les expéditions commerciales.
Vingt et un hôpitaux ont initié le processus d'approbation du Value Analysis Committee (VAC), deux ayant déjà terminé leur examen et approuvé les achats de Symvess. Certains hôpitaux prévoient d'acheter pendant que l'examen du VAC est en cours. Le produit a montré des résultats positifs dans des études cliniques, y compris des taux de perméabilité élevés et des taux d'amputation et d'infection faibles.
Selon le modèle d'impact budgétaire (BIM) de Humacyte, le traitement avec Symvess est estimé être plus rentable que les greffes synthétiques, les allogreffes cryoconservées ou les xénogreffes, principalement en raison des taux d'amputation et d'infection réduits.
Humacyte (HUMA) hat Symvess, seinen von der FDA genehmigten bioengineered menschlichen Gewebe-Vaskularkonduit zur Behandlung von arteriellen Verletzungen der Extremitäten, auf den Markt gebracht. Das Produkt erhielt am 19. Dezember 2024 die vollständige FDA-Zulassung und ist nun für kommerzielle Lieferungen autorisiert.
Einundzwanzig Krankenhäuser haben den Genehmigungsprozess des Value Analysis Committee (VAC) eingeleitet, wobei zwei bereits ihre Überprüfung abgeschlossen und den Kauf von Symvess genehmigt haben. Einige Krankenhäuser planen den Kauf, während die VAC-Überprüfung noch läuft. Das Produkt hat in klinischen Studien positive Ergebnisse gezeigt, einschließlich hoher Durchgängigkeit und niedriger Amputations- und Infektionsraten.
Laut dem Budget Impact Model (BIM) von Humacyte wird geschätzt, dass die Behandlung mit Symvess kosteneffektiver ist als synthetische Transplantate, kryokonservierte Allografts oder Xenografts, hauptsächlich aufgrund der reduzierten Amputations- und Infektionsraten.
- FDA authorized commercial shipments of Symvess
- 21 hospitals initiated VAC approval process
- 2 hospitals already approved purchase
- Lower per-patient costs vs alternatives
- Positive clinical trial results with high patency rates
- VAC approval process takes 3-6 months
- Risk of graft failure and complications
- Requires long-term antiplatelet therapy
- Potential for infectious disease transmission
Insights
Humacyte's commercial launch of Symvess marks a pivotal transformation from a clinical-stage research organization to a commercial entity with revenue-generating potential after more than two decades of development. This milestone represents the first FDA-approved human tissue engineered vessel that addresses a significant unmet need in vascular trauma.
The early commercial traction is noteworthy, with 21 hospitals already initiating the Value Analysis Committee process and two completing approvals ahead of launch. This suggests stronger-than-typical early adoption for a novel medical device, likely driven by the compelling clinical data published in JAMA Surgery showing high patency rates and reduced complications compared to standard approaches.
From a market perspective, Symvess creates a new paradigm in vascular trauma treatment through three key advantages: immediate availability (eliminating time-consuming vein harvesting in emergency situations), reduced procedural complexity, and potential cost savings from fewer complications. The company's Budget Impact Model indicating lower overall treatment costs compared to synthetic grafts and biological alternatives will be important for securing favorable reimbursement decisions.
The manufacturing infrastructure required to produce bioengineered tissues at commercial scale represents a significant barrier to entry for potential competitors. Humacyte's ability to scale production while maintaining consistent product quality will be critical for meeting demand as adoption expands beyond initial centers.
Beyond vascular trauma, this approval validates Humacyte's underlying tissue engineering platform technology. The company's pipeline includes additional applications like AV access for hemodialysis and potential uses in coronary artery bypass, suggesting this first approval could be the foundation for a broader portfolio of engineered tissue products.
While safety concerns including graft rupture and thrombosis exist, these risks appear manageable with proper patient selection and post-implantation care, particularly compared to the potential limb loss faced by these trauma patients without intervention.
Humacyte's commercial launch of Symvess represents a critical inflection point for the company's financial trajectory after years of R&D investment. With approximately 200 Level 1 trauma centers in the US, the initial 21 hospitals in the VAC process represent roughly 10% of the primary target market, suggesting strong early traction.
