About Oresteban Carabeo, CEO, Inventor

Professional Experience

Oresteban Carabeo, an inventor, scientist, and the CEO of Biomolecular LLC, is an innovative medical device scientist and advocate for diabetes prevention, treatment, and cure. He has more than 10+ years’ experience in training of intellectual property and research, biomedical engineering, software engineering, biomedical analysis, designing electro-mechanical products, implementing medical devices, testing sensors, creating prototypes, managing Cybersecurity technologies, testing Blockchain cloud computing functionality, developing specification designs, optimizing microchip system performance, programming, and writing cutting edge advances in the field of science, medicine, and technology . His accomplishments include the invention of a revolutionary new medical procedure via a special-purpose device applicator that uses a novelty waveform designed to cure type 1 diabetes, type 2 diabetes, and insulin resistance through the neurophysiologic stimulation. The aforementioned is the creation of a new disciple known by correcting the human body’s cell defectiveness of the ionic channels to polarize and repolarize the beta cells, enabling them to regenerate. Mr. Carabeo’s key finding discovery began employing the theory of integrating his profound abnormal bilateral weakness findings into a treatment, instead of leaving his work simply as diagnostic results. His optokinetic testing was an essential link in the discovery of a cure for diabetes. It led to the use of the asymmetric biphasic waveform to impact the electrons from the defective positive side of the optokinetic measurements in group testing results.

Oresteban Carabeo’s dedication to a life in medicine and inventions began in 2007, when he first heard about the Italian physician Luigi Galvani’s newly discovered force “animal electricity” around 1790 that laid the foundations for modern fields of electrophysiology, neuroscience, and that also inspired Volta, who invented the modern battery. He also took to heart outstanding research done by others, including what is called the caloric response developed by Robert Barany in 1906, for which he was awarded a Nobel Prize. Mr. Carabeo received his Bachelor of Science in Health Science from Kaplan University School of Sciences , Chicago, Illinois., and completed a Master of Science in Cybersecurity Management with a specialization in Information Security Auditing at St. Thomas University in Miami Gardens, Florida. He completed his technical training and experience while working with Western Systems Research (WSR) located in Pasadena, California. Western Systems Research is a cutting-edge company in the design, development, and marketing of neuro-medical devices. WSR specializes in the vestibular apparatus of the inner ear. Mr. Carabeo also managed to gain an intricate knowledge of different mechanisms within vestibular systems and recommended to WSR an accurate numeric measurement for the CRP (Corneo-Retinal Potentials). Mr. Carabeo served as a quality control expert while testing NASA, Electronystagmography-ENG, Vestibular Autorotation Test-VAT, and Bi-Thermal Caloric systems, which played a great part in the testing and clinical status evaluation for all future pre or post flight analysis of space missions, astronauts, and cosmonauts, including long-term missions to Mars. Mr. Carabeo evaluated treatments of many vestibular disorders and created software that yielded outstanding data analysis, interpretation parameters, MedTrack, and WSR.

Mr. Carabeo’s interest, experience, and research in medical devices led to his invention of a new proven market-ready prototype, medical procedure, and special-purpose device applicator using a specific novelty waveform that provides a serious, non-invasive and reliable cure for diabetes. It took him nearly ten years to complete the research and testing needed to make it work and apply for a patent. When he first conceived of the device in 2012, his idea was more advanced than the technology available at the time. The device is applicable to all 422 million adults with diabetes around the world. It is also useful for pre-diabetes and insulin resistance sufferers. With the invented device, Mr. Carabeo was able to provide a diabetes cure to numerous individuals who had been diabetics for over 30 years, which represents a significant scientific breakthrough because it uses a specific waveform that controls membrane potentials to release the body’s own insulin without the usage of any medications or other forms of legacy medical intervention, and reactivates the cells’ memory, causing them to continue working properly as they did before contracting the disease.

Mr. Carabeo is also a professor of Computer Science at St. Thomas University, School of Science, Technology, and Engineering Management.

Patents

United States Patent and Trademark Office, 2020, U.S. Patent No. 10,673,617, entitled Methods, System and Point-to-Point Encryption Device Microchip for AES-SEA 512-Bit Key Using Identity Access Management Utilizing Blockchain Ecosystem to Improve Cybersecurity.
United States Patent and Trademark Office, 2020, U.S. Design Patent Application No. 29/734,322, entitled Electro Mechanical Dendron Soma Special Purpose Device Applicator.
United States Patent and Trademark Office, 2020, Reg No. 6,205,665, entitled Oresteban Carabeo Intellectual Property Built to Perfection.
United States Patent and Trademark Office, 2018, U.S. Provisional Patent Application No. 62/661,694, entitled Blockchain Technology Point-2-Point-Encryption Device Mechanism and System Software.
United States Patent and Trademark Office, 2017, Reg No. 5,284,433, entitled Diabetes Killer New Electro+Neuro-Waveforms.
United States Patent and Trademark Office, 2014, U.S. Patent No. 8,768,468, entitled device for Neuro- Physiologic Stimulation.
United States Patent and Trademark Office, 2014, U.S. Patent No. 8,688,240, entitled Device for Neuro- Physiologic Stimulation.
United States Patent and Trademark Office, 2013, U.S. Patent No. 8,457,745, entitled Method, System and Apparatus for Control of Pancreatic Beta Cell Function to Improve Glucose Homeostasis and Insulin Production.
United States Patent and Trademark Office, 2012, U.S. Patent. reference application No. 61/619,352, entitled Bio-Cellular Treatments for Diabetes Mellitus.
United States Patent and Trademark Office, 2012, U.S. Patent. Design No. 29/442,086, entitled Bio-Electric Compass Applicator.

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Certifications

Harvard University | edX | MCB80.1x: Fundamentals of Neuroscience, Part 1: The Electrical Properties of the Neuron, Credential ID https://courses.edx.org/certificates/bc8bd00660374c75ae65012a2b088e94
Harvard University | edX | X Series Certificate, U.S. Government, Credential ID https://credentials.edx.org/credentials/d90795d232684ec99379dba1026024c1/
Harvard University | edX | HKS101A_4: U.S. Public Policy: Social, Economic, and Foreign Policies, Credential ID https://courses.edx.org/certificates/5908e1fb96a347bc9762628a3c637418
Harvard University | edX | HKS101A_3: Citizen Politics in America: Public Opinion, Elections, Interest Groups, and the Media, Credential ID https://courses.edx.org/certificates/087109fd883b4b439e4fd3a41c46e2de
Harvard University | edX | HKS101A_2: U.S. Political Institutions: Congress, Presidency, Courts, and Bureaucracy, Credential ID https://courses.edx.org/certificates/cf4335fae3604e5c8ef8e0666631e007
Harvard University | edX | HKS101A_1: American Government: Constitutional Foundations, Credential ID https://courses.edx.org/certificates/007929743da34810972bdcadd8dd7675
Harvard University | edX | HLS2X: Contract Law: From Trust to Promise to Contract, Credential ID https://courses.edx.org/certificates/757a7d0fca9d42f1b937659d5b8662a2
Duke University | Coursera Copyright for Multimedia, Credential ID https://www.coursera.org/account/accomplishments/certificate/U24ETNFUK64W
University of Pennsylvania - Coursera Copyright Law, Credential ID https://www.coursera.org/account/accomplishments/certificate/KUK2FMPQVEKK
University of Pennsylvania - Coursera Intellectual Property Law Specialization, Credential ID https://www.coursera.org/account/accomplishments/specialization/certificate/BTLHEKj9PK54
University of Pennsylvania - Coursera Patent Law, Credential ID https://www.coursera.org/account/accomplishments/certificate/4CUY5HE2P7C7
University of Pennsylvania - Coursera Trademark Law, Credential ID https://www.coursera.org/account/accomplishments/certificate/QF5GEH8J9C7X
University of Pennsylvania - Coursera Introduction to Intellectual Property, Credential ID https://www.coursera.org/account/accomplishments/certificate/2F4JV8GHW3A6
World Intellectual Property Organization – WIPO Introduction to the Patent Cooperation Treaty, Credential ID https://welc.wipo.int/lms/verify/index.php?q=7ZH2DJBh4g
Collaborative Institutional Training Initiative (CITI Program) Humanitarian Use Devices (HUDs), FL, Credential ID 36694646, 2020
Collaborative Institutional Training Initiative (CITI Program) Nanotechnology, FL, Credential ID 36694650, 2020
Collaborative Institutional Training Initiative (CITI Program) Select Agents, Biosecurity, and Bioterrorism, FL, Credential ID 36694648, 2020
Collaborative Institutional Training Initiative (CITI Program) CITI Good Clinical Practice, FL, Credential ID 29169951, 2019
Collaborative Institutional Training Initiative (CITI Program) Additional Groups in the Course for The Protection of Human Subjects (Curriculum Group) Study Coordinators/Key Research Staff (Biomedical), FL, Credential ID 2127820, 2019
National Institutes of Health (NIH) Protecting Human Research Participants, MD, Certification No. 2130421, 2016
Collaborative Institutional Training Initiative (CITI Program) CITI Health Information Privacy and Security (HIPS) for Clinical Investigators, FL, Credential ID 15029863, 2015

