Financial

Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access

– Dr. Robert J. Kossmann has served as a prominent advocate for kidney disease patients in multiple roles including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America – – Dr. Prabir Roy-Chaudhury is the Immediate Past President of the American Society of Nephrology, serves as the Drs Ronald and Katherine Falk Eminent Professor at UNC, and is the Co-Director of the UNC Kidney Center – DURHAM, N.C., July 14, 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 Robert J. (Rob) Kossmann, MD, FACP, FASN and Prabir Roy-Chaudhury, MD, PhD, FASN, have joined the Company as advisors to prepare for Humacyte’s planned commercialization of the acellular tissue engineered vessel (ATEV) in hemodialysis access. In their roles, these leading nephrologists will contribute to the development of health economic, reimbursement and market access strategies as well as provide peer-to-peer scientific support and medical education. These appointments follow the release last month of positive results from the V012 Phase 3 dialysis access study in women and Humacyte’s announcement of plans to file a supplemental Biologic License Application with the Food and Drug Administration. Dr. Kossmann is a leading nephrologist and healthcare executive who served in senior medical leadership roles at Fresenius Medical Care from 2014 – 2026, including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America. Prior to joining Fresenius, he practiced clinical nephrology for more than two decades and developed extensive expertise in chronic kidney disease, dialysis, and multi-organ disease management. Dr. Kossmann earned his Doctor of Medicine degree from Case Western Reserve University and completed his nephrology training at the University of Washington. Throughout his career, he has been a prominent advocate for kidney disease patients and the nephrology profession, serving as President of the Renal Physicians Association, participated in founding the organization’s Nephrology Coverage Advocacy Program, advising the American Medical Association on nephrology reimbursement issues, and helping establish the New Mexico Renal Disease Collaborative Group. Dr. Roy-Chaudhury is an internationally recognized nephrologist, researcher, and academic leader who serves as the Drs. Ronald and Katherine Falk Eminent Professor of Nephrology and Co-Director of the UNC Kidney Center at the University of North Carolina at Chapel Hill, as well as a staff nephrologist at the Salisbury VA Medical Center. A graduate of the Armed Forces Medical College in Pune, India, he completed training in internal medicine and nephrology at the University of Aberdeen in Scotland and Beth Israel Hospital at Harvard Medical School. His research focuses on uremic vascular biology, dialysis vascular access, and cardiovascular complications in kidney disease, and he has received extensive NIH, VA, and industry funding. Dr. Roy-Chaudhury has published more than 250 scientific manuscripts and book chapters, delivered hundreds of lectures worldwide, and held numerous leadership positions within the nephrology community, including as President of the American Society of Nephrology (ASN) for 2025. He was also the founding ASN co-chair of the Kidney Health Initiative, a public-private partnership between the ASN and the U.S. Food and Drug Administration aimed at accelerating innovation in kidney disease treatments and technologies. “I have seen firsthand the negative outcomes, especially catheter infections, experienced by patients who suffer non-working or suboptimal dialysis access. This is particularly problematic for women and other patients having higher risk of AV fistula failure. With the positive V007 and V012 study results in hand, I am excited to work with Humacyte to bring the ATEV to hemodialysis patients so that we can get the right access to the right patient at the right time and in the right way,” said Dr. Roy-Chaudhury. “Working with patients, both as a treating physician and then as a service provider, has highlighted the clear need for an improved dialysis access methodology. There have been no truly novel dialysis access conduits introduced during my career, and I look forward to assisting Humacyte in meeting the needs of patients while reducing the cost of overall care,” said Dr. Kossmann. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency 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 Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). 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 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. 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, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect 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, competitive and/or reputational 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, 2025 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

AngioDynamics Reports Record Fiscal Year 2026 Fourth Quarter and Full Year Financial Results; Continued Execution Drives Med Tech Growth and Full-Year Profitability

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, today announced financial results for the fourth quarter and fiscal year 2026, which ended May 31, 2026. Fiscal Year 2026 Fourth Quarter Financial Highlights     Quarter Ended May 31, 2026   Pro Forma* YoY Growth Pro Forma* N

Embolx Secures New CMS HCPCS Level II G-Code for Pressure-Generating Catheter Procedures Performed in the Physician Office (OBL)

New code, effective July 1, 2026, expands patient access to advanced embolization procedures at a lower-cost site of service SUNNYVALE, Calif., July 13, 2026 /PRNewswire/ — Embolx, Inc., a leader in advanced microcatheter technology for targeted embolization procedures, today announced…

