Subtitle Text Here Zylon Medical Devices Smaller Is Better Supported by NIH SBIR PHASE II Grant # 5 R44 H

Subtitle Text Here

Overview The Zylon ® Angioplasty catheter with “ZeroFold” Balloon Innovative cardiovascular device Developed to expand clinical application of percutaneous transluminal coronary angioplasty (PTCA) Based on patented technology Angioplasty balloon catheter with “absolutely the lowest profile” Allows certain previously un-crossable or difficult-to-cross stenosed coronary arteries to be crossable and dilatable with efficacy and precision Supported by NIH SBIR Phase II Grant # 5 R44 H

PTCA Percutaneous Transluminal Coronary Angioplasty (PTCA) Minimally invasive surgical approach For treatment of coronary artery blockages Stenosed artery

Current Catheters Current Balloon Catheters As typically used in PTCA procedures Balloon is pre-sized, folded, wrapped and located at end of catheter Catheter is placed across a stenotic lesion Upon presserization, balloon unfolds to force open the stenosis

Crossing the Lesion Physician must be able to cross the lesion to dilate the stenosis Any increase in crossing resistance restricts clinical usefulness, especially in these procedures: Small arteries Tight stenoses Chronic Total Occlusion (CTO)

Surgery Inability to Cross Lesion Consigns patient to open heart surgery Open heart surgery is effective, but characterized by: High morbidity High Expense Long recovery times The Preferred treatment is the minimally invasive balloon angioplasty procedure

The Problem Reducing the profile of the balloon in PTCA catheters still remains clinically significant in interventional cardiology.

The Zylon ® Solution The Zylon ® PTCA Catheter with ZeroFold Balloon Based on patented technology Utilizes a non folded balloon Inflates to full size after crossing target stenosis Eliminates the folded and wrapped balloon of current angioplasty catheters

The Zylon ® Solution Standard Catheter and Balloon Full size balloon attached to catheter shaft Then wrapped and folded to reduce profile Creates region of high cross resistance due to presence of multiple layers of wrapped and folded balloon material

The Zylon ® Solution Zylon ® Catheter with Zero Fold Balloon Balloon has NO wrapped or folded material Exhibits smooth, continuous transition from tip to proximal shaft “Absolutely the lowest profile” possible

The Zylon ® Solution Inflation Zylon ® “ZeroFold” balloons inflate with predictable radial expansion characteristics High burst strength High flexibility Low axial growth

The Zylon ® Solution Zylon ® “ZeroFold” balloon vs. standard folded balloon No Fold Balloon Folded Balloon Inner Lumen

The Zylon Solution Upper Catheter 0.024” Hole Test Fail - at distal fold Zylon Catheter 0.024” Hole Test Pass - entire balloon

The Zylon Solution Other advantages Improved Pushability Easier crossing, less resistance Flexible Smooth gentle inflation Easier to manufacture Simple, no retraining required Smaller* profile over entire range of coronary balloon catheter sizes ( *)

The Zylon Solution Applications CTO Pre-dilation POBA (plain old balloon angioplasty) Stent delivery – lower profile with custom stent Rx, over-the-wire, fixed wire versions

Intellectual Property The following patents and patent applications have relevance to ZeroFold balloon technology: US 5,900,444, Irradiation Conversion of Thermoplastic to Thermoset Polyurethane. US 6,596,818, Irradiation Conversion of Thermoplastic to Thermoset Polymers. US 6,558,732, Process for producing and implantable apparatus comprising a biomedical device coated with cross-linked TPU. US 6,656,550, Dilatation device of uniform outer diameter. EP , Irradiation Conversion of Thermoplastic to Thermoset Polymers. Canada 2,267,684, Irradiation Conversion of Thermoplastic to Thermoset Polymers. IS129342, Irradiation Conversion of Thermoplastic to Thermoset Polymers. US , Process for producing and implantable apparatus comprising a biomedical device coated with cross-linked TPU. US , Irradiation Conversion of Thermoplastic to Thermoset Polymers. US , Reduced Profile Medical Balloon Element.

Intellectual Property Trademarks Zylon, US 2,174,478 Penetrator US Irracure US 2,574,588 Fluorothane US 2,505,088

Subtitle Text Here Zylon Corporation 600 Chestnut Ridge Road Chestnut Ridge, NY Zylon Corporation 600 Chestnut Ridge Road Chestnut Ridge, NY