Reva Medical Announces Regarding Showcases of Clinical Data

REVA Medical, Inc., a leader in bioresorbable polymer technologies for vascular applications, sponsored a symposium on May 23, 2018, at the Paris Course on Revascularization (“EuroPCR”) entitled FANTOM: the new vision of BRS performance, which highlighted 24-month data from the Company’s FANTOM II clinical trial.

Dr. Gregg Stone from the Columbia University Medical Center and the Cardiovascular Research Foundation and Dr. Ulf Landmesser from Charite Berlin chaired the symposium.

Dr. Alexandre Abizaid, Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, provided a review of the 24-month data from the FANTOM II trial, which included a low 5.0% rate of Major Adverse Cardiac Events (“MACE”) which demonstrates a strong safety profile for Fantom. Dr. Abizaid also discussed the Company’s expansion trials in long lesions, multi-vessel disease and acute myocardial infarction

Dr. Gregor Leibundgut from Kantonsspital Baselland in Liestal, Switzerland provided a review of Tyrocore, REVA’s proprietary polymer, which is different from the polylactic acid polymers used to construct first generation scaffolds such as Absorb. Tyrocore is the foundation for both Fantom, REVA’s current commercial product and Fantom Encore, the Company’s third generation product. The use of Tyrocore allows Fantom and Fantom Encore to offer improved features including a thinner strut profile, improved ease-of-use, and full x-ray visibility. Dr. Leibundgut also announced that Fantom Encore will have 95, 105 and 115 micron strut profiles for the 2.5, 3.0 and 3.5 mm diameters, respectively. The sequentially larger strut profiles for the three sizes are designed to achieve the thinnest strut profile possible while optimizing strength for each scaffold diameter. The 95 micron strut profile on the 2.5 mm diameter is the smallest strut profile of any commercially available BRS.

Dr. Neils Holm from the Skejby-Aarhus University Hospital in Aarhus, Denmark provided a review of the 24- month Optical Coherence Tomography (“OCT”) sub-study results. The OCT imaging results in a subset of patients treated with Fantom demonstrated vessel patency (maintenance of a wide open artery) and sustained healing with 100% strut coverage at 24 months.

Dr. Matthias Lutz from Universitatsklinikum Schleswig-Holstein in Kiel, Germany presented a selection of patient case reviews as well as an introduction to the Company’s implant technique, referred to as the REVA Technique.


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