KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of EMPAVELI® (pegcetacoplan), Expands European Label for FreedomEdge®

Rhea-AI Summary

KORU Medical Systems (NASDAQ: KRMD) has received 510k clearance for its FreedomEdge infusion system, which will now deliver pegcetacoplan (EMPAVELI®/Aspaveli®) in the U.S. This drug treats paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder affecting about 15,000 patients globally. The company's President emphasized the expansion of their infusion technology to enhance patient care and emphasized their online training support for healthcare providers. This development aligns with KORU's strategy to broaden its infusion solutions.

Positive

• 510k clearance obtained for FreedomEdge infusion system to deliver pegcetacoplan.
• Expands treatment options for paroxysmal nocturnal hemoglobinuria (PNH) patients.
• Demonstrates commitment to enhancing patient care through innovative infusion technology.

Negative

• None.

KORU expands label indication for self-administered FreedomEdge infusion system

CHESTER, N.Y.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005725/en/

Greg Chodaczek

347-620-7010

investor@korumedical.com

Source: KORU Medical Systems

FAQ

What recent clearance did KORU Medical Systems receive?

KORU Medical Systems received 510k clearance for its FreedomEdge infusion system.

What drug is now approved for use with KORU's FreedomEdge system?

The FreedomEdge system is now cleared to deliver pegcetacoplan, branded as EMPAVELI® or Aspaveli®.

What condition does the drug pegcetacoplan treat?

Pegcetacoplan is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.

How many patients are affected by PNH globally?

Approximately 15,000 patients worldwide are affected by paroxysmal nocturnal hemoglobinuria (PNH).

What is KORU Medical's strategy regarding infusion technology?

KORU Medical aims to expand the use of its self-administered Freedom pump platforms to enhance the infusion experience.