Neuromodulation Execs Voice Their Opinions at NANS i3

by Sharena Rice, contributing editor

February 2025 issue

The recently concluded annual meeting of the North American Neuromodulation Society in Orlando, FL, attracted a large number of pain physicians, surgeons, neural engineers, and neuroscience researchers. There was also a considerable industry presence, particularly during the i3 preconference workshop organized by the editors of Neurotech Reports.

The i3 workshop, dedicated to invention, investment, and invigoration, featured a session with executives from major firms in the neuromodulation industry. The panel discussion, moderated by NBR editor James Cavuoto, featured Allen Burton from Abbott, Ash Sharan of Medtronic, David Caraway of Nevro, and Dan Brounstein of Saluda Medical. The discussion illuminated the regulatory, financial, and competitive forces shaping the SCS market—critical considerations for neurotech entrepreneurs, investors, and analysts tracking market trajectories.

A central focus was the evolving regulatory landscape, with panelists contrasting Europe’s historically favorable environment against the U.S. market. Europe, once the go-to region for launching new neuromodulation technologies, now faces headwinds from a new Medical Device Regulation framework. As MDR’s complexity has slowed innovation without delivering clear patient benefits, many firms have pivoted toward the U.S. FDA pathway as their primary entry point. Encouragingly, the FDA has shown signs of adaptability, streamlining approvals for breakthrough therapies while upholding rigorous safety standards—a customer-focused approach. Geopolitical factors, including Brexit and regulatory changes in Australia and Canada, further complicate global strategies, underscoring the need for agile navigation by industry players.

Reimbursement emerged as another pressing challenge. The panelists dissected the traditional SCS business model, where manufacturers play an outsized role in patient care—from implantation to long-term device management. There is a key disconnect here: unlike pharmaceuticals, where sales conclude with a prescription, the person offering neuromodulation to patients is often a key player in patient care. Neuromodulation demands ongoing support without corresponding reimbursement structures. This burden pushes companies toward innovation, with Nevro’s AI-driven patient engagement platform cited as a standout example. Leveraging patient feedback to optimize stimulation, such tools aim to enhance outcomes and cut costs—a trend investors should watch as digital health integration accelerates.

Negative publicity also drew scrutiny, with panelists lamenting the outsized influence of flawed studies in major journals. This calls for a unified industry response, advocating real-world evidence and patient registries to counter misinformation. The panel urged neurotech leaders to emulate pharmaceutical-style advocacy, engaging patient groups to amplify the transformative impact of neuromodulation—an opportunity for startups to build credibility and sway payers.

Mergers and acquisitions sparked lively debate, with Brounstein drawing on his startup and corporate experience to advise entrepreneurs. He emphasized raising sufficient capital early to avoid over-reliance on a single acquirer, a strategy that preserves leverage in negotiations. While intellectual property disputes loom large, the panel downplayed fears of idea theft, citing robust legal protections. Looking forward, brain-computer interfaces and novel targets like depression and movement disorders are generating buzz, though clinical and scalability hurdles must be cleared before real excitement arises for neurotechnology innovations—sage advice for innovators and investors eyeing the next big breakthrough.

The panel also explored neuromodulation’s expansion beyond chronic pain into areas like stroke rehabilitation, psychiatric disorders, and autonomic regulation. Abbott’s ongoing deep brain stimulation trial for depression exemplifies this shift, refining patient selection to boost efficacy. Meanwhile, the FDA’s expedited pathways for neurodegenerative conditions like ALS signal a regulatory tailwind—a boon for tech transfer teams seeking to commercialize cutting-edge research.

The i3 strategics panel at NANS 2025 painted a vivid picture of an industry at a crossroads. Regulatory shifts, reimbursement gaps, and competitive pressures pose real challenges, yet the convergence of AI-driven care, new clinical applications, and a more innovation-friendly FDA offers a compelling growth narrative. For neurotech entrepreneurs, investors, and industry analysts, the takeaway was unmistakable: success hinges on collaboration, data-backed advocacy, and sustainable business models. As the field evolves, those who bridge these gaps will drive neuromodulation’s next chapter, delivering transformative therapies to patients worldwide.

At the scientific meeting, Biotronik Neuro unveiled new data from the BENEFIT-03 clinical study of its Prospera SCS system. This system integrates the company’s Resonance multiphase stimulation with automatic, objective, daily remote monitoring and proactive care to optimize management of SCS patients’ chronic pain. The 24-month data revealed that participants experienced significant pain relief, along with better sleep, improved function and reduced opioid medication use. Patients and clinicians reported positive experiences with the Prospera SCS system’s remote monitoring and remote programming capabilities, which enabled rapid resolution of issues to optimize therapy and reduced burdens for both patients and clinicians.

Highlights of the 24-month interim results include significant pain relief; at 24 months, therapy responder rates were 86% for back pain, 89% for leg pain, and 82% for overall pain. Also daily function improved: mean daily pain intensity was reduced to 1.8 at 24 months vs. 6.6 at baseline, and function was improved with 73% of participants reporting minimal/moderate disability at 24 months vs. 5% at baseline. Among baseline opioid users, 80% eliminated or reduced dosage by at least 50% at 24 months.

Abbott announced new four-year data showing long-term and sustained relief that its proprietary BurstDR SCS technology provides people with chronic pain, particularly pain in the back and legs. The data, reinforces the high level of satisfaction people have with the treatment, represents outcomes from the four-year mark of a multi-year follow-up study.

Abbott’s BurstDR SCS therapy uses pulses—or bursts—of mild electrical energy without paresthesia to change pain signals as they travel from the spinal cord to the brain. Patients using BurstDR have reported a significant reduction in the impact chronic pain has on their emotional and mental states, particularly as it relates to “pain catastrophizing,” worrying about future pain that may magnify pain sensations.