Merit Medical receives ‘breakthrough device’ from FDA


SOUTH JORDAN, Utah, March 07, 2022 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), today announced that it has received “Breakthrough Device Designation” from the Food & Drug Administration (FDA) of United States for Embosphere ® Microspheres for the indication Genicular Artery Embolization (GAE).

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

The FDA’s Breakthrough Devices Program aims to provide patients and healthcare providers with faster access to breakthrough technologies that have the potential for more effective treatment or diagnosis of diseases or conditions potentially fatal or irreversibly debilitating. Under this program, the FDA is committed to providing priority review and interactive communication regarding device development and clinical trial protocols through marketing decisions.

This groundbreaking designation for the new indication adds to the innovative history of the product. “We are thrilled with the FDA’s recognition and partnership, which allows new and innovative products to reach market faster,” said Fred P. Lampropoulos, president and CEO of Merit Medical. “Merit’s embolotherapy product platform 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.

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 hospital customers worldwide with a domestic and international sales force and clinical support team totaling more than 500 people. Merit employs approximately 6,500 people worldwide with facilities in South Jordan, Utah; Perland, TX; 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, UK; Johannesburg, South Africa; and Singapore.

Statements contained in this release that are not purely historical, including, but not limited to, statements regarding Merit’s anticipated plans, the FDA approval process, and the potential for FDA approval of products of Merit, 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 documents filed with the SEC. These risks and uncertainties include the risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; disruptions to Merit’s supply chain, manufacturing or sterilization processes; reduced availability and price increases associated with commodity components; risks related to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize internally developed or acquired technology in connection with completed, proposed or future transactions; adverse 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 security breaches and changes in privacy and data protection regulations; governmental review and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving merit; litigation and other legal proceedings affecting merit; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; changes in customer buying habits or the range of products that Merit sells; expenditures related to research, development, testing and regulatory approval or licensing of Merit’s products and the risks that such products will not be successfully developed or approved for commercial use; the possibility of fines, penalties or other adverse consequences if Merit employees or agents violate the US Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare sector; the potential for material adverse changes in applicable regulations, including reforms to Merit’s product approval or clearance procedures by the FDA or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other countries; the termination of relationships with Merit’s suppliers or the inability of such suppliers to perform; exchange rate fluctuations; concentration of a significant portion of Merit’s revenues among a few products and processes; the development of new products and technologies that could render Merit’s existing or future products obsolete; market acceptance of new products; volatility in the market price of Merit common stock; modification or limitation of government or private insurance reimbursement policies; changes in health care policies or markets related to health care reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; the risks of work stoppage or transport; failure to introduce products in a timely manner; price and product competition; availability of labor and materials; fluctuations and obsolescence of inventory; and other factors referenced in the 2021 Annual Report and other filings 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. The forward-looking statements included in this release speak only as of the date of this release, and unless otherwise required by applicable law, Merit undertakes no obligation to update or disclose revisions to any forward-looking statements.

Unless otherwise noted, 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.

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