$HUMA Announces First Symvess™ Sale to Military Treatment Facility.
“We are excited to see the first purchase and use of Symvess by a military treatment facility,” said Dr. Laura Niklason, President and CEO of Humacyte, Inc”. https://t.co/sPdmnYJ5nS
Humacyte has just announced that Symvess™ has been awarded Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency, which makes Symvess available to healthcare professionals at U.S. Department of Defense and U.S. Department of Veterans Affairs facilities.
For more details, please read the full press release here: https://t.co/Ab1zA1VBBG
#Humacyte #HealthcareInnovation #Bioengineering #Biotech
Thank you for taking the time to learn more about Humacyte’s FDA Approved, Symvess™, Acellular Tissue Engineered Vessel (ATEV™), this past weekend at SCCACS. As this is a first-in-class, universally implantable, bioengineered human vessel, it was exciting to share this new, lifesaving technology with you.
The discussions were educational for us, and we hope they were for you as well. We appreciated everyone's enthusiasm to learn more. We look forward to continuing the conversations!
Learn more about Symvess here: https://t.co/1f77QQzSoV
See the Prescribing Information, including Boxed Warning: https://t.co/Eg2XmrWRso
#Humacyte #SCCACS2025 #RegenerativeMedicine #Innovation #Biotech #Firstinclass $HUMA @AmCollSurgeons
$HUMA update.
Humacyte Provides Update on Commercial Launch and Pricing of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma.
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 10% of achievers in their prior sales organizations. All sales team members have demonstrated consistent overachievement with average hospital medical device and biotech experience exceeding 15 years. Each sales team member has experience in vascular surgery and/or trauma surgery, and 80% have previous experience selling regenerative therapies. All team members have experience selling clinically differentiated disruptive technologies and premium priced portfolios.
Humacyte announced that the price of Symvess will be $29,500 per unit. The Company has developed a Budget Impact Model based on the clinical results supporting the approval of Symvess, and the estimated reduction in clinical complications potentially achievable by treating specific patients with Symvess versus current standard of care. Based on the model, the 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. Major drivers of cost savings associated with Symvess were attributed to reductions in the rate of amputation and vascular conduit infection.
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.