YUKON Choice PC

®

Sirolimus Eluting Coronary Stent System with a Biodegradable Polymer

Technology Highlights

YUKON Choice PC is manufactured by Translumina Therapeutics in their manufacturing Facility at Pharma City Dehradun. Its a collaboration between Advance Therapeutics and Translumina GmbH, Germany.

• This is the first project where a proven technology of a drug Eluting Stent is sourced from Europe and is manufactured in India using international standards .

• The technology is proven in large trials in Europe but shall be sourced from India for world.

• For the first time, High end machines and layout are created as per the specifications of European guidelines.

Translumina GmbH-Germany

• Founded in 1998 ,The promoters were in Senior Management positions in Guidant(Now abott) and Boston Scientific.

• The company is based at Hechingen ,Germany with state of the art manufacturing facility.

• Translumina was the first company to launch a Drug Eluting Stent without a polymer,YUKON Choice, using a innovative technology of in-cath lab coating in 2003 .

• Translumina is marketing its products in India for the last 6 years.All the raw materials for Indian manufacturing shall be provided by Translumina GmbH

• YUKON Choice PC is a combination of : - Sirolimus - Microporous Stent surface - Biodegradable Polymer Resomer R202S - Shellac Resin • YUKON Choice PC is a third generation Sirolimus eluting Stent System that combines the synergistic effect of surface modification and biodegradable polymer to create optimum release.

• YUKON Choice PC’s Stent surface is coated abluminally with no drug or polymer on the luminal side of the Stent for enhanced safety.

YUKON Choice PC - A generation ahead

less polymeric load compared to other DES

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YUKON Choice PC® has microporous surface which enables minimum load of a biodegradable Polymer for optimizing the release kinetics

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Micro-pores which act like reservoirs for delivering the drug to the targeted sites use Van-der-Waals forces to control the release- kinetics of the drug

YUKON Choice PC - Safety Features

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Better Endothelialization-No coating on the Luminal side of the Stent Biodegradable Polymer-Degrades in 90 days Less Polymeric Load-1/4th of the polymeric load compared to other DES

Release Kinetics Drug and Polymer are co-released in 30-45 days

YUKON Choice PC - Efficacy Vs. Xience & Cypher ISAR-TEST 4 is the first prospective randomized trial which compares 3 DES i.e.

YUKON Choice PC, Xience and Cypher for their efficacy & safety

YUKON Choice PC

ISAR-TEST 4 is the only trial with planned angiographic follow up at 2 years in more than 70% patients

ISAR-TEST 4 - Results

YUKON Choice PC proves non-inferior to Xience and Cypher at 3 years follow up published in JACC Sept. 2011

ISAR-TEST 4 - Results

YUKON Choice PC proves non-inferior to Xience and Cypher at 3 years follow up published in JACC Sept. 2011

ISAR-TEST 4 - Results

YUKON Choice PC shows similar TLR’s compared to Xience and Cypher at 2 years follow up

ISAR-TEST 4 - AMI Sub-group

YUKON Choice PC has least polymeric load of a biodegradable polymer and thus is hypothesized to how better results than Xience and Cypher

ISAR-TEST 4 - AMI Sub-group

YUKON Choice PC shows better results than Xience and Cypher in AMI patients

Yukon Choice PC 4 years follow-up data compared to first generation DES

ISAR-TEST 4 - 3 years follow-up

ISAR-TEST 4 is the only comparative trial of 3 DES, YUKON Choice PC Xience and Cypher, with 3 years follow-up

ISAR-TEST 4 - Study Flow

ISAR-TEST 4 - Results

YUKON Choice PC is the First DES which has shown statistical significant reduction of Stent Thrombosis by 50% compared to first generation DES.

ISAR-TEST 4 - Results

YUKON Choice PC shows 78% reduction in Stent Thrombosis compared to first generation DES.

YUKON Choice PC - Excellent Safety Profile

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YUKON Choice PC is the First DES which has shown statistical significant reduction in Stent thrombosis compared to first generation DES.

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YUKON Choice PC shows 78% reduction in Stent Thrombosis compared to first generation DES.

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The unique combination of microporous Stent surface and less biodegradable polymeric load ensures that it becomes a BMS after the drug delivery.

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The presence of drug only on the abluminal side ensures healthy endothelialization.

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Limited anti-platelet regimen may be required after implantation.