ForCast Orthopedics and KORU Medical Systems Announce Agreement for Novel Antibiotic Infusion Therapy

DENVER, CO AND MAHWAH, NJ / ACCESS Newswire / September 18, 2025 / ForCast Orthopedics, Inc. and KORU Medical Systems, Inc. (NASDAQ:KRMD) today jointly announced an agreement leveraging KORU Medical's FreedomEDGE® infusion system as part of ForCast's technology platform for the treatment of periprosthetic joint infection (PJI). PJI is a rare but serious complication of joint replacement procedures, and is challenging to treat because the infecting bacteria adhere to the prothesis and can form a protective biofilm which is resistant to standard systemic antibiotics.

KORU Medical's FreedomEDGE pump will provide the infusion technology to support ForCast's proprietary delivery system for PJI treatment, known as WIIS (Wearable Intra-Articular Infusion System), in anticipation of initiating a clinical trial in 2026.

"We are excited to kick off this development program with KORU," said Peter Noymer, PhD, Executive Chairman and CEO of ForCast. "After reviewing the entire landscape of infusion pump technologies available, it became clear that KORU's products were best suited for partnering with our WIIS platform and for meeting the needs of PJI patients."

ForCast's lead program, FC001, has received both Orphan Drug Designation and Qualified Infectious Disease Program (QIDP) designation from the U.S. Food & Drug Administration, which enable eligibility for Fast-Track Designation and Priority Review.

"We look forward to working with ForCast and helping them achieve their mission to modernize the standard of care for PJI," said Linda Tharby, President and CEO of KORU Medical. "Supporting such a novel delivery system highlights the utility of the Freedom System and we are proud to be a trusted supplier for our valued partners."

About ForCast Orthopedics

ForCast Orthopedics is a development-stage company pioneering the treatment of periprosthetic joint infection (PJI) with targeted antibiotic therapy. ForCast's mission is to modernize the standard of care for PJI and improve quality of life for the growing population of joint replacement patients.

About KORU Medical Systems

KORU Medical develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the "Freedom System") currently includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Services and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including but not limited to the success of KORU Medical technology supporting WIIS and timing to complete the clinical readiness assessment. Actual results may differ materially from these statements due to potential risks and uncertainties such as those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024 which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of September 18, 2025. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

Investor Contacts:

Peter Noymer, PhD
Executive Chairman and CEO
[email protected]

Louisa Smith
[email protected]

SOURCE: ForCast Orthopedics

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