Sapheon, Inc. Santa Rosa, California 95403 www.sapheoninc.com707-206-6819 Sapheon, Inc. Santa Rosa, California 95403 www.sapheoninc.com707-206-6819 Sapheon.

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Presentation transcript:

Sapheon, Inc. Santa Rosa, California Sapheon, Inc. Santa Rosa, California Sapheon Closure System for the Treatment of Venous Reflux Disease in the Great Saphenous Vein

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

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

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

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

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

 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 *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

For more information contact: For more information contact: Don Crawford President and Chief Executive Officer Sapheon, Inc Westwind Blvd. Santa Rosa, California Don Crawford President and Chief Executive Officer Sapheon, Inc Westwind Blvd. Santa Rosa, California