Neuro

WallabyPhenox Announces First Patient Enrolled in PROMISE Study Evaluating Treatment of Medium Vessel Occlusion Stroke

IRVINE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) — WallabyPhenox today announced that the first patient has been enrolled in PROMISE (PROspective study on Management of Ischemic Stroke secondary to mEvo), an investigator initiated prospective study examining how medium vessel occlusion (MeVO) acute ischemic strokes are managed within the first 24 hours. The first subject was enrolled at Indiana University, Methodist Hospital. Dr. Devi Patra and Dr. Ann Jones are co-leads at Indiana University. Medium vessel occlusions account for a meaningful share of acute ischemic strokes, yet the field has not reached consensus on how best to treat them — mechanical thrombectomy versus medical management. PROMISE is designed to capture real-world practice across participating U.S. sites and to help characterize the current “equipoise” among treating physicians, enrolling patients managed with mechanical thrombectomy as well as those treated medically and following their outcomes over six months. “Management for MeVO related stroke is one of the next frontiers in advancing care for stroke patients. We planned this study to better understand the practice and challenges involved in management of these patients in a prospective, unbiased way. To achieve a higher level of nuanced understanding we planned the imaging to be core lab adjudicated. I thank WallabyPhenox for their support to this investigator-initiated project.” — Kaustubh Limaye, MD, Global Principal Investigator, Associate Professor at Indiana University Medical Center “This important study is expected to help answer a critical clinical question: whether revascularization attempt benefits patients with medium-vessel occlusion (MeVO). Current evidence remains largely equivocal, underscoring the need for clearer data to guide treatment decisions,” said Dr. Devi Patra, MD, a neuroendovascular surgeon at Indiana University Medical Center. Dr. Froehler, Director of Cerebrovascular Program at Vanderbilt University Medical Center said, “This study is important because it includes all MVO patients; not just those treated endovascularly. The results will help us to understand real-world MVO outcomes.” WallabyPhenox is supporting PROMISE as part of its commitment to advancing the evidence base behind stroke care. “Reaching first enrollment in PROMISE reflects WallabyPhenox’s commitment to advancing the science behind stroke care, not just the tools that support it. We’re proud to stand behind Dr. Limaye and the investigators as they generate the evidence the neurovascular community needs to make the best possible decisions for MeVO patients.” — Ruilin Zhao, Chief Executive Officer, WallabyPhenox The registry plans to enroll patients across 30 participating U.S. sites. The study is registered with Clinical Trials.gov https://clinicaltrials.gov/study/NCT07746947 CONTACT: CONTACT Ruilin Zhao
Chief Executive Officer
COMPANY WallabyPhenox
PHONE 1-844-674-3669
EMAIL cs@phenox.com
WEB https://www.phenox.com/

Galaxy Therapeutics Achieves CE Mark for SEAL™ Embolization System, Enabling Commercial Launch Across Europe and International Markets

MILPITAS, Calif., Aug. 4, 2026 /PRNewswire/ — Galaxy Therapeutics, a privately held medical device company dedicated to advancing the treatment of intracranial aneurysms, today announced that it has received CE Mark under the European Medical Device Regulation (EU MDR 2017/745) for the SEAL™ Embolization System, following successful assessment by Notified […]

InspireMD Appoints Carotid Intervention Commercial Leader Kathleen Kennedy as Senior Vice President of Global Sales and Marketing

Ms. Kennedy returns to InspireMD having previously served as Sales Director supporting the initial U.S. launch of CGuard PrimeMIAMI, July 30, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of accomplished commercial leader Kathleen Kennedy as Senior Vice President of Global Sales and Marketing, reporting to CEO Marvin Slosman. Ms. Kennedy brings more than 30 years of medical device sales leadership experience, including significant expertise in carotid intervention and carotid stenting. Having previously led regional sales efforts supporting the U.S. launch of CGuard Prime, she returns to InspireMD with deep relationships across the vascular, neurovascular and cardiovascular physician communities, as well as extensive experience working with health systems that are key to driving adoption of carotid therapies. “Kathy’s appointment reflects our continued commitment to building a highly talented and productive commercial team in anticipation of the planned U.S. commercialization of the CGuard platform, and I am very pleased to welcome her back to InspireMD,” stated Marvin Slosman, Chief Executive Officer. “As we prepare for the potential U.S. approval and commercial relaunch of the CGuard platform, including CGuard Prime 80cm for TCAR procedures, Kathy’s deep expertise in carotid intervention, proven commercial leadership and established relationships throughout the field make her invaluable to our U.S. commercial organization and scaling our commercial growth.” “I have seen firsthand the impact CGuard and its proprietary MicroNet mesh technology can have for patients,” said Ms. Kennedy. “The strength of the clinical data, combined with the significant opportunity in the U.S. carotid intervention market, made the decision to return to InspireMD an easy one. I am excited to work with our commercial organization, physician partners and hospital customers to expand access to this important technology.” Throughout her career, Ms. Kennedy has held commercial leadership positions in cardiovascular, vascular and neurovascular medical technologies, building extensive experience in physician engagement, market development, and sales execution. Ms. Kennedy re-joins InspireMD from Omniscient Neurotechnology, where she served briefly as Vice President of Sales for North America. Prior to that, she served as Sales Director at InspireMD, as Senior Area Director at Silk Road Medical, and as Chief Commercial Officer at CAE Healthcare (now Elevate Healthcare). Earlier in her career, Ms. Kennedy held commercial positions of increasing responsibility at several healthcare companies, including Cordis, Biomet, Guidant Corporation (now Boston Scientific), and Angiodynamics. She earned a BA in Communications Studies from Northern Illinois University. About InspireMD, Inc.InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information, please visit www.inspiremd.com. Forward-looking StatementsThis press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. In particular, forward-looking statements in this press release include expectations regarding potential FDA approvals for CGuard Prime Carotid Stent System 80 cm implant for use in TCAR procedures. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the Company’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy product delays in key markets; the Company’s ability to maintain compliance with the Nasdaq listing standards; the Company’s ability to generate significant revenues from its products; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry of new competitors and products and potential technological obsolescence of the Company’s products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with the Company’s research and products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to the Company’s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental and other third-party payers; the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Investor Contacts:Jeff WarrenLifeSci Advisorsjwarren@lifesciadvisors.cominvestor-relations@inspiremd.com 

First Patient Enrolled in Penumbra’s FORWARD Study Evaluating Mechanical Thrombectomy and Computer Assisted Vacuum Thrombectomy for Distal Acute Ischemic Stroke

ALAMEDA, Calif., July 7, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced the initiation of its FORWARD study, an international, real world prospective, multi-center study. The study will collect safety and efficacy data on mechanical…