Aptus Heli-FX Overview

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Aptus Heli-FX Overview Physician Slide Deck Developed by Aptus Endosystems, Inc. MMA05141501

Major Studies Show Higher 2nd Interventions in EVAR vs. Open Repair DREAM EVAR-1 ACE De Bruin et al. N Engl J Med 2010;362:1881-9 R.M. Greenhalgh et al. N Engl J Med 2010, 10.1056/NEJM 0909305 Becquemin JP et al. J Vasc Surg 2011;53(5):1163-73. Late ruptures in EVAR, none in open surgery Unlike open repair, endoleaks and migration are major complications of EVAR Predictors for rupture, and risks increase with time Open surgery remains a ‘more durable option’ In ACE, 16% re-interventions in EVAR vs. 2.4% for open repair at 3 yr median f/u

Hostile Proximal Necks Further Challenge EVAR Meta-Analysis of 7 major studies in EVAR by Antoniou et al1 compared outcomes in hostile vs. friendly neck anatomies (total patients N = 1559) Study Sample Size Endografts Torsello et al, 2011 177 Endurant AbuRahma et al, 2010 238 AneuRx, Excluder, Zenith, Talent Hoshina et al, 2010 129 Excluder, Zenith Abbruzzese et al, 2008 565 AneuRx, Excluder, Zenith Choke et al, 2006 147 Talent, Zenith, Excluder, AneuRx Fulton et al, 2006 84 AneuRx Fairman et al, 2004 219 Talent Type I endoleaks 4.5x more likely at 1-year after endograft implantation in hostile proximal aortic neck anatomy (P = .010) Aneurysm-related mortality risk 9x greater in hostile neck anatomy (P= .013) 1Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38.

Hostile Proximal Necks Further Challenge EVAR Another similar meta-analysis by Stather et al. of 16 major studies confirms higher risks in hostile necks Total sample size: N=11,959 patients Further substantiation that EVAR still faces significant challenges in hostile proximal neck anatomy Stather PW et al. J Endovasc Ther. 2013;20:623–637

Influence of Multiple Hostile Neck Parameters Speziale et al. shows greater proximal seal complication risks as the number of hostile neck parameters increases Neck hostility Intra-op adjunctive procedures Intra-op endoleaks All cause mortality On label 9.9% 0.5% 1.1% 2 hostile neck parameters 26.7% 6.7% 13.3% >2 hostile neck parameters 50% 16.7% Greater than 1 hostile neck parameter substantially increases mortality, major adverse events, intra-op endoleaks and adjunctive procedures Speziale F et al, Annals of Vascular Surgery (2014), doi: 10.1016/j.avsg.2014.06.057.

Certain ‘on-label’ necks can be at-risk Which Proximal Necks are Hostile? Study by Jordan WD et al. assesses proximal neck anatomic criteria that are most predictive of success or failure after EVAR Evaluated N=221 patients from ANCHOR post-market registry Failure defined as: Type Ia endoleak upon endograft implantation Type Ia endoleak identified in post-op follow-up* *In endografts without EndoAnchors Identified proximal neck variables that independently predict type Ia endoleak: Neck diameter ≥ 26 mm P = .002 Neck length ≤ 17 mm P = .017 Certain ‘on-label’ necks can be at-risk Jordan WD et al. J Vasc Surg. 2015 Feb 28. pii: S0741-5214(15)00065-8.

Multiple recent studies confirm neck dilatation in EVAR remains REAL Neck Dilatation: A Cause for 2nd Intervention Multiple recent studies confirm neck dilatation in EVAR remains REAL Author Follow-Up Grafts studied Proximal Neck Dilatation Rate Outcomes in dilated necks Oberhuber et al.1 39 mos average Zenith (N=29), Talent (N=35), Excluder (N=39) 22% (defined as >2mm diam increase) 31% re-interventions Pintoux et al.2 57 mos average Talent (N=33), AneuRx (N=25) 24% (defined as >3mm diam increase) 5% late type Ia endoleak 16% migration Bastos Gonçalves et al.3 5 yrs median Excluder (N=144) 37% overall, 66% in pts >7 yrs f/u Increased odds of migration (≥5mm) 5.5x 1Oberhuber A et al. J Vasc Surg 2012 April;55(4): 929-34 2Pintoux D et al. Ann Vasc Surg. 2011 Nov;25(8):1012-9 3Bastos Goncalves F et al. J Vasc Surg. 2012 Oct;56(4):920-8

Compromise of EVAR and Long-Term F/U Standard follow-up imaging has shortcomings Patient risk & contraindications (radiation, contrast media)1,2 Patients lost to follow up Quality of Life impact Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5):547-54. Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4):425-30.

