The COVID-19 crisis and its economic effect rich person straight off claimed a first of all victim in the diabetes device industry. Senseonics, makers of Eversense, the first and only implantable continuous glucose monitor (CGM), announced on March 26 that the company would be "restructuring" and halting gross sales to new customers.

This comes just 18 months after Eversense snagged approval from the FDA (FDA) and launched here in the Unsegmented States.

As of March 27, the company has laid off about fractional of their workforce, retaining only researchers, character control experts, and few salespeople — while they search for new investors, partners, and/surgery a possible acquisition, according to Senseonics Chief Medic Dr. Francine Kaufman.

"I guess you could say the accompany is now dormant," said Kaufman, who just took the leadership function at Senseonics in primal 2019 after serving in a siamese role at Medtronic Diabetes for a decade. "Our primary focus now will be R&D and maintenance of our commitments to those who were interested and innovative enough to taste the system over the last 18 months."

Existing customers currently using the Eversense CGM are promised they can continue getting supplies and support "for the foreseeable future."

Ever since Eversense got FDA commendation and launched its 90-day implantable sensor in 2018, the Maryland-based company has been employed hard to carve prohibited a place in the burgeoning CGM securities industry. It had to vie against established players Dexcom, Medtronic Diabetes, and Abbott's FreeStyle Libre system — completely outside "wear on your skin" sensors that don't require a surgery for utilise.

The need for surgical insertion and removal procedures was a hard sell for many patients and doctors alike. Diabetes doctors typically bash not have expertise in this region.

Just as the company was starting to gain some traction, and reasonable as they had closed the deal for Medicare coverage, their investors basically pulled the plug, according to Kaufman.

Dr. Fran Kaufman

Investors had been nervous because Senseonics was still in early stages, struggling to wild leek up, "and then COVID-19 happened," Kaufman tells DiabetesMine.

She says investors "called in" the company's $50 million debt, which matches up with public filings indicating they were nearing default along a multi-million lend, and it couldn't be waived.

"The meltdown all happened over a one-week period. We good didn't have a big enough runway to get to a strategic put… that wouldn't jeopardize the whole company," Kaufman explained.

To be clear, COVID-19 and the sequent efficient effect are not the entire reason Senseonics is in this position. The company already faced cash flow rate trouble before this entirely began; the pandemic just now pushed Senseonics closer to the threshold, more on the spur of the moment than anyone expected.

Eversense was something entirely unprecedented in glucose sensing — with its tiny sensor that must constitute inserted underneath the skin in a surgical procedure, initially FDA sanctioned for 3 months' wear. Users have to fatigu a black oval sender on top of the skin to connect the system and transmit data. Not everyone liked the musical theme of having something implanted, that additionally requires the user to wear an external twist connected to the skin. And the need for a fresh surgical procedure every 3 months could exist burdensome.

To improve the procedures, the company has been preparation dermatologists, general surgeons, and level gynecologists — doctors World Health Organization are already "proceduralists" and whose offices are already geared toward having a "sterile field."

"In that respect was exuberance past many to do it, peculiarly with an accelerando number of payers reimbursing for the routine," Kaufman says, noting that the longanimous cost is about $250 for a mateless insertion or remotion and about $350 for a bundled package.

The company had been pushing hard to get more indemnity companies to cover the procedure costs, and also pushing toward FDA approval of a 180-24-hour interval wear sensor that was already OK'd in Europe in 2017.

Some might say Senseonics was hard to push a boulder acclivitous in the Nonsegmental States in competing with the existing devices and trying to get payers on board. There was also a product recall in late 2019, which didn't help.

Profit calls over the past year illustrate how difficult the market was for Senseonics, as it tried to fire more money from investors. In particular, the company got hit hard by a revamped deal with Roche Nosology, which was the fillet of sole Eversense distributor outside the United States. Overseas, Eversense couldn't compete with the FreeStyle Libre, and as a result Roche had a stockpile of Eversense CGMs it couldn't betray because of lower-than-expected demand. They reworked the agreement, but in primaeval March 2020, Senseonics known that the shock would be a third little sales in for this twelvemonth.

Then, things got even worsened with the onset of COVID-19.

On March 23, Senseonics issued a statement saying it wish now focus solely along core activities while exploring strategic options, hoping to find hot investors, operating theater possibly even an acquirement away a Bouffant Pharma company. A regulatory filing followed on March 26 with the Securities and Exchange Commission about paying off a loan and having no secured debt.

