Merit Medical wins FDA’s breakthrough designation for pain relief therapy

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• Merit Medical (MMSI -1.1%), a company focused on disposable medical devices, announced on Monday that the U.S. Food & Drug Administration (FDA) granted its “breakthrough device designation” for Embosphere Microspheres for the Genicular Artery Embolization (GAE) indication.
• A process designed to reduce blood flow to the knee and minimize inflammation, GAE provides pain relief and addresses disability in patients with knee osteoarthritis.
• With its breakthrough device program, the FDA intends to allow timely access to breakthrough technologies with more potential in the diagnosis and treatment of fatal or irreversibly debilitating conditions.
• The companies with the designation can receive priority review and interactive communications from the federal agency with regard to device development and clinical trial protocols.
• With its Q4 2021 results last month, Merit Medical (NASDAQ:MMSI) projected ~$1.117B – $1.140B in net revenue that came ahead of average Street forecasts.