Image courtesy of National Institute of Health Type I Endoleak? What Have Been Our Options… TAA Classification Possible TI EL TX Options Ascending Open surgical conversion Aortic Arch TEVAR Revision*, hybrid Descending TEVAR Revision* AAA Classification Possible TI EL TX Options Infra-renal EVAR Revision*, open surgical conversion, FEVAR conversion Juxta-renal Open surgical conversion, FEVAR conversion, CHIMPs Supra-renal *Ballooning, cuffs, Palmaz, coils, Onyx and/or CHIMPs may be considered in EVAR/TEVAR revision What do we do when? Standard revision techniques cannot be used or don’t seal endoleak? Patients are unfit for FEVAR or open surgical conversion? Image courtesy of National Institute of Health Image courtesy of National Institute of Health

Tailored Seal and Fixation of EndoAnchors Create the stability of A surgical anastomosis In EVAR and TEVAR Surgical Anastomosis EndoAnchoring Displacement force in Newtons Chart from data published in Melas N, et al. J Vasc Surg 2012;55(6):1726-33 Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD.

Long-Term Objectives of EndoAnchors in EVAR Replicate surgical anastomosis Prevent late term seal complications in primary setting Treat seal complications & prevent recurrence in revision setting Mitigate reinterventions in EVAR Improve surveillance intervals by preventing type I leaks and sac growth Legend: Status of clinical substantiation Completed In-process Next phase

Heli-FX Indications for Use (FDA and CE Mark) Intended to provide fixation and augment sealing between endovascular aortic grafts and the aorta Indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications The Aptus EndoAnchor and Heli-FX have been evaluated and determined to be compatible with the following endografts: Cook Zenith Gore Excluder Medtronic AneuRx Medtronic Endurant Medtronic Talent Jotec GmbH

Resolve proximal seal failures How to Manage EVAR with EndoAnchors? PROPHYLAXIS TREATMENT Hostile Anatomy Overcoming concerns for implant stability Challenging neck anatomies (e.g. wide, short, conical, angulated) Difficult landing (e.g. birdbeaking, close to branched vessels) Normal Anatomy Mitigating risk of re-interventions Severe comorbidities that preclude safe re-intervention Patients potentially lost during F/U Long remaining life expectancy (young pts) Resolve proximal seal failures Targeted sealing of acute type I endoleaks Targeted sealing of late type I endoleaks Augmented stability in migrated grafts Case image from Gandhi RT, Katzen BT Treating a Type 1A Endoleak Using EndoAnchors. Endovascular Today March 2012 23:26.

equivalent to 10 years in vivo EndoAnchor Tailored Seal and Fixation Performance Verified equivalence to the strength of a surgical anastomosis 1 Designed to provide radial support and resist neck dilatation Safety In >4,000 cases and >23,000 EndoAnchors implanted to- date, no confirmed graft damage or late anchor fracture 3 No anchor dislocation after successful implantation in aortic tissue3 No unanticipated adverse device events in ANCHOR registry (N=319)2 Benefits Customizable placement to target concerning anatomical areas and Type I endoleaks Steerable guide for precise and accurate placement Motorized controls for two-stage deployment with repositioning No damage post 400M cycles, equivalent to 10 years in vivo 1 Melas N et al, J Vasc Surg 2012;55:1726-33 2 Jordan WD et al, J Vasc Surg 2014 Jul 31. pii: S0741-5214(14)00929-X. doi: 10.1016/j.jvs.2014.04.063 3 Based on data on file at Aptus as of May 2015 Images courtesy of Aptus Endosystems, Inc.

Heli-FX System: Applier + Guide + 10 EndoAnchors Cross Bar 3 mm 1.0 mm 3.5 mm Images courtesy of Aptus Endosystems, Inc.

Aptus Heli-FX Product Offerings Aptus™ Heli-FX™ Thoracic EndoAnchor ™System 18Fr OD, 90cm working length Aptus™ Heli-FX™ EndoAnchor™ System 16Fr OD, 62cm working length Images courtesy of National Institute of Health and Aptus Endosystems, Inc.

