Sana Health’s 2024 Updates

The Department of Defense has granted Sana Health a $3.4 million grant to conduct a pivotal study on PTSD through the first quarter of 2026. This grant is part of a broader investment by the Department of Defense into Sana's technology, which also includes grants for pilot studies on Adjustment Disorder and Pain and Fatigue in military healthcare workers.

Sana Health has achieved significant clinical results, with their PTSD pilot study demonstrating statistical significance in PTSD, Anxiety, and Depression. This study was led by Dr. Ron Acierno at the Ralph H. Johnson VA Medical Center. Additionally, Sana Health’s Neuropathic Pain Pivotal study was run by Dr. David Putrino at Mount Sinai Hospital and is set to be submitted as a De Novo application to the FDA in May of 2024. 

With the De Novo timeline, Sana Health expects FDA approval between the end of 2024 and the second quarter of 2025, with expedited coding and coverage anticipated for Neuropathic Pain and PTSD due to their existing Breakthrough Device Designation.

Sana Health has initiated new key initiatives, including a pilot study in Pain and PTSD in collaboration with the Israeli Ministry of Health to be carried out in rehab clinics in Isreal this year, and an application for a $10M ARPA-H Launchpad grant for adolescent and young women's PTSD. 

In terms of financing, Sana Health is currently raising $3 million on an existing SAFE note to provide two years of runway, with plans for a Series B funding round post-FDA approval and post-VA commercial pilots.

Sana Health expresses gratitude for the support received and aims to fulfill their mission of addressing high unmet needs in healthcare, starting with Neuropathic Pain and PTSD, for a population of 35 million individuals in the U.S. alone. 

Investors, please click here to contact Sana Health’s CEO, Richard Hanbury. 

Hospitals and health plans please click here to contact Sana Health regarding future partnerships.

Interested in joining a future clinical trial with Sana Health? Please click here.

Sana Health Wins an Otto Award

We are honored to have won an Otto Award in the Health category - out of almost 1,000 applicants. The jury loved our origin story and mission.

The Otto Award is the world’s most valuable communications Award, celebrating companies’ ability to frame the mission of their startup in a way that makes it bigger, more surprising, more important, more shocking, more interesting, and more unavoidable. Cheers!

Sana Health wins 2022 Medical Innovation Challenge

Advanced Technology International (ATI), TechConnect and four medtech industry consortia today announced the seven winners of the 2022 Medical Innovation Challenge as well as an eighth winner from innovations created by students. Selected from a field of 25 finalists, winners were presented a total $250,000 in cash prizes at the Defense TechConnect (DTC) Innovation Summit & Expo, the nation's largest annual gathering of non-traditional, dual-use emerging technologies aligned with government priority requirements.

…Sana Health, Inc., Sandy, Utah: An neuro-modulation device that provides anxiety relief on demand by using audiovisual stimulation to increase the balance between the left and right sides of a patient’s brain.

Note: this contains future-looking statements. The Sana device is not currently approved for use for the treatment of medical conditions and should be used for the purposes of rest and recovery only, until such time as appropriate clinical evidence is approved through FDA processes.

Click here to read more about the challenge

SOCAP 2022 Panel Discussion

Sana Health’s CEO, Richard Hanbury, participated in a panel discussion at SOCAP 2022. This panel discussed what it means to be an early-stage company in the disability market, problems addressed by their products, why these solutions are designed to be additive to the overall tech market and why the disability market has tremendous potential to drive both profits and purpose, returning value to investors and society.

https://socapglobal.com/events/socap22/

The Sana device is not currently approved for use for treatment of medical conditions and should be used for the purposes of rest and recovery in healthy adults, until such time as appropriate clinical evidence is approved through FDA processes. Use of the Sana device for purposes other than enhanced rest and recovery in healthy adults is not approved or recommended.

