You are here
Inspire Medical Systems, Inc. Announces Publication of Data From ADHERE Registry
Data Demonstrated Substantial Reduction in Severity of Obstructive Sleep Apnea with Inspire Therapy Treatment
Results from 508 Inspire Therapy Patients Represent Largest International Data Set Generated to Date
Data Published Online in European Respiratory Journal
MINNEAPOLIS, Nov. 30, 2018 (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 the publication of data from the first 508 Inspire therapy patients included in the 2,500-patient ADHERE registry. The data demonstrated that Inspire therapy is an effective treatment option with high patient satisfaction and low adverse events. These results represent the largest international data set for Inspire therapy generated to date.
The publication, entitled “Post-Approval Upper Airway Stimulation Predictors of Treatment Efficacy in the Adhere Registry,” is available online (http://erj.ersjournals.com/content/early/2018/10/25/13993003.01405-2018) in the European Respiratory Journal, the flagship journal of the European Respiratory Society. The lead authors of the publication are Dr. Clemens Heiser of the Technische Universität in Munich, and Dr. Maurits Boon of Thomas Jefferson University Hospital.
“We continue to add to the already large body of clinical evidence showing Inspire therapy to be a safe and effective therapy for CPAP-intolerant patients,” said Inspire President and CEO, Tim Herbert. “Our focus remains on generating consistent and predictable patient outcomes with Inspire therapy, in order to drive further growth in adoption. The patient outcomes generated to date from ADHERE are very compelling, and we look forward to generating further data from this large international registry in the months ahead.”
Key results highlighted in the publication included:
- Substantial reduction in OSA severity in response to Inspire therapy
• Median Apnea-Hypopnea Index was reduced from 34.0 to 7.0 events/hour
• Median Epworth Sleepiness Scale was reduced from 12 to 7, as the level of daytime sleepiness was reduced from “mildly excessive sleepiness” to “higher normal sleepiness”, demonstrating quality of life normalization
- Patients used Inspire an average of 5.7 hours per night after 12 months
- Highly positive rates of patient-reported response to therapy experience:
• 94% stated that they would undergo Inspire implant again
• 96% of patients reported that they would recommend Inspire to family and friends
• 94% of patients reported overall satisfaction with Inspire therapy
The ADHERE registry is evaluating 2,500 Inspire therapy patients in the U.S. and Europe.
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. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
Investor and Media Contact: