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Fink Densford

Baxter shares dip despite Q1 earnings beat

April 25, 2019 By Fink Densford

Bax

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 […]

Filed Under: Business/Financial News, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Baxter

Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study

April 18, 2019 By Fink Densford

Cook Medical - updated logo

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular

Surmodics ticks up on renewed SurVeil DCB trial enrollment

April 17, 2019 By Fink Densford

SurModics

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: Surmodics

Pulmatrix, Cipla Technologies ink deal for inhaled anti-fungal

April 16, 2019 By Fink Densford

Pulmatrix

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory Tagged With: cipla, Pulmatrix Inc.

DarioHealth touts updated diabetes management software

April 11, 2019 By Fink Densford

DarioHealth updated

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 […]

Filed Under: Business/Financial News, Diabetes, Featured, Patient Monitoring Tagged With: dariohealth

Histogenics to merge with Ocugen

April 9, 2019 By Fink Densford

Ocugen, Histogenics

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 […]

Filed Under: Business/Financial News, Featured, Mergers & Acquisitions, Wall Street Beat Tagged With: histogenics, ocugen

Drug delivery tech dev Modular Medical raises $4m

April 5, 2019 By Fink Densford

Modular Medical

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Wall Street Beat Tagged With: modularmedical

Pulmatrix prices $14m offering

April 4, 2019 By Fink Densford

Pulmatrix

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 […]

Filed Under: Business/Financial News, Featured, Wall Street Beat Tagged With: Pulmatrix Inc.

Avanos Medical wins FDA nod for ON-Q Bolus pump

April 3, 2019 By Fink Densford

Avanos

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 […]

Filed Under: Drug-Device Combinations, Pain Management, Regulatory/Compliance Tagged With: avanosmedical

FDA accepts second application for Ocular Therapeutix’s drug-delivering implant

April 3, 2019 By Fink Densford

Ocular Therapeutix logo

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Ocular Therapeutix

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