Credit: Shutterstock photoIt was nearly 13 years ago that Lori Swearingen changed her life forever after a fall on the job - and it took a decade for her to discover what it was like to be relatively pain-free again.
A Reno, Nev., firefighter at the time, Swearingen was helping a rig back down an ice-packed hill on New Year's Eve 2004. When she slipped and landed on her backside, she was the only woman in the crew.
"I got right back up, shook it off and kept going," she recalls.
But Swearingen soon began experiencing pelvic pain radiating into her lower back that affected her daily for another decade. No one thought to check her tailbone which, as it turns out, had been fractured. After a number of surgeries and drugs failed to relieve the mind-numbing pain, she discovered the answer: an implantable device called a neuromodulator.
[ibd-display-video id=2326965 width=50 float=left autostart=true] Such implants are now part of a big business that could well someday do the job of opioids and other medications for treating pain. All told, it's estimated to be a $3.9 billion total addressable market this year, Needham analyst Mike Matson wrote in a recent note to clients.
Matson expects the neuromodulation market to grow in the upper-single digit range for the next few years. The leader in the space is Medtronic ( MDT ) with 52.3% of the market, while Abbott Laboratories ( ABT ) and Boston Scientific ( BSX ) on its heels, Matson says.
But competition is mounting. Matson estimates that Medtronic's neuromodulation sales were down 6% in its fiscal first quarter, reported in August, to about $416 million, short of his original forecast. Medtronic doesn't break out its neuromodulation sales. Companies like Nevro ( NVRO ) and LivaNova ( LIVN ) are swiping share.
Neuromodulation, also called neurostimulation, has been around for decades. It's only been in recent years, though, that the techniques have become less "crude," says Dr. Mark Malone, founder of Advanced Pain Care in Austin, Texas. Malone, who uses one of the devices himself as a patient, sees neuromodulation becoming mainstream in coming years.
"In the last 18 months or so, a new generation has come out including (Abbott's) Burst and Dorsal Root Ganglion," Malone told Investor's Business Daily. "These two techniques are far more effective and it's really an amazing revolution. For the first time ever, we've been able to say things like 'cure chronic pain.'"
So, What Is It?
Neuromodulation essentially tricks the brain into thinking a region of the body is no longer in pain, says Dr. Allen Burton, Abbott's medical director for neuromodulation, movement disorders and pain. The modern iteration is the result of a better understanding of the nervous system.
"This is the application of electrical energy in the nervous system to quiet down pain impulses," he told IBD. "It's more of a language. You're speaking to the nervous system in the language of the nervous system and telling the brain the pain is no longer important."
Burton explains the difference in old vs. new technology in terms of a hammer. When you hammer a nail and miss, hitting your thumb, you rub the thumb to dull the pain. That introduces a new sensory signal, thereby blocking the pain signal. It's called tonic stimulation.
With the new technology, neuromodulation has adopted the electrical signals of the nervous system. Abbott uses what it calls BurstDR and Dorsal Root Ganglion stimulation, the latter of which treats a mysterious pain condition called complex regional pain syndrome.
Boston's Precision Spectra System, Precision Novi and Precision Montage MRI products use software called Illumina 3D to treat chronic pain, including complex regional pain syndrome and failed back surgery syndrome.
All About Pain Relief
For patients like Swearingen, it's not the specific device maker that matters - though she did a lot of research before settling on a device from Boston Scientific - it's the pain relief.
Swearingen had her tailbone removed several years after the incident, plus an appendectomy, a partial hysterectomy and back surgery - all in an effort to ease the pain in her pelvis. None of it helped.
She worked for another few years, staving off the pain on a cocktail of opioids, antidepressants, epidurals, radio-frequency ablation and acupuncture. Sometimes Swearingen worked in emergency medical, other times she went back on the fire line, pain permitting. After eight years, Swearingen finally took a medical retirement.
IBD'S TAKE:The 119-company Medical-Products industry group is now ranked No. 23 out of 197 groups tracked. It's led by Align Technology, which has a best-possible Composite Rating of 99, meaning it performs in the top 1% of all stocks. Head to IBD Stock Checkup for a look at other strong medtech players.
"I met with a psychologist to learn coping skills and techniques for my family to not focus on my pain," she told IBD. "I was pretty depressed. I was gaining weight because I had a very physical job and a very physical lifestyle. I was kind of circling that depression drain."
