Reva Medical returns with $45M to bring its bioresorbable stent to the US

Reva Medical has returned, raising $45 million to complete its work in the historically difficult market of bioresorbable stents. 

The California-based outfit went through Chapter 11 bankruptcy proceedings in early 2020, as reported by the San Diego Union-Tribune, and re-emerged as a private enterprise after about a decade as a publicly traded company.

In that time, the stent industry has seen bioresorbable entrants come and go—most notably Abbott, which pulled its Absorb coronary implant from the clinic in 2017 after poor sales and an FDA analysis that showed higher rates of major cardiac side effects. Once poised to be a major competitor to their permanent, metal cousins, polymer-based bioresorbable stents are designed to slowly dissolve over time and disappear after reopening a constricted artery.

Reva previously received CE Mark approvals in Europe for its Fantom Encore device, designed with thinner struts for use within the heart’s coronary vessels, as well as for its larger, flexible MOTIV drug-eluting stent for treating peripheral artery disease below the knee.

Post-bankruptcy, however, Reva decided to drop its work on developing Fantom Encore for the U.S. market and focused instead on its MOTIV stent for the legs, as well as its TyroSphere embolic beads, which are made of the same bioresorbable material and designed to cut off the blood supply to certain kinds of growing tumors. Fantom, Fantom Encore and MOTIV are available in select countries in Europe and the Middle East, the company said.

Nearly 15 years after collecting $42 million through its last venture capital round in 2007 before going public, Reva’s new series B proceeds will help the company move forward with a pivotal clinical trial to support the FDA’s review of the MOTIV stent, President and CEO Jeffrey Anderson said in a press release. The latest round was led by an unnamed global medical device investor and joined by BioStar Capital.

Earlier this year, Reva presented preliminary results (PDF) from a study of its MOTIV sirolimus-eluting stent in patients with severe peripheral artery disease symptoms and potentially facing tissue loss or amputation.

The study showed that 90% of treated blood vessels remained open after six months, after 99% of stents were placed successfully. 

Eight of the 58 treated patients died more than a month after the procedure; Reva said the deaths were not related to the device and listed organ failure and septic shock as the primary causes. One patient also had a lower leg amputation, caused by a wound-healing disorder that was also unrelated to the MOTIV stent, the company said. The single-arm trial will continue to follow its participants for up to three years.