Edgewise Therapeutics Completes Sale of Sevasemten for Up to $2.65 Billion, Strengthening Balance Sheet and Centering Company Focus on Cardiovascular Pipeline

— Edgewise receives $1.55 billion in upfront cash and is eligible to receive up to $1.1 billion in regulatory and commercial milestones — — Transaction creates strategically focused cardiovascular company — — Upfront proceeds expected to fully fund EDG-7500 development through potential…

Stereotaxis Completes Acquisition of Robocath

ST. LOUIS and ROUEN, France, July 09, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has completed its previously announced acquisition of Robocath, an innovator of robotic technologies for interventional cardiology and neurointerventions. Robocath will now be fully integrated into Stereotaxis, combining complementary technologies and expertise to accelerate the development of next-generation robotic solutions for electrophysiology, interventional cardiology, and neurointerventions. The combined platform strengthens Stereotaxis’s position as the leader in robotic technologies across the full spectrum of endovascular procedures. “We’re very excited to join Stereotaxis,” said Philippe Bencteux, Robocath Founder and CEO. “Combining the strengths, expertise, and technologies of two pioneers in endovascular robotics, we now have the opportunity to accelerate innovation, expand our global reach, and bring robotic solutions to many more physicians and patients around the world.” “The addition of Robocath’s technology and team to Stereotaxis accelerates our strategy, enhances our technological leadership, provides attractive commercial synergies in an expanded addressable market, and supports new strategic opportunities,” said David Fischel, Stereotaxis Chairman and CEO. About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com. About RobocathFounded in 2009 by Philippe Bencteux, MD, Robocath designs, develops and markets smart robotic solutions to treat cardiovascular and neurovascular diseases. Robocath robotic solutions integrate a unique bionic technology that optimizes the safety of robotic-assisted coronary angioplasty. Robocath’s robotic solutions are designed to operate with precision and perform accurate movements, creating better interventional conditions. Robocath has obtained CE and NMPA certifications for its first robotic solution. Several multicenter clinical studies have been conducted, and a meta-analysis has demonstrated R-One’s safety and efficacy as it achieved more than 98% technical procedure success with no major adverse cardiovascular events. Currently R-One is used in Europe and China. Robocath, based in Rouen (France), a world leader in vascular robotics, continues to push the boundaries of interventional cardiology technology by developing smart digital solutions. Its ambition is to guarantee equal access to treatment for vascular emergencies through the development of remote interventions, offering the best care for all. Cautionary Note Regarding Forward-Looking StatementsThis press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. These forward-looking statements include without limitation statements regarding the recently completed acquisition of Robocath, the anticipated financial performance of Stereotaxis and Robocath related thereto, including the anticipated benefits expected from the acquisition, the potential strategic implications as a result of the acquisition, and the potential for achievement of the regulatory and commercial milestones that would trigger contingent payments in the transaction. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involving the following: the ability of Stereotaxis to successfully integrate Robocath’s operations, and continue the commercialization, development and sales of Robocath’s products and services, and disruption of Robocath’s or Stereotaxis’s current plans and operations as a result thereof; the ability of Robocath or Stereotaxis to retain and hire key personnel; competitive responses to the proposed transaction; unexpected costs, charges or expenses resulting from the proposed transaction; the ability of Stereotaxis to implement its plans, forecasts and other expectations with respect to Robocath’s business following the completion of the transaction and realize additional opportunities for growth and innovation; the ability of Stereotaxis to realize the anticipated benefits from the transaction in the anticipated amounts or within the anticipated timeframes or at all; the ability to maintain relationships with Stereotaxis’s and Robocath’s respective employees, customers, other business partners and governmental authorities; and the other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. Additional information will also be set forth in future filings that we make with the SEC from time to time. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Company Contacts:David L. FischelChairman and Chief Executive Officer Kimberly R. Peery Chief Financial Officer 314-678-6100Investors@Stereotaxis.com

Solaris Endovascular Strengthens Leadership Team with Appointment of Rowan Hettel as CTO and David Stack as Director

DALLAS, TX, UNITED STATES, July 7, 2026 /EINPresswire.com/ — Solaris Endovascular, Inc., a medical technology company developing next-generation drug-eluting covered stents for the treatment of vascular disease, today announced the appointment of Rowan Hettel as Chief Technology Officer (CTO) and David Stack as an independent member of its Board of Directors. The appointments strengthen […]

