SOURCE: Renew Medical

Renew Medical

May 18, 2016 09:00 ET

Renew Medical Launches New Solution to Help Prevent Accidental Bowel Leakage

The Renew Insert Gives Patients the Confidence to Live an Active Life Without Worrying About Embarrassing Moments

FOSTER CITY, CA--(Marketwired - May 18, 2016) - Renew Medical Inc. (Renew) announced today the U.S. launch of the Renew Insert, an innovative silicone rectal insert device now available by prescription for patients with Accidental Bowel Leakage (ABL) in the United States. The Center for Disease Control estimates that ABL or fecal or bowel incontinence affects 17% of people 65 years of age or older.1 A majority of ABL sufferers report a significant quality of life disruption, yet only a small number of those affected (approximately one in 10) have been clinically diagnosed.2

The Renew Insert is a discreet, easy-to-use device that is designed for self-insertion to comfortably seal the rectum from the inside to help prevent ABL. Renew Inserts are delivered directly to the patient's home.

Dr. Emily S. Lukacz, Division Director, Female Pelvic Medicine and Reconstructive Surgery UC San Diego Health System said, "Renew Inserts are a new way to manage ABL. They are very soft, comfortable, convenient, safe, and easy to use. Most of my patients have been thrilled with the results."

A published U.S. clinical study demonstrated that the Renew Insert is safe to use and that the device reduces ABL by 82%.3 Users of Renew Insert rated overall satisfaction at 4.8 out of 5 after nearly three years of continuous use.4

Renew Inserts have FDA clearance and CE Mark approval. For more information about Renew Inserts, please visit www.renew-medical.com.

1 CDC/DHHS Publication No. 2014-1420, Prevalence of Incontinence Among Older Americans, June 2014
2 Nielsen Mature Women's Health Survey commissioned by Renew
3 Dis Colon Rectum 2015; 58: 892-898
4 35 month UK Consumer Panel - MKT-008 Study

About Renew Inserts
The Renew Insert is a new product developed to allow people suffering from Accidental Bowel Leakage (ABL) to live a normal and active life. It is made of soft and flexible silicone and is suitable for use for women and men. The Renew Insert provides protection from solid and liquid stool leakage and is indicated for continuous use. Renew Inserts are designed for single-use and are naturally expelled with a bowel movement.

About the Renew Pivotal Clinical Study
Renew Medical conducted a multicenter, prospective, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in patients with moderate-to severe accidental bowel leakage. The results, which were published in Dis Colon Rectum 2015; 58: 892-898, included:

  • Reduction in the frequency of ABL episodes was measured by comparing pre-and post-treatment results on 85 patients who used the Renew Insert for at least one week or more during the 12-week treatment period.
  • The study showed a median reduction of 81.8% in the frequency of ABL episodes when the Renew Insert was used.
  • There were no reported severe, serious or unanticipated adverse events. Nearly all (98.7%) of the adverse effects possibly related to the Renew Insert were rated as mild and included the sensation of urge, irritation or soreness around the anal area.
  • The reported overall satisfaction among the majority of Insert users was high, with 91.4% rating overall experience and ease of use rated as a 9.5 (median) on a 10 point scale.

About Renew Medical Renew Medical is a privately-held continence-care company that is passionate about improving the lives of people suffering from Accidental Bowel Leakage. We have researched, developed and clinically tested the Renew Insert for over seven years in the U.S. and Europe. To learn more about Renew Medical, Inc, please visit: www.renew-medical.com

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