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Sapheon, Inc. Santa Rosa, California 95403 www.sapheoninc.com707-206-6819 Sapheon, Inc. Santa Rosa, California 95403 www.sapheoninc.com707-206-6819 Sapheon Closure System for the Treatment of Venous Reflux Disease in the Great Saphenous Vein
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Varicose Veins Symptoms: – Pain, ranging from discomfort to incapacitation – Burning, itching, unsightly edema, thrombophlebitis – 70% of patients are female Symptoms: – Pain, ranging from discomfort to incapacitation – Burning, itching, unsightly edema, thrombophlebitis – 70% of patients are female 22
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Sapheon Procedure No compression stockings Patients can immediately return to normal activity No compression stockings Patients can immediately return to normal activity Sapheon Entry site treated with band aid Sapheon Closure System RF/Laser Ablation 33
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Sapheon Animal Studies Sapheon CA adheres the intima of the vein together – Not an embolic filler Animal studies demonstrate a benign foreign body reaction resulting in an occlusive scar with minor inflammation resulting in permanent occlusion in <30 days. n-BCA formulation in animal studies has no significant toxicity and similar break-down profile as in other approved uses of n-BCA Sapheon CA adheres the intima of the vein together – Not an embolic filler Animal studies demonstrate a benign foreign body reaction resulting in an occlusive scar with minor inflammation resulting in permanent occlusion in <30 days. n-BCA formulation in animal studies has no significant toxicity and similar break-down profile as in other approved uses of n-BCA 44
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Glue Stability Study 3 swine (3 epigastric veins) were treated with the Sapheon Closure Adhesive to establish if glue migration occurs and if so, how far. Summary: Compression with an ultrasound probe provides a broad area of compression (~2 cm in width); therefore the extent of the glue migration is within the area of the compression. The glue rapidly creates coaptation of the vein walls. No glue is detected in the superior vein or in the lungs. These results are consistent with earlier animal studies (27 swine, 10 goats). 3 swine (3 epigastric veins) were treated with the Sapheon Closure Adhesive to establish if glue migration occurs and if so, how far. Summary: Compression with an ultrasound probe provides a broad area of compression (~2 cm in width); therefore the extent of the glue migration is within the area of the compression. The glue rapidly creates coaptation of the vein walls. No glue is detected in the superior vein or in the lungs. These results are consistent with earlier animal studies (27 swine, 10 goats). 55
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Human Clinical Studies Conducted 2 phases of a single clinical study – Phase 1: First in Humans, n=8, December 2010 – Phase 2: Continuation of Protocol, n=30, July 2011 – Four Investigators - 3 US, 1 German Conducted 2 phases of a single clinical study – Phase 1: First in Humans, n=8, December 2010 – Phase 2: Continuation of Protocol, n=30, July 2011 – Four Investigators - 3 US, 1 German 66
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Efficacy Pre-op Average 24 – 72 hr Average 30d Average 180d Average Closure Rate--100%97%**100% VCSS6.02.2*1.9*1.1 † # of Symptoms per patient 5.01.8*1.5*1.2 † N=38 N=37N=8 *p<0.001, paired t-test compared to pre-op value. **1 patient had partial closure, requiring 2 access points to treat a discontinuous, large (8.3 mm average GSV. The patient had symptom improvement per CEAP and VCSS scores. †Comparison statistic not calculated. *p<0.001, paired t-test compared to pre-op value. **1 patient had partial closure, requiring 2 access points to treat a discontinuous, large (8.3 mm average GSV. The patient had symptom improvement per CEAP and VCSS scores. †Comparison statistic not calculated. Human Clinical Study Results 77
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For more information contact: For more information contact: Don Crawford President and Chief Executive Officer Sapheon, Inc. 3579 Westwind Blvd. Santa Rosa, California 95403 707-206-6819don.crawford@sapheon.netwww.sapheoninc.com Don Crawford President and Chief Executive Officer Sapheon, Inc. 3579 Westwind Blvd. Santa Rosa, California 95403 707-206-6819don.crawford@sapheon.netwww.sapheoninc.com 88
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