DURHAM, N.C., Feb. 09, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the recently adopted FY 2026 U.S. Department of Defense (DoD) Appropriations Act includes dedicated funding to support the evaluation and incorporation of biologic vascular repair technologies for the warfighters suffering from traumatic vascular injuries. The FY2026 National ...

Core Insights - Humacyte, Inc. announced results from a five-year analysis of hospital charges and healthcare costs related to extremity arterial injuries, highlighting the financial burden of preventable complications [1][2][5] Group 1: Financial Impact of Complications - Average hospital charge for extremity arterial injury repair was $316,600 per patient, with preventable complications like amputation and conduit infection increasing charges by approximately $493,000 and $590,000 respectively [1][3] - The average reimbursed cost for extremity arterial injury repair was significantly lower at $75,947, indicating a disparity between hospital charges and reimbursement [3] - Vascular graft infection and amputation resulted in additional hospital charges of $589,921 and $492,986 respectively, with average reimbursements of $84,598 and $116,611 [3] Group 2: Symvess Product Overview - Humacyte's Symvess is an acellular tissue engineered vessel designed for urgent revascularization in extremity arterial injuries when autologous vein grafts are not feasible [4][6] - Symvess has demonstrated low rates of infection and high limb salvage rates compared to historical controls, with infection rates one-ninth and amputation rates one-fifth of those seen with synthetic grafts [4][5] - The product is designed to be available off-the-shelf, which can save critical surgical time in emergency situations [5] Group 3: Clinical and Market Context - The analysis included data from 964 adult patients treated for extremity arterial injuries from 2018 to 2023, prior to the FDA approval of Symvess [2] - The patient cohort had an average age of 36.5 years, with 26% treated using conduits other than autologous vein, indicating a significant market for alternative solutions like Symvess [3][5] - Recent positive results from the V005 Phase 2/3 study of Symvess provide the first long-term data for traumatic arterial repair using a biologic conduit [5]

Core Insights - Humacyte, Inc. announced the publication of long-term data on Symvess, a bioengineered vessel, demonstrating high limb salvage rates and low infection rates in extremity arterial trauma patients over a follow-up period of up to 36 months [1][2][3] Group 1: Study Results - The study published in the Journal of Vascular Surgery Cases, Innovations and Techniques found that Symvess maintained structural integrity, exhibited a 92.9% infection-free rate from months 3 to 36, and had limb salvage rates of 87.3% at 12 months and 82.5% at 24 months [1][2] - No deaths, amputations, or mechanical failures were attributed to Symvess, and there was no evidence of spontaneous ruptures or structural failures during the follow-up period [2][3] Group 2: Clinical Significance - The results represent the first prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit, providing a reliable alternative when autologous vein grafts are not feasible [3][4] - Symvess is designed to be immediately available off-the-shelf, which is critical in emergency situations where time is of the essence [4] Group 3: Company Overview - Humacyte is developing a biotechnology platform for universally implantable bioengineered human tissues and has received FDA approval for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication [13] - The company is also advancing other vascular applications and has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) designation for its ATEVs [13]

