Device: Reva Medical's Fantom scaffold
CE mark: No, commercialization targeted for mid-2016
European clinical trials: Yes for predecessor; first Fantom implantation expected in Q4 2014
Reva Medical's Fantom couldn't be more aptly named. Not only is it designed to disappear, like all other bioresorbable stents, but the device also appeared abruptly when the company scrapped plans for its ReZolve2 platform in March 2014 amid layoffs, after saying in January that it would file a CE mark for that bioresorbable stent before the end of the year. The Fantom is expected to appear commercially in 2016. For now, though, it remains mysterious.
In the Fantom's first appearance (at least on paper), Reva said it aims to cut the strut thickness in half without decreasing radial strength, as compared to the ReZolve2. The company has promised many of the same features as it did for the ReZolve2 such as X-ray visibility and expansion with a single inflation of the angioplasty balloon, which would make for a smoother surgery. In addition to the lower strut thickness, Reva said the Fantom is easier to manufacture than ReZolve2.
|Reva's Fantom bioresorbable scaffold--Courtesy of Reva|
GlobalData's Priya Madhavan noted that all of the offerings feature radiometers on the stent's delivery catheter to assist in visualization during surgery, but she believes that Reva's X-ray visibility promise could mean that the Fantom stent itself will also contain radiometers, which would enable visibility postsurgery, something the competitors don't offer.
Another differentiating feature is the material. While not as unique as the metallic component in Biotronik's DREAMS, the polymer desaminotyrosine polycarbonate has different properties from the lactic acid polymer used by Abbott ($ABT), Elixir and several other market players in earlier stages of development. The company did not announce what drug Fantom will elute if any; ReZolve2 eluted sirolimus, in line with the industry standard.
Patients in the Restore II trial of the ReZolve2 will be followed for 5 years, as originally planned. The predecessor achieved a 5.6% rate of major cardiovascular events at 6 months. The first-generation ReZolve demonstrated a mean in-stent late lumen loss of 0.29 mm, which is in line with drug-eluting stents, Reva said. However, the two CE-marked devices both proved late lumen gain. Biotronik's stent also showed late lumen loss, which contributed to the need for another trial, Madhavan said.
Founded in 1998, Reva launched the ReZolve stent trial in December 2011. It began trials for the second-generation ReZolve2 in March 2013; improvements in that iteration included a lower profile and a sheathless delivery catheter to lower risk of injury to vessels during delivery, as well as a 30% increase in scaffold strength to provide increased support to coronary lesions prior to the stent's disappearance, Reva said.
The Fantom is the company's third iteration since going public in Australia, but will it be good enough for regulators? We won't know for another two years, and FDA approval will take even longer. With no products on the market, a loss of $28 million and about $13 million in cash on hand by the end of Q1 2014 (down from $19.3 million a year prior), Reva had better hope so, or it could truly become a phantom.
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