Inspire Medical Systems (NYSE:INSP) said yesterday that it received two additional draft Local Coverage Determinations for its minimally invasive therapy for sleep apnea. The latest proposals were issued by National Government Services and CGS Administrators, which represent a combined 12 states. The companies have different public comment periods, with NGS’s running from Sept. 26 to Nov. […]
Respiratory
Body Vision Medical raises $20m for lung diagnostic tech
Body Vision Medical said today that it closed $20 million in Series C funding, which is earmarked for its LungVision 2.0 platform. The Ramat Ha Sharon, Israel-based company said the money will be used to streamline commercialization and manufacturing activities for the LungVision 2.0. LungVision 2.0, which was cleared by the FDA in May, features […]
Pulmatrix doses first patient in Pulmazole trial
Pulmatrix (NSDQ:PULM) said yesterday that it dosed the first patient in its Phase II trial of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis asthmatics. The 64-patient study is a randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of three dose levels of the anti-fungal drug itraconazole formulation Pulmazole. The multi-center, four-arm trial will […]
Senzer Pharmaceuticals wins CE Mark for cannabinoid inhaler
Senzer Pharmaceuticals said yesterday that it has received the CE Mark for its cannabinoid inhaler. London-based Senzer said the Class IIa medical device approval, obtained in a joint project with manufacturing partner Europlaz, is the first-ever granted in the cannabinoid space and will allow the company to accelerate its plans to launch in the UK and […]
Judge adds $10m in damages in Vectura-GSK patent spat
This article has been updated with a statement from Glaxo Smith Kline. A federal judge in Delaware has awarded British inhaler company Vectura an additional $10.5 million in compensatory damages from Glaxo Smith Kline (NYSE:GSK) in a patent dispute. In May, a jury awarded Vectura $89.7 million in damages for the period from August 2016 through December 2018 for an infringement […]
Gala Therapeutics wins FDA breakthrough nod for RheOx
Gala Therapeutics said today that it won breakthrough device designation from the FDA for its RheOx bronchial rheoplasty device for patients with chronic bronchitis. Menlo Park, Calif.-based Gala’s RheOx system is designed for the minimally invasive delivery of non-thermal energy to airways, reducing mucus-producing cells associated with chronic bronchitis. Current treatments target bronchodilation and inflammation […]
Dance Biopharm, DarioHealth partner up on smart inhaler
Dance Biopharm said today that it has partnered with DarioHealth (NSDQ:DRIO) to integrate Dance’s smart inhaler into DarioHealth’s digital therapeutics program. Durham, N.C.-based Dance Biopharm’s smart inhaler includes vibrating mesh designed to create a soft mist that improves medication coverage in the lung. In clinical trials, the device delivered insulin in mist form with a faster […]
Inspire Medical adds more LCDs
Inspire Medical Systems (NYSE:INSP) yesterday said, for the second time this week, that two local coverage determination drafts were published for coverage of its sleep apnea therapy. Inspire Medical had two LCDs published August 26 by Medicare contractors Noridian Medicare and Palmetto GBA. Yesterday the Minneapolis-based company said Novitas Solutions and First Coast Service Options also […]
Pulmonx touts new coverage for Zephyr valve
Pulmonx said today that its Zephyr valve designed to treat chronic respiratory disease is now covered by Priority Health under a revised lung volume reduction policy. Redwood City, Calif.-based Pulmonx’s Zephyr valves are designed to provide a less-invasive treatment option for emphysema and chronic obstructive pulmonary disease by blocking off the diseased area of the […]
Inspire Medical Systems touts reimbursement wins
Inspire Medical Systems (NYSE:INSP) said two local coverage determination drafts were published to propose coverage of its sleep apnea therapy system. Minneapolis-based Inspire’s sleep apnea device uses hypoglossal nerve stimulation to treat obstructive sleep apnea. The two LCDs will be issued by Noridian Medicare and Palmetto GBA. The two companies collectively represent 19 states. According […]
Electromed inks distro deals for SmartVest
Electromed (NSDQ:ELMD) announced agreements with two unnamed home medical equipment distributors for the sale and distribution of its SmartVest airway clearance system in the U.S. The distributors – one regional and one national – will sell directly to patients, according to a release. Electromed said it expects minimal impact to fiscal 2020 revenues and expenses […]