FDA CLEARS NESS HANDMASTER FOR US STROKE-VICTIM MARKET.

NESS (Neuromuscular Electrical Stimulation Systems Ltd) has announced the Food and Drug Administration's (FDA) 510(k) clearance of their noninvasive, neuro-prosthetic device, the Handmaster.

This medical device helps activate the impaired or paralyzed hand of a person who has suffered a stroke.

NESS (http://www.nessltd.com) Handmaster represents a significant and long-awaited technological advance, bringing new hope for a more independent lifestyle to over 1 million disabled stroke survivors in the U.S. alone. Inside the Handmaster is NESS' patented, integrated surface electrode design. Low-level electronic pulses stimulate the neuromuscular system and activate the muscles of the hand and forearm to restore natural flowing patterns of movement to the hand.

"As a result of many years of research and development, we have been successful in developing the technology to restore to persons who have suffered a debilitating stroke the functional use of their plegic or paralyzed hand. I am thrilled each time I see one of our Handmaster users overcome their disabilities and achieve more and more in life," stated Roger Nathan Ph.D, NESS vice president of research and development and board member of the International Society of Functional Electrical Stimulation Systems (ISFES).

The Handmaster is designed for simple home usage. An intensive study was conducted at the University of Maryland-Baltimore to document, statistically and clinically, the functional benefits to individuals that have residual paralysis of the hand following stroke. "The Handmaster showed impressive results with our study group. Within three weeks, all were able to grasp, hold and release objects while using the device and perform tasks they were previously unable to do," stated Dr. Gad Alon, Principle Investigator, University of Maryland School of Medicine. Among activities regained included: The ability to pour and drink from a glass, food preparation, and the return to pleasurable hobbies like gardening and woodworking. NESS has engaged the consulting services of The Lewin Group, a unit of Quintiles Transnational Corp., to facilitate Medicare reimbursement procedures.

"The Handmaster is presently marketed in Israel and Holland. We expect to have the product available in the US by the second quarter of 2002. In addition to obtaining clearance for the Handmaster for the stroke population, we are also studying the return of hand function in the traumatic brain injury group to go along with this clearance and a previous one in the spinal cord injured population," added Shmulik Shany, NESS CEO.

NESS maintains international headquarters in Ra'anana, Israel, just north of Tel Aviv. Founded in 1991, NESS is a company devoted to creating new and innovative medical devices.

For more information, call 908/638-5347. TI CONCEPTUS GETS CANADIAN APPROVAL TO MARKET ESSURE >TX Conceptus, Inc. (Nasdaq:CPTS), San Carlos, Calif., developer of the non-incisional permanent birth control procedure Essure(TM), has received clearance from Health Canada to market Essure in Canada.

The company estimates that there are approximately 122,000 surgical tubal ligation procedures performed in Canada each year.

Conceptus has also submitted its first Pre-Market Approval (PMA) module to the U.S. Food and Drug Administration (FDA).

"We are very pleased to have received Canadian approval almost a full year ahead of our expected timeline," stated Cindy Domecus, senior vice president of Clinical Research & Regulatory Affairs for Conceptus. "Our original timeline included the assumption that Health Canada and the U.S. FDA would require the same amount of clinical data. However, based on the strength of our clinical data to date, we were confident in pursuing Canadian marketing approval sooner than we had expected."

Steven Bacich, Conceptus' chief executive officer, added, "On behalf of everyone on the Conceptus team, I'd like to congratulate Cindy and her staff on this significant accomplishment. Our sales plans call for partnering out Essure in Canada and as a result of this speedy approval, we have stepped up discussions with potential marketing partners. In preparation for the U.S. market, we continue to make progress on our domestic regulatory pathway. Our first PMA module has been submitted to the FDA with a goal of completing our PMA submission by the end of the second quarter of 2002."

Permanent Birth Control

Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive and costly. About 93% of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring between four to five hours of hospital recovery time and an average of three to ten days before returning to regular activities. An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to spend about two to three hours of her day for an Essure procedure, and to have a rapid return to regular activities. Reliance on Essure does not involve taking drugs or hormones, which can interfere with the body's natural menstruation cycle.

About Conceptus

Conceptus, Inc. is developing Essure, an investigational medical device and procedure in the U.S., which is designed to provide a non-incisional alternative to tubal ligation, the leading form of contraception worldwide. Data from the United Nations show that worldwide, 33% of reproductive couples using contraception rely on surgical tubal ligation. Additionally, a survey performed by the United States Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of contraception in the United States, and that 35% of women age 35-44 have had a surgical tubal sterilization. An estimated 700,000 surgical tubal ligations are performed each year in the United States.

The Essure procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access.

For more information, visit http://www.conceptus.com or call 650/802-7240.