Reva Medical, a medical device company, has today commenced the very first clinical trial of its ReZolve™ bioresorbable coronary stent. A patient in Brazil was implanted with the device overnight, which flags an exciting chapter for Reva Medical.
This patient is the first participant in a prospective, multi-center study designed to evaluate the safety of the ReZolve™ scaffold in 50 patients in Brazil and several European countries. The data will be made available in 2012.
This announcement is a significant boost for Australian investors – it’s the news they’ve been waiting for. In fact, it’s a milestone they should be very proud of, after having volunteered their confidence in Reva’s technology during its IPO in December 2010 in which it raised $85m. Now the curve is in healthy shape to climb, particularly when you consider that global annual sales for coronary stents are estimated at $5billion; in 2010 approximately 3.4 million stents were implanted across the world.
A quick definition of this device for your background: Stents are implantable medical devices used by interventional cardiologists for the treatment of coronary artery disease. Stents help stabilise diseased coronary arteries by propping them open and restoring blood flow and are typically made of metal. Metal stents remain in the heart as a permanent scaffold; however, it is now generally believed that a stent’s functional purpose is fully served in less than six months. Reva’s bioresorbable stent acts as a temporary scaffold during the healing process, then slowly dissolves, leaving the patient free of a permanent implant.
The first human implant of ReZolve™ is a significant milestone, because it’s a formal endorsement of research that’s already been undertaken by the company and an insightful step forward into the treatment sphere for which this device has been designed… For the first time, scientists will be able to see how this technology performs in humans, and they’re confident it will significantly outperform its peers. Here’s why…
All currently approved stents are made of metal, which serve as a permanent scaffold inside a vessel. However, the placement of a permanent metal stent can result in long-term complications. Comparatively, bioresorbable stents are intended to provide the same benefits as traditional metal stents with the added benefit of being dissolved in the body after treatment of the artery, and may reduce some of the risks associated with permanent metal stents, including potentially fatal blood clots.
This announcement provides an ideal ‘mark in the sand’ to do a story about Reva’s technology and projected performance on the Australian stock market. The company started almost 14 years ago in Delaware USA and was originally chasing success as a bare metal stent company. In early years, Reva came head on with the drug-eluting stent revolution and completely overhauled its focus to pioneer a bioresorbable stent. With a strategic partner on board, and a successful IPO down under, Reva Medical is now commencing its first clinical trial. This achievement is a testament to the company’s perseverance and ability to evolve in the space of medical device technology. Reva Medical is a company to watch, and one that investors will most definitely have in their sights in the new year.