Inspire Medical Systems, Inc. Announces Regulatory Approval of Inspire Therapy in Australia
Inspire Medical Systems, Inc. (NYSE: INSP) has received approval from the Australian Therapeutic Goods Administration (TGA) for its Inspire therapy targeting moderate to severe obstructive sleep apnea (OSA) in patients unable to use CPAP. OSA affects about 5% of Australians, with around one million qualifying as moderate to severe cases. The company is now pursuing reimbursement approval from the Medical Services Advisory Committee (MSAC) and expects to launch its therapy in Australia post-2021. CEO Tim Herbert emphasizes the therapy's strong clinical evidence supporting its safety and efficacy.
- Approval of Inspire therapy by Australian TGA for moderate to severe OSA.
- Large market opportunity in Australia with approximately one million patients.
- Strong clinical evidence backing the safety and efficacy of Inspire therapy.
- Dependency on successful reimbursement approval from MSAC, with no guarantee of funding.
- Projected commercial launch heavily reliant on completion of the reimbursement process, which is uncertain.
MINNEAPOLIS, Aug. 12, 2020 (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”), today announced that the Australian Therapeutic Goods Administration (“TGA”) has approved Inspire therapy to treat moderate to severe OSA in patients who are unable to benefit from continuous positive airway pressure (“CPAP”).
Recent published data estimates that nearly
“This approval for our Inspire therapy is the first step to providing patients and physicians in Australia with a new alternative for the treatment of moderate to severe OSA,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “Inspire therapy is supported by a strong and growing body of clinical evidence demonstrating the safety and efficacy of our therapy. We look forward to completing the reimbursement process in Australia and initiating our commercial activity.”
Concurrent with the regulatory review, Inspire has applied for reimbursement in Australia, and the application is under review by the Medical Services Advisory Committee (“MSAC”), which is an independent committee established by the Australian Government Minister for Health to evaluate new medical services proposed for public funding. Inspire will continue with the active discussions with the MSAC, including in-person meetings in late 2020. The reimbursement process is anticipated to be completed during 2021 and Inspire expects to launch its therapy in Australia thereafter.
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. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning: our expected commercial launch of Inspire therapy, estimates regarding our market opportunity in Australia and the timing of discussions involving and completion of the reimbursement process in Australia. 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 United States and our market opportunity outside the United States, 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, including in Australia; the impact of the global COVID-19 pandemic; 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; general and international economic, political, and other risks, including currency and stock market fluctuations and the uncertain economic environment; 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 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, 2019, as updated in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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 and Media Contact:
Bob Yedid
LifeSci Advisors
bob@lifesciadvisors.com
646-597-6989
FAQ
What regulatory approval did Inspire receive for its therapy?
How many Australians are estimated to have obstructive sleep apnea?
What is the role of the Medical Services Advisory Committee (MSAC) in Inspire's launch?
When does Inspire expect to launch its therapy in Australia?
What is the significance of the clinical evidence for Inspire's therapy?
