Humacyte Announces Issuance of U.S. Patent Covering Manufacturing of Symvess™ and Other Bioengineered Tissues
Humacyte (Nasdaq: HUMA) has been granted U.S. Patent No. 12,195,711 for its 'Drawer System for Cultivating Tissue,' covering key aspects of their bioreactor manufacturing system until 2040. The patent specifically relates to the production of Symvess, their first-in-class bioengineered human tissue designed as a universally implantable vascular conduit.
The company operates an 83,000 square foot bioprocessing facility capable of manufacturing human tissue at commercial scale. Notably, the FDA granted full approval for Symvess on December 19, 2024, for use in adults requiring urgent revascularization due to extremity arterial injury when autologous vein grafts aren't feasible.
Symvess offers an off-the-shelf solution that eliminates the need for harvesting veins from patients during acute trauma. The product is currently undergoing clinical trials for arteriovenous access in hemodialysis and peripheral artery disease, with preclinical development for coronary artery bypass grafts.
Humacyte (Nasdaq: HUMA) ha ricevuto il brevetto statunitense n. 12,195,711 per il suo 'Sistema a Cassetto per la Coltivazione dei Tessuti', che copre aspetti chiave del loro sistema di produzione di bioreattori fino al 2040. Il brevetto riguarda specificamente la produzione di Symvess, il loro tessuto umano bioingegnerizzato di prima classe progettato come un condotto vascolare impiantabile universalmente.
L'azienda gestisce una struttura di bioprocessing di 83.000 piedi quadrati in grado di produrre tessuto umano su scala commerciale. È importante notare che la FDA ha concesso l'approvazione totale per Symvess il 19 dicembre 2024, per l'uso in adulti che necessitano di revascularizzazione urgente a causa di lesioni arteriose agli arti quando i trapianti di vena autologa non sono fattibili.
Symvess offre una soluzione pronta all'uso che elimina la necessità di prelevare vene dai pazienti durante traumi acuti. Il prodotto è attualmente in fase di sperimentazione clinica per l'accesso arteriovenoso in emodialisi e per la malattia delle arterie periferiche, con sviluppo preclinico per i bypass coronarici.
Humacyte (Nasdaq: HUMA) ha recibido la patente estadounidense n. 12,195,711 para su 'Sistema de Cajón para el Cultivo de Tejidos', que cubre aspectos clave de su sistema de fabricación de bioreactores hasta 2040. La patente se relaciona específicamente con la producción de Symvess, su tejido humano bioingenierizado de primera clase diseñado como un conducto vascular implantable universalmente.
La empresa opera una instalación de bioprocesamiento de 83,000 pies cuadrados capaz de fabricar tejido humano a escala comercial. Cabe destacar que la FDA otorgó la aprobación total para Symvess el 19 de diciembre de 2024, para su uso en adultos que requieren revascularización urgente debido a lesiones arteriales en las extremidades cuando los injertos de vena autóloga no son viables.
Symvess ofrece una solución lista para usar que elimina la necesidad de extraer venas de los pacientes durante traumatismos agudos. El producto está actualmente en ensayos clínicos para acceso arteriovenoso en hemodiálisis y enfermedad arterial periférica, con desarrollo preclínico para injertos de bypass de arteria coronaria.
Humacyte (Nasdaq: HUMA)는 '조직 배양을 위한 서랍 시스템'에 대한 미국 특허 제 12,195,711호를 부여받았으며, 이는 2040년까지 그들의 바이오리액터 제조 시스템의 핵심 측면을 포함합니다. 이 특허는 Symvess의 생산과 구체적으로 관련되어 있으며, 이는 보편적으로 이식 가능한 혈관 도관으로 설계된 최초의 클래스의 생체 공학적 인체 조직입니다.
회사는 상업적 규모로 인체 조직을 제조할 수 있는 83,000 평방 피트의 바이오 프로세싱 시설를 운영하고 있습니다. 특히, FDA는 2024년 12월 19일 Symvess에 대해 긴급 재혈관화가 필요한 성인에게 사용하기 위해 완전 승인을 부여했습니다. 이는 자가 정맥 이식이 불가능할 때 적용됩니다.
Symvess는 급성 외상 중 환자에게서 정맥을 채취할 필요성을 없애는 즉시 사용 가능한 솔루션을 제공합니다. 이 제품은 현재 혈액투석과 말초 동맥 질환을 위한 동정맥 접근에 대한 임상 시험을 진행 중이며, 관상동맥 우회 이식을 위한 전임상 개발이 진행되고 있습니다.
Humacyte (Nasdaq: HUMA) a obtenu le brevet américain n° 12,195,711 pour son 'Système de Tiroir pour la Culture de Tissus', couvrant des aspects clés de leur système de fabrication de bioreacteurs jusqu'en 2040. Le brevet concerne spécifiquement la production de Symvess, leur tissu humain bio-ingénierie de première classe conçu comme un conduit vasculaire implantable universel.
