Science
Regulatory Position & Clinical Development
Lionheart Health is developing additional applications of the Lionheart 240 Stimulus through its IRB-approved Lionheart Klotho Wellness Protocol, covering muscle, brain, immune, gut, vision, sexual vitality, joint, skin and hair/scalp wellness. The protocol combines bioelectric stimulation with diet, exercise, supplements and other specified modalities to evaluate safety and clinical outcomes.
The company’s regulatory strategy builds on the Sys*Stim 240 platform’s FDA 510(k) clearance, K113017. Lionheart’s research explores whether the cleared physiological effects, within multimodal protocols, can support additional wellness and therapeutic outcomes.
The company relies on the FDA-cleared indication of improving local circulation as a cornerstone for improvements in wellness of specific target organs. Muscle recovery is also a major contributor for specific organs targeted for wellness improvement, including muscles surrounding joints, facial cheek muscles, hair scalp muscles and within sexual organs, including improvements of range of motion of those target muscles.
Cleared devices in the Lionheart platform
FDA 510(k) K113017
Lionheart 240 Stimulus (Sys*Stim 240 platform)
Includes increasing local blood circulation and, for specified waveform ranges, muscle re-education, prevention or retardation of disuse atrophy, maintenance or improvement of range of motion, and pain indications including arthritis and other inflammatory related pain.
FDA 510(k) K181955
Wiemspro EMS suit with the BodStim™ protocol program
Cleared for augmenting health benefits of exercise and building muscle in healthy subjects.
FDA cleared
Saebo stimulator (distributed by Lionheart Health)
Cleared for stroke recovery in addition to improving local circulation, pain and muscle recovery.
FDA 510(k) K141342
AxioBionics stimulators (distributed by Lionheart Health)
Cleared indications matching the 240.
Stimulation applications expressly listed in K141342
- TENS for pain relief (including inflammation as well as arthritis-related pain and also itchy sore tissues)
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation (covering a broad range of applications)
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postoperative calf stimulation to prevent venous thrombosis
- Functional electrical stimulation (covering a broad range of applications)
Commercialization strategy
Lionheart’s commercialization strategy is to maintain claims within applicable regulatory requirements, assess general-wellness eligibility for each specific product and use, and pursue additional FDA authorization where required. Clinical data will inform future submissions, with regulatory requirements, timing and outcomes remaining subject to FDA review.
Due diligence
FDA clearance letters, IRB documents, the investigators list, the regulatory compliance dashboard and SOPs are available as PDFs.