KORU Medical Systems Announces a Feasibility Study to Enter Ambulatory Infusion Settings with a Commercialized Biologic
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Insights
The collaboration between KORU Medical Systems and a global pharmaceutical manufacturer to conduct a feasibility study on the Freedom Infusion System represents a strategic move to expand the application of this medical device into new therapeutic areas. The fact that the device is being considered for a rare disease therapy underscores the potential for targeted treatments in niche markets. Moreover, the mention of the system's use in ambulatory infusion centers (AIC) and ambulatory infusion suites (AIS) in the U.S., as well as hospitals in the EU, signals a diversification of the delivery settings for such therapies.
From a research perspective, the feasibility study is a critical step in validating the device's effectiveness and safety for a new indication. If successful, the subsequent FDA submission could enhance the device's marketability and therapeutic reach. The adaptation of the Freedom Infusion System for subcutaneous administration of a large volume therapy also aligns with current trends in patient-centric care, potentially improving the quality of life for patients by offering more convenient treatment options outside of traditional hospital settings.
The announcement by KORU Medical Systems may have a positive influence on its market position and investor sentiment. Entering the rare disease market with a specialized delivery system could open up new revenue streams for the company. Rare diseases, by definition, affect a smaller segment of the population, but the treatments often command higher prices due to the lack of alternatives and the specialized nature of the drugs. This could translate into a high-margin business for KORU Medical if the feasibility study and subsequent FDA clearance are successful.
Furthermore, the expansion into AICs and AISs could be seen as an opportunity to capitalize on the growing trend of outpatient care. As healthcare systems worldwide are moving towards cost-effective and patient-friendly treatment options, KORU Medical's move could position it favorably within this evolving landscape. The market will be watching closely for the results of the feasibility study and the FDA submission timeline, as these milestones could significantly impact the company's stock performance and competitive edge.
The financial implications of KORU Medical's announcement are multifaceted. Initially, the costs associated with conducting the feasibility study and developing a customized Freedom System for the rare disease therapy could weigh on the company's short-term financials. However, the long-term prospects of entering a new market with a patented delivery system could be lucrative. It is important to monitor how the company manages its R&D expenses and whether it can secure additional funding or partnerships to mitigate financial risks.
The potential FDA clearance within the next 12 months is a key milestone for investors to track. Regulatory approval would not only validate the company's technology but also potentially accelerate its time to market. Given the high stakes of regulatory outcomes, investors should consider the inherent risks and the company's track record in navigating the FDA approval process. The market's response to these developments will be contingent on the perceived probability of success and the expected impact on KORU Medical's revenue growth and profitability.
Upon successful completion of the feasibility study, KORU Medical intends to develop a customized Freedom System that will deliver this large volume therapy via subcutaneous administration. Healthcare providers administer this rare disease drug in the growing ambulatory infusion center (AIC) and ambulatory infusion suite (AIS) setting in
“We are excited to continue our leadership in large volume subcutaneous infusion within a new rare disease biologic therapy and new therapeutic settings, such as AICs and AISs,” said Linda Tharby, KORU Medical’s President and CEO. “Expansion of our use case from home subcutaneous administration into these new settings demonstrates the versatility and flexibility of the KORU Medical Freedom Infusion System in delivering life-changing therapies wherever patients are being treated. Upon success of the feasibility study, we expect to submit the device for FDA clearance within the next 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™. These devices are used for infusions administered in the home and alternate care settings. 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 Company’s development of a customized Freedom System, submission of a device for FDA clearance, entry into AICs and AISs, and continuing leadership in large volume subcutaneous infusion. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, success of the feasibility study, agreement with the pharmaceutical manufacturer with respect to customization of the system, 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, 2022 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, which are 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 March 5, 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.
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Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems, Inc.
FAQ
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