Humacyte Provides Update on Commercial Launch and Pricing of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma
Humacyte (NASDAQ: HUMA) provided updates on the commercial launch of Symvess, their FDA-approved bioengineered vascular conduit for extremity arterial injury. The company has set the price at $29,500 per unit and has assembled a highly experienced sales team of ten members, each with over 15 years of experience in medical device and biotech sales.
The company has developed a Budget Impact Model showing that Symvess treatment costs less than synthetic grafts, cryopreserved allografts, or xenografts, primarily due to reduced amputation and infection rates. Humacyte has submitted an NTAP application to CMS in October 2024, which, if approved, would provide additional reimbursement starting October 1, 2025.
Symvess received FDA approval on December 19, 2024, for use in adults when urgent revascularization is needed and autologous vein graft isn't feasible. The company is currently responding to hospital quotation requests and initiating Value Analysis Committee approval processes.
Humacyte (NASDAQ: HUMA) ha fornito aggiornamenti sul lancio commerciale di Symvess, il loro condotto vascolare bioingegnerizzato approvato dalla FDA per il trattamento delle lesioni arteriose agli arti. L'azienda ha fissato il prezzo a 29.500 $ per unità e ha assemblato un team di vendita altamente esperto composto da dieci membri, ognuno con oltre 15 anni di esperienza nelle vendite di dispositivi medici e biotecnologie.
L'azienda ha sviluppato un Modello di Impatto sul Bilancio che dimostra come i costi del trattamento con Symvess siano inferiori a quelli degli innesti sintetici, degli allograft criopreservati o degli xenograft, principalmente a causa della riduzione dei tassi di amputazione e infezione. Humacyte ha presentato un'applicazione NTAP al CMS nell'ottobre 2024, che, se approvata, fornirebbe un ulteriore rimborso a partire dal 1° ottobre 2025.
Symvess ha ricevuto approvazione dalla FDA il 19 dicembre 2024, per l'uso negli adulti quando è necessaria una rivascolarizzazione urgente e l'innesto venoso autologo non è fattibile. L'azienda sta attualmente rispondendo a richieste di preventivi ospedalieri e avviando processi di approvazione con il Comitato di Analisi del Valore.
Humacyte (NASDAQ: HUMA) proporcionó actualizaciones sobre el lanzamiento comercial de Symvess, su conducto vascular bioingenierizado aprobado por la FDA para lesiones arteriales en las extremidades. La empresa ha establecido un precio de 29,500 $ por unidad y ha formado un equipo de ventas altamente experimentado de diez miembros, cada uno con más de 15 años de experiencia en ventas de dispositivos médicos y biotecnología.
La empresa ha desarrollado un Modelo de Impacto Presupuestario que muestra que los costos del tratamiento con Symvess son inferiores a los injertos sintéticos, injertos alogénicos criopreservados o xenoinjertos, principalmente debido a la reducción de tasas de amputación e infección. Humacyte presentó una solicitud de NTAP a CMS en octubre de 2024, que, si se aprueba, proporcionaría un reembolso adicional a partir del 1 de octubre de 2025.
Symvess recibió la aprobación de la FDA el 19 de diciembre de 2024, para su uso en adultos cuando se necesita una revascularización urgente y el injerto de vena autóloga no es factible. La empresa está respondiendo actualmente a solicitudes de cotización de hospitales e iniciando procesos de aprobación del Comité de Análisis de Valor.
Humacyte (NASDAQ: HUMA)는 Symvess의 상업적 출시 업데이트를 제공했습니다. 이 제품은 FDA에서 승인한 말초 동맥 손상에 대한 생체 공학 vascular conduit입니다. 회사는 29,500달러 per unit로 가격을 책정하였으며, 각각 15년 이상의 의료기기 및 생명공학 판매 경험을 가진 10명의 고도로 경험이 풍부한 영업 팀을 구성했습니다.
회사는 Symvess 치료가 합성 이식편, 저온 보존한 이식편 또는 이종 이식편보다 비용이 적게 드는 예산 영향 모델을 개발했습니다. 이는 주로 절단 및 감염 비율 감소로 인한 것입니다. Humacyte는 2024년 10월에 CMS에 NTAP 신청서를 제출하였고, 만약 승인된다면 2025년 10월 1일부터 추가 상환을 받을 수 있습니다.
Symvess는 2024년 12월 19일, 긴급 재혈관화가 필요하고 자가 정맥 이식이 불가능한 성인을 위해 FDA의 승인을 받았습니다. 회사는 현재 병원 견적 요청에 응답하고 가치 분석 위원회 승인 프로세스를 시작하고 있습니다.
