Laborie Set to Acquire Cogentix
Laborie Medical Technologies is set to acquire Cogentix Medical for about $239 million in a deal that will close in the second quarter of 2018. The price represents a 28% premium over Cogentix average 30-day closing price.
Minnetonka, MN-based Cogentix specializes in urology devices. The firm’s products include Urgent PC, a neuromodulation system for percutaneous tibial nerve stimulation. It treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence on an outpatient basis.
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Source: MDDI - March 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Laborie Medical to pay $214m for Cogentix
Laborie Medical Technologies said today that it agreed to pay $214 million for Cogentix Medical (NSDQ:CGNT) and its line of urology and gynecology devices.
Formed by the 2015 merger of Vision-Sciences and Uroplasty, Minnetonka, Minn.-based Cogentix makes the Urgent PC neuromodulation device for treating overactive bladder syndrome, the PrsimeSight cystoscopy and EndoSheath devices and Macroplastique, an injectable soft-tissue bulking agent for treating female stress urinary incontinence.
The $3.85-per share cash offer is slated to close during the first half of the year, Toronto-based Laborie said. It’s a 14.2...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Urology Wall Street Beat Women's Health Cogentix Medical Laborie Medical Technologies Source Type: news
Valencia Tech wins FDA nod for eCoin neurostim overactive bladder trial
Valencia Technologies said today it won FDA investigational device exemption approval to launch a pivotal trial of its eCoin neurostimulation device exploring its ability to treat overactive bladder.
The system, which is approximately the size of a nickel, is designed to implanted in a 10 minute procedure and send electrical impulses to the tibial nerve to stimulate the part of the brain that controls bladder response, the New York-based company said.
“There is great excitement for a therapy that delivers more than modest improvement in overactive bladder symptoms while avoiding the side-effects of drugs,” uro...
Source: Mass Device - March 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Valencia Technologies Source Type: news
FDA Approves Pivotal Clinical Trial for Technology to Treat Overactive Bladder
NEW YORK, March 9, 2018 -- (Healthcare Sales & Marketing Network) -- Yesterday, the FDA approved the conduct of a pivotal clinical trial using a new technology to treat overactive bladder. The technology, developed and manufactured by Valencia Technologie... Devices, Urology, FDA Valencia Technologies, overactive bladder, eCoin , neuromodulation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 9, 2018 Category: Pharmaceuticals Source Type: news
StimGuard launches head-to-head trial against Medtronic ’ s InterStim
StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT).
Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve.
The new study is designed to compare that treatment with InterStim sacral nerve stimulation therapy, which involves the ...
Source: Mass Device - March 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Neuromodulation/Neurostimulation Urology Women's Health Medtronic StimGuard Source Type: news
Overactive bladder treatment may also lead to better sleep
(Reuters Health) - Women with overactive bladder who take medication to address the problem may feel the urge to urinate less often and also sleep better at night as a result, a U.S. study suggests. (Source: Reuters: Health)
Source: Reuters: Health - February 1, 2018 Category: Consumer Health News Tags: healthNews Source Type: news
5 medtech stories we missed this week: Jan. 26, 2018
[Image from unsplash.com]From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are 5 medtech stories we missed this week but thought were still worth mentioning.
1. Attune Medical gets FDA 510(k) clearance
Attune Medical announced in a Jan. 8 press release that it has received FDA 510(k) clearance for its EnsoETM model that administers tube feeds or medication while cooling or warming patients. The device manages a patient’s temperature through the esophagus while allowing for enteral fluid administration with the company’s ENFit connector.
2. Ally Bridge, LifeTech...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Food & Drug Administration (FDA) Hospital Care Neuromodulation/Neurostimulation Regulatory/Compliance Respiratory Ally Bridge Group Attune Medical Axonics Modulation Technologies LifeTech Scientific Corp. MedTech ResMed Inc. Source Type: news
Axonics touts first patients treated in sacral neuromod study
Axonics Modulation Technologies said today that the first 11 patients in its Artisan-SNM sacral neuromodulation study have been implanted with the company’s device designed to treat urinary and bowel dysfunction.
The patients were implanted at four centers across the US and Western Europe, the Irvine, Calif.-based company said. The trial will look to enroll 120 patients across 15 centers in total.
The single-arm, prospective pivotal study, which won FDA approval last November, is examining the safety and effectiveness of the r-SNM system as an aid to treating urinary urgency incontinence with patients who failed or ...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blog Axonics Modulation Technologies Source Type: news
Cogentix touts MAC coverage extension for OAB neuromod treatment
Cogentix Medical (NASDAQ: CGNT) said today that Medicare Administrative Contractor Palmetto GBA extended granted coverage for percutaneous tibial nerve stimulation procedures to treat overactive bladder with the company’s PC Neuromod System.
