Heart failure patients sent home early with a wearable diuretic pump spent about four more days alive and out of the hospital over the next month than patients who stayed in for standard IV treatment. That’s the main finding of SUBCUT HF II, a randomized U.K. trial now published in the Journal of the American College of Cardiology (JACC). SQ Innovation, the privately held Swiss company behind the pump, announced the publication in a press release on October 14, 2026.

The product is Lasix ONYU. The FDA approved it in October 2025. What this trial adds is controlled evidence that patients can run a hospital-level course of the drug themselves, at home.

SQ Innovation has no stock to trade. But the data land in a market where a public company, MannKind Corporation (Nasdaq: MNKD), already sells a rival product.

What the Trial Tested

SUBCUT HF II enrolled 172 patients, aged 34 to 92, at 20 National Health Service (NHS) hospitals. All had been admitted for heart failure and needed IV diuretics. Ninety-two were randomized to early discharge with Lasix ONYU. Eighty stayed in the hospital on IV furosemide.

The drug in both arms is furosemide, a loop diuretic that has been in use for more than 50 years. It pushes the kidneys to flush out salt and water. That matters because fluid overload, called edema, is behind many heart failure admissions. Lasix ONYU packs a concentrated, pH-neutral version into a small cartridge, and a pump worn on the abdomen infuses 80 mg under the skin over five hours.

The study was open-label, so patients and doctors knew who got what. It was investigator-sponsored, run by the University of Glasgow and NHS Greater Glasgow and Clyde. SQ Innovation paid for it through a grant and supplied the drug and device. The company says it had no role in the trial’s design, conduct or analysis.

The Headline Numbers

The primary endpoint was days alive and out of hospital, or DAOH, at 30 days. The early discharge group gained 4.0 days (95% CI, 2.1-5.8; P<0.001). At 60 days, the gain was 4.2 days (95% CI, 0.9-7.4).

The index stay, meaning the admission that brought patients into the study, ran 5.5 days shorter on average (95% CI, 3.6-7.4; P<0.001).

Keep one thing in mind. Early discharge was the intervention. A shorter first stay is partly built into the design, so the sharper question is what happened once patients got home.

Patients self-administered about 900 mg of furosemide over their treatment, according to SQ Innovation CEO Pieter Muntendam. He describes that as comparable to what a hospital admission might deliver.

The Number to Watch

Readmissions. By day 60, 23.9% of the at-home group had been rehospitalized for any cause, versus 17.5% on usual care. The gap wasn’t statistically significant (p=0.33). Still, it ran the wrong way, and a 172-patient trial isn’t built to rule out a real difference.

Other safety measures looked similar. Serious adverse events hit 25% of the at-home arm and 23% of the usual-care arm. Device problems turned up in 3% of pump placements, and none were serious.

What the Release Leaves Out

Trial size is the big one. A U.K. Health Research Authority summary of SUBCUT HF II listed a planned enrollment of 550 patients. The final count was 172. The release doesn’t address the shortfall, and it limits how much any secondary result, readmissions included, can tell us.

Geography is the other. This was a Phase 2 study run entirely in the U.K., while Lasix ONYU’s only approval so far is American. SQ Innovation says a European brand name hasn’t been set yet.

A Rival With a Head Start

Lasix ONYU wasn’t first. SQ Innovation itself calls it a second-generation product that follows Furoscix, an on-body infusor that also delivers 80 mg of subcutaneous furosemide over roughly five hours. Furoscix won FDA approval for heart failure edema in October 2022 and added chronic kidney disease in 2025.

MannKind owns it now. The company closed its purchase of Furoscix developer scPharmaceuticals on October 7, 2025, and reported $23 million in Furoscix net sales for the fourth quarter of that year.

MannKind hasn’t stood still. In July 2026, the FDA approved Furoscix ReadyFlow, an autoinjector that delivers the dose in 10 seconds or less instead of five hours. MannKind said it expected U.S. availability by the end of August 2026.

