Bard Receives FDA Clearance to Market Novel New Device to Treat Chronic, Severe Heartburn.

Business Editors & Health/Medical Writers

MURRAY HILL, N.J.--(BW HealthWire)--April 5, 2000

C. R. Bard, Inc. (NYSE:BCR) today announced it has received clearance from the Food and Drug Administration to market the Bard(R) Endoscopic Suturing System to treat GERD, gastroesophageal reflux disease. Bard's Interventional Products division, located in Billerica, MA, will market the new device.

GERD is a chronic digestive condition in which stomach acid backs up into the esophagus, causing severe heartburn. Prolonged exposure to reflux can lead to ulceration, asthma, strictures, and may promote the development of esophageal cancer. Studies suggest that 60 million people have monthly heartburn and approximately 15 million experience daily heartburn, with one's chances of developing the condition increasing with age.

During the Bard Endoscopic Suturing procedure, a thin, flexible endoscopic tube is inserted down the patient's throat - a method that requires no incisions and usually, no general anesthesia. At the end of the endoscope, a tiny device, much like a miniature sewing machine, is used to place stitches in two different locations near a valve (lower esophageal sphincter) located near the gastroesophageal junction. The suturing material is then tied together to "tighten" the valve, thus preventing stomach contents from flowing back up into the esophagus. The procedure is performed on an outpatient basis, and patients can typically return to normal activities the next day.

To bring this new product and procedure to market, Bard will partner with selected gastrointestinal medical centers and other respected thought leaders throughout the United States. A significant component of this partnering will be an extensive training and clinical support program implemented by Bard Interventional Products.

"The Bard Endoscopic Suturing System gives gastroenterologists a cost-effective, simple, treatment option that eliminates the discomfort and burning experienced by their patients, reduces or eliminates their medications, and can help eliminate the need for invasive surgical procedures," said Bard Chairman and Chief Executive Officer, William H. Longfield. "This product will provide a breakthrough therapy and complement Bard's complete line of minimally invasive diagnostic and therapeutic products used with flexible endoscopy in gastroenterology," he explained. The estimated cost per procedure using the Bard Endoscopic Suturing System is under $3,000.

In the past, the use of acid controlling medications was the only non-invasive treatment option for GERD sufferers. In 1998, more than 81 million prescriptions were written for anti-ulcerant medications - at a cost of $6.2 billion healthcare dollars. Medications, however, do not cure this condition; they only reduce the amount of acid the stomach produces, and often, a lifetime's use of medication is required.

For patients who don't respond to medications, or elect not to take daily medications, surgery has been the only other available option - an invasive, inpatient procedure requiring a recovery period of 7-13 days. It is estimated that over 70,000 anti-reflux surgeries were performed in 1999; two studies done in 1995 estimate the cost of this surgery to be $15,000 per procedure.

C. R. Bard, Inc. (www.crbard.com) is headquartered in Murray Hill, New Jersey, and is a leading multinational developer, manufacturer, and marketer of health care products in the fields of urology, oncology, and vascular, and in surgical specialty products.