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Surmodics SurVeil™ Drug-Coated BalloonTRANSCEND Pivotal Trial 12-Month Results The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated BalloonPresented at LINC 2021: Late Breaking Clinical TrialJanuary 25, 2021 Dr.Kenneth Rosenfield on behalf of TRANSCEND Steering Committee and Investigators
THESIS: similar outcome with lower dose of cytotoxic drug advance the state of the art provide better therapeutic choice TRANSCEND Pivotal Trial 12-month Results SurVeil™ DCB: Third-Generation GOALS for 3rd generation device (SURMODICS)CLINICAL - Similar therapeutic outcome with lower doseLower potential for complications Wider therapeutic windowTECHNOLOGICAL – Reduce Paclitaxel dose to 2.0 µg/mm²; improve uniformity of drug delivery/distributionBetter efficiency of drug transferReduction in downstream embolization Uniform drug topcoatPaclitaxel + proprietary excipient2.0 µg/mm² drug load360°coating coverage 0.035” OTW PTA platform4–7 mm x 40–150 mm Shaft coatingSerene® hydrophilic coating Proprietary PhotoLink® basecoat SurVeil™ DCB CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
First U.S. head-to-head DCB trial comparing novel device to control device that has 75% more drug loadPaclitaxel debate Enrollment pause slows study completionCOVID 19 Subject follow-up more challenging TRANSCEND Pivotal Trial 12-month Results TRANSCEND Trial journey CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results TRIAL OVERVIEW PRINCIPAL INVESTIGATORSMarianne Brodmann, MDWilliam Gray, MDKenneth Rosenfield, MDTRIAL DESIGN, BIOSTATISTICS, DSMB, CECBaim Institute TRIAL OPERATIONS Medpass (OUS); Clinlogix (US) Prospective, multicenter, international, randomized, single-blind trial of Surveil DCB versus IN.PACT Admiral DCB (1:1)446 subjects randomized52 US sites (N=290) and 13 OUS sites (N=156)Surveil (N=222) and IN.PACT ADMIRAL (N=224)60-month follow-upIndependent and blinded: DUS Core Lab, Angiographic Core Lab, Clinical Events Committee; unblinded Data Monitoring CommitteeHypotheses test - Non inferiority (15% NI margin for efficacy; 10% for safety) Global Site Participation CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results KEY INCLUSION CRITERIA CLINICAL ANGIOGRAPHIC Subject ≥ 18 yearsTarget limb Rutherford Class 2, 3, or 4 De Novo or non-stented restenotic lesion > 90 days after POBA angioplasty or > 180 days post prior DCB treatment Target lesion length ≤ 180 mmTarget lesion starts ≥ 10mm below common femoral bifurcation and terminates at or above end of P1 segment of popliteal arteryTarget vessel diameter ≥ 4mm and ≤ 7mmTarget lesion must have ≥ 70% stenosis by visual estimateTarget lesion residual stenosis ≤ 70% after pre-dilatation CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results baseline patient and lesion characteristics SURVEILN = 222 subjects IN.PACTN = 224 Subjects P-value Age (yrs) 68.7 ± 9.4 (222) 67.4 ± 9.3 (224) 0.136 Male 62.6% (139/222) 63.4% (142/224) 0.922 Rutherford Class 2 21.6% (48/222) 34.4% (77/224) 3 75.7% (168/222) 61.2% (137/224) 0.022 (*) 4 2.7% (6/222) 4.5% (10/224) Lesion length (mm)1 72.5 ± 48.4 (221) 70.0 ± 50.5 (223) 0.597 Minimum Lumen Diameter (mm) 1 1.4 ± 1.1 (221) 1.3 ± 1.0 (223) 0.106 Reference Vessel Diameter (mm) 1 5.3 ± 0.9 (221) 5.3 ± 0.7 (223) 0.842 % Diameter stenosis1 72.9 ± 18.8 (221) 75.8 ± 18.1 (223) 0.102 1 Core Lab reported dataData reported as Mean±SD (N) or % (n/N)(*) t-test for equality of means CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results Primary Endpoints Safety (composite) Freedom from device- and procedure-related death through 30 daysFreedom from major amputation (above ankle) Freedom from clinically-driven target vessel revascularization (CD-TVR) through 12 months Efficacy Primary patency through 12 months, defined as a composite of Freedom from clinically-driven target lesion revascularization (CD-TLR) Freedom from binary restenosis (peak systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis)1 1Assessed by independent DUS and angiographic core labs. In cases when there is a discrepancy between angiographic and DUS assessment of patency, angiographic assessment takes precedence. CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
