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.

Humacyte 公司（纳斯达克股票代码：HUMA）是一家商业阶段的生物技术平台公司，致力于以商业规模开发通用可植入的生物工程人体组织，今天宣布推出 Symvess（脱细胞组织工程血管类型），供成人在需要紧急血管重建以避免肢体丧失，以及无法进行自体静脉移植时用作肢体动脉损伤的血管导管。美国食品药品管理局（FDA）于2024 年 12 月 19 日FDA 现已完成对商业批次信息的必要审查，并已授权人类细胞开始商业运输。

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.

FDA 批准后不久，人类细胞开始收到医院对 Symvess 的报价请求。21 家医院已经启动了 VAC 审批流程，预计还会有更多医院启动该流程。这些医院包括一些领先的创伤中心，它们曾参与人类细胞临床研究与新引入 Symvess 的机构相结合。此外，这些医院的范围从单个机构到提供更大医院网络访问的中心。尽管 VAC 流程通常需要三到六个月才能完成，但两家医院已经完成审查并在市场推出之前批准购买 Symvess。人类细胞还收到通知称，在 VAC 流程仍在进行期间，许多医院将购买 Symvess。

“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.”

“这是一个伟大的时刻人类细胞但更重要的是，对于急需动脉修复的患者来说，这有助于挽救他们的肢体或生命。”劳拉·尼克拉森，医学博士，哲学博士，创始人兼首席执行官人类细胞。“经过 20 多年的研发，我们很高兴能够将 Symvess 交付给致力于改善患者治疗效果的医院和外科医生。此次商业发布标志着血管外科和患者护理的新时代，也是下一个增长阶段人类细胞。我们的商业团队将继续与医疗保健提供商密切合作，确保全国患者都能使用 Symvess。”

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.

Symvess 或 ATEV™（脱细胞组织工程血管）是一流的生物工程人体组织，旨在成为一种通用植入式血管导管，用于动脉置换和修复。在临床研究中，Symvess 已被美国各地一级创伤中心的血管和创伤外科医生使用我们和以色列修复严重的危及肢体和生命的伤害，以及在前线医院乌克兰治疗战时受伤。与从患者身上采集静脉（这会造成进一步伤害并耗费宝贵时间）不同，Symvess 是现成的，不需要进一步伤害患者。Humacyte 的 BLA 包括 V005 关键 2/3 期临床研究的积极结果，以及来自治疗战时受伤的真实证据乌克兰根据人道主义援助计划。Symvess 已用于治疗由车祸、枪伤、爆炸伤和工业事故引起的多种类型的伤害。这些民用和战时创伤研究的结果于JAMA Surgery上发表2024 年 11 月 20 日. 在临床研究中，Symvess 被观察到具有高通畅率或血流率，并且截肢和感染率较低。

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.

为了传达 Symvess 的健康经济价值，人类细胞已经根据支持 BLA 的临床结果以及使用 Symvess 相对于当前标准治疗可能实现的临床并发症减少量开发了预算影响模型 (BIM)。根据 BIM，使用 Symvess 治疗患者的每位患者总成本估计低于使用合成移植物、冷冻保存的同种异体移植物或异种移植物治疗创伤患者的成本。与 Symvess 相关的成本节约的主要驱动因素是截肢率和血管导管感染率的降低。一篇描述 BIM 的论文已被一家主要医学杂志接受发表。

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.

适应症 SYMVESS 是一种脱细胞组织工程血管，适用于成人肢体动脉损伤的血管导管，当需要紧急血管重建以避免即将发生的肢体损失，而自体静脉移植又不可行时使用。