Rx only, Aging Medicine
WavePhysio™ uniquely blends personalized medical care into the patient’s everyday living through digital technology. This prescription therapeutic is a stand alone treatment for an un-addressed medical condition that imparts a substantial humanistic and economic disease burden.
WavePhysio™ has been developed for the youngest of the aging population (ages 65 through 77) to address the incipient and sub-clinical stage of a progressive disease. Addressing this incipient disease stage will subsequently limit the downstream functional decline and disability in this vulnerable patient group as they age.
Product Description: WavePhysio™ is a hand held non-invasive, physio-therapeutic device with a wireless interface. This devise is coupled with a digital treatment. This dual system is for at home use and provides the patients individual biometrics and usage to their medical practitioner. These personalized inputs establish objective data for evaluation, prognosis or the need to modify treatment. With the patient’s consent, a support person – caregiver may also monitor usage.
This multi-dimensional treatment (patient engagement) also integrates behavioral digital health technology. This digital component is available to the patient via desktop or mobile app 24/7; on an as needed basis. The at home cognitive behavioral engagement cultivates health capabilities and adaptive behavior rather than focusing on the patient’s medical condition. The personalized implementation and competency messaging of the digital component have been developed to limit the onset of comorbid affective symptomatology for the prescribed indication(s). Additionally, the educative constructs, context and aesthetic presentation of this engagement fortifies patient adoption, and retention of the patient’s primary medical management.
WavePhysio™ is a multi-dimensional therapeutic that cultivates multiple aspects of patient care to achieve optimal patient outcome.
WavePhysio™ expands healthcare access, provides convenient at home treatment, 24/7 availability, reduces barriers to care and healthcare inequities for this highly vulnerable patient group.
WavePhysio™ is shipped directly to the patient, or is provided directly from the medical practitioner’s office for the patient to take home.
This digital technology enhanced patient therapeutic (engagement) also provides cost efficient adjunctive care for several International Classification of Diseases prescribed indication(s). WavePhysio™ is applicable as an interdisciplinary, post care rehabilitation therapeutic for select indications.
WavePhysio™ is anticipated to enter the market quarter 1 of the year 2025. Due to ongoing product development the specific disease indication(s) is/are not disclosed herein.
As noted, WavePhysio™ has a tangible component that is integrated with digital technology. The tangible component, the physio-therapeutic device is manufactured in an FDA registered facility in the United States in accordance with ISO 13485 guidelines/processes.
Both the tangible component and digital treatment are regulated as one therapeutic through the FDA – CDRH division via the 510(k) class II pathway. This digital component is termed software as a medical device. The software architecture is developed in the United States, under ISO 13485 standards.
WavePhysio™ is effectuated with HIPPA compliant applications and workflow utilization.
WavePhysio™ is offered exclusively by Anu-Soma Healthcare USA 2024.
