How Noctrix Health Is Redefining Sleep for Restless Leg Syndrome Patients

At the LSX World Congress in Boston, MedTech Spotlight Live by Orthogonal featured conversations with leaders shaping the future of healthcare technology. Orthogonal’s Randy Horton spoke with Shri Raghunathan , CEO of Noctrix Health, Inc. , about Nidra, the first FDA-cleared wearable treatment for Restless Leg Syndrome (RLS), and how thoughtful digital integration can enhance therapy outcomes without distracting from core innovation.

RLS: The Most Common Disease You’ve Never Heard Of

Restless Leg Syndrome affects roughly 1 in 10 adults in the U.S., yet it remains under-recognized. Patients often describe the sensation as a painful, tingling feeling “like Coca-Cola flowing through your veins” that worsens at night and disrupts sleep. Relief typically comes only through movement, leading to chronic sleep-onset insomnia.

For years, treatment has relied almost entirely on dopaminergic drugs. However, several of these medications have been removed from standard-of-care guidelines because of side effects and long-term risks. That gap left millions of patients with few options until Noctrix Health introduced a non-pharmaceutical alternative.

The Nidra Device and How Patients Use It

Nidra is a wearable neurostimulator that delivers mild electrical stimulation to the peroneal nerves in both legs, reducing the uncomfortable sensations that prevent sleep. Patients typically use it right before bedtime and can fall asleep with the therapy active, as the stimulation is generally non-disruptive.

The device’s design also supports on-demand use throughout the day, for example, during long car rides or flights when symptoms flare. As a wearable therapy, it puts control directly in patients’ hands, giving them immediate access to relief when they need it most.

Commercial Growth and Clinical Validation

Noctrix Health has grown to a team of about 100 employees, with headquarters in San Francisco and an engineering office in Pittsburgh. The company is now fully commercial, with more than a year in the market.

Key milestones include obtaining reimbursement codes and payment approval, as well as inclusion in the American Academy of Sleep Medicine’s standard-of-care guidelines. These achievements signal strong clinical credibility and make therapy access easier for patients and providers.

Building a Digital Ecosystem That Serves the Patient

Shri emphasized that in the digital era, companies must take charge of their narrative. Many RLS patients are highly proactive, searching online for solutions and joining forums to discuss their experiences. In fact, some discover Nidra through the company’s website and print information sheets, and then bring them to their doctors to request the device.

Rather than build its own sleep tracker, Shri plans to partner with established wearable brands such as Oura, Fitbit, or Apple to correlate therapy data with objective sleep metrics. Patients are already integrating these tools on their own, sharing improved sleep scores as tangible proof of progress.

Measuring Outcomes in a Condition Without Biomarkers

Unlike other chronic conditions, RLS lacks clear objective biomarkers to measure treatment success. To address this, Shri’s team is conducting one of the largest real-world evidence studies in RLS, enrolling more than 330 patients. The study uses standardized patient-reported outcomes, including sleep quality, depression, and insomnia indices, to capture meaningful improvements.

For patients who have gone years without sleeping well, even 4 to 6 hours of restful sleep can transform daily functioning and mental health. Shri also highlighted the growing phenomenon of Ortho-somnia, the anxiety of tracking sleep metrics too closely, and cautioned that, for RLS patients, progress should be measured by real rest, not perfect numbers.

The Hard Road to Reimbursement

Shri was candid about the challenges of navigating reimbursement pathways for new digital and therapeutic technologies. His advice: there are no shortcuts. Success depends on rigorous clinical evidence, randomized controlled trials, peer-reviewed publications, and inclusion in guideline reviews.

He also stressed the importance of staying current with CMS and payer policies around remote monitoring and digital health reimbursement. Innovators must align their strategies with the latest frameworks to avoid building models that regulatory changes may later undercut.

Focusing Resources and Partnering Wisely

Reflecting on the company’s journey, Shri underscored the importance of knowing what to build in-house and what to outsource. Noctrix concentrated its internal talent on core device engineering and firmware, while partnering with specialists for user interfaces and app development. This approach allowed the company to deliver a high-quality digital experience without diluting focus or resources.

He cautioned against the “one big app” mindset, advocating instead for small, iterative releases that evolve with patient feedback. This flexible, modular approach prevents digital distraction and keeps the focus on patient outcomes.

Convergence Across Pharma, MedTech, and Digital Health

At LSX, Shri observed how discussions around reimbursement, outcomes, and digital integration now span both pharma and medtech tracks. The boundaries between these industries are rapidly dissolving. For Noctrix, operating in a pharma-defined market meant mirroring pharmaceutical rigor, replicating the clinical trials and evidence standards used for RLS drug therapies. Shri believes more device companies should adopt this approach when entering established therapeutic spaces.

Takeaways for MedTech Leaders

Shri’s perspective offers a blueprint for building modern MedTech companies:

• Define your digital ecosystem early so patients and clinicians can find accurate, helpful information.
• Instrument your therapy with just enough connectivity to support adherence, service, and insight.
• Prioritize clinical validation and evidence generation before seeking reimbursement.
• Stay informed on policy and regulatory trends that can shape your business model.
• Focus internal resources on proprietary strengths and partner with external experts when external expertise can accelerate progress.

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