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Inspire Medical Systems, Inc. Announces Issuance of Positive Assessment for Inspire Therapy by Blue Cross Blue Shield Association’s Evidence Street
MINNEAPOLIS, Minn., Jan. 07, 2019 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (“OSA”), announced today that the Blue Cross Blue Shield Association's (“BCBSA”) Evidence Street issued a positive assessment of Inspire therapy to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield (“BCBS”) companies that, when combined, is one of the leading health associations in the U.S.
The report summarized that sufficient evidence exists to determine that hypoglossal nerve stimulation results in a meaningful improvement in the net health outcome for patients meeting the following selection criteria, which are based on information from clinical study populations and clinical expert opinion:
- age ≥ 22 years in adults, or adolescents with Down’s syndrome (age 10 to 21 years); and
- diagnosed moderate to severe OSA (with less than 25% central apneas); and
- CPAP failure or inability to tolerate CPAP; and
- body mass index ≤ 35 kg/m2 in adults; and
- favorable pattern of palatal collapse.
“This positive assessment demonstrates the strength of the clinical evidence for Inspire therapy and is an important step forward in securing coverage from health insurance providers in the BCBS affiliate network,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “This positive Evidence Street assessment for Inspire therapy will provide us with key support in our ongoing discussions with BCBS companies that relate to positive coverage decisions in the future. The positive review further validates the benefits of Inspire therapy, and we continue to believe that our growing body of clinical and real-world data will be the basis for additional coverage decisions by other major health plans, as well as provide support to centers in obtaining individual prior authorization approvals.”
The BCBSA’s Evidence Street platform provides health care decision-makers easy access to impartial medical evidence reviews for devices, diagnostics and pharmaceuticals and was created to make BCBSA’s evidence review process of medical technologies and therapies more transparent, efficient and comprehensive. BCBSA collects and analyzes available peer-reviewed evidence, then synthesizes that data and ascertains if the evidence is sufficient or insufficient to determine the effect on health outcomes.
The BCBSA’s Evidence Street does not determine whether each of the 36 BCBS companies nationwide cover a medical technology. However, it provides BCBS companies with evidence-based opinions that the BCBS companies often consider in their decisions.
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.
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, without limitation, statements regarding the potential impact of BCBS’s positive assessment and any resulting positive insurance coverage. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” ‘‘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; 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 expand our indications and develop and commercialize additional products and enhancements to our Inspire system; 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 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.; 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; 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 our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims of infringement. 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 final prospectus filed under Rule 424(b) on December 7, 2018, 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. 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.
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