University Hospital Galway

REDWOOD CITY, Calif.--(BUSINESS WIRE)--InterVene, Inc., a medical device company pioneering interventional devices for venous inflow and outflow obstructions, announced today that the first patient has been treated with its Recana Thrombectomy Catheter System for venous in-stent restenosis (ISR). The Recana System is the first fully integrated mechanical thrombectomy system designed specifically to address the long-term complications of venous disease, including ISR and native vein obstructions. The case was performed at University Hospital Galway in Galway, Ireland, by Dr. Gerry O’Sullivan, consultant interventional radiologist. “The long-term sequelae of venous obstructions, whether in-stent or native vessel, are a devastating consequence of deep venous thrombotic disease. There remains a considerable gap in effective interventional treatments for physicians and their patients living with persistent symptoms related to venous outflow obstructions,” said Dr. O’Sullivan. “I had previously tried and failed to recanalize this patient’s vessels on four separate occasions – Recana succeeded in just one. This technology offers real promise for patients with limited treatment options.” ISR is a common and challenging complication of venous stenting, typically managed with balloon angioplasty or stent relining – both of which are suboptimal for restoring and maintaining long-term patency.1,2 Every year, millions of patients are affected by the long-term complications of deep venous obstructions, experiencing persistent symptoms such as leg pain, swelling, skin discoloration, and in the most severe cases, venous leg ulcers.3,4 The case was a result of successful collaboration between InterVene, Inc. and the University of Galway Institute of Clinical Trials. “We are proud to see Recana become one of the first innovations to enter clinical use in Ireland through the Hypercare initiative,” said Fidelma Dunne, MD, PhD, director of the Institute for Clinical Trials at the University of Galway. “This first-in-human procedure reflects Hypercare’s core mission to streamline the clinical trial process and accelerate patient access to breakthrough therapies.” “This successful first-in-human procedure comes after several years of rigorous work to prove a transformative design to address a major unmet need in venous disease,” stated Jeff Elkins, CEO of InterVene. “We are proud to support Dr. O’Sullivan in caring for patients suffering from the life-limiting effects of ISR. Completing this first case marks an important milestone in bringing our technology to patients affected by the long-term complications of venous disease.” About InterVene, Inc. InterVene is a privately held medical technology company based in Redwood City, Calif., focused on developing transformative products to treat the long-term complications of venous disease. Its flagship technology, the Recana Thrombectomy Catheter System, was designed to treat venous in-stent restenosis and native vein obstructions. InterVene is backed by RiverVest Venture Partners and Treo Ventures. For more information visit www.intervene-med.com. Caution: Investigational device. Limited by Federal (or United States) law to investigational use. Caution: The Recana Thrombectomy Catheter System is an investigational device to be used exclusively for clinical investigations. References Notten P, Ten Cate H, Ten Cate-Hoek AJ. Postinterventional antithrombotic management after venous stenting of the iliofemoral tract in acute and chronic thrombosis: A systematic review. J Thromb Haemost. 2021. Raju S, Davis M. Anomalous features of iliac vein stenosis that affect diagnosis and treatment. J Vasc Surg Venous Lymphat Disord. 2014. Engeseth M, Enden, T, Sandset, P.M. Predictors of long-term post-thrombotic syndrome following high proximal deep vein thrombosis: a cross-sectional study. Thrombosis J. 2021. Rabinovich A, Khan S. How I treat the possthrombotic syndrome. blood. 2018.

