Trestle Bio Announces Research Collaboration with Humacyte
Trestle Biotherapeutics and Humacyte (Nasdaq: HUMA) have announced a research collaboration to explore technology synergies for bioengineering vascularized organs for transplantation. The partnership will investigate the integration of Trestle Bio's biofabricated human kidney tissues with Humacyte's FDA-approved ATEV™ technology.
The collaboration aims to develop a human bioengineered kidney with vascular perfusion, targeting the significant global need in kidney disease treatment. Currently, over 800 million patients worldwide suffer from chronic kidney disease, with 600,000 US patients dependent on dialysis. While approximately 100,000 patients are on the transplant waiting list, only 25,000 successful transplants occur annually.
Trestle Bio's technology focuses on developing implantable bioengineered kidney tissue designed to reduce ESRD patients' dialysis dependency. This collaboration follows Humacyte's recent FDA approval for ATEV™ as a vascular conduit for extremity arterial injury treatment.
Trestle Biotherapeutics e Humacyte (Nasdaq: HUMA) hanno annunciato una collaborazione di ricerca per esplorare le sinergie tecnologiche nella bioingegneria di organi vascolarizzati per il trapianto. La partnership indagherà l'integrazione dei tessuti renali umani biofabbricati di Trestle Bio con la tecnologia ATEV™ di Humacyte, approvata dalla FDA.
La collaborazione mira a sviluppare un rene bioingegnerizzato umano con perfusione vascolare, rispondendo al notevole bisogno globale nella cura delle malattie renali. Attualmente, oltre 800 milioni di pazienti nel mondo soffrono di malattia renale cronica, con 600.000 pazienti negli Stati Uniti dipendenti dalla dialisi. Sebbene circa 100.000 pazienti siano in lista d'attesa per il trapianto, solo 25.000 trapianti di successo si verificano annualmente.
La tecnologia di Trestle Bio si concentra sullo sviluppo di tessuti renali bioingegnerizzati impiantabili progettati per ridurre la dipendenza dalla dialisi nei pazienti con malattia renale terminale. Questa collaborazione segue l'approvazione recente da parte della FDA di Humacyte per ATEV™ come condotto vascolare per il trattamento delle lesioni arteriose agli arti.
Trestle Biotherapeutics y Humacyte (Nasdaq: HUMA) han anunciado una colaboración de investigación para explorar sinergias tecnológicas en la bioingeniería de órganos vascularizados para trasplante. La asociación investigará la integración de los tejidos renales humanos biofabricados de Trestle Bio con la tecnología ATEV™ de Humacyte, aprobada por la FDA.
La colaboración tiene como objetivo desarrollar un riñón bioingeniero humano con perfusión vascular, atendiendo la significativa necesidad global en el tratamiento de enfermedades renales. Actualmente, más de 800 millones de pacientes en todo el mundo sufren de enfermedad renal crónica, con 600,000 pacientes en EE. UU. dependientes de diálisis. Aunque aproximadamente 100,000 pacientes están en lista de espera para trasplante, solo se realizan 25,000 trasplantes exitosos anualmente.
La tecnología de Trestle Bio se centra en desarrollar tejidos renales bioingenierizados implantables diseñados para reducir la dependencia de la diálisis en pacientes con enfermedad renal en etapa terminal. Esta colaboración sigue a la reciente aprobación de la FDA para ATEV™ de Humacyte como conducto vascular para el tratamiento de lesiones arteriales en extremidades.
트레슬 바이오테라퓨틱스와 휴마사이트 (Nasdaq: HUMA)는 이식용 혈관화된 장기를 위한 바이오 공학 기술 시너지를 탐구하기 위한 연구 협력 관계를 발표했습니다. 이 파트너십은 트레슬 바이오의 생체 제작된 인체 신장 조직과 휴마사이트의 FDA 승인 ATEV™ 기술의 통합을 조사할 것입니다.
이 협력의 목표는 혈관 관류가 있는 인체 생체 공학 신장을 개발하는 것으로, 신장 질환 치료에 대한 전 세계적인 필요를 충족하는 것입니다. 현재 전 세계적으로 8억 명 이상의 환자가 만성 신장 질환으로 고통받고 있으며, 미국에서 60만 명의 환자가 투석에 의존하고 있습니다. 약 10만 명의 환자가 이식 대기 명단에 올라 있지만, 매년 성공적으로 이루어지는 이식은 2만 5천 건에 불과합니다.