Humacyte (NASDAQ: HUMA) a fourni des mises à jour sur le lancement commercial de Symvess, leur conduit vasculaire bio-ingénierie approuvé par la FDA pour les lésions artérielles des extrémités. L'entreprise a fixé le prix à 29 500 $ par unité et a constitué une équipe de vente hautement expérimentée de dix membres, chacun ayant plus de 15 ans d'expérience dans la vente de dispositifs médicaux et de biotechnologie.
L'entreprise a développé un modèle d'impact budgétaire montrant que les coûts de traitement avec Symvess sont inférieurs à ceux des greffes synthétiques, des allogreffes cryopréservées ou des xénogreffes, principalement en raison de la réduction des taux d'amputation et d'infection. Humacyte a soumis une demande NTAP au CMS en octobre 2024, qui, si elle est approuvée, permettrait un remboursement supplémentaire à partir du 1er octobre 2025.
Symvess a reçu l'approbation de la FDA le 19 décembre 2024, pour une utilisation chez les adultes lorsque une revascularisation urgente est nécessaire et que la greffe de veine autologue n'est pas envisageable. L'entreprise répond actuellement aux demandes de devis des hôpitaux et lance des processus d'approbation avec le comité d'analyse de la valeur.
Humacyte (NASDAQ: HUMA) hat Updates zum kommerziellen Launch von Symvess bereitgestellt, einem von der FDA genehmigten bioengineering vaskulären Leitungsrohr für arterielle Verletzungen an den Extremitäten. Das Unternehmen hat den Preis auf 29.500 $ pro Einheit festgelegt und ein hochqualifiziertes Vertriebsteam mit zehn Mitgliedern zusammengestellt, von denen jeder über mehr als 15 Jahre Erfahrung im Verkauf medizinischer Geräte und Biotechnologie verfügt.
Das Unternehmen hat ein Budgetauswirkungsmodell entwickelt, das zeigt, dass die Behandlungskosten mit Symvess niedriger sind als die von synthetischen Transplantaten, kryopreservierten Allo- oder Xenotransplantaten, hauptsächlich aufgrund reduzierter Amputations- und Infektionsraten. Humacyte hat im Oktober 2024 einen NTAP-Antrag an CMS gestellt, der, wenn genehmigt, ab dem 1. Oktober 2025 eine zusätzliche Erstattung bieten würde.
Symvess erhielt am 19. Dezember 2024 die FDA-Zulassung zur Anwendung bei Erwachsenen, wenn eine dringende Revascularisierung notwendig ist und eine autologe Venenverpflanzung nicht möglich ist. Das Unternehmen reagiert derzeit auf Krankenhaus-Angebotsanfragen und initiiert die Genehmigungsprozesse des Value Analysis Committee.
- FDA approval received for Symvess on December 19, 2024
- Price point set at $29,500 per unit with favorable Budget Impact Model results
- Lower treatment costs compared to alternative solutions
- Experienced sales team assembled with proven track records
- Potential additional reimbursement through NTAP application
- Product shipment authorization still pending
- Serious safety concerns including risk of graft failure and thrombosis
- Ongoing antiplatelet therapy required post-treatment
- Risk of infectious disease transmission from manufacturing process
Insights
The commercial launch details for Symvess represent a significant milestone in the vascular surgery market. The pricing strategy of
The sales team composition is particularly noteworthy - all members being top
The pending NTAP application could significantly impact hospital adoption rates. If approved by October 2025, the additional Medicare reimbursement would effectively lower the barrier to entry for hospitals, potentially accelerating market penetration.
The FDA approval of Symvess addresses a critical unmet need in trauma surgery. The off-the-shelf availability eliminates the time-consuming process of harvesting autologous veins, which is particularly valuable in time-sensitive trauma cases. The clinical data published in JAMA Surgery, demonstrating high patency rates and low infection rates, supports its potential as a standard-of-care option.
The broad application scope - from car accidents to wartime injuries - coupled with successful outcomes in both U.S. and international settings, validates its versatility. However, the boxed warning regarding graft failure and the requirement for long-term antiplatelet therapy are important considerations that will influence patient selection and post-operative management protocols.
The commercial strategy appears robust with multiple value drivers. The Budget Impact Model's demonstration of cost advantages over synthetic grafts, cryopreserved allografts and xenografts positions Symvess favorably for Value Analysis Committee approvals. Early hospital engagement through quotation requests signals promising initial market reception.
The timing of the NTAP decision in October 2025 could create a significant inflection point for revenue growth. With a
– 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
Humacyte announced that the price of Symvess will be
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 ≥
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 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
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