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ABOUT US

Areas of Expertise

In 2009, Biomolecular LLC was founded by Oresteban Carabeo, M.Sc. in Cybersecurity. Currently, Oresteban is the owner and Chief Executive Officer of Biomolecular LLC, which is a company with cutting edge technology in the areas of Diabetes Mellitus, Medical Device, and Intellectual property. Biomolecular LLC holds patent ownership for patent inventions to cure Diabetes and Insulin Resistance.

Patent Technology Medical Device

Non-invasive medical technology to produce your own Insulin.

a specific electrical waveform that normalized ionic

channels, corrected cell defectiveness, and utilized new electro-medical technology to polarize and repolarize beta cells, enabling them to regenerate. In other words, electro-neurologic waveforms were being applied to the anatomy of the patient successfully.

The waveform utilized in the new technique had a particular utility in the neurophysiologic stimulation of the pancreas and thus

presented the opportunity for a method to effectively treat of diabetes.

An Apparatus for the electro-physiologic Stimulation of the Human Nervous System

The medical technology provides an apparatus and special-purpose applicator for the application of electro-neurologic waveforms to the anatomy of the patient, such as vagus, celiac schema of the sympathetic nervous system. The apparatus is useful in innervating neural pathways associated with the pancreas and the activity of its beta cells.

UNITED STATES PATENT LAW

Under United States law,

A patent is a right granted to the inventor of a (1) process, machine, article of manufacture, or composition of matter, (2) that is new, useful, and non-obvious. A patent is the right to exclude others, for a limited time (usually, 20 years) from profiting of a patented technology without the consent of the patent-holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, and/or offering a product specially adapted for practice of the patent. Patent law is designed to encourage inventors to disclose their new technology to the world by offering the incentive of a limited-time monopoly on the technology.

The Copyright Clause (also known as the Intellectual Property Clause, Copyright and Patent Clause, or the Progress Clause[1]) describes an enumerated power listed in the United States Constitution (Article I, Section 8, Clause 8).

The clause states that:

"[the United States Congress shall have power] To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."

The clause is the basis of intellectual property laws in the United States, specifically copyright and patent laws.

Patentable subject matter (§101)

"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title."

— 35 U.S.C. 101.

To be patent eligible subject matter, an invention must meet two criteria. First, it must fall within one of the four statutory categories of acceptable subject matter: process, machine, manufacture, or composition of matter. Second, it must not be directed to subject matter encompassing a judicially recognized exception: laws of nature, physical phenomena, and abstract ideas.

Novelty (§102)

Section 102 of the patent act defines the "novelty" requirement. The novelty requirement prohibits patenting a technology that is already available to the public. Specifically, 35 U.S.C. 102 states:

(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless— (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention ...

For a technology to be "anticipated" (and therefore patent-ineligible) under 35 U.S.C. 102, the prior art reference must teach every aspect of the claimed invention either explicitly or impliedly. "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987).

Obviousness (§103)

To be patentable, a technology must not only be "new"but also "non-obvious." A technology is obvious (and therefore ineligible for a patent) if a person of "ordinary skill" in the relevant field of technology, as of the filing date of the patent application, would have thought the technology was obvious. Put differently, an invention that would have been obvious to a person of ordinary skill at the time of the invention is not patentable. Specifically, 35 U.S.C. 103 states:

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter. A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.

Note:

The following proves the legality and ownership of the invention we are offering you and likewise proves beyond doubt the qualification, existence, and veracity of our invention.

History of the invention

United States Patent and Trademark Office, 2013, U.S. Patent No. 8,457,745, entitled Method, System and Apparatus for Control of Pancreatic Beta Cell Function to Improve Glucose Homeostasis and Insulin Production

As is well-known, the sympathetic nervous system (SNS) is a branch of the autonomic nervous system (ANS) and of the central nervous system (CNS) and is related to the parasympathetic nervous system (PNS). The SNS operates through a series of interconnected neurons. Sympathetic neurons are frequently considered part of the PNS, although many lie within the CNS. Sympathetic neurons of the spinal cord are, of course, part of the CNS, and communicate with peripheral sympathetic neurons through a series of sympathetic ganglia. The PNS is considered an automatic regulation system, that is, one that operates without the intervention of conscious thought. As such, fibers of the PNS innervate tissues in almost every organ system, providing at least some regulatory function to areas as diverse as the diameter of the eye, gut motility, and urinary output. For purposes of the present invention, the only organs so regulated by the SNS shown are lung, hair follicles, liver, gall bladder, pancreas, adrenal glands, and management of hypertension generally. To reach target organs and glands, axons must travel long distances in the body, and to accomplish this, many axons relay their message through a second process known as synaptic transmission. This entails the use of neurotransmitters across what is termed the synaptic cleft which activates further cells known as post-synaptic cells. Therefrom, the message is carried to the destination in the target organ, in this case the pancreas. It is known that messages travel through the SNS in a bi-directional fashion. That is, so-called efferent messages can trigger changes in different parts of the body simultaneously referenced as the fight-or-flight response function of the SNS.

