As implantable CGM company Senseonics continues to wait for clearance from the FDA, the company isn't sitting on its hands. On a Q2 earnings call, CEO Tim Goodnow reported that the company continues to expand its operations in Europe, is close to a CE Mark for a longer-lasting second generation device, and is partnering with Roche and Type Zero on an artificial pancreas study with an eye on commercialization.
As for FDA clearance, which would finally bring Senseonics' Eversense offering to the United States, Goodnow is now expecting the FDA to convene a special panel, like it did for Dexcom's nonadjunctive dosing claim.
"It is our belief that the agency will convene an advisory panel to explore the community’s feedback on the safety elements of an implantable sensor, as well as the training programs designed to introduce endocrinology, diet, and pathology professionals to the in-office procedures of sensor placement and removal," Goodnow said. "This process will allow the interested medical community to comment on an implantable product. We are confident that the strong patient data demonstrated in our US pivotal trial, our European pivotal trial, and our robust post-market surveillance program -- currently underway in Europe -- will support and confirm the efficacy and safety of the Eversense system. We continue to anticipate the advisory panel will likely be held in the late fall and that our final approval will closely follow this conclusion."
A little over a year out from Senseonic's European launch, the company is now live in seven countries, adding Belgium and Austria this quarter. European sales have also brought in $814,000 in revenue this quarter, up from just $19,000 this time last year. The company is forecasting $6 to $7 million in revenue for full year 2017.
Senseonics is also close to securing a CE Mark for Eversense XL, a new version of the sensor that can be implanted for 180 days, twice the length of the current model.
"With Eversense XL, for the first time patients can extend a single sensor wear across three seasons," Goodnow said. "They can insert in the late summer, wear through the fall, and finally remove it in the winter. This is truly remarkable for our industry and a long ways from when we rejoiced when sensors last three days a decade ago."
As for the company's previously announced R&D partnership with Roche and Type Zero, Goodnow affirmed during the Q&A that the research partnership does have designs on creating a commercial product eventually.
"The key focus for us and requirement in the participation is that it’d be more than a research project," he said. "So we are actively working with both of those partners such that we do, as we call it, a pivotal trial, to certainly support at the very least the CE Mark for the product, and to fully enable and educate us for the conversations with the FDA in regards to what their requirements will be. ... The work is intended to commercialize a product out of the clinical program."
In addition, Senseonics is also working with Roche as a distribution partner in Europe, and, Goodnow announced on the call, Eversense is the first CGM to be incorporated into Rocher's Accu-Chek Smart Pix data management system for use by cliniciansNike Magista Obra