It was a decision the company had been waiting on for approximately 3 years, CEO Dean Irwin told MassDevice.com in an interview, and signaled a significant shift forward.
“In 2014, we submitted to the FDA, and here in 2017, just on May 24th, we received the go ahead to begin marketing in the United States,” Irwin said.
Ra Medical won CE Mark approval in the European Union last October, giving the company time to launch in the region, which it’s been operating in for several months, Irwin said.
“That was a much shorter process,” Irwin said. “We’ve been operating in Europe now for several months, and here in the United States for a few months. We’ve now done over 100 procedures – in fact, over 200 procedures worldwide.”
The Carlsbad, Calif.-based company is now looking to a potential initial public offering early next year, hoping the capabilities of its Dabra arteriosclerosis laser make it stand out to investors.
The field of atherectomy is competitive, but the unique properties of its Dabra system provide significant advantages over the competition, Irwin said.
“It’s very different from a balloon angioplasty, or a stent. In balloon angioplasty, a balloon pushes the plaque to the side, compressing it or expanding the vessel, and a stent will just keep it propped open. But we felt that, and many feel, that it’s better if you can remove some of that plaque to help get the blood flowing a little bit better,” Irwin said. “Our laser does that by a process called photochemical ablation. It actually breaks down the plaque material into its fundamental chemistry of proteins, lipids, water and some gases. Those are just naturally present in the blood stream. So it almost in a way dissolves the plaque. Other devices tend to either cut it, or carve it, or try to heat it, or just grind it up.”
The Dabra system breaks down plaque without releasing particulate matter into the bloodstream, Irwin said, something that devices that grind or cut plaque can’t do. Instead, the system works on the molecular level, giving it advantages in dealing with multiple types of plaque.
“Sometimes plaque is very hard – we call that calcified plaque. Sometimes it’s soft, like thrombus or atheroma. Many cutters and spinners work well on 1 type of plaque, and not well on another. But with our laser system, it seems to work well on all kinds of plaques,” Irwin said. “That saves a lot of time and performs the atherectomy better than other devices that can only either work on calcium or thrombus.”
With clearance in hand, Ra Medical is now looking to raise capital to reach more markets, Irwin said. The company is currently in the process of selecting banks, reviewing materials and preparing for the offering, Irwin said
“In order to reach some of these markets, particularly coronary artery disease, we may need to raise some capital. A good way to do that is through the public markets, so we are planning for an initial public offering. Our current target date is February of next year – of course that’s always subject to change,” Irwin said.