Late last month, the White House issued a statement declaring the opioid crisis a national health emergency. Many companies in the healthcare field are aware of this issue, but only a handful of pain-treating device makers are focused on fighting the crisis.
Atlanta-based Medovex is aiming to be one of the few.
Medovex produces the DenerveX system, a combined therapy device designed to treat patients with chronic lower back pain related to facet joint syndrome. It’s a system that prez & COO Patrick Kullmann is hopeful will both be successful and help stem the opioid crisis in the US.
“We have made a creative new breakthrough technology to directly treat a condition called facet joint syndrome, and it is a very large market globally, affecting about 31% of the 10% adult population in the United States, Europe, and Asia,” Kullmann said in an interview with MassDevice.com.
Facet joint syndrome is an osteo-arthritis-related disease that is mainly treated with opioids, according to Kullmann. Approximately 40% of patients with chronic lower back pain are treated with pain killers, he clarified, with the most common pain killer being an opiate-class drug.
But Kullmann and his team at Medovex are hopeful that the DenerveX device could help to fight the opioid crisis as the treatment has been shown to reduce pain as well as opioid consumption over a long period of time.
“It is a really, really big issue. And we have a device with a mechanical and thermal method of treating this disorder, and have had a very positive impact on the use of these drugs. These patients can be treated and have their pain significantly reduced or eliminated,” Kullmann said.
The DenerveX system uses both a slowly rotating burr to remove targeted facet joint synovial membrane and radiofrequency ablation technology to destroy tissue and denude any residual nervous and synovial membrane on the joint, effectively removing sensory tissue from it.
Other options for treating facet joint syndrome include radiofrequency ablation, which doesn’t last as long according to Kullmann, only giving patients six to nine months before they must return for treatment.
Patients can also receive anti-inflammatory or steroidal drug injections into the facet joints, but those only lasts up to a few months.
“The DenerveX’s centerpiece on the buying proposition is that we deliver longer-lasting pain relief or pain reduction, up to three years. In the world of pain, three years is long enough that these patients can be brought back into a lifestyle where they can function, they can pick up a grandchild, they can play a round of golf. 70 is the new 50. A lot of people, they’re very active. And so, this can be a very debilitating disease that, right now, is only being treated with pain killing drugs that are addictive, or ineffective devices that deliver temporary relief,” Kullmann said.
Medovex’s device has CE Mark approval in the European Union, and the company said it will be engaging in a randomized trial in the US as it pursues regulatory approval from the FDA.
So far, the device has done well as it sees global launches, Kullmann said, giving him hope that the device will be as impactful in the US as it is elsewhere.
“The device works. We’ve launched the product with the CE marking in Europe, in a number of different countries. We’ve received orders from countries on three different continents. The rollout’s going very well – in fact, I’ve been in this business about 38 years, and I will say that this is probably the best launched rollout that I’ve been involved with, with a new disruptive technology from a product adoption perspective,” Kullmann said. “We haven’t had a single physician that’s looked at it and said, ‘I’m not interested,’ or ‘I would not use that product.’ That’s why I feel this has been the best launch for me in my career, from a product adoption perspective. People really get it. They get it, and they know that the standard of care of injections, and the standard radiofrequency ablation are not working, and they’re looking for a good answer. And we think, and they think, that this is it.”
The success of the device, Kullmann said, can mean more than just a flourishing company. It could be part of the puzzle that leads to a healthier, less opioid-reliant US healthcare system.
According to a British medical society journal from 2015, opioid prescriptions for back pain have increased, and become the most commonly prescribed drugs for the condition. This, Kullmann says, is very dangerous.
“This is a two-edge sword, this drug class. Patients get temporary pain relief, but no one’s ever really shown that these patients do that much better after being treated with an opioid versus not being treated with it. So, we run a high risk of addiciont with little long-term published evidence, clinically, and this is a mainstay of how some of these patietns are treated early on in the diagnostic and therapeutic continuum,” Kullmann said. “Our proposition, with the DenerveX sevice, is that we can really impact and treat, in a very positive way, these patients that would normally receive opiate drugs. Now, they can receive long-term pain relief or reduction.”