Perioperative ischaemia

-FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma- -Reported Positive Topline Results from Phase 3 Trial of ATEV in Hemodialysis Access- -ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA in Advanced Peripheral Artery Disease- -Conference call and live webcast at 8:30 a.m. ET today- DURHAM, N.C., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the second quarter ended June 30, 2024 and highlighted recent accomplishments. “We were surprised to be notified by the FDA that they will require additional time to complete their review of the BLA for our ATEV (acellular tissue engineered vessel) in vascular trauma,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “FDA leadership noted that Humacyte’s ATEV is a first-in-class product, and that Priority Review had been granted, which involves only a six-month review cycle, as compared to the standard ten-month review cycle for most products. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma, although we currently do not yet have a revised action date.” “The ATEV continues to make significant progress in its other investigational indications, including in hemodialysis access,” continued Dr. Niklason. “We were pleased to announce positive top-line results from the V007 Phase 3 clinical trial in patients with end-stage renal disease, in which the ATEV was observed to have superior functional patency over current standard of care. In addition, the ATEV received its third RMAT designation from the FDA, specifically in advanced peripheral artery disease. This serves as a recognition from the Agency that Humacyte’s ATEV may provide an important therapeutic option for patients with advanced arterial disease in their legs, who are facing potential amputation. We are proud that the ATEV’s broad potential continues to be recognized and look forward to presenting additional results across our pipeline at upcoming medical meetings.” Second Quarter 2024 and Recent Corporate Highlights ATEV (acellular tissue engineered vessel) FDA extension of time to complete review of BLA for ATEV in the Treatment of Vascular Trauma– On August 9, 2024, in a phone call, Center for Biologics Evaluation and Research (CBER) leadership from the U.S. Food and Drug Administration (FDA) notified the Company that the FDA will require additional time to complete its review of the Company’s Biologics License Application (BLA) for the ATEV in the vascular trauma indication. The ATEV trauma BLA was submitted to FDA in December 2023, FDA granted a Priority Review in February 2024, and assigned a PDUFA date of August 10, 2024. Positive Topline Results of ATEV in Hemodialysis Access – In July 2024, Humacyte reported positive topline results from the V007 Phase 3 clinical trial (NCT03183245) of the ATEV in arteriovenous (AV) access for patients on hemodialysis. The V007 trial is prospective, multi-center, randomized clinical study in 242 hemodialysis patients in the United States. Participants were randomly assigned to receive either the ​​ATEV or an AV fistula for hemodialysis access and are being followed for up to 24 months. In the trial, the ATEV was observed to provide superior functional patency at six and 12 months (co-primary endpoints; p=0.0071) compared to autogenous fistula, which is the current standard of care for hemodialysis patients. Patients on ATEV also achieved a significantly longer duration of hemodialysis using the ATEV over the first 12 months, as compared to autogenous fistula (p=0.0162). Humacyte anticipates that detailed results from the trial will be presented at upcoming medical meetings. ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA – In July 2024, the FDA granted RMAT designation of the ATEV for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for the PAD indication. This is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and AV access in hemodialysis. Medical and Scientific Publications and Presentations PAD Publication: In June 2024, Dr. Todd Rasmussen and colleagues at the Mayo Clinic in Rochester MN published outcomes of arterial bypass using the ATEV in patients with chronic limb ischemia (severe PAD). In this paper, appearing in the Journal of Vascular Surgery in June, all patients treated with the ATEV for severe PAD had no suitable vein of their own for bypass, and were treated under an investigator-sponsored protocol. Outcomes for ATEV patency (or blood flow) and limb salvage in patients with severe PAD and no vein were compared to historical control patients, having similar disease but receiving a bypass using their own vein at the Mayo Clinic. Mayo investigators reported that patency and limb salvage were similar for patients receiving ATEV, and patients receiving bypass with their own vein. This result highlights the potential impact that Humacyte’s ATEV may have on patients suffering from severe PAD and having no vein of their own to perform a bypass operation.Presentations Highlighting Advancement of Diabetes Program – In June 2024, Humacyte presented positive results from ongoing preclinical studies supporting the potential of Humacyte’s BioVascular Pancreas (BVP™) product candidate to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes: At a presentation at the Breakthrough T1D (formerly, JDRF) Beta Cell Consortium Meeting in New York City, scientists presented data in which stem cell-derived islets, manufactured at Humacyte, were