REVA Achieves Target Patient Enrollment in FANTOM II Trial

February 23, 2016—Reva Medical, Inc., a clinical-stage company that is developing the Fantom sirolimus-eluting bioresorbable coronary scaffold, announced that it has achieved the targeted enrollment of 110 patients in cohort B of the FANTOM II clinical trial, bringing the total enrollment to 227 patients. FANTOM II is a clinical study of the safety and performance of the Fantom scaffold. Patients were enrolled at clinical sites in eight countries outside of the United States. 

On September 30, 2015, the Company announced that it had achieved the targeted enrollment of 110 patients in the first cohort (cohort A) of the trial. Seven additional patients were subsequently enrolled in this cohort. Patients in cohort A are currently undergoing a 6-month imaging assessment, and data from these patients will be used in a CE Mark application planned for the third quarter of this year. Additionally, Reva plans to provide the 6-month data on a subset of patients in cohort A at EuroPCR, the Paris Course on Revascularization, which will be held in May 17–20, 2016 in Paris, France.

Reva advised that the data from patients in cohort B are intended to provide further clinical evidence regarding the use of Fantom 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 TCT 2016, the Transcatheter Cardiovascular Therapeutics Conference, which will be held October 29 through November 2 in Washington, DC.

The Fantom bioresorbable scaffold, which is Reva’s initial product, has been designed to offer an ideal balance of thinness and strength and distinct ease-of-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations. Successful clinical trial results and regulatory approvals will be required before the Fantom can be commercialized, advised the company.