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product approval

FDA Approves Myrbetriq Combo Treatment for Overactive Bladder

The Food and Drug Administration (FDA) has approved Myrbetriq (mirabegron extended-release tablets; Astellas) in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturitions per 24 hours (primary endpoint), and the volume voided per micturition (secondary endpoint) compared to placebo or to individual active components. Long-term data also demonstrated that the effects of combination treatment were maintained throughout a 1-year treatment period. Read more.

Source: MPR, April 30, 2018

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Essity Partners with Plug and Play to Drive New Innovation in Hygiene

Essity, one of the world’s leading hygiene and health companies, announced that it will expand its partnership with Silicon Valley’s Plug and Play.  Plug and Play is the world’s leading startup accelerator and open innovation platform that connects startup companies with corporations for business development and investment opportunities. Essity joined Plug and Play’s Health & Wellness innovation platform last year to gain access to the company’s global ecosystem of startups, focusing on technologies that would strengthen Essity’s feminine care and baby care products. The relationship has now expanded to include professional hygiene and incontinence products. Read more.

Source: Market Insiders, April 27, 2018

drugs for overactive bladder (OAB)

Certain Common Medications Tied to 30% Higher Dementia Risk, Study Finds

Many older adults know that long-term use of certain medications can negatively affect cognition and increase one’s risk of dementia.  But a new study suggests that some classes of anticholinergic drugs — particularly those used to treat depression, Parkinson’s and urinary incontinence — carry a higher risk than others.  Anticholinergic drugs function by blocking the effects of acetylcholine, a chemical released by nerve cells to send signals to other nerves and muscles. They are prescribed to 20% to 50% of older adults in the United States to treat a variety of neurological, psychiatric, gastrointestinal, respiratory and muscular conditions, according to a 2009 study. In the UK, 34% to 48% of older adults take them, another study found.  Read more.

Source: CNN, April 25, 2018

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Restech acquires Mederi Medical

Medtech developer Respiratory Technology Corp said today it acquired Mederi Therapeutics, and its Stretta catheter and Secca system, for an undisclosed amount.  Houston-based Restech said that the addition of the Stretta catheter, designed to treat gastroesophageal reflux disease, and the Secca system, designed to treat bowel incontinence, are complimentary to its existing diagnostic devices.  Mederi’s Stretta catheter system is designed to apply low-power radio frequency energy to remodel the lower esophageal sphincter to restore natural barrier function and reduce spontaneous regurgitation caused by transient relaxations of the sphincter.  The Secca device uses a low-power radiofrequency generator to remodel the muscle of the internal anal sphincter to treat bowel incontinence, the company said.  Read more.

Source: Mass Device, April 26, 2018

product approval

ProvenMed, wins MIT Arab Startup competition Award 2018

North African start-up, ProvenMed, has been named startup winner of the MIT Arab Startup competition 11th edition Award.  ProvenMed Co-Founder & CEO, Souheil Guessoum received the award at the ceremony chaired by the chair of the board of MIT Enterprise Forum Pan Arab, Hala Fadel. Promoted by MIT Enterprise Forum, the Arab Startup competition Awards aim to create an ecosystem based on the most outstanding startups from across the Arab countries. In addition to demonstration of innovation and a viable business model, winners are selected based on their contribution to advancing sustainability, active social responsibility engagement and participation in Arab projects and partnerships.  The 11th edition competition took place in Sultanate Oman on 19th of April 2018 and was supported by Community Jameel, a founding partner for 10 consecutive years. As a local support and engagement in the Sultanate of Oman, strategic partners this year include Riyada, the competition’s governmental backbone, and Omantel, the key contributor and supporter. Regionally, partners also include Zain Group, the competition’s digital partner.  ProvenMed, based in Tunis, was founded in 2017 and currently at the commercialization stage of its flagship innovative product ActivGo™ for men. Read more.

Source: Zawya, April 24, 2018

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LABORIE Medical Technologies and Cogentix Medical Announce Completion of Acquisition

LABORIE Medical Technologies (“LABORIE”) and Cogentix Medical, Inc. (NASDAQ: CGNT) (“Cogentix”) today announced the completion of the acquisition by LABORIE of Cogentix through LABORIE’S affiliate Camden Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of LM US Parent, Inc. (“Parent”). After the previously announced completion of the tender offer for all of the outstanding shares of Cogentix, LABORIE completed the second step merger under Delaware law, resulting in Cogentix becoming a wholly owned subsidiary of Parent. At the effective time of the merger, all shares of Cogentix common stock not purchased in the tender offer (excluding those shares for which holders properly exercised appraisal rights under Delaware law and those held by Cogentix) were converted into the right to receive US$3.85, net to the seller in cash without interest thereon and subject to any required withholding tax, which is the same price that was paid for shares of Cogentix common stock purchased in the tender offer. Cogentix common stock will no longer be listed on the Nasdaq Capital Market or any other securities exchange. Read more.

Source: The Virginian-Pilot, April 23, 2018