MHRA CLASS 1 MEDICAL DEVICE
BS EN 14476 - Virucidal efficacy test
BS EN 13727 - Bactericidal efficacy test
BS EN 13624 - Fungicidal efficacy test
BS EN 14476 - Virucidal efficacy test
BS EN 13727 - Bactericidal efficacy test
BS EN 13624 - Fungicidal efficacy test
Amatorus has successfully registered as a Class 1 Medical Device with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Following this regulatory milestone, an application for FDA 510(k) clearance is currently underway in the United States
The cost of wound infections in the US varies depending on the type and location of the wound, but overall estimates for all wound types range from $28.1 to $96.8 billion annually in Medicare spending alone.
Amatorus delivers advanced, evidence-based medical device solutions designed to mitigate the risk of Surgical Site Infections (SSIs) and combat antimicrobial resistance (AMR). The nose serve as a primary anatomical reservoir for pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA). Patients with nasal colonization frequently shed these pathogens onto their skin, leading to direct intraoperative translocation into the surgical incision. Our targeted decolonization protocol eradicates nasal bacterial load and establishes an active antimicrobial barrier, protecting your surgical field from endogenous contamination.
Amatorus delivers advanced, evidence-based medical device solutions engineered to mitigate surgical site infections (SSIs) and combat antimicrobial resistance (AMR). Our flagship product, Wound Guard, establishes a robust barrier against external contaminants, preventing both contact and airborne pathogens from entering the surgical field.
With clinical data showing that 1% to 3% of all surgeries—and up to 10% of spinal procedures—result in bacterial infections, the need for effective prevention is critical. Wound Guard directly addresses this challenge, demonstrating complete eradication of antibiotic-resistant strains, such as Methicillin-resistant Staphylococcus aureus (MRSA), within two hours during rigorous evaluation at government-approved testing centers.
"The study evaluated the effectiveness of Amatorus EVI-12 Gel against Staphylococcus aureus, a commonly encountered bacterium known to cause a range of infections. Under the conditions of the test, the product demonstrated a high level of efficacy.
Specifically, within a two-hour period following application, Amatorus EVI-12 Gel successfully eliminated all detectable S. aureus bacteria present in the test environment. These results indicate that the product is highly effective at rapidly reducing bacterial presence when used as directed.
It is important to note that, following this initial eradication, no bacterial growth was observed within a 24hr period. This suggests that the product not only eliminates existing bacteria efficiently but also prevents regrowth in the absence of recontamination.
Overall, the findings support the conclusion that Amatorus EVI-12 Gel is a reliable and effective solution for controlling S. aureus under the conditions tested."
Amatorus Wound Guard demonstrates a distinct competitive advantage over currently available wound care solutions due to its triple-action efficacy that passes rigorous BS EN antimicrobial standards without triggering antimicrobial resistance. Recent clinical testing results highlight how our product differentiates itself from traditional treatments in a crowded medical field.
Traditional wound care options often rely heavily on harsh synthetic chemicals, iodine, or silver-based delivery systems to destroy pathogens. The formulation introduces a structural shift in how infections are prevented:
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* No Tissue Toxicity: It avoids cellular damage to healthy skin.
* Mechanical Defense: It creates a physical, safe-for-use barrier.
* Traditional Risk: Competitors can delay healing via chemical toxicity.
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While most available standard products primarily target basic bacterial strains, the testing results for Amatorus reveal a broader scope of protection:
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* Triple Action Protection: It treats viral, bacterial, and fungal risks.
* Broad Spectrum Efficacy: It passes difficult European Standards (BS EN).
* Competitor Limitations: Most existing gels only kill limited bacteria.
* Viral Elimination: It is among the first to address viral transmission.
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Addressing Antimicrobial Resistance (AMR)
A major metric in recent testing is how a product impacts the global crisis of drug-resistant superbugs.
* No Resistance Triggers:
Microbes cannot evolve resistance to its mechanism.
* Synthetic Overuse:
Traditional antibiotics face rapidly declining efficacy rates.
* Hospital Cost Reduction:
It prevents expensive, resistant secondary wound infections.
* MHRA Approval: Achieved official MHRA Medical Class 1 status.
* FDA Pipeline: Currently applying for US FDA 510(k) clearance.
* Pre-Order Demand: Already secured hospital pre-orders prior to US rollout.
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At Amatorus, our mission is to provide healthcare professionals with innovative, high-quality anti-bacterial and anti-viral products. We focus on protecting patients from bacterial infections, antibiotic resistance, and viral transmission through advanced medical device solutions.
Amatorus has achieved MHRA medical class 1 approval. It contains no chemicals and is the worlds first product to protect against the virus!
It took over two years to develop a formulation that performed to the level required to pass the quoted BS EN tests whilst also maintaining “safe for intended use” credentials.