Sana Health named finalist in UCSF Health Hub Digital Health Awards 2022

Sana Health is proud to announce that we were selected from hundreds of competing companies as a Rising Star Finalist in the New Telehealth Innovation category for a 2022 Digital Health Award. The Digital Health Awards honor outstanding health technologies and innovations dramatically transforming healthcare, so we are especially honored to be considered for this prestigious award. The Rising Star track is new this year, recognizing up-and-coming companies to watch in the digital health space. Join us for a conversation with the finalists, Wednesday 11/1 at 11 am PST on Zoom.

Read more here

Registration link: https://bit.ly/3CH0YuD #DHA2022

Product Prototypes to Combat Drug Craving Challenge First Place Winner Announced: Sana Health

The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), is announcing the “Product Prototypes to Combat Drug Craving” Challenge. The Challenge goal is to solicit working prototypes of multifaceted products that will help with drug craving in people who experience substance use problems or with substance use disorder (SUD). Ideally, these multifaceted product prototypes would combine several different tools or features to address drug craving, providing long-term, on-demand, and personalized comprehensive assistance that can ultimately reduce the likelihood of return to use (also known as recurrence). NIDA expects that the Challenge will inspire many different product prototypes to help people address their drug cravings and prevent recurrence of drug use.

First place prize of $50,000:

• Sana Health, Inc., Louisville, CO

• Submission Title: "The Sana Portable Neuromodulation Device for Reducing Anxiety and Drug Cravings"

Read about the challenge here

The Sana device is not currently approved for use for treatment of medical conditions and should be used for the purposes of rest and recovery in healthy adults, until such time as appropriate clinical evidence is approved through FDA processes. Use of the Sana device for purposes other than enhanced rest and recovery in healthy adults is not approved or recommended.

Another FDA Submission

Sana Health Receives FDA "Breakthrough Device Designation" for Sana Device

LAFAYETTE, CO March 31, 2021

Sana Health, a Colorado-based medical device startup, has received Breakthrough Device designation status from the Food and Drug Administration for the Sana device, a wearable mask that uses audiovisual stimulation to guide the user into deep states of relaxation.

The Sana Device is a self-directed, low burden solution that is effective in relieving many of the symptoms of Fibromyalgia that can be easily adapted to the needs and schedule of the patient.  The benefits of using the singular Sana device may allow Fibromyalgia patients to lower or discontinue partially ineffective drug treatments that include unwanted side effects as well as to consolidate their treatment plan to focus on the most effective additional interventions.

The FDA Breakthrough Device Program is intended to help patients receive access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will work with Sana Health in multiple ways, including priority review, interactive communication regarding device development, and commercialization decisions.

Contacts: Richard Hanbury, CEO, Tasha Bond, COO    

StartUp Health Studio Interview with Richard Hanbury

Richard Hanbury, CEO & Founder of Sana Health, is on a mission to redefine healthcare’s approach to chronic pain and mental health. Sana Health, which joined StartUp Health in 2020, has developed an audio-visual neuro-modulation wearable that produces anxiety relief on demand. The device can also be applied to other pain and mental health conditions where anxiety and sleep are components. The FDA has ratified Sana as a ‘Device of General Wellness’ and current studies on fibromyalgia are showing excellent results.

Note: this contains future-looking statements. The Sana device is not currently approved for use for the treatment of chronic pain conditions and should be used for the purposes of rest and recovery only, until such time as appropriate clinical evidence is approved through FDA processes.

Watch the interview here.

PAINWeek 21 Summary Show | Pain Pod

PAINWeek remains the US pain conference with the most expansive curriculum and is the favorite destination for frontline practitioners to enhance their competence in pain management.

Listen is as Public Health Pharmacist, Dr. Christina Madison, PharmD sits down with Sana Health CEO, Richard Hanbury, on the Pain Pod at The Cosmopolitan in Las Vegas to hear about Richard's story, the journey of Sana, pain management, and the Sana device.

Note: this contains future-looking statements. The Sana device is not currently approved for use for the treatment of chronic pain conditions and should be used for the purposes of rest and recovery only, until such time as appropriate clinical evidence is approved through FDA processes.

Click here to listen to the podcast.