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Lasix® ONYU Achieves CE Marking and EMA Review Eligibility

SQ Innovation, a biopharmaceutical company focused on innovative therapies, has recently announced two significant achievements in its expansion efforts with the Lasix® ONYU. The product has received its CE marking, confirming compliance with the European Medical Device Regulation (MDR 2017/745), and has been accepted by the European Medicines Agency (EMA) for a centralized review. These milestones mark a substantial advance in making this groundbreaking at-home treatment for heart failure-related edema accessible in Europe and beyond.

Understanding the CE Marking Process

The CE marking is a vital certification that declares a product meets essential health, safety, and environmental protection requirements in the European market. The certification for Lasix ONYU indicates that the infusion device adheres to the General Safety and Performance Requirements (GSPRs) set by the EU. This approval was independently assessed by a Notified Body, affirming SQ Innovation's commitment to high-quality safety standards and effective device functionality.

Moreover, the EMA's confirmation means that Lasix ONYU qualifies for a centralized review process, paving the way for simultaneous market authorization across all EU member states. This is significant for SQ Innovation as it allows for an expedited approval route based on the product's technical innovation, recognized as a novel approach in addressing unmet medical needs in patients suffering from edema due to heart failure.

The Significance of Lasix ONYU

Lasix ONYU is particularly designed for patients requiring treatment for edema, a condition commonly related to heart failure and a frequent cause for hospital admissions among the elderly. Current treatment often requires intravenous administration in a hospital, which can put additional strain on healthcare resources. The innovative subcutaneous delivery system of Lasix ONYU not only simplifies the treatment process but allows patients to receive care in the comfort of their own homes. This innovative approach could potentially reduce hospitalization rates, enhance patients' quality of life, and decrease overall healthcare costs.

Pieter Muntendam, MD, founder and CEO of SQ Innovation, expressed optimism with these developments. He stated, "The CE Marking and EMA's acceptance are pivotal milestones on this path home for the millions of patients that are now treated in hospitals." With the FDA approval already secured in the United States in October 2025, SQ Innovation is poised to make strides in global markets.

The Lasix ONYU product boasts a high-concentration formulation of furosemide specifically developed for outpatient treatment. The infusion device consists of two main components: a Reusable Unit housing essential electronic parts and a Disposable Unit designed for single-use that holds the furosemide cartridge. This two-component design emphasizes convenience while maintaining rigorous safety and control standards during the infusion process, delivering 80 mg of furosemide over five hours. This gradual release avoids abrupt shifts associated with traditional IV treatment methods, making it safer and more comfortable for patients.

Looking Ahead

As SQ Innovation aims for Market Authorization later this year, the company is also pursuing discussions with potential distribution and commercialization partners across key international markets. The progress made in gaining CE marking and EMA approval not only signifies a leap forward for Lasix ONYU but also underscores the company's long-term vision of transforming the management of heart failure-related conditions.

For health systems facing growing challenges related to heart failure hospitalizations, solutions like Lasix ONYU represent much-needed advancements. The potential for shifting care from hospitals into patients' homes aligns with current trends towards patient-centered healthcare and innovations that prioritize accessible and affordable care.

The successful rollout of Lasix ONYU could set a new standard for treating chronic conditions outside of traditional healthcare settings, offering both patients and healthcare systems a promising avenue for improved outcomes.

For further information about Lasix ONYU and its implications for home health treatment, visit Lasix ONYU's official website.