트레슬 바이오의 기술은 말기 신장 질환 환자의 투석 의존도를 줄이기 위해 설계된 이식 가능한 생체 공학 신장 조직 개발에 중점을 두고 있습니다. 이 협력은 휴마사이트의 ATEV™가 사지 동맥 손상 치료를 위한 혈관 도관으로 FDA의 최근 승인을 받은 이후 이루어진 것입니다.
Trestle Biotherapeutics et Humacyte (Nasdaq: HUMA) ont annoncé une collaboration de recherche pour explorer les synergies technologiques dans la bio-ingénierie d'organes vascularisés pour la transplantation. Le partenariat examinera l'intégration des tissus rénaux humains biofabriqués de Trestle Bio avec la technologie ATEV™ de Humacyte, approuvée par la FDA.
La collaboration vise à développer un rein bio-ingénierisé humain avec perfusion vasculaire, répondant à un besoin mondial significatif dans le traitement des maladies rénales. Actuellement, plus de 800 millions de patients dans le monde souffrent de maladies rénales chroniques, avec 600 000 patients aux États-Unis dépendants de la dialyse. Bien qu'environ 100 000 patients soient sur la liste d'attente pour une transplantation, seules 25 000 transplantations réussies ont lieu chaque année.
La technologie de Trestle Bio se concentre sur le développement de tissus rénaux bio-ingénierisés implantables conçus pour réduire la dépendance à la dialyse chez les patients atteints de maladie rénale terminale. Cette collaboration fait suite à l'approbation récente par la FDA d'Humacyte pour ATEV™ en tant que conduit vasculaire pour le traitement des blessures artérielles aux extrémités.
Trestle Biotherapeutics und Humacyte (Nasdaq: HUMA) haben eine Forschungszusammenarbeit angekündigt, um technologische Synergien für die bioengineering von vaskularisierten Organen für Transplantationen zu erkunden. Die Partnerschaft wird die Integration von Trestle Bios biofabrierten menschlichen Nierengeweben mit der von der FDA genehmigten ATEV™-Technologie von Humacyte untersuchen.
Das Ziel der Zusammenarbeit ist die Entwicklung einer bioengineering menschlichen Niere mit vaskulärer Perfusion, um dem erheblichen globalen Bedarf an der Behandlung von Nierenerkrankungen gerecht zu werden. Derzeit leiden weltweit über 800 Millionen Patienten an chronischen Nierenerkrankungen, wobei 600.000 Patienten in den USA von Dialyse abhängig sind. Während etwa 100.000 Patienten auf der Warteliste für Transplantationen stehen, werden jährlich nur 25.000 erfolgreiche Transplantationen durchgeführt.
Die Technologie von Trestle Bio konzentriert sich auf die Entwicklung von implantierbarem bioengineering Nierengewebe, das darauf abzielt, die Dialyseabhängigkeit bei Patienten mit terminaler Nierenerkrankung zu verringern. Diese Zusammenarbeit folgt der kürzlichen FDA-Zulassung von Humacyte für ATEV™ als vaskuläres Leitungsrohr zur Behandlung von arteriellen Verletzungen an den Extremitäten.
- FDA approval received for ATEV™ technology
- Addresses massive market of 800M+ chronic kidney disease patients
- Strategic partnership combines complementary technologies
- None.
Insights
Humacyte's new research collaboration with Trestle Biotherapeutics represents a strategic extension of Humacyte's human acellular vessel technology into the kidney disease space. This partnership targets the $90+ billion kidney disease market, an area with massive unmet needs where 600,000 U.S. patients depend on dialysis and 100,000 await transplants.
The collaboration leverages Humacyte's FDA-approved ATEV™ technology alongside Trestle's bioengineered kidney tissues, potentially creating a pathway toward functional bioengineered kidneys with proper vascular connections. This provides Humacyte a relatively low-risk avenue to explore applications beyond vascular injuries while validating their platform's broader utility.
What's particularly notable is the timing - this collaboration comes shortly after Humacyte secured FDA approval for ATEV™ in vascular trauma applications. The approval establishes regulatory precedent and manufacturing validation that could accelerate development timelines for kidney applications.