The autonomic nervous system includes both said SNS and PNS divisions which, collectively, regulate the body's visceral organs, their nerves and tissues of various types. The SNS and PNS must, of necessity, operate in tandem to create synergistic effects that are not merely an “on” or “off” function but which can better be described as a continuum of effect depending upon how vigorously each division must execute its function in response to given conditions. The PNS often operates through what are known as parasympathetic ganglia and includes so-called terminal ganglia and intramural ganglia which lie near the organs which they innervate, this inclusive of the pancreas. The extensions of the vagus nerve, known as the anterior and posterior vagus trunks and right sympathetic trunk provides the extensive role of the vagus nerve, its offshoots in human physiology and the many neural pathways—efferent, afferent, and parasympathetic, enabled by the functions of the vagus nerve. The pancreas is a large organ situated below the diaphragm, above the kidneys, to the right of the intestine, and with the circulatory system through the pancreatic duct. The CNS is activated mainly by nerve centers located in the spinal cord, brainstem, and hypothalamus. Autonomic nerves are formed by nerves of efferent fibers leaving the CNS (less the striated muscles); there are some efferent fibers that transmit information of the ANS. The PNS is formed by isolated ganglia that use acetylcholine as a neurotransmitter, which is responsible for storing and conserving energy, and maintains the body in normal situations. It always appears as an antagonist of the SNS, controlling involuntary acts. Its nerves are carried in the cranial nerves including the vagus and its offshoots. The PNS and its fibers enter the CNS through sympathetic trunk and the Cranial Nerves III, VII, IX, and X although like the SNS, it does not have pre- and post-ganglionic neurons. The preganglia fibers travel through, without interruption, all the way to the tissue that it innervates. In the wall of the nerves are the neurons (postganglionic). Postganglionic fibers make synapses and spread throughout the body (some 1 millimeters to a few centimeters). The parasympathetic innervation of the intestine runs through the vagus nerve and sacral nerves in the pelvis producing among other stimulation of the exocrine secretions of glandular epithelium, with an increase in the secretion of gastrin, secretion, and insulin. It is noted that insulin is released only by beta cells in pancreatic Islets (i.e., small isolated masses of one type of tissue within a different type), known as the Islets of Langerhans. Insulin is one of the endocrine system secretions (i.e., secretions that are distributed in the body by way of the bloodstream) of the Islets of Langerhans, which helps integrate and control bodily metabolic activity. The Islets also include alpha cells, which produce glucagon, delta cells which produce somatostatin, and a small number of PP cells which produce pancreatic polypeptide (“PP”). The beta cells tend to be in the center of the pancreatic Islets, while the alpha cells tend to occupy the periphery. The beta cells generally constitute 60-70% of the Islets, the alpha cells 20-25%, and the delta cells approximately 10% Gap junctions exist between neighboring islet cells, permitting the ready flow of molecules and electrical current between cells. If these gap junctions are disrupted, insulin secretion is markedly reduced. Islet cell clusters function better as electrical than biochemical syncytia. Under normal circumstances, insulin is secreted by the beta cells in response to an elevated level of plasma glucose via the following steps. The transportation of glucose across the beta cell membrane is facilitated by a specific transporter molecule known as GLUT-2. Once inside the beta cell, the enzyme glucokinase causes glucose to phosphorylate (i.e., to take up or combine with phosphoric acid or a phosphorus-containing group), which prevents its efflux. High levels of glucose and glucose-6-phosphate within the cell lead to a rapid increase in the ratio of adenosine triphosphate (ATP) to adenosine diphosphate (ADP), which leads directly to the closure of ATP-sensitive transmembrane potassium ion (K+) channels. This prevents the normal efflux of K+ from the beta cell, and the cell depolarizes, i.e., closing of some ionic channels. Voltage-regulated calcium ion (Ca++) channels open in response to this depolarization, allowing an influx of Ca++. Elevated intracellular Ca++ leads to activation of protein kinases and ultimately to fusion of insulin-containing secretory granules with the beta cell membrane, thus leading to exocytosis of insulin into the systemic circulation. This entire sequence occurs within one minute of exposure to elevated glucose levels. Insulin is a hormone that serves a variety of functions, the primary action of which is to potentiate the uptake of glucose from the bloodstream by muscle and adipose tissue. It also promotes conversion of glucose to a storage form (i.e., glucagon) in the liver and fat in adipose tissue. These actions serve to decrease the circulating level of glucose. Glucagon is released primarily under conditions of hypoglycemia, and it tends to have effects opposite those of insulin. Release of glucagon is also promoted by alpha-adrenergic neurotransmitters, and it is inhibited by beta-adrenergic neurotransmitters, cholinergic neurotransmitters, and insulin. Somatostatin secretion is stimulated by glucose, glucagon, beta-adrenergic neurotransmitters, cholinergic neurotransmitters, and several other chemical factors; its release is inhibited by insulin and by alpha-adrenergic neurotransmitters. Somatostatin tends to inhibit the release of both insulin and glucagon.

Parasympathetic Stimulation

Secretion of insulin may also be modulated by other neural and chemical factors. Parasympathetic stimulation and the consequent release of acetylcholine tends to increase the secretion of insulin. Sympathetic stimulation produces competing effects, as beta-adrenergic neurotransmitters tend to increase insulin secretion while alpha-adrenergic neurotransmitters tend to decrease insulin secretion. Insulin secretion is also increased by a number of other factors, including K+, Ca++, arginine, lysine, glucagon-like peptide 1, gastric inhibitory peptide (GIP), secretion, cholecystokinin (CCK), and beta-3-agonists. Insulin secretion is also decreased by several other factors, including somatostatin, galanin, pancreastatin, and leptin. As above noted, a significant body of research exists describing the influence of parasympathetic activity on insulin secretion by the pancreatic beta cells. Parasympathetic nerve stimulation in the dog produces a marked increase in insulin secretion and a moderate increase in glucagon secretion. In addition, parasympathetic activation produces increased insulin and glucagon secretion in proportion to pulse frequency, while inhibiting somatostatin release. Cholinergic neurotransmitters, which are the neurotransmitters most commonly secreted by parasympathetic nerve fibers, were found to be responsible for this influence. However, findings also suggest that a non-cholinergic neurotransmitter(s) may also be involved in parasympathetic regulation of pancreatic hormone secretion. The specific parasympathetic pathways innervating the pancreatic Islets are known. Three branches of the vagus nerve mediate both insulin and glucagon release. The posterior gastric branch (198% and 117% increase from basal for insulin and glucagon, respectively), the anterior gastric branch (177% insulin increase and 104% glucagon increase), and the hepatic branch (103% insulin increase the 60% glucagon increase).

Sympathetic Stimulation

The sympathetic nervous system also exerts a significant influence on insulin and glucagon secretion by the pancreatic Islets. The sympathetic splanchnic nerve, arising from the paraspinal sympathetic trunks, is the primary sympathetic influence on the pancreas. Its primary neurotransmitter is norepinephrine, which activates alpha-adrenergic and beta-1-adrenergic receptors, but has relatively little influence on beta-2-adrenergic receptors. The pancreas is comprised mostly of acini and the Islets of Langerhans. Acini comprises over 80% of the gland. Each acinus is lined with wedge-shaped acinar cells. Acinar cells are the site of production and secretion of the digestive enzymes. Capillaries allow hormones from the Islet cells to reach the acinar cells. Islets of Langerhans are scattered irregularly throughout the pancreas and contain the Islet cells, which are responsible for secreting the endocrine hormones: insulin, glucagon, somatostatin, and pancreatic, polypeptides. The insulin-secreting beta cells comprise about 60-70% of the Islet. They are surrounded by a mantle of glucagon-secreting alpha cells, somatostatin-secreting delta cells, and pancreatic polypeptide-secreting PP cells. The various cells of the Islets are separated from another by a rich capillary network.

The present invention provides electrical stimulation to at least one or more of the above mentioned areas as a treatment for diabetes. It is known that cells of the human body are acutely responsive to electrical and electromagnetic stimulation through neurotransmitters and otherwise, as has long been established by research in the area. Calcium has been determined to be the final transmitter of electrical signals to the cytoplasm of human cells. More particularly, changes in cell membrane potential are sensed by numerous calcium-sensing proteins of cell membrane which determine whether to open or close responsive to a charge carrying elements, in this case, the calcium anion Ca2+. Stated otherwise, calcium anions transduce electrical signals to the cells through what are termed voltage-gated calcium channels. It is now recognized that electrical signaling of voltage-gated channels (of which there are many categories) of human cell membranes is controlled by intracellular free calcium (and other) ionic concentrations, and that electrical signals are modulated by the flow of calcium and other anions into cytoplasm from the external medium or from intra cellular stores through ionic specific channels. These channels act as gates, in which concept of an “ion channel” was first proposed in the year 1950, that these channels represent a wide variety of biological processes, and rapid changes in the cells: Contraction of the muscle, transport of activation of (T) lymphocytes, the release of insulin by the beta cells of the pancreas, and cellular osteogenesis occur. Differentiation, remodeling or hypertrophy, among other functions also occur.

Ionic channels have two important characteristics:

1. Conduction of ions.

2. Recognition and selection of ions.

When changes occur in the voltage across a membrane, some channels are opened by electrical stimulus, or they may respond to chemicals, drugs or hormones. Neurotransmitters, or may be activated by ligands. If there are changes in temperature or deformation by narrowing, widening of the membrane, they may be opened and mechanically. Some ionic channels are opened or closed randomly regardless of the value of the membrane potential in which it is said that this “gating” is independent of voltage. However, certain ionic channels control membrane potential. When such channels are open, they can conduct electric current allowing ions to pass through the cytoplasmic membrane of the cell. These ions generate a current and establish an electromechanical gradient either positive or negative, depending charges on the ions, their quantity of direction, inward or outward, and the structure of the cytoplasmic membrane itself. Involved are different processes of activation, deactivation, inactivation, and finally reactivation. Activation is the process of opening up the cell channels, responsive to the fact that the voltage within the cell membrane is more positive with respect to the outside. This is known as depolarization. Deactivation is the opposite process, which relates to the closing of a channel responsive to reversal of membrane potential. Voltage of the interior of the membrane becoming more negative this is known as repolarization. Inactivation relates to the closing of the channels during deactivation and occurs as the interior of the membrane is more positive. However, there is always a delay with respect to activation of a channel. As suggested above, a difference of voltage between the sides of a channel of a cell membrane causes the voltage gradient across said channels, also known as the current gate. Some of these channels have a “refractory” aspect, also known as an inactive channel and is believed to be caused by an opening of a sub-unit of the channel.