EndoAnchor Deployment Animation

ANCHOR Registry Capturing Real-World Usage Registry Principal Investigators Europe: Dr. Jean-Paul de Vries – Chief of Vascular Surgery, St. Antonius Hospital US: Dr. William Jordan – Chief of Vascular Surgery/Endovascular Therapy, Univ. of Alabama Registry Design Prospective, observational, international, multi-center, dual-arm Registry Treatment Arms “Primary” – Up to 1000 pts, Prophylactic “Revision” – Up to 1000 pts, Therapeutic Duration 5 Years Follow-up Per Standard of Care at each center & discretion of Investigator Over 570 Patients enrolled as of May 2015

5 papers published since 2014 ANCHOR in the Scientific Literature 5 papers published since 2014 Rationale of EndoAnchors in abdominal aortic aneurysms with short or angulated necks De Vries JP et al. J Cardiovasc Surg (Torino). 2014 Feb;55(1):103-7 Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy Jordan WD et al. J Vasc Surg. 2014 Oct;60(4):885-92.e2. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use de Vries JP et al. J Vasc Surg. 2014 Dec;60(6):1460-7.e1 Outcome-based anatomic criteria for defining the hostile aortic neck Jordan WD et al. J Vasc Surg. 2015 Feb 28. pii: S0741-5214(15)00065-8 Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy Jordan WD et al. J Endovascular Therapy 2015; 22(2):163–170

ANCHOR Shows High Prophylactic Use Indications for EndoAnchoring in Revision n=99 Indications for EndoAnchoring in Primary n=307 Jordan WD et al. J Vasc Surg. 2014;60:885-892

ANCHOR Includes All Major Endografts Complex AAA and complications have warranted EndoAnchor tailored seal and fixation with ALL major endografts Confirms EndoAnchoring need is independent of endograft design, dependent on anatomical challenges and post-implant disease progression Jordan WD et al. J Vasc Surg. 2014;60:885-892

ANCHOR Parallels Commercial Experience1 Excellent Safety No confirmed late EndoAnchor Fractures or Graft Damage in >23,000 anchors implanted to date Usage patterns consistent with ANCHOR In over 4,000 cases to-date, 71% in primary In majority of primary EVAR cases, EndoAnchors address concerns for late complications Consistency with ANCHOR Demonstrates registry reflects real-world use of EndoAnchors 1Based on Aptus data on file as of April-15

High Ratio Hostile Neck Anatomy in ANCHOR Proximal Neck Anatomical Characteristics (based on Corelab) Primary n=242* Revision n=77* Max Aneurysm Diameter [mm], mean (+ SD) 56 + 11 65 + 13 Neck Length [mm], mean (+ SD) 17 + 13 15 + 12 Necks ≤ 10mm Length, N (%) 101 (41.7%) 36 (46.5%) Necks ≤ 15mm Length, N (%) 141 (58.3%) 47 (60.5%) Neck Diameter1 [mm], mean (+ SD) 26 + 4 29 + 5 Conical Necks2, % 41.7% 46.5% Neck Thrombus ≥ 2mm 37% 21% Neck Calcium ≥ 2mm 48% 12% Hostile Neck3 53% 63% (1) At most distal renal artery ≥10% diameter change over 10mm length As determined by the investigator *Note: Corelab sample sizes is different from total patients in ANCHOR. Corelab for all patients is still in-process. All above data is per Corelab except the ‘Hostile Neck’ line item which is investigator reported. Jordan WD et al. J Vasc Surg. 2014;60:885-892

Percentage Short Necks by Study Among Major EVAR Studies, ANCHOR Has the Shortest Necks GREAT4 (C3 Excluder) mean: 28mm Mean Infra-Renal Neck Length 10mm 0mm 5mm 15mm 20mm 25mm 30mm ZFEN8 (Cook) mean: 8mm ANCHOR3 (EndoAnchor) mean: 16mm OVATION5 (Trivascular) mean: 23mm ITER2 (Excluder) mean: 26mm ENGAGE1 (Endurant) mean: 28mm Percentage Short Necks by Study Infra-Renal Neck Length* ENGAGE (Endurant) GREAT4 (C3 Excluder) ITER2 (Excluder) OVATION5 (Trivascular) FORWARD6 (Nellix) ANCHOR3 (EndoAnchor) ≤10mm 2.2% 1.5% N/A 15.5% 17% 41.7% ≤15mm 4.3% 9.5% 29% 58.3% 5. Mehta M et al. J Vasc Surg 2014;59:65-73 6. Presentation by Dr. Andrew Holden at VEITHsymposium 2014 Stokmans RA et al. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):369-75 Oderich GS et al. J Vasc Surg 2014;60:1420-8. *Cut-offs for neck length may be based on ≤xx mm or <xx mm Pol RA et al. J Vasc Surg 2014;60:308-17 Pratesi C et al. J Vasc Surg 2014;59:52-7 Jordan WD et al. J Vasc Surg. 2014;60(4):885-92.e2 Verhoeven et al. Eur J Vasc Endovasc Surg. 2014 Aug;48(2):131-7