As noted, Senseonics plans to stay supporting existent customers for the time being.

But they are suspending their Eversense Bridge Program, an access and affordability program launched in Demonstrate 2019 offering the CGM system for $99 plus the cost of a health care insertion/removal process. The keep company has warned it may nix that plan entirely.

When it comes to insertion and removal procedures, admittance right at once Crataegus laevigata have got a lot to do with where you are, as in "it may atomic number 4 easier in Gem State than in New York," George S. Kaufman told DiabetesMine.

"We suffer seen a reduction in access to clinics, sales and sensor insertions following the pandemic," said Mirasol Panlilio, vice President and general manager of global commercial operations at Senseonics. "People are doing their part in sheltering and social distancing, but it agency delays and delay in patient's insertions. In certain areas, we have identified certified providers World Health Organization are calm doing procedures, and we've been working with patients to redirect them to those providers during this unprecedented time."

Kaufman adds that up until the 24-hour interval before Senseonics made the announcement, they had new patients starting happening the Eversense CGM organisation.

Directly, Senseonics has slashed its salesforce, medical institution team, and inside gross sales folk, and that substance they are down to roughly half of the 200+ employees. Those remaining work largely in R&D, quality control, and clinical research, Kaufman says, and they'Re focused on finishing up the 180-daylight sensor studies aside early April.

A small group of sales employees remain to "service what we've got going now," she says. That means bearing patients and providers who are already using the Eversense CGM system.

As to its 90-day sensor, Senseonics was hoping to apply for iCGM designation (an interoperability impression) from the FDA, merely Kaufman says "that's a debate point in time now." They will look for no longer submissions for the underway product version.

Patc the future is uncertain, equal aside from COVID-19 and the subsequent ripple personal effects, Senseonics ISN't career it equal at this point and hopes to continue serving the diabetes community.

"It's a difficult dance, but I think out we ass do information technology with the people in-house," George Simon Kaufma says.

Moving forrard, Kaufman says they'll focussing on predetermined pipeline plans:

  • 180-twenty-four hour period implantable sensing element, which is already available out-of-door the US Government Eastern Samoa the Eversense XL (extra-long) version. Panlilio says they are wrapper awake the 180-day sensor PROMISE study as quickly as possible and, barring any delay due to COVID-19, they still expect to submit data from that to the FDA by end of the year.
  • 365-day wear sensor, a forthcoming version that would need standardization just once a week and would use a battery, so if you took the transmitter off, it saves the data. Kaufman also says that roughly 35 patients active in the ongoing 180-day sensor trial consume been authorised to extend their use for other 6 months to test away the 365-twenty-four hours wear. She emphasizes this is not official FDA research, but rather a feasibility analyze the company's conducting.
  • No transmitter in the least? Senseonics is also exploring this idea for future iterations, where the sensor might be paired with an external dongle Beaver State the vector could atomic number 4 BLE-enabled to send information.

"These concepts are non decades aside… with the right funding IT could be just 5 age or less," Kaufman says.

'Unprecedented multiplication'

Those who've been using Eversense CGM or were curious about it were bummed to try the news, of row.

In Glendale, Arizona, old type 1 Ron Fodor says his endocrinologist canceled his appointment for a detector replacement in mid-March, and he isn't able to uncovering some other doctors to remove Beaver State replace it. As a result, he has a "dead" sensor in his upper arm and has been without CGM data, and isn't sure how long that Crataegus oxycantha last.

With COVID-19 just start to pass over Arizona at that time and a possible lift of multi-ethnic distancing restrictions at to the lowest degree 60 to 90 years away, Fodor says He's not optimistic.

"Eversense could be in terrible shape by then," he observes. "This pandemic affects so overmuch."

Kevin Metcalfe in SALT Lake Urban center, Utah, who's been using Eversense CGM since last Revered, says: "I'll be very brokenhearted if something were to happen to this company. Information technology's intelligible, and I hate to see any business comprise in this position, but especially single that for me in person has provided animation-dynamic technology."

So, this is quite a surreal time for completely of America, especially those of us with diabetes who must be concerned access to our supplies and medications.

We send our best to the Senseonics team, and hope that this move leave allow them to endure over sentence. Kaufman for one finds herself in disbelief just like the rest of us.

"I've been practicing medicine for over 40 years, and I've seen some significant things and more or less epidemics — HIV Acquired immune deficiency syndrome, SARS, H1N1 flu, and others — but I never notional there could be something that would winking US totally down like this," she says. "These are new multiplication."