From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EOI wins FDA nod for FLXfit15 expandable cage EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance […]
Clinical Trials
Humacyte lands $14m to expand uses for human acellular vessel
Humacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis. The Research Triangle Park, N.C.-based company said it plans to evaluate […]
Titan Medical adds Columbia University Med Center to Sport feasibility trials
Titan Medical (TSX:TMD) said today it inked a deal to add Columbia University Medical Center to the feasibility and validation studies of its robotic Sport surgical system. The Toronto-based company said it expects the study to commence at Columbia by the 4th quarter of 2017 and into 2018. “Single port robotic surgery has tremendous potential to be […]
Bellerophon nabs $23m in private placement
Bellerophon Therapeutics (NSDQ:BLPH) said today that it inked a deal with new and existing investors to raise $23.4 million in a private placement of common stocks and warrants. The financing was led by Puissance Capital Management and Venrock Healthcare Capital Partners, supported by existing investors like New Mountain Capital and Linde North America, the Warren, N.J.-based […]
Engage Therapeutics raises $23m Series A for epilepsy drug-device therapy
Summit, N.J.-based Engage Therapeutics said today that it closed a $23 million Series A round to fund a Phase IIb trial of its lead product, Staccato alprazolam. The round was led by TPG Biotech, Adage Capital Management and Lumira Capital. The drug-device product combines a hand-held inhaler technology, which is FDA-approved, with alprazolam, an FDA-approved benzodiazepine. If […]
Edwards Lifesciences has ‘key events’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark […]
ASTRO ’17 Round-up: Novocure touts five-year results for Optune, chemo combo in newly-diagnosed glioblastoma patients
Novocure (NSDQ:NVCR) touted data today from the Phase III pivotal trial of its Optune device in combination with temozolomide for the treatment of newly-diagnosed glioblastoma. The analyses were presented at the American Society for Radiation Oncology’s 2017 annual meeting in San Diego. Get the full story at our sister site, Drug Delivery Business News.
Gelesis touts study of hydrogel obesity drug
PureTech subsidiary Gelesis today touted results from a pivotal weight-loss study of its obesity drug, Gelesis100. The study met one of its two primary endpoints, with 58% of adults in the treatment arm experiencing clinically-meaningful weight loss of 5% or more. Get the full story at our sister site, Drug Delivery Business News.
Clinical trials system is ‘broken’, FDA’s Woodcock says
The clinical trials system is “broken,” according to the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock. The system needs new clinical trial networks and the adoption of mater protocols – protocols for trials that focus on multiple therapies for a single disease or a single treatment that could apply to […]
Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including […]
Reva Medical’s Fantom bioresorbable, drug-eluting vascular scaffold succeeds at 6 months
As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices. In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary bioresorbable […]