Catalyst MedTech Announces Channel Partnership with APQ Health to Expand Access to Advanced Cardiac CT Analysis

PITTSBURGH, July 07, 2026 (GLOBE NEWSWIRE) — Catalyst MedTech, a leader in nuclear medicine and molecular imaging solutions, today announced a strategic channel partnership with APQ Health to expand access to advanced cardiac CT angiography (CCTA) visualization and plaque analysis services. As clinical guidelines and demand continue to shift toward earlier detection and more personalized risk assessment, scalable access to advanced plaque analysis is becoming increasingly important in the management of coronary artery disease. Cardiac CT continues to gain adoption as a front-line diagnostic tool for chest pain and healthcare providers are increasingly seeking ways to move beyond traditional anatomical assessment toward more advanced, quantitative plaque analysis. However, many organizations face barriers including limited access to specialized software, workflow complexity, and lack of scalable analysis capabilities, often preventing broader adoption and consistent clinical utilization. Through this partnership, Catalyst MedTech will introduce APQ Health’s coronary CTA viewer software and Autoplaque® analysis services to healthcare providers—enabling a streamlined workflow that combines on-site image review with access to advanced, FDA-cleared plaque quantification and reporting. Customers working with Catalyst MedTech will gain access to on-premises CCTA visualization tools alongside optional remote plaque analysis services performed by APQ Health, delivering quantitative plaque characterization reports designed to support physician interpretation and documentation workflows for advanced plaque analysis, including applicable reimbursement pathways, with rapid turnaround — without the need to build internal analysis infrastructure. Catalyst MedTech offers this solution configured on new and refurbished PET/CT systems, new and refurbished CT angiography systems, and as an upgrade to existing PET/CT or CT systems—providing a flexible, scalable pathway for customers to adopt advanced cardiac CT analysis based on their current infrastructure and clinical goals. By addressing both workflow and analysis challenges, the partnership enables providers to more efficiently integrate advanced CCTA capabilities into routine clinical practice supporting physician interpretation, cardiovascular assessment and longitudinal evaluation over time. This approach also helps expand access to advanced cardiac imaging while reducing operational burden on clinical teams. This partnership represents a natural extension of Catalyst MedTech’s commitment to delivering integrated imaging solutions—bridging advanced imaging technologies with clinical workflow and FDA-cleared AI-powered quantitative analysis. By combining Catalyst’s commercial, technical, and clinical support capabilities with APQ Health’s specialized analysis platform, healthcare providers can expand their cardiac imaging capabilities with greater efficiency and confidence. “This partnership allows us to extend beyond imaging alone and into advanced quantitative analysis and clinical workflow,” said Martin Shirley, President & CEO of Catalyst MedTech. “By working with APQ Health, we are enabling our customers to access sophisticated plaque analysis capabilities as part of a more complete cardiac imaging solution.” “We are excited to partner with Catalyst MedTech to expand access to advanced AI-driven plaque analysis and CCTA workflow solutions,” said Damini Dey, Chief Scientific Officer at APQ Health. “Catalyst MedTech’s strong commercial reach, technical expertise and clinical infrastructure make them an ideal channel partner to help bring these capabilities to more providers.” About APQ Health APQ Health is a health technology company specializing in AI-powered, automated quantitative analysis of 3D medical images, with a focus on cardiovascular diagnostics. APQ Health is the exclusive worldwide licensee of the Autoplaque®, a cutting-edge AI software platform developed at Cedars-Sinai by the founders of APQ Health. Autoplaque® delivers AI-driven quantitative analysis and characterization of coronary plaque burden, plaque features, and stenosis from CCTA scans. APQ Health’s mission is to translate clinically validated imaging innovations into practical tools that provide physicians with quantitative information to support clinical evaluation. Automated Personalized Quantitative Health www.apqhealth.comMedia Contact: info@apqhealth.com About Catalyst MedTech Catalyst MedTech is a national leader in nuclear medicine and molecular imaging, delivering equipment, service, and clinical solutions to healthcare providers across the United States. Our purpose is to provide access to advanced diagnostic imaging so that patients get the care and treatment they need. As both an OEM innovator and ISO-certified service provider, Catalyst offers a comprehensive, multi-vendor approach that enables healthcare organizations to overcome barriers and expand access to advanced diagnostic imaging. The company supports cardiology, neurology, and oncology through advanced imaging technologies, including SPECT, PET, PET/CT, and optimized Brain PET. With one of the largest multi-vendor service networks in the country and a nationwide team of clinical and technical experts, Catalyst ensures imaging programs operate efficiently, reliably, and at scale. See What’s Possible.www.catalystmedtech.com Media Contact:Kate KinsellDirector of MarketingCatalyst MedTechkkinsell@catalystmedtech.com

