The Endocross Enabler-P: First in-Human Results Maurice Buchbinder, MD Foundation for Cardiovascular Medicine La Jolla, CA

Disclosure Speaker’s name: Maurice Buchbinder, MD  I have the following potential conflicts of interest to report: EndoCross Inc.  Consulting  Employment in industry  Stockholder of a healthcare company  Owner of a healthcare company  I do not have any potential conflict of interest 2

Current Limitations of CTO Treatments Despite the advent of new devices / guide wires as well as improved operator technique, success rates remain limited (60-80%) Unsuccessful attempts are primarily due to inability to cross lesions with a guidewire Typically CTO procedures are associated with extended procedural time, radiation exposure and increased contrast load. Treatment of CTO lesions remains highly dependent on operator skill and experience.

ENABLER-P System Includes 2 components: Support balloon catheter: Catheter lumen 0.35 compatible Catheter length 135cm Balloon length 20mm Balloon Diameter 6mm 4

Pressure Control Unit (PCU) : ENABLER-P System Pressure Control Unit (PCU) : Disposable, battery operated unit Allows additional cyclical balloon Inflations and Deflations 5

ENABLER-P System These reciprocating inflations result in guidewire gripping, balloon elongation which in turn leads to forward movement of the guidewire while increasing axial force at the tip of the wire (18x) 6

ENABLER-P System 7

First Human Use Experience : Apollo I Designed to evaluate the Safety and Effectiveness of the ENABLER-P System in crossing Chronic Total Occlusions located in the Superficial Femoral and popliteal Artery 8

Case NB-501 41 Year old male with a 50mm occlusion of the mid left SFA. Moderate calcification Failed attempt with standard wires PCU activation : 50sec 9

CASE NM-501 10

Case NB-501 11

Case sample 2: highly calcified occlusion Highly calcified lesion Occlusion length: 45mm System activation duration: 2min This patient underwent traditional angioplasty attempt Occlusion Vessel calcification GW across occlusion 12

Case sample 3: HS-410 71 Year old male with a 40mm occlusion of the right SFA. Severe calcification PCU activation : 8min 13

Case sample 3: HS-410 14

Case sample 3: HS-410 15

Case sample 3: long occlusion, retrograde approach 59 Year old male Occlusion length: 180mm System activation duration: 22min Estimated occlusion age: > 12m Proximal cap distal cap Activation Post dilatation 16

Clinical Experience to Date Patients enrolled: 36 Average age: 66.5 years (41-87) Occlusions location: SFA Occlusions length: 80mm (10mm-340mm) Vessel diameter: 4-6mm Calcification level: 12 heavy calcified 15 moderate 9 non-calcified

Clinical Results n=36 Successful crossing 31 Serious adverse events Device related adverse events 1 Procedure related adverse events 3* Successful revascularization Average system operation time 5.4 min. * One Proximal dissection from initial vessel access resulting in guidewire placement into false lumen. One vessel perforation -performed with a dilatation balloon after the removal of the ENABLER-P Catheter. 18

Conclusions ENABLER-P System is a promising novel device for treatment of Chronic Total Occlusions. In this early experience the Enabler appears to be safe and effective in crossing challenging long and calcified lesions in the peripheral circulation. Ongoing evaluation (including below the knee disease) continues to be extremely favorable. 19