Lionheart HTM OUS Export Products
(Available Only for Investigational Use in the USA)
Lionheart HTM Products
Available for Sale OUS (Investigational Use Only in the USA with IRB Approval and Patient Consent)
Lionheart HTM MedSpa and Sports Medicine Physio Therapy Products are of the highest quality. Manufactured for Lionheart Health, Inc. by High Tech Medical (HTM) Electronics Brazil (Est. 1999). HTM Electronics sells over $127 million of these products annually OUS primarily in Brazil as a leading high quality manufacturer. The Lionheart Health, Inc. patented bioelectric signaling sequences improve the performance results with many of the HTM products as confirmed in pre-clinical and clinical testing. Lionheart Health, Inc. is sponsoring the registration of these products with the FDA via 510K filings and Cosmetic Regulations. In certain circumstances they may be available now in the USA for low risk (Non-Significant Risk – FDA guidance link here https://www.fda.gov/media/75459/download) clinical evaluations or studies for skin, hair, body toning with proper IRB approval in place and patient consent properly followed.