Our current bench top stimulator produced in Anaheim, California has FDA 510K K113017 Download Here
Full market clearance and CE Mark for indications of use of improving blood circulation, pain relief, improving muscle motion, arthritis treatment and joint recovery. This FDA 510K market clearance is applicable to these startups in our 2020 portfolio…AortaCell, Vascustim, PressureStim, CerebraCell, TremorStim, Second Brain, MemoryStim, Stem Cell Bra, DentaCell, OrthodontiCell, SkinStim, MyoStim ED ErectiStim, HairCell, TestiStim, ImplantStim, EyeCell, PancreaCell, KidneyCell, OrthoStim, LiverCell, EarCell, BladderCell, InStim, RegenaLung primarily based on the improving blood circulation FDA cleared indication of use and in some cases also pain relief.
PRF centrifuges and kits, adipose tissue processing kits plus devices, exosomes and regenerative fluid from amniotic sourcing all have FDA clearances for U.S. sales or research use at this time following specific labelling requirements.
Nearly all regenerative and healing product pipelines in our 2020 portfolio are divided into three related product developments following this pattern using HairCell as an example.
HairCell TM – bioelectric non-invasive treatment alone (FDA 510K)
HairCell Plus Lite TM – bioelectric + PRF and either amnio fluid or exosomes and sometimes adipose tissue derived components (FDA 510K plus lab blood bank certifications)
HairCell Plus TM – bioelectric + full stem cell and biologics composition up to fifteen components (requires BLA approval).
Both HairCell TM and HairCell Plus Lite TM may legally be commercially available now in the USA under current FDA clearances for improving blood circulation, PRF and regenerative fluid produced in certified laboratories. HairCell Plus TM bioelectric + full biologics including stem cells will require a Biologics License Approval (BLA) based on results from a well controlled pivotal study usually with > 125 treated patients and 6 to 12 months followup.
Nearly all startups in our portfolio follow this same pattern ie; MyoStim ED ErectiStim TM bioelectric only mild to moderate ED treatment, ErectiStim Plus Lite TM bioelectric + PRF and regenerative fluid for moderate to severe ED treatment, ErectiStim Plus TM bioelectric + stem cells and full biologics mix for severe advanced ED treatment. SkinStim TM bioelectric only skin treatment for mild skin regeneration, SkinStim Plus Lite TM bioelectric + PRF and regenerative fluid for moderate skin regeneration, SkinStim Plus TM bioelectric + stem cells and full biologics mix for advanced skin regeneration.
Product developments may also be further categorized as (1) non-invasive, (2) minimally invasive and (3) invasive. Non-invasive treatments are usually under FDA 510K pre-market notification clearance. Minimally invasive treatments can be covered under a combination of a FDA 510K and lab certifications while fully invasive treatment products usually require a full FDA PMA or BLA.