When Unity Stoakes recently caught up with long-time StartUp Health community member Richard Hanbury of Sana Health, the conversation started the way so many founder stories do: a real-world moment that demanded calm under pressure. Hanbury had just navigated a winter backcountry emergency in Yellowstone with his nine-year-old, relying on satellite connectivity to call for help. He laughed about it, but the point landed: entrepreneurship is its own form of weather, constantly shifting, forcing you to act with the information you have.

That mindset has defined Sana Health’s path to this moment.

Recently, Sana Health received a Health Canada medical device license for its audiovisual neuromodulation approach in neuropathic pain, which Hanbury described as the first regulatory approval of its kind for this modality. 

Sana has also just received a neuropathic pain De Novo grant from the US Food and Drug Administration. While the device is not yet FDA-approved for any specific indication, this moment represents a major inflection point after years of clinical development and regulatory groundwork.

Getting here required a fundamental shift in how Sana approached validation. As Hanbury put it, “credibility is not a bar when it comes to data and medical proof. It’s a ladder.” Hanbury’s advice to other entrepreneurs: You cannot jump rungs. “If you try to jump the ladder, it doesn’t work.” Innovators need to start with “the cheapest, simplest data you can get,” then climb methodically, gaining better and better data, until the company earns the right gain grants and proceeds to larger randomized trials and regulatory review.

Neuropathic pain represents both an enormous unmet need and a strategic proving ground. Hanbury pointed to gabapentinoids like gabapentin and pregabalin as the current standard of care, noting that “90% of people who take gabapentinoids are not taking them at the two-year mark because of the side effects.” When those medications fail, options narrow quickly. “That just leaves opioids,” he said, “and we all know where that road leads.”

Sana is positioned as an adjunct, non-pharmacologic option designed to reduce pharmacologic need and symptom burden without adding new side effects. In the pivotal data submitted to the FDA, the data showed a 78% reduction in gabapentenoids in the active group. 

Success in neuropathic pain, Hanbury emphasized, is not just about one indication. It is about establishing the level of clinical and regulatory credibility needed to unlock broader adoption across mental health and pain care.

Sana’s approach centers on audiovisual neuromodulation, using carefully designed pulses of light and sound to influence brain activity patterns associated with relaxation, recovery, and reduced pain perception. 

The origin of the technology is deeply personal. After surviving severe injury, nerve damage, and PTSD, Hanbury found that traditional meditation heightened his awareness of pain rather than relieving it. What helped instead were moments of deep immersion, when his brain entered a flow state and pain receded.

That insight became the foundation of Sana: recreating those brain patterns through external stimulus rather than willpower alone. Most long-term use happens at night, often as part of a sleep routine, because, as Hanbury explained, “sleep probably underlies the clinical benefit across the board.” As sleep improves, pain, anxiety, and mood often improve together. “Chronic pain is essentially a mental health problem,” he said, shaped by whether the nervous system is stuck in fight-or-flight or able to return to rest-and-recovery.

Alongside pain, Sana has built significant momentum in PTSD research, including support from the US Department of Defense and trials conducted within the VA system. Hanbury was candid about the limitations of today’s standard PTSD treatments, describing gold-standard care as deeply challenging for patients. “It’s prolonged exposure,” he said. “You’ve had trauma, so sit and talk to me about your trauma until it’s less traumatizing.”

In early pilot studies, Sana combined with standard care delivered markedly stronger outcomes than standard care alone. “When we combined the device with standard care, we saw three times the improvement compared to standard care alone,” Hanbury shared. 

That work is now expanding internationally. In Israel, Sana has launched a study focused on combat-injured veterans experiencing both PTSD and chronic pain, one of the most complex populations to treat. Early results have already crossed thresholds considered clinically meaningful, suggesting that international adoption could move faster than US reimbursement pathways.

Sana Health is now focused on bridging into early commercial traction, a pivotal moment after years of validation. Hanbury was candid that additional capital is needed to reach that milestone, particularly in a market where early-stage funding can be constrained while later-stage commercial capital becomes available once revenue is established.

Equally important are partnerships with organizations building end-to-end, at-home pain and mental health platforms. Sana is designed to plug into multimodal models of care rather than attempting to own the entire experience. Looking ahead, Hanbury believes “the health system won’t be able to bear the cost unless pain and mental healthcare move to multimodal care,” combining neuromodulation, software-enabled therapy, and medication when appropriate.

Throughout the journey, Hanbury credits the strength of the StartUp Health community for helping sustain momentum and providing critical support at every rung of the ladder. As Sana Health advances FDA review, expands global research, and moves closer to commercialization, that community foundation remains central to proving that scalable, human-centered care can fundamentally change how pain and mental health are treated worldwide.