Two years later, she discovered the neuromodulator.
After retiring from firefighting, Swearingen moved to Seattle, where she began seeing a pain management doctor. Her doctor's office featured a poster on neuromodulation. Swearingen says she didn't know anything about the devices when she first saw the poster.
"I thought maybe it was a delivery system for drugs," she said. "Then I realized those were leads going up my spinal cord and I thought, 'Oh, heck no.' I spent two years looking at that poster."
Unintended Consequences
Physicians are looking at neuromodulation as a first step to treat some forms of chronic pain - often in the back - replacing doctors' penchant for prescribing an addictive course of opioids. Opioids are a huge drug market, projected to reach $17.7 billion by 2021 in the U.S. alone.
Opioids are also tied to major unintended consequences, including addiction and dependence, often leading to overdoses. There's also a major black market for opioids, which has created somewhat of a stigma for patients seeking pain treatment, Malone says.
"Doctors question the motives," he said. "It's a mess out there. All of that on top of the current opioid crisis on the news everyday. So it's really an amazing gift that we suddenly have this treatment that's so effective for even the worst pain patients and it's completely drug free."
Malone has had his own neuromodulator for more than six months. Before his implant, he was on disability for a year and had worked part-time for several years following a back injury. When he saw the success of 80%-100% in his own patients, he had his medical practice partner implant an Abbott device.
The difference was night and day. Malone gets choked up talking about it. His relief is near 100%.
"I can tell patients I've been through it, it's very real," he said. "Even my own wife was wondering, 'Has he given up? He doesn't want to work anymore.' I was just laying in bed day after day. The pain is real."
Potential Markets In Migraines, Depression
During the trial period, a temporary device is implanted under sedation and attached to an external battery taped to the skin. The patient can use a remote control to flick through different signal settings and strength, Malone said. Abbott's Burton estimates nine in 10 opt for the permanent implant.
Neuromodulators differ from opioids in that they are completely drug-free and reversible. Before they are implanted, a patient learns the potential risks and benefits. And the patient has a unique chance to try out the device before going the permanent - though still reversible - route, Burton said.
"One of the big problems with opioids is people are often initiated without much talk about the risks and benefits," he said. "The first prescription comes from the ER for a pain pill, a short, low dose. But as the pain becomes chronic and doesn't turn around or heal up, suddenly the patient becomes resistant."
What started as a traumatic injury often leads to a chronic pain problem, and the need for sleeping meds and/or antidepressants, he said. Now, a patient who never before needed medications is on three or four of them, all of which interact with one another.
Electricity isn't addictive, Burton said. And there's no euphoric side effect.
Still, neuromodulation isn't the end-all answer for every type of pain. It has its limitations. The most notable uses are in chronic back pain including complex regional pain syndrome and failed back surgery syndrome. But it wouldn't work in widespread pain like fibromyalgia.
The lion's share of Malone's patients are those who've gone ahead with back surgery and attained no relief. But Needham's Matson says there's also a market for neuromodulation in Parkinson's disease, essential tremors, incontinence, epilepsy, depression, migraines and obesity.
Still, neuromodulation remains the best, accidental secret in the pain community. Interventional pain is a new specialty, Malone says. Most neurosurgeons and orthopedists aren't aware of it.
The Road Back
For Swearingen, she was finally persuaded to give neuromodulation a shot after attending a patient seminar and doing exhaustive research on her own part - a recommendation she would give to anyone considering an implant. Indeed, days into her trial implant, she was ready for the permanent device.
Today, she's back in the gym, strengthening her core and has lost the weight she gained due to immobility. She rides her bicycle and horses, and lifts hay bales on her property in Seattle. Walking to the mailbox is no longer a daunting prospect, she said.
"In the last couple of years, my husband says, 'I have my Lors back,'" she said. "And I am back."
Meanwhile Swearingen is left to wonder if she could she have stayed on at the firehouse.
"I will never know that. There would be a possibility, but I'm 54 now. I retired on medical and at this point I don't care to (return to work)," she said. Instead, she's focused on the positive.
"This was life-changing for me, for my family, for everyone around me," she said.
RELATED:
Abbott Zeros In On A 2-Year High After Topping Q2 Sales, Profits
This Drug Bellwether's Sales Miss Actually Bodes Well For The Sector
Medtronic Sinks After Sales Lag, Though Earnings Beat Views
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
