Theraclion (EPA:ALTHE) said today that the 1st patients were treated in the U.S. pivotal clinical trial evaluating the safety and efficacy of the company’s Echopulse echotherapy device as a non-invasive treatment for breast fibroadenomas. The clinical trial is slated to enroll 100 patients, the France-based company said, at 4 sites across the U.S. and 1 site […]
Clinical Trials
Helius Medical touts data from multiple sclerosis pilot study of PONS system
Helius Medical Technologies said today that clinical data from a multiple sclerosis pilot study of its portable neuromodulation stimulator was published in the Multiple Sclerosis Journal: Experimental, Translational and Clinical. The company’s PONS system is designed to treat neurological symptoms, caused by trauma or disease, non-invasively through the tongue. Helius’ pilot study evaluated its PONS device combined […]
EnteroMedics touts long-term data for vBloc therapy
EnteroMedics (NSDQ:ETRM) said today that 3-year data from a study of its vBloc neurometabolic therapy in obese patients with type II diabetes were published in the Journal of Diabetes and Obesity. The St. Paul, Minn.-based company’s vBloc system is designed to intermittently block the vagus nerve using high-frequency, low-energy electrical impulses. The therapy is approved in the […]
Acorda’s inhaled Parkinson’s drug meets primary endpoint in Phase III trial
Acorda Therapeutics (NSDQ:ACOR) said today that the phase III clinical trial evaluating its inhaled formulation of Parkinson’s drug levodopa met its primary endpoint. The drug was studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms. The randomized phase III trial enrolled 339 patients to evaluate the efficacy […]
UPDATE: Medtronic wins Health Canada license for drug-coated balloon, touts Japanese data
Medtronic (NYSE:MDT) touted 1 year data from the In.Pact SFA Japan trial of its drug-coated balloon compared to plain balloon angioplasty. The company also said today it won regulatory approval in Canada for its In.Pact Admiral DCB in patients with peripheral artery disease in the upper leg. The trial enrolled 100 patients, 68 of whom […]
Arms Pharmaceutical touts oral spray for upper respiratory tract infections
Arms Pharmaceutical touted data from a proof-of-concept clinical trial evaluating its oral spray formulation, Arms-I, for upper respiratory tract infections. The placebo-controlled trial demonstrated that the oral spray formulation is safe, well-tolerated and reduced influenza symptoms, according to the Cleveland-based pharmaceutical company. Get the full story at our sister site, Drug Delivery Business News.
Mercator MedSystems touts data for Bullfrog microinfusion device
Mercator MedSystems touted data today from its Dance clinical trial evaluating the company’s Bullfrog micro-infusion device as a delivery system for a generic anti-inflammatory steroid, dexamethasome. Mercator’s results were presented at the International Symposium on Endovascular Therapy and Leipzig Interventional Course. The steroid was delivered to tissues around femoropopliteal arteries after patients underwent endovascular intervention […]
Motus GI raises $26m in new offering
Motus GI raised $25.6 million in a new offering, with 171 investors contributing to the round, according to regulatory filings. The Tirat Carmel, Israel-based company said it still has $4.4 million left to raise. Although the company has not made a formal statement detailing how it plans to spend its newly-acquired funds, it wrote in an SEC […]
NIH launches pivotal trials for artificial pancreas
The National Institutes of Health said this week that it is funding 4 projects dedicated to testing fully automated artificial pancreas devices in patients with Type I diabetes. The race to develop an artificial pancreas met a milestone last year, after the FDA approved Medtronic’s (NYSE:MDT) hybrid model of an artificial pancreas – the 1st of its kind […]
Owlstone Medical launches 1,400-patient study for colon cancer ‘breathalyzer’
Owlstone Medical said today it is launching a 1,400-patient clinical trial of its breath-based colorectal cancer diagnostic technology. The Intercept trial aims to explore the accuracy of the U.K.-based company’s ‘breathalyzer’ test in detecting colorectal cancer at an early stage. Owlstone’s breathalyzer uses field asymmetric ion mobility spectrometry to detect volatile organic compound metabolites in […]
Carmat rescinds bid to resume artificial heart trial
Carmat (FRA:CXT) said yesterday that it won’t seek to resume implantations of its artificial heart after all, after French regulators suspended a clinical trial last fall after the 5th death in the study. France’s national drug agency, ANSM, suspended the the trial in December 2016 after the patient died. Yesterday Carmat said the patient’s death was […]