KORU Medical Systems Announces Phase III Clinical Trial Collaboration for a New Drug Indication in Nephrology
30 Gennaio 2025 - 10:05PM
Business Wire
KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the
“Company”), a leading medical technology company focused on the
development, manufacturing, and commercialization of innovative and
patient-centric large volume subcutaneous infusion solutions, today
announced a collaboration with a global pharmaceutical manufacturer
on a Phase III clinical trial for an expanded indication of a
commercialized drug therapy. The expanded indication is intended to
treat a rare renal disorder in a population of approximately 30,000
patients with a projected 300,000 annual infusions.
This announcement highlights an additional collaboration between
KORU Medical and its partners in the development of novel therapies
and enhanced drug delivery experiences for patients living with
rare conditions. The Phase III trial aims to assess the safety,
efficacy, and performance of the drug to treat patients with
complications from kidney transplants.
“We continue to see growth in the overall large volume
subcutaneous market with multiple new drugs entering clinical
trials and several others receiving regulatory approval. With over
2 million infusions administered on the KORU Freedom Infusion
System every year, KORU continues to be a leading collaboration
partner for large volume subcutaneous drug therapies in both the
home and infusion clinic settings,” said Linda Tharby, President
and CEO of KORU Medical. “Assuming successful completion and
results from this Phase III clinical trial, this drug’s expanded
indication will give us access to a new patient base and enable the
delivery of a therapy to improve the lives of those with rare renal
disorder.”
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™. 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 Novel Therapies 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 the Phase III trial, success of the regulatory
clearance, number of potential infusions available to the Freedom
Infusion System. 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,
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 January 30, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20250129094544/en/
Investor Contact: Louisa Smith
investor@korumedical.com
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