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PRODUCTS/SERVICES

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Our Solution for Diabetic Foot Ulcers

Our biotherapeutic solution is built on the Aurix System, which has FDA 510(k) clearance and is supported by multiple randomized controlled trials and real‑world studies showing significantly higher healing rates compared with standard of care. These include pivotal trials in chronic diabetic foot ulcers and broad “all‑comers” populations, as well as extensive post‑marketing data used in U.S. reimbursement decisions.

In Saudi Arabia, Madarik has completed ISO‑certified quality processes and obtained SFDA approval specifically for the treatment of diabetic foot ulcers. All certification, shipping, consultancy, storage, and medical personnel costs for the initial deployment have been fully funded by Madarik to accelerate access.

Madarik in Saudi Arabia

Product Overview

Madarik provides an autologous, platelet‑rich biotherapeutic system for chronic, non‑healing diabetic foot ulcers. Using a small sample of the patient’s own blood, the system produces a biodynamic haematogel that delivers a broad mix of endogenous growth factors directly to the wound, supporting tissue repair in complex clinical settings

The system is indicated for Wagner grade 1–4 diabetic foot ulcers and can be used on large, deep wounds, including those with exposed tendon, muscle, or bone, and in patients with multiple comorbidities.

Clinical Evidence and Regulatory Status

Madarik has worked with the Ministry of Health to initiate and complete clinical demonstration cases in regions including Qassim and Madinah, with all enrolled patients completing the protocol successfully. These demonstrations are designed to document medical outcomes, support local clinician adoption, and inform the wider rollout of the therapy across the Kingdom’s health system.

We are now working with partners to establish a dedicated centre of excellence in Riyadh, integrating clinical care, AI‑supported wound assessment, and local manufacturing capabilities for diabetic foot ulcer treatment.

AI‑enabled Wound Assessment

How We Work with Providers

As part of our solution, Madarik is developing an AI engine that uses image‑based telemetry to support diagnosis and longitudinal tracking of diabetic foot ulcers. This tool is intended to help clinicians monitor healing, stratify patient risk, and standardise documentation, while creating a rich local dataset to guide future research and quality improvement.

We partner with hospitals, clinics, and health authorities to:

Design and run demonstration and scale‑up programs for diabetic foot ulcer management.
Train multidisciplinary teams in the autologous biotherapeutic protocol and workflow.
Integrate AI‑based assessment tools into existing diabetic foot care pathways.