8-K

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

January 28, 2021

Date of report (Date of earliest event reported)

Surmodics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Minnesota	0-23837	41-1356149
(State of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

9924 West 74th Street Eden Prairie, Minnesota	55344
(Address of Principal Executive Offices)	(Zip Code)

(952) 500-7000

(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):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12)

☐ Pre‑commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b))

☐ Pre‑commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common Stock, $0.05 par value	SRDX	Nasdaq Global Select Market

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
99.1	TRANSCEND Pivotal Trial 12-Month Results
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

EX-99.1

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 

XML

Document and Entity Information	Jan. 28, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 28, 2021
Entity Registrant Name	Surmodics, Inc.
Entity Incorporation, State or Country Code	MN
Entity File Number	0-23837
Entity Tax Identification Number	41-1356149
Entity Address, Address Line One	9924 West 74th Street
Entity Address, City or Town	Eden Prairie
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55344
City Area Code	952
Local Phone Number	500-7000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Entity Central Index Key	0000924717
Title of 12(b) Security	Common Stock, $0.05 par value
Trading Symbol	SRDX
Security Exchange Name	NASDAQ