HealthTech of the Week: 3D Printing Technology and Modern Outpatient Solution Join Forces Against Fistulas with Semiflex

Modern medicine has struggled for decades to effectively treat perianal fistulas, especially in patients with Crohn’s disease. This complication, not only burdensome and painful but also psychologically and economically taxing, remains one of the most insufficiently addressed clinical challenges. In response to this need, the Semiflex was developed—an innovative vacuum-assisted therapy that is redefining standards for treating tunnelling wounds. Behind this project stands an interdisciplinary team led by Sława Madelska, co-founder and CEO of the company.

At Healthtech of the Week, we aim to showcase the varied challenges that modern medicine faces, particularly those born from the real experiences of patients, surgeons, and caregivers, whose combined perspectives formed the foundation of this breakthrough. As Madelska explains, it is a truly unique innovation.

– What sets the Semiflex apart from existing solutions is its distinctive design and targeted purpose. It is the world’s first vacuum-assisted closure (VAC) device specifically engineered to treat perianal fistulas. The system’s key components are flexible silicone catheters, produced using 3D printing technology in up to thirty different sizes, allowing precise tailoring to the depth and shape of each fistula – parameters that have long been a limiting factor for effective treatment – explains the CEO.

By leveraging parametric design and additive manufacturing technologies, the team created a solution that simultaneously meets stringent clinical requirements and can be used outside the operating room. With no need for anesthesia, the therapy’s ambulatory nature, and the ability to be managed at home, the system not only enhances patient comfort but also significantly relieves healthcare systems.

A Response to Suffering

Semiflex holds particular significance for patients suffering from inflammatory bowel diseases (IBD), including Crohn’s disease. In this population, fistulas are notoriously difficult to heal—even after multiple surgeries—and patients often endure years of pain, discomfort, and deteriorating quality of life.

Research indicates that 73% of patients with fistulas experience depressive episodes. Repeated recurrences, multiple procedures, and no real prospect of recovery compound feelings of helplessness. Fistulas are not only a health issue; they also present an economic burden, with treatment costs in Europe alone exceeding €5 billion annually.

– Patients suffering from fistulas face a wall every day, as too many treatments only temporarily alleviate symptoms – underscores Madelska. – Our goal was to design a system that offers a genuine chance at lasting remission.

Breakthrough or Revolution in Waiting?

In 2023, the Amsterdam University Medical Center—one of Europe’s leading centers for IBD treatment—conducted a pilot study involving 20 patients with perianal fistulas. Most had been battling the disease for an average of five years and had seen no improvement despite prior therapeutic attempts.

The results using the Semiflex were highly promising, demonstrating both efficacy and safety. In 65% of patients, the treatment was feasible and well tolerated, indicating high clinical acceptability. For half of the participants, clinical closure of the fistula was achieved, a significant therapeutic success in persistent and hard-to-treat cases. Notably, 45% of treatments were managed at home, drastically reducing the need for hospitalization and associated costs and burden on healthcare resources. Additionally, patients reported an average pain score of just 1.6 out of 10 on the VAS scale, underscoring the system’s minimal invasiveness and high treatment comfort.

From Lab to Patient

Developing this innovative system—which fulfills both medical and user requirements—required overcoming numerous technological hurdles. The Semiflex team used advanced tools like 3D printing and rapid prototyping to iterate and refine the drain design quickly. The system’s technological flexibility will allow further personalization to individual patient anatomy and fast implementation of design improvements based on new clinical data.

Although the current system does not incorporate predictive algorithms or artificial intelligence, Madelska emphasizes that this is a key direction for future development. Conceptual work is also underway to integrate Semiflex with remote patient monitoring systems, such as mobile apps that track pain levels, wound healing status, and overall quality of life. Such digital support could not only boost treatment effectiveness but also enable individualized care at home.

Toward Global Certification and Deployment

Semiflex is now in an advanced development phase. The product was designed in close collaboration with clinical teams, has passed functional testing, filed for patent protection, and completed pilot clinical trials. The next steps include obtaining certification under the European MDR framework and initiating regulatory approval processes with the FDA (USA) and EMA.

The system’s creators are actively seeking strategic partners who can support global deployment, both in regulatory terms and on the commercial front. The Semiflex exemplifies how interdisciplinary collaboration, technological boldness, and patient-centered empathy can yield a genuine therapeutic breakthrough. It is not just a product innovation but a new paradigm for managing chronic, debilitating conditions, with safe, effective, and home-appropriate treatment.

If forthcoming studies affirm the current results, Semiflex could become the new gold standard in treating perianal fistulas, especially in patients with IBD. For many of them, it will not only represent a shift in therapy but, above all, a new hope for a life free from pain and helplessness.

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Stay tuned for more in the “HealthTech of the Week” series, where we’ll continue to uncover fascinating stories from the world of medical technologies that are changing the face of healthcare. If you’re working on an innovative project in the field of new technologies and medicine or want to recommend an interesting solution, contact us at: [email protected].