Incontinence Control

Objective: Develop a reliable, small device to restore bladder control and quality of life for moderate to severely incontinent patients.
Market: There are 12 million patients in the U.S. alone suffering some degree of incontinence. Ninety percent are women and 2 million are classified as severely incontinent (complete lack of bladder control). The primary method of treatment is the use of adult diapers (Depends). Various attempts have been made at providing insertable technology, all of which have failed due to lack of performance, encrustation, infection, and quality of life issues. The primary surgical procedure is a bladderneck suspension for moderate incontinence, estimated at 200,000 procedures per year. Other treatments include bulking agents, such as collagen, which has had moderate success ($40 million annual sales). Incontinence is one of the leading causes for admissions to nursing homes and is estimated to cost billions in medical care. A solution to severe incontinence has not yet been developed. The market opportunity for an effective surgically implanted incontinence device is several hundred million dollars.
Technology: Beta is developing a surgically implantable device that will be reliable, small, and installed through a minimally invasive outpatient surgical procedure. This surgically implanted device would restore quality of life and full continence and act as an artificial sphincter. The device is based on the shape memory alloy cardiovascular stent technology we developed with Nitinol Devices & Components. It can be manually or electrically actuated and provides failsafe and adjustable features.
Commercialization: We are currently in a funding process to develop initial prototypes and clinical trials for the ICD device. Initial marketing is planned for introduction in Europe while the FDA process is pending in the U.S. Beta is seeking a corporate partner or investor group that funds development stage medical devices to purchase this opportunity.
Patents: Patent Numbers 4,556,050 and 5,409,460. Patents are currently pending for the manually activated device using the stent-based technology.
Contact: John Krumme