The FDA sent a warning letter to Entellus Medical (NSDQ:ENTL) over its failure to prevent physicians from violating the approved protocol for a pediatric trial of its Xpress sinus dilator. The April 6 letter, published online this week by the federal safety watchdog, stems from an inspection that began exactly a year ago of a […]
Ear Nose & Throat (ENT)
Entellus Medical (NSDQ:ENTL) said today that it inked a deal worth some $81 million to acquire Spirox and its Latera absorbable nasal implant. The deal calls for Entellus to pay $25 million in cash and 3.4 million shares of its own stock for Redwood City, Calif.-based Spirox, which won 510(k) clearance from the FDA for the Latera […]
Tusker Medical said yesterday that it raised more than $10 million for the pediatric ear surgery device it’s developing. The Menlo Park, Calif.-based company raised $10.2 million in an equity sale from a single unnamed investor, according to a regulatory filing. Get the full story at our sister site, Drug Delivery Business News.
The FDA is warning of the risk that frameless stereotactic navigation systems, used to plan and conduct ear, nose & throat, brain and facial surgeries, might not be accurate if not used properly. Stereotactic navigation uses computed tomography or magnetic resonance imaging scans to generate a “map” surgeons use to guide their instruments. Some systems […]
A federal judge in Boston this week lifted the bail and travel restrictions imposed on a pair of former Acclarent executives who were acquitted of felony fraud charges in July. Former CEO William Facteau and ex-sales vice president Patrick Fabian were convicted on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into interstate commerce.” Facteau is […]
Intersect ENT (NSDQ:XENT) said today that it won a positive coverage decision from CareFirst BlueCross BlueShield for its Propel and Propel Mini drug-eluting sinus implants. The devices are designed to elute the anti-inflammatory steroid mometasone furoate; Menlo Park, Calif.-based Intersect won FDA approval for the original Propel implant in August 2011 and for the Propel Mini the following September. The […]
Intersect ENT (NSDQ:XENT) shares jumped today after the medical device company reported preliminary 2nd-quarter sales numbers that beat the consensus forecast on Wall Street. Menlo Park, Calif.-based Intersect said it expects to post sales of $19.3 million for the 3 months ended June 30, for a 27% top-line gain compared with Q2 2015. Analysts are predicting sales […]
Medtronic (NYSE:MDT) said today that its NuVent sinus dilation device won expanded indications from the FDA. The new indications cover patients with scarred, granulated, or previously surgically-altered tissue, according to the Fridley, Minn.-based medical device giant. The device works with an electromagnetic navigation tool called Fusion, which is designed to help physicians confirm anatomy and optimize placement during balloon […]
Entellus Medical (NSDQ:ENTL) said it paid $11 million in cash to acquire the XeroGel surgical sinus packing from Cogent Therapeutics. “We are pleased to secure ownership of this best-in-class nasal dressing technology as well as solidify control of the supply chain and distribution to our physician customers. We are excited about the opportunity to leverage our […]
Spirox said this week that it nailed down an $18.5 million Series B round to back development and commercialization of its device to treat patients with nasal obstructions.
Venrock and Aisling Capital led the round for Menlo Park, Calif.-based Spirox, with existing investors Aperture Venture Partners, Correlation Ventures and Western Technology Investment also participating.
SinuSys executives Thomas Schreck and Dr. Jerome Hester had a very different relationship just 3 years ago. Schreck, a serial entrepreneur now on his 3rd venture, was Hester’s patient up until a fateful lunch meeting in Menlo Park, Calif., that led to the founding of SinuSys.
The pair are now busy with the commercial phase of their joint venture, having earlier this year won FDA clearance for the Vent-Os sinus dilation system.