Intersect ENT (NSDQ:XENT) this morning posted wider-than-expected losses but topped the consensus sales estimate with its third-quarter results. Menlo Park, Calif.-based Intersect reported losses of -$12.8 million, or -41¢ per share, on sales of $24.1 million for the three months ended Sept. 30, widening its losses by 69.1% on a -2.5% sales decline compared with […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” “Orsiro will be a valuable addition to our […]
Pixarbio CEO Reynolds convicted in $13m investor fraud case
Pixarbio founder & CEO Frank Reynolds reportedly faces two decades behind bars after a jury yesterday convicted him of defrauding investors of nearly $13 million. Federal authorities arrested Reynolds, longtime friend and Pixarbio employee Jay Herod and PixarBio CIO Kenneth Stromsland in April 2018 on securities fraud charges, claiming they misled investors about the opioid substitute […]
DarioHealth beats forecast with Q3 results
DarioHealth (NSDQ:DRIO) posted lower-than-expected net losses during the third quarter and met the consensus revenues forecast. The Israeli company, which makes mobile phone-compatible blood glucose and blood pressure monitors, reported losses of -$2.8 million, or -6¢ per share, on sales of $1.9 million for the three months ended Sept. 30. DarioHealth pared its losses by -31.0% […]
BD to shutter Minnesota Lutonix plant, layoffs ahead for 53
Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. The decision means layoffs for 53 of the New Hope, Minn., site’s 85 workers; the remaining 32 employees will either move to roles at BD’s Tempe, Ariz., location […]
Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells […]
iRadimed clears 5-year-old warning letter
iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps. The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, […]
Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on […]
Valeritas jumps on $25m refi, Q3 prelims
Valeritas (NSDQ:VLRX) said today that cut its debt load by $25 million in a refinancing move and released its third-quarter preliminary results, sending its share price up on Wall Street in early trading. The terms of refi saw the exchange of $25.0 million in senior debt owned by CR Group and another creditor for new […]
TCT 2019 Roundup: Medtronic’s Resolute Onyx non-inferior to Biosensors BioFreedom stent
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
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