KORU Medical Systems Receives Regulatory Clearance for FreedomEdge® Infusion System in Japan

Rhea-AI Summary

KORU Medical Systems (NASDAQ: KRMD) has secured regulatory clearance for its FreedomEdge® Infusion System in Japan. This approval includes the delivery of multiple drugs such as CSL Behring’s Hizentra, Takeda Pharmaceutical’s Cuvitru, and Sobi’s Aspaveli for conditions like Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH).

This clearance marks a significant milestone for KORU Medical, expanding its international market reach and enhancing patient care in Japan. The FreedomEdge® System, known for its reliability and patient-friendly design, allows for convenient at-home or clinical administration of large volume subcutaneous therapies.

CEO Linda Tharby highlighted this regulatory success as a testament to KORU’s commitment to improving global healthcare solutions. The system’s customizable features and portable design offer flexible and effective therapy management for patients and healthcare providers alike.

Positive

• Regulatory clearance of FreedomEdge® System in Japan.
• Approval includes key drugs: Hizentra, Cuvitru, Aspaveli.
• Enhances patient care for SCIg and PNH therapies.
• Expands KORU Medical's international market presence.
• System's reliability and user-friendly design praised.

Negative

• None.

Medical Research Analyst

Regulatory clearance for the FreedomEdge® Infusion System in Japan is a significant milestone for KORU Medical Systems. This event opens up the Japanese market, enabling access to a substantial patient base that can benefit from advanced subcutaneous therapies. The system's approval for delivering multiple drugs, including CSL Behring’s Hizentra, Takeda Pharmaceutical’s Cuvitru and Sobi’s Aspaveli, highlights its versatility and potential to meet diverse medical needs.

From a medical perspective, this clearance is pivotal as it introduces a reliable and patient-friendly option for administering large volume subcutaneous therapies. This is important in treating conditions like subcutaneous immunoglobulin therapy (SCIg) and paroxysmal nocturnal hemoglobinuria (PNH), which require frequent and precise drug administration. The system’s efficiency and ease of use promise to enhance patient compliance and outcomes, which can translate into better overall health management.

Moreover, the approval indicates that the device meets rigorous Japanese regulatory standards, which can bolster its credibility in other markets. This can potentially accelerate its adoption in regions with similar regulatory frameworks.

Investors should consider the long-term benefits of such a device in chronic disease management, potentially leading to steady revenue streams due to recurring usage and high patient demand.

Market Research Analyst

The entry of the FreedomEdge® Infusion System into the Japanese market is a strategic move that could significantly bolster KORU Medical Systems’ market presence and revenue. Japan is one of the largest healthcare markets globally and gaining regulatory clearance means access to a substantial and growing market for chronic disease management.

This move aligns with KORU Medical’s international expansion strategy and underscores their commitment to global growth. The company’s ability to secure regulatory approval in a stringent market like Japan also suggests robust regulatory and quality control processes, which are attractive to potential investors and partners. It positions KORU Medical favorably against competitors who have not yet penetrated this market.

From a market perspective, the introduction of the FreedomEdge® System could lead to increased market share and brand recognition in the Asia-Pacific region. It also opens up opportunities for partnerships with local healthcare providers and potentially other pharmaceutical companies looking for reliable drug delivery solutions.

For retail investors, this regulatory clearance indicates a positive growth trajectory and an expansion of the company’s market footprint, which could potentially lead to an appreciation in stock value.

MAHWAH, N.J.--(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 that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).

The regulatory milestone marks a significant advancement in patient care in Japan, providing patients and healthcare providers with access to cutting-edge treatment options for Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH). The FreedomEdge® System, known for its reliability, precision, and patient-friendly design, offers convenient and efficient administration of large volume subcutaneous therapies at home and in the clinic.

"We are very pleased to have received regulatory clearance for the FreedomEdge® System in Japan," said Linda Tharby, President and CEO of KORU Medical. "This accomplishment underscores our commitment to advancing healthcare solutions that enhance patients' lives worldwide and further strengthens KORU’s expansion into international markets. With the approval of the FreedomEdge System in Japan, we are proud to broaden access to critical therapies, empowering patients and healthcare providers with a reliable and user-friendly drug delivery platform."

The FreedomEdge System is designed to meet the diverse needs of patients and healthcare professionals, offering customizable features for personalized treatment experiences. Its compact and portable design allows for flexibility in treatment administration, enabling patients to manage their therapy effectively in various settings.

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™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Novel Therapies business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. 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 success of the feasibility study and the commercialization timing of a device for the oncology biologic drug. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, results of the feasibility study, 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, 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 July 2, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240702236315/en/

Investor Contact:

Greg Chodaczek

investor@korumedical.com

Source: KORU Medical Systems, Inc.

FAQ

What is the significance of KORU Medical’s regulatory clearance in Japan for KRMD?

The regulatory clearance for the FreedomEdge® Infusion System in Japan is a significant milestone for KORU Medical (KRMD), expanding its market reach and enhancing patient care for SCIg and PNH therapies.

Which drugs are included in the approval of KORU Medical's FreedomEdge® System in Japan?

The approval includes CSL Behring’s Hizentra, Takeda Pharmaceutical’s Cuvitru, and Sobi’s Aspaveli for Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH).

How will KORU Medical’s FreedomEdge® System benefit patients and healthcare providers in Japan?

The FreedomEdge® System offers reliable, customizable, and user-friendly features, allowing for convenient at-home or clinical administration of large volume subcutaneous therapies.

What impact will the regulatory clearance of FreedomEdge® have on KORU Medical's market presence?

The regulatory clearance enhances KORU Medical's international market presence, providing access to critical therapies and supporting the company's global expansion efforts.

What makes the FreedomEdge® Infusion System notable in its design and functionality?

The FreedomEdge® System is known for its reliability, precision, and compact, portable design, which allows for flexible and efficient management of subcutaneous therapies.