The University of Alabama at Birmingham

DURHAM, N.C., March 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Thursday, March 28, 2024 at 8:00 AM ET, featuring Timmy Lee, MD, MSPH (University of Alabama at Birmingham) and Prabir Roy-Chaudhury MD, PhD, FRCP (University of North Carolina School of Medicine) who will discuss the profiles of patients receiving an AV Access who have higher rates of complications and the associated costs of treating them. To register, click here. TitleHemodialysis Access: A Crossroads of CareConfronting Complications, Challenges, and Costs with InnovationDateThursday, March 28, 2024Time8:00 AM Eastern TimeWebcastClick Here Humacyte recently announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the Human Acellular Vessel™ (HAV™) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. In addition, in April 2023 Humacyte completed enrollment in a Phase 3 trial in AV Access comparing the HAV to the current standard of care, autologous arteriovenous fistula. Top-line results are planned to be available during 2024. A live question and answer session will follow the formal presentations. A replay will be made available here after the call. 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 opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. 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 HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. 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, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; the outcome of our ongoing discussions with the FDA concerning the design of our ongoing V005 Phase 2/3 clinical trial, including determination of trial size, and the scope of any approved indication for our HAVs; and our estimated available market opportunity. 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 included under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, 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

A group of coastal Alaska Native tribes in 2016 began monitoring shellfish, a traditional harvest, for deadly biotoxins because the state only tests commercial harvests. The program fills an essential gap in public health protection and has found success, with 17 tribes now in the testing network. Securing stable, long-term funding and improving public outreach could improve outcomes even further, a new study reports. A group of coastal Alaska Native tribes in 2016 began monitoring shellfish, a traditional harvest, for deadly biotoxins because the state only tests commercial harvests. The program fills an essential gap in public health protection and has found success, with 17 tribes now in the testing network. Securing stable, long-term funding and improving public outreach could improve outcomes even further, a new study reports. Toxins from some types of algae blooms can accumulate in shellfish and, when consumed, cause paralytic shellfish poisoning (PSP). Even small quantities of the toxin can lead to death. Alaska tests commercially sold shellfish, and the state's Division of Environmental Health advises against eating shellfish harvested from beaches that have not been recently tested. But because local community shellfish harvests are not for commercial sale, the shellfish can't be tested with the state. Coastal indigenous communities are at high risk of poisoning because many depend on traditional wild-harvested shellfish. Between 1993 and 2021, Alaska Natives suffered 53% of recorded PSP cases despite only making up 16% of Alaska's population. In 2014, Alaska Native tribes founded the Southeast Alaska Tribal Ocean Research network (SEATOR), with early testing beginning in 2016. SEATOR's tribal partners regularly collect shellfish samples, encourage community members to collect and send in their own shellfish for testing, and share toxin data with communities to inform harvesting decisions. Seventeen tribal communities are now involved, increasing participation and risk awareness. Even with this success, funding and community perceptions around risks limit how widespread and effective the toxin testing program can be, the study reports. "Shellfish harvesting is central to coastal Alaska Native culture," said Hugh Roland, an environmental sociologist at the University of Alabama at Birmingham who led the study. "Filling this gap between commercial shellfish testing and community needs is critical, especially for rural communities that rely more heavily on shellfish. And to do that, we really need to understand how the testing network has been effective, as well as what has constrained testing efforts and capacities. Then we can address those barriers, and communities can continue their traditions safely." The study was published in GeoHealth, which publishes research investigating the intersection of human and planetary health for a sustainable future. In testing we trust? To understand the barriers to the program's reach and effectiveness across Alaska and how it is perceived by communities, Roland and his collaborators interviewed 27 SEATOR staff who help manage testing, and they also interviewed other individuals with shellfish toxin expertise. They discussed several broad themes: community perceptions of toxin testing and the risks of shellfish harvesting; the status of toxin testing in those communities; and barriers to or facilitators of the actual toxin testing process. Overall, the researchers found that communities with active toxin testing were very aware of shellfish poisoning, but reactions varied widely. Some people were less concerned, relying on personal experience with the safety of the traditional shellfish harvest. Others took the risk of PSP so seriously that they stopped harvesting shellfish altogether. "It's about bringing both sides to the middle," said Jacob Kohlhoff, the environmental education coordinator for the Sitka Tribe. "We want to show that harvesting is good. We don't want to stop it. But we have to do it safely." But successful risk communication relies on consistent, timely testing, which can be a problem. The program struggled with delays particularly during the height of the COVID-19 pandemic, with the testing facility closed between October 2021 and February 2023 and delays in testing until July 2023. That halt in testing just a few years into the program damaged trust with communities, interviewees said. People don't want to keep shellfish in the freezer indefinitely while they're waiting for test results, especially if they're relying on it for food during lean winter months. "Full-scale testing had just begun in late 2018 and was relatively new, so trust eroded pretty quickly," Kohlhoff said. It has been difficult to get people to buy back into the program when it seems like testing could stop again at any time, he said. Climate change is further complicating risk communication, Roland said. As coastal waters warm and their nutrient fluxes change, harmful algae blooms -- the source of shellfish toxins -- are becoming more frequent and widespread, and they are occurring over a longer season. Historically, winter was a safe time to harvest, but "things are changing," one participant said. "We find paralytic shellfish toxins in our shellfish pretty much year-round at this point." Room for improvement The researchers found major barriers related to the communities' remoteness, which makes it more difficult to work and attract workers, and low and unreliable funding from grants. The first issue is geographic: Many Southeast Alaska Native communities are deeply isolated and difficult to get to. There, the cost of living is high, and housing is limited and expensive. Those factors make carrying out sampling difficult, and it can be a tough sell for would-be staff members. The second hurdle is financial. The toxin testing is funded by a series of grants, each supporting novel work and each lasting only a few years. However, more rural communities with fewer resources are less able to apply for these grants. The need to apply for new funding every few years also contributes to high staff turnover. SEATOR enables communities to better pool resources and apply for grants together, but applying still takes staff time and resources. Despite these barriers, the toxin testing program has enabled small or remote tribes to take the safety of traditional harvests into their own hands when the state falls short. The network's success could serve as a model for other community-led environmental health efforts elsewhere, Roland said.

