KORU Medical Systems Announces Successful Appeal in EU Notified Body Review
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Insights
The announcement by KORU Medical Systems regarding the successful appeal of the BSI assessment report is a positive development for the company's operations in the European market. The decision allows KORU to maintain its product certification and continue sales without disruption. This outcome may alleviate concerns among investors regarding potential revenue impacts and market access in the EU, which is a significant market for medical technology companies.
From a market perspective, uninterrupted access to the EU market is essential for maintaining revenue streams and growth trajectories, especially for a company like KORU that emphasizes international expansion. The ability to continue operations as usual may be viewed favorably by the market, potentially influencing the company's stock valuation in the short term. Long-term implications include sustained market presence and the possibility of leveraging this positive regulatory outcome to enhance credibility with other international regulatory bodies.
The regulatory landscape for medical devices in the EU is stringent, with the Medical Device Regulation (MDR) imposing rigorous standards for product safety and performance. KORU Medical's successful appeal against the recommendation for non-certification signifies the company's commitment to compliance and its ability to navigate complex regulatory processes.
This development may instill confidence in stakeholders regarding KORU's regulatory competence, which is important for long-term success in the medical device sector. The ability to promptly address nonconformances and maintain certifications can be a differentiator in the industry, potentially impacting KORU's competitive standing. For peers and competitors, this serves as a reminder of the importance of robust quality management systems and the need for proactive engagement with notified bodies like BSI.
The successful appeal by KORU Medical Systems highlights the company's resilience in addressing challenges that could have led to a significant setback in the EU, a key market for healthcare products. The healthcare industry, particularly the segment dealing with large volume subcutaneous infusion solutions, is highly competitive and sensitive to regulatory compliance. A suspension or interruption in certification could have had a cascading effect on KORU's market share and growth potential.
By avoiding such a scenario, KORU not only secures its current position but also sends a strong signal to the market about its reliability and stability as a supplier. This could potentially lead to increased trust among healthcare providers and patients, ultimately translating into sustained or increased adoption of their products. The company's proactive approach and transparent communication about the appeal process may also contribute positively to its reputation, which is a vital asset in the healthcare market.
The Company’s appeal of an assessment report from BSI regarding a recommendation against continued certification in connection with prior audit nonconformance, was upheld. As a result, the Company will proceed through the routine BSI assessment process without suspension or interruption of the Company’s sale of products in the EU.
“We are pleased by our successful appeal to BSI’s assessment report. Our team’s swift response and positive interaction with BSI, resulted in no interruption of sales of KORU Medical’s products to the market and our patients,” said Linda Tharby, KORU Medical’s President and CEO. “Our products remain certified, marketed and sold in the EU, and we are excited by the continued expansion of our international business.”
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 sales expansion into new regions. Actual results may differ materially from these statements due to potential risks and uncertainties such as 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 April 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240411104030/en/
Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems, Inc.
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