SQ Innovation
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.
- Company typePrivate
- Founded2019
- HeadquartersBurlington, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
SQ Innovation firmographics
Firmographics- 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
SQ Innovation industry classification
Industry- 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
Where SQ Innovation is headquartered
LocationHeadquarters
- HQ city
- Burlington
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
SQ Innovation business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Treatment Kit - $475 WAC |
| Unit Pricing | One time/ perpetual license | Reusable Component - $299 WAC |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels6 records
SQ Innovation product offering
Product offeringCore 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
Companies that use SQ Innovation
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
SQ Innovation technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
SQ Innovation partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core.
- University of GlasgowcoreCo-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 BoardcoreCo-sponsor of SUBCUT HF II trial under investigator-initiated grant. Trial funding and product supplied by SQ Innovation.
- Walmart Specialty PharmacycoreCollaboration 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.coreStrategic 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)coreMedicaid National Drug Rebate Agreement signed with CMS, enabling 340B-eligible hospitals, clinics, and pharmacies to order Lasix ONYU under rebate terms.
- Cardinal HealthcoreSpecialty Pharmaceutical Distribution partnership for ordering Lasix ONYU through participating medical facilities and affiliated retail pharmacies.
- CencoracoreSpecialty Distribution partnership (formerly AmerisourceBergen) for ordering Lasix ONYU through medical facilities and pharmacies.
- GerresheimercoreGerresheimer'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 PharmaceuticalscoreExclusive 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
SQ Innovation competitors and assessment
Company assessmentDirect 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
SQ Innovation social profiles
Digital presenceSQ Innovation financial estimates
Financial estimateRevenue estimate
Valuation estimate
SQ Innovation leadership team
Management profileNumber of profiles
Profiles5 records
SQ Innovation funding detail
Funding detailFunding overview
Funding rounds1 record
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SQ Innovation M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SQ Innovation
What does SQ Innovation do?
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.
Is SQ Innovation a public or private company?
SQ Innovation is a private company. It is classified as venture growth investor backed and is currently operating.
When was SQ Innovation founded?
SQ Innovation was founded in 2019. It employs 11 to 50 people.
Where is SQ Innovation based?
SQ Innovation is headquartered in Burlington, United States, in the North America region.
How does SQ Innovation make money?
Two revenue lines are on record. Pharmaceutical Product Sales are the primary driver. The others are specialty Distribution Revenue.
Who are SQ Innovation's main competitors?
MannKind Corporation is listed as a direct peer. Emerging players are Halozyme Therapeutics, Enable Injections, Cytokinetics, Lexicon Pharmaceuticals and Corvia Medical. Broad incumbents are United Therapeutics, AstraZeneca, Boehringer Ingelheim and Novartis.
Does SQ Innovation have an API?
No public API is recorded for SQ Innovation.
What industry is SQ Innovation in?
SQ Innovation's product category is Specialty Biopharmaceuticals (Heart Failure Therapeutics). Its primary akta.pro industry code is HLAHAFAL, Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation). Its NAICS code is 334510 and its SIC code is 3841.