L'entreprise exploite une installation de bioprocessing de 83 000 pieds carrés capable de fabriquer du tissu humain à l'échelle commerciale. Il est à noter que la FDA a accordé une approbation totale pour Symvess le 19 décembre 2024, pour une utilisation chez les adultes nécessitant une revascularisation urgente en raison de blessures artérielles aux extrémités lorsque les greffes de veines autologues ne sont pas réalisables.
Symvess offre une solution prête à l'emploi qui élimine le besoin de prélever des veines chez les patients lors de traumatismes aigus. Le produit est actuellement en cours d'essais cliniques pour l'accès artérioveineux en hémodialyse et pour la maladie artérielle périphérique, avec un développement préclinique pour les pontages coronariens.
Humacyte (Nasdaq: HUMA) hat das US-Patent Nr. 12,195,711 für sein 'Schubladensystem zur Kultivierung von Gewebe' erhalten, das bis 2040 wichtige Aspekte ihres Bioreaktorsystems abdeckt. Das Patent bezieht sich speziell auf die Produktion von Symvess, ihrem erstklassigen bioengineerten menschlichen Gewebe, das als universell implantierbarer Gefäßleiter konzipiert ist.
Das Unternehmen betreibt eine 83.000 Quadratfuß große Bioprozessierungsanlage, die in der Lage ist, menschliches Gewebe im kommerziellen Maßstab herzustellen. Bemerkenswerterweise erteilte die FDA am 19. Dezember 2024 die vollständige Genehmigung für Symvess zur Verwendung bei Erwachsenen, die eine dringende Revaskularisierung aufgrund von arteriellem Verletzungen an den Extremitäten benötigen, wenn autologe Venenverpflanzungen nicht möglich sind.
Symvess bietet eine sofort einsatzbereite Lösung, die die Notwendigkeit beseitigt, Venen von Patienten während akuter Traumata zu entnehmen. Das Produkt befindet sich derzeit in klinischen Studien für arteriovenösen Zugang bei Hämodialyse und peripherer arterieller Erkrankung, mit präklinischer Entwicklung für koronare Bypass-Transplantate.
- FDA approval secured for Symvess in December 2024
- New patent protection extends until 2040
- 83,000 sq ft commercial-scale manufacturing facility operational
- Multiple potential market applications in development
- FDA approval only for specific trauma cases
- Other applications still in clinical/preclinical phases
Insights
Humacyte's newly issued U.S. Patent No. 12,195,711 represents a critical strategic asset that secures their proprietary bioreactor manufacturing system through 2040. This patent timing is particularly significant as it follows just two months after Symvess received FDA approval in December 2024, effectively creating a 16-year exclusivity window for their commercial-stage product.
The patent specifically protects the drawer cultivation system within their LUNA200 production equipment – the manufacturing backbone for Symvess and potentially numerous future bioengineered tissue products. This manufacturing protection extends beyond just the currently approved trauma indication to encompass Humacyte's entire pipeline, including applications in hemodialysis access, peripheral artery disease, and coronary bypasses.
From a business perspective, this patent strengthens Humacyte's position in three key ways:
- Creates significant barriers to entry for competitors attempting to develop similar bioengineered vessels
- Protects their manufacturing economics and potential margin advantages as they scale production at their 83,000 square foot facility
- Enhances their partnership leverage and potential acquisition value by securing long-term exclusivity for their platform technology
The off-the-shelf nature of Symvess addresses a critical unmet need in trauma care by eliminating the time and additional patient injury associated with autologous vein harvesting. With manufacturing protection now secured through this patent, Humacyte appears well-positioned to execute their commercial strategy while pursuing expanded indications that could significantly increase their addressable market.
– Patent provides coverage into 2040 for key aspects of the bioreactor manufacturing system –
– Symvess, the acellular tissue engineered vessel, is manufactured in this patented system –
DURHAM, N.C., Feb. 27, 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 issuance of a U.S. Patent covering key aspects of the manufacturing of Symvess (acellular tissue engineered vessel-tyod) and other bioengineered human tissues. U.S. Patent No. 12,195,711, titled “Drawer System for Cultivating Tissue,” covers key aspects of the bioreactor system that Humacyte uses to manufacture bioengineered human tissues. The newly issued patent provides protection into 2040. The new patent complements a family of existing patents and patent applications encompassing the design and composition of Humacyte’s products, and their methods of manufacture.
Humacyte’s lead product Symvess, or the ATEV™ (acellular tissue engineered vessel-tyod), 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. The ATEV is produced in proprietary manufacturing systems, including the LUNA200™ production equipment, that are covered by the newly issued U.S. patent. The Company has an 83,000 square foot bioprocessing facility, with the ability to manufacture human tissue of different diameters and lengths at commercial scale.
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. In contrast to harvesting a vein from the patient in the setting of acute trauma, which causes further injury and takes valuable time, Symvess is available off-the-shelf, and does not require further injuring the patient. The ATEV is also being evaluated in clinical trials in arteriovenous (AV) access for hemodialysis and peripheral artery disease, and preclinical development is underway in coronary artery bypass grafts.
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.
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.
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
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