Senseonics Holdings, Inc. (NYSE: SENS) rose after the company disclosed favorable outcome of the FDA Advisory Committee on the Eversense System.
The company, based in Germantown, Md., is a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes,
The FDA panel, comprised of independent medical experts, voted unanimously, that the benefits outweigh the risks, that the system is safe, and that the system is effective.
Senseonics CEO Tim Goodnow said, "We are pleased that the advisory panel believes in the benefits of the Eversense system. We are confident that the benefits of the system – longest life sensor, sustained accuracy, predictive glucose alerts, removable smart transmitter, gentle-on-skin adhesive – can be life changing for people with diabetes, and this is another step toward offering these benefits to patients in the U.S.
"We thank the panel members, the participants in today’s meeting, the clinical trial participants and the FDA, and are eager to continue the positive dialogue with FDA in pursuit of approval for Eversense."
The Eversense system is a first of its kind implantable continuous glucose monitoring system utilizing a sensor that lasts for up to 90 days. The company demonstrated safety, efficacy and a favorable risk benefit profile for Eversense through real world data from patients currently using the system in Europe and data from the U.S. PRECISE II study.
The shares moved higher 12.4 cents, or 4.1%, to $3.12 in late Monday trading.
