Impel NeuroPharma (NSDQ:IMPL) announced that it priced an underwritten public offering of common stock worth $45 million.
The offering includes 3 million shares of common stock priced to the public at $15 per share, with gross proceeds set to total $45 million before deducting underwriting discounts and commissions and other offering expenses payable by Impel NeuroPharma.
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Tactile Systems this week announced that it has acquired the assets of the AffloVest respiratory therapy business from International Biophysics.
Minneapolis-based Tactile Medical financed the transaction through a combination of cash on hand and $55 million of borrowings under an existing credit facility. The credit facility is provided by Wells Fargo Bank.
AffloVest is a portable, wearable vest that International Biophysics designed to treat patients with chronic respiratory conditions, such as COPD-associated breathing conditions, or conditions resulting from neuromuscular disorders and cystic fibrosis. It manages airway clearance and is battery-powered with high-frequency chest wall oscillation.
“The addition of AffloVest represents an ideal strategic fit for Tactile Medical as it aligns well with our focus of treating patients with underserved chronic conditions in the home,” Tactile Medical president and CEO Dan Reuvers said in a news release. “We e…
Corin Group announced today that it appointed former Medtronic executive Jacob Paul as its new CEO.
Cirencester, UK-based Corin Group said in a news release that Corin “brings unparalleled strategic and operational experience” to the company and is “well placed” to lead it through the next phase of its mission to improve patient activity and wellbeing with implants and connected technologies.
Paul most recently served as SVP and president of Medtronic’s cranial and spinal technologies segment, growing the medtech giant’s business with technologies including robotics, navigation, imaging and AI-driven surgical planning.
“I am very pleased and proud to welcome Jacob to Corin,” Corin interim CEO & non-executive chairman of the board David Floyd said in the release. “His appointment will be pivotal in driving the innovation and expansion of our successful orthopaedic business into the rapidly evolving and g…
A late-breaking abstract presented at the virtual European Respiratory Society (ERS) International Congress 2021, supported by ResMed, found that using positive airway pressure (PAP) therapy as directed can significantly increase sleep apnea patients’ chances of living longer, according to a news release.
The Alaska study, “CPAP Termination and All-Cause Mortality: a French Nationwide Database Analysis,” found that those with obstructive sleep apnea (OSA) who continued PAP therapy were 39% more likely to survive than OSA patients who didn’t continue therapy.
Researchers evaluated more than 176,000 people in France with sleep apnea over a three-year period, finding that the survival rate gap remained significant when accounting for patient age, overall health, other pre-existing conditions and causes of death o…
Novocure (NSDQ:NVCR) announced today that the FDA granted breakthrough designation for its NovoTTF-200T liver cancer treatment system.
St. Helier, Jersey-based Novocure designed its NovoTTF-200T system, a tumor treating fields (TTFields) delivery system for use in tandem with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.
According to a news release, the FDA granted breakthrough device designation based on clinical data from Novocure’s Phase 2 pilot Hepanova trial evaluating the safety and efficacy of TTFields together with sorafenib for treating advanced liver cancer.
TTFields, electric fields designed to disrupt cancer cell division, are intended principally for use with other standard-of-care cancer treatments, as Novocure touts a body of evidence supporting its broad applicability with other cancer therapies, including radiation along with certain chemotherapies and immunother…
Invo Bioscience (OTCQB:IVOB) announced today that it acquired a Canadian-based entity formed to offer its InvoCell platform in Canada.
The unnamed entity previously completed a number of important procedures and the documentation required to establish InvoCell within clinical operations in Canada, according to a news release. The acquisition included a $25,000 cash payment and 30,000 shares of common stock, plus an incentive provision under which additional common stock shares can be issued for each clinic established that employs the Invo procedure in which the original Candian entity shareholders provide support.
Sarasota, Florida-based Invo Bioscience plans to leverage the newly acquired entity to advance the distribution of the Invocell infertility treatment platform and take advantage of the existing product registration in the Canadian market. The company will also initiate the development of joint ventures to establish Invo Centers within the Canadian ma…
Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy.
Through the breakthrough device program, Madorra will have priority review and communication regarding the development of the device until the product goes on the market.
Madorra’s handheld device is designed as a prescription, noninvasive home-use device that applies ultrasound waves along the vaginal canal to stimulate local heat and blood flow and produce natural vaginal lubrication to alleviate symptoms of vulvovaginal atrophy (VVA).
“VVA is a silent condition under-discussed by society but for postmenopausal women it’s very real and impacts their lives,” Dr. Rodney Baber, a doctor at Royal North Shore Hospital in Sydney, said in a news release. “A majority of women in this trial who used the Madorra device experienced symptom relief and wanted to continue using the device…
Better Therapeutics announced today that it expects its merger with Mountain Crest Acquisition Corp to close next month.
San Francisco-based Better Therapeutics announced its intention to merge with Mountain Crest, a publicly-traded, special purpose acquisition corporation (SPAC), in April. At the time of the announcement, the companies expected the merger to be completed some time in the summer of 2021.
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The prosecutors alleged on opening day that Holmes was manipulative and knowingly defrauded investors and patients through false and misleading claims.
“This is a case about fraud, about lying and cheating to get money. It’s a crime on Main Street, and it’s a crime in Silicon Valley,” said Assistant U.S. Attorney Robert Leach.
Holmes’ defense lawyers rebutted with a description of her that reflected someone who was a young, hardworking startup executive who really believed the Theranos technology could work and believed in the mission of the company, reports NPR. They claimed that she “overly trusted” lab directors an…
The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug.
According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by Sept. 16, having told the agency that the information “was helpful, but significant questions remain.”
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MiMedx (NSDQ:MDXG) announced today that its recently filed shelf registration with the SEC has become effective.
Marietta, Georgia-based MiMedx last month filed the shelf registration statement on Form S-3 with the SEC with the intent to be allowed to sell up to $350 million in various types of securities over the next three years once the shelf registration was declared effective.
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Sanofi (NYSE:SNY) announced today that it entered into a definitive merger with therapeutic developer Kadmon (NSDQ:KDMN) for $1.9 billion.
The acquisition adds Rezurock (belumosudil), a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for patients over 12 years old who have failed at least two prior lines of systemic therapy, to Sanofi’s transplant portfolio.
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