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Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $0.8 million, with $0.7 million from U.S. sales of Symvess, a significant increase from $0.1 million in Q3 2024 [20][21] - Net loss for Q3 2025 was $17.5 million, down from a net loss of $39.2 million in the prior year [23] - Cash, cash equivalents, and restricted cash totaled $19.8 million as of September 30, 2025, with an additional $56.5 million raised post-quarter [24] Business Line Data and Key Metrics Changes - Product sales of Symvess improved to $703,000 in Q3 2025, up from $100,000 in the previous quarter [6] - Research and development expenses decreased to $17.3 million in Q3 2025 from $22.9 million in the prior year [21] - General and administrative expenses increased slightly to $7.6 million in Q3 2025 from $7.3 million in the prior year [22] Market Data and Key Metrics Changes - 25 hospitals have completed the Value Analysis Committee (VAC) process, representing 92 civilian hospitals eligible to purchase Symvess [5][6] - An additional 45 VAC committees are currently reviewing Symvess [6] Company Strategy and Development Direction - The company is focused on the commercial launch of Symvess and advancing other bioengineered vessel programs, including dialysis access and coronary tissue engineered vessels [5][18] - The company plans to file a supplemental Biologics License Application (BLA) for dialysis access in the second half of 2026 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong results from the V007 phase III trial for dialysis access, indicating a significant market opportunity [15][31] - The company is optimistic about the ongoing commercial rollout of Symvess and the potential for further validation through research publications [19][26] Other Important Information - The company has expanded its intellectual property estate with a new U.S. patent covering a bioengineered esophagus, providing protection until 2041 [19] - The company has seen a positive response from surgeons regarding the usability and function of Symvess in clinical settings [35] Q&A Session Summary Question: How many hospitals that have started ordering have begun the reorder process? - Management indicated that the majority of hospitals that have ordered Symvess have also reordered, although specific data was not disclosed [30] Question: How does the new data from the V007 trial change the view for Symvess in dialysis? - Management believes the strong results in duration of usability in high unmet need subgroups will support the supplemental BLA application for dialysis access [31] Question: What is the status of the interim analysis for the V012 trial? - The interim analysis is planned when the first 80 patients reach one year of follow-up, expected around April 2026 [17] Question: How is the sales force transitioning towards hemodialysis? - The company is strategically adding a small number of sales representatives to target the same surgeons who perform both trauma and dialysis access operations [52] Question: What is the strategy regarding the NTAP submission? - The company has opted not to resubmit for the NTAP in trauma, focusing instead on driving market activity through price reductions [59][61]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $0.8 million, with $0.7 million from U.S. sales of Symvess, a significant increase from $0.1 million in Q2 2025 [19][20] - Research and development expenses decreased to $17.3 million in Q3 2025 from $22.9 million in the prior year, reflecting cost reductions and capitalization of manufacturing costs [20] - Core net loss for Q3 2025 was $17.5 million, down from $39.2 million in the prior year, indicating improved financial performance [22] Business Line Data and Key Metrics Changes - Product sales of Symvess improved to $703,000 in Q3 2025 from $100,000 in Q2 2025, showing strong market traction [5][19] - 25 hospitals have completed the Value Analysis Committee (VAC) process, with approvals representing 92 civilian hospitals eligible to purchase Symvess [4][5] Market Data and Key Metrics Changes - The company has recorded its first commercial sale of Symvess to U.S. military facilities following ECAT approval, indicating expansion into military healthcare [7][18] - The ATEV for dialysis patients demonstrated superior duration of use over 24 months compared to autogenous fistula, targeting a historically underserved market [14][15] Company Strategy and Development Direction - The company is focused on expanding its commercial launch of Symvess and advancing its bioengineered vessel programs, including dialysis access and coronary tissue engineered vessels [4][18] - The strategy includes targeting high-risk patient populations, particularly women and men with diabetes and obesity, for dialysis access solutions [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential and value generation for the remainder of 2025 and beyond, supported by strong clinical data and market adoption [25] - The company plans to submit a supplemental BLA for dialysis access in the second half of 2026, contingent on positive interim results from ongoing trials [16][22] Other Important Information - The company has expanded its intellectual property estate with a new U.S. patent covering a bioengineered esophagus, enhancing its product portfolio [18] - Cash position as of September 30, 2025, was $19.8 million, with additional net proceeds of approximately $56.5 million from a recent stock sale, providing a cash runway exceeding 12 months [23] Q&A Session Summary Question: How many hospitals that have started ordering have begun the reorder process? - Management indicated that the majority of hospitals that have ordered Symvess have also reordered, although specific data was not disclosed [29] Question: How does the new data from the trial for V007 change the view for Symvess in dialysis? - Management believes the strong results in duration of usability in high unmet need subgroups will support the supplemental BLA application for dialysis access [30] Question: What is the status of the cost savings initiatives? - Management confirmed that cost savings initiatives are on track, with significant reductions already realized in R&D and operating expenses [40] Question: How will the sales force transition to target hemodialysis? - The company plans to strategically add a small number of sales representatives to target the same surgeons who perform both trauma and dialysis access operations [52] Question: What is the strategy regarding the NTAP submission? - Management decided not to resubmit for NTAP in trauma, focusing instead on driving market activity through price reductions [58][61]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $0.8 million, with $0.7 million from U.S. sales of Symvess, a significant increase from $0.1 million in Q3 2024 [18] - Core net loss decreased to $17.5 million for Q3 2025 from $39.2 million in Q3 2024, and net loss for the nine months ended September 30, 2025 was $16.0 million compared to $127.8 million for the same period in 2024 [22] - Cash, cash equivalents, and restricted cash totaled $19.8 million as of September 30, 2025, with an additional $56.5 million raised post-quarter, providing a cash runway exceeding 12 months [23] Business Line Data and Key Metrics Changes - Product sales of Symvess improved to $703,000 in Q3 2025 from $100,000 in Q2 2025, indicating strong market traction [5] - 25 hospitals have completed the Value Analysis Committee (VAC) process and approved the purchase of Symvess, representing 92 civilian hospitals eligible to purchase [4][5] Market Data and Key Metrics Changes - The commercial rollout of Symvess has been supported by recent publications demonstrating its effectiveness in vascular trauma, enhancing its market acceptance [6][8] - The company is targeting underserved populations in dialysis access, particularly women and high-risk men, who represent over half of the dialysis access market [12][14] Company Strategy and Development Direction - The company is focused on expanding its commercial launch of Symvess and advancing its bioengineered vessel programs, including dialysis access and coronary tissue engineered vessels [4][16] - A new U.S. patent covering a bioengineered esophagus was granted, extending protection into 2041, indicating a commitment to expanding its intellectual property portfolio [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential and value generation for the remainder of 2025 and beyond, citing strong commercial execution and a promising pipeline [25] - The company is optimistic about the upcoming interim analysis of the VO12 trial and its implications for filing a supplemental BLA for dialysis access [14][77] Other Important Information - Research and development expenses decreased to $17.3 million for Q3 2025 from $22.9 million in the prior year, reflecting cost reductions and the capitalization of manufacturing costs [19] - The company has seen a positive response from surgeons regarding the usability and functionality of Symvess in surgical settings [33] Q&A Session Summary Question: How many hospitals that have started ordering have begun the reorder process? - Management indicated that the majority of hospitals that have ordered Symvess have also reordered, although specific data was not disclosed [29] Question: How does the new data from the trial for V007 change the view for Symvess in dialysis? - Management believes the strong results in duration of usability in high unmet need subgroups will support the supplemental BLA application for dialysis access [30] Question: What is the status of the launch and how many units have been used versus initial stocking orders? - Initial stocking orders range from one to three units, with hospitals reordering as they reach their par levels, and positive feedback from surgeons has been received [32][33] Question: How has the price reduction for Symvess impacted adoption? - The price reduction has accelerated the VAC process and opened doors to hospitals that previously did not consider the product [36] Question: What are the expectations for cost savings initiatives? - Management confirmed that they are on track to achieve the targeted $50 million in cost savings, with reductions already observed in operating expenses [40] Question: What is the strategy regarding the NTAP submission? - The company has opted not to resubmit for NTAP in trauma, focusing instead on driving market activity through price reductions [60] Question: How are real-world outcomes being tracked post-approval? - A post-approval registry study is planned to follow at least 100 trauma patients for a year, with data expected to emerge in 2027 [45] Question: How does the company plan to transition its sales force for dialysis? - The company plans to strategically add sales representatives targeting the same surgeons who perform both trauma and dialysis access operations [51]

