General

The Nuero-Kinesis CGCI technology platform was designed and developed to provide a robotic work-station for providing an effective methodology for the precision guidance of a magnetic tipped catheter from an insertion point directly to a targeted point of interest within the human body. The CGCI technology uses advanced mapping software and high fidelity OC sensor catheters to rapidly generate a digital model of the environment, outlining with high precision to the operator, the location of an area of concern such as arrhythmic tissue in a heart chamber, and then allow the operator to perform a variety of procedures, such as ablation or biopsy of the tissue robotically in less than half the time it currently takes to remove it. In addition, once an area has been mapped, the CGCI system provides the operator with the ability to return to any mapped location at the push of a button

As such, the CGCI platform has application in a variety of treatment areas including:

• Electrophysiology (EP)
• Gastroenterology (GI)
• Interventional Cardiology (IC)
• Neurosurgery
• Gynecology
• Hypertension
• Renal Denervation

 Electrophysiology and AFib

To date, the main focus of the CGCI development has been on addressing a new method for optimizing cardiac mapping and ablation for those suffering from Atrial Fibrillation (AFib). AFib manifests as an irregular heartbeat that occurs when the heart’s electrical system is not working properly to coordinate the task of pumping blood throughout the body. AFib is projected to grow from 5.2 million diagnoses in the US to 12.1 million cases by 2030. In 2017, AFib was listed on 166,793 death certificates and was the underlying cause of death in 26,077 of those deaths. AFib Counts for more than 454,000 hospitalizations per year in the U.S.  About 88,000 deaths a year are attributed to AFib and the death rate for women with this condition is 2.5 times greater than those of men with it. The cost of treating AFib is estimated to be approximately $6.65 billion in the U.S. per year including direct and indirect medical costs such as procedures like catheter ablation and pacemakers, costs of drugs and other treatment materials such as beta-blockers and antiarrhythmic drugs, cost to patients family members for adapting to new lifestyle changes which include insurance, lifestyle and on-going self-treatment costs.

In a recent longitudinal study on the utilization and complication rates for catheter ablation procedures to treat cardiac arrhythmias, data from the National Inpatient Sample and Nationwide Inpatient Sample estimated that 519,951 catheter ablations were performed in the US from 2000 to 2013. Because of a variety of factors including an aging population, poor lifestyle choices in diet and exercise, continual increases in the number of annual ablations, number of hospitals performing ablations, mean patient age, patient comorbidity index, rate of one or more complication, and hospital length of stay were noted.

In a study published in the European Heart Journal regarding the efficacy and safety of various catheter ablation procedures performed between January 1, 2006, and December 31, 2015, the volume of ablations increased 138% (from 1,953 in 2006 to 4,648 in 2015). Although the numbers increased for all ablation procedures, the majority of growth occurred in atrial fibrillation (AF) ablation procedures. The absolute number of AF ablation per year increased by 430% over the ten years study period. In 2015, the last year of the study, 40% of all ablations performed were for the treatment of AF. A similar trend, although less marked, has been observed by Pallisgaard et al. through a Danish registry of 5,392 patients undergoing AF ablation between 2005 and 2014. They reported a 171% increase in the number of first-time AF ablation procedures over the study period.

As a result, revenues from catheter-based ablations for hospitals has continued to see a significant growth spike and is expected to continue its increase for some time to come. Indeed the Electrophysiology (EP) market which accounted for $4.6 billion in 2018, is expected to witness the growth of over 5.8% CAGR through 2025.

By providing greater efficacy and reliability in cardiac mapping, ablation point targeting, ablation procedure, and general catheter navigation, the CGCI platform is well-positioned to not only become the technology of choice for the EP physician but the solution for helping reduce the cost, incidence of postoperative complications, and recovery time for the thousands of affected patients suffering from AFib.