That’s the field Lasix ONYU is competing in. It brings a reusable pump unit and now a published randomized trial supporting early discharge. Furoscix brings a head start, a public parent and a much faster delivery option. Neither company has reported a head-to-head comparison, and their trials used different designs, so any side-by-side reading is suggestive at best.

What Comes Next

SQ Innovation also reported interim results this month from Gator SCALES-WHF, a separate single-arm study at the University of Florida. With no control group, it can speak to feasibility but not to comparative benefit.

Lasix ONYU is approved only for edema in adults with chronic heart failure. Whether hospitals adopt an early-discharge model will likely turn on patient selection, which trial investigator Mark Petrie has called crucial, and on reimbursement, which the company flags among its key risks. This article covers clinical trial data and is not medical or investment advice.

Sources

• SQ Innovation: Trial Demonstrates Feasibility of At-Home Subcutaneous Diuretic Therapy for Heart Failure-Associated Edema, PRNewswire, October 14, 2026. Primary source release.
• U.K. Health Research Authority: SUBCUT-HF II Research Summary, cited for the trial’s originally planned enrollment of 550 patients and furosemide’s 50-plus years of use, neither of which appeared in the release.
• ClinicalTrials.gov: SUBCUT HF II (NCT05419115), cited for trial registration and principal investigators.
• Drugs.com: Lasix ONYU FDA Approval History, cited for the October 2025 FDA approval date.
• Drugs.com: Furoscix FDA Approval History, cited for Furoscix’s 2022 heart failure approval and 2025 chronic kidney disease expansion.
• MannKind: MannKind Completes Acquisition of scPharmaceuticals, cited for MannKind’s ownership of Furoscix and the October 7, 2025 closing date.
• MannKind Fourth Quarter and Full Year 2025 Results (SEC EDGAR, Form 8-K Exhibit 99.1), cited for Furoscix fourth-quarter 2025 net sales.
• MannKind: FDA Approval of Furoscix ReadyFlow Autoinjector, cited for the July 2026 approval and expected U.S. availability.
• TCTMD: Subcutaneous Furosemide Aids With Earlier Discharge: SUBCUT II HF, cited for investigator Mark Petrie’s comments on patient selection.

Editorial Disclosure

This article reports on clinical trial results published in the Journal of the American College of Cardiology (JACC) regarding Lasix ONYU, based on a press release issued by SQ Innovation on October 14, 2026. Securities and corporate structures discussed: SQ Innovation, Inc. is privately held and has no publicly traded securities; MannKind Corporation (Nasdaq: MNKD) is referenced as the owner of the competing product Furoscix. BioTech Stocks Daily has not received, nor will it accept, any compensation, direct or indirect, from SQ Innovation, MannKind Corporation, or any other corporate or third-party sponsor for the preparation or publication of this coverage. No staff member, principal, or affiliate of BioTech Stocks Daily holds a position, option, or financial interest in any of the securities mentioned as of the date of publication. Competitive-landscape details on Furoscix and MannKind, the trial’s originally planned enrollment, and FDA approval dates were drawn from independent sources cited above, since the original release did not address them. Statements regarding future adoption of at-home diuretic therapy, reimbursement, commercial competition, product availability, and the outcomes of ongoing studies are forward-looking statements. They involve substantial risks, regulatory uncertainties, and scientific variables; actual clinical outcomes, commercial uptake, and market conditions may differ materially. Biotechnology and pharmaceutical investments carry a high degree of financial risk, including clinical, regulatory, reimbursement, and competitive risks that can result in the total loss of invested capital. This article is published strictly for independent news reporting, market context, and educational purposes only. It does not constitute an investment recommendation, endorsement, or professional financial, legal, or tax advice. Furthermore, this content is not medical advice; patients and healthcare providers should consult appropriate clinical professionals for medical guidance.

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