Freedom from Type Ia Endoleak at Final Angio Remains Excellent . . . Despite Hostile Proximal Neck Anatomy Arm N Success % Successful Primary 242 223 92.1% Revision 77 67 87.0% High success in treating type I endoleaks 83% for acute T1 ELs in primary 80% for late T1 ELs in revision In majority of persisting type I endoleaks, standard adjuncts failed to treat or could not be administered Reflects high ability for EndoAnchors to treat difficult endoleaks Reasons for Unsuccessful Results: Primary (N=3): 3 Unresolved type 1a endoleak at final angio – 1 resolved @1-M F/U; 1 resolved @3-M F/U; 1 Pt required a re-intervention 6-days post-op for a kink & Type I (Collapsed Gore Graft) Revision (N=7): Persistent Type 1a endoleak at final angio 1 Pt w/Persistent Endoleak (Pre-existing Condition), 3 Pts outside Aptus IFU (significant Thrombus & Calcium) Other Pts undergoing Corelab review Jordan WD et al. J Vasc Surg. 2014;60:885-892

Reason for Secondary Procedure Re-Interventions Over 9-Mo Mean F/U Seal Durability Exceeds Expectations from Standard EVAR in Hostile Proximal Neck Anatomy Reason for Secondary Procedure Primary Arm (242) Revision Arm (77) All (319) Conversions (Open) Type Ia Leak Repair 1 (0.4%) 7 (9.1%) 8 (2.5%) Type II Leak Repair 4 (5.2%) 5 (1.6%) Migration Treatment Graft Limb Kinking Treatment 1 (1.3%) 2 (0.6%) Graft Limb Occlusion 2 (0.8%) 3 (0.9%) Access Vessel Injury Treatment 1 (0.3%) Lower Extremity Revasc. Total Secondary Procedures 7 (2.9%) 11 (14.3%) 18 (5.6%) Total Patients w/Secondary Procedures 14 (4.4%) Jordan WD et al. J Vasc Surg. 2014;60:885-892

Excellent Outcomes as Prophylaxis in ANCHOR, Despite Majority Hostile Neck Anatomy Midterm outcomes (14-month mean f/u) exceed expectations from standard EVAR Shorter necks did NOT have significantly poorer outcomes N = 1 related to proximal seal: endograft body collapse in area with no EndoAnchor penetration N = 2 associated with significant thrombus/calcium and 4- 5mm length necks Ruptures, migrations or open surgical conversions 0.0% (0/208) Freedom from AAA-related re-interventions 96.2% (200/208)1 Freedom from type Ia endoleaks per Corelab 98.5% (128/130)2 Freedom from AAA expansion (>5 mm) per Corelab 98.4% (122/124) Jordan WD et al. J Endovascular Therapy 2015; 22(2):163–170

Seal Durability in F/U Compares Favorably ANCHOR Results vs. Antoniou et al. Meta-Analysis Studies Median Follow-Up Type 1 Endoleaks in Hostile Necks Meta-analysis, Antoniou et al1 12-Months 20/205* (9.8%) ANCHOR Registry2 14.3-Months 2/178** (1.1%) Antoniou GA et al. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2012 Podium presentation by W Jordan, “Benefit of EndoAnchors in Endovascular Aneurysm Repair,” 2014 Vascular Annual Meeting * Hostile neck criteria: neck length <15 mm and neck angulation > 60 degrees ** Hostile as determined by physician in Primary Arm No EndoAnchor Related SAEs or Re-Interventions Reported To-Date

STAPLE-2 Shows Promise to Prevent Failures Aptus IDE Study: Highest sac regression, shortest average neck length among all EVAR IDEs Late durability data exceeds expectations2,3 Aptus has the highest sac regression among all EVAR IDEs at years 2 and 31 At year 3, 82% sacs regressed1 High sac regression predictor for lower complications4 Endpoint Median 3.4 yr. Type 1 Endoleak 0.0% (0/155) Graft Migration (>1cm) 3.2% (5/155) [a] AAA Ruptures EndoAnchor-related safety adverse events [a] No type I endoleak or EndoAnchor dislocation observed in migrations, no evidence of endograft movement relative to aortic wall 1Based on Aptus data on file as of January 2014 2Mehta M et al. STAPLE-2: The Pivotal Study of the Aptus Endovascular AAA Repair System - 24-Months Results. Abstract presented at SVS 2012 3Mehta M et al. J Vasc Surg 2014;60(2):275-285 4Goncalves FB et al. Br J Surg. 2014 Jun;101(7):802-10

EndoAnchoring to Target Acute Type I Endoleak Short, reverse taper proximal neck Intraoperative Type I post-implantation of Cook Zenith 6 EndoAnchors implanted - Type I endoleak resolved Images from article: Gandi RT and Katzen BT, Treating a Type Ia Endoleak Using EndoAnchors, Endovascular Today, March 2012

EndoAnchoring to Re-Establish Seal in Migration 3 year F/U showed migrated Talent with type Ia endoleak Endurant cuff and EndoAnchors implanted - endoleak resolved Images from article: de Vries JP et al, Use of Endostaples to Secure Migrated Endografts and Proximal Cuffs after Failed Endovascular Abdominal Aortic Aneurysm Repair, J Vasc Surg 2011; 54:1792-4.

