Shares in Baxter (NYSE:BAX) fell today despite the medical device maker beating expectations on Wall Street with its first quarter 2019 earnings results. The Deerfield, Ill.-based company posted profits of $347 million, or 66¢ per share, on sales of approximately $2.63 billion for the three months ended March 31, seeing the bottom line shrink 10.8% while […]
Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study
Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]
Surmodics ticks up on renewed SurVeil DCB trial enrollment
Surmodics (NSDQ:SRDX) shares have ticked up today after the company updated on the TRANSCEND clinical trial of its SurVeil drug-coated balloon, saying that it has resumed patient enrollment. Last month, the Eden Prairie, Minn.-based company paused enrollment after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease […]
Pulmatrix, Cipla Technologies ink deal for inhaled anti-fungal
Pulmatrix (NSDQ:PULM) said yesterday that it inked a deal with Cipla to co-develop and commercialize an inhaled iSperse formulation of the anti-fungal drug itraconazole, intended for treating allergic bronchopulmonary aspergillosis in asthma patients. Lexington, Mass.-based Pulmatrix said that it in the deal, Cipla’s Cipla Tech subsidiary will make an upfront payment of $22 million to Pulmatrix […]
DarioHealth touts updated diabetes management software
DarioHealth (NSDQ:DRIO) said yesterday it launched a new version of its Dario system and DarioEngage platform. The new V4.2.0 update to both digital health programs are intended to improve user engagement, lower barriers to behavioral change and to streamline the experience and process efficiency for both users and their coaches, the Israel-based company said. DarioHealth said that […]
Histogenics to merge with Ocugen
Histogenics (NSDQ:HSGX) said yesterday that it inked a definitive merger agreement with Ocugen through which both companies will combine into a single publicly-traded, clinical-stage biopharmaceutical company. The combined entity will operate under the Ocugen name, the companies said. As part of the deal, Ocugen’s shareholders will become the majority owners of Histogenics outstanding common stock upon […]
Drug delivery tech dev Modular Medical raises $4m
Drug delivery tech developer Modular Medical has raised $4.2 million in a new round of equity financing, according to a recently posted SEC filing. The stealthy Escondido, Calif.-based company is developing a new medication delivery technology to “remove the burden of daily injections” and compliment individual lifestyles, according to its website. Modular Medical has not […]
Pulmatrix prices $14m offering
Pulmatrix (NSDQ:PULM) yesterday priced an upcoming offering looking to raise approximately $14.4 million. The Lexington, Mass.-based company said that it plans to float approximately 10.7 million units at a price of $1.35 per unit. Each unit in the offering is comprised of one share of common stock and one warrant to purchase a single share of […]
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device. The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management. The newly cleared device […]
FDA accepts second application for Ocular Therapeutix’s drug-delivering implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is […]
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