SURVEILN = 222 subjects IN.PACTN = 224 Subjects P-value Stenosis (%) After Pre-Dilatation1 29.5 ± 15.2 (212) 31.2 ± 16.0 (218) 0.280 After DCB deployment2 20.3±10.4 (215) 19.9±10.1 (220) 0.728 Final2 18.7 ± 9.6 (217) 18.9 ± 9.3 (223) 0.875 Max Inflation Pressure (atm)3,4 8.3 ± 2.4 (290) 9.2 ± 2.4 (266) <0.001 Inflation Duration (sec)3 183.3 ± 64.4 (290) 185.5 ± 63.6 (267) 0.686 Final MLD (mm)2 4.3 ± 0.8 (221) 4.3 ± 0.7 (223) 0.604 Dissection (>/= Grade C) (Post Procedure)2 21.7% (47/217) 15.7% (35/223) 0.108 % of subjects requiring Post dilatation 18.0% (40/222) 17.4% (39/224) 0.902 % of subjects with Bailout stenting 8.1% (18/222) 6.7% (15/224) 0.592 1 Site Data 2 Core Lab data 3 Information based on number of devices used4Nominal pressure for IN.PACT 8atm and 5atm (200mm and 250mm), 6atm for SurVeil. TRANSCEND Pivotal Trial 12-month Results PROCEDURAL CHARACTERISTICS Data reported as Mean±SD (N) or % (n/N) CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results 12-Month safety Results (ITT) ENDPOINT MET SURVEIL ARM IN.PACT ARM DIFFERENCE(2-sided 95% CL) P-VALUE for Non-Inferiority (NI=10%) Primary safety1 91.7% 89.6% 2.1(-4.0%, 8.2%) <0.001 Freedom from all cause death at 30 days2,3 99.5% (217/218) 100.0% (223/223) Freedom from target limb amputation2,5 100.0% (196/196) 100.0% (215/215) Freedom from CD-TVR2,4 92.4% (183/198) 89.9% (195/217) 1Multiple Imputation2Complete case analysis3 Denominators include subjects with at least 28 days of follow-up or subjects experiencing device- or procedure-related death through 30 days. 4 Denominators include subjects with at least 335 days of follow-up or subjects experiencing clinically-driven TVR through 365 days.5 Denominators include subjects with at least 335 days of follow-up or subjects experiencing target limb amputation through 365 days. CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results kaplan-Meier for Primary sAFETY endpoint (ITT) CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results 12-Month Primary EFFICACY Results (ITT) ENDPOINT MET SURVEIL ARM IN.PACT ARM Difference(2-sided lower 95% CL) P-Value for Non-Inferiority (NI = 15%) Primary effectiveness1 81.7% 85.9% -4.2% (-12.0%, 3.6%) 0.003 Freedom from CD-TLR (12 months)2,3 91.9% (182/198) 94.4% (203/215) Freedom from Binary restenosis (PSVR ≥2.4 or ≥50% stenosis)2,4 88.0% (139/158) 91.2% (165/181) 1Multiple Imputation 2Complete Case Analysis3Denominators include subjects with at least 335 days of follow-up or subjects experiencing clinically-driven TLR through 395 days. 4Denominators include subjects with evaluable 12-month DUS (within or outside the visit window of 365±30 days) or subjects whose stenosis status could have been imputed from later assessments. CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results kaplan Meier for Primary EFFICACY endpoint (ITT) CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.
TRANSCEND Pivotal Trial 12-month Results kaplan Meier for Freedom from cd-tlr (ITT) CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use. K-M Estimate for Freedom from CD-TLR (ITT)
First head-to-head RCT of next generation low-dose DCB vs high-dose DCBSafety and Efficacy endpoints were achieved in a pivotal RCT SurVeil DCB non-inferior to market leading IN.PACT DCB with respect to Composite Patency, including CD-TLR and Binary restenosisComparable effectiveness achieved at a substantially lower dose of drug CAUTION: SurVeil™ Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use. TRANSCEND Pivotal Trial 12-month Results Conclusions