Merit Medical Receives FDA “Breakthrough Device Designation” for Embosphere® Microspheres for Use in Genicular Artery Embolization for Symptomatic Knee Osteoarthritis

Rhea-AI Summary

Merit Medical Systems, Inc. (NASDAQ: MMSI) has received FDA breakthrough device designation for its Embosphere® Microspheres for Genicular Artery Embolization (GAE) aimed at treating knee osteoarthritis. This designation accelerates the review process and enhances communication between the FDA and Merit, potentially leading to quicker market access. The Embosphere Microspheres, used in over 250,000 procedures, are recognized for their effectiveness in embolotherapy. Chairman and CEO Fred P. Lampropoulos emphasized the designation's role in expanding treatment options for patients.

Positive

• FDA breakthrough device designation received for Embosphere Microspheres, indicating potential for quicker market access.
• Embosphere Microspheres are the most clinically utilized and studied embolic solution with over 250,000 procedures and 200 clinical articles supporting its efficacy.

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• None.

SOUTH JORDAN, Utah, March 07, 2022 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), announced today that it has received “breakthrough device designation” from the U.S. Food & Drug Administration (FDA) for Embosphere® Microspheres for the Genicular Artery Embolization (GAE) indication.  

GAE is a procedure intended to reduce pain and disability caused by knee osteoarthritis by reducing blood flow to the knee, minimizing the inflammatory process. As a market-leading solution in embolotherapy, Embosphere Microspheres are the most clinically utilized and clinically studied spherical embolic. With more than 20 years of clinical experience, Embosphere Microspheres have been used in more than 250,000 procedures and featured in more than 200 clinical articles.   

The FDA Breakthrough Devices Program is intended to provide patients and healthcare providers with more timely access to breakthrough technologies that have the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA has undertaken to provide priority review and interactive communication regarding device development and clinical trial protocols, through commercialization decisions.  

This breakthrough designation for the new indication adds to the innovative history of the product. “We are pleased with the recognition and partnership of the FDA, making it possible for new and innovative products to reach the market faster,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO. “Merit’s embolotherapy platform of products has provided consistent and predictable results for effective embolization. We believe this breakthrough designation allows us to accelerate our programs to study and obtain FDA clearance for the GAE indication for Embosphere Microspheres, ultimately expanding treatment options for patients.”  

ABOUT MERIT MEDICAL  
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.  

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS 
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s forecasted plans, the FDA approval process and the potential for FDA approval of Merit’s products, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Annual Report”) and other filings with the SEC. Such risks and uncertainties include risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; disruptions in Merit’s supply chain, manufacturing or sterilization processes; reduced availability of, and price increases associated with, commodity components; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; negative changes in economic and industry conditions in the United States or other countries; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; litigation and other judicial proceedings affecting Merit; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; expenditures relating to research, development, testing and regulatory approval or clearance of Merit’s products and risks that such products may not be developed successfully or approved for commercial use; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the FDA or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other countries; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; fluctuations in exchange rates; concentration of a substantial portion of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; volatility in the market price of Merit’s common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; failure to introduce products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referenced in the 2021 Annual Report and other materials filed with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results.  Forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to forward-looking statements. 

TRADEMARKS  
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc. and its subsidiaries in the United States and other jurisdictions.  
  
CONTACTS  
PR/Media Inquiries  
Sarah Comstock 
Merit Medical
+1-801-432-2864 | sarah.comstock@merit.com
  
Investor Inquiries  
Mike Piccinino, CFA, IRC  
Westwicke - ICR  
+1-443-213-0509 | mike.piccinino@westwicke.com

FAQ

What is the FDA breakthrough device designation for MMSI's Embosphere Microspheres?

The FDA breakthrough device designation allows for expedited review and priority communication for devices that provide more effective treatment for serious conditions, such as knee osteoarthritis.

How many procedures have utilized Embosphere Microspheres?

Embosphere Microspheres have been used in over 250,000 procedures.

What is the purpose of Genicular Artery Embolization?

Genicular Artery Embolization aims to reduce pain and disability caused by knee osteoarthritis by minimizing blood flow to the knee.

What does the breakthrough designation mean for Merit Medical and its investors?

The breakthrough designation may lead to faster commercialization of the Embosphere Microspheres for GAE, potentially benefiting Merit Medical's market position and financial performance.