observed to restore normal blood sugar in diabetic mice. In the mice, the stem cell-derived islets survived and continued to produce insulin, with no evidence of adverse safety events from the stem cell-derived islets. These experiments were performed in collaboration with the Diabetes Research Institute (DRI) at the University of Miami.At the American Diabetes Association annual meeting in Orlando, Florida, Humacyte reported successful implantation of BVPs into non-human primate recipients. In the study, also performed in collaboration with the DRI, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study. Islets also developed capillaries to support survival of the insulin-producing cells. CABG Preclinical Remodeling Results – Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small-diameter ATEV into human clinical trials in coronary artery bypass graft (CABG) surgery. Humacyte has observed remodeling of the ATEV to a diameter that closely matches that of the native coronary vessels in non-human primates, which is an outcome not observed with any other conduit and highlights the potential adaptability of the ATEV in vivo. These promising results of ATEV patency and remodeling were presented at the Tissue Engineering and Regenerative Medicine (TERM-2024) Conference on June 11-12, 2024. Corporate Updates Strengthened Board of Directors – In July 2024, Humacyte announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company’s Board of Directors. Second Quarter 2024 Financial Highlights There was no revenue for either the second quarter of 2024 or the second quarter of 2023, and there was no revenue for the six months ended June 30, 2024 and 2023.Research and development expenses were $23.8 million for the second quarter of 2024, compared to $20.5 million for the second quarter of 2023, and were $45.0 million for the six months ended June 30, 2024, compared to $37.8 million for the six months ended June 30, 2023. The current-period increases resulted primarily from increased materials and personnel expenses to support expanded research and development initiatives and our clinical trials, including the expansion of manufacturing activities and support of the FDA review of the BLA in vascular trauma.General and administrative expenses were $5.7 million for the second quarter of 2024, compared to $6.2 million for the second quarter of 2023, and were $11.1 million for the six months ended June 30, 2024, compared to $11.4 million for the six months ended June 30, 2023. The slight decreases during 2024, resulted primarily from a decrease in non-cash stock compensation expense, partially offset by increased personnel expenses and increased professional fees.Other net income (expense) was net expense of $27.2 million for the second quarter of 2024, compared to net income of $4.0 million for the second quarter of 2023, and other net expense of $32.5 million for the six months ended June 30, 2024, compared to other net expense of $10.4 million for the six months ended June 30, 2023. The increase in other net expense for the second quarter of 2024 and the six months ended June 30, 2024 compared to 2023 resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the Company’s August 2021 merger with Alpha Healthcare Acquisition Corp.Net loss was $56.7 million for the second quarter of 2024, compared to $22.7 million for the second quarter of 2023, and net loss was $88.6 million for the six months ended June 30, 2024, compared to $59.7 million for the six months ended June 30, 2023. The current-period increase in net loss resulted primarily from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.The Company reported cash and cash equivalents of $93.6 million as of June 30, 2024. Total net cash provided was $13.1 million for the first six months of 2024, compared to net cash used of $35.2 million for the first six months of 2023. The increase in net cash provided resulted primarily from the receipt of approximately $43.0 million in net proceeds from an underwritten public offering of Humacyte’s common stock in March 2024, and $20 million in proceeds from an additional draw under its funding arrangement with Oberland Capital Management. Conference Call and Webcast Details Title:Humacyte Second Quarter 2024 Financial Results Corporate UpdateDate:Tuesday, August 13, 2024Time:8:30 a.m. ETConference Call Details:Toll-Free: 1- 877-704-4453International: 1-201-389-0920Conference ID #: 13747913Call meTM Feature (avoid waiting for operator):Click HereWebcast:Webcast Link - Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. 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 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 is currently under review by the FDA and was granted Priority Review. 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. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. 