Pioneering Patient-Centric Solutions: The KORU Medical Systems Story
In the ever-evolving landscape of healthcare, one company stands out for its unwavering commitment to patient-centric innovation and excellence: KORU Medical Systems. Since its inception, KORU Medical has been at the forefront of developing, manufacturing, and commercializing innovative and patient-centric subcutaneous infusion solutions for use in the home and in ambulatory infusion clinics.
For many patients, managing their immunodeficiency meant frequent trips to the hospital for IV administration. With the movement of care from the hospital to the home, many can now administer treatments at home, gaining independence and improving their quality of life.1 Led by a visionary team and driven by a passion for improving patient outcomes, KORU Medical is revolutionizing the field of subcutaneous therapy, providing simple, cost-effective, and user-friendly solutions for patients and healthcare professionals worldwide.
Join us as we delve into the remarkable journey of KORU Medical, a beacon of hope and innovation in the healthcare industry.
Linda Tharby, could you provide us with a brief overview of KORU Medical and its services?
KORU Medical develops, manufactures, and commercializes innovative and patient-centric large-volume subcutaneous infusion solutions that improve the quality of life for patients around the world. The company was incorporated in March 1980 as Repro Med Systems. In 1994, with the first FDA clearance of the Freedom Infusion System, the door opened to a new way for patients and healthcare professionals to administer their drug therapy. In 2019, the company rebranded to KORU Medical Systems – with the word KORU and our logo, symbolizing new life, growth and strength for the patients that we serve. The company was uplisted to the NASDAQ in 2020, with a trading symbol of KRMD.
KORU Medical is committed to sustainability, with many of our product offerings being reusable to help pharmaceutical partners meet their sustainability goals. By emphasizing reusable products, we aim to minimize environmental impact and contribute to a more sustainable healthcare industry.
KORU Medical’s focus on generating clinical evidence to support the efficacy and safety of its products demonstrates a dedication to evidence-based practice and a commitment to transparency and accountability. By showcasing our research findings through peer reviewed published papers, posters and abstracts at key conferences, we seek to enhance our reputation as a trusted leader in the field of subcutaneous therapy.
KORU Medical’s aggressive approach to protecting its intellectual property through patents reflects our commitment to safeguarding our investments in innovation and maintaining a competitive advantage in the market. With over 70 global patents and ongoing patent applications, we are well-positioned to defend our innovations and capitalize on new opportunities as they arise.
KORU Medical’s experience in the healthcare industry showcases our dedication to innovation, patient-centered care, and sustainability. With a focus on continuous improvement and collaboration, KORU Medical is well-positioned to drive positive change and improve patient outcomes in the years to come.
Our strategic vision for 2026 reflects a commitment to excellence, innovation, and strategic growth, positioning the company for continued success and leadership in the global market for subcutaneous therapy.
Can you tell us about Immunodeficiency Diseases, and how does KORU Medical assists patients dealing with them?
KORU Medical currently services over 40,000 immunodeficient patients globally.7 This journey began in 2010 with the first FDA clearance of Hizentra®, a subcutaneous immunoglobulin drug. Immunodeficiency Diseases encompass a group of rare genetic disorders characterized by defects in the immune system, resulting in a weakened ability to fight off infections and diseases caused by various pathogens.8
These disorders, which include Primary Immunodeficiency (PIDD), Secondary Immunodeficiency (SID), and Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), pose significant health risks to affected individuals. PIDD and SID are immunodeficiency disorders, while CIDP is an autoimmune disorder affecting the peripheral nervous system. Individuals with these conditions typically require lifelong replacement therapy with immunoglobulin (Ig) to reduce the risk of infection and maintain their health.8
Both IVIg and SCIg are forms of immunoglobulin therapy used to treat various medical conditions, including primary immunodeficiency diseases (PIDD), autoimmune diseases, and certain neurological conditions. Here’s a comparison of the two treatment modalities:
Intravenous Immunoglobulin Therapy (IVIg) and Subcutaneous Immunoglobulin Therapy (SCIg)9:
IVIg involves the intravenous administration of immunoglobulins, which are purified antibodies derived from human plasma. Treatment typically takes place in a hospital or clinical setting and is administered by a trained medical professional, such as a nurse or physician. IVIg infusions can take several hours to complete, depending on the dose and patient’s tolerance. Patients receiving IVIg may experience side effects such as headache, fever, chills, nausea, and allergic reactions. Despite the inconvenience of hospital visits and potential side effects, IVIg therapy remains an effective treatment option for many patients with PIDD and other conditions.9
SCIg involves the subcutaneous administration of immunoglobulins, which are injected under the skin using a needle, syringe and an infusion pump. Unlike IVIg, SCIg therapy can be administered at home by the patients themselves or with the assistance of a caregiver, following appropriate training from healthcare professionals. SCIg infusions can be scheduled at times convenient for the patient, offering flexibility and independence in managing treatment. Because SCIg is absorbed slowly into the bloodstream, it can lead to more stable antibody levels over time compared to IVIg.10 Additionally, SCIg therapy is associated with a lower rate of adverse events and side effects compared to IVIg, making it a preferred option for some patients.11 While SCIg therapy may require more frequent infusions compared to IVIg, the ability to administer treatment at home and reduce the need for hospital visits can lead to lower healthcare costs and improved quality of life for patients.9
KORU Medical plays a crucial role in assisting patients dealing with Immunodeficiency Diseases by offering simple, easy-to-use, and cost-effective home-based subcutaneous infusion treatments. Subcutaneous immunoglobulin (SCIg) drug therapy and our Freedom Infusion System allows patients to self-administer their medication in the comfort of their own home, providing them with greater control over their treatment schedule and environment.