Minimum 4 EndoAnchors Recommended Tips for EndoAnchor implantation: 30º-45º RAO 30º-45º LAO C-arm positioning critical for proper spacing, visualization & implantation Min 4 EndoAnchors recommended For prox neck dia. > 29mm, min 6 EndoAnchors recommended Strive for even spacing around neck circumference EndoAnchors should penetrate vessel wall Select positions lacking excessive thrombus/calcium EndoAnchors # of C-arm positions Recommended angular offset 4 EndoAnchors 2 ~90° 6 EndoAnchors 3 ~60° Note: C-arm positions above show just one possible combination

C-Arm Positioning for 6 EndoAnchors 30º RAO 30º LAO 90º Lateral Note: C-arm positions above show just one possible combination

C-Arm Positioning for T1 EL Treatment Move C-Arm in 15-20 degree increments Identify leak channel and then create a “suture line” along wall. Circumferential anchoring before/after T1 EL treatment is recommended: address concerns of long-term neck morphology changes

Conclusions Major EVAR studies highlight late durability limitations e.g. ‘EVAR 1,’ ‘ACE,’ ‘DREAM’ Greater complications in more hostile proximal neck anatomies Proximal seal stability remains key EndoAnchors designed to bring long-term stability of surgical anastomosis to EVAR Favorable safety profile Maturing data supports hypothesis of prophylactic benefits Clinical experience shows EndoAnchoring addresses clear needs in EVAR & TEVAR Augment strength when concerns exist for late complications Target and treat acute and late type I endoleaks

Appendix

Challenges in Treating Urgent Aneurysm Patients Limited options FEVAR lead times too excessive CHIMPs outcomes not definitive May be unfit for open repair Logistical difficulties Fast treatment needed to stop bleeding in rAAA Time constraints often preclude proper case planning and graft sizing Complex cases Anatomical challenges: typically hostile anatomy with short or angulated infrarenal necks and durability risks Type I endoleaks: can be lethal, highly critical to prevent onset or treat Types of patients receiving urgent treatment: Ruptured AAA Symptomatic AAA Rapid AAA expansion Large AAA diameter 6.5cm diameter AAA Ruptured AAA Images courtesy of Nic Nelken MD, Kaiser Hawaii and ANCHOR investigators

Challenges in Treating Urgent Aneurysm Patients Need for immediate effective treatment vs. inter-facility transfer 16% rAAA patients transferred to another facility die before receiving AAA repair1 Early benefits realized with EVAR vs. open repair in rAAA2 Lower 30-day mortality (24% vs. 40%) Lower early major complications (58% vs. 76%) However, durability after EVAR remains problematic3 Substantially higher late re-interventions after EVAR 25.8% vs. 4.7% for open repair Endoleak highest cause of post-EVAR re-interventions Constitute 43.8% of re-interventions Whereas no endoleaks after open repair Abstract presentation by Mell MW and colleagues of Stanford University at the 28th Annual WVS Meeting von Meijenfeldt GC et al. Eu J Vasc Endovasc Surg. 2014 May;47(5):479-86 Rollins KE et al. Br J Surg. 2014 Feb;101(3):225-31.

Outcomes after Treating Urgent AAA1 EndoAnchors shown as a useful adjunct to optimize seal and address concerns for re-bleed or initial rupture Rapid, high sealing performance in complex anatomy (N=39) 15 minutes average EndoAnchoring time with 100% implantation success 92% freedom from endoleaks at final angio despite >90% hostile proximal necks Durability maintained in follow-up 0% ruptures, 0% rebleeds, 0% proximal seal re-interventions (14 month mean clinical f/u) 0% Type Ia endoleaks per Corelab (3 month mean imaging f/u) Comparison with historical data shows EndoAnchors may reduce late type I endoleak risk Substantially lower rates in ANCHOR vs. comparable studies in standard EVAR 1Based on abstract presentation at VIVA 2014 late breaking trials session by Dr. Peter Schneider: “EndoAnchors in Urgent Endovascular Aneurysm Repair: Results from the ANCHOR Global Registry”