Yahoo Finance Inspire Medical's (INSP) Inspire Therapy Gets CE Mark Approval
Inspire Medical Systems, Inc. INSP recently received the CE mark certification under the European Union’s Medical Device Regulation (EU MDR) for Inspire therapy. Per management, the European Parliament enacted a new regulatory framework for the certification of medical devices in the E.U. in 2017. This prompted the entire medical device industry to repeat the process for both design and quality system certification to the new and more stringent requirements.
The latest regulatory achievement is a significant milestone for Inspire Medical, which is expected to solidify its foothold in the global obstructive sleep apnea treatment space.
Significance of the Approval
Following the receipt, there are two changes to Inspire therapy that are now CE marked under the EU MDR, that were not previously certified under the Active Implantable Medical Device Directive. First, Inspire Medical’s patients in the EU may now undergo full-body magnetic resonance imaging (MRI) scans in the 1.5T MRI environment, provided the conditions specified in the company’s MRI Guidelines Manual are met. Secondly, the current version of Inspire therapy’s leads with silicone insulation are now CE-marked in the EU.
Industry Prospects
Per a report by Fortune Business Insights, the global sleep apnea devices market is projected to grow from $9.70 billion in 2024 to $18.30 billion in 2032 at a CAGR of 8.3%. Factors like the globally increasing incidence of disorders, including cardiovascular disorders and hypertension, and the rising elderly population and associated comorbidities are likely to drive the market.
Given the market potential, the latest regulatory clearance will likely provide a significant impetus to Inspire Medical’s business.
Notable Development
In May, Inspire Medical announced its first-quarter 2024 results, wherein it registered a robust improvement in the top and bottom lines. Strength in year-over-year U.S. revenues and revenues from outside the United States was also recorded.
Price Performance
Shares of Inspire Medical have lost 50.3% in the past year compared with the industry’s 23.7% decline. The S&P 500 has witnessed 21.7% growth in the said time frame.
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Zacks Rank & Stocks to Consider
Currently, Inspire Medical carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are Globus Medical, Inc. GMED, Stryker Corporation SYK and Boston Scientific Corporation BSX.
Globus Medical, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 12.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 10.8%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Globus Medical’s shares have gained 18.8% against the industry’s 1.7% decline in the past year.
Stryker, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 10.6%. SYK’s earnings surpassed estimates in each of the trailing four quarters, with the average being 4.9%.
Stryker has gained 17.3% against the industry’s 2.9% decline in the past year.
Boston Scientific, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.5%. BSX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.5%.
Boston Scientific’s shares have rallied 48.7% against the industry’s 2.9% decline in the past year.
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Boston Scientific Corporation (BSX) : Free Stock Analysis Report
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Inspire Medical Systems, Inc. (INSP) : Free Stock Analysis Report