By enabling home-based SCIg therapy, KORU Medical empowers patients with Immunodeficiency to take an active role in managing their condition, promoting a sense of independence and autonomy. Patients no longer need to rely solely on healthcare professionals or visit healthcare facilities for their infusion treatments, which can be especially beneficial for individuals with chronic conditions requiring lifelong therapy.
In addition to the convenience and flexibility afforded by home-based SCIg therapy, KORU Medical’s solutions are designed to be user-friendly, ensuring that patients can easily and safely administer their medication. This simplicity and accessibility are essential for promoting adherence to treatment regimens and improving patient outcomes.
Could you educate us about IVIg and SCIg?
Both IVIg and SCIg are forms of immunoglobulin therapy used to treat various medical conditions, including primary immunodeficiency disorders (PIDD), autoimmune diseases, and certain neurological conditions. Here’s a comparison of the two treatment modalities:
Intravenous Immunoglobulin Therapy (IVIg): IVIg involves the intravenous administration of immunoglobulins, which are purified antibodies derived from human plasma.
Treatment typically takes place in a hospital or clinical setting and is administered by a trained medical professional, such as a nurse or physician.
IVIg infusions can take several hours to complete, depending on the dose and patient’s tolerance. Patients receiving IVIg may experience side effects such as headache, fever, chills, nausea, and allergic reactions.
Despite the inconvenience of hospital visits and potential side effects, IVIg therapy remains an effective treatment option for many patients with PIDD and other conditions.
Subcutaneous Immunoglobulin Therapy (SCIg): SCIg involves the subcutaneous administration of immunoglobulins, which are injected under the skin using a needle and syringe or an infusion pump.
Unlike IVIg, SCIg therapy can be administered at home by the patients themselves or with the assistance of a caregiver, following appropriate training from healthcare professionals. SCIg infusions can be scheduled at times convenient for the patient, offering flexibility and independence in managing treatment.
Because SCIg is absorbed slowly into the bloodstream, it can lead to more stable antibody levels over time compared to IVIg.
Additionally, SCIg therapy is associated with a lower rate of adverse events and side effects compared to IVIg, making it a preferred option for some patients.
While SCIg therapy may require more frequent infusions compared to IVIg, the ability to administer treatment at home and reduce the need for hospital visits can lead to lower healthcare costs and improved quality of life for patients.
Both IVIg and SCIg are effective forms of immunoglobulin therapy used to manage various medical conditions. The choice between IVIg and SCIg depends on factors such as patient preference, treatment goals, and clinical considerations, and should be made in consultation with a healthcare provider.
How do you keep your team updated with current trends and updates?
Our approach to keeping our team updated with current trends and updates is comprehensive and aligns well with best practices for fostering a culture of continuous learning and innovation. Here are some key elements of our strategy:
Participation in Industry Events, Forums, and Networking Opportunities:
Actively participating in industry events, forums, and networking opportunities provides our team members with exposure to the latest developments, trends, and best practices in the field.
By engaging with key stakeholders and thought leaders, our team gains valuable insights and perspectives that can inform their work and decision-making processes.
Can you provide insight into the Freedom Infusion System for our readers?
Our Freedom Infusion System is a comprehensive and user-friendly solution designed to facilitate subcutaneous infusion therapy for patients in home and alternate care settings. Here’s an overview of its components:
FREEDOM60® and FreedomEdge® Syringe Driver Pumps:
- The FREEDOM60® pump is compatible with 50 mL syringes (including prefilled syringes), while the FreedomEdge® pump is compatible with 20 mL and 30 mL syringes (including prefilled syringes).
- Both pumps are designed to be simple and easy to use and are fully mechanical allowing the user to turn a dial to activate the system and do not require batteries or electricity to operate, enhancing reliability and convenience for patients.
Precision Flow Rate TubingTM:
- The Precision Flow Rate TubingTM is an essential component of the infusion system, allowing healthcare providers to tailor the infusion flow rate to meet specific patients and drug manufacturer requirements.