GuideAI Health Appoints Renowned Interventional Radiologist Dr. James Benenati to Advisory Board Following FDA 510(k) Clearance of VAOT

Leading Vascular Specialist and Penumbra Chief Medical Officer Joins GuideAI to Help Advance Its Recently FDA-Cleared VAOT Triage SoftwareBOSTON, July 06, 2026 (GLOBE NEWSWIRE) — GuideAI Health Corp. (Cboe CA: GDAI) (“GuideAI” or the “Company”) recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VascularAssist Occlusion Triage (VAOT) (please see news release dated June 22nd, 2026), the Company’s artificial intelligence software designed to support the prioritization and triage of vascular occlusion in the lower extremities. Building on this milestone, the Company is pleased to announce the appointment of James F. Benenati, MD, FSIR, a board-certified interventional radiologist and recognized leader in vascular medicine, to its Advisory Board. Dr. Benenati brings more than three decades of clinical, research, and industry leadership in vascular care to support GuideAI’s mission of detecting vascular disease earlier and improving treatment precision through artificial intelligence. VAOT is a Class II, AI-based Software as a Medical Device (SaMD) operating as a Computer-Aided Triage and Notification device (CADt). The software aims to assist radiologists in identifying and characterizing peripheral arterial disease (PAD), a leading contributor to both acute and chronic limb ischemia, by flagging suspected vascular occlusion for prioritized review within existing imaging workflows. By surfacing high-priority cases earlier, VAOT is designed to help clinical teams reduce time to diagnosis and intervention for patients at risk of limb-threatening disease. Dr. Benenati currently serves as Chief Medical Officer of Penumbra, Inc., where he also oversees the company’s clinical research efforts. Prior to that, he practiced interventional radiology at the Miami Cardiac & Vascular Institute at Baptist Hospital for 31 years, including roles as medical director of the noninvasive vascular laboratory and fellowship program director. He is a clinical professor of radiology at the Florida International University Herbert Wertheim College of Medicine and a collaborative professor of radiology at the University of South Florida Morsani College of Medicine. A past President of the Society of Interventional Radiology (SIR), Dr. Benenati has received the SIR Gold Medal and the Charles T. Dotter Award, and has authored more than 150 scientific publications and book chapters. “Vascular disease remains one of the most underdiagnosed and costly health challenges we face, and far too many cases are caught only after serious harm has been done,” said Dr. Benenati. “GuideAI is tackling this problem at its root by bringing AI-powered early detection into routine imaging workflows. I’m excited to support a team working to give clinicians the tools to identify disease sooner and guide patients toward the right treatment.” Raj Shah, MD, MBA, Chief Executive Officer of GuideAI Health, commented, “We are honoured to welcome Dr. Benenati to our Advisory Board. As one of the most respected voices in interventional radiology and vascular care, his clinical expertise, research leadership, and deep understanding of the treatment landscape will be invaluable as we advance our platform.” About GuideAI Health Corp. GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease. By surfacing disease earlier, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care. For more information, please visit www.guideaihealth.com. On Behalf of the Board of Directors: Raj Shah CEO Contact: Phone: (416) 309-3583Email: info@guideaihealth.com Cautionary Note Regarding Forward-Looking Statements This news release contains certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to, the intended design and use of VAOT and the Company’s vision. These statements are based on assumptions and expectations that management considers reasonable as of the date of this release. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, the risks described in the Company’s public disclosure documents available under its profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Cboe Canada has not reviewed, approved, or disapproved the contents of this news release, and does not accept responsibility for the adequacy or accuracy of this release.

CorVista Health Announces New AMA Category III CPT® Code for Augmentative AI Analysis of Cardiopulmonary Disease

BETHESDA, Md.–(BUSINESS WIRE)–CorVista Health, has announced that the American Medical Association (AMA) has granted a new Category III Current Procedural Terminology (CPT®) code for novel augmentative AI algorithmic analysis of potential coronary artery disease (CAD), pulmonary hypertension (PH), and elevated pulmonary capillary wedge pressure (PCWP). The new code encompasses the FDA-cleared CorVista® System for CAD and PH, as well as the anticipated PCWP Add-On algorithm which is currently