MINNEAPOLIS - Inspire Medical Systems, Inc. (NYSE: NYSE:INSP) has achieved CE mark certification under the European Union's Medical Device Regulation (EU MDR 2017/745) for its updated Inspire therapy, a treatment for obstructive sleep apnea (OSA). The new certification allows patients in the EU to undergo full-body MRI scans and introduces silicone-insulated leads to the therapy.
Inspire, a company specializing in minimally invasive solutions for OSA, has maintained compliance with the EU's quality system and CE mark requirements since 2010. The recent certification marks a significant regulatory accomplishment as the medical device industry adapts to the EU MDR 2017/745, which imposes more stringent certification requirements for medical devices.
According to Andreas Henke, Executive Vice President, Managing Director Europe at Inspire, the transition to the new regulatory framework has been challenging for the industry. Inspire's success in obtaining the CE mark for its therapy under these rigorous conditions underscores the company's commitment to meeting high-quality standards.
The updated Inspire therapy now approved in the EU includes two significant changes. First, it permits patients with the neurostimulation device to have full-body MRI scans in a 1.5T MRI environment, provided specific conditions outlined in the Inspire MRI Guidelines Manual are met. Second, the therapy's leads, which now feature silicone insulation, have received CE mark approval.
Inspire's proprietary therapy is the first and only FDA-approved neurostimulation technology for the treatment of moderate to severe OSA. The company's forward-looking statements indicate plans to commercialize the therapy in France, among other markets.
This information is based on a press release statement from Inspire Medical Systems, Inc.
In other recent news, Inspire Medical Systems has seen adjustments in stock targets by several analyst firms. Truist Securities lowered its price target to $217, maintaining a Buy rating, based on an estimated 2025 revenue of around $946 million and potential risks in out-year TAM realization. Baird also revised the company's price target to $220, maintaining an Outperform rating, anticipating a slight beat on Q2 top-line revenue and continued growth in utilization.
Mizuho Securities reduced its price target to $200 while keeping an Outperform rating following comprehensive Q2 checks and analysis. BofA Securities cut its price target from $225 to $185 due to projected deceleration in revenue growth, maintaining a Neutral rating. Lastly, Oppenheimer maintained its Perform rating on Inspire Medical Systems, addressing debates surrounding the efficacy of hypoglossal nerve stimulation therapy.
InvestingPro Insights
In the wake of Inspire Medical Systems' recent CE mark certification for its updated Inspire therapy, investors are closely watching the company's financial health and market performance. According to InvestingPro data, Inspire Medical Systems has a market capitalization of approximately $4.09 billion, reflecting the market's valuation of the company amidst its regulatory achievements and expansion plans.
While the company's stock has experienced significant volatility, with a 1-month price total return of -15.13% and a 3-month price total return of -39.87%, it's noteworthy that analysts predict a bright future ahead. One of the InvestingPro Tips suggests that Inspire's net income is expected to grow this year, which could signal a turnaround from the recent price declines and potentially attract investors looking for growth opportunities.
Another key metric for potential investors is the company's revenue growth, which stands at an impressive 41.71% over the last twelve months as of Q1 2024. This robust growth indicates that despite the stock's recent performance, the underlying business is expanding at a healthy rate, which could be a positive sign for future profitability.
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