Dexcom Patients Will Have Longer Wait for G7 as COVID-19 Disrupts Pivotal Trial

COVID-19 is creating much uncertainty across the medical device industry, both in terms of revenue guidance and in terms of clinical trial timing. For Dexcom, that uncertainty will directly impact the timing of the company's latest continuous glucose monitoring (CGM) sensor, the G7. "We remain confident in our ability to deliver G7, but acknowledge that the timing of the pivotal trial will be delayed due to the pausing of new trials at most clinical sites," Dexcom CEO Kevin Sayer said during the company's first-quarter earnings call, according to SeekingAlpha transcripts. Sayer said the company currently expects COVID-19 to delay the G7 trial by at least six months. The new model was previously on track for a 2021 market launch with a limited launch possible by the end of this year, pending FDA approval. Matthew O'Brien, an analyst at Piper Jaffray, said most people had expected to see a bit of a delay with the G7 trial, but six months was longer than he had expected. O'Brien had been under the impression that it was a 14-day trial, but Sayer explained that the pivotal trial is not, in fact, just a 14-day study. "If we could run a 14-day study and put several hundred people on it for 14 days that would be relatively simple," Sayer said. "These trials are not that simplistic. There's going to be at least four in-clinic days where blood is drawn for 12 hours and we can only handle two to three patients at a time, at a clinic per day. So, these trials are very well orchestrated ...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 Business Source Type: news