As FDA wait continues, Senseonics starts consumer push in early European markets

By Dave Muoio
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Implantable continuous glucose monitor (CGM) maker Senseonics is still making the long trudge toward FDA clearance, but at least the company has plenty of European activity to keep it occupied in the meantime.

On a Q3 earnings call, CEO Timothy Goodnow shared details on his company’s continued ramp-ups and rollouts across Europe, its first entry into an international market, and the receipt of a CE Mark for its second generation CGM. Along with a breakdown of revenue growth and other financials, he also gave a brief update on the company's ongoing foray into development of an automated closed-loop, mobile-driven insulin delivery system and other research projects.

“We had a significant new product approval, meaningful new market launches, a new milestone in quarterly revenue, and balancing improvement with a successful capital raise,” Goodnow said. “It’s very clear that the pace of innovation for diabetes management is increasing. It’s also evident that users and clinicians are clearly seeing its acceleration, and appreciate the value of new technologies.”

Senseonic’s Eversense CGM, a pill-sized implantable device that can last up to 90 days without need of replacement, is now available in 13 countries, six of which Goodnow said are new expansions for the company. This group includes South Africa, Senseonic’s first non-European market.

The bulk of the company’s revenue this quarter — approximately $2.1 million — came from product sales in Germany, Sweden, and Italy, Goodnow and CFO Don Elsey explained, and both the revenue and install base growth of this quarter were greater than the sum of all previous quarters combined. Total net loss for the quarter was $17.4 million, compared to Q3 2016’s $10.9 million, and was attributed to rising operating expenses through scale-up. Taken together, Goodnow said that the company is on track with earlier forecasts of $6 million to $7 million in revenue for 2013-2017.

"Early market detailing focused exclusively on introductions to the medical professionals. Now in the more mature Eversense markets, we are successfully transitioning to add consumer awareness, and thereby creating a customer pull,” Goodnow said. “We expect this momentum will carry through the balance of the year as our new countries add more clinics during their controlled launches, as more countries move into full launch, and as our full launches continue with generating consumer and professional awareness to patient adoption.”

Of note, this quarter also saw a CE Mark receipt for the company’s second generation implantable CGM, the Eversense XL, which boasts twice the implant duration of its predecessor. Senseonics has already completed prelaunch activities for the new sensor and plans to begin clinic onboarding in the coming month. This would allow a broader launch of the product across Europe during in the first quarter of 2018, which Goodnow said he expects will “contribute meaningfully to our continued penetration and expansion in Europe.”

But while substantial regulatory progress has been made in Europe, things are moving much more slowly for Senseonics in the US. Goodnow’s comments on the Eversense CGM’s FDA approval process were largely similar to those of the previous quarter, with Senseonics expecting the agency to convene an advisory panel exploring the safety of the implantable sensor. The CEO said that this panel would most likely be held in early 2018, but should not impede the device’s eventual approval.

“We are confident that the strong patient safety data and efficacy data demonstrated in our US pivotal trial, our European pivotal trial, and our robust post-market surveillance program currently underway in Europe will support the FDA approval of Eversense,” he said. “As we enter the U.S. market, we will execute a controlled launch as we work with payers to improve Eversense into the existing CGM coverage policies, after which we expect the ramp to accelerate.”

Despite the wait, Senseonics is still reaching out to payers and otherwise moving forward with its US launch plans, Goodnow said. The company is preparing US clinical trials for the XL device as well.

Outside of these major points, Goodnow gave brief mention of his company’s other ongoing research projects. Among these notes was the completion of the first clinical trial of the 180-day sensor in pediatric participants in Canada, for which he noted “very positive” feedback. The other project involves work on an integrated automated insulin delivery system that combines Eversense’s sensors with TypeZero’s artificial pancreas algorithm and Roche’s Accu-Chek Insight pump. The experimental device is being tested as part of the NIH-sponsored International Diabetes Closed Loop trial, which is being conducted at various institutions across Europe.

“To wrap up, we are excited about our accomplishments in the first nine months of 2017 and about our growth prospects looking ahead. We’re thrilled to have XL available for our users, and we’re happy to have us setting revenue milestone and/or completed our equity financing. We have another busier quarter ahead of us, as we finish the year and enter 2018 well-positioned for accelerating momentum,” Goodnow said.