Biocomposites' New Weapon in the War on Post-Surgical Infections

KEELE, UK – September 09, 2026 – In the high-stakes world of orthopedic surgery, the battle against infection is relentless. A successful joint replacement or spinal fusion can be tragically undermined by bacteria that form stubborn, drug-resistant colonies on implants. Now, a UK-based medical device company is poised to showcase a significant advancement in this fight. Biocomposites, a global leader in infection management, is heading to the 44th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) in Porto, Portugal, armed with powerful new data and a game-changing regulatory certification for its flagship product, STIMULAN®.

The company's prominent role as a Platinum Sponsor at the prestigious conference, held in cooperation with the Musculoskeletal Infection Society (MSIS), signals more than just a marketing push. It represents a pivotal moment to present compelling evidence for a technology that could fundamentally alter how surgeons treat and prevent complex bone and soft tissue infections, potentially saving patients from debilitating secondary surgeries and reducing the immense burden on healthcare systems.

A Strategic Victory in a Tough Regulatory Arena

At the heart of Biocomposites' recent momentum is a major strategic achievement: securing European Union Medical Device Regulation (MDR) certification for its STIMULAN® products earlier this year. This is no small feat. The EU's MDR, which fully replaced the previous Medical Device Directive (MDD) in 2021, established a far more stringent and demanding regulatory framework. For manufacturers, navigating this new landscape requires substantial investment and rigorous validation of a product's safety and performance.

Biocomposites successfully cleared this high bar in February 2026, earning a certification with a crucial distinction. STIMULAN® is now confirmed as the only calcium matrix product certified under MDR for use with combinations of antibiotics. This allows surgeons to mix the dissolvable calcium sulfate beads with broad-spectrum antibiotic combinations—such as vancomycin paired with gentamicin or tobramycin—directly in the operating room. This capability is critical for tackling complex infections that may involve multiple types of bacteria, a common and challenging clinical scenario.

This unique regulatory status provides the company with a powerful competitive advantage. While other calcium-based products exist, STIMULAN®'s specific clearance for combination therapy gives it a validated, on-label use case that competitors lack. It provides surgeons with both clinical flexibility and regulatory assurance, positioning the product as a new standard of care. As CEO Michael Harris stated, this certification “reaffirms STIMULAN® as the only calcium matrix antibiotic carrier certified for mixing with a combination of Gram-positive and Gram-negative antibiotics,” a key differentiator in the crowded MedTech market.

Redefining the Battle Against Surgical Infections

The clinical challenge STIMULAN® addresses is one of the most feared complications in orthopedics: biofilm-associated implant infections. When bacteria colonize the surface of a prosthetic knee, hip, or spinal hardware, they form a protective slime layer known as a biofilm. This shield makes them notoriously resistant to systemic antibiotics, which often cannot penetrate the biofilm or reach sufficient concentrations at the infection site without causing toxic side effects. The result is often a cycle of pain, implant failure, and the need for high-risk revision surgeries.

STIMULAN® bypasses this problem through localized delivery. The small, absorbable beads act as a carrier, loaded with a surgeon-selected antibiotic regimen and packed directly into the infected site during surgery. The beads then dissolve over a period of weeks, releasing a high concentration of antibiotics precisely where they are needed most. This targeted assault overwhelms the biofilm's defenses in a way that systemic drugs cannot. Because the calcium sulfate matrix is fully absorbed by the body, there is no need for a second surgery to remove the implant, a significant benefit for both patient recovery and healthcare costs.

At the upcoming EBJIS-MSIS meeting, Biocomposites will convene a symposium titled, 'From Spine to Arthroplasty: What Infection Specialists Can Learn Across Disciplines.' The session, featuring prominent specialists like Professor Yvonne Achermann, Mr Abtin Alvand, and Mr Oliver Stokes, underscores the broad applicability of this technology. By bringing together experts from both spinal surgery and joint replacement, the company is highlighting the universal principles of local antibiotic delivery in managing these complex infections, regardless of the anatomical location.

The Science of Eradicating Biofilms

Bolstering its clinical and regulatory case is new in-vitro research that Biocomposites will present via a scientific poster at the conference. The study, 'Antibacterial efficacy of antibiotic loaded calcium sulfate beads against Staphylococcus aureus biofilms on different orthopedic implant surfaces,' provides a compelling look at the science behind STIMULAN®'s effectiveness. Staphylococcus aureus is a leading cause of prosthetic joint infections, and its ability to form resilient biofilms is a primary driver of treatment failure.

The research evaluated STIMULAN® beads loaded with combination antibiotic regimens against S. aureus biofilms grown on materials commonly used in orthopedic implants: titanium, stainless steel, and polyethylene. The results were definitive. The study demonstrated complete eradication of early-stage biofilms and a significant reduction in mature, well-established biofilms across all tested surfaces. This data provides crucial pre-clinical evidence that supports the product's mechanism of action and its potential to resolve even entrenched infections.

This scientific validation is critical, as it moves the conversation from theoretical benefit to demonstrated efficacy. “The new data adds to the growing body of evidence supporting how STIMULAN® can be used to deliver combination antibiotics locally, to reduce the need for revision surgery and improve outcomes for patients,” commented Michael Harris, CEO of Biocomposites. This focus on evidence-based practice is paramount in gaining the trust of the surgical community, and the presentation in Porto will place this compelling data directly in front of the world's leading infection specialists.