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, the outcome of the FDA’s review of our BLA seeking approval of the ATEV in the vascular trauma indication; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, the anticipated characteristics and performance of our ATEV; 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, 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 AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Humacyte, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(unaudited)(in thousands except for share and per share amounts) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Revenue$— $— $— $— Operating expenses: Research and development 23,753 20,540 45,017 37,818 General and administrative 5,746 6,191 11,060 11,425 Total operating expenses 29,499 26,731 56,077 49,243 Loss from operations (29,499) (26,731) (56,077) (49,243) Other income (expense), net: Change in fair value of contingent earnout liability (25,571) 3,627 (30,164) (10,564)Other income (expense) (net) (1,593) 398 (2,318) 132 Total other income (expense), net (27,164) 4,025 (32,482) (10,432)Net loss and comprehensive loss$(56,663) $(22,706) $(88,559) $(59,675) Net loss per share, basic and diluted$(0.48) $(0.22) $(0.78) $(0.58)Weighted-average shares outstanding, basic and diluted 119,174,681 103,361,501 113,710,344 103,312,785 Humacyte, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands) June 30,2024 December 31,2023Assets Current assets: Cash and cash equivalents$93,563 $80,448 Prepaid expenses and other current assets 2,547 2,830 Total current assets 96,110 83,278 Property and equipment, net 24,820 26,791 Finance lease right-of-use assets, net 16,536 17,313 Other long-term assets 815 841 Total assets $138,281 $128,223 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$6,005 $6,490 Accrued expenses 8,950 9,340 Other current liabilities 2,802 2,613 Total current liabilities 17,757 18,443 Contingent earnout liability 68,080 37,916 Revenue interest liability 60,078 38,600 Finance lease obligation, net of current portion 15,123 16,293 Other long-term liabilities 5,530 3,425 Total liabilities 166,568 114,677 Stockholders’ equity Common stock and additional paid-in capital 597,586 550,860 Accumulated deficit (625,873) (537,314)Total stockholders’ equity (28,287) 13,546 Total liabilities and stockholders’ equity$138,281 $128,223

Calgary, Alberta--(News - June 3, 2024) - Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) (FSE: 2VF0) is pleased to announce it has signed a Letter of Intent ("LOI") with CytoImmune Therapuetics ("CytoImmune") to re-establish production of ACP-01 ("ACP") in CytoImmune's state-of-the-art clinical cell manufacturing facility. The Company is also pleased to announce that it has received commitments for $1,800,000 of Units in a non-brokered private placement as more fully described below. CytoImmune To view an enhanced version of this graphic, please visit: CytoImmune has approximately 40 employees with hundreds of years of cumulative experience in biologics and cell manufanufacturing along with a 38,000 square foot state-of-the-art cell manufacturing facility in Toa Baja, Puerto Rico. CytoImmune is entering a technology transfer and manufacturing agreement with Hemostemix for the commercial supply of ACP-01. In addition, CytoImmune will subscribe for $1,370,000 of Units of Hemostemix at $0.05 as described below. This commitment underscores CytoImmune's dedication to fostering partnerships that fuel the future of cell therapy and improve patients' lives. "Our company's industry-leading expertise in cell therapy development and clinical manufacturing will accelerate Hemostemix's success and expand Puerto Rico's legacy as "America's Medicine Cabinet," said Jose Vidal, CEO of CytoImmune Therapeutics, Inc. "Puerto Rico employs nearly 100,000 pharmaceutical executives and manufactures nearly 20% of the United States drug exports. Adding cell and gene therapies is driven by Puerto Rico's initiative to rejuvenate its biopharma sector with new technologies." Globally, 236 million suffer from Peripheral Arterial Disease. Approximately 10% of these patients degenerate into CLTI. The incidence of CLTI in the U.S.A. is 1.33%, with an annual 10-40% amputation rate, and an annual 15-20% mortality rate. Globally, CLTI has a 60% mortality rate in 5 years. Therefore, saving a limb is saving a life. In Hemostemix's phase II clinical trial of ACP-01, 83% of patients followed for up to 4.5 years by the University of Toronto and University of British Columbia experienced healing of ulcers, cessation of pain, no major amputation, and improved. Unblinded, these 83% were treated with ACP. "This is a pivotal agreement that re-establishes production of ACP for sale to patients suffering from no-option chronic limb threatening ischemia and heart disease, under physician order," stated Thomas Smeenk, CEO. "It enables Hemostemix to ramp up production with CytoImmune, and with its own staff, to reach sales volumes of up to $2 million per month in 2025," Smeenk said. Hemostemix has organized with the principal investigators of its phase II trial up to 226 patients/month of CLTI specialist capacity. Globally, this provides individuals who are suffering in significant pain and facing limb amputation a second-opinion-before-amputation. Likewise, Hemostemix has organized with invasive cardiologists who completed 200 regulatory approved ACP heart treatments, capacity to treat 100 heart patients per month. Non-Brokered Private Placement (the "Offering") The Company may raise up to $2,000,000, or more if oversubscribed, from the sale of Units. Each Unit at $0.05 shall consist of one common share in the capital of the Company ("Common Share") and one common share purchase warrant ("Warrant"), with each Warrant entitling the holder to acquire one Common Share at a price of $0.12 per Common Share for a period of 24 months from the closing of the Offering, subject to the accelerated