Core Insights - Humacyte, Inc. reported total revenues of $753,000 for Q3 2025 and $1,571,000 for the first nine months of 2025, primarily from sales and collaborative research agreements [1][8] - The company is advancing its pipeline with plans for a Biologics License Application (BLA) filing for its acellular tissue engineered vessel (ATEV) in dialysis and initiating first-in-human studies for coronary artery bypass grafting (CABG) [1][3] - Significant sales growth of the Symvess product was noted, with Q3 sales reaching $703,000, a substantial increase from $100,000 in Q2 2025 [3][4] Financial Performance - Revenue for Q3 2025 was $753,000, with $703,000 from U.S. sales of Symvess and $50,000 from a research collaboration [8][19] - The net loss for Q3 2025 was $17.5 million, a decrease from a net loss of $39.2 million in Q3 2024 [13][19] - Research and development expenses decreased to $17.3 million in Q3 2025 from $22.9 million in Q3 2024, attributed to capitalizing costs related to Symvess manufacturing [13][19] Product Development and Pipeline - The company has received 25 Value Analysis Committee (VAC) approvals for Symvess, up from 13 in August 2025, allowing 92 civilian hospitals to purchase the product [4][5] - Positive results from the V007 Phase 3 trial for ATEV in dialysis were presented at Kidney Week 2025, indicating superior duration of use compared to autogenous fistulas [9] - Humacyte plans to submit a supplemental BLA for ATEV in dialysis in the second half of 2026, based on data from ongoing clinical trials [9][19] Intellectual Property and Research - Humacyte expanded its intellectual property portfolio with a new U.S. patent for a bioengineered esophagus, enhancing its existing claims for engineered trachea and urinary conduits [9][19] - The company published multiple studies highlighting the efficacy of Symvess in treating vascular complications, demonstrating high patency rates and limb salvage [4][5]

Core Insights - Humacyte, Inc. announced the publication of a study comparing the clinical outcomes of its product Symvess to autologous vein in treating extremity arterial trauma, showing similar short-term outcomes [1][2][4] Company Overview - Humacyte, Inc. is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][13] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma indications [13][14] Study Findings - The study published in the AAST's Trauma Surgery & Acute Care Open Journal indicated that Symvess achieved comparable outcomes to autologous vein in terms of primary patency (86.6% for Symvess vs. 91.8% for autologous vein), secondary patency (91.0% vs. 97.7%), amputation rates (7.5% vs. 8.2%), conduit infection (1.5% vs. 0%), and mortality (4.5% for both) [2][3] - The analysis utilized data from Humacyte's Phase 2/3 V005 study and the Humanitarian V017 study, matched against the PROOVIT registry [2][3] Product Indication - Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and autologous vein graft is not feasible [5][13] Market Context - Autologous vein has been the gold standard for treating extremity arterial trauma due to its resistance to infection and maintenance of patency, but may not always be available [2][3] - Symvess offers an off-the-shelf solution that can save critical surgical time in traumatic situations [3][4] Leadership Perspective - Humacyte's CEO emphasized the need for innovative alternatives to autologous vein grafts, highlighting Symvess as a safe and effective option for complex trauma cases [4][13]

Core Insights - Humacyte's shares experienced an 18% increase following the announcement of positive data from a humanitarian initiative utilizing their bio-engineered human tissue product, Symvess, for treating vascular trauma injuries [5] Company Summary - The initiative involved a total of 17 patients, indicating a focused application of Humacyte's technology in a real-world medical scenario [5]