Burlington – October 12, 2026 -- Eighty-six percent of 21 heart failure patients at imminent risk of hospital admission were decongested at home without hospitalization using SQ Innovation's subcutaneous furosemide product Lasix ONYU, according to interim results from the investigator-sponsored Gator SCALES-WHF study.
Three patients were admitted within 30 days for additional treatment. The data were presented on October 11 at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona.
University of Florida study tests same-day home treatment pathway
Gator SCALES-WHF is a prospective, open-label, single-arm, real-world study at the University of Florida in Gainesville. Principal Investigator Mustafa M. Ahmed, MD, leads the trial, and cardiology fellow Jude ElSaygh, MD, presented the interim data.
Eligible adults aged 18 to 80 had congestive heart failure with fluid overload despite oral diuretic up-titration. All were expected to need at least three days of parenteral diuretic therapy. Treatment started the same day, and patients self-administered the drug at home, alone or with a caregiver, and were followed for 30 days.
Dr. Ahmed said patients who fail oral diuretic up-titration have had few options other than hospital IV therapy, and that a structured at-home pathway can be implemented without delay.
Patients self-administer 95 doses with minimal device or safety issues
All 21 enrolled patients completed 30-day follow-up. Mean age was 63.1 years, 38% were women and 67% had heart failure with reduced ejection fraction. Median BNP at enrollment was 1,125 pg/mL (IQR, 204–4,300), comparable to levels in patients who typically are admitted for inpatient treatment after emergency room presentation.
Participants successfully self-administered 95 doses. User, device or safety issues were minimal, and no patient discontinued for user, device or adverse event-related reasons.
Payor coverage under Medicare Part B shapes commercial case
SQ Innovation founder, President and CEO Pieter Muntendam, MD, said the study mimics same-day initiation in patients at imminent risk of admission, which is now possible under the medical benefit for Medicare Part B and other insurers. He said this use provides value to payors and providers.
The company cites more than 1.2 million heart failure admissions in the U.S. each year, a significant contributor to Medicare and other insurance costs. Inpatient IV diuretic therapy for edema can take up to one week.
FDA-approved infusor delivers 80 mg of furosemide over five hours
The U.S. Food and Drug Administration approved Lasix ONYU on October 7, 2025, for edema in adults with chronic heart failure. The Infusor delivers 80 mg of furosemide over five hours, producing diuresis similar to IV in a more controlled manner designed for home use. The product is available for ordering from Cardinal Health and Cencora and for dispensing and overnight delivery from Walmart Specialty Pharmacy.
Lasix ONYU is a second-generation subcutaneous furosemide combination product, following the introduction of Furoscix in 2023.