expiry provision described below. If during any 10 consecutive trading days occurring after four months and one day has elapsed following the closing date of the Offering, the weighted average closing sales price of the Common Shares (or the closing bid, if no sales were reported on a trading day) as quoted on the TSX Venture Exchange ("Exchange") is greater than or equal to $0.15 per Common Share, the Company may provide notice in writing to the holders of the Warrants by issuance of a press release that the expiry date of the Warrants will be accelerated to the 30th day after the date on which the Company issues such press release. As announced on March 7th, 2024, the Company is continuing to work with Oak Hill Asset Management to raise low-dilution capital and to accelerate its business plan of offering no-option CLTI patients an outpatient procedure to save their limb from amputation under physician order. Proceeds from the Offering and other funding initiatives, will be used to initiate the processing of initial batches in 2024 and for general working capital purposes. Certain directors of the Company may participate in the private placement, which would constitute a "related party transaction" within the meaning of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and the policies of the TSXV. The Company is relying upon the exemptions from the formal valuation and minority shareholder approval requirements pursuant to sections 5.5(b) and 5.7(1)(a), respectively, of MI 61-101 on the basis that the Company is not listed on a specified stock exchange and, at the time the Offering was agreed to, neither the fair market value of the subject matter of, nor the fair market value of the consideration for, the transaction insofar as it involves an interested party (within the meaning of MI 61-101) in the Offering, exceeds 25% of the Company's market capitalization calculated in accordance with MI 61-101. All securities issued under the Private Placement will be subject to a four-month hold period from the closing date under applicable Canadian securities laws, in addition to such other restrictions as may apply. About CytoImmune Therapeutics CytoImmune Therapeutics is at the forefront of a novel natural killer cell therapy for lung cancer, currently in phase 1 clinical trials. In addition, we are now offering cell therapy development and clinical manufacturing services to both biotechnology companies and academia. Our state-of-the-art clinical cell manufacturing facility in Toa Baja, Puerto Rico, is custom built to support the development and commercialization of cutting-edge T cell or NK cell therapies. At CytoImmune, we are dedicated to fostering collaborations that drive the future of cell therapy and improve the lives of cancer patients. Discover how our expertise in cell therapy development and clinical manufacturing can accelerate your path to success. For additional information, please visit: Cytoimmune.com. About Hemostemix Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient's blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. For more information, please visit Hemostemix.com. For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder EM: tsmeenk@hemostemix.com PH: 905-580-4170 Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: financing of the Company and its lead product ACP-01, and the commercialization of ACP-01 via the sale of compassionate treatments under physician order. ‎There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory ‎approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the ‎economy generally; consumer ‎interest in Hemostemix's services and products; competition and ‎Hemostemix's competitive advantages; and Hemostemix obtaining satisfactory financing to ‎ fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemis mayface; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation ‎affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete;‎ lack of qualified, skilled labour or loss of key individuals; and risks ‎related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to ‎try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and ‎financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a ‎possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at . Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law. To view the source version of this press release, please visit

Over 200 million people around the world experience peripheral artery disease (PAD) -- a condition caused by the narrowing of the blood vessels from the heart to the lower limbs that leads to pain when walking -- and for roughly 1-in-10 this advances to chronic limb-threatening ischemia (CLTI), an advanced form of PAD. Those with CLTI often suffer severe pain even at rest, caused by fatty plaque buildup obstructing blood flow, typically to the leg or foot. Study reveals diminished quality of life among patients with chronic limb-threatening ischemia, a severe form of peripheral artery disease, and emphasizes the benefits of revascularization on wellbeing Over 200 million people around the world experience peripheral artery disease (PAD) -- a condition caused by the narrowing of the blood vessels from the heart to the lower limbs that leads to pain when walking -- and for roughly 1-in-10 this advances to chronic limb-threatening ischemia (CLTI), an advanced form of PAD. Those with CLTI often suffer severe