Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
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.
Forward Science buys EarAid smart earplugs from Dental Innovations
Forward Science said yesterday that it acquired exclusive rights to earpieces from Dental Innovations for smart earplug technology for dental health providers. The Dental Innovations device, which Forward Science will rebrand as EarAid, is designed to protect dental professionals who are exposed to damaging noise from high-speed handpieces, high-volume suction, ultrasonic instruments, model trimmers and […]
U.S. exempts more Chinese medtech products from tariffs
The U.S. has exempted another 18 medical devices or device components from the 25% tariffs imposed on Chinese goods by the Trump administration. The new list includes ultrasound, X-ray, MRI and infusion equipment. The Office of the U.S. Trade Representative (USTR) said the new exclusions are retroactive to August 23, 2018, when additional tariffs went […]
Apple announces medical studies using new Research app
Apple (NSDQ:AAPL) said yesterday that it is launching medical studies into women’s health, hearing, and heart function and movement with its new Research app. The Cupertino, Calif.-based company said the app will show how medical research is conducted and allow participants to contribute to potential medical discoveries. The Research app will be available as a free […]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The company applied to the Securities and Exchange Commission have its common stock listed on The Nasdaq Global Market […]
IotaMotion adds nearly $3m, touts human factors study
IotaMotion said today that it raised nearly $3 million in a second round of funding as it moves toward commercializing its iotaSoft robotic system for cochlear implantation surgery. The Iowa City-based startup raised $2.52 million and said it’s focused on achieving developmental and regulatory milestones on its way to commercialization for the IotaSoft system. The […]
Dalent Medical readying to launch Sinusleeve device
Dalent Medical said last week that it has listed its Sinusleeve balloon sinus dilation device with the FDA. Sinusleeve is a single-use, disposable device used for treating chronic sinusitis, according to the Miami-based company. Sinusleeve is an FDA 510(k)-exempt Class 1 device that the company said it will begin marketing immediately to otolaryngologists in Florida. Get […]
FDA approves delivery system for Intersect ENT’s Propel implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for a new delivery system for its Propel Mini steroid-eluting sinus implant. The Menlo Park, Calif.-based company said the straight delivery system is designed to place the mometasone furoate-eluting Propel Mini in the ethmoid sinus behind the nasal bridge. The SDS is slated to hit […]
Frequency Therapeutics inks $625m deal with Astellas, adds $62m Series C
Frequency Therapeutics said today that it raised a $62.0 million Series C round for the hearing loss drug it’s developing and inked a development and overseas distribution deal with Astellas Pharma that’s worth $625 million. Woburn, Mass.-based Frequency drew a $42 million Series B early this year; including the financing announced today, a $32 million Series A and seed […]
Report: Researchers create smartphone-based ear infection detection app
A group of researchers from the University of Washington have created an application that only requires a smartphone and a folded piece of paper to detect ear infections, according to a recent Gizmodo report. Researchers published data from a study of the application, dubbed EarHealth, on Wednesday in the journal Science Translational Medicine, according to […]
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