Heart Failure Care Goes Home: SQ Innovation Inks Key Deal for Revolutionary Device

By Deborah Cooper

BURLINGTON, Mass. – April 15, 2026 – A strategic pact between two key players in the pharmaceutical world is set to bolster a major shift in medical care, moving the treatment of chronic heart failure from crowded hospital wards into the patient's own home. SQ Innovation, the developer of the recently approved Lasix ONYU device, has announced a long-term supply agreement with FIS Fabbrica Italiana Sintetici, a leading European manufacturer of active pharmaceutical ingredients (APIs).

The agreement secures a stable, high-quality supply of furosemide, the critical drug component in Lasix ONYU, a novel device designed to manage fluid overload (edema) in heart failure patients. This partnership not only ensures the continued production of the groundbreaking product for the U.S. market but also lays the groundwork for SQ Innovation's planned global expansion, signaling a robust future for at-home, patient-managed care.

A New Paradigm for Patient Care

Approved by the U.S. Food and Drug Administration on October 7, 2025, Lasix ONYU represents a significant leap forward in managing one of the most challenging aspects of chronic heart failure. Fluid overload is a primary driver of hospitalizations for this patient population, placing a immense burden on both individuals and the healthcare system. Traditionally, severe cases require intravenous (IV) diuretics administered in a clinical setting.

Lasix ONYU upends this model. The drug-device combination consists of a small, wearable infusor that slowly administers a high-concentration formulation of furosemide subcutaneously (under the skin) over five hours. This mimics the effectiveness of an IV drip but does so in a controlled manner that avoids the sudden, intense diuretic effects of a rapid IV push. Patients can now manage their condition proactively at home, potentially preventing the emergency room visits and costly hospital stays that characterize advanced heart failure.

"Securing a reliable supply of high-quality furosemide API is critical to our mission of providing innovative heart failure treatment options that aim to provide an alternative to hospitalizations," said Pieter Muntendam, MD, Founder, President and CEO at SQ Innovation, in the official announcement. "FIS's reputation for excellence in API manufacturing and their commitment to quality align with our standards and our growth objectives."

The device itself features a thoughtful, two-part design: a reusable electromechanical unit that can be used up to 48 times and a sterile, single-use disposable unit containing the pre-filled drug cartridge. This approach is intended to reduce waste and lower the overall cost of treatment, making the technology more accessible to patients, providers, and payers.

The Unseen Engine of Pharmaceutical Innovation

The announcement shines a spotlight on a frequently overlooked but vital segment of the healthcare industry: the API supply chain. An innovative drug or device is only as effective as its availability, which hinges on the reliable production of its core ingredients. Furosemide has been a staple diuretic for decades, but the high-concentration formula required for the Lasix ONYU device necessitates a specialized and dependable manufacturing partner.

Enter FIS. The Italian-based firm is a powerhouse in the API world, serving as a Contract Development and Manufacturing Organization (CDMO) for pharmaceutical companies globally. By partnering with FIS, SQ Innovation de-risks its manufacturing process, ensuring that the foundational component of its flagship product is consistently available and meets rigorous quality standards.

"We are proud to partner with SQ Innovation in advancing transformative solutions for heart failure treatment," stated Daniele Piergentili, CEO and Chairman at FIS. "By combining our advanced manufacturing expertise with rigorous quality and regulatory standards, we can provide the strong, reliable supply foundation for this proven ingredient for innovative products to the benefit of patients worldwide."

The agreement includes undisclosed "exclusivity provisions," a common strategic move in such partnerships. These provisions likely grant SQ Innovation a degree of exclusive access to the specific furosemide API from FIS, creating a competitive moat by making it more difficult for rivals to replicate their product with the same components and quality assurances.

Navigating a Competitive Landscape

While Lasix ONYU is a trailblazer, it does not enter the market unopposed. The concept of subcutaneous, at-home diuretic therapy has been gaining traction. Another product, Furoscix by scPharmaceuticals, was approved by the FDA in 2022 for a similar indication. This underscores a growing industry trend toward developing more patient-centric, home-based solutions for chronic disease management. In a notable industry connection, SQ Innovation's founder, Pieter Muntendam, was also the founder of scPharmaceuticals, highlighting his long-standing vision for this therapeutic approach.

SQ Innovation's strategy appears to be built on differentiation through device design, usability, and a robust commercial plan. Since becoming available for ordering in February 2026 through major distributors like Cardinal Health and Cencora, the company has focused on establishing clear pathways for patient access, including securing agreements that make the product available to 340B-eligible hospitals and facilities.

The strategic supply agreement with FIS is a critical pillar of this commercial strategy. By locking in a predictable and high-quality source for its API, SQ Innovation can focus on market education, physician adoption, and patient support. It provides the stability needed to not only compete effectively but also to execute its long-term vision of expanding into European and other global markets, bringing its innovative treatment to a wider population of patients desperately in need of better options for managing their chronic condition.