KORU Medical Systems Announces Strategic Collaboration for Phase III Clinical Trial on Expanded Drug Indication for Rare Renal Disorder
KORU Medical Systems (NASDAQ: KRMD), a prominent medical technology company focused on innovative, patient-centric large volume subcutaneous infusion solutions, has announced a new collaboration with a global pharmaceutical manufacturer to conduct a Phase III clinical trial. The trial seeks to expand the indication of an already commercialized drug therapy to address a rare renal disorder. This development is expected to target an underserved patient population, estimated at approximately 30,000 individuals, with an anticipated 300,000 annual infusions required for treatment.
The collaboration underscores KORU Medical’s role as a key player in the growing field of large volume subcutaneous infusion therapy, where the company continues to push the boundaries of drug delivery solutions designed to improve patient outcomes, particularly in cases of rare and complex conditions. The Phase III trial aims to evaluate the safety, efficacy, and performance of the drug in treating patients who have complications arising from kidney transplants.
Linda Tharby, President and CEO of KORU Medical, emphasized the company’s growing leadership in the market for large volume subcutaneous drug therapies. “We continue to see significant growth in the overall market, driven by multiple new drugs entering clinical trials and several others achieving regulatory approval,” Tharby said. “With over 2 million infusions administered annually through our KORU Freedom Infusion System, we have established ourselves as a leading collaboration partner for large volume subcutaneous drug therapies, both in the home and infusion clinic settings.”
The clinical trial’s focus on a rare renal disorder provides an opportunity for KORU Medical to expand its portfolio of therapies, offering innovative solutions that cater to the unique needs of patients who would otherwise have limited treatment options. The expected outcomes of the trial could be transformative, not only for the targeted patient group but also for the healthcare landscape as a whole.
A New Frontier in Subcutaneous Infusion Therapy
KORU Medical’s collaboration with the global pharmaceutical manufacturer marks a significant step forward in the development of novel therapies that leverage subcutaneous infusion systems. These therapies are designed to improve the quality of life for patients by making drug delivery more convenient and less invasive than traditional methods, such as intravenous infusions. Subcutaneous infusion therapies have gained prominence in recent years due to their potential to be administered at home, providing patients with greater autonomy and reducing the need for frequent hospital visits.
For patients with rare renal disorders, particularly those who have undergone kidney transplants, this new drug indication offers the promise of more effective treatment options. Kidney transplant recipients often face a range of complications, including issues related to immune suppression, organ rejection, and infections. The ability to treat these complications with a drug administered via subcutaneous infusion could lead to significant improvements in patient outcomes.
Addressing the Needs of a Growing Patient Population
The renal disorder targeted by this expanded drug indication is relatively rare, but the patient population is significant, with an estimated 30,000 individuals in need of treatment. With kidney transplants becoming more common and more successful, the need for effective therapies to manage transplant-related complications has never been more pressing. The projected 300,000 annual infusions required for this patient group highlights the scale of the need for effective, accessible treatment options.
Moreover, the focus on large volume subcutaneous infusion systems aligns with a broader trend in the healthcare industry toward more patient-centric care models. These systems offer a more comfortable and convenient alternative to intravenous infusions, which are often administered in clinical settings. By expanding the use of subcutaneous infusion systems for this new indication, KORU Medical is helping to improve patient care while also driving innovation in the drug delivery space.
A Growing Market for Large Volume Subcutaneous Infusions
The market for large volume subcutaneous infusion systems has experienced steady growth, fueled by increasing patient demand and advancements in drug delivery technologies. As more pharmaceutical companies develop drugs that can be administered subcutaneously, the need for efficient, reliable infusion systems has become more pronounced.
KORU Medical has been at the forefront of this growth, with its KORU Freedom Infusion System becoming a key player in both the home and infusion clinic settings. The system, which is used to administer a range of therapies, has facilitated over 2 million infusions annually, solidifying KORU’s position as a trusted partner in the industry.
Tharby noted, “With over 2 million infusions administered on the KORU Freedom Infusion System every year, we continue to build on our leadership position in the market for large volume subcutaneous drug therapies.” This extensive experience positions KORU Medical to play a vital role in the Phase III trial, as the company brings its expertise in infusion systems to support the delivery of the expanded drug indication.
The Potential Impact on Patients and Healthcare Providers
If the Phase III clinical trial is successful, the expanded indication for this drug will open new avenues for treating patients with rare renal disorders. Kidney transplant recipients often face a complex set of challenges, and the ability to treat complications using a subcutaneous drug infusion system could significantly improve patient outcomes. The convenience and comfort of subcutaneous infusion, coupled with the efficacy of the drug, could result in better disease management, fewer hospital visits, and an overall improvement in quality of life for these patients.
Additionally, healthcare providers will benefit from the expanded treatment options, as it offers a new tool for managing kidney transplant complications. By collaborating with a global pharmaceutical manufacturer, KORU Medical is helping to streamline the development process, ensuring that the therapy reaches the patient population that needs it most.
KORU Medical’s collaboration on the Phase III clinical trial is just one example of the company’s ongoing commitment to advancing patient care through innovative drug delivery solutions. The company has built a strong foundation in large volume subcutaneous infusion technology, and this latest collaboration is a testament to its dedication to improving the lives of patients living with rare and complex conditions.
“As we continue to see growth in the large volume subcutaneous market, we remain focused on expanding our product offerings and forging new partnerships that will enable us to deliver better therapies to patients,” Tharby said. “The successful completion of this Phase III trial could pave the way for further advancements in the treatment of rare renal disorders, as well as other conditions that could benefit from subcutaneous drug delivery.”
With its robust portfolio of infusion systems and a growing network of strategic partnerships, KORU Medical is well-positioned to continue driving innovation in the field of large volume subcutaneous infusion therapies. The collaboration on this Phase III trial is just the beginning of what promises to be a bright future for the company and the patients it serves.
