As anticipated, FDA has approved the next generation Eversense 180-day continuous glucose monitoring (CGM) system from Senseonics. This approval is one of many big milestone activities expected in the diabetes management space in 2022.

Germantown, MD-based Senseonics said the Eversense E3, which includes sacrificial boronic acid (SBA) technology to extend longevity of the sensor to six months, is expected to be available to U.S. patients through Ascensia Diabetes Care, its commercial partner, beginning in the second quarter of 2022.

“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” said Satish Garg, MD, a professor of medicine and director of the adult diabetes program at the Barbara Davis Center of the University of Colorado. Garg is also the principal investigator of the PROMISE Study1, which formed the basis for the FDA approval. “The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last six months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”

In addition to offering patients a longer lasting CGM sensor, the Eversense E3 CGM system includes a removable smart transmitter, held in place with a mild silicone-based adhesive, providing discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.

“Further extending the duration of the longest lasting CGM system to six months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” said Tim Goodnow, PhD, president and CEO of Senseonics. “The review was delayed by one year due to COVID-19 priorities and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to U.S. patients beginning in the second quarter. We look forward to initiating Eversense E3 sales and believe that, with Ascensia’s newly dedicated CGM commercial organization, the launch of the new six-month product will establish the foundation for growth in our installed base later in 2022 and beyond.”

Patients who are interested in getting started on Eversense today can sign up at www.eversensediabetes.com/get-started-today, and will be among the first to know when Eversense E3 is commercially available. Physicians, nurse practitioners, and physician assistants interested in offering the Eversense CGM System for their patients can sign up at https://www.ascensiadiabetes.com/eversense/become-a-provider/register/.

Along with announcing FDA approval, Senseonics said it now expects full year 2022 global net revenue to be in the range of $14 million to $18 million, which is quite a bit lower than the $30.7 million that most analysts were forecasting.

"This range is also significantly lower than the previous 2022 financial projections presented in September 2020 ($30 million to $40 million), understandable in light of the lengthy wait for FDA approval," Marie Thibault, a medtech analyst at BTIG said in a report Friday. "What surprised us is the lack of meaningful net revenue growth in 2022, from $13.5 million in 2021 to $16 million at the midpoint of this new range."

Thibault explained that this is the result of an anticipated revenue decline in the first quarter as Senseonics works through remaining inventory and the required transition for payer contracts to start covering E3 with its longer wear time.

"We do expect patients and prescribers to demonstrate reinvigorated interest in the Eversense E3 platform, but that patient assistance programs and discounts will continue to be required through much of this year as that payer transition takes place, leading to the disappointing net revenue outlook that disguises this enthusiasm," she said.

A flurry of diabetes management activity

There hasn't been a year quite like this one in terms of how much activity there has already been in the diabetes management space, and how much more activity is expected before the year is over.

Earlier this year Insulet won FDA clearance for its Omnipod 5 automated insulin delivery system for people ages six and up with type 1 diabetes. Omnipod 5 is the first tubeless automated insulin delivery system that integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin and help protect against highs and lows. It's also expected to be integrated with Abbott's FreeStyle Libre, and the Dexcom G7 CGM, which is also expected to win FDA clearance this year.

“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, president and CEO of Insulet. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”

The Omnipod 5 System consists of the tubeless pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription.

Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.

“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” said Kevin Sayer, Chairman, president and CEO of Dexcom. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”

Medtronic's MiniMed 780G insulin pump, combined with its Guardian 4 CGM sensor, are also under FDA review, although the timing of a decision on that one is less clear. The company received an FDA warning letter in December that was related to its earlier recall of the MiniMed 600 series insulin pump.