Influence announces Investigational Device Exemption - IDE - and grant of expedited review for the In-Flow incontinence product by FDA

Business Wire, May 21, 1997

SAN FRANCISCO--(BW HealthWire)--May 21, 1997--Influence Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) for the company's In-Flow(TM) remote-controlled intraurethral valve-pump catheter.

The IDE, part of the PMA application process, allows Influence to begin a human clinical trial for the In-Flow(TM) product in the U.S. The clinical trial is intended to be conducted at 10 clinical sites and will monitor the safety and efficacy of the In-Flow(TM) in approximately 150 patients.

Influence also announced that the FDA has agreed to provide an expedited review of the PMA when submitted.

Influence's In-Flow(TM) catheter is designed for women with overflow incontinence caused by atonic bladder (a condition where the bladder lacks the normal muscle tone, resulting in the inability to urinate normally; it can be the result of spinal cord injury, nervous system disorders caused by Multiple Sclerosis or Diabetes and medication).

The In-Flow(TM) is a temporary, 29-day catheter containing a valve-pump assembly, designed to provide continence and controllable urine flow. To urinate, the patient uses a remote-control device to activate a miniature pump, which draws urine from the bladder. The In-Flow(TM) has received CE mark approval in Europe, and the company is marketing the catheter through a direct sales force in Germany and England and using distributors in other European countries and Asia.

Peter Bick M.D., president and chief executive officer of Influence commented: "We are very excited to have received a commitment from the FDA for expedited review. We believe that the In-Flow(TM) is an important technological breakthrough for patients who otherwise have no option but to catheterize themselves 5-6 times a day, or live with an indwelling catheter. The quality of life implications of this product are significant."

Influence was founded in 1994 as a technology company dedicated to providing innovative solutions for incontinence management to the estimated 50 million persons worldwide afflicted with the disorder. With offices in the U.S., Israel, Germany and the U.K., the company intends to develop and market a complete disease management system of products for the diagnosis and treatment of urinary incontinence in both women and men. Influence recently received 510(k) clearance for its In-Tac(TM) and In-Fast(TM) devices that are used for bladder neck fixation and sling procedures for stress urinary incontinence. -0-

This news release contains certain forward looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those in such forward looking statements. Potential risks and uncertainties include, without limitation, the unpredictability of market acceptance, likelihood of additional FDA requirements, safety, practicality and efficacy of the products mentioned in this release.

CONTACT: Influence Inc.

John Harland, 415/421-5600