New J-code supports same-day, in-facility initiation of Lasix ONYU as an alternative to a multi-day hospital admission for worsening heart failure for selected patients.

BURLINGTON, Mass., Sept. 2, 2026 /PRNewswire/ — SQ Innovation today announced that the Centers for Medicare & Medicaid Services (CMS) has established a new Healthcare Common Procedure Coding System (HCPCS) Level II code, J1946 (“Injection, furosemide (Lasix ONYU), 1 mg”), for its product Lasix® ONYU (furosemide injection). The code was published as part of CMS’ Q3 2026 HCPCS Level II Coding Cycle update, released September 1, 2026, and takes effect October 1, 2026. The new code for Lasix ONYU will facilitate billing third-party payers under the medical benefit when the drug and Infusor device are prepared, placed, and furnished incident to a physician’s or qualified healthcare professional’s service — the pathway used when a patient needs treatment initiated the same day, in a clinical setting, rather than dispensed later under the pharmacy benefit.

Lasix ONYU was designed for patients who are at imminent risk of hospital admission for worsening heart failure, offering an alternative to the multi-day inpatient stay typically required for intravenous diuretic therapy. Edema associated with worsening heart failure, also known as fluid overload, can progress rapidly, and treatment often must begin soon after a clinician determines that oral medications are no longer a viable option. Initiating Lasix ONYU in the emergency department, observation unit, or heart failure clinic — as part of the same visit in which that determination is made — is central to how the therapy is intended to be used.

Lasix ONYU includes a Travel Home feature that is unique to the product and was designed specifically for this scenario — a patient who is in a medical facility and, rather than being admitted, can instead go home to begin treatment. Using this feature, a clinician can prepare and place the Infusor on the patient before discharge. This allows the device to be in place and ready to go before the patient leaves the facility, without requiring the infusion to begin on site, further supporting timely hospital-avoidance treatment for patients who would otherwise require inpatient admission.

Providing Lasix ONYU incident to a physician’s service allows the first dose to be prepared and placed by clinical staff before the patient leaves the facility, supporting timely treatment initiation at the moment it is needed most.

“The ability to safely discharge a patient with a self-administered course of diuretics could be one part of a solution to the bigger problem of ER boarding and waiting room medicine,” said Sean Collins, MD, MSc, Professor of Emergency Medicine and Director of the Vanderbilt Coordinating Center, Vanderbilt Health, Nashville. “Avoiding an unnecessary admission and prolonged ED boarding by sending somebody safely home to continue diuresis may be a much better option for the patient and the healthcare system”.

SQ Innovation has contacted CMS and Medicare Administrative Contractors (MACs) to request coverage under the Medicare Part B benefit incident to a physician’s or qualified healthcare professional’s service so that patients at imminent risk of hospitalization can be safely referred to at-home self-treatment rather than admitted. Incident to a medical service under Medicare Part B complements availability under the Medicare Part D drug coverage.  

“This new code allows heart failure and emergency room clinicians timely initiation of diuretic treatment in a patient at imminent risk for hospital admission,” said Pieter Muntendam, MD, Founder, President and CEO of SQ Innovation. “Worsening heart failure occurs if patients. This coding pathway reflects the clinical reality of how and when this therapy needs to be used and the exact scenario for which we developed this product.”

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. Lasix ONYU is a second-generation combination product for subcutaneous furosemide that follows the introduction of Furoscix in 2023. While primarily intended for home use, the drug delivery system may also be prepared and placed in an emergency room, a physician’s office, or a hospital outpatient setting. The advanced two component design of Lasix ONYU offers benefits for patients, healthcare providers, payers, and the environment. For Important Safety Information, Prescribing Information and Instructions for Use, visit www.lasix-onyu.com.

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 about Lasix ONYU, including important safety information and the full prescribing information, please visit www.lasix-onyu.com.

INDICATION

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.

These are not all the possible side effects of Lasix ONYU. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Instructions for Use at www.lasix-onyu.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that may or are considered “forward-looking statements.” All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,” “target,” “will,” or “would”, the negative of terms like these, or other words or terms of similar meaning. These may include implied or express statements about our expectations regarding strategy, business plans, and objectives for Lasix ONYU; coding, coverage, and reimbursement determinations by CMS, Medicare Administrative Contractors, and other third-party payors, including whether Lasix ONYU is added to or kept off any Self-Administered Drug Exclusion List; decisions by regulatory authorities regarding marketing approval or material restrictions, limitations, or obligations on marketing and market access of the Company’s products; delays in arranging satisfactory manufacturing capabilities and establishing commercial infrastructure; the risk that third party payors (including governmental agencies) will not reimburse for the use of products at acceptable rates or at all; the risk that third parties will not agree to license any necessary intellectual property on reasonable terms or at all; and other risks set forth from time to time. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Lasix® ONYU is the proprietary name for the furosemide injection combination product in the US. The trademark Lasix® is registered for Validus Pharmaceuticals L.L.C. in the United States and used by SQ Innovation under license. The proprietary name for Europe has not yet been established. Furoscix is a trademark of Mannkind, Inc.

For Media Inquiries:
pr-media@sqinnovation.com
Ryan Jaslow; ryan@jaslowhealthcomms.com

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SOURCE SQ Innovation