Tag: Surmodics

Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for the SurVeil™ Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated […]

Differentiated Capabilities of Surmodics’ Crystalline Drug Release Platform for Sirolimus-Coated Balloons Presented at ISET Conference

Surmodics’ proprietary Crystalline Drug Release (CDR) platform enhances sirolimus stability, transfer, and retention in tissue CDR discussed in connection with 12-month data from Surmodics’ SWING trial of the Sundance™ Sirolimus-Coated Balloon January 19, 2023 08:30 AM Eastern Standard Time EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of […]

Surmodics Announces 12-Month Data from the SWING Trial Presented at VEITHsymposium

Sundance™ Sirolimus Drug-Coated Balloon exhibits excellent safety profile Primary patency maintained at 12 months in 80% of per protocol analysis population EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 12-month data […]

24-Month Data from Surmodics’ TRANSCEND Trial Presented at VIVA 2022 Conference

SurVeil™ Drug Coated Balloon (DCB) demonstrates sustained durability of safety, efficacy endpoints SurVeil™ DCB non-inferior to market leading IN.PACT® Admiral® DCB at a substantially lower drug dose EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 24-month […]

Surmodics Announces New Credit Facilities Providing up to $125 Million in Financing

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today announced that it has entered into a new, five-year credit agreement with MidCap Financial (“MidCap”), comprised of up to $100 million in term loans and a $25 […]

6-Month Data from the Surmodics SWING BTK First-in-Human Trial Presented at AMP Europe

Sundance™ Sirolimus DCB demonstrates lowest binary restenosis at 6 months compared to relevant BTK clinical trials Excellent safety profile observed with no major amputations and low rates of MAE EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, […]

6-Month Data from the Surmodics SWING First-in-Human Study to be Presented at AMP Europe

35-subject trial evaluating safety, performance of Surmodics’ Sundance™ Sirolimus Drug-Coated Balloon EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that Professor Ramon Varcoe will present 6-month data from the SWING Trial, a first-in-human study of […]

Pounce™ Thrombectomy System First-in-Human Data Show 100 Percent Technical Success in Early Cases

Thrombolytics in target lesion were not used for 19 of 20 patients treated with next-generation mechanical arterial thrombectomy device EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ : SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that its Pounce™ Thrombectomy System […]