Inspire Medical Systems invests in EnsoData and Ognomy

Sleep apnea treatment developer Inspire Medical Systems has invested in two private companies with digital health tech that could better screen people for sleep problems.

Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. It made a $10 million minority equity investment in Madison, Wisconsin–based EnsoData, creator of an FDA-approved sleep study analysis platform called EnsoSleep. The EnsoSleep platform integrates with a sleep labs’ existing software and diagnostic devices, using AI to automatically analyze and score sleep studies.

Inspire Medical also provided seed funding to Buffalo, New York–based Ognomy, creator of the Ognamy app that sleep physicians built to shift sleep apnea diagnosis and treatment from the clinic to people’s homes.

Tim Herbert, CEO of Inspire Medical Systems, said the tools created by EnsoData and Ognomy could help clinician…

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Inspire Medical Systems beats The Street in Q4, expects strong 2022 sales despite COVID-19 impact

Inspire Medical Systems (NYSE: INSP) shares ticked up today on fourth-quarter results that topped the consensus forecast.

The Minneapolis-based sleep apnea treatment developer posted losses of $2.4 million, or 9¢ per share, on sales of $78.4 million for the three months ended Dec. 31, 2021, for a bottom-line gain closer to breakeven on sales growth of 70.4%.

Inspire Medical’s losses per share of 9¢ came in well ahead of Wall Street projections of 44¢. The company’s revenues also topped analysts’ projections, coming in 0.3% ahead of expectations.

“We experienced significant momentum throughout our business in the fourth quarter,” Inspire Medical Systems President and CEO Tim Herbert said in a news release. “The 70% year-over-year revenue growth achieved in the fourth quarter reflects accelerated patient demand for Inspire therapy and our increasing capacity at new and existing centers. In addition, our ability to improve patient access t…

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These medtech companies care a lot about research

[Image from Unsplash] They’re making glaucoma-treating stents, tumor-treating fields, coin-sized CGMs and more. Discover the medtech companies that spend the most on research as a percentage of revenue.

The list comes from our annual Big 100 report, which examines the world’s 100 largest medical device companies and ranks them by revenue. (Check out our full Big 100 report here.) 

Medtech companies that have spent the most on R&D as a percentage of revenue have had much to boast about:

Glaukos’s iStent inject is an eye implant designed for cataract surgery to reduce intraocular pressure in adults with mild-to-moderate primary open-angle glaucoma. It was a Prix Galien USA Awards nominee last year. Novocure announced in September 2021 that the FDA had granted breakthrough designation for its NovoTTF-200T liver cancer treatment system. NovoTTF-200T system is a tumor treating fields (TTFields) delivery system for use in tandem with atezolizumab and be…
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Inspire Medical Systems says reimbursement questions cleared up at CMS

Inspire Medical Systems (NYSE: INSP) says CMS has answered some questions about how it will reimburse its implantable sleep apnea treatment device.

The Golden Valley, Minnesota–based company announced on November 10 that CMS has published updated addendum files for the 2022 ambulatory surgery center payment system.

The update included an assigned device offset percentage and final payment rate for new CPT code 64582 — already approved by the AMA CPT Editorial Panel for closed-loop hypoglossal nerve stimulation.

The updated files reflect the national average ASC reimbursement rate for CPT code 64582 of $24,828.64 — versus an initial proposal to peg it at roughly $17,000. The new rate goes into effect on January 1, 2022.

SVB Leerink Research analysts previously noted on November 2 that a CMS final rule published after market close still showed a roughly $17,000 reimbursement range, though Inspire Medical Systems management pointed out CMS commentary…

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Inspire Medical Systems soars on Street-beating Q1, raised guidance

Inspire Medical Systems (NYSE:INSP) shares ticked up before hours on second-quarter results that topped the consensus forecast.

INSP shares were up 12.3% at $210 per share before the market opened today.

The Minneapolis-based company posted losses of -$13.1 million on sales of $53 million for the three months ended June 30, 2021, for a 43.3% bottom-line gain, having more than quadrupled its revenues year-over-year.

