MINNEAPOLIS, April 16, 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, announced today that the 5,000th patient has been implanted with Inspire therapy since the inception of the program. The 5,000th procedure was performed by Dr. Christopher Larsen at The University of Kansas Health System (TUKHS) in Kansas City, Kansas.
Significant milestones in the development and commercialization of Inspire therapy include:
- First patient received Inspire therapy in Antwerp, Belgium on July 25, 1996 while the program was still managed by Medtronic
- First patient in Europe following the CE Mark regulatory approval received the therapy in Amsterdam, the Netherlands, on October 12, 2011
- First patient in the U.S. following FDA approval received the therapy in Pittsburgh, Pennsylvania on May 16, 2014
- 1,000th patient received the therapy in Pamplona, Spain on August 12, 2016
- 2,500th patient received the therapy in Athens, Georgia on January 24, 2018
- 5,000th patient received the therapy in Kansas City, Kansas on April 16, 2019
“This is simply a tremendous and very significant milestone for Inspire,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “It takes many years of dedicated efforts and persistence from a very talented team and many experienced healthcare providers to be successful in introducing a new implantable product, and we are excited to celebrate this achievement and even more focused as we begin the process of advancing towards our 10,000th procedure and beyond.”
Dr. Larsen performed his first Inspire therapy procedure in 2016 and this most recent case was the 110th procedure completed at TUKHS. He is an Associate Professor in the department of Otolaryngology, Head and Neck Surgery at TUKHS. Dr. Larsen’s colleague, Dr. David Rouse also performs the Inspire procedure at TUKHS and the team includes two sleep departments; the Department of Neurology with Dr. Suzanne Stevens, and the Department of Pulmonology and Critical Care Medicine with Dr. Damien Stevens, Dr. Sowjanya Duthuluru, and Dr. Usman Nazir.
“For many years, there have been limited painful or technically demanding options for obstructive sleep apnea patients who are not able to benefit from CPAP,” stated Dr. Larsen. “With the introduction and rapidly growing adoption of Inspire therapy, as well as the reduced burden to obtain reimbursement approvals, many more patients will be provided the opportunity to receive Inspire therapy to resolve their obstructive sleep apnea.”
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 continued adoption of Inspire therapy. 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 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; the timing or likelihood of regulatory filings and approvals; risks related to our debt and capital structure; our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims of infringement; tax risks; risks that we may be deemed an investment company under the Investment Company Act of 1940; regulatory risks; the volatility of the trading price of our common stock; and our expectations about market trends. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this presentation 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 filed with the SEC on February 26, 2019, 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 presentation. Any such forward-looking statements represent management’s estimates as of the date of this presentation. 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: