Reva raises $25M to get CE mark for bioresorbable scaffold

Reva Medical has raised $25 million in debt from Goldman Sachs and Senrigan Capital. The financing had been months in the making and is expected to enable the development-stage company to get its latest bioresorbable stent on the market in Europe.

First disclosed in late September and then approved by Reva shareholders on Oct. 31, the financing completed on Nov. 20. The San Diego-based company, which was founded in 1998 and went public on the Australian Stock Exchange in 2010, has issued US$25 million in convertible notes and 8.75 million options. Each option allows shareholders to purchase one share of Reva's common stock at a later date.

Fantom Bioresorbable Scaffold--Courtesy of Reva

Reva plans to continue its clinical work with its Fantom scaffold, with initial human implants starting late this year in Brazil and Europe. In January, the company completed enrollment of 112 patients in Australia, Brazil, Europe and New Zealand in a clinical trial of its scaffold technologies. This trial is expected to have data at 9 and 12 months, with patients followed for a total of five years.

"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," Reva chairman and CEO Bob Stockman said in a statement.

Fantom is a drug-eluting bioresorbable coronary stent made from a proprietary polymer. The idea is that it dissolves over time, ultimately returning the artery to its natural movement. Its polymer enables the stent to be visible in x-rays after it is placed, which the company said unique to its product. This helps healthcare providers to confirm correct placement of the scaffold and is used routinely for metal stents.

It also has a drug coating that offers controlled release of the anti-proliferative drug Sirolimus. This is intended to minimize scar tissue formation and reduce the chances of restenosis, a re-narrowing of the artery that can occur after scaffold implantation.

The company is trying to catch up after switching gears in March. At that time, Reva said it would focus on Fantom rather than its ReZolve platform. Fantom is smaller and stronger than ReZolve, with half the strut thickness without a reduction in radial strength. Fantom retains the x-ray visibility that characterized ReZolve.

The convertible notes are for five years and bear 7.54% interest annually, allowing for cash redemption at 26 months, at maturity or upon a change of control. Interest compounds annually, but is payable only upon redemption. The options can be converted anytime at a price of A$0.25 per Chess depositary interest (CDI), which is the form that Reva trades in. The maximum number of CDIs is 113.4 million.

The micro-cap company gained 4% on the financing news to A$0.40.

- here is the release

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