REVA Achieves Target Patient Enrollment in FANTOM II Trial
San Diego, California (Tuesday, February 23, 2016, PST) – REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”) is pleased to ann ounce it has achieved the targeted enrollment of 110 patients in Cohort B of the FANTOM II clinical trial, br inging total enrollment to 227 patients. FANTOM II is a clinical study of the safety and performance of the Fantom® sirolimus- eluting bioresorbable coronary scaf fold. Patients were enrolled at cl inical 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 Grove s, REVA’s Chief Executive Officer. “With this trial and additional trials that we may initiate in the futu re, 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 ha d achieved the targeted enrollment of 110 patients in the first cohort of the trial (“Cohort A”). Seven additional patient s were subsequently enrolled in this cohort. Patie nts 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 Revascularizatio n (“EuroPCR”), which will be held in May.
The data from patients in Cohort B is 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 re leased at industry conferences, beginning at the Transcatheter Card iovascular Therapeutics (“TCT”) Conference in October.
REVA is a clinical stage medical devi ce company located in San Diego, California, USA, that is working to commercialize its proprietary bioresorbable stents, whic h are called “scaffolds”. The Company’s scaffolds have been developed as an alternative to metal stents, which are small tube-like devices pe rmanently implanted into an artery to treat coronary artery diseas e. Scaffolds provide restoration of blood flow, support the artery through the healing process, then disappear (or “resorb”) from the body over a period of time. This resorption allows the return of natural movement and function of the artery, a result no t attainable with permanent metal stents. The Company’s initial product, the Fantom ® scaffold, has been designed to offer an ideal balance of thinness and strength and distinct ease-of-use features includi ng complete scaffold visibility under x -ray, expansion with one continuous inflation, and no procedural time limitations. REVA will require successful clinical trial results and regulatory approval before it can commercialize Fantom or any other product.
This announcement contains or may contain fo rward-looking statements that are based on management's be liefs, assumptions and expectations and on information currently available to management. All statements that are not statements of historical fac t, including those statements that address futu re operating performance and events or de velopments that we expect or anticipate will occur in the future, are forward-looking statements, such as those statements regarding our ability to obtain regulatory approvals, timely and successfully complete our clinical trials , protect our intellectual property position, commercialize our products if and when approved, develop and commercialize new pr oducts, recruit and retain our key personnel, and estimates regarding our capital requirements and financial performance. You should not place undue reliance on forward-looking statements. Although management believes forward-looking statements are reasonabl e as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to vary materially from those expressed in forward-looking statements, including the risks and un certainties that are described in the "Risk Factors" section of our Annual Report on Form 10-K filed with the US Securitie s and Exchange Commission (the “S EC”) on March 30, 2015, and as may be updated in our periodic reports thereafter. Any forward-looking statements in this announcement speak only as of the date when made. REVA does not assume any obligation to publicly update or revise any forward-looki ng statements, whether as a result of new information, future events, or otherwise.
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