TORONTO--( BUSINESS WIRE )--Cosm Medical proudly announces FDA clearance for Gynethotics™ Pessaries, marking it as the first personalized pessary available to patients. This milestone follows a recent Health Canada clearance and marks a significant advancement in pelvic care, emphasizing Cosm’s commitment to enhancing patient outcomes and revolutionizing treatment options for women worldwide. Gynethotics™ are the first pessary to be FDA cleared in about 5 years with almost 10 million pessary configurations that clinicians can conveniently order online. That is compared to about 100 configurations that are offered by other commercially available pessaries. The benefits of personalized Gynethotics™ Pessaries were demonstrated in a pilot study completed at Sinai Health Systems and published in Urogynecology, the Journal of the American Urogynecology Society, in 2023. “Our vision is to become the world leader in precision gynecological devices for unique bodies and needs.” said Derek Sham, Founder & CEO of Cosm Medical. “With our first FDA clearance, we are one step closer to realizing this vision and making a meaningful impact on the lives of over a million patients by 2030. This will set a new standard of care in gynecology like the established billion-dollar markets of custom orthotics, dental and hearing.” Half of all women will experience a pelvic floor disorder such as prolapse and incontinence in their lifetime. “Aging and women’s health are both severely underserved markets with high clinical unmet needs, demonstrated by the fact that Femtech and Agetech are both projected to be growing at over 15% CAGR.” said Ivneet Bhullar, Investment Partner at Fusion Fund and Cosm Board Member. “It’s been great supporting Cosm over the past 2 years as they’ve achieved major milestones towards driving precision care into gynecology.” Beyond pessaries, Cosm has signed a strategic partnership with the University of Alabama at Birmingham to work with Holly E. Richter, Ph.D., M.D. and Max Cadena, M.D. on a novel design and indication for Gynethotics. “We look forward to improving surgical outcomes and are currently completing Phase 1 of a clinical study with the goal of implementing a new paradigm for impacting post-operative healing,” Richter said. “This is especially important as there are limited evidence-based options for augmenting vaginal native tissue repairs.” About Cosm Medical Based in Toronto, Canada, Cosm Medical is personalizing gynecological devices for precision care because every woman is different. Cosm’s digital gynecology platform leverages novel diagnostics, AI, cloud software, and 3D printing to create patient-specific gynecological devices for unique bodies and needs. For more information, visit: www.cosm.care About Fusion Fund Based in Palo Alto, California, Fusion Fund is a venture capital firm that focuses on backing early-stage entrepreneurs in building forward-thinking companies with technical and data advantages. Since 2015, Fusion Fund has invested in over 80 portfolio companies across the US and Canada in the healthcare, enterprise AI, and industrial automation sectors. For more information, visit: www.fusionfund.com