pain even at rest, caused by fatty plaque buildup obstructing blood flow, typically to the leg or foot. Those with CLTI face elevated risks of amputation, cardiovascular disease and premature death, yet research on the condition's impact on quality of life remains limited. Investigators from both of Mass General Brigham's founding members, Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH), as well as Boston Medical Center (BMC), sought to address this problem. Following their previous study highlighting the clinical results of the BEST-CLI trial -- Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia -- published in the New England Journal of Medicine (NEJM), the team assessed patient health-related quality of life before and after revascularization treatment. Results are published in Circulation. "Our study indicates that patients with CLTI have a notably poor quality of life -- substantially lower than with many other chronic conditions," said Matthew Menard, MD, co-director of the Endovascular Surgery Program at BWH and co-principal investigator of BEST-CLI. "Our findings show that revascularization, which restores sufficient blood flow back into the legs, significantly improves quality of life. This confirms the critical role that revascularization plays not just in extending the length of patients' lives but also its importance in optimizing their wellbeing." Among patients with CLTI, those eligible for surgical treatment often have two options: surgical bypass (Bypass), where surgeons restore blood and oxygen to the lower limb by reconstructing the blocked vessel, or endovascular therapy (Endo), which involves placing a stent or catheter inside an artery and opening it up to bring blood flow through a blockage. Funded by the National Heart, Lung, and Blood Institute, with ongoing post-enrollment support from theNovo Nordisk Foundation, the BEST-CLI trial enrolled over 1,800 patients with CLTI from 150 research sites in the U.S., Canada, Finland, Italy, and New Zealand between August of 2014 and October of 2019. Investigators assessed how clinical outcomes (previously reported in NEJM) and quality of life metrics varied between revascularization techniques. "Medicine is generally moving towards a more patient-centric model of care. That means looking at what's best for each patient, taking into account an evidence-based approach. Quality of life is one important element in this determination," said co-principal investigator Kenneth Rosenfield, MD, head of the Section of Vascular Medicine and Intervention in the Division of Cardiology at MGH. Investigators sorted 1,528 participants into two cohorts. The first cohort was made up of 1,193 patients, all of whom had an available, good-quality, single-segment great saphenous vein (SSGSV), which previous studies have shown is optimal for Bypass. The second cohort was made up of 335 patients who did not have an available SSGSV. Patients in both cohorts were randomized to undergo Bypass or Endo procedures. Researchers assessed quality of life by administering voluntary surveys asking participants about pain levels, activities of daily living, disease symptoms and severity, physical activity, and mental health (anxiety and depression). Surveys were collected at baseline, 30 days post-procedure, at three months, 12 months, then once yearly until the end of the study. "Patient-reported outcome measures are essential to our understanding of the patient experience," said co-principal investigator Alik Farber, MD, MBA, interim chair of the Department of Surgery, chief of the Division of Vascular and Endovascular Surgery at BMC and professor of Surgery and Radiology at Boston University Chobanian & Avedisian School of Medicine. "Yet these metrics are not often used and sometimes ignored. Here we found an opportunity to hear our patients' voices and use them to improve CLTI outcomes." While the trial's previously published clinical outcomes revealed that patients treated with Bypass had fewer major amputations and less need for repeat procedures than those treated with Endo, quality of life did not significantly differ between treatments. Survey results instead revealed that participants generally experienced significant improvements in quality of life after treatment, regardless of their cohort or whether they underwent Bypass or Endo. They further highlighted that patients with CLTI overwhelmingly conveyed that their quality of life was low upon entering the trial, before receiving treatment. This study is limited in that patients filled out quality-of-life questionnaires at distinct periods throughout the trial, but these time points did not necessarily line up with significant health events such as additional revascularization procedures or amputations. Further, there remains a dearth of quality-of-life research for patients with PAD, and there are no specific metrics to assess the quality of life for patients with PAD or CLTI. Going forward, the team aims to assess differences in the cost-effectiveness of these procedures, and how cost, among other factors, affects patient quality of life and overall health outcomes. "The next step is to integrate quality-of-life measures into a more sophisticated care plan to account for the clinical status of the patient and the cost-effectiveness of treatment options, both for the patient and the viability of the healthcare system," said Farber.