Pavmed Inc. (NSDQ:PAVM) today reported the preliminary results of its offer to exchange two Series W warrants for a single Z warrant. Approximately 10,151,682 Series W warrants were tendered and not withdrawn, which represents 96.4% of outstanding Series W warrants, the New York-based company said. Pavmed plans to accept all 10.2 million of the Series W […]
Otolaryngology Ear, Nose & Throat
Intersect ENT launches Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) launched its steroid-releasing sinus implant, Sinuva, in the U.S. today. The company’s drug-eluting device is designed to treat nasal polyp disease in patients who have undergone previous sinus surgery. Sinuva is placed during a routine doctor’s office visit and releases an anti-inflammatory steroid, mometasone furoate, directly to the patient’s nasal polyps for up to […]
Frequency touts first-in-human safety study for hearing loss therapy
Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. The patients enrolled in […]
Sensorion, Cochlear collab to study combo therapies for patients with cochlear implants
Sensorion, a biotech working on therapies for inner ear diseases, said today that it inked a deal with Cochlear Ltd (ASX:COH) to study combination therapies for patients with cochlear implants. According to the deal, the companies will combine Sensorion’s SENS-401 compound with cochlear implants in preclinical studies starting next year. The drug-device therapies could be […]
Intersect ENT wins FDA nod for Sinuva polyp-disease-treating sinus implant
Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]
Pavmed shares climb after Q3 EPS beat
Shares in Pavmed Inc. (NSDQ:PAVM) rose today after the medical device maker beat expectations on Wall Street with its third quarter results. The N.Y.-based company posted a net loss of -$5.37 million, or -40¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -178.5% compared with the same period last year. Adjusted […]
FDA conducts pre-approval inspection for Intersect ENT’s Menlo Park facility
Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant. Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 […]
Draper develops novel device to deliver drugs to the inner ear
Millions of people around the world are losing their hearing thanks to inner ear disorders and the pharmaceutical industry has spent years working to develop therapeutics to help address this patient population. But Jeff Borenstein, lead scientist for drug delivery at Draper, discovered by talking to experts in the hearing loss field that many of […]
Intersect ENT beats Q3 sales estimates, raises full-year forecast
Shares in Intersect ENT (NSDQ:XENT) rose slightly today after the steroid-eluting implant maker beat sales expectations on Wall Street with its third quarter results. The Menlo Park, Calif.-based company posted a net loss of -$4.3 million on sales of $22.3 million for the 3 months ended Sept. 30, for sales growth of 21% compared with the […]
OptiNose IPO pulls in $120m
OptiNose (NSDQ:OPTN) raised $120 million with its initial public offering last week, adding $20 million to the target is set earlier this month. Yardley, Penn.-based OptiNose floated 7.5 million shares at $16 apiece in the offering, above the range it set Oct. 3 for 6.3 million shares at $15 to $17 apiece. The stock, trading on the […]