KORU Medical Systems Announces Novel Therapies Collaboration for Late-Stage Endocrinological Biologic

Rhea-AI Summary

KORU Medical Systems has announced an agreement with a biopharmaceutical company to validate its FREEDOM Infusion System for use with a novel biologic drug. The drug developer is expected to begin Phase III studies by the end of 2023 for the treatment of a rare genetic disease. This collaboration adds to KORU Medical's existing partnerships for Phase II and Phase III studies of treatments in various medical fields.

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• KORU Medical Systems has secured a collaboration agreement with a biopharmaceutical company for the validation of its FREEDOM Infusion System, which could lead to increased adoption of the system and potential commercialization opportunities. The drug developer's Phase III studies for a rare genetic disease with no current pharmaceutical treatments could provide significant market potential for KORU Medical.

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MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced an agreement with a biopharmaceutical company to validate its FREEDOM™ Infusion System for use with the biopharma company’s drug, a novel biologic. Under terms of the Agreement, Koru Medical will validate the Freedom Infusion System for use with the company’s drug. The drug developer is expected to begin Phase III studies by the end of 2023 for treatment of a rare genetic disease with global prevalence of roughly 10,000 that currently has no pharmaceutical treatments.

The agreement adds to KORU Medical’s previously announced collaborations with multiple biopharmaceutical companies for Phase II and Phase III studies of treatments for neurology, immunology, pulmonology, and other diseases outside of KORU’s Medical’s core subcutaneous immunoglobulin market.

“Adding a late-stage pharmaceutical collaboration is a major milestone for our Novel Therapies business as we continue to progress our relationships to help drive greater knowledge and adoption around the benefits of subcutaneous drug delivery for patients in the home. We are excited to partner with this rare disease biopharmaceutical company to bring a therapy to an area of significant unmet need where patients have few options today,” said Linda Tharby, KORU Medical’s President and CEO. “We believe drug development companies are choosing Koru’s Freedom System because of our proven experience in delivering millions of subcutaneous home infusions each year paired with our ability to rapidly customize the Freedom System for use in their development programs and a high-confidence path to commercialization.”

About KORU Medical

KORU Medical develops, manufactures, and commercializes innovative and easy-to-use 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 that involve risks and uncertainties. Forward-looking statements can be identified by words such as "will" and “seek” and include without limitation the success and potential benefits of the Freedom System adaptation. Actual results may differ materially from the results predicted. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, whether KORU Medical can successfully develop and obtain regulatory approval for the adaptation and those risks and uncertainties included under the captions "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, which is available on the SEC website at www.sec.gov and on our website at www.korumedical.com/investors. All information provided in this release and in the attachments is as of July 27, 2023 and based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230727853994/en/

Investor Contact:

Greg Chodaczek

347-620-7010

investor@korumedical.com

Source: KORU Medical Systems, Inc.

FAQ

What is KORU Medical Systems' agreement with the biopharmaceutical company?

KORU Medical Systems has entered into an agreement to validate its FREEDOM Infusion System for use with a novel biologic drug.

What is the expected timeline for the drug developer's Phase III studies?

The drug developer is expected to begin Phase III studies by the end of 2023.

What is the significance of this collaboration for KORU Medical Systems?

This collaboration adds to KORU Medical's existing partnerships and could lead to increased adoption of its FREEDOM Infusion System, as well as potential commercialization opportunities.

What is the target disease for the drug developer's Phase III studies?

The drug developer is conducting Phase III studies for the treatment of a rare genetic disease with no current pharmaceutical treatments.

What are the potential market opportunities for KORU Medical Systems?

The collaboration with the drug developer for a rare genetic disease treatment could provide significant market potential for KORU Medical.