#Heart Failure #Lasix ONYU #SQ Innovation

Promising Advancements in Heart Failure Treatment

In a groundbreaking announcement, SQ Innovation has revealed interim results from the Gator SCALES-WHF study, demonstrating the potential of its novel product, Lasix® ONYU, for treating worsening heart failure at home. This innovative subcutaneous formulation of furosemide represents a significant shift in how patients at imminent risk of hospitalization can manage their condition effectively and safely without needing immediate inpatient care.

Study Overview

The Gator SCALES-WHF study, which took place at the University of Florida, is a prospective, open-label, single-arm trial assessing the effectiveness of Lasix ONYU. According to findings presented on October 11, 2026, at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona, the study involved 21 participants who were at high risk for hospital admission and initiated treatment with Lasix ONYU on the same day they presented. Remarkably, 86% of these patients experienced successful decongestion without necessitating hospitalization, showcasing the product’s promise.

The interim results emphasize an opportunity for a structured at-home care pathway, one that minimizes hospital visits and associated complications. Dr. Mustafa M. Ahmed, the study's principal investigator, noted, “Patients who have failed up-titration of oral diuretics have, until now, had few alternatives other than inpatient IV therapy.”

The Path to At-Home Treatment

Traditionally, heart failure patients requiring diuretic therapy were subjected to long hospital stays. This is where Lasix ONYU comes in, allowing patients to self-administer furosemide at home, either independently or with a caregiver's assistance. The unique aspect of this study is its real-world approach—directly addressing the needs of patients who previously faced limited options for managing their worsening symptoms outside of hospital settings.

Eligible participants were adults aged 18 to 80 with congestive heart failure signs and symptoms of fluid overload. Many had issues with oral diuretic titration and were deemed at imminent risk for hospital admission. The interim findings showcase how effectively these patients managed their medications: they successfully self-administered a total of 95 doses of Lasix ONYU, with minimal user or safety issues reported.

Device Innovation

The Lasix ONYU Infusor represents a considerable advancement in drug delivery systems. It slowly administers 80 mg of furosemide over a five-hour period, mirroring the effects of intravenous (IV) administration but in a controlled manner designed for home use. This method avoids the intense diuretic response often seen with rapid IV infusions, providing a gentler approach to fluid management.

Pieter Muntendam, MD, the founder and CEO of SQ Innovation, emphasized the importance of these findings, stating,