We’re thrilled to share a major breakthrough at BioMAdvanced! Our kidney diagnostic product has just completed its first analytical clinical study, and the results are nothing short of encouraging. The results confirm our goal of obtaining our CE Mark by the end of 2025.
Here’s a quick dive into the key highlights.
The finished product is performing exceptionally well, aligning closely with the promising results from our Proof of Concept (POC).
More specifically :
- The primary Endpoint (the main criteria on which the product is evaluated) shows that the tests’ results provide statistically excellent discrimination : they are clinically meaningful.
- The Negative Predictive Value (NPV), indicating the probability of not being in a subclinical rejection (SCR) state when the patient is genuinely not experiencing SCR, is close to 98%. This aligns precisely with our expectations and stands as one of the highest values in the market for this specific indication.
This success propels us forward, allowing us to embark on a subsequent prospective European multicentric study, last step before CE marking by the end of 2025.
The upcoming study, a pivotal step in our clinical plan, aims to validate the product’s performance across a diverse European population. With nearly 2/3 of the 600 anticipated patients already enrolled, we’re on track to demonstrate the effectiveness of our innovative diagnostic solution.
Our kidney product is designed to revolutionize patient care post-kidney transplant. It provides a composite score that confirms the absence of subclinical rejection, enabling clinicians to make more informed treatment decisions.
KEY ADVANTAGES FOR CLINICIANS
✔ Precision Diagnosis : Our solution eliminates the need for frequent biopsies.
✔ Tailored Treatments : Allows for personalized adjustments to immunosuppressive therapies.
✔ Improved Patient Care : Ensures timely and accurate information on graft acceptance.
We’re grateful for the dedication of our team and the support from the medical community. Together, we’re advancing healthcare with innovative solutions!