Radionics Announces Two FDA Clearances - One for its XPlan System to Assist in Treatment of Brain Tumors, and Clearance of the Cosman Coagulator.

BURLINGTON, Mass.--(BW HealthWire)--Nov. 11, 1997--Radionics Inc. announced today that its software division has received FDA 510(k) clearance for the XPlan(r) Radiation Treatment Planning System, a high precision graphics software package which gives clinicians a three-dimensional view of brain tumors to enable them to pinpoint treatment of the tumors.

The XPlan System includes software which allows physicians to clearly identify the site of brain tumors and create a complex treatment plan that is more accurate than standard radiation treatment, resulting in less damage to healthy tissue. In addition to the software program, the FDA has also given clearance for the use of stereotactic hardware, which uses a head frame to keep patients still and position the head in relation to the radiation beam used in non-invasive treatment. Radionics is currently working to extend this technology to other parts of the body. The XPlan System was given 510(k) clearance on October 28, 1997.

In a related matter, the FDA also gave 510(k) clearance to a second Radionics product on October 27. The FDA gave clearance to the Cosman Coagulator, a microprocessor-based electrosurgical device for use in general surgery. The Cosman Coagulator was designed to produce local tissue heating at the tip of an electrode. Special electrode design and techniques allow clinicians to ablate tumors in a minimally invasive way.

"We are delighted with these clearances," said Eric Cosman, Chief Executive Officer of Radionics. "This brings the number of FDA clearances received this year to six. We are continually expanding our efforts to deliver advanced medical instruments in the fields of neurosurgery, pain relief, radiation therapy and cardiology, while keeping ease-of-use and patient safety as our primary objectives."

Earlier this year, the FDA issued clearance for the following Radionics products:

The Optical Tracking System (OTS)(TM) is a comprehensive image-guided surgery system that allows the surgeon to use a patient s CT or MR scans interactively during surgery. This enables the surgeon to identify critical anatomy, locate and target lesions, plan the procedure prior to the incision and navigate confidently and accurately to the target area. Unique features give the surgeon full control of the system by enabling access to software features right from the surgical field during surgery. FDA 510(k) clearance was received for cranial image-guided procedures, which include craniotomies, tumor localization and resection, catheter placement and ENT procedures. FDA 510(k) clearance was received June 7, 1997.

The RF Lesion Generator (RFG-3CF)(TM) is microprocessor controlled minimally invasive lesioning device. It is used for neurosurgical lesioning procedures, examples of which include lesioning of nerve fibers for treatment of pain and lesioning of the brain for treatment of movement disorders such as Parkinson s disease. FDA 510(k) clearance was received March 12, 1997.

The Equi-Flow(TM) Valve and the Burr Hole Valve are used for the treatment of hydrocephalus, a condition of excess fluid on the brain. The valves are designed to control this fluid flow. FDA 510(k) clearance for the Equi-Flow Valve was received on January 31, 1997; clearance for the Burr Hole Valve was received on June 4, 1997.

Radionics is a nearly 60-year old, Massachusetts-based company which specializes in the design and manufacture of medical products; there is particular emphasis on minimally invasive techniques for the treatment of cancerous tumors, pain, and certain intractable cardiac conditions. Among its many products are the XKnife(r) Radiosurgery System, the Optical Tracking System (OTS)(TM), the CRW(r) Stereotactic System, lesion generators and disposable shunts and electrodes.

Radionics is located at 22 Terry Avenue, Burlington, MA 01803 (www.radionics.com) 781-272-1233. For further information, contact Allison Jones Hallacy at extension 307.

CONTACT: Radionics Inc.

Allison Jones Hallacy, 781/272-1233

or

Hawthorne Associates

Christine Sullivan, 617/489-4084