KORU Medical Systems Presents Data at Partnership Opportunities in Drug Delivery (PODD) Conference Demonstrating Nursing Preference for Use of KORU FreedomEdge® Infusion System over Manual Syringe Administration for Subcutaneous Oncology Infusion
KORU Medical Systems presented data at the PODD 2024 Conference showing strong nursing preference for their FreedomEdge® Infusion System over manual syringe administration for subcutaneous oncology infusions. The study, conducted across 6 Danish hospitals with 33 nurses performing over 3,000 infusions, revealed significant advantages: 97% of nurses reported more patient interaction time, 81% experienced less hand pain, 91% found it easier to use, and 73% observed reduced patient discomfort. The company plans to file for FDA clearance with an oncology biologic in 2025.
KORU Medical Systems ha presentato dati alla Conferenza PODD 2024 che mostrano una forte preferenza da parte degli infermieri per il loro FreedomEdge® Infusion System rispetto all'amministrazione manuale con siringa per le infusioni oncologiche sottocutanee. Lo studio, condotto in 6 ospedali danesi con 33 infermieri che hanno effettuato oltre 3.000 infusioni, ha rivelato vantaggi significativi: il 97% degli infermieri ha riportato più tempo di interazione con i pazienti, l'81% ha avvertito meno dolore alle mani, il 91% ha trovato più facile l'uso e il 73% ha osservato un minore disagio per i pazienti. L'azienda prevede di presentare una richiesta di approvazione alla FDA con un prodotto biologico oncologico nel 2025.
KORU Medical Systems presentó datos en la Conferencia PODD 2024 que muestran una fuerte preferencia por parte de las enfermeras por su FreedomEdge® Infusion System en comparación con la administración manual de jeringas para infusiones subcutáneas en oncología. El estudio, realizado en 6 hospitales daneses con 33 enfermeras que realizaron más de 3,000 infusiones, reveló ventajas significativas: el 97% de las enfermeras informó tener más tiempo de interacción con los pacientes, el 81% experimentó menos dolor en las manos, el 91% encontró más fácil su uso y el 73% observó una reducción en la incomodidad del paciente. La empresa planea presentar la solicitud de aprobación a la FDA para un biológico oncológico en 2025.
KORU Medical Systems는 PODD 2024 회의에서 FreedomEdge® Infusion System이 피하 종양 주입을 위한 수동 주사기 투여보다 간호사들에게 강한 선호를 받고 있음을 보여주는 데이터를 발표했습니다. 33명의 간호사가 3,000건 이상의 주사를 시행한 6개의 덴마크 병원에서 수행된 이 연구는 상당한 이점을 드러냈습니다: 97%의 간호사가 더 많은 환자 상호 작용 시간을 보고했으며, 81%는 손의 통증이 줄어들었다고 했고, 91%는 사용이 더 쉬웠다고 하였으며, 73%는 환자의 불편함이 줄어드는 것을 관찰했습니다. 이 회사는 2025년에 종양학 생물학 제품을 FDA에 승인 요청할 계획입니다.
KORU Medical Systems a présenté des données lors de la Conférence PODD 2024 montrant une forte préférence des infirmières pour leur FreedomEdge® Infusion System par rapport à l'administration manuelle avec seringue pour les perfusions oncologiques sous-cutanées. L'étude, réalisée dans 6 hôpitaux danois avec 33 infirmières ayant effectué plus de 3 000 perfusions, a révélé des avantages significatifs : 97 % des infirmières ont signalé plus de temps d'interaction avec les patients, 81 % ont éprouvé moins de douleurs aux mains, 91 % ont trouvé l'utilisation plus facile et 73 % ont observé une réduction de l'inconfort chez les patients. L'entreprise prévoit de demander une autorisation à la FDA pour un produit biologique en oncologie en 2025.
KORU Medical Systems präsentierte Daten auf der PODD 2024-Konferenz, die eine starke Präferenz von Pflegekräften für ihr FreedomEdge® Infusion System im Vergleich zur manuellen Spritzenverabreichung für subkutane Onkologie-Infusionen zeigen. Die Studie, die in 6 dänischen Krankenhäusern mit 33 Pflegekräften durchgeführt wurde, die über 3.000 Infusionen durchführten, zeigte erhebliche Vorteile: 97% der Pflegekräfte berichteten über mehr Interaktionszeit mit den Patienten, 81% erfuhren weniger Handbeschwerden, 91% fanden die Anwendung einfacher und 73% stellten eine geringere Unannehmlichkeit für die Patienten fest. Das Unternehmen plant, 2025 einen Antrag auf FDA-Zulassung für ein onkologisches Biologikum einzureichen.
