SQ Innovation

What SQ Innovation does

SQ Innovation is a privately held Swiss biopharmaceutical company, founded in 2019, that develops and commercializes drug-device combination products for subcutaneous drug delivery to enable at-home treatment of conditions traditionally managed in hospitals. Its lead product, Lasix ONYU, combines a novel high-concentration furosemide formulation (80 mg/2.67 mL at 30 mg/mL, enabled by Ligand's Captisol cyclodextrin technology) with a two-component on-body Infusor device (reusable electromechanical unit plus sterile disposable with micropiston pump and 29-gauge needle) to deliver subcutaneous diuretic therapy over five hours. The company received FDA approval in October 2025 and CE Marking in April 2026 for treatment of edema in adult chronic heart failure patients, targeting the ~6.7 million Americans living with heart failure and the ~1.2 million annual heart failure hospitalizations.

SQ Innovation operates through a B2B2C model selling to hospital systems, IDNs, retail and specialty pharmacies, and 340B-eligible entities via wholesale acquisition (WAC) pricing: $475 per Treatment Kit and $299 per Reusable Component, with a typical patient requiring 6-12 kits per edema episode. Distribution is handled through Cardinal Health and Cencora specialty pharmaceutical networks in the U.S., with Walmart Specialty Pharmacy providing nationwide overnight home delivery. Reimbursement frameworks have been established with Medicaid (CMS National Drug Rebate Agreement) and the company is engaging Medicare and commercial payors directly. The company employs 11-50 people across offices in Burlington, MA (U.S. headquarters), Zug, Switzerland (Swiss HQ), and Rotterdam, Netherlands, and is led by founder Pieter Muntendam, MD (President and CEO) and Chairman Erwin Conradi.

The company's strategic positioning rests on proprietary formulation patents (through 2039) and Captisol licensing (through 2034), FDA/EMA regulatory clearances, a partnership-driven supply chain (Gerresheimer for device, Ligand for formulation chemistry, FIS for API), and clinical evidence from the SUBCUT HF II randomized controlled trial across 20 NHS hospitals showing 4 fewer hospital days versus IV standard of care. Revenue was not disclosed; the company completed a Series B financing in October 2025 led by Marco van der Poel and is in the earliest phase of U.S. and EU commercial launch.

Name

SQ Innovation

Legal name

SQ Innovation, Inc.

Website

https://sqinnovation.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

SQ Innovation is a Swiss biopharmaceutical company that develops and commercializes Lasix ONYU, an FDA-approved drug-device combination enabling at-home subcutaneous furosemide infusion for adult chronic heart failure patients with edema, distributed in the U.S. via Cardinal Health, Cencora, and Walmart Specialty Pharmacy.

Ownership category

akta.pro rank

Product category

Specialty Biopharmaceuticals (Heart Failure Therapeutics)

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

• Subcutaneous furosemide therapy
• Drug-device combination products
• Heart failure edema treatment
• At-home diuretic infusion
• Specialty biopharmaceutical therapeutics

Headquarters

HQ city

Burlington

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Sale of Lasix ONYU drug-device combination products including Treatment Kits ($475 WAC per kit) and Reusable Components ($299 WAC). Revenue from wholesale acquisition to distributors, specialty pharmacies, and healthcare facilities.
2. Specialty Distribution Revenue: Products distributed through Cardinal Health and Cencora specialty distribution networks to hospitals, clinics, and retail pharmacies. Medicaid rebate agreement enables 340B entity access.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

SQ Innovation develops and commercializes Lasix ONYU, an FDA-approved drug-device combination product for the at-home subcutaneous infusion of furosemide (80 mg/2.67 mL at 30 mg/mL) to treat edema in adult patients with chronic heart failure. The product pairs a novel Captisol-enabled high-concentration furosemide formulation with the Lasix ONYU Infusor, a two-component delivery system (reusable electromechanical unit plus sterile disposable unit) that enables self-administered 5-hour subcutaneous diuretic therapy outside the hospital setting.

Product overview

SQ Innovation offers a single unified drug-device combination product, Lasix ONYU, which combines a novel high-concentration Captisol-enabled furosemide formulation (80 mg/2.67 mL at 30 mg/mL) with the two-component Lasix ONYU Infusor delivery system. The Infusor consists of a reusable electromechanical unit (up to 48 treatments) and a sterile disposable unit with a 29-gauge needle. Together, these components enable at-home subcutaneous infusion of furosemide over 5 hours, allowing selected heart failure patients to self-administer diuretic treatment without hospitalization or healthcare professional administration.

Differentiator

Problem solved

Functional benefit

Brands

• Lasix ONYU: A drug-device combination product for subcutaneous infusion of furosemide for the treatment of edema in adult patients with chronic heart failure, enabling at-home treatment as an alternative to hospital-based IV diuretic therapy.

Products and services

• Lasix ONYU Drug-device combination product for at-home subcutaneous infusion of furosemide (80 mg/2.67 mL at 30 mg/mL concentration) over 5 hours, indicated for the treatment of edema in adult patients with chronic heart failure. Combines a novel high-concentration furosemide formulation with the Lasix ONYU Infusor so selected patients can self-administer diuretic therapy without a healthcare professional or hospitalization.
• Lasix ONYU Treatment Kit Sellable unit containing a pre-filled glass cartridge with 80 mg furosemide in 2.67 mL (30 mg/mL concentration) plus the sterile single-use Disposable Unit (micropiston pump, fluid path, 29-gauge needle). Priced at $475 WAC; patients typically require 6–12 kits per edema treatment episode.
• Lasix ONYU Reusable Component Sellable motorized electromechanical unit (battery, motor, electronics) that powers the Lasix ONYU Infusor. One unit is required per patient starting treatment and can be used for up to 48 treatments before recycling. Priced at $299 WAC.