With the extension, patients with Medicare coverage in North Carolina, South Carolina, parts of Virginia and West Virginia will be eligible to receive PTNS therapy for up to 3 years, adding an additional year onto previous coverage, the Minneapolis, Minn.-based company said.
“On behalf of the many overactive bladder patients who can benefit from Urgent PC’s therape...
Source: Mass Device - December 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Urology Cogentix Medical Source Type: news
Outpost Medicine Appoints Scott Byrd as Chief Executive Officer and Raises $20 Million in Series A Financing Extension
New Investor Takeda Ventures Joins Syndicate; Proceeds to Fund Lead Clinical Stage Program for the Treatment of Overactive Bladder and Irritable Bowel Syndrome
INDIANAPOLIS and LONDON, Nov. 15, 2017 -- (Healthcare Sales & Marketing Network) -- Outpost ... Biopharmaceuticals, Venture Capital, Personnel Outpost Medicine, Irritable Bowel Syndrome, Overactive Bladder (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 15, 2017 Category: Pharmaceuticals Source Type: news
FDA approves Axonics IDE trial for r-SNM neuromod
Axonics Modulation Technologies said today it won FDA investigational device exemption clearance to engage in a pivotal study of its r-SNM rechargeable sacral neuromodulation system designed for treating overactive bladder and bowel dysfunction.
The Irvine, Calif.-based company said it expects to begin enrolling patients in the clinical study in November, aiming to enlist 120 patients at 15 centers in the US and Western Europe.
“During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that w...
Source: Mass Device - November 7, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Axonics Modulation Technologies Source Type: news
Digging For Gold
This article appeared in the most recent edition of our specialist publication,Trends in Medical Affairs.Click here to download a copy. Related Content: Pragmatic Trials: The Real-World Data RevolutionNavigating The New LandscapeWhen Real-World Evidence met Patient-CentricityBig Data, Huge OpportunityPrimary Event: Medical Affairs Europe 2018Pr écis: As Medical gets more involved in real-world evidence, what challenges does it face in proving the value of a medicine?Premium`: Freemium`: Channels: Patients and MedicalTags: medical affairsChannelimage: (Source: EyeForPharma)
Source: EyeForPharma - November 1, 2017 Category: Pharmaceuticals Authors: Lucy Fulford Source Type: news
Digging For Gold
This article appeared in the most recent edition of our specialist publication,Trends in Medical Affairs.Click here to download a copy. Related Content: Pragmatic Trials: The Real-World Data RevolutionNavigating The New LandscapeWhen Real-World Evidence met Patient-CentricityBig Data, Huge OpportunityPrimary Event: Medical Affairs Europe 2018Pr écis: As Medical gets more involved in real-world evidence, what challenges does it face in proving the value of a medicine?Premium`: Freemium`: Channels: CommercialTags: medical affairsChannelimage: (Source: EyeForPharma)
Source: EyeForPharma - November 1, 2017 Category: Pharmaceuticals Authors: Lucy Fulford Source Type: news
Prostate problem? Take 2 nuts
By age 60, you have a 50/50 chance of having a clinically enlarged prostate. And it only gets worse every year. When your prostate isn’t functioning properly, it’s hard to enjoy life.
Traditional doctors give you two choices.
Go under the knife or you take Big Pharma’s drugs.
Either way, you have a good chance of ending up with your manhood on the line…
If you have surgery, there’s a big risk you’ll be saying goodbye to your sex life for good. The rate of impotence is a shocking 50 to 60% after prostate surgery.1
Big Pharma’s meds to shrink your prostate are no better. These synthetic drugs have a history ...
Source: Al Sears, MD Natural Remedies - October 19, 2017 Category: Complementary Medicine Authors: Cathy Card Tags: Anti-Aging Source Type: news
Are your medications affecting your memory?
Many of today’s most popular drugs can make you forgetful.
They inhibit your brain’s chemical messengers. And this blocks your concentration, memory and ability to focus.
More specifically, these drugs block the activity of a neurotransmitter in your brain called acetylcholine.
Acetylcholine is directly involved in learning and memory. And blocking it is a risky business…
I’ve seen confusion, memory loss, and declining mental skills in patients who take these drugs. New research confirms what I see in my own practice.
One recent study found that people taking these kinds of drugs had shrunken areas of the brain ...
Source: Al Sears, MD Natural Remedies - October 19, 2017 Category: Complementary Medicine Authors: Cathy Card Tags: Anti-Aging Source Type: news
