MAHWAH, N.J. / May 14, 2024 / Business Wire / KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, is pleased to announce the signing of a Phase III clinical supply agreement for a novel enzyme replacement therapy to treat a rare endocrinological disease.

This significant milestone marks the progression of this collaboration, previously announced in July 2023. Since then, the KORU Medical Freedom System successfully passed validation testing to meet the subcutaneous infusion administration specifications for this novel drug. The Phase III trial will evaluate bi-weekly infusions using the Freedom System. If successful in the Phase III trial, this drug would be the first disease-modifying treatment option for the 10,000 patients worldwide afflicted by this rare genetic disease. The drug has been granted Breakthrough Therapy, Rare Pediatric Disease, and Fast Track designations by the FDA, as well as Orphan Drug designation in the US and Europe.

“We are proud of our role in developing devices that meet large volume subcutaneous delivery needs in collaboration with our valued pharmaceutical partners,” said Linda Tharby, President and CEO of KORU Medical Systems. “With the start of this Phase III clinical trial, we look forward to continuing to demonstrate our capability to successfully administer rare disease drugs across a growing range of indications.”

About KORU Medical Systems

KORU Medical Systems 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^™. These devices are used for infusions administered in the home and alternate care settings. 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 those relating to the start of the Phase III clinical trial and the use of the Freedom System in the clinical trial. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, success of the clinical trial, and by those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, 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 May 14, 2024. 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.