There are many ways to treat and manage conditions like overactive bladder (OAB). But could a market brouhaha over neuromodulation IP impact how practitioners leverage established treatments?
The two main players in the field, Medtronic and Axonics, have been butting heads for a while. Both are determined to dominate the OAB treatment market segment that could always use more attention, and the winner will likely be the company that is most innovative over the longer-term. The battle is truly one of “David versus Goliath”. Here's what the battle for the OAB neuromodulation crown might mean for urology and urogynecology practices.
OAB Basics
Overactive bladder is a condition characterized by a sudden, strong urge to urinate. This urge may be difficult to control. When the sensation of urgency is overwhelming, patients may experience urine leakage before they can make it to the toilet.
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OAB is a bothersome, disruptive problem. Sufferers may experience urges at any time of day or night, and the possibility of sudden incontinence makes living with the condition anything but easy.
Tragically, a 2018 review found that even though this condition might impact no less than 33 million adults in the U.S., a large number of people never seek help. In many cases, this is because they're embarrassed or unaware of what they're dealing with.
The 2018 study also noted that although it's known that different factors can contribute to an individual's likelihood of developing OAB, the precise cause remains elusive. The most widespread opinion maintains that OAB is related to the overactivity of the detrusor muscle in the bladder wall.
Detrusor contractions help push urine from the bladder and into the urethra. Under normal conditions, this muscle remains relaxed, making it easy for healthy people to retain their urine with minimal effort.
If prevailing theories hold, bladder overactivity has to do with uncontrolled detrusor contractions. On the other hand, its symptoms and characteristics are similar to numerous other urinary conditions, necessitating a nuanced treatment approach for each patient.
OAB Treatment
Patients can and do live quality lives after OAB diagnoses thanks to the existence of a wealth of treatment options. Here are a few starting with the most conservative.
The first line of treatment usually involves lifestyle changes. A clinician may advise a patient to maintain a healthy weight, adjust their diet, avoid caffeine, or drink plenty of fluids. Many clinicians prescribe exercises specifically tailored to help strengthen the pelvic floor muscles, such as Kegels and vaginal weight training.
If these changes don't work, the patient may be prescribed medication, of which there are many options. For instance, anticholinergic/antimuscarinic drugs work by blocking acetylcholine – a common neurotransmitter with many functions including triggering contractions. This relaxes the muscles in the bladder, including the detrusor, making it easier to avoid urination.
Other drug regimens may include antispasmodic medications designed to reduce neural activity thought to be causing unwarranted contractions. Like antimuscarinic drugs, antispasmodic medications may cause unpleasant side effects that could promote treatment noncompliance. Alternatively, clinicians may inject botulinum toxin (such as Botox) into the detrusor muscle to inhibit the release of acetylcholine.
OAB Neuromodulation in Review
If the other options aren't a good fit, the patient may need to undergo surgery. One common type of surgery, OAB neuromodulation, targets one of the sacral spinal nerve pairs – which are responsible for controlling the muscles in the bladder, urinary sphincter, colon, anal sphincter, and muscles of the pelvic floor.
Neuromodulation involves implanting a device that sends electrical signals to a specific nerve to impact its behavior. A 5-year, multicenter trial that wrapped up in 2007 found that sacral nerve stimulation using a Medtronic device named InterStim contributed to several benefits. For instance, it increased the amount of urine subjects passed each time – implying improved retention – and reduced the number of times they needed to void themselves daily.
OAB neuromodulation may appeal to patients who simply like its odds over the alternatives, but it also has other intrinsically appealing qualities. For instance, the 2007 trial didn't observe any irreversible or threatening adverse events, and the benefits seemed to last.
Public opinion might also be swayed by the therapy's longevity. Multiple sacral neuromodulation devices are FDA-approved for treating OAB. Success rates for this specific use have also improved over the past twenty years – as have sacral neuromodulation outcomes for other urinary issues.
Enter the Market Factors
This happy vignette of an effective treatment technology isn't quite perfect. There's something off about the scene: a dispute over IP with no end in sight.
