Inspire Medical Systems, Inc. Announces Investments in EnsoData and Ognomy

MINNEAPOLIS, April 27, 2022 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) ("Inspire"), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), today reported equity investments in two private companies, EnsoData, Inc. in Madison, WI, and Ognomy Inc. in Buffalo, NY.

EnsoData increases sleep lab capacity and efficiency with their FDA-approved sleep study analysis platform, EnsoSleep. Using waveform Artificial Intelligence (AI), EnsoSleep automates the scoring and analysis of polysomnography (PSG) and home sleep testing, freeing clinician time to focus on patients. Further, EnsoSleep analyzes sleep test waveform data to provide accurate sleep staging and event detection for clinician review. The technology integrates with the sleep labs’ existing software and diagnostic devices, automatically analyzes and scores sleep studies, and requires no change to existing clinical workflows. EnsoSleep is currently available in over 500 sleep centers in the U.S. and analyzes over 30,000 sleep studies per month. Inspire’s minority investment in EnsoData is $10 million.

Ognomy was built by sleep physicians to increase access to sleep apnea care by shifting diagnosis and treatment from the clinic to patients’ homes. The Ognomy app provides the interface between the patient and a sleep physician, while the Ognomy web portal allows clinicians to see and manage patients from any location. Following a digital consultation, the physician can order a home sleep study to be sent directly to the patient. Typically, the patient can receive a completed sleep evaluation and clinician follow-up in just a few days. Inspire provided seed funding to Ognomy to further develop their platform and to initiate a pilot program intended to support its integration with the Inspire Advisor Care Program starting in May of 2022.

Over 20 million Americans have OSA, and many go undiagnosed or untreated due to limited capacity for specialty sleep care. Convenient access to sleep specialists through Ognomy and efficient, accurate scoring from EnsoData both play an important and emerging role in increasing sleep practice capacity to address this growing health challenge.

"These partnerships emphasize our focus on developing a digital platform to help patients navigate their journey to an effective solution for their OSA, such as Inspire therapy," stated Tim Herbert, Inspire Medical Systems President & CEO. "As we expand our Advisor Care Program, we understand that long sleep study wait times are a challenge for many patients. We need innovative solutions to help patients quickly, conveniently, and accurately assess the severity of their OSA and subsequently connect appropriate patients with a qualified healthcare provider to consider treatment options, including Inspire therapy. These investments will allow EnsoData and Ognomy to more rapidly grow their respective businesses, which will benefit Inspire’s ability to more broadly leverage their technologies."

"Using AI technology to support sleep physicians in the collection and prompt analysis of sleep data in the patient care pathway enhances the patient's experience and increases the physician's efficiency, thereby adding capacity to their practices," added Herbert. "Finally, these tools provide clinicians insight into patients diagnosed with moderate to severe OSA who are not currently receiving adequate therapy, thereby identifying potential patients in need of therapy adjustment or alternatives, such as Inspire."

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

For additional information about Inspire, please visit www.inspiresleep.com.

About EnsoData

EnsoData is a Waveform AI healthcare technology company that performs complex and time-consuming data interpretation and analysis. Our FDA Cleared, AI-assisted sleep scoring solution, EnsoSleep, automates the scoring of studies, and reduces the time RPSGTs spend scoring. This time savings provides clinicians with opportunities to expand patient care, improve outcomes and treat more patients. EnsoSleep’s additional products include EnsoViewer, an FDA cleared, web-based, sleep study reviewing, editing, and reporting software, and EnsoTST, which enables measurement of Total Sleep Time through more commonly available data found in HSATs.

For additional information about EnsoData, please visit www.ensodata.com.

For additional information about Ognomy, please visit www.ognomy.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including those relating to the expected benefits of the investments. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "future," "outlook," "guidance," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential," "continue," or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our Inspire therapy; the impact of the ongoing and global COVID-19 pandemic; general and international economic, political, and other risks, including currency and stock market fluctuations and the uncertain economic environment; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to accurately forecast customer demand for our Inspire system and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to increase the number of active medical centers implanting Inspire therapy; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; risks related to information technology and cybersecurity; risk of damage to or interruptions at our facilities; our ability to commercialize or obtain regulatory approvals for our Inspire therapy and system, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the U.S. and international markets; and the timing or likelihood of regulatory filings and approvals. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release can be found under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 to be filed with the SEC, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website at www.inspiresleep.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor & Media Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com