Current Challenges in
Cardiac Mapping and Ablation

31% market growth for IP & OP ablations
17% growth in institutions offering catheter ablation for AF
Reimbursement will not be able to match the cost of technologies used for these procedures
Despite Positive Trends,
Challenges To Catheter Ablation Remain
$250K to $800K initial cost of current cardiac 3D mapping systems
$4,000 to $6,500 cost per procedure
Making Catheter Ablation More Cost Effective and Efficient Can Allow this Treatment to Expand Beyond 5% of the Population

Navik 3D: Clinically Validated

How Navik 3D is Going to Revolutionize Cardiac Mapping
Successful Cryoablation
Based on 3D localization:
73-year-old female with persistent atrial fibrillation, failed cardioversion on sotalol, dilated left atrium LAVI: 45.4 mL/m2 and normal LVEF
  • Over 150 procedures performed to date
  • First case with approved system performed on March 26, 2018
  • Five publications-Several pending
Highly effective and simple 3D cardiac mapping system that allows physicians to confidently perform interventional procedures that are critical for the treatment of AF and other heart rhythm disorders.

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Navik 3D Differentiated

Visually maps cardiac chambers using any catheter, including Cryoballoon, in 3D
Detection and tip tracking of ablation catheters
Can instantly visualize and integrate multiple electrodes and electrograms

Navik 3D Intellectual Property

APN Health has pursued an aggressive IP protection policy, with 13 patents relating to the Navik 3D technology already allowed. Four more have been filed and ten additional patents have been identified and are being processed.

APN Health’s IP has never been challenged, as its unique and sophisticated approach not been pursued by other providers.

Patent applications are being drafted and submitted throughout the development cycle to provide maximum protection against duplication by competitors.
10,004,414 Detecting stimulus pulses Jun 2018
9,986,931 Automatically determining 3D catheter location and orientation using 2D fluoroscopy only Jul 2018
9,314,179 Time transformation of local activation times Jun 2018
9,078,575 Heartbeat categorization Jul 2015
9,078,572 Heartbeat detection and categorization Jul 2015
9,014,794 R-wave detection method Apr 2015
8,948,857 Multi-channel cardiac measurements Feb 2015
8,948,856 Multi-channel cardiac measurements Feb 2015
8,849,388 R-wave detection method Sep 2014
8,812,091 Multi-channel cardiac measurements Feb 2014
8,788,024 Multi-channel cardiac measurements Jul 2014
8,768,440 Multi-channel cardiac measurements Jul 2014
8,634,896 3D model creation of anatomic structures using single-plane fluoroscopy Jan 2014

About APN Health

APN Health, LLC is a next generation medical device company that has developed highly effective, easy to use and hardware agnostic proprietary and patented software algorithms to create an innovative and cost-effective 3D cardiac imaging system called Navik 3D.

Introducing
Navik 3D

Indications for Use

Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.


Navik 3D received FDA clearance in February 2016

Navik 3D Features

Catheter Tracking
Navik 3D automatically detects the mapping and ablation catheter in the 2D fluoroscopic images. The user can observe the incoming fluoro stream live in the upper left portion of the Navik 3D interface.
Cryoballoon Visualization
The pulmonary veins are considered the trigger sites for most paroxysmal AFib patients, and the cryoballoon visualization provides the location of where the ablation occurred.
Point List
The Point List includes all points taken for a given map, including Activation, Ablation, Location and Scar Points. The user can change this default to filter the list to show only one category of points at a time.
3D Viewer
Navik 3D displays the 3D model of the cardiac chamber of interest and allows the user to rotate the model to any desired point of view.
Annotation Window
Navik 3D automatically detects the cardiac cycle length and also marks the reference and mapping channel recordings to determine the local activation time or voltage at the current location of the mapping and ablation catheter.
Real-Time ECG/EGM
Navik 3D users can continuously monitor the cardiac rhythm by observing the Real-Time ECG window.

Ahead Of The Curve In
Restoring Heart Rhythm

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