scientific foundation

Our Therapeutic Method: A Patented Protocol for Diabetes and Insulin Resistance

Our innovative treatment protocol leverages established and contemporary principles of neuro-endocrinology to address the core metabolic dysfunctions of Type 2 Diabetes Mellitus (T2DM). The therapy utilizes a proprietary applicator and a unique neuro-physiologic waveform to counteract the three key physiological failures that characterize the disease:

1. Insulin Resistance: An insufficient response of cellular insulin receptors.
2. Beta Cell Dysfunction: The impaired ability of pancreatic beta cells to produce and secrete insulin.
3. Glucagon Dysregulation: The abnormal synthesis of glucagon, which is also heavily influenced by the autonomic nervous system (Ahren, 2000).

Our method, developed under U.S. Patent No. 8,457,745, directly targets these issues by modulating the body's neuro-physiologic network to restore cellular health. The therapy is designed to reduce the accumulation of glycoproteins in cell membranes and counteract the thickening of capillaries, thereby improving the cell's membrane potential and creating a better physiological environment for metabolic function (Garcia et al., 2013).

A Multi-Phase, Bilateral Treatment Protocol

The treatment is administered using a specialized applicator device that delivers our proprietary waveform to specific anatomical points. This approach is directly aligned with the current scientific understanding of the complex "brain-pancreas connectivity," a sophisticated neural network that is essential for maintaining glucose homeostasis (Banzhaf et al., 2021).

Phase 1 & 2: Vagus Nerve and Celiac Plexus Stimulation

The protocol begins by targeting the primary neural pathways to the pancreas through the celiac plexus and, critically, the vagus nerve. As detailed by Banzhaf et al. (2021), these nerve pathways do not simply send one-way signals; they form a complex, bidirectional circuit that allows the brain to both monitor and precisely control pancreatic islet function. By stimulating the vagus nerve, our therapy directly engages this regulatory network to promote the natural, physiological release of insulin.

Phase 3: Sacral Nerve Modulation

The third phase targets the sacral area of the spine to engage the lower autonomic pathways that contribute to metabolic regulation.

Phase 4: Bilateral Application for Comprehensive Treatment

To ensure complete and symmetrical treatment, the entire three-phase process is repeated on the opposite side of the spinal column. This "spinal axial reversal" guarantees that the entire neural network innervating the pancreas is thoroughly engaged.

The Reverberatory Circuit and Sustained Effect

The therapeutic waveform is delivered in a precise cycle: six seconds of active stimulation followed by a two-second rest period. During the active stimulation, the targeted neural pathways are directly engaged.

Crucially, during the two-second "off" period and for many hours after the treatment is complete, a phenomenon known as the reverberatory circuit of the nervous system is utilized. This sustained neural activity continues to facilitate the intestinal mucosa, which in turn releases hormones that powerfully stimulate the release of insulin from pancreatic beta cells. This mechanism, known as the incretin effect, is a fundamental process in glucose homeostasis, as extensively detailed by Drucker & Nauck (2006). By promoting the release of these hormones, the therapy ensures that its benefits extend long after the session has concluded, promoting a lasting restoration of the body's natural glucose-regulating systems.

From Vestibular Science to Metabolic Restoration: The Discovery of a Novel Bioelectric Therapy

The development of a novel therapeutic system for diabetes was not a linear process aimed at a single disease but rather a convergence of insights from disparate scientific fields. This patented methodology is the culmination of a century of landmark discoveries, creating a revolutionary approach that holds the potential to serve as a foundation for treating other complex diseases, including cancer, obesity, and conditions requiring internal organ regeneration.

The Catalyst: A Hypothesis from Vestibular Science

The initial insight originated from a specialized area of neurophysiology: the study of vestibular systems. Oresteban Carabeo, PhD, building upon the Nobel Prize-winning work of Robert Barany on the caloric response, conducted extensive research into the diagnostic indicators of vestibular dysfunction. His work in bi-thermal caloric testing revealed that conditions such as unilateral weakness and directional preponderance were often evidence of underlying organ disease, particularly Meniere's syndrome.

The pivotal moment came when Dr. Carabeo proposed a transformative idea to Julio L. Garcia, M.D.: What if the abnormal bioelectric signals observed in diagnostics were not merely symptoms, but could be harnessed for treatment? He hypothesized that a precisely engineered, asymmetric biphasic waveform—mimicking the defective signals—could be used to reprogram dysfunctional cells, restoring them to a healthy, electrically charged state. This concept, born from optokinetic testing, formed the cornerstone of the new therapeutic approach.

