SAN DIEGO, Nov. 20, 2014 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased to announce that the financing transaction approved by the Company's shareholders at the Special Meeting of Stockholders held in Sydney, Australia on October 31, 2014, has been successfully completed.
Under the terms of the Prospectus dated October 24, 2014 and in accordance with the Convertible Note Deed dated September 25, 2014, REVA issued an aggregate principal amount of US$25 million in senior unsecured convertible notes and 8,750,000 options; each option allows the noteholders to purchase one share of REVA's common stock.
The proceeds from the financing will be used to fund the Company's ongoing operating, clinical and capital needs, including the clinical program for its Fantom™ bioresorbable scaffold. "We are very pleased to announce the close of this financing," said REVA's Chairman and Chief Executive Offer, Bob Stockman. "The funding we have secured will allow REVA to move forward with our clinical plans and to take the product through to CE mark application, which we expect will occur in 2016."
Fantom is a bioresorbable coronary stent made from REVA's proprietary polymer that is designed to dissolve over time, leaving the artery free of a permanent implant and thereby allowing the artery to return to its natural movement or "vasomotion." Due to this temporary nature, bioresorbable stents are commonly referred to as scaffolds. Fantom's polymer properties also enable complete x-ray visibility of the scaffold when placed in the artery, an attribute unique to REVA among bioresorbable scaffolds. REVA believes that this distinct feature will offer a procedural advantage, as x-ray visibility helps confirm proper placement of the scaffold and is a tool interventional cardiologists routinely rely on when implanting metal stents.
About REVA
REVA is a development stage medical device company located in San Diego, California, USA, that is focused on the development, testing, and eventual commercialization of its proprietary bioresorbable stents, which are called "scaffolds" because of their temporary nature. The Company's scaffolds are being developed as an alternative to metal stents, which are small tube-like devices permanently implanted into an artery to treat coronary artery disease. 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 not attainable with permanent metal stents. The Company has conducted clinical studies of its scaffold technologies; a total of 112 patients were enrolled in its most recent clinical trial in Australia, Brazil, Europe, and New Zealand, with enrollment completed during January 2014. The patients in this trial will be followed for a total of five years, with primary data to be obtained at nine and 12 months. The Company is now developing and testing its FantomTM scaffold, with initial human implants planned for late 2014 at multiple centers in Brazil and Europe. The Fantom scaffold has been designed to offer distinct ease-of-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, no procedural time limitations, and standard storage and handling. REVA will require successful clinical results and regulatory approval before it can commercialize Fantom or any of its other products.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that are not statements of historical fact, including those statements that address future operating performance and events or developments that we expect or anticipate will occur in the future, are forward-looking statements, such as those statements regarding our ability to raise financing to fund our operations on terms favorable to us or at all, our ability to obtain the regulatory approvals, our ability to timely and successfully complete our clinical trials, our ability to protect our intellectual property position, our ability to commercialize our products if and when approved, our ability to develop and commercialize new products, and our estimates regarding our capital requirements and financial performance, including profitability. You should not place undue reliance on these forward-looking statements. Although management believes these forward-looking statements are reasonable 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 the forward-looking statements, including the risks and uncertainties that are described in the "Risk Factors" section of our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the "SEC") on March 17, 2014, and as updated in our periodic reports since then. 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-looking statements, whether as a result of new information, future events, or otherwise.