KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of EMPAVELI® (pegcetacoplan), Expands European Label for FreedomEdge®
May 02 2022 - 4:01PM
Business Wire
KORU expands label indication for
self-administered FreedomEdge infusion system
Repro Med Systems, Inc. dba 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 easy-to-use specialty infusion
solutions that improve quality of life for patients, today
announced 510k clearance for use of the KORU Medical FreedomEdge®
infusion system to deliver pegcetacoplan 20 mL solution, branded as
EMPAVELI® or Aspaveli® and commercialized by Apellis in the United
States and by Sobi outside the United States.
EMPAVELI® and Aspaveli® are approved to treat adults with a
chronic disease called paroxysmal nocturnal hemoglobinuria (PNH),
which affects approximately 15,000 patients with PNH worldwide. PNH
is a rare, life-threatening blood disorder caused by an acquired
mutation, which leads to the body’s immune system destroying its
own red blood cells, causing frequent transfusions and symptoms
such as severe fatigue, hemoglobinuria, and difficulty breathing
(dyspnea).
"As the leader in subcutaneous self-administration of
high-volume (>10 milliliters) drug delivery in the home, we are
pleased to expand our label to another drug therapy class with the
addition of EMPAVELI® and Aspaveli®," said Linda Tharby, KORU
Medical's President and Chief Executive Officer. "We're confident
that our online training capability and our support to healthcare
providers, as proven by our work with tens of thousands of
subcutaneous immunoglobulin patients, will help enable EMPAVELI®
and Aspaveli® infusions. The FreedomEdge was used in EMPAVELI’s PNH
pivotal studies and is now commercially available. This FDA
clearance is another example of our strategy to expand the use of
our self-administered Freedom pump platforms to further drug
therapies and optimize the infusion experience."
About KORU Medical Systems
KORU Medical Systems develops, manufactures, and commercializes
innovative and easy-to-use specialty infusion solutions that
improve quality of life for patients around the world. The FREEDOM
Syringe 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.
Trademark Statement
EMPAVELI® trademark is property of Apellis and Sobi. Aspaveli®
trademark is property of Sobi.
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", "seeks to", and "trend". 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, actual
performance of the parties under the collaboration, patient demand
for new in-home infusion products, 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 May 2, 2022 and
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/20220502005725/en/
Greg Chodaczek 347-620-7010 investor@korumedical.com
KORU Medical Systems (NASDAQ:KRMD)
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