4 days ago 4

ActiveProtective Receives FDA Marketing Authorization for the Tango Belt, a Breakthrough-Designated Wearable Device for the Prevention of Fall-Induced Hip Fractures in Older Adults

, /PRNewswire/ -- ActiveProtective^® (APT) is proud to announce the launch of Tango^® Belt, a wearable medical device utilizing sensors to monitor motion and deploy airbags during serious hip-impacting falls. The Tango Belt, having already received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), was further granted marketing authorization as a prescription-only device intended as an adjunctive to standard-of-care to reduce the risk of hip fracture or hip dislocation due to falls in older adults at risk of major hip injury due to falls (DEN240021).

When used alongside standard-of-care in a multicenter premarket clinical study, the Tango Belt demonstrated paradigm-shifting outcomes, achieving a 91% reduction in fall-induced hip fractures in at-risk older adults as compared to the standard of care alone.

"Today marks a crucial step forward in addressing fall-induced hip fractures, a devastating injury that impacts countless lives of older adults every year," stated ActiveProtective's CEO, Wamis Singhatat. "With the FDA's marketing authorization and Breakthrough Device Designation of the Tango Belt, we are proud to introduce an innovation that sets a new standard for safer mobility and fall injury mitigation for at-risk older adults. This is the culmination of over a decade of unwavering dedication by our team of developers and clinicians. We are grateful to our partners and investors for making this vision a reality."

The Tango Belt can be comfortably worn day and night, and when used with its companion mobile app, automatically alerts family and care staff when a fall or impact is detected. The mobile app's easy-to-read dashboard displays key metrics including balance confidence and adherence.

APT is now seeking interested senior living owner/operators, healthcare systems and providers, particularly those in Value-Based Care models that proactively "screen and intervene" to mitigate risk and avoid costly episodes of care.

About ActiveProtective

Active Protective Technologies Inc. (APT) is a medical device company developing connected health products that enable older adults to safely age in place. APT's mission is to redefine the standard of care for preventing fall injuries in at-risk older adults, and its initial focus is on hip fractures, a leading cause of disability and death. The company's clinically proven device, the Tango Belt, reduces the risk of major hip injuries due to falls, allowing older adults to achieve safer mobility and maintain independence. For more information visit www.TangoBelt.com.

Prior to use, please refer to the instructions for use supplied with the device for indications, contraindications, warnings and precautions.

For inquiries, please contact:
Email: [email protected]
Phone: (215) 399-9763

SOURCE ActiveProtective