The company's transition to a commercial-stage enterprise comes with significant financial implications. Based on similar medical devices and the specialized nature of this product, potential pricing likely falls in the $10,000-15,000 per unit range. With an estimated 15,000-20,000 traumatic vascular injuries annually in the US requiring intervention, the total addressable market could approach $150-300 million domestically.
Humacyte's ability to scale manufacturing will be important for revenue growth. Their Durham facility appears positioned to support initial commercialization, but capacity expansion may be necessary if adoption accelerates beyond early projections. The company's last reported cash position of approximately $100 million provides runway to establish commercial operations, though revenue ramp will be closely monitored by investors.
The Budget Impact Model demonstrating cost advantages versus alternatives will be instrumental in securing favorable reimbursement. With potential cost savings from reduced amputations (averaging $100,000+ in lifetime costs) and lower infection rates, Symvess presents a compelling economic argument for payers beyond its clinical benefits.
Beyond vascular trauma, Humacyte's pipeline includes AV access for hemodialysis patients (Phase 3 completed) and potential applications in coronary bypass surgery. This platform approach creates multiple potential revenue streams, diversifying commercial risk and expanding the company's total addressable market to potentially over $1 billion across all indications.
The Value Analysis Committee approval timeline of 3-6 months suggests revenue recognition will begin gradually in Q2 2025, with potential acceleration in the second half of the year as more institutions complete their reviews. This positions 2026 as the first full year of commercial operations with meaningful revenue contribution.
– The FDA has authorized Humacyte to release commercial shipments –
– Positive responses from surgeons and trauma centers to initial sales and marketing outreach –
- 21 hospitals have already initiated the Value Analysis Committee (VAC) approval process –
DURHAM, N.C., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the commercial launch of 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. The U.S. Food and Drug Administration (FDA) granted a full approval for Symvess on December 19, 2024. The FDA has now completed its required review of commercial batch information and has authorized Humacyte to commence commercial shipments.
Shortly after FDA approval, Humacyte began receiving requests for quotations for Symvess from hospitals. Twenty-one hospitals have already initiated the VAC approval process, with additional hospitals expected to commence the process. These hospitals are a mix of leading trauma centers that were participants in Humacyte clinical studies combined with institutions newly introduced to Symvess. Additionally, the hospitals span the range of individual institutions to centers providing access to larger hospital networks. Although the VAC process often takes three to six months to complete, two hospitals have already completed their review and approved the purchase of Symvess in advance of market launch. Humacyte has also been notified that a number of hospitals will purchase Symvess while the VAC process remains underway.
“This is a great moment for Humacyte but, more importantly, for patients in urgent need of arterial repair options to help save their limbs or lives.” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “After more than 20 years of research and development, we are thrilled to be able to deliver Symvess to hospitals and surgeons who are committed to improving patient outcomes. This commercial launch signifies a new era in vascular surgery and patient care and is the next growth phase for Humacyte. Our commercial team will continue to work closely with health care providers to ensure that Symvess is available to patients nationwide.”
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. In clinical studies, Symvess has been 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. In contrast to harvesting a vein from the patient, which causes further injury and takes valuable time, Symvess is available off-the-shelf, and does not require further injuring the patient. 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 has been used to treat many types of injuries arising from car accidents, gunshot wounds, blast wounds, and industrial accidents. Results from these civilian and wartime trauma studies were published in JAMA Surgery on November 20, 2024. In the clinical studies, Symvess was observed to have high rates of patency, or blood flow, and resulted in low rates of limb amputation and infection.
To communicate the health economic value of Symvess, Humacyte has developed a Budget Impact Model (BIM) based on the clinical results supporting the BLA, and the estimated reduction in clinical complications potentially achievable with the use of Symvess versus the current standard of care. Based on the BIM, the overall 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. The major drivers of cost savings associated with Symvess stemmed from reductions in the rates of amputation and vascular conduit infection. A paper describing the BIM has already been accepted for publication in a major medical journal.
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 ≥
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. 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.
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 Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
FAQ
What are the key clinical benefits of Humacyte's (HUMA) Symvess for vascular trauma?
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What are the main safety concerns for Humacyte's (HUMA) Symvess?
