Wearable Ultrasonic Device for Patient Self-Administered Treatment of Inflammation

The Ultran Group has developed a novel method to treat inflammation disorders by modulating the immune system using non-invasive focused ultrasound. This method delivers focused ultrasonic energy to a patient’s spleen causing a modulatory response in the immune system which reduces chronic or acute inflammation in the body. The SecondWave MINI 2.2R is a human-use clinical device which was developed for this purpose with funding from the DARPA SBIR program (Contract 140D0419C0092) and is currently being used in a first-in-human clinical study to treat rheumatoid arthritis (RA). Nearly complete, the study has demonstrated positive results, indicating a reduction in disease activity amongst the aggregated patient population. These results indicate feasibility for the device and therapy to treat inflammation disorders. However the MINI 2.2R requires a trained user to administer the therapy which is not practical for widespread use; RA patients will need to self-administer therapy at home and acute hyperinflammation (i.e. COVID-19 or sepsis) requires rapid ambulatory application. To close this gap and bring this therapy to the mainstream, further intelligence and an enhanced user interface is required for both patient at-home use and improved ambulatory administration. The proposed follow-on Phase II effort will build upon technology developed under the prior SBIR to include the necessary on-board intelligence for active spleen targeting. While the current MINI 2.2R provides feedback to the trained user for accurate device placement between the 9th and 10th ribs and above the spleen, the new MINI V3 device developed under this proposed effort will process detected data on-board and actively steer the ultrasonic beam between the patient’s ribs and at the spleen. Further, the MINI V3 device will incorporate motion detection for identification of a patient’s breathing cycle state using accelerometry data which has been directly correlated to the location of a patient’s ribs relative to the surface of their skin. This will allow for the MINI device to actively track and follow the spleen when it is routinely displaced due to inhalation, increasing dose delivery to the patient and potentially further improving efficacy. Ultran’s subsidiary, SecondWave Systems will conduct the pivotal study for FDA clearance and upon successful approval, will commercialize the device and therapy. The pivotal study will be funded by private sources through SecondWave’s Series A raise, which is currently underway and is being led by Johnson & Johnson, a worldwide medical device and pharmaceutical manufacturing company. This proposed effort to complete development of the pivotal device will have a critical and direct impact upon the effort to commercialize and distribute the MINI device and provide therapy to patients who suffer from inflammation disorders.