- 97% of nurses would recommend the FreedomEdge® Infusion System
- Strong clinical data showing multiple benefits over manual administration
- Planned FDA clearance filing in 2025 for oncology biologic application
- Targeting market of one million global infusions across five biologic oncology drugs
- FDA clearance still pending for oncology application
- to specific geographic region (Denmark) for the study
Insights
This nursing preference study demonstrates strong potential for KORU Medical's FreedomEdge® Infusion System in the oncology market. The data shows
The planned FDA clearance filing in 2025 for oncology biologics could open up a significant new revenue stream, expanding beyond their current market. The study's robust methodology - involving 33 nurses across 6 hospitals and over 3,000 infusions - provides credible evidence for potential market adoption. The
The subcutaneous oncology drug delivery market represents a strategic growth opportunity for KORU Medical. The trend toward subcutaneous formulations of IV biologics in oncology, combined with the company's established expertise in subcutaneous delivery systems, positions them well for market expansion. The strong preference data from healthcare providers could accelerate market penetration and drive adoption in clinical settings.
With five approved large-volume biologic oncology drugs and more in development, KORU's timing for market entry aligns well with industry trends. The system's ability to improve workflow efficiency while reducing healthcare provider strain could be particularly appealing to healthcare facilities facing staffing challenges and seeking to optimize resources.
The objective of the Nursing Preference Study was to assess time spent with patients, impact on nursing and patient comfort, and overall nurse preference when comparing manual syringe administration versus mechanical pump administration with the KORU FreedomEdge® Infusion System during subcutaneous oncology biologic drug infusions. The study was conducted by KORU Medical across 6 hospitals in
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Increased Patient Interaction:
97% of nurses reported having more time to interact with patients while using the KORU FreedomEdge® Infusion System versus manual syringe administration
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Reduced Nurse Discomfort:
81% of nurses experienced less hand pain while using the KORU FreedomEdge® Infusion System compared to manual syringe administration
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Ease of Use:
91% of nurses found the KORU FreedomEdge® Infusion System easier to use, with a shorter setup time compared to manual syringe administration
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Reduced Patient Discomfort:
73% of nurses observed less patient pain during infusions with the KORU FreedomEdge® Infusion System versus manual syringe administration
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Recommended by Nurses:
97% of nurses would recommend the KORU FreedomEdge® Infusion System over manual syringe administration, citing ease of use and reduced discomfort as key reasons
Subcutaneous formulation of formerly intravenous biologics is a growing trend with oncology pharmaceutical manufacturers. There are five greater-than-5mL biologic oncology drugs that have been cleared for in-clinic administration by healthcare professionals for an estimated one million global infusions.1,2 Evidence indicates that subcutaneous administration of oncology therapy simplifies treatment protocol, reduces pressure on hospitals, and improves patients’ quality of life.3 As further development of subcutaneous drug therapies increases, the optimization of drug administration has created a significant opportunity for drug delivery solutions like the KORU FreedomEdge® Infusion System.
“The growing prevalence of large-volume subcutaneous oncology drug therapies has the potential to create challenges in the clinical setting for the manual push method, particularly related to limiting workflow as a result of hands-on administration time required,” said Linda Tharby, President and CEO of KORU Medical. “Nurses are required to apply continuous manual pressure on syringes containing highly viscous drugs for a nearly-10-minute administration time.”
Ms. Tharby continued, “KORU’s FreedomEdge® Infusion System represents an alternative that may address these concerns and simplify the drug delivery experience. We are pleased that the results of this study demonstrate that KORU’s FreedomEdge® Infusion System is widely preferred by nurses and expect to file for FDA clearance of our system with an oncology biologic in 2025.”
About KORU Medical Systems
KORU Medical 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. All statements that are not historical fact are forward-looking statements and can be identified by words such as “expect,” “will,” "believe" and "potential". Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, 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 October 31, 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.
References:
- Third party data source on file
- Third party data source on file
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Cook G, Ashcroft J, Fernandez M, Henshaw S, Khalaf Z, Pratt G, Tailor A and Rabin N (2023) Benefits of switching from intravenous to subcutaneous daratumumab: Perspectives from
UK healthcare providers. Front. Oncol. 13:1063144. doi: 10.3389/fonc.2023.1063144.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031750047/en/
Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems, Inc.
FAQ
What were the key findings of KORU Medical's (KRMD) nursing preference study?
When will KORU Medical (KRMD) file for FDA clearance for oncology applications?
How many infusions were evaluated in KORU Medical's (KRMD) Danish hospital study?