While still in research phase with no disclosed financial terms, this represents intelligent portfolio expansion by exploring synergies between Humacyte's proven vessel technology and a high-value therapeutic target. For investors, this collaboration expands Humacyte's addressable market well beyond the trauma space and into chronic conditions affecting millions globally, providing a potential long-term growth avenue beyond their initial approval.
This collaboration addresses one of regenerative medicine's fundamental challenges: creating functional vascularization for complex bioengineered organs. Success here could be transformative for the field.
Humacyte's ATEV™ technology provides a important missing piece to the kidney tissue engineering puzzle - the vascular infrastructure necessary for blood perfusion. Without proper vasculature, engineered tissues fail due to insufficient oxygen and nutrient delivery. Humacyte's vessels, already proven functionally equivalent to native vessels in clinical settings, could potentially solve this critical bottleneck.
The technical synergy is compelling. Trestle brings expertise in kidney stem cell biology and biofabrication, while Humacyte contributes a clinically-validated vascular conduit technology with demonstrated biocompatibility and functionality. Integration of these technologies could significantly accelerate development of transplantable kidney tissues.
For context, no company has yet successfully developed a bioengineered kidney with sufficient function to replace dialysis. The regulatory pathway remains complex, requiring demonstration of both safety and functionality of these complex tissues. However, Humacyte's experience navigating the FDA approval process provides valuable institutional knowledge.
While early stage, this collaboration represents a science-driven approach to addressing one of medicine's most persistent challenges using complementary technologies with established proof-of-concept. The potential market impact extends well beyond kidney disease to the broader field of bioengineered replacement organs.
The aim of the recently announced research collaboration and material transfer agreement is for the two companies to explore potential avenues of technology integration. The collaboration offers both groups the opportunity to expand their own R&D programs while exploring the interaction of Trestle Bio’s biofabricated human kidney tissues with Humacyte’s acelluar tissue engineered vessel-tyod (ATEV™), with a goal of generating a human bioengineered kidney with vascular perfusion.
Trestle Bio is pioneering the development of an implantable bioengineered kidney tissue for patients living with ERSD. Once implanted, Trestle Bio’s stem cell-based, biofabricated human kidney tissues will be designed to provide sufficient levels of renal function to take ESRD patients off dialysis, delay their need for organ transplantation, and become the technological foundations from which transplantable bioengineered organs are biomanufactured to address the global organ shortage.
Humacyte recently received FDA approval for ATEV™ 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 grafting is not feasible.
Globally, there are more than 800 million patients who suffer from chronic kidney disease (CKD). In the US, there are 125,000 new diagnoses of kidney failure made each year and there are approximately 600,000 patients who depend on dialysis for survival. There are approximately 100,000 patients on the transplant waiting list, and while kidney transplantation remains the only definitive treatment option for ESRD patients, there is a significant and persistent organ shortage resulting in just 25,000 successful transplants, annually.
Of the announcement, Laura Niklason, M.D., Ph.D., Humacyte Founder and CEO, said, “Trestle is doing cutting edge work in a field that desperately needs innovation and risk-taking. We are excited to explore ways in which our teams can work together to catalyze the development of new solutions for addressing kidney failure.”
Ben Shepherd Ph.D., Trestle Bio’s co-founder and CEO, stated, “We have been following Humacyte closely for some time now and I think it’s fair to say that they are really the gold standard for developing an FDA-approved regenerative medicine product. We’ve been highly focused on developing our kidney stem cell biology and biofabrication programs, and this is a natural progression for us. The broad application of Humacyte’s ATEV technology to treat kidney disease patients is clear, and we’re excited to collaborate with Humacyte to start bringing these engineering concepts to life.”
About Trestle Biotherapeutics
Trestle Biotherapeutics, Inc. is a preclinical stage company developing bioengineered tissues for patients living with end stage renal disease. Once implanted, these bioengineered stem cell-derived tissues will take patients off dialysis, delay their need for transplantation, and one day become replacement organs. Learn more at trestlebio.com.
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
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Trestle Bio Contact:
Ben Shepherd
+1-619-300-6866
Information
Email: contact@trestlebio.com
Source: Trestle Biotherapeutics, Inc.
FAQ
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