Two weeks after gaining European CE mark for the world’s first implantable glucose monitor, Senseonics has signed up a distribution partner with impressive reach: Roche. The largest player in diabetes devices will sell the Eversense monitor in Germany, Italy and the Netherlands, and Senseonics claims that the device is life-changing.
“You don’t have to deal with long-term consequences including complications leading to death if you aggressively manage your blood glucose levels,” Tim Goodnow, Senseonics’ chief executive, tells EP Vantage. “We hope to take that burden away. A sensor with a very long life, up to six months, reduces the headache of daily management.”
Eversense is approved in Europe for three months’ use, though Mr Goodnow says in the next few months the company will seek to expand its indication to 180 days. The sensor, implanted in a patient’s upper arm in a five-minute doctor’s office procedure, communicates wirelessly with a transmitter worn in an armband or stuck to the skin with adhesive.
The Eversense sensor implant
The transmitter sends alerts to a mobile app when the patient’s sugar levels hit preset lows or highs. The transmitter itself can also vibrate to alert the patient.
The system has already hit the market in Sweden via a Scandinavian distribution partner, Rubin Medical, but the new deal combines a major name in diabetes with a push into two of Europe’s big five markets. The company expects high demand if reimbursement can be achieved – surely something Roche will help with.
An implantable sensor may sound invasive but current options for a patient trying to keep track of blood sugar levels are far from satisfactory.
“Their alternatives are to stick their finger and get a small drop of blood four, six, 10 times a day or go on a continuous monitor,” Mr Goodnow says.
Two companies, Medtronic and Dexcom, sell continuous glucose monitors (CGMs), and the devices are similar, consisting of a sensor inserted under the skin of the abdomen to measure glucose levels in tissue fluid. Unlike Senseonic’s product, they are connected to its transmitter physically, necessitating an open port through the skin.
“It’s very difficult to shower with [a CGM] because you have an open wound you have to always protect,” Mr Goodnow says. Moreover, these sensors last six or seven days before they have to be replaced. Patients might find that the four-times-a-year replacement procedure for Senseonic’s device is not so onerous.
CGMs are themselves a fairly new technology – only around 5% of diabetics in Europe use the devices, and around 10% in the US. Senseonics believes that it will be able to lure some of these patients away from their CGMs, while also appealing to those who use the older blood glucose-testing strips.
It should also be noted that neither CGMs nor Eversense do away with finger stick blood testing entirely; patients must use this technique twice a day to keep continuous sensors calibrated. Senseonics hopes to prove sufficient accuracy to do away with this requirement.
Eversense will be priced “competitively” with CGMs, the company says. CGMs vary in price from region to region depending on the healthcare system and reimbursement rules, but $5,000 per year including disposables and hardware is a reasonable ballpark figure.
Abbott has an external system that is not a CGM but competes in the same space. The FreeStyle Libre is a sensor that is worn on the arm constantly for two weeks and uses a filament to measure glucose in interstitial fluid. This does not require calibration via finger puncture.
The Eversense transmitter and app
Though Senseonics is in the lead for implantable devices, there at least one other company pursuing an implantable monitor. San Diego-based GlySens is trialling an implanted sensor that it says could run for up to 18 months. At the beginning of the year GlySens closed a $20m series D round to pay for clinical trials in Europe and the US.
So Senseonics is probably at least a year ahead of the competition in Europe, and is looking towards the US. A 90-patient trial, Precise II, is due to conclude next month, and the company says it will file a PMA application by the end of the year. Approval could come next year or in the first half of 2018.
Precise II is broadly similar to the 81-patient Precise trial that enabled European approval, and focuses on proving that the sensor is accurate throughout the 90-day period.
Specifically, the primary endpoint is mean absolute relative difference for paired sensor and reference measurements through 90 days post-insertion for reference glucose values of 40-400mg/dl. Generally, glucose levels of less than 70mg/dl and more than 200mg/dl define hypo and hyperglycaemia respectively.
US approval is of course often the catalyst for a takeover approach, but Mr Goodnow says that the company is not focused on such an outcome. It has taken an unorthodox corporate development route so far, reversing into the OTC-listed app developer ASN Technologies last year, and in March conducting a $45m fundraising and uplisting to the NYSE MKT.
Since then its shares have risen 30%, with an 8% rise yesterday on the news of the Roche deal. “We started with a somewhat unconventional reverse merger, but as a mechanism to do a more traditional IPO which we did in March,” Mr Goodnow says.
“It had to do with the investing environment. Traditional IPO approaches are still pretty locked down in the US so a reverse merger and then a more direct investment by the large funds that showed interest was a good way to do it.”
A public company is generally a trickier prospect to buy than a private one, although with a market cap of around $370m a theoretical acquisition of Senseonics would be a fleabite for the larger diabetes players such as Medtronic, Roche or Abbott.
“But that’s down the road,” says Mr Goodnow. The company likely has enough on its plate with clinical development in the US and expanded indications and reimbursement efforts in Europe. How well it succeeds with these will determine its future.