Earnings per share were -48¢, 16¢ ahead of Wall Street, where analysts were looking for sales of $43.9 million.

“Our significant commercial momentum continued throughout the second quarter,” Inspire Medical Systems president & CEO Tim Herbert said in a news release. “We remain focused on our commercial execution driven by increasing our capacity at existing implanting centers, opening new centers and improving the education process with patients. We continue to closely track the ongoing challenges presented by COVID-19 a…

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Inspire Medical Systems beats The Street in Q1, raises guidance

Inspire Medical Systems (NYSE:INSP) yesterday posted first-quarter results that beat the earnings consensus on Wall Street and matched sales estimates.

The Minneapolis-based company reported losses of -$16.216 million, or -60¢ per share, on sales of $40.352 million for the three months ended March 31, for a sales growth of 89.0% compared with Q1 2020.

Earnings per share were -60¢, 6¢ ahead of The Street, where analysts were looking for sales of $40.35 million.

“We continued to execute on our key commercial initiatives during the first quarter,” president and CEO Tim Herbert said in a news release. “We did experience the expected seasonality early in the first quarter of 2021 due to high deductible insurance plans resetting as well as the resurgence of COVID-19 in certain geographies, but the team performed extremely well to overcome these challenges. Our growth in the quarter was primarily driven by the increased number of procedures occurring at existin…

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Inspire Medical wins coverage from Cigna

Inspire Medical Systems (NYSE:INSP) has announced that Cigna will provide insurance coverage for the company’s Inspire obstructive sleep apnea therapy beginning this week. Cigna insures approximately 16 million members in the U.S., the minimally invasive sleep apnea treatment developer noted.

The addition of Cigna brings the total of insurance policies covering Inspire to 54, representing over 180 million individuals compared to 83 million one year ago, the Minneapolis-based company said in a news release.

In addition to the 54 commercial coverage policies, Inspire therapy will soon have Medicare coverage across the entire United States. The final Medicare administrative contractor, Palmetto GBA, announced its final local coverage decision (LCD) policy date release of June 21, 2020, for covering Inspire therapy.

“Importantly, the Cigna policy and all of the Medicare LCD policies became, or will become, effective during the COVID-19 pandemic, and we antic…

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Inspire Medical names Ebeling as new COO

Obstructive sleep apnea therapy developer Inspire Medical Systems (NYSE:INSP) announced today that it appointed industry veteran Phil Ebeling as its new COO.

The company’s new COO is taking on responsibilities including oversight and leadership of operations, quality assurance, clinical research, regulatory affairs and business development activities, according to a news release.

Ebeling most recently served as VP & chief technology officer at Abbott (NYSE:ABT) after it acquired St. Jude Medical. He served for 10 years total between the two companies as a member of the executive team and corporate officer with both. He also spent 12 years in multiple senior positions at Boston Scientific (NYSE:BSX).

“I am thrilled to join the dynamic team at Inspire during this exciting period of robust growth highlighted by the recent positive advancements in reimbursement,” Ebeling said in the news release. “The ongoing development of Inspire therapy and futu…

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Inspire Medical raises $10.7m, names new COO

Inspire Medical Systems (NYSE:INSP) announced today that it raised $10.7 million and named Phil Ebeling as its new chief operating officer.

According to a news release, Inspire entered into an underwriting agreement on June 3 with A.G.P./Alliance Global Partners in the offering of more than 7.6 million units consisting of one share of Inspire’s common stock and one Series F warrant to purchase a share, plus nearly 14.6 million pre-funded units that included one pre-funded warrant and one Series F warrant.

Underwriters also had a 45-day option to purchase up to an additional 3.3 million shares of common stock at 45¢ per share and/or up to 3.3 million additional Series F warrants. The offering closed on June 5 with the underwriter option exercised nearly in full, yielding gross proceeds of $11.5 million, turning into net proceeds worth $10.7 million.

The obstructive sleep apnea (OSA) therapy developer intends to use the net proceeds for research and …

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