Operating theory
Studies of the influence of electromagnetic fields (EMF) on living organisms have been conducted since the middle of the last century. Thus, it has been established that EMFs can affect biochemical reactions and the behaviour of charged molecules near membranes (Barnes, 1992), namely: create electric fields in conductors, exert a force on moving charge carriers, change the diffusion rate through membranes, distort bond angles, which affects the binding of proteins and the synthesis of macromolecules, etc.
Research in the field of molecular biology has made it possible to establish the presence of endogenous bioelectric signals, as well as to determine their sources and influence on embryogenesis, regeneration and neoplasms. Ionic fluxes and voltage gradients generated by ion channels and pumps are key regulators of cell proliferation, migration, and differentiation (Levin, 2003). Closed channels have movable folds in proteins that can alternately be open, allowing ions to pass through the channel, or closed, preventing ions from passing through the channel (Sherwood et al., 2005).
The uneven distribution of several key ions (Na+, Cl-, K+) between the intracellular and extracellular fluids and their selective movement across the plasma membrane determines the electrical properties of the membrane (Panagopoulos et al., 2002; Pall, 2013). All plasma membranes have a membrane potential; therefore, the membrane potential (Vmem) leads to charge separation across the membrane (Sherwood et al., 2005). Every time the Vmem value differs from 0 mV, in the positive or negative direction, the membrane is in a state of polarization. The magnitude of the polarization potential is directly proportional to the number of positive and negative charges separated by the membrane. In other words, changes in Vmem cause changes in the movement of ions across the membrane. Trigger events, such as exposure to an exogenous electromagnetic field (EMF), whose frequencies resonate with endogenous EMF, also cause changes in membrane permeability (Funk et al., 2009). Changes in membrane potential, among other things, regulate the proliferation of progenitor cells, stem cells and regenerative systems (Sarah Sundelacruz et al., 2009), as well as the efficiency of cytotoxic T lymphocytes (Jesse A et.al, 2019).
Other studies have shown that voltage gradients were not just membrane potentials, but specific signals for key metabolic processes in regenerative wound healing (Hotary and Robinson, 1992; Levin, 2007; Nuccitelli, 2003). These signals determine the migration path of cells, forming voltage gradients between the intracellular and extracellular environment (Funk and Monsees, 2006). Voltage gradients are localized DC electric fields that turn on and off at different stages of development (McGaig et al., 2005). They spread into the extracellular space, as well as into the cytoplasm of one or more cells connected by gap junctions (Funk et al., 2009). These gradients can penetrate the cell membrane, into the cytoplasm, and even the membrane of the cell nucleus through signal transmission, while the EMF signal is received through receptors on the cell surface, and then processed by G-proteins that bind the receptors to effectors such as ion channels (Ermakov et al. others, 2012). It is known that these signalling processes have a correlation between the presence of EMF gradients and the cellular response (Funk and Monsees, 2006; Sundelacruz et al., 2013).
In the process of technical implementation of the BIOL device, these particular features were taken into account and the frequencies of the meter and decimeter wave ranges were selected.
Back in 1993 (Adey et al.) It was found that a sinusoidal waveform, which creates coherent fields, has a stimulating effect on the immune system. For this, repetitive signals must be generated regularly and must be present for a certain minimum period of time (Litovitz et al., 1993). This resonant coherence is the key to producing larger effects with low thresholds (Panagopoulos et al., 2002). Our studies have shown that a triangular waveform is more efficient than a sinusoidal one due to the uniform distribution of the carrier frequency over the spectrum. Therefore, it is this waveform that is used in BIOL. Depending on the EMF parameters (“what field we are treating”) and the target biological process (“what we are treating”), either stimulation/activation of biochemical processes or inhibition/suppression can occur. And given the effect of EMF on biochemical reactions and the behaviour of charged molecules near cell membranes, the increase in the effectiveness of the drugs used in combination with the treatment with the BIOL apparatus becomes explainable (noted in practice). By changing the permeability of the cell membrane using EMF, we increase the possibility of the formation of an immunological synapse between an infected or oncological cell and cytotoxic T-lymphocytes, which allows the latter to efficiently release perforins1 and granzymes2 into the affected cells. Perforin molecules are incorporated into cell membranes and form pores through which granzymes enter the cell, stimulating the death of affected cells (along the path of regulated apoptosis - the process of programmed cell death).
Initially, the biological activity of the radiation of the medical device BIOL was tested at the Department of Genetics and Cytology of the Kharkiv National University. V.N. Karazin on the cytobiophysical method (2008). The effect of EMF on buccal epithelial cells in vitro was studied at different exposure times on donors. The normalizing effect on the bioenergetic properties of the cell nuclei of native human epithelial cells was reliably established, which made it possible to draw conclusions about the healing effect of EMF radiation.
The BIOL device was clinically tested at the Kyiv Regional Hospital No. 2 (2009) for patients aged 17-94 with the following diseases: intercostal neuralgia, osteochondrosis, rhinolaryngitis, rhinosinusitis, osteoarthritis, rhinitis. The results showed an improvement in physical condition in 80% of patients (a 40% decrease in pain syndrome and a 20% decrease in clinical manifestations of upper respiratory tract diseases) and in 20% no changes in the course of the disease were observed.
In 2009, for 128 patients of the sanatorium "Ukraine" (Simferopol, Crimea), the BIOL device was used as part of the complex therapy of hypertension of the II-III degree (of which, with a concomitant diagnosis of chronic ischemic heart disease (CHD), angina pectoris - 125, conditions after arriving cerebral circulation disorders - 3). A reliable therapeutic effect was obtained, confirmed by hemodynamic parameters and laboratory studies. More than 50% of patients noted a significant improvement in well-being, a decrease in the number of angina attacks and an increase in the action of nitrates (cardiket, nitroglycerin, isoket).
In 2011, in several research centres in Europe, the BIOL device was used for patients with the following diseases (21): prostate adenoma, breast cancer (with and without metastases), lung and colon tumours (adenocarcinoma), and squamous cell carcinoma of the larynx. All patients noted an improvement in the quality of life and a significant reduction in pain. In 4 patients, the state of the tumour remained unchanged (did not improve but did not worsen). The remaining 17 patients showed a decrease in tumours by an average of 15% (10-18%), and in patients with metastases, a decrease in the degree of metastasis (in one of the patients, metastases disappeared).
In 2017-2018, BIOL was used in Taiwan for 3 patients with nasopharyngeal carcinoma, ankylosing spondylitis and colorectal cancer. After a year, all patients showed regression of the disease (according to CT data) and an improvement in the quality of life.
Note 1: Activated killer T cells kill cells with a foreign antigen, to which they have a receptor, by inserting perforins (proteins that form a wide, non-closing opening in the membrane) into their membranes and injecting toxins (granzymes) inside.
Note 2: Granzymes are serine proteases released by cytoplasmic granules of cytotoxic T cells and natural killer (NK) cells. They induce programmed cell death (apoptosis) in the target cell, thereby eliminating cells that have become cancerous or infected with viruses or bacteria. Granzymes also kill bacteria and inhibit viral replication. In NK cells and T cells, granzymes are packed in cytotoxic granules with perforin.
