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By: Brittany Meiling
Ra Medical’s DABRA system, which recently received FDA OK for sales, uses liquid encased in a tube, rather than chunks of glass or woven fiber optic bundles, to deliver its laser. Photo courtesy of Ra Medical Systems Inc.
San Diego — A medical device company in Carlsbad is preparing to make its debut on the public markets following a product launch that could boost its revenues ninefold.
The company, Ra Medical Systems Inc., just launched a new laser catheter device that could compete with a product of Spectranetics Corp., a company that just got acquired by Philips for $2.2 billion.
Like Spectranetics, Ra Medical developed a laser catheter to treat a condition called peripheral artery disease, or PAD. The condition would be familiar to diabetes patients, a subgroup that’s prone to developing the disease. In PAD, blocked arteries cause poor circulation in the legs, which leads to pain and — in serious cases — amputation. PAD is common, with more than 8.5 million cases in the U.S. per year.
The condition is commonly treated with clot-dissolving drugs and angioplasty, a procedure in which a small hollow tube (catheter) is threaded through the blood vessel to the affected artery. There, a small balloon on the tip of the catheter is inflated to reopen the artery. Sometimes a stent is placed to keep it open.
Another option to treat the blocked arteries is to blast the blockage with a high-energy light, essentially vaporizing the blockage inside the vessel. This method is called laser atherectomy, and it’s what Ra Medical’s product is for.
Ra Medical’s device is called the DABRA system, and the Carlsbad company is no novice in UV light. The company has been selling a laser dermatology product called Pharos since 2004, and the company has been working on the technology behind the DABRA system for nearly a decade.
In fact, Ra Medical’s director of research and development, James Laudenslager, was one of the founding fathers of the medical excimer lasers now used in lasik eye surgery and other angioplasty procedures. His laser technology, developed at a company called Advanced Interventional Systems, was later acquired by Spectranetics.
Laudenslager has been at Ra Medical since 2008, working with the team to bring the DABRA system to the market. Just last month, the company received clearance from the U.S. Food and Drug Administration to sell its DABRA system.
Ra Medical CEO Dean Irwin said the laser could increase the company’s revenues by 900 percent, from $10 million in 2016 to potentially $100 million the first year the product is on the market.
“The market size is potentially very large with 600,000 to 800,000 of these procedures done every year,” Irwin said.
The company, which employs about 50 people, plans to hire an additional 25 to 50 individuals across several departments to manage growth over the next 12 months.
“We have a tremendous number of ideas and applications for this laser platform,” Irwin said, including using the device for cardiovascular disease. The new funds will help the company pursue clinical studies to validate those applications.
Up for the Competition
Irwin said he believes Ra Medical’s laser could be very competitive to Spectranetics’ device and others like it.
“Their catheter (Spectranetics’) is expensive, their treatment is very slow, and they can’t treat all the types of calcium and plaque that we can,” Irwin said.
That’s because most lasers used for PAD are designed differently than the Dabra system. The status quo is to use fiber optics (flexible fibers of glass) at the end of the catheter to deliver the laser energy to the blockage.
“In order to be flexible, the fiber optic strands have to be very tiny,” Irwin said. “Applying a tiny spot of light to your blocked arteries is not very helpful. Some arteries are as big as your thumb, so if a fiber optic strand is the diameter of a human hair then that’s not going to help very much.”
In the 1990s, makers of these laser catheters used big chunks of glass to cover a greater surface area, but the design made the catheter too stiff to navigate through the arteries. Spectranetics got around that by weaving together lots of tiny glass fibers into a bundle.
“But that means there’s lots of space between these fiber optics; lots of dead space where light doesn’t make it through,” Irwin said.
Ra Medical’s approach was to avoid glass altogether and instead used a liquid encased in a tube.
“Water transmits better than glass,” Irwin said. “Our light comes out like a fire hose, and (Spectranetics’) comes out like a showerhead.”
As part of the company’s clinical trial work, Ra Medical systems distributed its DABRA system to a diverse set of practitioners in hospitals and clinics. One participating physician, Dr. Rahotham Patlola of the Louisiana Cardiovascular and Limb Salvage Center, presented clinical data on the system at an industry conference in June.
“DABRA enables me to treat my patients more efficaciously and at a lower cost than other devices,” Patlola said, calling the system a “limb-saving device.”
Irwin said that Patlola and other participating physicians of the clinical trials are not affiliated with Ra Medical.