KORU Medical Systems Signs a Clinical Supply Agreement for Phase 3 Trial with Leading Pharma Partner Using Custom Device for a Novel Subcutaneous Immunoglobulin
06 Mars 2024 - 1:00PM
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 a clinical supply agreement for a novel
subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials.
The custom product developed for this clinical trial under a prior
agreement was built off the foundation of the KORU Medical Freedom
System and tailored to meet the unique subcutaneous infusion
administration specifications of this novel drug.
This significant milestone represents an essential advancement
in developing novel therapies for patients with immunological
disorders. The Phase 3 trial aims to assess the safety, efficacy,
and performance of the SCIg drug in treating various medical
conditions, including autoimmune diseases, primary immunodeficiency
disorders, and neurological disorders.
The newly developed custom device, designed by KORU Medical's
team of experts, includes advanced technology and user-friendly
interfaces to enhance patient comfort and ensure precise therapy
delivery.
“We are proud of our role in developing devices that meet large
volume subcutaneous delivery needs, demonstrating KORU Medical’s
ability to support our pharmaceutical partners’ drug development
process and patient needs,” said Linda Tharby, President and CEO of
KORU Medical. "We are excited to announce the execution of this
Phase 3 clinical supply agreement, marking a critical step forward
in our commitment to advancing healthcare through innovation.
Assuming successful completion and results of the Phase 3 trial, we
expect to file a 510k and commercialize with this novel SCIg
drug."
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 Company’s development of a customized Freedom
System, submission of a device for FDA clearance, entry into AICs
and AISs, and continuing leadership in large volume subcutaneous
infusion. Actual results may differ materially from these
statements due to potential risks and uncertainties such as, among
others, success of the feasibility study, agreement with the
pharmaceutical manufacturer with respect to customization of the
system, successful development of the system, obtaining regulatory
clearances, 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, 2022 and our Quarterly Report on Form 10-Q
for the quarter ended September 30, 2023, which are 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 March 11, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240306735727/en/
Investor Contact: Louisa Smith
investor@korumedical.com
KORU Medical Systems (NASDAQ:KRMD)
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