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Surmodics Inc (SRDX.O)

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Latest Key Developments (Source: Significant Developments)

Surmodics Resumes Patient Enrollment In TRANSCEND Clinical Trial
Wednesday, 17 Apr 2019 11:00am EDT 

April 17 (Reuters) - Surmodics Inc ::SURMODICS PROVIDES UPDATE REGARDING TRANSCEND CLINICAL TRIAL.SAYS RESUMED PATIENT ENROLLMENT INTO ITS TRANSCEND CLINICAL TRIAL AND IS NEARLY 75 PERCENT OF WAY TO ITS GOAL OF 446 RANDOMIZED PATIENTS.SAYS FOLLOWING PUBLICATION OF MARCH 15 FDA COMMUNICATION, WE REACHED OUT TO AGENCY SEEKING GUIDANCE ON RECOMMENDATIONS, IMPACT ON TRANSCEND.SAYS TAKEN ACTIONS IN RESPONSE TO FDA'S RECOMMENDATIONS, INCLUDING UPDATES TO INVESTIGATOR COMMUNICATIONS, PATIENT INFORMED CONSENT FORMS.SAYS CONTINUES TO ASSESS IMPACT OF MARCH 15 FDA COMMUNICATION ON EXPECTATIONS ON TIMING OF COMPLETION OF PATIENT ENROLLMENT IN TRANSCEND TRIAL.SAYS NUMBER OF TRIAL SITES HAVE SECURED IRB OR ETHICS COMMITTEE APPROVAL OF UPDATED ICF AND ARE ACTIVELY ENROLLING, RANDOMIZING PATIENTS.SAYS TAKEN ACTIONS IN RESPONSE TO FDA'S RECOMMENDATIONS, INCLUDING UPDATES TO DATA SAFETY REVIEW AND PATIENT FOLLOW-UP PROCEDURES.  Full Article

Surmodics IVD Launches Breakthrough Matrixguard Diluent
Tuesday, 31 Jul 2018 08:30am EDT 

July 31 (Reuters) - Surmodics Inc ::SURMODICS IVD LAUNCHES BREAKTHROUGH MATRIXGUARD™ DILUENT.SURMODICS INC - ANNOUNCED LAUNCH AND IMMEDIATE AVAILABILITY OF MATRIXGUARD DILUENT.  Full Article

Abbott And Surmodics Announce Agreement For Next-Generation Drug-Coated Balloon
Tuesday, 27 Feb 2018 09:00am EST 

Feb 27 (Reuters) - Abbott Laboratories ::ABBOTT AND SURMODICS ANNOUNCE AGREEMENT FOR NEXT-GENERATION DRUG-COATED BALLOON.SURMODICS INC - ‍PURSUANT TO TERMS OF AGREEMENT, SURMODICS WILL RECEIVE A $25 MILLION UPFRONT PAYMENT​.SURMODICS INC - ‍PURSUANT TO TERMS OF AGREEMENT, CO MAY EARN AN ADDITIONAL $67 MILLION FOR VARIOUS PRODUCT DEVELOPMENT MILESTONES​.SURMODICS - ENTERED INTO AGREEMENT WHEREBY ABBOTT WILL HAVE EXCLUSIVE WORLDWIDE COMMERCIALIZATION RIGHTS FOR CO'S SURVEI DRUG-COATED BALLOON.SURMODICS INC - WILL BE RESPONSIBLE FOR MANUFACTURE AND SUPPLY OF CLINICAL AND COMMERCIAL QUANTITIES OF PRODUCT​.SURMODICS INC - ‍ABBOTT ALSO RECEIVED OPTIONS TO NEGOTIATE AGREEMENTS FOR CO'S BELOW-THE-KNEE AND AV FISTULA DRUG-COATED BALLOON PRODUCTS​.  Full Article

Surmodics Posts Q1 Adj. Earnings Per Share $0.10
Thursday, 8 Feb 2018 07:30am EST 

