At Flen Health, the vision is clear and deeply human: a world where wounds and skin disorders no longer prevent patients from living the life they love. As a Belgian company, this purpose-driven ambition has guided the company for over 25 years, shaping their innovation strategy, international growth, and now their expansion into the United States, the world’s most significant and complex healthcare market.
Founded in Belgium and rooted in family entrepreneurship, Flen Health has evolved into a globally active healthcare company with a strong scientific foundation, a culture of innovation, and an unwavering commitment to patient empowerment.
From a Family Story to a Global Mission
Flen Health is a family-owned company, founded by
Philippe Sollie, who is also the inventor of their products. The origin of the
company traces back to a family gathering, where a one-year-old girl suffered
severe burns as a result of an accident involving a deep fryer. During her
hospitalization in a burn's unit, it became clear that she was suffering
allergic reactions to the standard treatment products available at the time. It
is there that Flen health was established following a real and urgent unmet medical
need: the search for a better-tolerated treatment option for a young burn
patient.
Recognizing the critical unmet need, Philippe Sollie reached out to the head of the hospital’s burns department. Together, they began developing an alternative solution that would be both effective and better tolerated. That collaboration resulted in the creation of Flamigel®, a product that became the cornerstone of the company’s growth and innovation platform.
In 1999, Flamigel® obtained their CE mark, and in 2000, Flen Health was officially established in Belgium.
Building a Strong European Base
Over the years, Flen Health has expanded their product portfolio and
geographical footprint. In addition to Flamigel®, the company developed
Flamirins®, a wound cleanser; Flaminal®, a topical gel for the
treatment of chronic wounds; and Extraclam®, designed to relieve itch.
Today, Flen Health operates in seven affiliates across Europe, including Belgium, Luxembourg, Germany, Italy, Ireland, the United Kingdom, and the Netherlands, and distributes products in more than 35 countries worldwide. With 110 employees and a strong research-driven culture, Flen Health has built a solid European base while remaining firmly anchored in Belgium, where their headquarters and core R&D activities are located.
Recently, Flen Health made the strategic decision to pursue entry into the US healthcare market.
Why the United States — and Why Now
Flen Health’s objective is to empower patients
worldwide who suffer from wounds and skin disorders to reclaim the quality of
life they deserve, and this aspiration extends to the United States market.
The US (bio)pharmaceutical chronic wound healing sector has seen limited innovation in recent years. Flen Health aims to fill this innovation gap by introduction a new generation of scientifically advanced solutions tailored to the needs of the US patients, clinicians, and the healthcare systems.
While the US represents the most complex healthcare landscape in the world, it is also the largest, making it a critical focus for the company’s mission. Flen Health is committed to introducing their innovative products, which have demonstrated strong clinical performance over the past two decades, to US patients, thereby enabling to live the lives they cherish.
Navigating Regulatory Complexity
Early dialogue with the
U.S. Food and Drug Administration (FDA) revealed that Flaminal® could not
follow the same medical-device regulatory pathway used in Europe. Instead, the
FDA classified the product as a combination product with a primary biologic
mode of action.
Rather than viewing this as a barrier, at Flen Health, it was treated as a strategic inflection point.
Flen Health undertook a comprehensive redevelopment of the product, secured a new patent in 2024, and resumed discussions with the FDA regarding their revised approach. Today, Flen Health is progressing through the FDA registration process for their newly developed product as a biologic, specifically for the treatment of diabetic foot ulcers within the United States.
In January, Flen Health reached a key milestone by participating in an INTEREACT meeting with the FDA, during which they received favorable feedback on their Chemistry, Manufacturing, and Controls (CMC) development plan.
The Road Ahead
“Today, we are building on our foundation with a new patented enzyme composition designed to create an even more effective generation of Flaminal. We start introducing this innovation in the United States as a biopharmaceutical product. Early interactions with the FDA have been highly encouraging, though we will still undergo the full registration, clinical trial and evidence‑generation process.
Stay tuned—we will continue sharing updates as our US journey unfolds.”
Several major milestones lie ahead on Flen Health’s US journey:
- Initiation of Phase 0 and Phase 1 clinical trials in Belgium
- A Pre-Investigational New Drug (Pre-IND) meeting with the FDA
- Submission of the Investigational New Drug (IND) application
- Launch of Phase 2 and Phase 3 clinical trials in the United States
- Submission of a Biologics License Application (BLA) to the FDA
By 2030, Flen Health aims to complete Phase 3 clinical studies in the US and begin preparations for their Biologics License Application (BLA) submission, marking a transformative step in the company’s evolution. With the ongoing expansion of their Research and Development department, located in Belgium, they aim to secure additional patents and advance the development of new products.
Strengthening Belgium Through US Expansion
Far from diverting focus away from Belgium, expansion toward the US is actively reinforcing Flen Health’s activities at home. The biologics classification requires them to elevate their regulatory and quality management frameworks to fully comply with biopharmaceutical standards.
This shift supports Flen Health’s ambition to establish themselves as a recognized biopharmaceutical innovator and lays the groundwork for future drug discovery and development initiatives, led from Belgium.
A Strong Focus on Innovation
Innovation is central to this transformation. Transitioning to a
biologic required all ingredients to meet strict pharmaceutical-grade standards.
To achieve this, Flen Health developed enzymes using recombinant technologies,
in some cases pioneering these methods on a global scale. This innovation is
driven by research conducted in-house in Belgium and strengthened through
strategic collaborations with leading universities and research partners.
Since their foundation, Flen Health has consistently invested in research infrastructure and scientific talent, ensuring innovation remains at the core of their long-term strategy.
As they continue their journey from a family-owned innovator to a global healthcare player, Flen Health’s story reflects the strength of Belgian entrepreneurship: science-driven, patient-focused, and unafraid to take on the world’s most demanding markets.
Established in Belgium in 2000
Locations in Belgium, Luxembourg, Germany, Italy, Ireland, the UK, and the Netherlands.
110 employees
Distribution in +35 countries worldwide
€40 million
in sales in 2025, with 30% generated in Belgium
Flen Health: Innovating Wound Care from Belgium to the United States