#USA #Burlington #Heart Failure #Lasix ONYU #SQ Innovation

SQ Innovation Launches Lasix® ONYU

SQ Innovation, Inc., a biopharmaceutical company located in Burlington, Massachusetts, has unveiled an important new product in the fight against chronic heart failure. Following its FDA approval granted in October 2025, the company’s Lasix® ONYU (furosemide injection) is now available for order through major U.S. pharmaceutical distributors, Cardinal Health and Cencora, previously known as AmerisourceBergen.

Lasix® ONYU represents a significant advancement in the treatment of edema due to fluid overload in adult patients with chronic heart failure. Traditionally, patients often require hospitalization for intravenous (IV) treatments, but this new formulation allows patients to receive prescribed therapies in the comfort of their own homes. This shift not only promotes patient convenience but also addresses the increasing need for outpatient treatment options.

Dr. Pieter Muntendam, President and CEO of SQ Innovation, expressed his enthusiasm regarding the availability of Lasix ONYU. He stated, "By ensuring broad availability through Cardinal Health and Cencora at a cost-effective price point, we are eliminating two of the most significant barriers to making the home the preferred setting of care for selected patients with worsening heart failure due to fluid overload.” This new approach intends to streamline the patient experience while maintaining close collaboration with healthcare providers to establish evidence-based pathways for treatment.

What is Lasix ONYU?

Lasix® ONYU is a drug-device combination consisting of a high-concentration formulation of the loop diuretic furosemide at 30 mg/mL concentration. The medication is housed in a pre-filled glass cartridge that delivers 80 mg of furosemide in a total volume of 2.67 mL.

The device comprises two main components: the Reusable Unit, which contains the battery and motor, and the Disposable Unit that incorporates the sterile drug cartridge. Once activated, the Lasix ONYU Infusor slowly administers medication via a 29-gauge needle inserted into the abdomen, providing a continuous infusion that mimics the effects of IV delivery but in a more controlled manner. This innovative delivery method helps avoid the quick, intense diuretic effects that can accompany traditional IV infusions.

The product has been designed with a focus on patient safety, environmental sustainability, and cost-effectiveness, making it suitable for use in non-hospital settings. As the healthcare landscape evolves, the demand for home-based treatments is escalating, and SQ Innovation’s commitment to this transition is evident.

Accessibility and Future Developments

In addition to partnering with major distributors, SQ Innovation has secured a Medicaid National Drug Rebate Agreement (NDRA) with the Centers for Medicare & Medicaid Services (CMS). This agreement paves the way for Lasix ONYU to be accessible to 340B-eligible hospitals, medical facilities, and pharmacies, enhancing its reach to patients who can benefit from this life-changing treatment.

As the distribution networks are now firmly established, SQ Innovation is focusing on collaborating with the clinical community to develop comprehensive support tools and care pathways for patients. This forward-thinking approach ensures that patients diagnosed with heart failure can receive timely and convenient care in their own homes, thereby reducing hospitalization rates and improving overall health outcomes.

For those interested in ordering Lasix ONYU, detailed information is available on the company’s website at www.lasix-onyu.com/order.

Important Safety Information

Like all medications, Lasix ONYU comes with important safety considerations. It is crucial for patients to discuss any medical conditions or allergies with their healthcare provider prior to starting treatment. Common side effects may include dehydration, low blood pressure, and infusion site reactions, among others. Patients are advised to report any unusual symptoms to their healthcare team immediately.

As this innovative therapy reaches more patients, SQ Innovation is setting a precedent for the future of outpatient treatments in chronic heart failure management.