Dosage Information

Superior Extended Dosage

By placing the BioElectronics devices such as the human (ActiPatch) or the animal (HealFast) devices directly onto the injured tissue the microchip can deliver an equivalent dosage of a full size pulsed diathermy device.

The Bioelectromagnetics Research Laboratory, State University of New York has established that the BioElectronics Therapy is providing an equivalent and adequate dosage of electromagnetic energy for the treatment of soft tissue. ”ActiPatch Therapy emits a pulsed 1000 Hz signal that is propelled into the body on a 27 MHz frequency wave. These waves introduce an electromagnetic field into the affected tissue and creates a low frequency electrical current in the damaged tissue. Each pulse is 100 µsec in duration at a duty cycle of 10% (turned off for 900 µsec,). The induced electrical current affects the cells which have been traumatized and physically separated by intercellular fluids, precluding the individual cells in the tissue from communicating with one another. Electrotherapy’s induced electrical signal serves as a synchronization signal, allowing cells to reestablish communication and begin working as a tissue again and terminating the inflammatory response. Exposures in the extremely low frequency range (less than 3000 Hz) induced electric field levels of less than 10 microvolts/centimeter, corresponding to induced power levels less than 10-12 W/cm3, are sufficient to produce significant biological effects.

While much smaller energy levels are required to achieve a biological stimulation, the field intensities utilized by ActiPatch devices are still well above the threshold levels established by the NIH Working Group. Based on recent work focusing on establishing thresholds for continuous cell exposure, ActiPatch devices induce electric fields which are at least 10 times the threshold levels required to achieve a biological response.

Key points of evaluation:

Cumulative absorbed energy at the skin level is equivalent to traditional high power devices.
Effect of continuous delivery provides greater therapeutic benefit.
The BioElectronics therapy power level is 6 to 9 orders of magnitude higher than that which is required to show a biological effect.

Two key questions arise:

  • Is the reduced power of the ActiPatch compensated by the close proximity to the tissue and the longer treatment durations, and
  • Is the device delivering an efficacious therapeutic dose of electromagnetic energy to the tissues?

The answer to both of these questions is “Yes”. While the ActiPatch field intensity is 150 times less than the traditional devices, ActiPatch is used continuously, as compared to the relatively short treatments. An antibiotic analogy would possibly be that of a time released patch: a timed release distributes therapy throughout the day instead of in one or two doses. Total dose to the tissues is similar. In the same manner, therapeutic, efficacious PEMFs are induced in the tissues by the ActiPatch, resulting in increased capillary flow, edema reduction, and the other effects discussed.

The literature on PEMF effects shows that the ActiPatch power level is 6-9 orders of magnitude above the threshold for demonstrated cell and tissue effects in vitro. Required power density levels to achieve field-induced tissue effects are shown in the table below. PEMFs have been shown to influence cell behavior in in-vitro models wound healing, of morphological adaptation (cellular alignment in the induced electric field), and in vitro models of differentiation.

The ActiPatch affixes onto patient for a convenient 24-hour treatment, with an “overnight” suggested minimum treatment time. Therapeutic efficacy requires consideration of the treatment time difference factor. ActiPatch Therapy Device produces a 24 hour absorbed energy of 630 mJ/cc compared to traditional pulsed electromagnetic devices which produce a 15 minute absorbed energy in the range of 110 mJ/cc at the 1.5 watt power setting This suggests that a 6 to 8 hour ActiPatch Therapy treatment is well within the range of efficacy for soft tissue injuries.

ActiPatch™ Therapy power density at the skin surface is between 14 and 73 uW/cm². It is reasonable to assume that 10% of the incident energy is absorbed in the first centimeter of tissue depth, or maximum energy absorption of up to 7.3uW/cm3 in skin. While that absorbed power appears to be a very low exposure level, in fact, this level is well above the threshold levels necessary to ensure non-thermal biological responses from electromagnetic field exposures. To understand this statement it is important to note that non-thermal effects of electromagnetic field exposure are due to the induced electric field in the tissue and not the magnetic field. ActiPatch produces an induced electric field of typically 10 milliVolt/cm.

In a fibroblast/collagen wound healing model, field intensities as low as 30 uV/cm rms were sufficient to significantly reduce protein excretion by cells (consistent with a reduction in edema and scarring) for exposure durations of 12 hours (McLeod, et al. 1987). This field intensity corresponds to an induced power level of 10-11 Watts/cm3. More recently, investigations on other aspects of cell phenotypic expression related to the healing process, including differentiation, cell morphologic adaptation, and cell motility, suggest that even this very low exposure level can be further reduced by extending the exposure time. In a study on morphologic adaptation of cells to induced electromagnetic fields, 3.5 uV/cm rms electric fields were found to be sufficient to induce significant morphologic changes if the exposure times were extended to 24 hours, corresponding to induced power levels of 10-13 Watts/cm3 (Lee & McLeod, 2000). Moreover, a study on regulation of differentiation in mesenchymal cells, utilizing exposure durations of up to 64 hours, showed that cells were capable of responding to induced field intensities as low as 0.7 uV/cm rms, corresponding to induced power densities of 5×10-15 Watts/cm3 (McLeod & Collazo, 2000).

It is clear, therefore, that use of ActiPatch™ Therapy, resulting in adsorbed power levels in the range of 7.3 uW/cm3, provides field exposure levels at the target tissue that are five to nine orders of magnitude above the thresholds which have been established for non-thermal electromagnetically induced biological effects at the cell and tissue level. Second, these studies clearly demonstrate that progressively longer treatment durations are associated with progressively lower required field levels to obtain significant biological effects. That is, it is not the power level, per se, that is relevant, but the product of duration of exposure and power delivered to the tissue.

  • In vitro wound healing (McLeod, 1987)10-11 W/cm3
  • In vitro morphological adaptation (Lee and McLeod, 2000)10-13 W/cm3
  • In vitro differentiation (McLeod and Collazo, 2000)10-15 W/cm3

Conclusion
The peer-reviewed studies, from clinicians around the world, adequately address and substantiate the clinical evidence of the effectiveness of low power extended duration therapy and ActiPatch™ therapy, RecoveryRx, and Allay, menstrual cycle therapy.
Clinical Trials – Confirming Low Power and Extended Treatment Duration Clinical Studies

Included here are published clinical studies conducted at 27 MHz at a power at or below the traditional pulse electromagnetic short field therapy levels. The studies explored each of the key stages of healing inflammation, regeneration and remodeling in various medical specialties. Those studies demonstrated that ActiPatch, RecoveryRx, and Allay Menstrual Pain Therapy accelerated healing, reduced pain, swelling, and bruising, and increase the tensile strength of the wounds.