KORU Medical Systems Partners on Phase III Clinical Trial for Innovative Nephrology Drug Indication

KORU Medical Systems Partners on Phase III Trial for Rare Renal Disorder Treatment, Expanding Its Reach in Subcutaneous Infusion Solutions

KORU Medical Systems (NASDAQ: KRMD), a leading innovator in large-volume subcutaneous infusion solutions, has announced an exciting collaboration with a global pharmaceutical manufacturer to support a Phase III clinical trial for an expanded indication of a commercialized drug therapy. This new indication aims to address a rare renal disorder affecting approximately 30,000 patients globally, with an estimated 300,000 annual infusions required. The partnership underscores KORU Medical’s growing role as a key collaborator in advancing novel therapies and enhancing patient experiences through its cutting-edge drug delivery technologies.

The Phase III trial will evaluate the safety, efficacy, and performance of the drug in treating complications arising from kidney transplants. If successful, this expanded indication could significantly improve outcomes for patients living with this rare condition while further solidifying KORU Medical’s position as a leader in the large-volume subcutaneous infusion market.

A Strategic Collaboration to Address Unmet Need

This collaboration marks another milestone in KORU Medical’s ongoing efforts to partner with biopharmaceutical companies in developing innovative treatments for underserved patient populations. By leveraging its expertise in large-volume subcutaneous infusion systems, KORU Medical is helping bring life-changing therapies to patients who face challenges accessing effective treatments.

“Assuming successful completion and results from this Phase III clinical trial, this drug’s expanded indication will give us access to a new patient base and enable the delivery of a therapy to improve the lives of those with a rare renal disorder,” said Linda Tharby, President and CEO of KORU Medical. “We continue to see growth in the overall large-volume subcutaneous market, with multiple new drugs entering clinical trials and several others receiving regulatory approval.”

With over 2 million infusions administered annually using the KORU Freedom Infusion System, the company has established itself as a trusted partner for both home-based and clinical infusion settings. This latest collaboration highlights KORU Medical’s ability to adapt its technology to meet the unique needs of diverse therapeutic areas, including nephrology.

The Freedom System: Revolutionizing Drug Delivery

At the heart of KORU Medical’s success is its flagship product line, the FREEDOM Syringe Infusion System (the “Freedom System”). Designed to enhance patient convenience and treatment adherence, the Freedom System includes:

  • FREEDOM60®: A robust syringe infusion driver ideal for high-volume infusions.
  • FreedomEdge®: A compact and portable option for patients requiring flexibility in their treatment regimens.
  • Precision Flow Rate Tubing™: Ensures accurate and consistent delivery of medications.
  • HIgH-Flo Subcutaneous Safety Needle Sets™: Minimizes discomfort and maximizes safety during self-administration.

Since receiving its first FDA clearance in 1994, the Freedom System has become a cornerstone of subcutaneous drug delivery, empowering patients to self-administer treatments at home or receive care in ambulatory infusion centers under the supervision of healthcare professionals. Its versatility and reliability make it an invaluable tool for delivering therapies across various medical fields, including immunology, oncology, and now nephrology.

Driving Innovation Through Novel Therapies

Beyond its commercial products, KORU Medical plays a pivotal role in supporting biopharmaceutical companies during the drug development process. Through its Novel Therapies business unit, the company provides tailored solutions for feasibility studies and clinical trials, ensuring that emerging therapies can be delivered safely and effectively. When necessary, KORU Medical also customizes its Freedom System to meet the specific requirements of different drug categories, enabling seamless integration into clinical and commercial applications.

This collaborative approach not only accelerates the development of groundbreaking treatments but also ensures that patients have access to therapies designed with their needs in mind. For individuals managing chronic or rare conditions, such innovations can mean the difference between a life limited by illness and one marked by improved health and independence.

Expanding Access to Rare Disease Treatments

Rare diseases often present significant challenges due to limited treatment options and complex care requirements. The renal disorder targeted in this Phase III trial is no exception, affecting a relatively small yet vulnerable population. By supporting the expansion of this drug’s indication, KORU Medical is contributing to a broader effort to address unmet medical needs and improve quality of life for patients worldwide.

If the trial yields positive results, the drug could offer a much-needed solution for individuals experiencing complications following kidney transplants. Moreover, the use of KORU Medical’s Freedom System ensures that patients can administer their treatments conveniently and comfortably, whether at home or in a clinical setting.

A Growing Market for Subcutaneous Infusion Solutions

The demand for large-volume subcutaneous infusion solutions continues to rise as more therapies transition from intravenous to subcutaneous administration. This shift is driven by the benefits of subcutaneous delivery, including reduced hospital visits, lower costs, and improved patient satisfaction. KORU Medical’s leadership in this space positions it to capitalize on these trends while fostering partnerships that drive innovation.

“We are proud to collaborate with forward-thinking pharmaceutical manufacturers to bring transformative therapies to market,” added Tharby. “Our mission is to empower patients with tools that enhance their quality of life, and this partnership exemplifies our commitment to that goal.”

About KORU Medical Systems

Headquartered in Chester, New York, KORU Medical Systems is a pioneering medical technology company dedicated to improving the lives of patients through innovative large-volume subcutaneous infusion solutions. The company’s flagship product, the FREEDOM Syringe Infusion System, is widely used for self-administration at home and professional delivery in ambulatory infusion centers.

Through its Novel Therapies business, KORU Medical supports biopharmaceutical companies in developing and delivering cutting-edge treatments for a wide range of conditions. With a focus on customization, reliability, and patient-centric design, KORU Medical continues to set the standard for excellence in drug delivery.

For more information about KORU Medical Systems and its transformative technologies, visit www.korumedical.com.

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