Surmodics, Inc. (NASDAQ:SRDX) Files An 8-K Other Events

Surmodics, Inc. (NASDAQ:SRDX) Files An 8-K Other Events
Item 8.01 Other Events.

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On August 11, 2017, Surmodics, Inc. (the “Company”) entered into a clinical trial services agreement (the “Agreement”) with Baim Institute for Clinical Research, Inc. (“Baim”) to which Baim will serve as the Company’s clinical research organization to assist the Company with the administration of the TRANSCEND™ clinical trial for the SurVeil® drug-coated balloon (“DCB”). The TRANSCEND trial is a randomized clinical trial intended to evaluate the SurVeil DCB for the treatment of peripheral artery disease in the upper leg compared to the Medtronic IN.PACT® Admiral® DCB. The trial will enroll up to 446 subjects at approximately 60 sites in the U.S. and 18 outside the U.S. to the Agreement, the Company will make payments to Baim for services rendered, costs incurred, and upon the completion of certain specified milestones. If all services and the milestones under the Agreement are completed and the estimated pass-through costs are incurred (including with respect to the expected number of clinical sites), the estimated total payments by the Company under the Agreement will be in the range of approximately $26.0 million to $33.0 million, which payments are likely to be concentrated during the first two to three years of the study. In addition, any changes to budget parameters identified in the Agreement may result in additional expenses. We estimate that the total cost of the TRANSCEND clinical trial will range between $32 million to $40 million over the next several years. There can be no assurance that Baim will complete its performance under the Agreement, and to the extent that such performance is completed, the clinical results for the SurVeil DCB will be satisfactory.


About Surmodics, Inc. (NASDAQ:SRDX)

Surmodics, Inc. is a provider of medical device and in vitro diagnostic technologies to the healthcare industry. The Company operates through two segments: Medical Device and In Vitro Diagnostics. The Company’s Medical Device segment consists of surface modification coating technologies to improve access, deliverability and predictable deployment of medical devices; international cardiology and peripheral balloon design, development and manufacturing, as well as drug delivery coating technologies to provide site-specific drug delivery from the surface of a medical device. The Company’s In Vitro Diagnostics segment manufactures or sells components for in vitro diagnostic immunoassay and molecular tests. The In Vitro Diagnostics segment manufactures and sells surface coatings to the diagnostic, biomedical research and life science markets. In Vitro Diagnostics segment offers protein stabilization reagents, substrates, antigens and surface coatings.

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