Senseonics (SENS) Stock Heads Up On FDA Approval

Senseonics SENS Stock News

Senseonics Holdings Inc (NYSEAMERICAN: SENS) is up more than 13% in the premarket hours after announcing an FDA approval. According to a press release, the FDA has approved the company’s request for a label change to include another indication for its flagship product.

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SESN Stock Gains On FDA Approval

In the release, Senseonics said that the FDA has approved the non-adjunctive indication for the Eversense Continuous Glucose Monitoring System. As a result of the approval, diabetic patients will be able to use the product as a replacement for fingersticks to make diabetes treatment decisions throughout the day.

In a statement, Tim Goodnow, President and CEO at SENS, had the following to offer:

Receiving the non-adjunctive indication from the FDA marks a major milestone for Senseonics. The Eversense CGM will soon be used as a replacement to fingersticks to make treatment decisions.

We expect this will allow our users to more conveniently and confidently live their lives with fewer interruptions. This approval is also another step toward providing access to Eversense CGM for people 65 and older, as non-adjunctive labeling is the first requirement for Medicare coverage. We look forward to working with the Centers for Medicare & Medicaid Services leadership team to explore opportunities for Senseonics to provide Eversense and its benefits to the Medicare population.

This News Could Quickly Become A Game Changer

Ultimately, SENS worked to create a diabetes monitoring product that improved the patients ability to undergo treatment throughout the day, and they have done so successfully.

The Eversense CGM System is the first long-term implantable CGM sensor. It is also the first to feature a smart transmitter that alerts the patient discreetly when blood sugar is too high or too low. This alert comes through on-body vibrations.

The system ultimately alleviates the majority of the need for fingersticks. While the system does require two fingersticks per day, many diabetes patients must check their blood sugar seven or more times per day. So, the reduction in annoying fingersticks could lead to a fast paced uptake of the Eversense product.

It’s also worth mentioning that current estimates put the diabetes devices market at a value of $35.5 billion by the year 2024. While it would be unreasonable to expect that the company will take the entire market share, even a small percentage of this large market would be a significant increase in value for SENS as the stock currently trades with a market cap of around $320 million.

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The Launch Is Going To Happen Quickly

In the press release, Senseonics said that it plans to launch its non-adjunctive product early within the fourth quarter. That’s just a few months away. Moreover, the company has already set up a web page for patients that can be visited here and a hotline for physicians, nurse practitioners and physicians assistance at (844) SENSE4U (844-736-7348). With a fast paced launch ahead of us, investors have plenty to be excited about.

What Do You Think?

Where do you think SENS is headed moving forward? Join the discussion in the comments below!

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