KORU Medical Systems, Inc. Announces 510(K) Submission for Freedom60® Infusion System With Hizentra® 50 Ml Prefilled Syringes
10 Juli 2023 - 1:01PM
Business Wire
KORU Medical Systems, Inc. (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 subcutaneous infusion solutions that
improve quality of life for patients, today announced that it has
submitted a 510(k) premarket notification submission to the U.S.
Food and Drug Administration for the use of its FREEDOM60® Infusion
System with Hizentra® 50 mL prefilled syringes.
"This submission is another milestone in KORU Medical’s mission
to make subcutaneous therapy radically simpler and easier for
patients. Through this application for the use of the Freedom60
Infusion System with Hizentra 50 mL prefilled syringes and our
earlier prefilled syringe clearance, we will be able to deliver
benefits to all patients who are self-administering subcutaneous
immunoglobulin treatment in the home," said Linda Tharby, KORU
Medical's President and CEO. "Our studies show up to an 80%
reduction in drug preparation tasks for patients using prefilled
syringes with the FREEDOM™ Infusion System as compared to vials.
With market data showing significant uptake in prefilled syringe
market growth, this 510(k) submission is another innovation
milestone for KORU Medical that will further enhance the patient
experience and potentially be an additional growth driver for home
subcutaneous therapy."
The FDA approved the 50 mL Hizentra prefilled syringe in April
2023. Hizentra is the most prescribed subcutaneous immunoglobulin
and the first to be available in prefilled syringes.
About KORU Medical Systems
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 certain forward-looking statements
regarding KORU Medical’s 510(k) premarket notification for the use
of its FREEDOM60 Infusion System with Hizentra 50 mL prefilled
syringes and the growth of the prefilled syringe market and home
subcutaneous therapy. Forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied in such statements, and there can
be no assurance that KORU Medical will obtain 510(k) clearance or
as to the timing of any such clearance. Many of these risks and
uncertainties are beyond KORU Medical’s control, including without
limitation, risks relating to regulatory clearance and market
acceptance of the use of the FREEDOM60 Infusion System with
Hizentra 50 mL prefilled syringes. KORU Medical expressly disclaims
any undertaking to update any forward-looking statements set forth
herein to reflect events or circumstances after the date hereof,
except as required by applicable laws or regulations.
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version on businesswire.com: https://www.businesswire.com/news/home/20230710530546/en/
Investor Contact: Greg Chodaczek 347-620-7010
investor@korumedical.com
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