Clinical trial artificial intelligence company Antidote is looking to improve access to and enrollment in clinical trials using technology from the e-commerce world, according to a Wired report. Former travel and airline fare aggregator Kayak VP Pablo Graiver is heading the operation, which streamlines access to clinical trials for patients seeking them out. Read the […]
BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study
BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]
Integrity Applications inks exclusive Dutch distro deal for GlucoTrack
Integrity Applications said today it inked an exclusive distribution deal with MediReva B.V. to distribute its GlucoTrack non-invasive glucose measuring device in the Netherlands, effective December 22. Integrity Application’s flagship GlucoTrack is a sensor that clips to the earlobe and uses a combination of metrics to determine blood glucose based on physiological changes in the body. […]
Spectral Medical wins FDA nod for Spectral Apheresis Machine
Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange. The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver […]
Beta Bionics raises $2m
Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. The company is […]
Medherant raises $5m to move transdermal ibuprofen patch to clinical trials
Transdermal drug-delivery company Medherant said yesterday it raised $5.1 million (GBP £3.8 million) in a funding round as it looks to move its drug-delivering ibuprofen Tepi Patch into clinical development early next year. The funding round was led by majority shareholder Mercia Technologies and joined by existing shareholders and new private investors, the Coventry, U.K.-based […]
Intersect ENT wins FDA nod for Sinuva polyp-disease-treating sinus implant
Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]
Regeneron scraps Eylea combo therapy after disappointing early trial results
Regeneron (NSDQ:REGN) is scrapping plans for a new combination drug pairing its Eylea with angiopoietin2 antibody nesvacumab after disappointing results from mid-stage clinical trials, according to a press release it published on Monday. Regeneron received results from 2 Phase 2 trials, the Ruby and Onyx studies, which reported that the combination drug “did not provide sufficient differentiation […]
Rebiotix expands Phase I trial of microbiota product after initial study success
Rebiotix said today it is expanding the Phase 1 study of its investigative RBX7455 drug designed to prevent recurrent Clostridium difficile infections after initial success in its two introductory cohorts in the trial. The Roseville, Minn.-based company’s RBX7455 is a lyophilized, non-frozen oral capsule formation of its Microbiota Resoration Therapy which it says is designed to “rehabilitate […]
Wearable CGM biosensor dev BioLinq raises $10m
Biosensor developer Biolinq said today it closed a $10 million Series A financing round to support its wirelessly-enabled biosensor patch designed for continuous monitoring of biomarkers, with an initial focus on monitoring glucose in diabetes patients. The round was led by M Ventures in collaboration with Hikma Ventures and joined by Grey Sky Venture Partners, […]