Historical and Scientific Foundations

This innovative hypothesis stood on the shoulders of giants in the field of bioelectricity. The work of Luigi Galvani, who first demonstrated "animal electricity" in the 1790s, and Alessandro Volta, inventor of the modern battery, provided the foundational understanding of electricity's role in biological systems (McNeal, 1977). Dr. Garcia guided the team in applying these historical principles, recognizing that a stable, controlled current—a gift from Volta—was essential for systematic investigation.

The next critical step was determining the optimal delivery of this current. The research of Michael Faraday, who discovered in the 1830s that interrupted (pulsed) electrical current was highly effective for nerve stimulation, proved instructive. This led the team to develop a specific therapeutic pattern: a six-second stimulation followed by a two-second rest period, a rhythm found to be optimal for activating the vagus nerve and reversing the progression of diabetes.

Further validation for this approach was found in contemporary research, particularly in the work compiled by Christine E. Pullar. Her text, The Physiology of Bioelectricity in Development, Tissue Regeneration, and Cancer, synthesized the growing body of evidence showing that endogenous electric fields are fundamental to tissue development, regeneration, and even pathological states like tumor growth (Pullar, 2011). This affirmed the team's conviction that manipulating these bioelectric fields at the cellular level could be a revolutionary therapeutic strategy.

Developing the Patented Protocol

The translation of these principles into a viable treatment required identifying the most effective gateways for introducing electrical current into the body. Dr. Garcia's years of investigation into the body's somatic segmentation points were invaluable. He determined that while some traditional acupuncture meridians were effective, others could impede energy circulation. His research identified a unique set of entry points optimized for bioelectrical therapy, a critical element not found in contemporary medical literature.

The team engineered a waveform designed specifically to normalize the function of cellular ion channels, restoring the cell's ability to depolarize and repolarize. This process enables cells to properly absorb nutrients and execute their physiological functions. The culmination of this work is a treatment that effectively reactivates the cellular memory of pancreatic beta cells. By enhancing the influx of calcium—a critical trigger for insulin exocytosis—the therapy restores the pancreas's ability to produce and release insulin, thereby normalizing blood glucose levels.

Clinical Success and Acknowledging Predecessors

This patented system has been used to treat thousands of patients with Type 2 diabetes, with remarkable results. The treatment not only restores pancreatic function but also yields significant improvements in common diabetic complications, including neuropathy, vasculopathy, and microangiopathy, through a phenomenon of reverberatory circuitry that promotes tissue health.

This breakthrough builds upon the work of previous innovators in the field of neuromodulation for diabetes. The team acknowledges the contributions of predecessors such as Houben et al. (2002), who developed pancreatic stimulation implants; Whitehurst et al., whose patents involved vagus nerve stimulation for drug delivery; Dobak (2010), who focused on splanchnic nerve stimulation; and Gross et al. (2012), who explored multi-site electrode implants.

The primary distinction of the current invention lies in its non-invasive nature, its meticulously perfected waveform, and its unique ability to directly and successfully stimulate the beta cells of the pancreas to restore their innate function. Through rigorous research and interdisciplinary innovation, this system represents a paradigm shift in the treatment of diabetes.

The Patented Applicator: A Device for Neuro-Physiologic Stimulation

 The core of the invention, as detailed in U.S. Patent No. 8,688,240, is a specialized medical device and its unique therapeutic waveform designed for the non-invasive neuro-physiologic treatment of diabetes. The system targets the underlying cellular dysfunction of pancreatic beta cells by restoring the normal function of their ion channels, a concept grounded in established principles of autonomic physiology (Garcia et al., 2014).

The Asymmetric Biphasic Waveform

The central innovation is a proprietary asymmetric, biphasic electrical waveform. This waveform consists of two distinct phases engineered for a specific therapeutic sequence:

1. Positive Phase: A sharp, high-energy positive pulse (approx. 50 milliseconds) acts as the "driver." Its primary function is to project the electrical signal through the nervous system to the pancreas. This targeting strategy is based on the well-documented principle that the autonomic nervous system provides potent regulation of pancreatic islet hormone secretion, a concept extensively reviewed by Ahren (2000).
2. Negative Phase: A prolonged, capacitor-mediated negative portion (approx. 206 milliseconds) immediately follows. The key innovation lies in this extended negative "tail," which sustains the therapeutic effect. It holds the cellular ion channels open for a longer duration than previously possible, allowing for an enhanced influx of essential nutrients like calcium (Ca²⁺).

