Business segment: Medical Device
Main benefit to customer: Prevention of female urinary incontinence and prolapse
Over 1.3 billion women suffer from urinary incontinence and/or genital prolapse worldwide (IPFD, 2007; Vos, 2012; Medtech Insight, 2014). Gynotech's non-surgical non-drug automatically size-adjustable vaginal ring pessary “GynoPess™” fully addresses urinary incontinence (i.e. involuntary escape of urine) and genital prolapse.
Silent Epidemics: Urinary Incontinence and Genital Prolapse
27.6% of all women, i.e. 1 billion women, suffer from urinary incontinence (IPFD, 2007). Genital prolapse occurs when the pelvic organs fall from their normal position into or through the vagina, causing discomfort, pain and discharge, which may also coexist with incontinence. 9.3% of all women, i.e. 316 million women, suffer from genital prolapse (Vos, 2012). Despite the high prevalence, current solutions are unhelpful Existing pessaries are the treatment of choice for many reasons, but they are rarely suitable to the sizes and the physiological activities of the woman, and therefore present a reduced efficiency.
GynoPess - The patented Technology
GynoPess™ is a revolutionary automatic electro-mechanical pessary that continuously senses the abdominal pressure that is being built in different conditions such as cough, sneeze and laugh, and instantaneously causes the expansion of the pessary diameter, so to counterbalance the changing abdominal pressure.
Initial Target Market: USA
In the USA, 19-20 million women suffer from urinary incontinence and 3.3 million women suffer from genital prolapse. The U.S. female urinary incontinence therapies market reached $1.3 billion (Medtech Insight, 2014). $19.5 billion was spent on urinary incontinence care and it accounts for 6% of nursing home admissions for elderly women, costing $3 billion (American College of Physicians, 2014).
In the USA, Gynotech will focus on selling its products through tier-1 distributors probably within a strategic partnership context.
Gynotech is seeking up to $1.5 million to (i) complete product development, (ii) perform clinical trials, (iii) obtain the necessary regulatory approvals, (iv) begin manufacturing and distribution. It is assumed that the company will need $0.5M per the first two years and then $1,000,000 for another year or two, at the end of which, it will reach a commercial phase.
Gynotech obtained both a U.S. patent and an Israeli patent on the self-adjustable vaginal ring and in 2016 applied for a new patent covering the electro-mechanical mechanism of GynoPess™.
Time-to-market is estimated to be around three years with sales ramping up from 2019, as detailed by its roadmap:
End-2017: GynoPess™ ready for clinical trials.
End-2018: Clinical trials and FDA 510K approval.
Dr. Abraham Nissenkorn CMO and Founder (M.D), Mr. Arieh Bar-Zeev, CTO electronic engineer, Dr. Meir Teichner CEO & Chairman