KORU Medical Systems Announces a New Feasibility Study with a Commercialized Oncology Biologic
KORU Medical Systems (NASDAQ: KRMD) announced a collaboration with a global pharmaceutical company to initiate a feasibility study for their Freedom Infusion System. This system, designed for subcutaneous administration, will be tested with an FDA and EMA approved oncology biologic drug currently administered manually by healthcare professionals. The Freedom System, a mechanical ambulatory drug delivery device, can deliver large volumes of medications from 2mL to over 100mL. If successful, the study could lead to the commercialization of the system within 12 months, addressing a growing trend in oncology for subcutaneous drug administration.
- Collaboration with a global pharmaceutical company suggests strong industry confidence in KORU Medical's technology.
- The feasibility study focuses on a commercially available oncology biologic drug, indicating a clear target market.
- Freedom Infusion System allows self-administration of therapy, which could reduce healthcare costs and improve patient quality of life.
- Potential commercialization within 12 months offers a near-term growth catalyst.
- The system's approval for 11 drugs and use by over 40,000 patients globally demonstrates proven reliability and market acceptance.
- The success of the feasibility study is uncertain and may not lead to commercialization.
- Dependence on the collaboration with the pharmaceutical company could pose risks if the partnership falters.
- The transition from manual to mechanical administration requires significant changes in clinical practice, potentially delaying adoption.
Insights
The announcement by KORU Medical Systems regarding a new feasibility study for the Freedom Infusion System in collaboration with a global pharmaceutical company is noteworthy for several reasons. The move towards subcutaneous administration (under the skin) of oncology biologics is a significant shift in the medical field. This method can simplify treatments, reduce hospital strain and enhance patient quality of life. Subcutaneous therapy allows patients to self-administer treatments at home, offering convenience and potentially better compliance.
The Freedom Infusion System aims to replace the current manual syringe administration, which typically requires a healthcare professional. This shift could lead to cost savings for healthcare systems and increased comfort for patients by enabling them to receive treatment in a familiar, less stressful environment. It also aligns with the broader trend in healthcare towards patient-centric solutions that improve treatment adherence and outcomes.
Given the system's existing approval for 11 drugs and usage by over 40,000 patients globally, its established track record underpins the feasibility study's credibility. The successful integration of the Freedom System for this subcutaneous oncology biologic could position KORU Medical favorably in a growing market, enhancing their competitive edge.
Overall, the implications for stakeholders include potential for increased market share, improved patient satisfaction and healthcare cost reductions.
From a financial perspective, the collaboration between KORU Medical Systems and a global pharmaceutical company to explore the use of the Freedom Infusion System is a promising development. The oncology drug market is substantial and tapping into it with an innovative delivery system could mean significant revenue growth. If the feasibility study is successful, KORU Medical anticipates commercialization within 12 months, which could lead to a notable increase in their market share and revenue streams.
Furthermore, the trend towards subcutaneous administration aligns with broader healthcare initiatives to reduce costs and improve patient care. The Freedom System's ability to facilitate at-home treatments is particularly relevant in the context of rising healthcare expenses and the ongoing need to alleviate hospital burdens. This system's adoption could result in lower operational costs for healthcare providers and increased convenience for patients, potentially driving higher demand and quicker market penetration.
Investors should consider the potential for accelerated revenue growth if the system is successfully commercialized. However, they should also be mindful of the risks inherent in feasibility studies, such as regulatory hurdles and market acceptance.
The Freedom System is a purely mechanical ambulatory drug delivery device with 11 drugs approved on the label and over 40,000 patients globally. The system is designed to deliver large volumes of biologic medications from 2mL to over 100mL subcutaneously. The Freedom System is capable of allowing patients to self-administer their therapy at home and/or by healthcare professionals in a clinic setting.
Conversion of IV biologics to subcutaneous administration formulations is a growing trend in the oncology market. Evidence suggests subcutaneous administration of oncology therapy simplifies treatment, reduces pressure on hospitals, and improves patients’ quality of life.1 With the development of new subcutaneous drug therapies, there is an opportunity to develop drug delivery administration solutions which will optimize drug administration for healthcare providers and patients.
“This collaboration presents an exciting, new opportunity to enter the growing oncology subcutaneous biologic market to solve significant unmet needs in the delivery of this life-saving therapy with our patient-centric solutions,” said Linda Tharby, KORU Medical’s President and CEO. Linda Tharby went on to say, “There are multiple subcutaneous oncology biologics currently approved using manual administration with an estimate of over one million global infusions. Upon successful completion of the feasibility study, we anticipate progressing to commercialization of the Freedom System for this drug within the following 12 months.”
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 June 4, 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.
Reference:
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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/20240604804089/en/
Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems, Inc.
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