The modulation of these ion channels by neural inputs is a cornerstone of pancreatic physiology, with autonomic neurotransmitters directly influencing the signaling cascades that lead to insulin exocytosis (Ahren, 2000). The extended period of channel activity generated by the waveform is crucial for restoring the cell's normal membrane potential, enabling the natural release of insulin that is otherwise inhibited in diabetic states.

The Neuro-Physiologic Stimulation Device

The patent describes a portable, self-contained apparatus engineered to deliver this precise waveform. Key features include:

• Non-Invasive Application: The device utilizes treatment electrodes placed on specific locations of the patient's back (dorsal region) to access the neuro-pathways innervating the pancreas.
• Safety and Isolation: Powered by a 3V DC battery, the system is fully isolated from ground and complies with IEC 60601-2-10 safety standards, ensuring a high degree of patient safety.
• Precision Control: An integrated microcontroller is pre-programmed to generate the exact waveform, with an adjustable amplitude (typically 70V peak-to-peak). The preferred frequency is 3.9 Hz, a rate corresponding to approximately three cycles for every one beat of a resting human heart.

In essence, the patent protects a complete system—a method, a circuit, and a device—that uses a novel bioelectrical signal to address the fundamental electrophysiological dysfunction underlying diabetes. Its approach is validated by a deep body of scientific evidence on the neural control of the pancreas, offering a non-pharmacological path to restoring its natural function.

The Patented Applicator: A Device for Neuro-Physiologic Stimulation

The technology central to our therapeutic approach is detailed in U.S. Patent No. 8,768,468, which protects a specialized device applicator designed for the precise neuro-physiologic stimulation of the human nervous system (Garcia et al., 2014). This apparatus is engineered to deliver our proprietary waveforms safely and effectively, forming the cornerstone of our treatment for diabetes and insulin resistance.

Apparatus and Design

The patent describes a self-contained, portable device consisting of two primary components connected by a flexible electrical cable:

• Positive Assembly: This unit houses the core technology, including an integrated circuit (IC) that generates the specific, physiologically compatible electromagnetic waveforms.
• Negative Assembly: This unit contains the negative treatment pad, completing the electrical circuit required for the therapy.

The ergonomic, ungrounded design ensures the safe and precise delivery of the waveform to the various anatomical points required by our treatment protocol.

Therapeutic Principle and Mechanism of Action

The device is designed to cure Type 1 and Type 2 diabetes by addressing the root cause of the disease at a cellular level. The treatment is founded on the principle that beta cell dysfunction in diabetes stems from a failure of cellular electrophysiology—specifically, the ion channels that control insulin secretion. As established by leading physiologists, the carefully orchestrated opening and closing of these channels is the absolute prerequisite for insulin exocytosis (Rorsman & Ashcroft, 2018).

The unique advantages of this patented system are:

• Normalization of Ion Channels: Our proprietary waveform is specifically engineered to restore the normal function of these critical ion channels. This allows the beta cells to properly depolarize and repolarize—the fundamental electrical processes required for them to sense glucose and release insulin (Rorsman & Ashcroft, 2018).
• Targeted Neuro-Physiologic Stimulation: The therapy engages the body's own neural pathways to achieve its effect. Modern research confirms that the pancreas is not an isolated organ but is regulated by a complex, bidirectional "brain-pancreas" neural network that is essential for maintaining glucose homeostasis (Banzhaf et al., 2021). Our protocol directly targets this network to restore its natural regulatory function, a concept supported by decades of research on the autonomic nervous system's role in controlling islet hormones (Ahren, 2000).
• Cellular Regeneration and Sustained Effect: By correcting the defective electrical behavior of the beta cells, the stimulation "reactivates" their physiological memory, enabling them to regenerate. This process is enhanced by the reverberatory circuitry phenomenon, a sustained neural effect that continues to promote nutrient exchange and cellular health long after the treatment session ends.

As the beta cell membranes are regenerated through this targeted stimulation, their ability to produce and release insulin is restored, leading to a natural reduction in blood sugar levels and the potential for a definitive cure.