- KORU Medical offers a variety of different flow rate options. This customization ensures that patients receive the appropriate infusion rate for their therapy, optimizing treatment efficacy and patient comfort.
High-Flo Subcutaneous Safety Needle SetsTM:
- The High-Flo Subcutaneous Safety Needle SetsTM are designed to provide safe and comfortable subcutaneous access for medication administration.
- Today available in two gauges (24G and 26G), multiple needle legs (1-4), and various needle lengths (4 mm, 6 mm, 9 mm, 12 mm, and 14 mm), these needle sets accommodate a wide range of patient characteristics and treatment requirements.
The Freedom Infusion System offers a reliable, customizable, and patient centric solution for subcutaneous infusion therapy. Its simplicity of use, compatibility with different syringe sizes, precise flow rate control, and versatile needle sets make it a valuable tool for healthcare providers and patients alike, facilitating effective and comfortable home-based infusion treatments. To learn more, visit www.korumedical.com
KORU Medical’s simple, easy-to-use, reusable mechanical pumps have been successfully utilized by over 40,000 global subcutaneous immunoglobulin (SCIg) patients, with over 8.4 million infusions over the last five years.
Recent data analysis demonstrates an impressive adherence rate of 97% to SCIg therapy for patients with Primary Immune Deficiencies (PIDD) using our FREEDOM60® and FreedomEdge® infusion systems,11 highlighting the effectiveness of KORU Medical’s pumps in promoting treatment compliance and enhancing patient outcomes.
We are excited to add increasing value to our patients, customers and shareholders as we continue to revolutionize the field of subcutaneous therapy, providing simple, cost-effective, and user-friendly solutions for patients and healthcare professionals worldwide.
References
- Cook G, Ashcroft J, Fernandez M, et al. Benefits of switching from intravenous to subcutaneous daratumumab: Perspectives from UK healthcare providers. Front Oncol. 2023;13:1063144. Published 2023 Feb 23. doi:10.3389/fonc.2023.1063144
- FREEDOM® Integrated Syringe Infusion System FDA 510(k) approval
- Vizcarra C. Trends, challenges, rewards, and pathways in infusion nursing. Trends, challenges, rewards, and pathways in infusion nursing | Wolters Kluwer. February 21, 2024. Accessed June 14, 2024. https://www.wolterskluwer.com/en/expert-insights/trends-challenges-rewards-and-pathways-in-infusion-nursing
- Blandford A, Furniss D, Galal-Edeen GH, et al. Intravenous infusion practices across England and their impact on patient safety: a mixed-methods observational study. Southampton (UK): NIHR Journals Library; February 2020.
- Bittner B, Richter W, Schmidt J. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs. 2018;32(5):425-440. doi:10.1007/ s40259-018-0295-0
- Dubbelboer IR, Sjögren E. Overview of authorized drug products for subcutaneous administration: Pharmaceutical, therapeutic, and physicochemical properties. Eur J Pharm Sci. 2022;173:106181. doi:10.1016/j. ejps.2022.106181
- Data on file with KORU Medical Systems Inc.
- Justiz Vaillant AA, Qurie A. Immunodeficiency. [Updated 2023 Jun 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK500027/
- Katzberg H, Lewis RA, Harbo T, Allen JA, Bullock M, Grosse-Kreul D, Smith JB, Bril V. Subcutaneous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy – Neurologist, Nursing and Patient Perspectives. European Neurological Review. 2019; 14(1): 44. doi:10.17925/ ENR.2019.14.1.44
- Goyal NA, Karam C, Sheikh KA, Dimachkie MM. Subcutaneous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy. Muscle Nerve. 2021;64(3):243- 254. doi:10.1002/mus.27356
- Rutland B, Bosshard J, Southworth C. Enhancing Drug Adherence and Patient Outcomes: The Role of SCIg Pump Selection in Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency Disease. Poster presented at: 2024 NHIA Annual Conference; March 23-27, 2024. Austin, TX.
Join us in shaping the future of healthcare: www.korumedical.com
“At KORU, our guiding principle is simple: put the patient first. Every decision, every innovation, is driven by our commitment to enhancing the patient experience and improving treatment outcomes.”
“By focusing on simplicity, reliability, and patient-centric design, we empower patients to take control of their treatment and live their lives to the fullest.”
“Innovation is not just about creating something new; it’s about making a meaningful difference in people’s lives. That’s what inspires us every day at KORU.”
“Our success is measured not only by our financial performance but by the number of lives we impact and the positive change we bring to the healthcare industry.”
“As a company, we believe in continuous improvement and never settling for the status quo. It’s this drive for excellence that propels us forward and sets us apart in the industry.”
Company Name : KORU Medical System
Website : www.korumedical.com
Management Team
Linda Tharby, CEO & President
Brian Case, Chief Technology Officer
Brent Rutland, VP of Global Medical Affairs