DexCom Says FDA Advisory Committee Votes For Its Non-Adjunctive Label for G5 Mobile CGM System

DexCom, Inc.

disclosed Friday that the FDA's panel of the Clinical Chemistry and Clinical Toxicology Devices voted in favor of its planned non-adjunctive indication for its G5 Mobile CGM system. According to the company, the indication would select the G5 Mobile CGM system as an alternative to fingerstick glucose testing for diabetes treatment decisions. DexCom President and CEO, Kevin Sayer, commented, "This recommendation is a big milestone for people with diabetes. The diabetes community turned out in force to support this decision. We commend the FDA for bringing this important subject into a public forum, and thank the panel members, as well as the public speakers for their willingness to participate. We look forward to continued positive discussions with the FDA as we seek the agency's approval of our application." The company indicated that the FDA panel voted 8 – 2 supporting that there was enough assurance that the system was safe for the planned indications for use. Similarly, 9 – 1 was the voting recorded for supporting that there was enough assurance that the system was effective for the planned indications for use. In the same way, 8-2 members felt that the system outweighed the risks for the planned indications for use. On Friday, the stock traded 4.67 percent higher.