It’s been a busy few months at Sana! Our intention is to provide regular updates to you all on what we are doing and the progress we are making.
Feel free to write with any questions.
The FDA have been enormously helpful and we have now met twice to map out our intended path to approval. Clearly the approval depends on our trial data and we are optimistic that we will be able to get a first approval by late 2019.
We have now completed our first major double blind trial at PRA, a major Clinical research site in Salt Lake City. The results were extremely positive, showing marked reductions in pain, anxiety, and opioid withdrawal symptoms. This trial was in Opioid Use Disorder (OUD) patients, as we wanted to see how much we could help people with the severest of symptoms in a number of areas. Next, we are studying Fibromyalgia this month, and then commencing a major registration study in chronic pain before the summer.
Thanks are due to our Clinical team and all the collaborators, and patients, who made these trials possible.
Our device is now validated and we are building in significant numbers for clinical trial supply. To go from the prototype to a reproducible unit has been a herculean team effort but our designers were amazing, and our engineers worked wonders.
Right now our focus is on building devices and studying them thoroughly to get FDA approval. Once that is achieved, we will be looking at marketing to ensure that the most people possible can get to use the device.
Passion for delivery
You can probably feel from our website that we share a passion. We are in delivery mode right now, please be patient as we get the data we need for our launch. Feel free to register for a device now as soon as we are approved.
All the best,
The Team at Sana
What will the device cost?
We have not yet set a price but our aim is to provide the lowest price possible to cover production and allow as many people as possible to use our device..
How many people work at Sana?
We like to think of ourselves as small, but we punch above our weight! We have a team of 8 full time staff and a great network of partners who support us.
Why are you focusing on OUD and pain?
We are looking at the areas where we can provide the biggest impact as soon as possible. We are then looking at several other areas including anxiety, mood disorders, sleep and cognition.
Why has it taken so long to get this far?
We have had to wait for the technology to catch up with Richard’s original hypotheses. It’s only quite recently that some of the supporting technology is available at scale.