The flow of electrons or existence of the electrons of a voltage gradient for a longer time and, therefore, in a greater quantity, enhances activation, causing a greater exchange of ions and more effective control of membrane potential, enhancing intracellular currents from the stage of repolarization by giving them more time to the cell to react. One must also remember that the function of excitable cells depends on the entry of Na+ at an intensity of +61 mV, via Na channels, when activated. This entry of Na+ produces a depolarization of the membrane potential, facilitating the opening of more channels to the Na+ potential for 1-2 milliseconds. When at rest the cells of Na+ ions cause little opening and therefore cause inactivation of the Na channels. The proteins associated with the extracellular K+ channels cause depolarization, that is, these channels are facilitated by the output of K+ ion about 90 mV of the cell which contributes to the polarization of the membrane potential, and its rest potential of 90 mV this activity automatically triggers the cells and helps the release of neurotransmitters, insulin secretion, cell control of membrane potential. Excitability, transportation of electrolyte and muscle contraction affect regulation of cell volume as do the channels of Na+. There exist K+ channels, which influence the membrane potential and causes potential of rest and regulation of the volume of intracellular liquid. These channels can be similarly modified as to the time and the quantity of the flow of electrons effected by the inventive treatment including variables of frequency, pulse, wavelength of applied stimulation. In resting cells, the intracellular concentration of Ca2+ is 20,000 times less at rest than outside. That is Ca2+ is too low but is permeable with activation. The membrane potential caused by the output of the K+ and its reactivation of channels produces a repolarization of the membrane, thus obtaining an input of Ca2+ for each K+ that exists out of the cell. Intracellular Ca2+ is important in many biological processes including the potential for action, duration of action, excitability and contraction, release of neuro-transmitters, release or hormones, release of growth factors, synaptogenesis, osteogenesis, process of cell differentiation, hypertrophy, remodeling and increase of the release of insulin to the beta cells of the islets of the pancreas, including the breaking of the intracellular vesicles that there are stored with insulin process our treatment is largely based on this process. Other important channels are those of calcium also regulate cellular excitability and its transmembrane by regulating the cellular pH and volume of influx.

One well-studied calcium dependent process is the secretion of neurotransmitters at nerve terminals. Within the presynaptic terminal of every chemical synapse, there are membrane-bounded vesicular-containing high concentrations of neurotransmitter molecules of various types. When such an action potential engages a neurotransmitter, the membranes having one or more of these vesicles in their surface membrane, release a group of neurotransmitters into the cellular space. In the pancreas, there exist the above noted pancreatic acinar cells which contain zymogen granules which assist in cellular functions thereof. Normally stimulated secretion from nerve terminals of most excitable cells require that the extracellular calcium anions Ca2+ pass thru ionic channels of the cell. A calcium anion channel of cell as well as the egress of a potassium anion through a so-called KATP channel when a calcium anion enters the cell. This process triggers a variety of functions which relate to insulin secretion. Lack of sufficient secretion is of course the primary cause of diabetes as it is broadly understood.

In summary, the role of the Ca2+ and K+ channels in insulin secretion indicates in a normal functioning of the beta cell, that when plasma glucose levels rise, glucose uptake and metabolism by the pancreatic beta cells is enhanced, producing an increase in the intracellular ATP which is the primary cellular energy source. These changes act in concert to close calcium channels in the beta-cell membrane because ATP inhibits, whereas MgADP activates, calcium ion channel activity. In that calcium channel activity determines the beta cell resting potential, its closure causes a membrane depolarization that activates voltage-gated calcium anion channels, increasing calcium influx and stimulating insulin release. However, insufficient charge upon intracellular calcium may, it is believed, be one cause of inhibition of the above-described normal metabolic process of the pancreatic beta cells. In other words, if intracellular calcium, or its relevant neurotransmitters, lack sufficient charge, insufficient electrical energy is provided to secretory granules sufficient to effect insulin release, that is necessary to metabolize glucose. Another view of insulin secretion is that, by blockage of potassium ion channels, sufficient charge can be sustained within the cell to maintain normal function of secretory granules and therefore of insulin release . Therapeutic drugs which seek to so modulate insulin secretion by control of the potassium channels are sulfonylurea and diazoxide.

In summary, when blood glucose rises, the uptake thereof is increased by the action of the calcium anions Ca2+ entering cell through channels. Aspects of this metabolism cause the potassium ATP channels to close which results in membrane polarization, a change of voltage potential at calcium ion channels , and an increase in cytoplasmic anionic calcium that triggers the function of insulin secretory granules. It is therefore desirable to regulate calcium channel activity by maintaining a low level of blood glucose. But, this requires that an adequate molarity of Ca2+ exist in the beta cells. An increase in membrane potential will increase the time that voltage-gated ionic channels of the cell are open. In view of the above, it appears an appropriate increase in ionic calcium within beta cells of the pancreas will bring about an increase in insulin release if supported by a sufficiency of the membrane potential. It is to be appreciated that the channels of K+ are dependent on the level of ATP and therefore of glucose in blood will be closed and the cell membrane is depolarized; with this, dependent Ca2+ channels of voltage are opened and the Ca2+ enters the cell. This increase in intracellular Ca2+ activation produces phospholipase that divides the phospholipids in the membrane phosphatidylinositol 1,4,5 triphosphate and diacylglycerol. The inositol 1,4,5-triphosphate (IP3) to protein receptors on the membrane of the endoplasmic reticulum allow the release of the Ca2+ (ER) via the channels increasing the intracellular concentrations of Ca2+.These amounts of Ca2+ increased are responsible for causing activation of the synaptotagmin, which helps to release insulin previously stored in the vesicles. With this being the main mechanism for the release of insulin. Other substances induce the release of the hormone, amino acids, acetylcholine, which is released from the stimulation of the terminations of the vagus nerve.

Our treatment stimulates the paravertebral ganglia and the superior mesenteric ganglion which stimulate enteroendocrine cells of the intestinal mucosa by freeing cholecystokinin that acts to release insulin. There are three amino acids, lysine, glycine, and arginine that act with the same mechanism from glucose in the blood, all of which activate the cellular membrane potential, that is, increase the permeability of ionic channels in the beta cells and produce an increase in insulin release. The autonomic nervous system (ANS), as above noted, controls involuntary action, receives information from visceral parts of the brain, and the internal environment, to act on the muscles, glands, and blood vessels, is an efferent system), transmitting impulses from the CNS up to the periphery's stimulating many peripheral elements. We have seen the activation of ion channels by voltage gradients, but there are other controls of membrane potential.

Other means of activation of ion channels include, for example, the ligands, which are produced by the interaction of neurotransmitters and hormones, with a portion of the channel receptor, which causes a cascade of enzymatic events and phosphorylation, all of which produce the necessary energy to keep the channels open or closed, as needed. Enabling receptors are located inside and outside of layers of the membrane and according to the electrical charges of proteins (positive or negative), depending on the existing gradient at a given channel. There are channels which are regulated by mechanical action that are directed by Pacinian corpuscles (PC). Such membranes open by stretching and/or contraction.

As a conclusion to the above, we see that the ionic channels occur in a wide variety of biological processes which require rapid changes in the cell, for example: Heart muscle contraction, transport of ions and nutrients through the epithelium, and T lymphocyte control of membrane. Activation and release of insulin by the beta cells of the Islets of the pancreas comprises our key objectives in the search for new methods and/or treatments to improve and to cure a number of pathological processes.

