SQ Innovation Lasix ONYU Gains CE Mark EMA Review

BURLINGTON, Massachusetts, USA, April 28, 2026

SQ Innovation has announced that its drug-device combination therapy Lasix® ONYU has achieved CE Mark certification under the EU Medical Device Regulation (MDR) and has also been accepted by the European Medicines Agency (EMA) for centralized procedure review, marking a significant dual regulatory milestone in its global expansion strategy. These achievements position the therapy for European market authorization and broader international adoption, highlighting its potential to transform the treatment of edema in patients with chronic heart failure through an innovative at-home delivery approach. The CE Mark confirms compliance with General Safety and Performance Requirements (GSPRs), while the EMA’s acceptance reflects recognition of the product’s technical innovation and clinical value in addressing unmet medical needs.

Dual Regulatory Milestones Strengthen Market Pathway

The CE Mark certification establishes that the Lasix ONYU Infusor meets the stringent requirements of the EU MDR 2017/745 framework, ensuring safety, performance, and quality for medical device deployment across European markets. This certification is a critical prerequisite for commercialization and is widely recognized as a benchmark for global regulatory acceptance of medical devices.

In parallel, the EMA’s decision to accept the therapy for review under the centralized procedure enables a single regulatory pathway for approval across all EU member states, significantly accelerating market access. The acceptance is based on the product’s technical innovation as a drug-device combination, highlighting its potential to deliver meaningful clinical benefits and improve patient care.

Innovative Drug-Device Combination Enables At-Home Treatment

Lasix ONYU is a subcutaneous furosemide delivery system designed to provide controlled diuresis comparable to intravenous administration, but in a home-based setting. The therapy combines a high-concentration formulation of the loop diuretic furosemide with a wearable infusion device, allowing gradual drug delivery over several hours. This approach addresses a major challenge in heart failure management, where patients often require hospitalization for intravenous diuretic treatment.

By enabling at-home administration, the system has the potential to reduce hospital admissions, improve patient convenience, and lower healthcare costs. The device incorporates advanced features such as a micro-piston pump, automated needle insertion, and controlled infusion mechanisms, ensuring precise dosing and patient safety.

Transforming Heart Failure Care and Healthcare Delivery

Heart failure-related edema remains a leading cause of hospitalization among elderly patients, placing significant strain on healthcare systems worldwide. The introduction of a home-based, subcutaneous therapy represents a paradigm shift in disease management, enabling earlier intervention and more consistent treatment. The dual regulatory milestones achieved by SQ Innovation reflect the growing importance of integrated drug-device solutions in modern healthcare, where innovation focuses on improving both clinical outcomes and patient experience.

From a cGxP perspective, the development and approval pathway of Lasix ONYU demonstrates compliance with Good Manufacturing Practice (GMP), device quality standards, and regulatory validation processes, ensuring that both the pharmaceutical and device components meet stringent safety and efficacy requirements. The combination of drug formulation and delivery technology introduces additional complexity in quality control, manufacturing integration, and regulatory oversight, making such products a key focus area for global regulators.

Following its FDA approval in the United States in 2025, the expansion into Europe marks a critical step in SQ Innovation’s strategy to bring this therapy to a broader patient population. The company is also actively pursuing partnerships to support distribution and commercialization across international markets, further strengthening its global footprint. As healthcare systems increasingly prioritize cost-effective, patient-centered care, innovations like Lasix ONYU are expected to play a central role in reducing hospital dependency and improving long-term disease management.

By combining pharmaceutical efficacy with advanced delivery technology, SQ Innovation is contributing to the evolution of next-generation therapeutic solutions, offering new hope for patients with chronic heart failure and setting a new standard for at-home treatment options.

Source: SQ Innovation press release