FDA Clears InToneMV for the Non-Surgical Treatment of Male Urinary and Fecal Incontinence

BROOKFIELD, Wis.–(BUSINESS WIRE)–InControl Medical gains FDA clearance forInTone®MVproviding the 12 million men nationally who suffer with urinary or fecal incontinence a non-surgical, implant-free solution.

“It’s terribly embarrassing for both men and women to have to live with fecal and urinary incontinence and even worse to have to resort to diapers, pads, meds or a surgical implant. InToneMV works. Men no longer need to suffer with fecal or urinary incontinence.”

“Due to the complex nature of the pelvic floor and bowel leakage, most interventions are invasive and require surgical procedures. Embarrassment and a lack of desirable treatment options can hinder a man’s lifestyle by avoiding recreational and social activities and decreasing sexual desire and performance for fear of accidental bowel or urinary leakage,” saysMichael Krychman, M.D.Executive Director of The Southern California Center for Sexual Health and Survivorship Medicine. “Difficulty with bladder control is primarily related to weakness of the pelvic floor muscle and spasms of the bladder muscle, allowing urine loss to occur with increased intra-abdominal pressure (coughing, laughing, sneezing or exercising.) Strengthening of the pelvic floor muscles will decrease bladder leakage and avoid embarrassment. It also impacts sexual function by increasing desire and performance and restores quality of life.”

InToneMVis a non-invasive treatment option and comprehensive pelvic floor rehabilitation program for men with bowel and urine leakage, designed to address the complexities of the pelvic floor, strengthen weakened musculature and improve sphincter closure, all within the comfort and privacy of home.

A customizable probe with muscle stimulation effectively strengthens the muscles of the pelvic floor and provides voice-guided volitional exercise and visual biofeedback to reinforce proper completion of exercises. Data from each home-based session is recorded allowing the health care provider to guide progress during monthly follow up visits. InToneMV stops bowel leakage for as little as $5.70 per day for 6 months.

“Our originalInTonedevice that was FDA listed as a Class II Medical Device for the treatment of female urinary incontinence, helped so many, that we had to design InToneMV which is a much smaller and more comfortable treatment solution to helpboth men and women with atrophy,” says Herschel Peddicord, founder and CEO ofInControl Medical. “It’s terribly embarrassing for both men and women to have to live with fecal and urinary incontinence and even worse to have to resort to diapers, pads, meds or a surgical implant. InToneMV works. Men no longer need to suffer with fecal or urinary incontinence.”

InControl Medical, LLC is responsible for developing and marketing solutions for women’s urinary incontinence including InTone® and Apex®, and has received ISO 13485 certification from the International Organization for Standardization (ISO) and the CE mark of the European Commission (EC), signifying that it meets comprehensive quality management requirements in the design and manufacture of medical devices. All products are available online athttp://www.incontrolmedical.com

Contacts

For InControl Medical

Suzy Ginsburg, 713-721-4774

suzy@gcomworks.com