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KORU Medical Systems Announces Subcutaneous Immunoglobulin Prefilled Syringe Development Agreement
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Rhea-AI Summary
KORU Medical Systems, Inc. (NASDAQ: KRMD) has announced a development agreement with a pharmaceutical company to enhance its Freedom Infusion System for subcutaneous immunoglobulin therapy using prefilled syringes. This adaptation aims to facilitate home drug delivery for patients, as prefilled syringes are preferred for their ease of use. The Freedom Infusion System is the only approved system for this application. While the financial terms of the agreement remain undisclosed, the partnership is seen as a significant step towards expanding the number of FDA-approved therapies available for patients globally.
Positive
Development agreement with a major pharmaceutical company to enhance the Freedom Infusion System.
Focus on subcutaneous drug delivery aligns with patient preferences for ease of use.
The Freedom Infusion System is uniquely approved for use with prefilled syringes.
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None.
MAHWAH, N.J.--(BUSINESS WIRE)--
KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients, today announced a development agreement with a pharmaceutical manufacturer of subcutaneous immunoglobulin therapy (SCIg) to develop and seek regulatory approval of the Freedom Infusion System with an SCIg prefilled syringe.
“As KORU Medical looks to simplify subcutaneous drug delivery for patients in the home, we are excited to partner with another major pharmaceutical company to further innovate our Freedom Infusion System™ for use with their prefilled syringes. Patients prefer prefilled syringes as they simplify the challenging task of transferring medication from vials,” said Linda Tharby, KORU Medical’s President and CEO. “The Freedom Infusion System is the only infusion system approved for prefilled syringes, and we are excited by the opportunity to expand the number of prefilled subcutaneous therapies that are FDA approved for our innovative infusion system.”
The agreement provides for KORU Medical to develop an adaptation to its Freedom Infusion System to enable an SCIg prefilled syringe to be usable by patients globally and seek regulatory authorization for adaptation. Terms of the agreement were not disclosed.
About KORU Medical
KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients around the world. The FREEDOM 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.
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 Annual Report on Form 10-K for the year ended December 31, 2021, 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 January 25, 2023 and based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.
What is the recent development agreement by KORU Medical Systems (KRMD)?
KORU Medical Systems announced a development agreement to enhance its Freedom Infusion System for subcutaneous immunoglobulin therapy using prefilled syringes.
How does the Freedom Infusion System benefit patients?
The Freedom Infusion System simplifies drug delivery, particularly for patients who prefer prefilled syringes, making medication administration easier at home.
Is the Freedom Infusion System approved for prefilled syringes?
Yes, the Freedom Infusion System is the only infusion system approved for use with prefilled syringes.
What future opportunities does the agreement create for KORU Medical Systems (KRMD)?
The agreement aims to expand the number of FDA-approved subcutaneous therapies employing the Freedom Infusion System.
What are the terms of KORU Medical's agreement with the pharmaceutical manufacturer?
The specific terms of the development agreement have not been disclosed.
