ZETROZ SYSTEMS LLC — Department of Health and Human Services SBIR Phase II: NIMHD

Description

DESCRIPTION provided by applicant Osteoarthritis OA is a degenerative disease of the joints which affects million Americans causing chronic pain limited mobility and overall reduction in the quality of life Americans with OA currently manage their symptoms through lifestyle changes weight loss exercise etc physiotherapy and medications to reduce pain and inflammation Although OA affects individuals from all races and backgrounds minorities and individuals lacking access to quality healthcare experience more negative outcomes and worse disease progressions including severe pain and working limitations Therapeutic ultrasound has shown promise as a non pharmaceutical treatment for OA but limitations on the accessibility cost and length of treatment have prevented therapeutic ultrasound from becoming widespread The investigative team proposes to develop a portable wearable self applied ultrasound device to deliver multi hour Sustained Acoustic Medicine for OsteoArthritis SAMOA The teams Phase I proposal demonstrated that the SAMOA device could be engineered for daily therapeutic self application by the participants at home and that SAMOA significantly reduced the pain of knee OA over the placebo device This Phase II project further develops SAMOA and moves towards commercialization of the technology for the symptomatic management of OA First the SAMOA device will be engineered for improved ergonomic function in the arthritic community ensuring that all user interface elements are streamlined for those who may have reduced manual strength or dexterity Second the device will be evaluated in a larger clinical trial providing a statistical demonstration of the treatmentandapos s benefit across minority groups which will be essential for regulatory approval and acceptance in the medical community Third the SAMOA device will be tested in the field for a real world evaluation of how physicians prescribe and patients adopt and interact with the device providing a critical final test of the system The SAMOA medical device will have a cost under $ to purchase and under $ per month to operate making it broadly accessible and less costly to operate for year than months of many prescription medications After the successful completion of Phase II SAMOA technology will have the potential to be adopted as a pharmaceutical free alternative to traditional OA care Furthermore the ease of use and low cost of this device will make it accessible to minorities and underserved communities reducing disparities in healthcare across America PUBLIC HEALTH RELEVANCE The proposed work is relevant to the symptomatic management of osteoarthritis OA which impacts over million Americans This research seeks to improve the care of osteoarthritis for minorities non minorities and patients with healt disparities by developing a novel non pharmaceutical long duration therapeutic ultrasound device for the treatment of chronic OA pain The technology has been preliminarily tested with positive results and now will be refined for general use by the arthritic patient and clinically evaluated as a drug free approach to OA care