KORU Medical Systems Announces Successful Appeal in EU Notified Body Review
April 11 2024 - 4:05PM
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, today
announced a successful appeal related to an ongoing audit by its
notified body in the EU, The British Standards Institute (BSI).
The Company’s appeal of an assessment report from BSI regarding
a recommendation against continued certification in connection with
prior audit nonconformance, was upheld. As a result, the Company
will proceed through the routine BSI assessment process without
suspension or interruption of the Company’s sale of products in the
EU.
“We are pleased by our successful appeal to BSI’s assessment
report. Our team’s swift response and positive interaction with
BSI, resulted in no interruption of sales of KORU Medical’s
products to the market and our patients,” said Linda Tharby, KORU
Medical’s President and CEO. “Our products remain certified,
marketed and sold in the EU, and we are excited by the continued
expansion of our international business.”
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
sales expansion into new regions. 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 April 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/20240411104030/en/
Investor Contact: Louisa Smith
investor@korumedical.com
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