Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced that it has acquired privately-held Contura Ltd. and its flagship product, Bulkamid, a best-in-class urethral bulking agent for women with stress urinary incontinence (SUI). Read more.
Source: Business Wire, February 25, 2021
Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.
Source: BioSpace, July 7, 2020
Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.
Source: Yahoo Finance!, March 4, 2020
Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.
Source: Yahoo! Finance, February 6, 2020
Contura has earned FDA approval for an injectable hydrogel [Bulkamid] to treat stress urinary incontinence in women, according to a premarket approval order posted by the agency Monday. The permanently implanted device acts as a scaffold for cells to grow through, supporting the closing mechanism of the urethra for better control of urine. Approval of the Bulkamid implant was based on a study of 228 women that showed 75% of those who got the device reported dryness or improvement in their symptoms. Read more.
Source: MedTechDive, February 4, 2020
Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, announced today that it has received approval of its Investigational Testing Application (ITA) from the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) treatment and a cryogen-only sham to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. Read more.
Source: Street Insider, December 18, 2019
Elidah, Inc (https://elitone.com/), a woman-owned medical device company, today announced the launch of ELITONE®, the first and only patented medical device providing non-invasive treatment for stress urinary incontinence in women. ELITONE is the first product of its kind launched under a newly created FDA product category for non-invasive incontinence therapy. Stress urinary incontinence is the loss of bladder control when activities such as exercising, coughing, laughing or sneezing increase the internal pressure placed on the abdominal cavity and pelvic floor muscles. Read more.
Source: PRNewswire, August 20, 2019
One of the most commonly performed surgeries to treat stress urinary incontinence in women may have better long-term results than another common surgical technique, according to a study led by Mayo Clinic researchers. The retrospective study of more than 1,800 cases at Mayo Clinic from 2002 to 2012 found that the need for additional surgery was twice as high after a transobturator sling surgery compared with a retropubic sling procedure. Reoperation rates within eight years after surgery were 11.2 percent for patients in the transobturator group compared with 5.2 percent in the retropubic group, according to the study, which will be published in the journal Obstetrics and Gynecology in August. Read more.
Source: Austin Daily Herald, July 16, 2019
Rinovum Women’s Health, the makers of the successful Stork® products for at-home conception has debuted a breakthrough reusable device, clinically proven to treat light bladder leaks that does not require a prescription, impacting the more than 15 million women in the U.S. who suffer from the embarrassing issue. The revolutionary product Revive™ is an FDA-cleared urethral support device designed to empower women and help them to take charge of their health by kicking stress urinary incontinence (SUI) to the curb. After successfully growing The Stork ®OTC, the first conception aid sold over-the-counter, Rinovum Women’s Health has made Revive available in nearly 5,000 retail locations nationwide and growing. Read more.
Source: BioSpace, June 24, 2019
“OMG. I just free’d myself!” Today, 20 million women in America will rewrite that whispered, uncomfortable admission of bladder weakness1 into a declarative, celebratory shout thanks to INNOVO®. As the first-in-class wearable, non-invasive solution for Stress Urinary Incontinence (SUI), INNOVO has the potential to positively impact the lives of one in three women.2 These women will now be able to laugh louder, exercise harder and even sneeze with ease. The INNOVO thigh-length, elasticized therapeutic shorts are outfitted with eight electrodes sewn in a crisscross formation across the pelvic region. When activated via its attached hand-held controller, INNOVO delivers a series of pelvic stimulations equivalent to Kegel exercises for strengthening the pelvic floor. Read more.
Source: PRNewswire, June 5, 2019