AngioDefender

Clinical Validation of AngioDefender

To address the limitations of the BAUI technique, Everist Genomics has developed a non-invasive diagnostic device (AngoDefender) for the assessment of Endothelial Dysfunction (‘EDF’) via Flow Mediated Dilation (‘FMD’) of the Brachial Artery (‘BA’).

The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis.  The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave data collected before and after BA occlusion by an upper arm sphygmomanometric cuff.

Clinical validation of the AngioDefender device has been completed in 6 clinical studies around the world and has demonstrated a strong correlation to the current gold-standard, BAUI and has demonstrated a strong correlation to the current gold-standard, BAUI.

AngioDefender identifies otherwise asymptomatic patients, presenting within normal blood pressure ranges, which are at risk of developing CVD and atherosclerosis.

By way of example, this capability was demonstrated in a recently completed evaluation conducted at Manipal Hospital, Bangalore, India:

  1. The Manipal Hospital evaluation demonstrated that the AngioDefender device rapidly produces (test time <15 minutes) accurate, easy to perform and clinically valuable assessment of Flow Mediated Dilation.
  2. There were zero instances of device malfunction or software crashes
  3. As illustrated in the data table below; AngioDefender identifies otherwise asymptomatic patients, presenting within normal blood pressure ranges, that are at risk of developing CVD and atherosclerosis.
    • Twenty out of twenty-five patients (refer to the exhibit below) tested presented within normal blood pressure ranges.
    • However, AngioDefender identified that eighteen of the patients that tested within normal blood pressure ranges had %FMD scores which identified them with early-stage CVD and at risk of developing more serious forms of CVD and atherosclerosis
  4. AngioDefender generated CVD clinical insight and risk stratification that blood pressure measurement or lipid testing alone are unable to produce

 

Summary of Manipal Hospital AngioDefender Evaluation Results

*Note: Patients DN-008 and YS-024 were tested twice.

 

 

Footnotes:

  1. AngioDefender Correlation with Brachial Artery Ultrasound: Conducted at the Moscow Medical Academy. This evaluation produced a strong correlation (R=0.84) between %FMD by AngioDefender with Brachial Artery Ultrasound; AngioDefender Study of Reproducibility: Conducted in Japan to demonstrate reproducibility. The study demonstrated the ability of AngioDefender to deliver highly reproducible results; R=0.88' AngioDefender Correlation Study With BAUI in Indian Population: Conducted at Medanta, Medical City, high degree of correlation between BAUI and AngioDefender (R=0.77)