As in Type II Diabetes Mellitus (T2D) ions passing through the cytoplasmic membrane for their normal metabolism have been discovered to exist in all human cells, functioning as a “biological clock.” Researchers from the University of California, at Irvine have reported important findings in day/night cycles and its relationship to metabolism and cellular energy, and have also suggested new treatments for cancer, obesity, and other diseases. Such circadian rhythms of 24 hours govern or direct fundamental physiological functions in almost all living organisms.

Sassone-Corsi discovered the relationship of proteins to a “protein clock” that modulates energy levels involved in the metabolism, equilibrium, and cellular aging. An imbalance in this process can cause disease. And other imbalances and therefore stimulus can induce lead or lag in the biological clock using effects of pulsed light and darkness during a 24-hour period to thus influence hormonal secretions of the glands in range of one to two hours, resulting in a system of internal regulation of the time. As such, nutritional factors, environment, and cycles of light/dark all influence the life of the cell and therefore the organism. This organization of time is altered in many pathophysiological conditions such an aging and endocrine diseases.

Researchers (the neuroscientist at the Cambridge University, Dr. Akhelesh Reddy) discovered a circadian oscillator in mammals located in suprachiasmatic nucleus of the anterior hypothalamus provides information of the physiological processes of the body, the operation of which is genetically pre-programmed. This postulates the necessity of a stable biological clock for healthy living in the early hours of the morning and considered ideal for work of concentration, the afternoon for manual work, and until the end of the afternoon for the proactive of sports where more energy is released by the cell. That is why our treatment, as below described, must be applied after 11:00 a.m. and before 8:00 p.m.

The period since about 1983 has witnessed a dramatic increase in the prevalence in patients of a cluster of inter-related metabolic disease stages, primarily caused by obesity and immune disease stages, jeopardizing homeostasis and leading to the diabetic state. The incidence of diabetes, with or without obesity, has reached epidemic proportions, bringing with it impaired quality of life and life span due to serious clinical co-morbidities such as peripheral vascular and neuropathic disease, with or without pain, ulcerative skin lesions often leading to infection, gangrene, and amputation, vision loss, cardiac and renal failure and brain disorders.

The inventive technology provided the methods, systems and apparatuses for preserving and restoring pancreatic beta cell function in a subject. These methods include electrically stimulating C-afferent sensory nerve fibers innervating pancreatic beta cells but originating in the spinal cord in a subject, in which the electrical stimulation modulates a secretion of calcitonin gene-related peptide (CGRP) from the C-afferent sensory nerve fibers; determining a level of a biomarker in the subject and repeating the electrical stimulation as a function of the level of the biomarker.

discovery of the invention

Finding the Essential Link in the Discovery of a Cure for Diabetes

Inventing the cure for diabetes did not begin with taking a closer look at diabetes and trying to figure out how to eradicate it. It did not begin with cell-level technology. Rather, it was the culmination of divergent paths coming together, from different fields of study merging to perfect the technology. By drawing upon several landmark discoveries from the last 100 years. It is our firm belief that this revolutionary new approach will be the spring board to cures of other dreaded diseases including: Cancer, Obesity, Internal Organ Regeneration, Sickle Cell Anemia and others.

One key area, in which Oresteban Carabeo, M.Sc. specialized, was the understanding of vestibular systems. He took to heart outstanding research done by others, including what is called the caloric response developed by Robert Barany in 1906, for which he was awarded a Nobel Prize. In a nutshell, Barany discovered while irrigating the ear to remove wax that the eyes went in different directions during application of cold and warm water. Later research has challenged some of Barany’s findings including some done by Carabeo. He found that during bi-thermal caloric testing, many patients suffered from unilateral weakness including directional preponderance, which could be an evidence of irregularities in the peripheral and central systems. He did further work in discovering the degree to which vestibular systems respond, and how symmetric those responses are between the left and right ears when testing of the lateral semicircular canals. All of this research, which has been undertaken by other scientists as well, has confirmed the conclusion that the most common cause of unilateral weakness in the vestibular system is organ disease. In fact, the ear disease that most often causes unilateral weakness is Meniere’s syndrome.

The key Finding discovery began when Oresteban Carabeo, M.Sc brought to the attention of Dr. Julio L. Garcia the theory of integrating his profound abnormal bilateral weakness findings into a treatment, instead of leaving his work simply as diagnostic results. The crux of his hypothesis was this: could the application of a defective waveform reprogram defective cells into new healthy electrically charged ones? The implications of that possibility were astounding of course. Carabeo’s optokinetic testing was an essential link in the discovery of a cure for diabetes. It led to the use of the asymmetric biphasic waveform to impact the electrons from the defective positive side of the optokinetic measurements in group testing results. This use of electricity to affect biology has been tinkered with for more than two thousand years (McNeal, 1977). Dr. Garcia influenced Carabeo by bringing to light the important studies in this area done by Galvani, who discovered bioelectricity (around 1790) and Volta, who invented the modern battery.

Galvani’s work is especially noteworthy. During an experiment in Bologna, Italy, in 1794, he launched the entire field of quantitative bioelectric science. Galvani observed motion in a severed frog’s leg after touching it with metallic wires, leading to the notion of a stored animal electricity, which governed the muscle activity that he observed. Likewise, Volta’s work with the first batteries had a huge impact on the generation of electricity and its application to science. Without batteries, very few of

the machines used to bring current to the body would be operable. The battery enables researchers to bring a steady current, perfect in systematic and controlled investigations, a true gift from Volta.

The next step to explore on the path to a cure was the proper timing for stimulation of segmentation points. The work of Faraday (around 1831) was instructive. He found that interrupted (pulsed) electrical current was an effective means of stimulating the nerves. Dr. Garcia guided Carabeo to see that such interrupted current would be the most effective to activate cells via the vagus nerve. As the treatment was perfected, Dr. Garcia found that the pattern of six seconds stimulation followed by two seconds of rest was optimal in turning diabetes back.

Another source that guided the team was the book The Physiology of Bioelectricity in Development, Tissue Regeneration, and

Cancer, edited by Christine E. Pullar, who has a PhD in immune cell signal transduction from the University of Sheffield, UK. Her research focused on promoting healing of chronic wounds to reduce scarring. She showed the team, via her book, how electric and magnetic applications could be used in future treatments especially in the area of the physiology of bioelectricity in tissue regeneration as part of the clinical treatment of human diseases. This field probably does not get enough exposure. Over the past several years, strong evidence has been accumulated showing that direct current and electric field gradients exist in all developing and regenerating animal tissues. Additionally, such current has actually been measured around tumors and sites of inflammation.

In accordance with Carabeo and Dr. Garcia’s treatment methods, the flowing of ions appears to be a fundamental feature in all aspects of bioelectricity. In short, electricity is essential to our existence. As mankind has evolved, he currently uses about half of his cells’ energy to live. With so much electrical activity going on in the body, it would seem logical sense that electrical treatments of the body at the cell level could be revolutionary in the treatment of many types of diseases. The fact

that we have evolved to expend half of our energy in generating ion concentration gradients and electric fields within our cells and tissues illustrates the importance of these fields for our life’s processes.

It is through such vigorous give and take that discoveries are created. As Carabeo began to grapple the potential of electrical treatment of disease, he sought guidance from Dr. Garcia regarding the somatic segmentation of the body and the vital touch points through which current could be introduced to the body in the most effective way.

This discussion led to further exchange about the absolute prime gateways to the body. Why did Dr. Garcia’s somatic points

differ from those used in acupuncture? He responded that the meridians used in acupuncture did have merit as entry points, but discovered that some could actually block the circulation of energy. Some points used in acupuncture did correspond with his recommended points of entry but not all. This led to still more queries such as why had Galvani and others failed to apply electricity at the cell level? Well, despite their brilliance, these early pioneers never thought about altering the cell through electricity. That concept was still several generations away. Even now with the understanding that electricity can absolutely alter a cell’s configuration, the entry points for such electrical treatment are not listed in recent medical books as keys to entering into the body to cure disease through bioelectrical treatment.

