Provisional T- sten/ng Future Outlook: Ra/onale of Plaque Incision + DCB

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1 Provisional T- sten/ng Future Outlook: Ra/onale of Plaque Incision + DCB Dr. Azeem La/b EMO- GVM Centro Cuore Columbus and San Raffaele Scien/fic Ins/tute, Milan, Italy

2 PCI in Coronary Bifurca/ons Up to 20-25% of PCIs involve bifurca/ons 1 True bifurca/ons represent >60% Widely considered to be one of the most technically challenging lesion subsets to treat Medina Classification 2 1. Reimers B, Colombo A, Tobis J. Bifurcation lesions. Colombo A, Tobis J, editors. Techniques in Coronary Artery Stenting. London: Martin Dunitz Ltd; p Medina, et al. Rev. Esp. Cardiol. 2006; 59(2):183-4

3 Provisional T- Sten/ng is the Recommended Approach There is a high risk of side- branch vessel compromise 1 during main vessel sten/ng due to plaque or carina shii stent jail spasm NORDIC 2, BBC ONE 3 & other studies strongly suggest single stent approach is preferred 1. Moussa et al. Catheter Cardiovasc Interv 2011:77: Steigen et al. Circulation 2006;114: Hildick- Smith Circulation 2010;121:

4 AGILITY Trial Ø A total of 93 pa/ents with complex true bifurca/ons were enrolled in this mul/center single arm study designed to assess the safety and efficacy of AngioSculpt for the treatment of side branch stenosis Ø Primary Endpoint: Procedural success, defined as: <30% DS in MB <70% DS in SB TIMI- 3 flow No in- hospital MACE (composite of cardiac death, Q wave or non- Q wave MI, or TLR) Ø Main Secondary Endpoints Rate of bailout sten/ng of SB Rate of crossover to final kissing balloon (FKB)

5 AGILITY Key Results Primary Endpoint Procedural success 91.4% Main Secondary Endpoints Final kissing balloon (FKB) without SB stent 16.3% Bailout sten/ng of SB 10.9% Other Key Secondary Endpoints Angiographic Success 93.5% AngioSculpt used as primary therapy in SB 97.8% AngioSculpt used to pre- dil MB 70.9% 9- Month MACE Rate 5.4%

6 AGILITY Demonstrated Low MACE rate at 9 months with use of AngioSculpt for SB 9- MACE Rate Ø Lower 9- Month MACE rate observed compared rates observed with pooled data* on true bifurca/ons 9,2% 17,3% *Data based on 657 pa/ents w/ true bifurca/ons enrolled in BBC ONE and NORDIC I 5,4% AGILITY True Bifurcation Simple Technique True Bifurcation complex Technique Behan Circ Cardiovascular Interv 2011;4:57-64

7 AGILITY Study Conclusions Use of the AngioSculpt as primary therapy for the SB vessel of complex true bifurca/on lesions facilitates a simplified provisional single stent strategy The angiographic success rate was excellent, with a very low rate of bailout SB sten/ng 9- month follow up data demonstrates a very low rate of MACE (5.4%) and clinically- driven TLR (3.3%)

8 Role of DCBs in PCI DCBs area a new and effec/ve PCI treatment op/on Advantages of DCB over direct stent approach Reduc/on in DAPT No foreign object lei behind (vascular restora/on possible) Current and poten/al indica/ons include ISR, small vessels, pa/ents on oral an/coagula/on or at high risk for ini/a/on of oral an/coagula/on True Bifurca/ons with long (>5mm) SB lesions or complex SB ISR difficult to treat with DES 1. Kleber et al. Drug- coated balloons for treatment of coronary artery disease: updated recommenda/ons from a consensus group. Clin Res Cardiol (2013) 102:

9 Drug- coated AngioSculpt AngioSculpt Planorm Paclitaxel (3 µg/mm 2 ) + proprietery excipient Diameters 2.0, 2.5, 3.0, 3.5 mm Lengths mm 6F GC compa/ble AngioSculpt X is not commercially available

10 Pre- clinical Evidence 30- day results Ø DCAS has significantly higher lumen area w/ less neointima area vs. POBA Ø Without vessel overstretch Cremers B, Schmitmeier S, Clever YP, Gershony G, Speck U, Scheller B. Inhibi/on of neo- in/mal hyperplasia in porcine coronary arteries u/lizing a novel paclitaxel- coated scoring balloon catheter. Catheter Cardiovasc Interv Dec 1;84(7):

11 Clinical Evidence In- Stent- Restenosis Treatment with POBA results in repeat restenosis rates 50% Neoin/mal hyperplasia predominant cause of ISR PATENT- C Designed to assess the effec/veness and safety of drug- coated AngioSculpt in BMS ISR Kang et al. Circ CI 2011;4:9-14 Scou et al. Advanced Drug Delivery Reviews 58;3:

