KORU Medical Systems Receives FDA 510(k) Clearance for the Use of the FREEDOM60® with Two Additional SCIg Drugs

Rhea-AI Summary

KORU Medical Systems (NASDAQ: KRMD) has received FDA 510(k) clearance to expand the on-label use of its FREEDOM60 Infusion System. The new clearance includes two additional subcutaneous Ig medications: Cutaquig® from Octapharma and Xembify® from Grifols. This move enhances KORU Medical's position in the home infusion market, providing patients and providers with more options for immunoglobulin therapy. The FREEDOM60 is now cleared for use with more SCIg drugs than any other system, reaffirming the company's leadership in this growing market.

Positive

• FDA 510(k) clearance to expand FREEDOM60 Infusion System to include additional medications.
• Supports enhanced patient treatment options with Cutaquig® and Xembify®.
• KORU Medical holds the leading position with more SCIg drug clearances than competitors.

Negative

• None.

CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use home infusion solutions, today announced FDA 510(k) clearance that expands on-label use of the FREEDOM60 Infusion System to two additional subcutaneous Ig (SCIg) medications, Cutaquig^®, manufactured by Octapharma, and Xembify^®, manufactured by Grifols.

“We are excited to announce another milestone for KORU Medical as we seek to further improve patients’ quality of life through the development and delivery of high-quality therapeutic drug delivery in the home. Having the FREEDOM60 Infusion System cleared for use with Xembify and Cutaquig allows patients and providers additional options for life enhancing subcutaneous immunoglobulin therapy treatment in the home with a system that has broad patient and healthcare worker adoption,” said Linda Tharby, President and CEO. “KORU Medical’s Freedom Infusion System is specifically cleared for use with more SCIg drugs than any other system. Adding Xembify and Cutaquig to our label, in addition to our recent FDA 510(k) clearance for use of Hizentra^® prefilled syringes with the FreedomEdge^®, extends KORU Medical’s leadership position in the growing SCIg market.”

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use specialty infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System currently includes the FREEDOM60^® and FreedomEdge^® Syringe Infusion Drivers, Precision Flow Rate Tubing^™ and HIgH-Flo Subcutaneous Safety Needle Sets^™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www.korumedical.com.

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Investor Contact:

Greg Chodaczek

347-620-7010

investor@korumedical.com

Source: KORU Medical Systems