Dr. Garcia explained to Carabeo that the gateways to cell treatment vary according to the objective of the treatment; some are used for certain maladies and others used for different treatments. The body allows certain entryways to work for the elimination of certain illnesses. Identifying the right entry points required years of study, practice, and investigation. Dr. Garcia had engaged in extensive and successful investigation.This made him an invaluable member of the team.

As Carabeo expanded his knowledge and curiosity of using electrical current to heal, he wondered why such stimulation had

not been more widely practiced? The team felt as if we were on the verge of a significant new discovery given the outstandingly significant amount of knowledge we now have.

Dr. Garcia hypothesized that a failure to understand the proper gateways would doom many treatments. There is also the question of pulsing current and constant current, where opinion is divided. Another matter would be the danger

to patients, such as when a pacemaker is installed. This is never a layup among procedures.

The best course of action Dr. Garcia and Carabeo recommended was a waveform that normalized the ionic channels, giving the cells the ability to depolarize and repolarize at the membrane level. This would enable the cell’s function to acquire the appropriate nutrients through the afferent and efferent pathways to continue. All of this wisdom has led to the ability to cure patients of diabetes type 2. This is accomplished by favoring the entrance of calcium nutrients to the cell, which is essential for the liberation of insulin production throughout the beta cells of the pancreas. In essence, this stimulation reactivates the cells’ memory to continue working properly as they did when the patient was a youth, before contracting the disease. As the cell membranes are regenerated through the treatment, insulin is captured and blood sugar circulation levels are diminished. Thousand patients have been treated according to the patented configurations developed by the team. Despite the fact that many patients had other complications or diseases unrelated to diabetes mellitus saw extraordinary results.

The reverberatory circuitry phenomenon, which influenced the cells and tissues and enabled the interchange of nutrients within the depolarization and repolarization of the human cell membrane, was seen as the key aspect of the treatment. For example, nerve cells that had acquired myelination in the case of neuropathy, a complication developed by diabetes, were affected quite positively. Neuropathy, vasculopathy, and microangiopathy were all eased through the treatment as well.

This discovery was not only going to impact the lives and careers of the members of the team, but the lives of millions who need to be cured of the scourge of diabetes. The genesis of this groundbreaking system drew upon the work of inventors before them. The team gives particular credit to trailblazers such as Houben, whose work on implants to stimulate the pancreas and to measure glucose received a patent in 2002 as well as Whitehurst, who helped to invent the Jaax patents that are implanted in the brain to stimulate the base of the vagus nerve and facilitate delivery of drugs to the pancreas. Dobak (2010) was another predecessor, focusing on a waveform to stimulate the splanchnic nerve and growing the field of knowledge around the resistance of insulin in the body. Gross (2012) was an immediate forerunner of the team’s treatment method, implanting multiple electrodes at many sites in the intestine and pancreas to treat diabetes.

The primary differences between these earlier versions of bioelectrical treatment to combat diabetes and the latest model

involves these primary differences: Most of the earlier systems were quite invasive. The amount of current delivered to the pancreas and other sites needed to be tweaked to perfection. Earlier versions did not successfully stimulate beta cells of the pancreas. Thanks to their hard work, meticulous research, willingness to experiment, and a flair for thinking outside of the box, the team was awarded three US patents that comprised their treatment system to cure diabetes.

SUMMARY of the invention

The United States Patent and Trademark Office, 2014, U.S. Patent No. 8,688,240, entitled Device for Neuro- Physiologic Stimulation

The present invention includes an electromagnetic asymmetric biphasic therapeutic waveform used in neurophysiologic treatment of conditions associated with the opening and closing of ionic and other channels associated with beta cells of the pancreas. The patent invention provides a waveform having particular utility in the neurophysiologic stimulation of nerves innervating the pancreas.

The patent invention provides a method, system, inclusive of a novel circuit, and neurophysiologic stimulator for the treatment of diabetes which uses said waveform. The method and system by which the nerves innervating the pancreas and its beta cells are reached by such waveform through the vagus nerve, celiac ganglia, and associated complexes. It should be noted that the patent invention provides a method, system and apparatus of the above type, by which the inventive waveform facilitates an extended period of opening and functionality of the ionic and other channels of the membranes of beta cells of the pancreas, thereby providing nutrients and membrane potential thereto.

Conceptually, the above-described neurophysiologic waveform and method of treatment operate to correct abnormal polarization and depolarization of the beta cells, such that calcium channel, potassium channel, sodium channels and other vital ionic as well as non-ionic channels are caused to open and close in a more normal fashion. Further, the negative portion of the inventive electromagnetic waveform and, particularly, its long capacitative extension contribute to maintaining open and active ionic channels of the beta cells which would normally close much more rapidly than in any of the prior diabetes technology , whether through means implantable or of external stimulation of the body. Thereby, the healthiest possible membrane potential indicated as area may be achieved for a duration sufficiently long to innervate the channels of the beta cells such that essential ions may reach them, thus enabling the release therefrom of insulin which is otherwise been blocked or handicapped by the diabetes condition TD2. The present methodology has also been found to be corrective of abnormality of the biological clock of cells which clock relates to the normal operation of channels of cell membranes.

The United States Patent and Trademark Office, 2014, U.S. Patent No. 8,688,240, entitled Device for Neuro- Physiologic Stimulation. It describes a certain medical device that is programmed to provide an impulse to an intended body part so that the stimulating mechanism begins to work. This bio-electrical system helps to create electrical waveforms that aid in stimulating the neurological system. Enhancing the bio-stimulation of the brain helps individuals to improve their physiological response. It mainly uses an apparatus that conveys electro-physiologic stimulation of the human nervous system, as an integrated circuit enhances electromagnetic wave response. The device is powered by a battery so that it can function without being attached to a live electrical wire, making it safer than even an typical household appliance.

The waveforms target the beta cells to produce insulin; the waveforms are important because they improve the pancreatic function. Beta cells are targeted and alpha and delta cells are also enhanced so that the body will improve its homeostatic level. The portable device in this patent is protected with specialized durable casing to ensure consistent and long-term application of the treatment to the patient. This patent focuses upon an electrical apparatus that will be utilized by health care professionals. The bio-electrical treatment will enhance the use of wavelengths and ensure that the movement of electrical impulses will be concentrated on the patient’s pancreas. The bio-electrical equipment will be placed on the back, a position that will directly access neuro-stimulation of the beta cells in the pancreas to start producing more insulin. The more the device is applied, especially in the dorsal/central/cervical/lumbosacral part of the patient’s back, the more likely the patient will receive positive results from the treatment.

The present system, however, does not require anti-grounding measures because the power source is the 3V DC battery , and no electrode of the battery is in electrical communication with the other treatment electrode. The battery itself is sealed and is UL approved. It is also important that the skin of the patient be as dry as possible to minimize what is termed “patient leakage current.” In IEC 60601-2-10, patient leakage current is defined as current flowing from the applied part of the body through the patient and to the earth, or flowing from the patient via a Type F device to the earth but originating from an unintended appearance of voltage from an external source, such as a power surge. In this case, the patient leakage current normally would be zero, since the power source of the present system is a battery that is completely isolated from the electrodes of the device. The system complies with the IEC 60601-2-10 standard for patient leakage current, which is that of up to 5 mA in a Type F device. Since a 3V battery is the power source of the system and the negative output of the battery does not communicate with either treatment electrode, the battery cannot be grounded. However, even if the system somehow did become grounded, the potentiometer of the system has a limit condition of 2.5 mA. Therefore, more than 2.5 mA could never be electrically communicated to the treatment electrodes, this value being one-half of the 5.0 mA leakage current limit for a Type F device.

Diabetes Cure Inventive Method and System:

The waveform employed for human application includes a positive portion and a negative portion. Therein, the positive portion is relatively simple, that is, it consists of a vertical upward step followed by a downward slope which in turn is followed by a long sharp downward drop which ends in a negatively directed point . Therefrom, the waveform begins an asymptotic return toward the negative or zero voltage level. The negative pulse aspect, in its early stage, is the same in time as the pulse width of positive part of the waveform, that is, in a range of 40 to 60 milliseconds with 50 milliseconds of each being preferable. Following the first part of the negative aspect, waveform is an extended gradual asymptotic approach of a second aspect of the waveform.