LIfT BioSciences announces partnership with University of Galway for clinical trial in Ireland London, 28 April 2025– LIfT BioSciences, (‘LIfT’ or ‘the Company’), a rapidly emerging biotech and the global leader in neutrophil immunotherapies, today announces progress in advancing the planned clinical trial for their Immunomodulatory Alpha Neutrophils (IMANs), a first-in-class cell therapy designed to overcome treatment resistance in solid tumours, which will be conducted in partnership with the University of Galway, one of Ireland’s leading cancer centres, and Hooke Bio, experts in clinical analytics and biomarkers. IMANs work by recruiting and modulating the patient’s own immune system to deliver a durable anti-tumour response. This strategic collaboration combines LIfT’s innovative immunotherapy approach, the University of Galway’s expertise in oncology, patient care, and advanced manufacturing, and Hooke Bio’s analytical expertise. Together, this enhances LIfT’s clinical-stage research capabilities, accelerating the pathway to delivering IMANs to patients and positions LIfT at the forefront of next-generation cancer immunotherapies. Alex Blyth, Chief Executive Officer of LIfT BioSciences commented: “We are thrilled to expand into Ireland and partner with the University of Galway and Hooke Bio to enhance our first-in-class IMAN therapy, which aims to transform cancer therapy by rejuvenating the immune system to overcome tumour resistance. This collaboration accelerates our clinical readiness and leverages Ireland’s biotech sector, advancing our goal of delivering breakthrough treatments for cancer patients.” Dr Alfonso Quintás Cardama, acting Chief Medical Officer of LIfT BioSciences added: “This trial aims to show how IMANs can fulfill a crucial unmet need by enhancing innate immune competence, which has been lacking in current solid tumor immunotherapies. We will closely monitor immune system recruitment into the tumour, vital for maximising immunotherapeutic benefits. Preclinical results have already shown that IMANs effectively attract T cells and NK cells, suggesting that similar outcomes in our trial could lead to better efficacy, especially against therapy-resistant cancers. Partnering with researchers at the University of Galway positions us to accelerate this groundbreaking immunotherapy's development.” Dr Michael McCarthy, Consultant Medical Oncologist and Principal Investigator at University Hospital Galway added: “Cancer remains a devastating epidemic, claiming over 10 million lives every year, with many patients lacking an effective treatment option. IMANs represent a revolutionary approach, offering the potential to combat treatment-resistant tumours. We look forward to supporting LIfT in accelerating this therapy toward the clinic and further strengthening Ireland’s leadership in advanced therapies." The trial is designed to first test the feasibility and safety of IMAN therapy administered to patients with metastatic cervical cancer or head & neck cancer who have exhausted all standard treatment options, such as checkpoint inhibitors. We intend to test progressively higher IMAN doses in sequential patient cohorts until we define the biologically active dose. Then, the study will be expanded to additional patients who will be infused with IMANs at the previously defined recommended dose in combination with checkpoint inhibitor therapy. We expect this combination to enhance the recruitment and competence of both the innate and the adaptive arms of the immune system to deliver a comprehensive anti-tumour immune response from which patients can derive meaningful clinical benefit. This news follows the recent announcement of the expansion of LIfT’s manufacturing and clinical operations into Ireland, establishing the Company’s presence in the European Union and providing access to the country’s established centres of excellence and growing biotechnology sector. Following the completion of the current funding round, the company anticipates entering the clinic in 2026, pending final regulatory approvals. Learn more about this collaboration here. About LIfT BioSciencesLIfT Biosciences is a UK & Ireland biotech that is bringing to market a first-in-class allogeneic alpha neutrophil cell therapy that overcomes treatment resistance in solid tumours. LIfT’s Immunomodulatory Alpha Neutrophils (IMANs) kill in a non-antigen specific manner and turn the tumour microenvironment against the tumour to give a durable response and lasting immunity. The patented breakthrough N-LIfT platform is produced using exceptional stem cells (iPSC or HSC), a proprietary enhancement media and genetic engineering. The company is preparing initiatives with a range of pharmaceutical license partners to develop a portfolio of engineered IMAN cell therapies to destroy a range of solid tumours. See www.LIfTBiosciences.com Further informationInvestors:Alex Blyth ablyth@LIfTBioSciences.com Media:ICR Healthcare Lindsey Neville, Namrata Taak, Evi Useh liftbiosciences@icrhealthcare.com

According to FIRE1, when fluids begin to build up in a body with a weakened heart muscle, the vein swells in a way that can be gauged more accurately compared to pressure measurements. \n Things are heating up for FIRE1, which posted a $120 million funding round to support its implant for tracking the hidden signs of heart failure.The Dublin-based company also announced that the FDA has handed down a breakthrough designation to its Norm system, which includes a minimally invasive sensor that sits within the body’s largest vein to help monitor for unsafe buildups in a patient’s internal fluid levels.In addition, the device was accepted into the agency’s Total Product Life Cycle Advisory Program, or TAP.The new funding round—a large step up from its previous $25 million raise in early 2023—was led by Polaris Partners and Patient Square Capital’s Elevage Medical Technologies, and was joined by new backers at Sands Capital and Longitude Capital.Returning investors included Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA, Novo Holdings and Seventure Partners. “FIRE1 has developed a groundbreaking solution to one of healthcare’s most pressing challenges: providing scalable ways to manage the disease of chronically ill patients and prevent the need for frequent hospitalizations,” Polaris partner Ellie McGuire said in a statement.“The Norm heart failure self-management system is a first-of-its-kind innovation that empowers patients to take greater control of their health. We believe this represents a paradigm shift in chronic disease management,” added McGuire, who will join FIRE1’s board of directors alongside Elevage’s chief operations officer, Michael Wasserman.The Norm sensor sits within the inferior vena cava and expands and contracts with the changing size of the vessel. According to FIRE1—short for Foundry Innovation & Research 1—when fluids begin to build up in the body, the vein swells in a way that’s easier to gauge more accurately compared to other types of pressure measurements. The sensor itself is activated through the skin by a wearable belt to record readings within a few minutes once a day. “FIRE1’s unique approach to heart failure—a more direct measure of volume instead of relying on proxies—has generated significant excitement in the clinical community,” said Wasserman. “This differentiated approach positions FIRE1 to unlock substantial market opportunities, and we are proud to support the company on this journey.”Last year, FIRE1 announced that the first Irish patient was successfully implanted with its approach as part of a clinical study at University Hospital Galway. Additionally, a feasibility study previously delivered preliminary results showing that Norm met its device safety and effectiveness endpoints after three months.