GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said yesterday that they filed a supplemental New Drug Application with the FDA, seeking an additional indication for GSK’s Trelegy Ellipta inhaler for the treatment of asthma in adults. The once-daily, single-inhaler triple-therapy device received FDA approval for the treatment of chronic obstructive pulmonary disease in September 2017. Trelegy Ellipta has not […]
FDA clears Exogenesis nano-modified hernia mesh
Exogenesis said yesterday that it won FDA 510(k) clearance for its hernia mesh implant for soft tissue repair in abdominal wall hernias and deficiencies. The Exogenesis mesh is made from polypropylene fibers warp-knitted together to create a device with large pores and minimum density and thickness, similar to current meshes on the market. It’s designed […]
Surgical Innovation Associates adds $4m
Surgical Innovation Associates said yesterday that it raised $4 million in an oversubscribed Series A round for the development and commercialization of its reconstructive and aesthetic surgery devices. Chicago-based Surgical Innovation, a medical device spinout from Northwestern University, said it has raised $6.5 million since its 2016 inception. The investor base for the recent $4 […]
Sleep Data, BetterNight raise $6m
Sleep Data said it raised $6 million to back the market expansion of its BetterNight virtual care platform. BetterNight, which launched in 2018, is designed to access care through telemedicine and remote patient monitoring to deliver lower cost of care and improved outcomes. San Diego-based BetterNight will put the funding toward market expansion of the […]
Axonics touts one-year data for r-SNM device, inks supply deal with Nebraska urology group
Axonics Modulation Technologies (NSDQ:AXNX) said today that results from its Artisan-SNM pivotal study highlighted durable outcomes and significant improvements in patients implanted with the Axonics r-SNM system for patients with urinary and bowel dysfunction. The announcement came one day after the company said it entered into an exclusive agreement to supply the Axonics r-SNM System to […]
TPC Wire & Cable acquires Cicoil, Pittsburgh Wire & Cable
TPC Wire & Cable Corp. last week announced the acquisition of Cicoil and Pittsburgh Wire & Cable to bolster its portfolio of specialized wire and cable solutions. Both acquisitions were announced by Macedonia, Ohio-based TPC in news releases Sept. 30. TPC did not disclose the financial details of either acquisition. Get the full story at […]
Frequency Therapeutics prices $84m IPO
Frequency Therapeutics said yesterday that it priced its initial public offering at roughly $84 million. The 6-million-share offering priced at $14 per share and includes a 30-day underwriters option on another 900,000 shares that’s worth $12.6 million, the Woburn, Mass.-based company said. Get the full story at our sister site, Drug Delivery Business News.
4C Medical pulls in $8m
4C Medical Technologies secured more than $8 million in an equity offering it hopes will reach the $20 million mark. The Maple Grove, Minn.-based company raised nearly $8.2 million in the offering, with $11.8 million remaining to be sold, according to an SEC Form D filed today. Forty-five unnamed investors have contributed to the offering. […]
Boehringer Ingelheim touts Spiolto Respimat inhaler data
Boehringer Ingelheim said yesterday that results from a study of its Spiolto Respimat inhaler showed benefits including improving symptoms and lung function in treating chronic obstructive pulmonary disease. The Spiolto Respimat is a soft-mist inhaler designed for the treatment of airflow obstruction in patients with COPD. A pooled analysis exploring COPD treatment with the tiotropium-based […]
Siemens Healthineers absorbs healthcare consultancy ECG
ECG Management Consultants said this week that it was joining Siemens Healthineers as a stand-alone unit in an effort to improve healthcare delivery and enhance client relationships. Siemens Healthineers will acquire a majority stake in ECG, with the transaction expected to close in the fourth calendar quarter of 2019, subject to regulatory approvals. ECG said […]
LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus
LifeScan said yesterday that it entered into an agreement with Willis Towers Watson to expand the commercialization of its OneTouch Reveal Plus digital diabetes therapy system. The companies hope the collaboration will see LifeScan and Willis Towers Watson combine to support self-insured employers in helping their employees and dependents manage diabetes. The OneTouch Reveal Plus […]