The second part or tail of the negative portion of the waveform is longer than that of the initial portion and, typically, can have a period in the range of about 100 to about 200 milliseconds, with 153 milliseconds representing the preferred embodiment. Accordingly, entire length of the first part of the negative portion starting at point and added to the second portion creates a total of about 206 milliseconds for the entire negative portion of the waveform which, when added to the 50 millisecond pulse width of the positive portion, yields an aggregate wave length of about 256 milliseconds in a preferred embodiment.

As is more fully described below, the primary electromagnetic physiologic function of the positive portion of the waveform is to project the electron content of the waveform through the vagus and celiac complexes of the nervous system, thereby reaching the pancreas and its beta cells through at least celiac axis , pancreatic duct , and superior mesenteric.

In general, it is the positive portion of the waveform that provides inertia or impetus for the movement of the waveform through the nervous system, in accordance with the method below-described, while it is the negative portion , largely facilitated by capacitor described below , which provides the unique benefits of the present system of extending the duration that the positive portion of the waveform will operate to open, normalize or re-polarize the ionic and other channels of the membranes of the beta cells of the pancreas.

The waveform employed may be termed a variable, asymmetric, biphasic wave having an amplitude in the range of 10 to 100 volts AC. The most salient about the waveform is its particular geometry, that is, its biphasic geometry. As above noted, the wave has two portions, namely, said positive portion having a positive pulse width of about 50 milliseconds and the negative portion having a total pulse width of about 156 milliseconds. However, it is the unique shape of the positive and negative portions and respectively of the inventive waveform, which is germane to the function of the inventive method.

As is more fully described above, positive portion and its sharp region is enabled by positive step which operates as a driver or spike which imparts electrons of the desired pulse width, amplitude, current and power throughout the nervous system to the ultimately intended organ, that is, the pancreas and the beta cells thereof, whereas the negative or capacitative portion , including its negative spike and long tail of the waveform , have, as their primary function, the extension of the period during which ionic and other cellular channels, as above described, are kept open, permitting a longer period of inflow or outflow (as the case may be with respect to a particular cellular component), thereby enhancing the effectiveness of the waveform over prior technologies efforts concerning the treatment of diabetes by electrical or electro physical means.

The total duration of portion and portion of waveform is preferably 256 milliseconds, which equates to 3.9 Hertz. It is noted that the preferred frequency of 3.9 Hertz (corresponding to an aggregate pulse width of 256 milliseconds) corresponds generally to three times the beat rate of the human heart when at rest. Thus, the heart at rest normally beats at 1.666 times per second. As such, 3.9 Hertz represents three reiterations of biphasic wave for each beat of the human heart. The waveform above-described may be accomplished through various circuitry in which, more particularly, is a conventional circuit diagram, circuit board schematic of the conventional circuit diagram of block diagram, and micro processor . The system also includes a novel arrangement of treatment electrodes. These electrodes include are electrode A (anode) and electrode B (cathode) in the circuit diagrams. In electrical terms, these electrodes are isolated from any ground (GND) associated with the system so that the integrity of waveform may at all times be maintained.

The circuit may be operated off of a three-volt DC Ultralife cell battery U10004, having a voltage range of 1.5 to 3.3 VDC. The microcontroller is pre-programmed to provide a pulse train of an amplitude and frequency usable by the present circuit.

The amplitude, that is, peak-to-peak amplitude of waveform is controlled by the potentiometer where the voltage from substantially zero to about 100 volts may be obtained, with 70 volts peak-to-peak representing a generally used amplitude, that is, +35V positive and −35 V negative.

In other words, the amplitude of the wave may be controlled from a relatively small to a considerable value as much as, for example, 100 volts peak, but preferably about 70 volts peak-to-peak. Although it is to be appreciated that the microcontroller at its input is powered by battery, which may be a three-volt DC lithium cell battery. As such, it is to be understood that the total power of the output waveform, although much greater in terms of peak-to-peak voltage cannot exceed the power of the three volt DC battery which powers the entire system.

The patent invention provides a block diagram of the microcontroller of the type used. As may be appreciated, a microcontroller of this type may be simply programmed given that its primary function is simply generation of pulse train having an appropriate amplitude, frequency and amperage. The microcontroller detects when battery is connected and thereafter generates a pulse train of appropriate parameters responsive to the instructions that have been programmed into the program memory.

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SPECIAL-PURPOSE DEVICE APPLICATOR

United States Patent and Trademark Office, 2014, U.S. Patent No. 8,768,468, entitled device for Neuro- Physiologic Stimulation

An apparatus for the electro-physiologic stimulation of the human nervous system includes a positive electrical assembly having an integrated circuit (IC) producing a sequence of physiologically compatible and acceptable electromagnetic waveforms, the IC having ungrounded positive and negative outputs of the waveforms, a battery substantially in electrical communication with the IC board, a positive treatment pad at a bottom of the positive assembly in electrical communication with the positive output of the waveforms. An upper and middle housing is in swivel contact with a lower housing. Also included is a flexible housing for the electrical cable. Further included is a negative assembly in electrical communication with an opposite end of the cable, carrying the negative side of the waveforms, a negative treatment pad in axial electrical communication with a bottom of a housing secured about the cable.

Biomolecular LLC produces and sells a revolutionary new medical procedure via a special-purpose device applicator that uses a novelty waveform designed to cure type 1 diabetes, type 2diabetes, and insulin resistance through the neurophysiologic stimulation. Its product is patent-protected and has shown considerable efficacy regenerating insulin-producing cells.

Unique advantages:

Include a novelty waveform that normalizes the ionic channels which give the cells the ability to depolarize and repolarize at the membrane level. The inventive waveform facilitates an extended period of opening and functionality of the ionic and other channels of the membranes of beta cells. Utilizes a specific procedure, the aforementioned device applicator, and waveform to correct the human body’s cell defectiveness of the ionic channels to polarize and repolarize beta cells, enabling them to regenerate.

Via the following factors, our medical procedure and special-purpose device applicator have the ability to cure patients of diabetes type 1, type 2, and insulin resistance: In essence, our stimulation reactivates the cells’ memory, causing them to continue working properly as they did before contracting the disease. The reverberatory circuitry phenomenon. It influences the cells and tissues and enables the interchange of nutrients within the depolarization and repolarization of the human cell membrane. As the cell membranes are regenerated through our treatment, insulin is captured, and blood sugar circulation levels are diminished.

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U.S Trademark registration

US Serial Number: 87287951

The mark consists of the stylized maroon, wording "DIABETES KILLER" appearing above the stylized blue wording "NEW ELECTRO+ NEURO-WAVEFORMS"; a stylized blood drop in five shades of blue appears to the upper-left of the wording "DIABETESKILLER"; at the right of this drop design appears a maroon zig-zag line representing asymmetric biphasic waveforms; the colors white and grey represent background, outlining, shading, and/or transparent areas and are not part of the mark.

Registration No. 5,284,433

Color(s) Claimed: The color(s) maroon and blue is/are claimed as a feature of the mark.

Goods and Services

Disposable Medical Devices to cure Type 2 Diabetes Mellitus

International Class(es)

010 - Primary Class

U.S Class(es)

026, 039, 044

"CURE GLOBAL DIABETES & NOVELTY TREATMENT"

An Innovative Method and Applicator for the Treatment of Diabetes Mellitus and Insulin Resistance

The novelty treatment is applied to the human anatomy by an applicator device used with the trademark DiabetesKiller New-Electro +Neuro-Waveforms, includes the anode and is applied against three general areas of the neurophysiological network.

