HydroCision Receives FDA 510(k) Clearance for SpineJet Curette™ Family Handpiece for the SpineJet Hydrosurgery System

ANDOVER, Mass., September 22, 2003 – HydroCision, Inc. (www.hydrocision.com) announced today that the United States Food and Drug Administration has granted 510(k) clearance to market its SpineJet Curette™ device for open and minimally invasive spine surgery. The SpineJet Curette will be the latest addition to the SpineJet Hydrosurgery System family of products. It is the first surgical instrument to combine the tissue removal properties of a curette with the tissue consuming and evacuation power of HydroCision’s patented Hydrodrive™ fluidjet-based technology. The SpineJet Curette will provide spine surgeons with a powered device that will allow them to more quickly and effectively prepare the disc space for implantation of a fusion graft (cages, allografts, osteobiologics) or an artificial disc or nucleus. The powered device will greatly reduce the number of instrument exchanges in the interbody space thereby reducing potential patient complications.

“The SpineJet Curette represents a very important addition to the SpineJet family of products,” commented Doug Daniels, President and CEO of HydroCision, Inc. “It will provide spine surgeons with a powered version of the curette tools that they have traditionally used and allow them to remove tissue faster and more efficiently. We believe that the SpineJet Curette will be the complete solution for the spine surgeon to effectively prepare the disc space for spinal fusion or implantation of artificial discs."

The SpineJet Curette will enable surgeons to simultaneously collect and remove soft and hard tissue precisely with a single powered instrument while preserving the surrounding tissue. The device will quickly, safely, and effectively remove soft tissue, such as disc nucleus, and harder cartilaginous tissue from the vertebral endplates in preparation for interbody fusions or implantation of an artificial disc or nucleus. HydroCision plans to launch several versions of the SpineJet Curette device in the first half of 2004.

About HydroCision

HydroCision is the leading developer, manufacturer and marketer of fluidjet-based surgical tools that are the foundation of a new surgical modality – ‘hydrosurgery’. Hydrosurgery improves patient care by selectively removing tissue, minimizing collateral damage and bleeding, and promoting the healing process. HydroCision believes its proprietary fluidjet technology is the basis of a new surgical modality because of its compelling features and versatility. Incorporated in 1996, the company continues to develop a broad range of fluidjet-based devices to meet the needs of multiple specialties. Current investors include Zero-Stage Capital, Newbury Ventures, and Oxford Bioscience Partners.

HydroCision is a registered trademark of HydroCision, Inc. VersaJet, SpineJet and The Leader in Hydrosurgery are trademarks of HydroCision, Inc.