Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of pulsed field ablation for atrial fibrillation, and while several trusts in the U.K. are already using these devices for their patients, the endorsement is certain to expand utilization in the U.K., which according to data from Clarivate’s Epidemiology Intelligence may come to nearly 4 million.
Comphya SA raised CHF 7.5 million (US$ 8.4 million) in a series A round for its implantable neurostimulation therapy, Caverstim, which treats men with erectile dysfunction who do not respond to medication.
Plasmacure B.V. secured €6 million (US$7 million) in series A funding for its Plasoma cold plasma system to treat complex wounds. The round was led by Venture Medical LLC, a U.S.-based provider of solutions for wound care, which also committed to spend over $10 million to support regulatory approval, reimbursement and U.S. market expansion of the Plasoma technology.
Nuclidium AG is poised to circumvent the complex production and supply issues that have held back access to radiopharmaceuticals after closing a CHF79 million (US$99.3 million) series B, to advance the clinical development of its copper isotopes and extend the global manufacturing network.
The U.K.’s National Institute for Health and Care Excellence (NICE) recommends the use of pulsed field ablation as an option to treat NHS patients with atrial fibrillation. NICE said evidence shows the procedure reduces atrial fibrillation and its symptoms, increases quality of life in the short term and raises no major safety concerns.
Actithera A/S is poised to bring small-molecule pharmacokinetics to radiopharmaceuticals after closing a $75.5 million series A that will fund initial clinical development of a candidate targeting the elusive fibroblast activation protein (FAP).
Alcon AG plans to acquire Lumithera Inc., adding its photobiomodulation (PBM) device designed to treat early and intermediate dry age-related macular degeneration (AMD) to the Alcon portfolio. The financial terms of the deal were not disclosed.
The move continues Alcon’s strategic expansion in eye care, following on its recent acquisitions of Aurion Biotech Inc. and Lensar Inc.
Glucomodicum Oy reported positive results from a clinical study in which its needle-free continuous glucose monitor, Talisman, was tested in participants across both standard multi-hour glucose tolerance and ambulatory conditions involving exercise and meals.
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.