What is the Vascustim treatment protocol?
It depends on the country you are in due to regulatory constraints and compliance requirements. In the USA the Vascustim treatment protocol is restricted to delivery of bioelectric stimulation signals that fall within the range authorized under the current 510K market clearance and the use of amniotic fluid filled membranes available under the FDA homologous exemption rules. In other countries where permitted we utilize a broader range of bioelectric signals and add repeat delivery of adipose tissued or bone marrow derived stem cells and selected growth factors, exosomes, Micro RNAs, platelet rich plasma, nutrient hydrogel and alkaloids.
What is the Vascustim mechanism of action?
Our patented and patent pending precise bioelectric signals with precise sequence control the release of VEGF, PDGF, SDF-1, eNOS, HGF and HIF 1 alpha all known from previous stand alone studies to promote new blood vessel formation thus improving circulation. eNOS serves to dilate existing blood vessels to a larger inner diameter promoting better blood flow. SDF-1 is stem cell homing signal the contributes to injury and wound repair. By placing the + positive anode of the stimulation leads on one side of a wound and the – negative on the other side the device can create current flow across the wound which has been demonstrated to accelerated healing and reduce risk of infection in previous studies. In countries where it is permitted the addition of repeat injections of stem cells and growth factors has been found to contribute to improving blood flow and healing in previous studies. Sequence control is important as it has been demonstrated VEGF alone creates leaky (due to porous immature walls) new blood vessels but when followed by SDF-1 stimulation these blood vessels become more mature with true endothelium linings, a larger inner diameter with greater flow without leaking.
See the Related Scientific Articles section of this web site for links to previous study references.
What is the regulatory status of Vascustim?
In the USA our electrical stimulation device has 510K market clearance for improving blood circulation, improving muscle function and recovery and mild pain relief. Amniotic fluid filled membranes as wound dressings are available in the USA and FDA’s homologous exemption. Outside of the USA autologous stem cells and growth factors may be added to the treatment protocol where permitted by law. Vascustim provides point of care lab kits to harvest these stem cells and growth factors from a person’s own fat (adipose) tissue or bone marrow.
What is the reimbursement from CMS and insurance for Vascustim?
We are preparing a complete reimbursement manual which will soon be published on our web site. Reimbursement cods are available for wound healing, pain relief, improving blood circulation, muscle function recovery and when sufficiently proven for by-pass (in this case biological bypass as a substitute to standard surgical vein bypass from the thigh to the foot).