Cyber Heart Inc May 2015 Cyber Heart Inc

Cyber. Heart, Inc. May 2015 Cyber. Heart Inc. Fogarty Institute for Innovation 2490 Hospital Drive Suite 310 Mountain View, CA. 94040 USA 609 -468 -1528 pmaguire@cyberheartinc. com

Cyber. Heart Technology • Consists of new 3 -D contouring software with currently available treatment planning software • Available contouring software not sufficiently accurate for this application • Software must enable EP’s and RO’s to define cardiac targets, and assess cardiac treatment plans for individual patients

The Cyber. Heart System • The Cyber. Heart System Proprietary Cardio. Plan software from Cyber. Heart • 3 D rendering software intended to aid in planning of targets for radiosurgical ablation in the myocardium Currently for use with: • Cleared Radiosurgery System (using the cyberknife) • Treatment Planning Software • Motion Tracking Cardiac-Gated CT Implantable Pacing Lead (Oscor, Inc. ) used as a fiducial

Cardio. Plan Functions • • 3 D structure visualization and target contouring – Cardiac surface generation – Ablation line definition – Efficient transfer of ablation lines to treatment system targets 3 D dose display on cardiac surface 3 D Segmentation Advantages • • Enables EP to place ablation line on cardiac surface in 3 D. Allows creation of precise/robust ablation target in a minimally invasive fashion. Boundaries • Does not create radiation dosing (treatment plan) 3 D Target Definition 3 D Dose Display

Surface Generation from CT scan Exclude unwanted structures Segment left atrium (or ventricle) as volume Generate cardiac surface • Segment cardiac surface from 3 D CT data set • Ablation lines can be defined on cardiac surface

Ablation Line Generation Drawing ablation lines about the atrium (PV Isolation in this case) • EP generates target volume on cardiac surface rendering

Dose Display of dose to surface (color-coded) • Display dose to surface – Evaluate continuity of tissue ablated and extent of prescription dose region.

The Procedure _______________ 1. Obtain Cardiac-Gated CT, following catheterfiducial placement 2. EP uses Cardio. Plan™ to define where ablation lesions are to be placed 3. Transfer to the cyberknife treatment planning system. 4. Physicians review, and treat Not painful, no anesthesia needed, outpatient 9

The evidence ____________ Proof of Concept Established…now in clinical trials - Pre-clinical : 50+ animals (pigs and dogs) – EP and safety endpoints - Clinical Endpoints achieved: Transmural Contiguous Safe Electrical Isolation achieved - Lesion (scar) is - Contiguous and Homogeneous - No Skip Lesions 10

VT - AF – and the future ______________ ure Left – Atrial Fibrillation treatment plans. Above: Outline of renal ganglia targets for hypertension.

Patients treated to date • Clinical Centers: Stanford, Harley St. (UK), Ostrava, Czech Republic, Christus Hospital, Monterrey. • 3 with Refractory Ventricular tachycardia • 1 with refractory atrial fibrillation • No device related adverse events. 3 of 4 still alive (1 mortality- • Observed reduction in arrhythmia and improvement in quality of life • 1 VT, 1 AF, 1 Renal nerve denervation patient pending compassionate use – cause of death: amiodarone pulmonary toxicity)