Propeller Health study suggests 84% of asthma inhaler use performed incorrectly

ResMed, Propeller Health

ResMed (NYSE:RMD) subsidiary Propeller Health today released results from a new study exploring real-world use of rescue or controller inhalers that indicated that the majority of users did not use their inhalers properly.

Results from the research were published in The Journal of Allergy and Clinical Immunology: In Practice, the Madison, Wisc.-based company said.

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ARS Pharmaceuticals wins fast track status for epinephrine nasal spray

ARS PharmaceuticalsARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1.

The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites.

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Medtronic risk prediction tool could help prevent opioid deaths: Here’s how

Medtronic logo updatedMedtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise.

The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S., Europe and Asia.

The study resulted in what Medtronic says is an easy-to-use risk prediction tool. Called the Prodigy score, it helps identify patients on the hospital general care floor who are taking opioid medications and are at high risk of developing a respiratory compromise.

The score takes into account variables including age, gender, sleep disorders, chronic heart failure and opioid naïvety. During the Prodigy study, it identified more than three-fourths of patients with confirmed respiratory depression.

Overall, opioid-induced respiratory depression occurred in nearly half of the patients in the study.

“Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor,” said Dr. Ashish Khanna, the primary study investigator and an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.

“These data validate an easy-to-use [opioid-induced respiratory depression] risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions,” Khanna said in a news release.

Opioid-induced respiratory depression is a “common, costly and deadly but preventable condition,” and Medtronic through the Prodigy study is committed to help, said Vafa Jamali, SVP and president of the Medtronic’s respiratory, gastrointestinal and informatics business.

“We are encouraged by the data demonstrating the use of the Prodigy OIRD risk prediction tool,” Jamali said. “It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”

 

 

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Cash-strapped Aradigm declares bankruptcy

AradigmAradigm Corp. (NSDQ:ARDM) announced last week that it’s officially declaring bankruptcy.

Strapped for cash, the Calif.-based company resigned to filing for Chapter 11 protection after it couldn’t confirm funding from its primary investor and partner, Grifols.

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Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy

PulmatrixPulmatrix (NSDQ:PULM) said today that the FDA approved a Phase II trial of the company’s inhaled formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in people with asthma.

The Lexington, Mass.-based company plans to kick off the trial in the first half of 2019, with top-line data expected in the second quarter of 2020.

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Mylan wins race for generic Advair approval

Mylan logo - updatedFDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application.

Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than recovered by noon today, reaching $39.23.

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ResMed shares plunge on Q2 sales miss

ResMed

Shares in ResMed (NYSE:RMD) fell nearly 20% after the respiratory-focused medical device maker missed sales expectations on Wall Street with its second quarter earnings results.

The San Diego-based company posted profits of $124.6 million, or 86¢ per share, on sales of $651.1 million for the three months ended December 31, for massive bottom-line growth of approximately 1208% while sales grew by a smaller 8.3% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $1, ahead of the 95¢ consensus on Wall Street where analysts expected to see sales of $672.9 million, which the company missed.

“We had a solid quarter with top-line growth and gross margin expansion, as well as continued fiscal discipline to drive leverage and improved operating profit. Our new AirFit F30 and AirFit N30i masks have been launched in many markets, and mask sales are growing well globally. During the quarter we further expanded our software and device ecosystems, through the acquisitions of MatrixCare and Propeller Health, to provide digital health solutions to millions more people worldwide. We are empowering people to live healthier and happier lives where they live, and we are doing this by providing innovative software, services, and solutions to improve outcomes, create efficiencies, and reduce overall healthcare system costs,” CEO Mick Farrell said in a press release.

Shares in ResMed fell 19.4% after the company released its earnings, closing last Friday at $94.56.

Earlier this month, ResMed said that it completed its $225 million acquisition of Propeller Health and its digital medicine platform.

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Circassia inks exclusive ventilator commercialization deal with AIT Therapeutics

Circassia Pharmaceuticals logoCircassia Pharmaceuticals said last week that it inked a deal for the exclusive commercialization rights to AIT Therapeutics’ nitric oxide device, AirNOvent, in the U.S. and China.

Using an electric voltage, the portable AirNOvent system produces nitric oxide from the nitrogen and oxygen in the air.

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Bellerophon closes $7m round

Bellerophon TherapeuticsBellerophon Therapeutics (NSDQ:BLPH) last week closed an underwritten public offering of 10,000,000 shares of common stock at 70¢ apiece.

The Warren, N.J.-based company also gave underwriters a 45-day option to buy up to an additional 1,500,000 shares of common stock at the same price.

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Bellerophon prices $7m offering

Bellerophon TherapeuticsBellerophon Therapeutics (NSDQ:BLPH) said yesterday that it priced an underwritten public offering of 10,000,000 shares of its common stock at 70¢ apiece.

The Warren, N.J.-based company also gave underwriters a 45-day option to buy an additional 1,500,000 shares of common stock at the same price. Bellerophon expects to reel in roughly $7 million in proceeds from the offering.

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