The FDA this week approved Amphastar Pharmaceuticals‘ (NSDQ:AMPH) over-the-counter Primatene Mist inhaler for the temporary relief of mild symptoms of intermittent asthma. The original version of Amphastar’s Primatene Mist device was taken off the market in 2011 because it contained chlorofluorocarbon propellants – a chemical compound that is linked to depletion of the Earth’s ozone layer. […]
Gala Therapeutics launches RheOx chronic bronchitis trial
Gala Therapeutics said today that it launched an early feasibility study of its RheOx system for treating chronic bronchitis, and that the first two patients in the trial have already been enrolled. Initial patient enrollment took place at the University of Pittsburgh Medical Center, with RheOx bronchial rheoplasty procedures performed by Dr. Frank Sciurba and Roy […]
ResMed to pay $750m for MatrixCare
ResMed (NYSE:RMD) said today that it agreed to pay $750 million to acquire MatrixCare and its post-acute-care software. The San Diego-based respiratory care giant said it plans to fund the buyout, which represents a 25x EBITDA multiple, using its credit facility. Bloomington, Minn.-based MatrixCare put up sales of $122 million last year, ResMed said. “The acquisition of MatrixCare is […]
Vapotherm sets range for $60m IPO
Vapotherm today set the pricing range on an initial public offering that would fetch $60 million at the midpoint. Exeter, N.H.-based Vapotherm developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of […]
ResMed’s fiscal Q1 tops forecast
ResMed (NYSE:RMD) yesterday reported fiscal first-quarter results that beat the consensus forecast. The San Diego-based respiratory device maker posted profits of $105.7 million, or 73¢ per share, on sales of $588.3 million for the three months ended Sept. 30, for bottom-line growth of 22.8% on sales growth of 12.3% compared with fiscal Q1 2018. Adjusted to […]
ResMed touts German win in continued Fisher & Paykel patent spat
ResMed (NYSE:RMD) yesterday touted a win in a German patent spat over masks used with continuous positive airway pressure machines with competitor Fisher & Paykel Healthcare (NZE:FPH). San Diego-based ResMed said that a trial court ruling from Germany’s Munich District Court found that Fisher & Paykel’s Simplus full face and Eson 2 nasal mask head gear infringes […]
Vapotherm registers $58m IPO
Vapotherm last week registered for an initial public offering worth nearly $58 million for the respiratory device it’s developing. Exeter, N.H.-based Vapotherm developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of […]
Pari Pharma lands FDA nod for Lamira nebulizer
Pari Pharma said this week that its Lamira nebulizer won approval from the FDA to deliver Insmed’s Arikayce amikacin liposome inhalation suspension for the treatment of MAC lung disease. The company’s Lamira drug-device combination product is intended to be used as part of a combination antibacterial drug regimen for adult patients with limited or no alternative […]
Owlstone Medical raises $50m
Owlstone Medical said today it raised $50 million (UK £38 million) in a new round of financing, with funds slated to help support the targeted launch of its breath biopsy kits and continued development of its technology platforms. The funding includes an initial $15 million (UK £11 million) the U.K.-based company reported raising in March, and […]
CSA Medical touts QoL improvements in RejuvenAir chronic bronchitis study
CSA Medical today released early results from a feasibility study exploring the use of its RejuvenAir Metered Cryospray system in treating patients with chronic bronchitis, touting improvements in quality of life for patients treated with the system. Results from the trial were presented at the 2018 European Respiratory Society Congress in Paris, the Boston-based company said. […]
Intuitive Surgical seeks FDA approval for lung biopsy robotic platform tools
Intuitive Surgical (NSDQ:ISRG) said yesterday it submitted a premarket notification application to the FDA seeking clearance for its new flexible, robotic-assisted catheter-based platform intended for use in the lungs. The new platform is designed for navigation through very small lung airways to reach peripheral nodules for biopsies, the Sunnyvale, Calif.-based company said in a press release. […]
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