Shares of Senseonics (NYSE:SENS) vaulted early Wednesday after the biotech company announced that it expects a review of its glucose monitoring system to be completed by the U.S. Food and Drug Administration (FDA) within the next few weeks.
Germantown, Maryland-based Senseonics is developing an implantable continuous glucose monitoring system for people with diabetes. The company says that it expects the FDA to issue a decision on whether to approve its glucose monitoring system in coming weeks, noting that it has answered all the questions raised by regulators.
Senseonics is focused exclusively on the development and manufacturing of glucose monitoring products for people with diabetes. Its implantable glucose monitoring system includes a small sensor inserted under the skin that communicates with a smart transmitter worn over the sensor.
Information about a person’s glucose is sent every five minutes to a mobile app on the user’s smartphone.
Senseonics says that its system works for three months at a time, distinguishing it from other similar systems.
Investors appear to be betting that the company’s implantable glucose monitoring system will be cleared by the FDA and become commercially available. However, while a decision is pending, Senseonics’ diabetes treatment has not yet won approval.
Should the FDA reject or delay approval, the company’s share price will likely fall sharply.
Today’s move higher represents a recovery for SENS stock, which has slumped 20% over the past six months. However, Senseonics stock is up 182% over the last year.
SENS bounced 27 cents, or 10.1%, to $2.95 soon after Wednesday’s opening bell.
