This is an INDEPENDENT website developed by long-time Emmy Award-winning Journalist Kym McNicholas.

 

This site is NOT in any way associated or affiliated with Ra Medical Systems or its DABRA Laser System

 

It depicts my journey following what I believe is a breakthrough medical device from FDA Clearance to commercialization to IPO...and beyond.

From the moment I started covering Ra Medical Systems I could immediately see how the excimer laser could be used beyond the peripherals. DABRA's first clearance is for crossing CTOs in the peripherals. But I've watched doctors in Italy successfully go off-label using it for veins and I've seen several doctors in the U.S. successfully using it off-label to treat in-stent restenosis, all on their own volition when they deemed medically appropriate, which has proven to me it has much greater value. Next, I can imagine it being used in coronary vessels. And doctors I've spoken with throughout my journey concur with this direction as it's laid out in Ra Medical's S1 Filing with the SEC.

The S1 states, "DABRA is cleared by the U.S. Food and Drug Administration, or FDA, as a tool for the minimally invasive endovascular treatment of vascular blockages resulting from lower extremity vascular disease, which includes peripheral artery disease, or PAD, which commonly occurs in the legs. We intend to pursue additional uses for DABRA, including seeking regulatory clearance for the use of DABRA as a tool for the treatment of vascular blockages associated with coronary artery disease, or CAD, in-stent restenosis, and other venous and arterial occlusions, or blockages in the veins or arteries."

At least at this point, however, as of this summer, it looks as though all efforts to move this breakthrough technology forward, is in question, in my journalistic opinion. I'm hoping to be proven wrong. Despite the thousands of hours of successful cases I've captured on camera and highlights of those cases I've shared publicly, in which doctors have used the DABRA Laser System to save life and limb around the world, coupled with three clinical studies proving it's effectiveness, Ra Medical Systems ousted the inventor of the technology -- the only person I've witnessed, in the last nearly four years following this company through clinical trials and global commercialization, that knows how to develop it, fix it, and train doctors and staff to use it successfully. The Board of Directors, according to an August corporate press release, ousted him without cause. More importantly, they ousted him without a secession plan that would ensure successful future development and they ousted him without the adoption of proven training techniques that led to the three successful clinical studies and every successful case I've witnessed over the last nearly four years.

Because they ousted the inventor of the product, I'm not surprised that the company recently filed a Form 8-K with the SEC, stating "Ra Medical Systems, Inc. (“Ra Medical”) has initiated a voluntary recall of its DABRA laser system single-use catheters due to a change in product labeling. As previously announced, Ra Medical’s DABRA laser system is experiencing inconsistent performance due to catheters that fail to calibrate prior to a procedure being performed, resulting in a temporary delay in the procedure."

Despite the filing, from my journalistic perspective based on years of observation, it does seem ironic that the product worked effectively enough while the inventor was at the company using his training methods to support doctors around the world. Just look at the videos I've captured and shared throughout this site that demonstrate its effectiveness. It's not that there weren't some inconsistencies. Did calibration issues happen once in awhile? Yes, of course. I captured those moments, too. But, the inventor would always have a new catheter on standby ready to calibrate within seconds so the case could continue and the DABRA could unblock a patient's artery in which other devices had previously failed. The delays were minimal as doctors could calibrate a new catheter as you see here, in 60 seconds.

You can't expect every product to work 100% of the time. I don't know any company without manufacturing issues while trying to scale. But in all my years covering technology, I've never seen such a far departure from what I witnessed and captured on camera first-hand. I've been in thousands of hours of cases observing the training an implementation of the DABRA Laser System -- more cases than most of the staff, combined. While I was following the company in the most recent months from January 2019 - May 2019 in particular, I documented successful calibrations from properly trained doctors and staff as well as the successful, effective use of the DABRA Laser System to unblock arterial blockages. It includes LIVE cases performed by doctors in front of their peers via satellite. All the while, those who did not adopt the successful protocols developed and utilized by the product inventor, would say the product didn't work and therefore couldn't sell it. I even followed the inventor and another company employee at the time into the manufacturing facility to test catheters in the very same lots in which sales staff complained there were inconsistencies, as well as several catheters that had been returned, and they all calibrated effectively.

I can't explain the inconsistencies. I can only share what I observed. And I know that there are millions of people around the world that could benefit from this technology from what I've seen so far in terms of its published clinical trials, what I've captured on film in real-time, as well as what dozens of doctors have said on camera to me without being compensated. This device, I truly believe, is the biggest breakthrough in enodvascular procedures in the last decade. I don't know of any other device in its class that has the clinical results this device has demonstrated on patients who have very few options left before bypass and amputation. I hope, with all of my heart, that it is revived, and not shelved. I really want to see how big of an impact it can have based on its successful run so far. As I said above, according to doctors I've spoken with over the years, this device has huge potential for the future treatment of arterial blockages in the legs as well as the heart. We'll have to wait and see what the company's plan is moving forward to fix its manufacturing issues without the inventor on board to drive its development. I'm keeping a close watch as I am eager to speak with more patients whose lives are changed for the better as a result of DABRA.