Aerin Medical today announced the publication of positive results from a 12-month study of its RhinAer platform. Results from Sunnyvale, California–based Aerin’s Rhintrac randomized, sham-controlled clinical trial, published in the International Forum of Allergy & Rhinology (IFAR), demonstrated that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer. Findings build on […]
Otolaryngology/Ear, Nose & Throat (ENT)
Lyra Therapeutics appoints new chief medical officer
Lyra Therapeutics (Nasdaq:LYRA) announced today that it appointed Dr. Richard Nieman as its new chief medical officer (CMO). Nieman’s appointment as CMO of Lyra, which develops the XTreo — a platform for enabling precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues — will be made […]
Aerin Medical reports positive 4-year results for VivAer treatment
Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO). Sunnyvale, California–based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the […]
Envoy Medical wins FDA IDE for Acclaim cochlear implant
Envoy Medical announced today that it received FDA investigational device exemption (IDE) for its Acclaim cochlear implant. White Bear Lake, Minnesota–based Envoy Medical will begin a single-center IDE early feasibility study with the fully implanted Acclaim cochlear implant at Mayo Clinic in Rochester, Minnesota. The company said in a news release that its Acclaim implant […]
Aerin Medical closes $60M equity financing
Ear nose and throat (ENT) treatment technology developer Aerin Medical announced today that it closed a $60 million equity financing. Sunnyvale, California-based Aerin’s financing was led by new investor Ally Bridge Group with participation from all existing major investors, including KCK MedTech, Questa Capital and OrbiMed. According to a news release, Aerin Medical intends to […]
Two-year data backs Aerin Medical’s chronic rhinitis treatment
Aerin Medical announced today that a study of its RhinAer technology demonstrated success in treating chronic rhinitis patients. Sunnyvale, California–based Aerin Medical — one of MassDevice’s 20 medical device startups you need to know in 2020 — designed its RhinAer temperature-controlled radiofrequency (RF) technology to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny […]
Medtronic completes Intersect ENT acquisition
Medtronic (NYSE:MDT) announced that it completed its previously announced $1.1 billion acquisition of Intersect ENT (Nasdaq:XENT). Fridley, Minnesota-based Medtronic announced in August 2021 that it would acquire all outstanding shares of the Menlo Park, California-based sinus implant maker for $28.25 per share in an all-cash transaction. As a result of the transaction, Medtronic acquires Intersect […]
FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
The FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events. The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. They are the only silicone-based EMG […]
Impel NeuroPharma rebrands to Impel Pharmaceuticals as part of corporate transformation
Impel NeuroPharma (Nasdaq:IMPL) announced today that it changed its name to Impel Pharmaceuticals as part of a corporate rebrand. Seattle-based Impel develops proprietary Precision Olfactory Delivery (POD) technology to treat patients suffering from diseases across a range of areas — and the central nervous system. The company’s Trudhesa nasal spray for treating migraine in adults received […]
DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]
Lyra Therapeutics closes $100.5M private placement
Lyra Therapeutics (Nasdaq:LYRA) announced today that it closed its previously announced private placement worth $100.5 million. The company announced last week that, in the private placement, investors had the option to purchase either shares of Lyra’s common stock at $4.22 per share or, in lieu thereof, pre-funded warrants to purchase shares of common stock with an […]