On one side, you have Medtronic, Inc. - the old-guard company with the bulk of the market share. It created the original InterStim neuromodulation implant, and it's been patenting related tech since at least the 1980s.
Axonics Modulation Technologies is the challenger of the story - a new startup that recently entered the market and found what it believed to be an effective way around the Medtronic patents.
As of March 2022, both Medtronic and Axonics had received approval for the latest versions of their sacral neuromodulation devices – with Medtronics' approval leading its competitor's by a mere two weeks! The rivalry is intense, and it provides for some interesting and exciting fireworks in the slow moving market of continence care.
The Conflict
Axonics has only been around since the early 2010s. The Irvine startup did well for itself by catering to overseas markets during its first seven years of existence. In November 2019, however, it ran into a rough patch – just in time for the first anniversary of its IPO.
Medtronic sued Axonics over multiple alleged patent infringements, causing an initial dip in shareholder confidence, but the setback proved short-lived. The FDA declared it was approving a key Axonics product just 10 days after the lawsuit announcement. This more than compensated for the company's initial stock price loss.
The timing around these events gets even more interesting – Some industry observers said that Medtronic had likely waited to file the suits until Axonics committed to a commercialization push. Unfortunately for the larger company, this attempt to catch its rival off-guard proved to be a miscalculation.
The subsequent FDA approval announcement and stock swing put enough wind in Axonics' sails to push back. Its new product's features also made the situation seem like the "safe and established" company was the one playing catch up.
Axonics' first FDA-approved device made for attention-grabbing headlines in a market with only one real option. It had a 15-year battery life and occupied a mere one-fifth to one-third of the volume required by InterStim implants – One urologist said it was like comparing a key fob to a cell phone. It even featured full-body conditional labeling for 1.5T MRI scanners.
Medtronic products had the advantage of an established history spanning more than two decades. Axonics, however, hit the ground running with a more modern, innovative style. The larger company's then-recent, all-too-public history of false Medicare and TRICARE claims penalty settlements and other bad PR may have also worked against it.
Whatever the thinking was, Axonics responded to the events by challenging a total of seven patents held by Medtronic. While the U.S. Patent Trial and Appeal Board found six of these claims merited review, it took about two years to issue a split decision, upholding only one of them. In other words, both sides walked away with a partial victory, leaving much unresolved.
This minor legislative slugfest was also interspersed with real innovations. During the review period, Medtronic released a flurry of upgrades, like devices with energy-saving settings, smaller profiles, and fewer maintenance requirements than their predecessors. Axonics did the same, improving its offerings despite never having made a single quarterly profit – even as of this writing.
The Ramifications
Is this a story about a plucky underdog destined for triumph? After all, one of the patents it challenged will expire in 2026, potentially rendering three of the rulings in favor of Medtronic irrelevant. Or will things end with the market giant using its heft and leverage to squash – or wear down – the upstart?
Urologists and urogynecologists want to know, particularly if they've been dealing with Medtronic for a long time. Those thinking of switching to Axonics aren't just wondering which product is better at producing cost-effective, positive patient outcomes. They are also considering the long-term technical support for the products they suggest and implant.
Even if Axonics products offer superior quality to complement their features, there's a risk that constant legal issues might someday put the startup in jeopardy. The company's bankroll has grown steadily despite its challenges, but compared to Medtronic's decades-old war chest – there's just no comparison.
Medtronic might someday attempt a buyout of Axonics, although this is just speculation. Such an action might reduce the likelihood of long-term clinical support for current Axonics technology.
On the other hand, Medtronic's catch-up game still hasn't quite caught up. Its most recent device is technically only rated for 10 years as compared to Axonics' original 15 – although the energy-saving mode is advertised to make it last longer.
At this point, the original lawsuits brought by the bigger company remain unresolved. 2026 isn't that far away, and if Axonics can keep Medtronic on its toes until then, it will have solidified its already-strong position as an investment-worthy market innovator.
Of course, you shouldn't have to wait that long to find out what happens next. Watch this space for the latest updates and pointers on keeping your practice updated for the market to come. We hope to update this blog post as this ongoing battle evolves.