Together, these milestones represent a significant step forward in bringing this novel at-home subcutaneous furosemide treatment to patients in Europe and other international markets.
CE Marking, supported by an EU Declaration of Conformity and independently assessed by a Notified Body, represents SQ Innovation's formal declaration that the Company's Infusor for subcutaneous delivery of furosemide meets the General Safety and Performance Requirements (GSPRs) of EU MDR 2017/745. CE Marking is a prerequisite for marketing medical devices within the EU and is recognized in numerous other countries as a basis for market authorization. Achieving CE Marking for Lasix ONYU is a critical milestone in SQ Innovation's global regulatory strategy and underscores the Company's commitment to rigorous quality and safety standards.
In a separate but complementary development, the EMA has confirmed that the Company's subcutaneous furosemide product, marketed in the United States under the name Lasix ONYU, is eligible for review under its centralized procedure — the regulatory pathway that, upon approval, grants simultaneous market authorization across all EU member states. Notably, the EMA's acceptance is based on technical innovation, a designation that reflects the EMA's recognition of the product as a meaningfully novel drug-device combination addressing an unmet medical need. This designation is consistent with the EMA's mandate to facilitate patient access to innovative medicines across the EU.
The product is developed for treatment of edema in patients with heart failure. Edema in heart failure is a leading reason for hospital admission among elderly patients, placing significant personal and financial burden on patients, families, and the healthcare system. In Europe, as in the United States, heart failure-related hospitalizations represent a substantial and growing challenge for health systems. The product's subcutaneous delivery mechanism enables effective diuresis comparable to intravenous furosemide but made possible in the comfort and convenience of the patient's home — potentially reducing hospitalizations, improving quality of life, and lowering overall healthcare costs.
"The CE Marking and EMA's acceptance for the centralized procedure are pivotal milestones on this path home for the millions of patients that are now treated in hospitals," said Pieter Muntendam MD, founder, President and CEO of SQ Innovation. "Following FDA approval in the United States in 2025, these European regulatory milestones reflect our commitment to bringing this transformative at-home therapy to patients globally. We believe subcutaneous infusion of loop diuretics has the potential to fundamentally change how heart failure-related edema is managed — shifting care from the hospital to the home, in a similar manner as has been done for countless other conditions over the past 50 years."
SQ Innovation expects to submit for the Market Authorization later this year and anticipates further updates on the European approval timeline. The Company is also actively engaging with potential distribution and commercialization partners in key markets outside the United States.
About Lasix ONYU
Lasix® ONYU is a drug-device combination that was approved by the U.S. Food and Drug Administration on October 7, 2025, for the treatment of edema in adult patients with chronic heart failure. Lasix ONYU is available for ordering from Cardinal and Cencora and for dispensing and overnight delivery from Walmart Specialty Pharmacy. The pharmaceutical component of Lasix ONYU is a novel, high-concentration formulation of the diuretic furosemide, at 30 mg/mL. It comes in a pre-filled glass cartridge containing 80 mg of furosemide in 2.67 mL. The Lasix ONYU Infusor consists of two main parts: the Reusable Unit and the Disposable Unit. The Reusable Unit is an electromechanical device that contains the battery, motor, and electronic components necessary for operation and safety functions. It can be used up to 48 times before it can be recycled. The Disposable Unit is a sterile, single-use plastic component that holds the drug cartridge. It includes a micro-`piston pump, fluid path, needle insertion and retraction mechanism, and a 29-gauge needle. After placement on the abdomen, the needle penetrates the skin when the device is activated. The Lasix ONYU Infusor slowly administers 80 mg furosemide over a period of five hours. This method results in significant diuresis similar to IV, but in a more controlled manner. This avoids the brief, intense diuretic effect that occurs with rapid IV infusion or injection. The advanced two component design offers benefits for patients, healthcare providers, payers, and the environment.
Lasix® ONYU is a loop diuretic indicated for the treatment of edema in adult patients with chronic heart failure.
IMPORTANT SAFETY INFORMATION
Before using Lasix® ONYU, read the Instructions for Use and tell your healthcare provider about all your medical conditions, including if you are allergic to furosemide or any of the ingredients in Lasix ONYU, have trouble urinating, or if you are allergic to medical adhesives.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines.
Warning: Only use the Lasix ONYU Prefilled Cartridge with the Lasix ONYU Infusor. Do not use insulin cartridges or other medicine cartridges in the Lasix ONYU Infusor. Doing so could cause severe injury.
What are the possible side effects of Lasix ONYU?
Dehydration: Lasix ONYU is a diuretic that can make you lose a lot of fluid and with it electrolytes. You may get a dry mouth, have increased thirst, get muscle pains or cramps, have reduced urine output or your urine may be more yellow than normal, you may get a headache, get dry skin, or have nausea or vomiting. Your healthcare provider may check your electrolytes while receiving Lasix ONYU.
Low Blood Pressure: Lasix ONYU may lower your blood pressure temporarily. You may feel lightheaded or dizzy. This usually happens when you stand. Getting up slowly may help.
High Blood Sugar: Lasix ONYU may increase blood sugar (glucose) levels if you have diabetes mellitus.
Loss of Hearing: Lasix ONYU can cause ringing in your ears. If so, tell your healthcare provider.
Risk of Sunburn: Your skin may be more sensitive to sunlight while taking Lasix ONYU.
Infusion Site Reactions: Lasix ONYU can cause infusion site pain, bruising and temporary swelling or redness at the site of the Infusor.
Incomplete Dosing: Make sure the Infusor does not get wet during use. Also limit your physical activities. Some movements or when it gets wet may stop the infusion and you may not get all the medication.
About SQ Innovation
SQ Innovation, Inc. is a privately held Swiss biopharmaceutical company with offices in Zug, Switzerland, Burlington, MA, USA, and Rotterdam, The Netherlands. The company was founded to develop and commercialize innovative, cost-effective therapies for subcutaneous delivery, enabling at-home treatment for conditions that are usually managed during hospitalizations. SQ Innovation has developed a novel drug-device combination for treating edema in adult patients with chronic heart failure — a condition typically requiring intravenous administration of diuretics in a hospital setting. Lasix ONYU was developed with consideration for patients, payors, healthcare providers, and environmental impact. Lasix ONYU received approval from the US Food and Drug Administration on October 7, 2025.
For more information please visit www.lasix-onyu.com.
