Evidence for the safety and efficacy of the FREEWAY™ 035 DEB in PAD

• 13 centers in Austria and Germany
• 148 patients with de novo or restenotic lesions that needed stent implantation
• long term follow-up, 5 years and beyond, of the randomized Freeway Stent Study²

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1. Significantly reduced need for clinically-driven target lesion revascularization at 5 years (FREEWAY™ 85.3 % vs PTA 72.7 %, p=0.032)
2. No elevated mortality
3. No trend for any accumulation of causes of death in both groups
4. No difference in administered paclitaxel dose in alive vs. died patients
5. No difference in minor or major amputations in both groups

FREEWAY Stent Study

Freeway drug-eluting balloon vs. post-stent dilatation with standard balloon with 12 months follow-up

FREEWAY™ Δ 16.4% better Primary Patency

• randomized multicenter trial in Austria and Germany
• 204 patients with de novo or restenotic lesions that needed stent implantation

Main Findings at 12 months follow-up:

1. significantly higher primary patency
2. clearly lower target lesion revascularization rate
3. significantly better improvement in Rutherford clinical classifications and proven safety due to low major adverse events rate for patients treated with stent + FREEWAY™ 035 DEB compared to stent + standard balloon PTA.

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PACBUA Trial

Freeway drug-eluting balloon vs. PTA with standard balloon with 12 months follow-up

FREEWAY™ Δ 27.3% better Primary Patency

• randomized study in Austria
• 74 patients with in-stent restenosis (DEB group vs. post-stent dilatiation with standard balloon)

Main Findings at 12 months follow-up:

1. significantly higher primary patency
2. clearly lower target lesion revascularization rate
3. clearly better improvement in Rutherford clinical classifications
4. proven safety due to low major adverse events rate for patients treated with FREEWAY™ 035 DEB
   compared to standard balloon PTA.

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