COMPANY HISTORY

• In the year 2000, the founders of BÂRRX Medical, Inc. developed an endoscopic device called the HALO³⁶⁰ System for treating Barrett's esophagus that addresses the limitations of existing technologies
• In 2001, the U.S. Food and Drug Administration cleared the HALO³⁶⁰ System for use in the ablation of bleeding and non bleeding sites in the gastrointestinal tract including Barrett's esophagus
• Before and after the commercial launch of the first generation of the HALO³⁶⁰ System in January 2005, the BÂRRX Medical team has conducted multi-center clinical trials to demonstrate the safety and efficacy of the system⁹
• Trials have been completed for all types of Barrett's tissue: intestinal metaplasia, low-grade dysplasia, and high-grade dysplasia
• March 20, 2006 marked the start of a new landmark human study comparing the effectiveness of the HALO Technology against a current standard of care for Barrett's esophagus, which includes regular endoscopic biopsy surveillance and appropriate medical management of associated acid reflux disease (also called GERD)
• On April 21, 2006, the HALO⁹⁰ System (focal ablation device), was cleared by the U.S. Food and Drug Administration for use in the ablation of bleeding and non bleeding sites in the gastrointestinal tract, including Barrett's esophagus
• The HALO⁹⁰ System compliments the existing HALO³⁶⁰ System and uses similar technology
• The system is available world-wide
• At the 2007 Digestive Disease Week conference, the current clinical data was presented demonstrating that 98.4% of participants were Barrett's-free after one to two treatment sessions using the HALO⁹⁰ and HALO³⁶⁰ Systems (at 30 month follow up)
• BÂRRX Medical’s continued commitment to product improvement and innovation is illustrated by the FDA clearance of the HALO³⁶⁰⁺ Ablation Catheter on July 2007
• The HALO³⁶⁰⁺ catheter is an addition to the HALO³⁶⁰ System and incorporates the same technology as the standard HALO³⁶⁰ catheter
• The catheter is available world-wide