Diagnostics startup Geneoscopy Inc. has enrolled the first patients its pivotal CRC-PREVENT clinical trial. The interventional study will assess the safety and efficacy of the company’s noninvasive, at-home, multifactor RNA screening test for the prevention of colorectal cancer.
Osso VR has raised $27 million in a series B financing led by GSR Ventures. The funds will be used to accelerate expansion of its library and virtual reality (VR)-powered surgical training and assessment platform.
Hyerfine Inc. and Liminal Sciences Inc. have joined a growing field of med-tech startups that are combining with blank check companies as an alternative path for venture-backed companies to an initial public offering (IPO). On Thursday, the companies announced a three-way combination with Healthcor Catalio Acquisition Corp., a special purpose acquisition company (SPAC), in a deal valued at approximately $580 million.
Surmodics Inc. has acquired Vetex Medical Ltd., a Galway, Ireland-based company focused on venous clot removal, for $39.9 million. The move gives Surmodics a second FDA-cleared mechanical thrombectomy device, Revene, to treat venous vasculature, adding to its Pounce arterial thrombus retrieval system. Founded in 2016, privately held Vetex’s sole product is the Revene thrombectomy catheter. The device received FDA clearance in December 2020 and CE mark approval in May for the mechanical declotting and controlled and selected infusion of physician-specified fluids, including thrombolytics – clot-busting drugs – in the peripheral vasculature.
The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
Sequana Medical NV reported positive results from the second interim analysis of its POSEIDON pivotal study evaluating the Alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. These latest results, from 26 patients in the roll-in cohort, affirm earlier interim data showing high scores on all primary endpoints and continued improvement in quality of life.
Merck KGaA is partnering with Neuroloop GmbH, a subsidiary of B. Braun SE, to develop a neurostimulator device that can complement existing drug therapies for people with chronic inflammatory diseases. The collaboration aims to adapt Neuroloop’s neurostimulation platform to enable targeted treatment of chronic inflammatory ailments. The new bioelectronics program intends to open up new technologies and markets that are close to Merck’s electronics and health care business sectors.
Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”
Princeton University spinout Neutigers Inc. is launching a study to explore the use of artificial intelligence (AI) and everyday wearables to flag early symptoms of sickle cell anemia vaso-occlusive crisis (VOC) before they get worse and land patients in the hospital. The aim is to reduce deaths and facilitate interventions to address the entire continuum of care for patients with the inherited red blood cell disorder, Adel Laoui, founder and CEO, told BioWorld.
Quanta Dialysis Technologies Ltd. raised $245 million in a series D round led by Glenview Capital. The funds will be used to accelerate commercialization of the company’s SC+ portable hemodialysis system. Novo Holdings co-led the oversubscribed and upsized financing, with support from Blackrock, Eldridge, Sands Capital, Millennium Management, Monashee Investment Management LLC, Puhua Capital, Segulah Medical and Ancora, alongside Orlando Health, an integrated delivery network.
