Med-tech companies are facing a new reality of high interest rates, inflation, bank failures, and geopolitical turmoil that are impacting financing and M&A opportunities. To secure finance and attract partnership deals they must keep their product simple, focus on proof of concept and ensure that it has quality, delegates at the LSX World Congress in London heard during a panel presentation.
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat patients with iliac arterial occlusive disease, a type of peripheral arterial disease where atherosclerosis narrows and blocks peripheral arteries.
The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
Scivita Medical Technology Co. Ltd. formed a long-term partnership with Boston Scientific Corp. to commercialize Scivita Medical's single-use percutaneous choledochoscope in China. This collaboration will increase the market penetration rate of the product.
New data presented at the Cardiovascular Research Technologies (CRT) 2023 meeting reinforced the safety and effectiveness of Boston Scientific Corp.’s Watchman FLX left atrial appendage occlusion (LAAO) device in routine, real-world clinical care. Building on positive 45-day outcomes presented at CRT 2022, the analysis shows sustained low stroke rate at one year, including ischemic stroke.
Pulsed field ablation (PFA) may not be the final word where energy sources for atrial fibrillation (AF) ablation are concerned, but several companies have adopted development programs that propose the use of PFA as an alternative to conventional energy sources. Dublin-based Medtronic plc appears to have at least a narrow lead over the competition in the PFA space thanks to the results of the PULSED AF pivotal study presented at the 2023 American College of Cardiology Scientific Sessions.
Abbott Laboratories continues to push its presence in the cardiovascular market with offerings for the left atrial appendage (LAA) closure and transcatheter aortic valve implant (TAVI) markets, both of which generated affirmative data presented at this year’s edition of the annual meeting of Cardiovascular Research Technologies (CRT 2023) in Washington.
Abk Biomedical Inc. has completed an oversubscribed $30 million series C funding round to support IDE approval for Eye90 microspheres designed to improve outcomes for patients with liver cancer. The departure point for the technology’s development is U.S. FDA-cleared Y90 technology such as Boston Scientific’s Therasphere and Sir-Spheres developed by Sydney, Australia-based Sirtex Medical Ltd. “They are the only radioembolization microspheres on the market and that is the clinical space in which we will be submitting our IDE application,” Abk chief business officer Gary Donofrio told BioWorld. “Hopefully we’ll get approvals for the pivotal study and eventually to market in that space. It’s going to be great to be able to innovate and improve on what’s already been done there.”
Seven new U.S. medtechs are poised to make a splash in the diagnosis and treatment of nervous system disorders thanks to funding under a new program within the National Institutes of Health (NIH) Blueprint for Neuroscience Research called Blueprint Medtech.
Boston Scientific Corp. offered $523 million in cash for 65% of Acotec Scientific Holdings Ltd., a manufacturer of vascular intervention devices. The acquisition would significantly expand Boston Scientific’s presence in China, which the company expects to account for about 25% of the global med-tech market by the end of the decade. The transaction is expected to close in the first half of 2023, subject to shareholder approval. The offer price of HK$20 or US$2.57 per share represents a premium of more than 31% over its close on Friday, Acotec reported.