12 PATENT C: Drug- coated AngioSculpt vs AngioSculpt Sponsor: INNORA GmbH, Prof. Dr. Ulrich Speck, Berlin, Germany PI: Prof. Dr. med. Bruno Scheller, Homburg, Germany Randomized Trial: Drug- Coated AngioSculpt vs. uncoated AngioSculpt Coronary BMS in- stent restenosis Mul/- center, core- lab adjudicated Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available

13 PATENT- C Methods 61 pa/ents: 28 uncoated and 33 coated Clinical follow- up at 30 days, 6 months, 1 and 2 years- 6 month repeat angiogram Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available

14 PATENT- C Methods: Selec/on Criteria Key Inclusion Criteria Clinical evidence of stable or unstable angina or a posi/ve func/onal study Pa/ents with 2 primary in- stent restenosis (ISR) lesions ( 70% diameter stenosis) within previously placed bare metal stents (BMS) Key Exclusion Criteria Acute MI within the past 72 hours Chronic renal insufficiency with serum crea/nine levels >2.0 mg per deciliter Life- expectancy < two years Stented segment length 30 mm, vessel diameter <2.5 mm, diameter stenosis <70% Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available

15 PATENT- C Procedural Results Post- procedure in- stent MLD (mm) PTX- Coated AS AngioSculpt (control) P- value 2.23± ± Acute Gain (In- stent) 1.22 ± ± Bail- out Sten/ng 3 (9.1%) Dissec/on- Type A 1 (3%) Dissec/on- Type C 1(3%) Procedure Success* 100% 92.6% 0.2 * Defined as <50% final diameter stenosis and the absence of in- hospital major adverse cardiac events (MACE) Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available

16 PATENT- C Primary Endpoint Results Ø 6 Month Late Lumen Loss Significantly Less in the coated- AS group (p=0.01) p = ,48 0,17 Coated AngioSculpt AngioSculpt Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available

17 PATENT- C 6- Month Angiographic Results DCAS group had significantly Ø Less binary restenosis Ø Lower % diameter stenosis Ø Larger MLD Binary Restenosis AngioSculpt (control) Coated- AngioSculpt 7,4% P= ,7% In- Segment MLD (mm) 0% 10% 20% 30% 40% 50% AngioSculpt (control) 1,39 In- Segment % Diameter Stenosis P= AngioSculpt (control) 46,8% Coated- AngioSculpt 1,8 P= ,5 1 1,5 2 Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available Coated- AngioSculpt 33,7% 0% 10% 20% 30% 40% 50%

18 Baseline OCT images show good acute gain and lack of recoil 15 minutes post procedure Sustained through 6 months Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015

19 PATENT- C 1- Year Results Ø Significant reduc/on in clinically- driven TLR and MACE rates at 1- year with DCAS 12- Month CD- TLR P= ,3% 12- Month MACE P= ,3% 9,4% 3,2% Coated- AngioSculpt AngioSculpt (control) Coated- AngioSculpt AngioSculpt (control) Scheller et al. Cath and Cardiovasc Interv ; epub Sep 2015 AngioSculpt X is not commercially available

20 PATENT- C Conclusions Adding a drug coa/ng to AngioScore resulted in significantly beuer outcomes at 6- and 12- months in the treatment of coronary in- stent- restenosis 24- Month Results will be reported at TCT Month LLL p = , Month CD- TLR P= ,3% 0,17 3,2% Coated AngioSculpt AngioSculpt Coated- AngioSculpt AngioSculpt (control) AngioSculpt X is not commercially available

21 Future Outlook: Drug- coated AngioSculpt for Bifurca/ons Mechanical Benefits contribute to reduc/on in stent rates acute luminal gain recoil major (C- F) dissec/on rate stability (no balloon slippage) Biological Benefits drug absorp/on drug effect 1. Fonseca A et al. Intravascular Ultrasound Assessment of the Novel AngioSculpt Scoring Balloon Catheter for the Treatment of Complex Coronary Lesions. J Invasive Cardiol. 2008:20: Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilatation versus conventional predilatation with a semi- compliant balloon versus predilatation with a new scoring balloon. Am J Cardiol 2007;100:812 7

22 Conclusions Plaque scoring improves acute luminal gain and reduces incidence and severity of dissec/ons. Ul/mately limits the need for sten/ng Drug- coated AngioSculpt combines the advantages of plaque scoring and drug delivery In the treatment of true bifurca/on within the widely established provisional T- sten/ng approach, drug- coated AngioSculpt has the poten/al role for SB treatment

23 Thank You