Key Points
- SPIRE is a neuromodulation company developing therapeutic ultrasound for depression and chronic pain.
- The company is now conducting clinical trials with its innovative neuromodulation device called DIADEM.
Low-intensity focused ultrasound (LIFU) is proving to be a safe and effective method for modulating the deep brain in humans. Headquartered in Salt Lake City, Utah, SPIRE is a neuromodulation company dedicated to developing therapeutic ultrasound technology for treatment-resistant depression and treatment-resistant chronic pain. SPIRE has designed, built, developed – and is now conducting clinical trials – with an innovative neuromodulation device called DIADEM. Founders Jan Kubanek, PhD, and Tom Riis, PhD, seek to provide the device at a large scale to patients with treatment-resistant chronic pain and depression We recently interviewed Dr. Kubanek to learn more.
How many years has your treatment platform or products been in development, and what are its origins?
Following four years of research, the team developed a LIFU device, DIADEM, which overcomes the key barrier for transcranial ultrasound: the human head and hair.
What are some of the technical challenges your group had to overcome?
Clinical translation of LIFU neuromodulation has been challenging because the human skull severely distorts ultrasound. DIADEM’s correction method, which was published in Nature Communications Engineering, has been instrumental to realizing the significant neuromodulation effects we are now seeing in human subjects.
What challenges do you have to tackle moving forward?
A current challenge is to eliminate the MRI-based guidance to maximize the spectrum of beneficiaries.
What are the benefits of your technology over companies?
DIADEM technology is unique in that it provides controlled, effective, and safe ultrasound intensity delivered into specified deep brain targets. The delivery of an effective and safe dose has been a key challenge for alternative approaches and transducers.
Have you learned any lessons for watching the experience of the other companies?
Market size and reimbursement are crucial factors that a successful company must consider carefully.
Do you partner with other companies or research teams?
SPIRE will partner with anyone who can accelerate the advancement of this technology in patients with chronic pain and depression.
Which health conditions or diseases will your technology be used for? Tell us about your clinical studies and the results.
- Treatment-resistant depression: Initial results were published in IEEE Transactions in Biomedical Engineering
(TBME).A follow-up clinical trial enrolled 20 participants, and its results are pending publication. - Essential tremor neuromodulation: Initial results were published in the Journal of Neural Engineering.
- Treatment-resistant chronic pain: A clinical trial enrolled 23 people, and its results are pending publication.
Is there anything else we should know about your company?
We have the unique opportunity to help millions of people with chronic pain and depression, people who are currently out of options. These two conditions underlie some of the most pressing issues of humankind: addiction, homelessness, and incarceration. With a device such as DIADEM, there is now a practical approach to make a difference. It can be done and will be done.
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