Feb 8 (Reuters) - Surmodics Inc ::SURMODICS REPORTS FIRST QUARTER FISCAL 2018 RESULTS, UPDATES FISCAL 2018 GUIDANCE.Q1 NON-GAAP EARNINGS PER SHARE $0.10.Q1 GAAP LOSS PER SHARE $0.12.SEES FY 2018 REVENUE $72 MILLION TO $75 MILLION.TOTAL REVENUE FOR Q1 OF FISCAL 2018 WAS $17.0 MILLION, AS COMPARED WITH $17.8 MILLION IN PRIOR-YEAR PERIOD.AS A RESULT OF TAX CUTS AND JOBS ACT OF 2017, FISCAL 2018 Q1 NET LOSS INCLUDED A ONE-TIME TAX EXPENSE OF $1.2 MILLION, OR $0.09 PER SHARE.EXPECTS DILUTED LOSS IN RANGE OF $0.45 TO $0.70 PER SHARE IN 2018.2018 NON-GAAP DILUTED EARNINGS PER SHARE GUIDANCE RANGE IS NOW BETWEEN LOSS PER SHARE OF $0.20 TO EARNINGS PER SHARE OF $0.05.Q1 REVENUE VIEW $17.2 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Surmodics Receives FDA Clearance For Telemark Peripheral Support Microcatheter
Monday, 22 Jan 2018 08:00am EST 

Jan 22 (Reuters) - Surmodics Inc ::SURMODICS RECEIVES 510(K) CLEARANCE FOR TELEMARK™ CORONARY/PERIPHERAL SUPPORT MICROCATHETER FROM THE U.S. FOOD AND DRUG ADMINISTRATION.SURMODICS INC - CO IS MAKING PRODUCT AVAILABLE FOR U.S. DISTRIBUTION IN COMING MONTHS.  Full Article

Surmodics Q4 gaap earnings per share $0.03
Wednesday, 8 Nov 2017 07:30am EST 

Nov 8 (Reuters) - Surmodics Inc :Surmodics reports fourth quarter fiscal 2017 results and provides fiscal 2018 guidance.Q4 non-gaap earnings per share $0.18.Q4 gaap earnings per share $0.03.Q4 revenue $20.1 million versus i/b/e/s view $17.3 million.Q4 earnings per share view $-0.01 -- Thomson Reuters I/B/E/S.Sees fy 2018 non-gaap loss per share $0.16 to $0.41.Sees fy 2018 loss per share $0.50 to $0.75.Sees fy 2018 revenue $72 million to $75 million.Fy2018 earnings per share view $0.23 -- Thomson Reuters I/B/E/S.  Full Article

Surmodics says received FDA 510(K) and CE mark clearance​
Monday, 18 Sep 2017 08:00am EDT 

Sept 18 (Reuters) - Surmodics Inc ::Surmodics announces global approvals of .014" low-profile pta balloon dilation catheter.Surmodics Inc - ‍company received FDA 510(k) and CE mark clearance​.  Full Article

Surmodics Q3 non-GAAP earnings per share $0.09
Thursday, 3 Aug 2017 07:30am EDT 

Aug 3 (Reuters) - Surmodics Inc :Surmodics reports third quarter fiscal 2017 results and updates fiscal 2017 guidance.Q3 non-GAAP earnings per share $0.09.Q3 GAAP earnings per share $0.05.Sees FY 2017 revenue $70 million to $72 million.Q3 revenue $17.8 million versus I/B/E/S view $16 million.Sees FY 2017 non-GAAP earnings per share $0.29 to $0.39.Q3 earnings per share view $-0.02 -- Thomson Reuters I/B/E/S.FY2017 earnings per share view $0.19, revenue view $67.6 million -- Thomson Reuters I/B/E/S.Sees FY 2017 earnings per share $0.15 to $0.25.  Full Article