KORU Medical Systems Signs a Clinical Supply Agreement for Phase 3 Trial with Leading Pharma Partner Using Custom Device for a Novel Subcutaneous Immunoglobulin
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The announcement by KORU Medical Systems regarding the clinical supply agreement for a novel subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials is a significant event that merits attention from various stakeholders in the healthcare and investment communities. The progression into Phase 3 trials indicates a substantial level of confidence in the potential efficacy and safety of the novel SCIg drug, which is designed to treat a range of immunological disorders.
From a research standpoint, the successful development and commercialization of this drug could represent a notable advancement in the treatment of autoimmune diseases, primary immunodeficiency disorders and neurological disorders. The custom device developed by KORU Medical, tailored to the drug's administration needs, underscores the company's expertise in creating patient-centric solutions that could improve therapeutic outcomes and patient adherence to treatment regimens.
Investors should monitor the trial's progress closely, as positive Phase 3 results could lead to a 510k filing and subsequent commercialization, potentially providing a new revenue stream for KORU Medical. It is also indicative of the company's ability to collaborate with pharmaceutical partners, which could open doors for future agreements and expand its market presence.
Entering into a Phase 3 clinical supply agreement is a pivotal moment for KORU Medical Systems from a financial perspective. The development of a custom product for the trial not only adds to the company's portfolio but also demonstrates its strategic capability to engage in lucrative partnerships within the pharmaceutical industry. Such agreements are typically multi-year, multi-phase engagements that can provide stable and forecastable revenue streams.
Investors should note that the costs associated with the research and development phase have already been incurred and the agreement now signals a transition towards potential commercialization. The anticipation of a 510k filing is crucial, as it signifies a near-term entry into the market upon approval. The market for SCIg therapies is growing and a successful launch could meaningfully contribute to KORU Medical's top-line growth.
However, the inherent risks of clinical trials should not be overlooked. Delays, unexpected adverse events, or failure to meet primary endpoints can significantly impact the company's financial projections and stock performance. Therefore, while the news is promising, it is important to balance optimism with caution until the trial outcomes are known.
The SCIg market is an evolving landscape with increasing demand due to the rising prevalence of immunodeficiency diseases and the convenience of subcutaneous administration. KORU Medical's involvement in developing a custom device for this novel SCIg drug positions the company favorably within this niche market. The focus on enhancing patient comfort and ensuring precise delivery through advanced technology could set a new standard in the industry, potentially increasing the adoption rate among healthcare providers and patients.
Moreover, the successful commercialization of the SCIg drug could disrupt the market by offering an alternative to intravenous therapies, which are often less convenient and more time-consuming. The ability to administer treatment subcutaneously allows for more flexibility and autonomy for patients, which is a significant trend in patient care. As healthcare continues to move towards more patient-centric and home-based treatment options, KORU Medical's device could see increased demand.
Long-term, the company's reputation as a partner in drug development and its demonstrated capability to meet specific pharmaceutical needs could lead to further collaborations. Such partnerships could help diversify KORU Medical's business and reduce dependency on any single product or market segment.
This significant milestone represents an essential advancement in developing novel therapies for patients with immunological disorders. The Phase 3 trial aims to assess the safety, efficacy, and performance of the SCIg drug in treating various medical conditions, including autoimmune diseases, primary immunodeficiency disorders, and neurological disorders.
The newly developed custom device, designed by KORU Medical's team of experts, includes advanced technology and user-friendly interfaces to enhance patient comfort and ensure precise therapy delivery.
“We are proud of our role in developing devices that meet large volume subcutaneous delivery needs, demonstrating KORU Medical’s ability to support our pharmaceutical partners’ drug development process and patient needs,” said Linda Tharby, President and CEO of KORU Medical. "We are excited to announce the execution of this Phase 3 clinical supply agreement, marking a critical step forward in our commitment to advancing healthcare through innovation. Assuming successful completion and results of the Phase 3 trial, we expect to file a 510k and commercialize with this novel SCIg drug."
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 11, 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.
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