REVA Achieves Target Patient Enrollment in FANTOM II Trial

SAN DIEGO, REVA Medical, Inc. is pleased to announce it has achieved the targeted enrollment of 110 patients in Cohort B of the FANTOM II clinical trial, bringing total enrollment to 227 patients. FANTOM II is a clinical study of the safety and performance of the Fantom^® sirolimus-eluting bioresorbable coronary scaffold. Patients were enrolled at clinical sites in eight countries outside of the United States.

“The completion of our targeted enrollment is yet another important milestone for the Company,” commented Reggie Groves, REVA’s Chief Executive Officer. “With this trial and additional trials that we may initiate in the future, our goal is to build a strong foundation of positive clinical data for Fantom that establishes it as a safe and effective treatment for patients suffering from coronary artery disease.”

On September 30, 2015, the Company announced it had achieved the targeted enrollment of 110 patients in the first cohort of the trial (“Cohort A”). Seven additional patients were subsequently enrolled in this cohort. Patients in Cohort A are currently undergoing a six-month imaging assessment and data from these patients will be used in a CE Mark application planned for the third quarter of this year. REVA plans to provide the six-month data on a subset of patients in Cohort A at the Paris Course on Revascularization (“EuroPCR”), which will be held in May.

The data from patients in Cohort B is intended to provide further clinical evidence regarding the use ofFantom to treat coronary artery disease and will be used for market support and other commercial purposes. Data from these patients are planned to be released at industry conferences, beginning at the Transcatheter Cardiovascular Therapeutics (“TCT”) Conference in October.

Source: REVA Medical, Inc.