Reva Medical ramps up production of bioresorbable scaffold

The new material contains 85% the same materials as the original compound used in its ReZolve scaffolds and does not need to be requalified, Robert B. Stockman, cofounder and CEO said in a conference call with investment analysts to discuss second quarter results. Reva Medical calls ReZolve a scaffold because it is not a permanent device like a stent, which is made from metal.

"We believe that, due to the number of risks associated with commercially available metal stents, bioresorbable stents will be the next major advance in coronary stent technology, and, if approved for commercialization by the relevant regulatory authorities, we believe the ReZolve scaffold will enable us to compete effectively in the stent market, which had approximately $4.9 billion in worldwide revenues during 2011," the company stated in its most recent annual report filed with the Securities and Exchange Commission.

Stockman said that 26 patients "continue to do well" in clinical trials in Europe and Brazil that began last December. A CE Mark (European approval) clinical trial is planned to begin later this year with ReZolve 2, the name of the product using the new plastic compound. Doctors and hospitals are also being lined up in Brazil, New Zealand and Australia, where as many as eight hospitals may be enrolled in the study, according to Stockman.

Reva Medical's research and development expenses were $10.3 million in 2009, $6.8 million in 2010, and $13.4 million in 2011.

Employment has ramped up from 60 last year to 71 to date this year, with the additional hires coming in engineering and operations. Production will soon be going from hundreds of units per week to thousands of units per week, said Robert Schultz, president of Reva Medical.

No specifics were disclosed on the types of equipment that will be added. Initial emphasis probably will be on assembly of the catheter, quality assurance, and packaging. Polymer production is outsourced to a domestic supplier, while polymer film pressing is performed at Reva's facility. Production of lasing stent parts from film is currently outsourced to a domestic fabricator. The drug coating is currently purchased from a foreign supplier and is prepared and applied in San Diego. A finished catheter and sheath system is currently purchased from a foreign supplier.

Interestingly, a sheath will no longer be required in the ReZolve 2, further facilitating its deployment in complex arterial systems.

Stockman said that a sheath is no longer needed because the radial strength of the scaffold made from the new compound is at least 30% greater and has three times the retention strength on board a balloon. The new system is equivalent in size to what's called a 6 French catheter guide profile.

"Our physician investigators are very excited about moving to the lower profile ReZolve 2 device," said Stockman. "We are comfortable with the ReZolve 2 safety profile, and it will have been thoroughly tested you can be sure before it goes into the first patient."

The medical plastic used in the scaffolds in an iodinated, tyrosine-derived polycarbonate.

The improved plastic will be important as Reva Medical competes against Abbott Vascular (Abbott Park, IL), which received CE Mark approval last year, for its bioresorbable vascular scaffold called Absorb made from polylactide. Biotronik (Berlin, Germany) is developing a second-generation Dreams magnesium-based resorbable stent.