Merit Medical's (MMSI) Product Included in FDA's Program

Merit Medical Systems, Inc. MMSI recently announced that it has received the FDA’s breakthrough device designation for its product, Embosphere Microspheres, for the Genicular Artery Embolization (“GAE”) indication. The FDA Breakthrough Devices Program is intended to offer more timely access to breakthrough technologies capable of more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

It is worth mentioning that Embosphere Microspheres is currently the preferred solution in embolotherapy, which has been used in numerous procedures and featured in several clinical articles.

With the latest regulatory inclusion, Merit Medical is expected to solidify its foothold in the global Peripheral Intervention business under the broader Cardiovascular arm.

Significance of the Recognition

The GAE procedure aims to lower pain and disability resulting from knee osteoarthritis by reducing blood flow to the knee, thereby minimizing the inflammatory process. The breakthrough designation for the new indication is another addition to the product’s innovative history. Merit Medical’s embolotherapy platform of products has been providing continued and predictable results for effective embolization.

Per management, the breakthrough designation is expected to enable the company to advance its programs to study and obtain FDA clearance for the GAE indication for Embosphere Microspheres. This, in turn, will likely expand treatment options for patients.

Industry Prospects

Per a report by MarketsandMarkets, the global embolotherapy market was valued at $3.4 billion in 2021 and is anticipated to reach $5 billion by 2026 at a CAGR of 8%. Factors like increasing incidences of peripheral vascular diseases and rising preference for minimally invasive procedures are likely to drive the market.

Given the market potential, the latest recognition and inclusion are expected to provide a significant boost to Merit Medical’s business globally.

Another Notable Development

Last month, Merit Medical reported its fourth-quarter 2021 revenues, which recorded a solid year-over-year uptick both on a reported and constant currency revenue, organic basis. The company’s Peripheral Intervention segment also performed impressively during the reported quarter.

Price Performance

Shares of the company have gained 10.2% in the past year compared with the industry’s 9.2% rise and the S&P 500’s 8.3% rise.

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Zacks Rank & Key Picks

Currently, Merit Medical carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space include Henry Schein, Inc. HSIC, Allscripts Healthcare Solutions, Inc. MDRX and AMN Healthcare Services, Inc. AMN.

Henry Schein, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 11.8%. HSIC’s earnings surpassed estimates in the trailing four quarters, the average beat being 25.5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Henry Schein has gained 33.3% compared with the industry’s 9.2% growth over the past year.

Allscripts has an estimated long-term growth rate of 16.3%. MDRX’s earnings surpassed estimates in the trailing four quarters, the average beat being 64.8%. It currently carries a Zacks Rank #2.

Allscripts has gained 36.1% against the industry’s 50.6% fall over the past year.

AMN Healthcare has an estimated long-term growth rate of 16.2%. AMN’s earnings surpassed estimates in the trailing four quarters, the average beat being 20%. It currently sports a Zacks Rank #1.

AMN Healthcare has gained 33.4% against the industry’s 57.7% fall over the past year.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.