Italian medical technology innovator Dialybrid has marked a pivotal moment in the evolution of nephrology and vascular surgery, successfully closing a €15 million ($17 million) Series A financing round. The capital injection is set to accelerate the clinical development of the company’s flagship product, the Silkothane arteriovenous (AV) graft, a novel device designed to revolutionize how patients with end-stage kidney disease (ESKD) access life-sustaining haemodialysis.
The funding round was spearheaded by XGEN Venture, with significant participation from the Rilancio Fund managed by CDP Venture Capital. This financial backing arrives in tandem with a major operational milestone: the successful implantation of the Silkothane graft in the first human patient, signaling the beginning of a clinical trial that could redefine the standard of care for dialysis patients globally.
The Clinical Imperative: Addressing the Dialysis Access Crisis
For the millions of patients living with end-stage kidney disease, vascular access is the literal lifeline that connects them to dialysis. Without a reliable, high-flow access point, the blood cannot be efficiently filtered, leading to life-threatening complications.
Currently, surgeons rely on two primary methods to create this access: native arteriovenous fistulas (AVFs) and synthetic grafts. While these methods are standard, they are far from perfect. Native fistulas often require significant time to mature before they can be used, and synthetic grafts, while immediately usable, are frequently plagued by issues such as thrombosis, infection, and long-term patency failure.
Dialybrid’s Silkothane graft introduces a hybrid material—a sophisticated composite of silk fibroin and polyurethane. By combining the biocompatibility and structural integrity of silk with the elasticity and durability of synthetic polymers, the company aims to offer a "best-of-both-worlds" solution. This design is intended to minimize the complication rates associated with traditional synthetic materials while providing the immediate usability required for urgent clinical needs.
Chronology of Development: From Concept to First-in-Human
The journey to the Silkothane first-in-human trial has been a methodical progression through rigorous laboratory testing and regulatory preparation.
- Early R&D Phase: Dialybrid focused on the material science of combining natural silk fibroin with polyurethane, aiming to create a scaffold that supports vessel growth while resisting the mechanical stresses of high-flow blood circulation.
- Preclinical Validation: Extensive bench testing and preclinical models validated the durability and hemocompatibility of the Silkothane material, confirming its potential to outperform existing PTFE (polytetrafluoroethylene) grafts.
- Regulatory Clearance: Dialybrid navigated the complexities of EU clinical trial regulations, securing the necessary approvals to launch a multicenter pilot study.
- Series A Financing (September 2026): The closing of the €15 million round provided the final runway required to move the device into the human clinical setting.
- First Patient Implantation (September 2026): Professor Matteo Tozzi, director of the vascular surgery department at ASST Sette Laghi and professor at Insubria University, successfully performed the inaugural procedure, marking the official commencement of the clinical evaluation phase.
The Clinical Trial: A Rigorous Evaluation
The current open-label, single-arm pilot study is designed to be a definitive assessment of the device’s real-world viability. Enrolling 18 adult participants across four specialized clinical centers in Italy, the trial seeks to generate high-quality data regarding the safety and performance of the Silkothane graft.
The study design is longitudinal, tracking patients over a 60-month follow-up period. This extended timeframe is critical in the field of vascular access, where "long-term patency"—the ability of the graft to remain open and functional—is the primary measure of success. Interim analyses are scheduled at six, 12, and 24 months, allowing researchers to gather data on cannulation success, infection rates, and the incidence of stenosis or thrombosis.
Perspectives from Leadership: The Vision for Silkothane
Francesco Giovanni Greco, Chairman and CEO of Dialybrid, views the recent developments as a vindication of the company’s long-term research strategy. Speaking on the significance of the funding and the trial, Greco emphasized the clinical gap that Silkothane is designed to fill.
"We are delighted to announce the closing of our Series A round and the start of the first-in-human trial, a transformative milestone for our company," said Greco. "According to the KDOQI (Kidney Disease Outcomes Quality Initiative) Clinical Practice Guideline for Vascular Access, the ideal haemodialysis access should provide adequate flow rates to sustain prescribed dialysis, be easy to access and cannulate, cost-effective, acceptable to patients, and associated with excellent long-term patency and minimal complications."
Greco believes that the current market offerings often force clinicians to compromise on one or more of these criteria. "We are developing the Silkothane arteriovenous graft to offer physicians and patients a novel vascular access solution that delivers all these characteristics, ultimately addressing a strong, unmet clinical need."
Supporting Data and Market Dynamics
The clinical need for better vascular access is backed by significant volume. In the European Union and the United States alone, more than half a million procedures are performed annually to create or maintain vascular access for haemodialysis.
The economic burden of these procedures is substantial. Complications arising from existing grafts—such as infections requiring hospitalization or interventions to clear thrombosed vessels—cost healthcare systems billions of dollars each year. Furthermore, the patient experience is significantly degraded by repeated surgeries and the anxiety associated with failing access sites.
By utilizing silk fibroin, a material known for its natural ability to integrate with human tissue, Dialybrid hopes to reduce the "foreign body response" that typically triggers scarring and subsequent graft failure. If the Silkothane graft can improve patency rates by even a small percentage compared to current synthetic standards, the reduction in re-intervention rates could prove both clinically superior and economically transformative.
Future Implications: Beyond Haemodialysis
While the immediate focus of the €15 million investment is to bring the Silkothane AV graft to market, the funding also grants Dialybrid the resources to look toward the horizon.
The company has explicitly stated that the capital will enable preclinical investigations into other vascular applications for the Silkothane material. The unique mechanical properties of the hybrid silk-polyurethane scaffold make it a candidate for a wide range of peripheral vascular interventions. Potential future applications could include:
- Peripheral Artery Disease (PAD): As a conduit for bypass surgery in patients with blocked lower-limb arteries.
- Vascular Reconstruction: As a structural material for complex arterial repairs where native tissue is insufficient.
- Stent-Graft Hybridization: Integrating the Silkothane technology into endovascular stent designs to improve endothelialization and reduce long-term intimal hyperplasia.
Conclusion
The successful Series A round and the commencement of the first-in-human trial for the Silkothane graft represent a significant step forward for the Italian medtech sector and the global nephrology community. By blending the ancient biological properties of silk with modern polymer engineering, Dialybrid is positioning itself at the forefront of vascular innovation.
As the 18-patient pilot trial progresses over the coming months and years, the global medical community will be watching closely. If the results match the potential of the preclinical data, the Silkothane graft may well become the new gold standard, providing end-stage kidney disease patients with the durability and reliability they have lacked for decades. For Dialybrid, the path ahead is clear: translate this clinical momentum into a commercially viable, life-changing solution that reduces the burden of chronic disease for thousands of patients worldwide.
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