Sana Health Founder on FDA Strategy
Richard Hanbury, founder of Sana Health, advised digital health founders to approach regulatory approval as a "ladder, not a bar" in a recent podcast. He recommends building credibility with smaller, less expensive data points before pursuing large-scale clinical trials. Hanbury's company is targeting the VA and international health systems to build a track record before seeking broader U.S. reimbursement.
- Sana Health's device has received a Breakthrough Device Designation from the FDA, a status given to technologies that could provide more effective treatment for life-threatening or irreversible diseases; this designation also helps expedite reimbursement upon final clearance. The company submitted its De Novo application for treating neuropathic pain in May 2024, with FDA approval anticipated by the second quarter of 2025. - The company's founder, Richard Hanbury, was motivated to create the device after a jeep crash in Yemen in 1992 resulted in a spinal cord injury and life-threatening chronic pain. He has spent over 25 years developing the technology, which uses audio-visual neuromodulation to relieve pain and anxiety. - Sana Health has raised a total of $107 million, including a $60 million Series B round co-led by Trust Ventures and Gigafund. The U.S. Department of Defense has also invested in the technology, granting the company $3.4 million to conduct a pivotal study on its effectiveness for PTSD, running through the first quarter of 2026. - For consumer health apps, data privacy is governed less by HIPAA and more by consumer protection laws and the FTC's Health Breach Notification Rule. HIPAA typically applies only to "covered entities" like doctors and health plans, not directly to most standalone wellness apps, meaning user data may not have the same legal protections as official medical records. - Successful consumer health apps like Noom and Calm often acquire users by offering valuable free features to build trust before upselling. Noom specifically leverages behavioral science to drive user engagement and retention, a strategy that has proven effective in the crowded wellness market. - AI algorithms are increasingly used in health apps to provide personalized care for chronic conditions by analyzing data from wearables to identify patterns between activity levels, sleep quality, and symptom flare-ups. Developers often prioritize integrating with wearables like Apple Watch, Fitbit, Garmin, Oura, and Whoop due to their reliable APIs and large user bases. - Venture capital investment in U.S. digital health startups reached $14.2 billion in 2025, the highest total since 2022. Companies focused on Artificial Intelligence attracted 54% of this funding, with an average deal size 19% larger than non-AI startups. - For founders transitioning from a technical role to CEO, data shows that prior CEO experience is not a prerequisite for success in health tech. A study of health tech companies found that 62% of CEOs who achieved a successful exit or significant revenue were first-time CEOs.
