UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
|
|
|
Date of report (Date of earliest event reported)
|
|
|
|
(Exact Name of Registrant as Specified in its Charter)
|
|
|
|
|
||
|
(State of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer
Identification No.)
|
|
|
|
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
|
(
|
|
(Registrant’s Telephone Number, Including Area Code)
|
Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):
Securities registered pursuant to Section 12(b) of the Act:
|
Title of Each Class
|
Trading Symbol(s)
|
Name of Each Exchange on Which Registered
|
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
|
Emerging growth company
|
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
|
☐
|
| Item 7.01 |
Regulation FD Disclosure.
|
On January 28, 2021, Surmodics, Inc. (“Surmodics”) will post to its website at www.surmodics.com the information attached to this
report as Exhibit 99.1 regarding 12-month results of the TRANSCEND pivotal trial of the Surmodics SurVeil™ drug-coated balloon.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities under Section 18, nor shall such information be deemed incorporated by reference into any filings of the Company under the Securities Act of
1933, as amended, or the Exchange Act.
| Item 9.01 |
Financial Statements and Exhibits.
|
| (d) |
Exhibits.
|
|
Exhibit
Number
|
|
Description
|
|
99.1
|
|
TRANSCEND Pivotal Trial 12-Month Results
|
|
|
|
|
|
104
|
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
|
|
SURMODICS, INC.
|
|
|
|
|
|
|
|
Date: January 28, 2021
|
/s/ Gordon S. Weber
|
|
|
Gordon S. Weber
|
|
|
Senior Vice President of Legal, General Counsel and Secretary
|
EXHIBIT INDEX
|
Exhibit
Number
|
|
Description
|
|
|
||
|
|
|
|
|
104
|
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
|
Exhibit 99.1
|
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