Quantifiable outcome

• 112% bioavailability compared to IV bolus
• +6 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Nine partnerships are on record, tiered core.

• University of GlasgowcoreStrategic or Co-development Partner · 4 May 2026Co-sponsor of SUBCUT HF II randomized controlled trial of at-home subcutaneous furosemide therapy for heart failure patients. Trial conducted across 20 NHS hospitals with 170 patients.
• NHS Greater Glasgow and Clyde Health BoardcoreStrategic or Co-development Partner · 4 May 2026Co-sponsor of SUBCUT HF II trial under investigator-initiated grant. Trial funding and product supplied by SQ Innovation.
• Walmart Specialty PharmacycoreChannel Partner/ Reseller/ Distributor · 21 April 2026Collaboration for nationwide overnight delivery of Lasix ONYU, improving access particularly for rural communities where transportation barriers limit timely treatment. Enables at-home administration as alternative to hospital-based IV diuretic therapy.
• FIS Fabbrica Italiana Sintetici S.p.A.coreTechnology or Integration · 15 April 2026Strategic supply agreement to secure long-term availability of pharmaceutical-grade furosemide active pharmaceutical ingredient (API) for Lasix ONYU and future pipeline products across U.S., Europe, and global markets. Includes certain exclusivity provisions.
• CMS (Centers for Medicare & Medicaid Services)coreOthers · 9 February 2026Medicaid National Drug Rebate Agreement signed with CMS, enabling 340B-eligible hospitals, clinics, and pharmacies to order Lasix ONYU under rebate terms.
• Cardinal HealthcoreChannel Partner/ Reseller/ Distributor · 9 February 2026Specialty Pharmaceutical Distribution partnership for ordering Lasix ONYU through participating medical facilities and affiliated retail pharmacies.
• CencoracoreChannel Partner/ Reseller/ Distributor · 9 February 2026Specialty Distribution partnership (formerly AmerisourceBergen) for ordering Lasix ONYU through medical facilities and pharmacies.
• GerresheimercoreTechnology or Integration · 28 October 2025Gerresheimer's Gx InPuls on-body device is used in SQ Innovation's FDA-approved Lasix ONYU combination product. Device platform based on Sensile Medical micro-pump technology acquired by Gerresheimer.
• Ligand PharmaceuticalscoreTechnology or Integration · 8 July 2019Exclusive worldwide license and supply agreements for Captisol technology in high-concentration furosemide formulation. SQ Innovation uses Captisol to achieve 30mg/mL concentration at neutral pH for subcutaneous delivery. Ligand eligible for milestone payments and royalties.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• MannKind Corporation: MannKind markets Furoscix (subcutaneous furosemide) for at-home treatment of edema in chronic heart failure — the closest direct competitor to Lasix ONYU, addressing the same indication, same drug, same subcutaneous administration route, and same target population.

Emerging players

• Halozyme Therapeutics: Halozyme's ENHANZE subcutaneous delivery platform enables high-concentration, large-volume SC injection of biologics and is licensed widely across pharma. Comparable to SQ Innovation's high-concentration Captisol-enabled formulation and two-component device approach for subcutaneous at-home delivery.
• Enable Injections: Enable Injections develops on-body subcutaneous infusion devices (enFuse) for large-volume and high-concentration drug delivery, enabling at-home self-administration. Closely analogous technology and use case to the Lasix ONYU Infusor.
• Cytokinetics: Cytokinetics is developing novel cardiac myosin modulators (e.g., omecamiv mecarbil, aficamten) for heart failure. Comparable emerging player addressing the same HF patient population with a complementary, mechanistically distinct therapeutic approach.
• Lexicon Pharmaceuticals: Lexicon Pharmaceuticals developed sotagliflozin (Zynquista/Inpefa) for heart failure, an SGLT1/2 inhibitor with HF indication. Comparable emerging player operating in the same heart failure treatment paradigm with overlapping patient populations.
• Corvia Medical: Corvia Medical develops the Corvia Atrial Shunt, an interatrial shunt device for HFpEF patients. Comparable emerging-stage medical-device company focused on reducing HF hospitalizations and improving quality of life for chronic heart failure patients.

Broad incumbents

• United Therapeutics: United Therapeutics develops and commercializes specialty pharmaceuticals for chronic and life-threatening conditions (pulmonary hypertension, neuroblastoma) with subcutaneous and inhaled delivery platforms, including the acquired SteadyMed Trevyent pump. Comparable specialty pharma with subQ delivery focus.
• AstraZeneca: AstraZeneca markets Farxiga (dapagliflozin), an SGLT2 inhibitor with strong heart failure (HFrEF/HFpEF) indications. As foundational HF therapy grows, AZ represents the most important indirect competitive dynamic shaping the diuretic-eligible HF population.
• Boehringer Ingelheim: Boehringer Ingelheim (with Eli Lilly) markets Jardiance (empagliflozin) for heart failure. SGLT2 class growth driven by BI/Lilly directly affects the long-term demand for diuretic-based HF treatment.
• Novartis: Novartis markets Entresto (sacubitril/valsartan) as foundational ARNI therapy for HFrEF. Entresto and other guideline-directed medical therapies reduce HF hospitalizations and shape the population still requiring diuretic intervention.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sq-innovation-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds1 record

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SQ Innovation