After close to eight years as Tandem Diabetes Care CCO, Brian Hansen notified the company of his decision to step down last August. His final day landed on Dec. 31, but he only remained retired for about a month. Senseonics CEO Tim Goodnow started by asking for 10-20 hours a week of consulting work.
However, PHC Holdings, Ascensia’s parent company, wanted somebody to build out the CGM business — a revenue-share partnership that has Ascensia exclusively commercializing Senseonics’ Eversense glucose monitors.
On Feb. 6, PHC, Ascensia and Senseonics announced the appointment of Hansen as president of CGM.
“And I was very fortunate to get this position and I now have a board seat at Senseonics and am very invested in the Senseonics side and that’s the team I know very well,” Hansen said, speaking to Drug Delivery Business News at the American Diabetes Association Scientific Sessions in Orlando, Florida. “But then I have my official position with PHC and Ascensia, so it’s really kind of a dream job. That’s why I chose to jump right back in.
“There’s a need and I think there’s an opportunity here.”
What’s in the pipeline?
Responsibilities for Hansen in his new role include the global commercialization and growth of the Eversense system.
The fully implantable CGM allows for the continuous measurement of glucose levels for up to six months — currently. With longevity, it also offers features like a removable transmitter, discreet on-body vibe alerts, accuracy and a smartphone app. In April, the company received FDA integrated CGM (iCGM) designation, allowing the long-term implantable CGM to connect with insulin pumps as part of an automated insulin delivery system. The company then submitted the 365-day sensor to the FDA for 510(k) clearance with that iCGM designation in May.
Last week, the company said the FDA review the next-generation, 365-day, once-per-week calibration Eversense implantable CGM is advancing as planned. It expects the progress to enable 510(k) clearance in the near future and a fourth-quarter 2024 launch.
Senseonics also has the Gemini and Freedom sensors under development. Gemini is a one-year sensor with battery for continuous and optional point-in-time reading. Freedom has no transmitter included in the system for direct communication between sensor and handheld device.
The draw here is that the systems are fully implantable. With these systems, users would no longer have a transmitter on the outside. Hansen said the systems would last for a year underneath the skin, powered by a “fairly small” battery, bringing a significantly higher value proposition.
“The 365-day [sensor] has a value proposition itself and we certainly expect inflection from that, but then we also look forward to the next two products that become fully implantable,” Hansen said. “We think that’s a more compelling product to all patients that are looking at CGM technology.”
Priorities right now for Senseonics and Ascensia
Despite plenty of excitement around the pipeline, the current priorities for the CGM business are clear.
“We have to sell what we have today,” Hansen explained. Regardless of what’s happening with iCGM and 365-day, we can’t look forward. We have to do with what we have in the bag and we’re growing our business nicely.
The company last week reaffirmed its expectation for $10 million in global revenue for the first half of the year, marking approximately 21% growth compared to the same period in 2023.
Senseonics said it also generated more than 200% new patient starts in the first half of this year compared to 2023 in the U.S. The company also began provider training and patient identification for its health system partnership with Mercy Health. It targets insertions in the third quarter of 2024 and acceleration in the fourth quarter.
For the full year, Senseonics expects revenue between $22 million and $24 million. It anticipates more than doubling U.S. new patient starts and an increase in the global installed base by about 50% compared to 2023.
Hansen said activity in terms of getting payers to pay for the year-long sensor upfront is “really positive” as well as he looks to simply “keep my people happy.”
In terms of the patient experience, the company is targeting a subset of CGM users that may not get the experience they want with common wearable CGMs, like the ones made by Abbott and Dexcom. Whether it’s the wear time, dealing with adhesives, or preferences over performance, the company knows there are people out there looking for a device like Eversense. Adding the value of a 365-day sensor, eliminating the hassle of two insertions per year as well as calibrations, could potentially bring more users over to Senseonics and Ascensia.
“[The other sensors] don’t work for everybody,” Hansen said. “We’re getting some of those patients, but we need to get more.”
The benefits of iCGM designation for Eversense
While the groundwork on iCGM designation was executed at Senseonics before Hansen’s arrival, he said he was impressed by the job the company did, as well as by the FDA’s “progressive” relationship with the diabetes space.
Hansen said he had three key takeaways from the iCGM designation achievement. First, he said it demonstrates that the product is above the high bar set for iCGM, first by Dexcom and later by Abbott. Second, it reduced the time needed to go through the FDA for future Eversense submissions, clearing the path for new updates and integrations. Otherwise, the device would have gone through the premarket approval cycle. Instead, the company has confidence in FDA clearance for the 365-day sensor in the fall.
Third, and finally, it allows Senseonics and Ascensia to have meaningful conversations with pump makers. It helps having Hansen, too, who was a key figure at a pump maker for years.
“We are now there and it kind of legitimizes our product,” Hansen said. “I was the guy sitting on the other side of the table for eight years saying no to [CEO] Tim [Goodnow]. I was the one saying no because the scale wasn’t there to go through that engineering project. When you have a list of priorities projects you want to do that falls below the line with many other things that we don’t have the resources to do. But now that iCGM is done, we’re starting to see some inflection and positivity and we have a pipeline that is more tangible today.”
While Hansen can’t disclose which pump companies are partaking in the conversations, they are ongoing and he is confident in the path forward for Senseonics, Ascensia and Eversense.
“I’m hopeful that we can get a couple partners moving in that direction, because people want it,” Hansen said. “We are behind the scenes working really hard to make sure we have all the things lined up to be successful.”
