Kurve Technology won a U.S. Defense Dept. contract to test a new formulation for combating traumatic brain injuries. The Mill Creek, Wash.-based company makes a controlled particle dispersion device designed to deliver liquid drugs through a controlled, turbulent flow, according to the company’s website. Its ViaNase electronic atomizer can deliver most drug compounds through the nose […]
Drug-Device Combinations
SkinJect raises $3m for skin cancer treatment patch
SkinJect said it raised nearly $3 million for the patch it’s developing to treat skin cancers. The $2.5 million equity round, revealed yesterday in a regulatory filing, involved 13 unnamed investors, Pittsburgh-based SkinJect said. Get the full story on our sister site, Drug Delivery Business.
Beta Bionics starts new trial for bionic pancreas
Boston-based Beta Bionics said this week that the first patients have begun home use of dasiglucagon in a clinical trial of the company’s iLet bionic pancreas system for people with Type 1 diabetes. The iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous glucose […]
EuroPCR 2019: Paclitaxel meta-analysis a ‘typhoon in a teapot’
The meta-analysis that suggested there was a link between paclitaxel-coated devices and heightened mortality compared to bare devices was described as a “typhoon in a teapot” at this year’s EuroPCR meeting, according to a report from MedScape. Dr. Alexandra Lansky of Yale University School of Medicine, who authored the organization’s formal statement on the matter, reportedly questioned the […]
Merged Smithwise and Catapult rebrand as Archimedic
After announcing their merger last month, medical product development firms Smithwise and Catapult Product Development have rolled out their new brand, Archimedic. “As we brainstormed a new name, we knew we wanted it to reflect the medical device industry we serve,” said Eric Sugalski, CEO of the joint entity, in explaining in a news release how they settled […]
Louisiana prisoners to get non-FDA-approved BioCorRx implant
BioCorRx (OTC:BICX) has begun a controversial pilot program to provide soon-to-be-released Louisiana prison inmates an opioid addiction treatment implant that has not been approved by the FDA. The pilot, announced last week, has drawn praise from corrections officials and concern from prisoner advocates and some medical professionals, according to a report in The Advocate, a Baton Rouge, La. newspaper. Ten […]
Innoviva-GSK project Trelegy Ellipta meets main endpoint in asthma pivotal trial
A combination drug-device therapy developed by GlaxoSmithKline(NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week. The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. The 2,436-patient Captain trial […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
Intersect ENT wins preliminary CMS reimbursement code
Shares in Intersect ENT (NSDQ:XENT) got a boost yesterday on news that the Centers for Medicare and Medicaid Services (CMS) had assigned the company’s Sinuva corticosteroid-eluting sinus implant a preliminary J-code. Intersect ENT stock, which had been bumping along just under $30 per share last week, jumped to $33.13 per share at Monday’s market open, then […]
Valeritas touts reduced A1c, insulin use in V-Go insulin delivery study
Valeritas (NSDQ:VLRX) today released results from the VERDICT study of its V-Go wearable insulin delivery device, touting improved A1c levels with less insulin. Data in the study came from a retrospective analysis of 139 patients with type 2 diabetes using the V-Go device, the Bridgewater, N.J.-based company said. Read the whole story on our sister site, […]
Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges
Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for the PAH drug treprostinil, sold […]