unSpoken™ is a 60 day, prescription gynecological treatment for at home use, in female patients 22 years of age and older.
This first in class, multi-dimensional, non invasive, non hormonal, stand-alone treatment is for an International Classification of Diseases indication. Due to ongoing business development and pre-launch planning the specific gynecological indication is not disclosed herein.
However, in basic terms, unSpoken™ is a dual mechanism gynecological treatment that integrates tangible components with interactive digital technology.
Anu-Soma’s participatory therapeutics are educative, introspective and actionable. Our Rx medical therapeutics are coupled with digital technology. unSpoken™ is a medical treatment it is not telehealth, not a virtual counselor, and is not health coaching.
The unSpoken™ multi-dimensional treatment combines tangible components with digital technology. This Rx therapeutic is packaged as a kit and is provided to the patient in a small box that is approximately 8” wide x 2.5” high and 4” depth. This kit is shipped directly to the patient’s home or is provided from the medical practitioner’s venue for the patient to take home.
This unSpoken™ digital technology based treatment is regulated through the FDA – CDRH division via the 510(k) class II pathway. The neurobehavioral component is termed software as a medical device (SaMD). The software architecture is developed in the United States, under ISO 13485 standards.
The tangible components are manufactured in the United States in accordance with cGMP guidelines. unSpoken™ is effectuated with HIPPA compliant applications and workforce utilization.
Note: this web page provides a brief overview of the unSpoken™ Rx product. A more in-depth business to business dialogue is conducted via private communications. May 2024.
How we think (cognition), feel (emotion) and act (behavior) are inseparable.
unSpoken™ is offered exclusively by Anu-Soma Healthcare 2023-24.