Lyra Therapeutics (NSDQ:LYRA) presented positive results from a Phase 2 study of its therapeutic for treating chronic rhinosinusitis (CRS). Watertown, Mass.-based Lyra’s Phase 2 Lantern study evaluated its LYR-210 long-acting product for CRS, which is administered in-office to deliver a sustained release for up to six months as a non-invasive alternative to surgery for patients who […]
Otolaryngology/Ear, Nose & Throat (ENT)
Envoy Medical touts study results for its Esteem middle ear implant
Envoy Medical announced today that its Esteem middle ear implant showed statistically significant improvements in postoperative results. White Bear Lake, Minn.–based Envoy’s Esteem osseointegrated active middle ear implant (AMEI) is for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids. Esteem is the first and only fully […]
How Lyra Therapeutics is advancing rhinosinusitis treatment
With the use of anti-inflammatory drugs constituting the standard of care for treating rhinosinusitis, Lyra Therapeutics sees an opportunity. Whatever treatments are out there for the disease in which cavities around the nasal passages are inflamed, they leave room for improvement. “We focused on chronic rhinosinusitis because it’s an area that has been ignored,” Lyra […]
Frequency Therapeutics drug shows promise in restoring hearing in small study
Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug. The small Phase 1/2 study, published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss. At present, there are no FDA-approved drugs for preventing or restoring such hearing loss. However, administering steroids can facilitate recovery of hearing […]
Intersect ENT posts mixed bag Q4
Intersect ENT (NSDQ:XENT) posted a mixed bag of results for the fourth quarter, topping consensus revenue estimates but missing on earnings. The Menlo Park, Calif.-based company posted losses of –$20.2 million, or –62¢ per share, on sales of $28.2 million for the three months ended Dec. 31, 2020, for a massive bottom-line slide from losses of […]
CMS consolidates coverage for Intersect ENT’s corticosteroid-eluting implant
Intersect ENT (NSDQ:XENT) announced today that it received consolidated Medicare coverage for its Sinuva sinus implant. Menlo Park, Calif.-based Intersect ENT said in a news release that CMS published an average selling price (ASP) for the Sinuva implant, providing predictability, transparency and confidence of reimbursement for providers and payers in the future. Get the full story […]
PavMed to spin off subsidiary Lucid Diagnostics
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics will spin off into a separate public company. In a news release, Pavmed said Lucid Diagnostics intends to spin off if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation. […]
Lyra Therapeutics names new chief medical officer
Lyra Therapeutics (NSDQ:LYRA) announced today that it appointed Dr. Robert Kern as its new chief medical officer. Kern will remain in his current position as the George A. Sisson Professor and Chair, Department of Otolaryngology – Head and Neck Surgery at the Northwestern University Feinberg School of Medicine while operating as Lyra’s CMO, according to a […]
Intersect ENT launches Mini sinus implant
Intersect ENT today announced that it has launched its Straight Delivery System with its Propel Mini Sinus Implant. The combination packaging originally received FDA premarket approval in July 2020. The Straight Delivery System (SDS) is an extension of Intersect ENT’s Propel family of implants that is engineered for precise, consistent and easy delivery of the […]
SafKan Health wins FDA clearance for ear-cleaning headset
Tucson-based startup SafKan Health this week announced FDA clearance for its automated ear-cleaning device, OtoSet. Developed to clean impacted earways, OtoSet has irrigation and microsuction technology built into an automated and wearable device. According to the American Academy of Otolaryngology, excessive or impacted earwax is present in 1 in 10 children, 1 in 20 adults, and […]
Ex-Sanovas CEO sentenced to 11+ years in fraud case
Former Sanovas president & CEO Larry Gerrans was sentenced yesterday to 135 months in prison for wire fraud and money laundering in connection with a scheme to defraud the medical device company. U.S. District Judge Edward M. Chen handed down the sentence following a guilty verdict after a two-week trial in San Francisco in January 2020. The […]