Type 2 diabetes mellitus is a metabolic syndrome characterized by three important key physiological dysfunctions:

1. Insufficient insulin receptor response to insulin or insulin resistance

2. Abnormal beta cells’ insulin production

3. Irregular glucagon syntheses

These three factors are associated with a genetic predisposition, along with obesity, and are usually used to explain the physiopathology of this widespread and growing disease. Insulin resistance, the first factor in the development of DM type 2, naturally increases with age, pregnancy, and puberty. Several theories have been hypothesized to explain the cellular mechanism that causes diabetes, which includes:

• The diminution of activation enzymes

• Reduced levels of glucose transporter in the cell membrane

• Abnormal receptor activity on target cells’ membranes

• Increased levels of circulating fatty acids

The insulin resistance will be accentuated in people with obesity and a sedentary lifestyle.7 The abnormal beta cells’ insulin production is the second factor in the development of type 2 DM. In the natural history of DM type 2, the secretion of insulin increases initially and exceeds the effect of the insulin resistance, but then it fails and allows the elevation of glucose levels. This produces the intolerance at the initial phase of the disease. The cause of the failure of the beta cells is unknown.

Different theories have been ascribed such as oxidative damage to beta cells or the possible effect of the amyloid polypeptide (amylin), which can bond with pancreatic beta cells and create plates and destruction of these cells. The third dysfunction is glucagon. This causes the liver to produce glucose from glycogen and, in addition, raises fatty acid levels. An anomalous synthesis of this hormone from the pancreas is also seen in this disease.

The elevated levels of glucagon might be related to the low levels of insulin and incretins, which inhibit the activity of alpha pancreatic cells; thus the number of alpha cells will be elevated. The method and special-purpose device applicator, developed by the United States patent No. 8,457,745, reduces the accumulation of glycoproteins in the cell membranes and the thickening of the capillary. This controls the membrane potential and guarantees a better outcome in diabetes patients.

The novelty treatment process starts at points A, B, C, D and E to provide innervations through the celiac complex including the celiac axis into the pancreas, the treatment process at A1, F and G provides electrophysiological stimulation to the vagus nerve and its extensive neural complex .

As the third step of the treatment protocol, the sacral area, therein anode is shown at A2 while the cathode which is placed at position H, the line therebetween being transverse to the S1 vertebrae of the sacral area. The on-off cycle is then twice enabled. This in turn is followed by movement of the cathode to position I. After the steps associated with Points A, A1, and A2, as above described are completed, the treatment process is repeated, however, in spinal axial reversal.

In other words, in the second phase of the three-step treatment process, A, A1 and A2 are all to the right of the spinal column while points A, B, C, D, E, F, G, H and I are all to the left of the spinal column. However, in all other respects, the treatment methodology of Steps 4-6 is identical. Over a period of months, the frequency of treatment can be reduced from every other day to monthly or less. This second phase of the treatment process is to assure that equal neuro stimulation is obtained between the left and the right side of the human body and that, to the extent that the beta cells and the pancreas which have not been reached by innervations from one direction, they will be reached by innervations from the opposite direction.

During the pairs of six second stimulation periods above described, any of pathways A through F may be effected. However, during the two second off or rest periods, only the reverberating circuit is utilized. This is known as the reverberating circuit of the human nervous system and reaches muscle layers as well as nerves. Through these electrical processes, whether occurring during the on or off period of treatment operate to facilitate the intestinal mucosa which, it is known releases cholecystokinin which in turn enables release of insulin from the beta cells. The reverberating circuit continues to function for many hours after a treatment is complete. The neural pathways are also central in increasing electron activity within the efferent, afferent, and parasympathetic fibers, many of which are carried within the vagus nerve and its extensive complex which reaches nearly every part of the human body.

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If you are a Diabetic patient, we need your signature to implement the patent technology to cure Diabetes without medication. The goal for technology implementation is 1 million signatures. Thank you for your support.

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cost of diabetes worldwide

Cost of diabetes hits $2.5 Trillion (2,500,000,000,000) By Year 2030

The global cost of diabetes is set to almost double to $2.5 trillion by 2030 finds research from King’s College London. It suggests that even if countries meet internationally set targets, the global economic burden from the disease will still increase by 88%. Diabetes is a major global health threat, and the number of cases is rapidly increasing. Recent estimates suggest that the number of people with diabetes across the world will increase from 415million in 2015 to 642million by 2040. Researchers from King’s, in collaboration with colleagues from The University of Gottingen, have now estimated future economic burden of the disease. This is calculated by looking at costs from medical care and costs incurred through loss of productivity and earnings in 180 countries across the world. They did this by assuming three different scenarios. First the prevalence and death rate associated with diabetes increasing in line with urbanisation and an ageing population, secondly the (even greater) increase if previous trends continue, and thirdly if global targets set to diabetes burden are achieved. The team found that, under all three scenarios, the economic cost of diabetes is predicted to increase significantly by 2030. They also found that a large economic burden isn’t limited to high-income countries in the West but is widely dispersed throughout the world. Justine Davies, Centre for Global Health, who co-led the paper, says: ‘It is imperative that actions are taken to reduce some of the risk factors for diabetes, for instance obesity and physical inactivity, to ensure costs do not rise further. ‘Policy makers also need to take urgent steps to prepare health and social security systems to mitigate the effects of diabetes.’ Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030 (Diabetes Care 2018 Feb; https://doi.org/10.2337/dc17-1962)

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Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030 (Diabetes Care 2018 Feb; https://doi.org/10.2337/dc17-1962)

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Why It's Time to Take Electrified Medicine Seriously

Bioelectronic Medicine

The remarkable convergence of advances in bioengineering and neurology has resulted in a fast-developing way to treat chronic diseases, known as bioelectronic medicine. These advances allow scientists to identify specific nerves and implant devices that can be activated when needed to stimulate or dial down their activity; that in turn controls cells in organs targeted by those nerves that regulate the body’s many immune and metabolic responses. While some bioelectronic, or electroceutical, therapies already exist to treat conditions such as headaches, certain cases of depression, as well as chronic and sinus pain, the new wave of electricity-based strategies could expand to help people with some of the most widespread chronic diseases in the world, including high blood pressure, arthritis, diabetes, some forms of blindness and even dementia.

Such promise is already attracting scores of startups and major drug companies. Even with the still rudimentary efforts at stimulating some of the larger nerves in the body to treat, for example, headaches and chronic pain, financial analysts expect the market to reach $7 billion by 2025. Companies like Abbott already have neuromodulation devices designed to stimulate nerves, approved by the Food and Drug Administration, for treating chronic pain. The potential of the electroceutical field is part of a profound shift in the pharmaceutical- industry, which has long been focused primarily on developing new pills. But as blockbuster drug development has stalled in recent years, established pharmaceutical companies like Glaxo-Smith-Kline see electroceuticals as a way to mine a new source of therapeutic possibility—through nondrug treatments that rely more heavily on device and procedure-based methods, such as gene therapies and the recently approved CAR T-cell treatments for certain cancers. “There has been frustration that for many diseases for which we make new drugs, there hasn’t been tremendous progress,” says Dr. Brian Litt, professor of neurology and director of the Penn Epilepsy Center at the University of Pennsylvania. If more of the chronic diseases that continue to command the most prescriptions and health care services can be treated with bioelectronic approaches, the market for the field could approach $40 billion. Electroceuticals “are the next wave of new treatments we will have to treat disease,” says Kris Famm, president of Galvani Bioelectronics, a biotech collaboration between Glaxo-Smith-Kline and Google’s Verily that is focused on developing electricity-based therapies.

The idea tapping into the body’s electrical network is centuries old. In the late 1700s, Italian scientist Luigi Galvani was walking through an open market during a lightning storm when he noticed that frog legs for sale were still twitching. Intrigued, he conducted among the first studies of electrical stimulation, using an electrode to pass a current through a frog leg and observing that the signal prompted the muscles to move.

Medicine’s attempts to exploit this system grew more refined with time. The earliest were as likely to be hit or miss. In the 1930s, nerves in the brain were stimulated to understand and alleviate some of the symptoms of epilepsy. Electroconvulsive therapy destroyed or compromised nerves to address psychiatric disorders such as schizophrenia and bipolar. In recent decades, with better understanding of how electrical signals work in the body, more effective bioelectronic devices focused on refined modulation of electrical signals—including pacemakers for the heart, cochlear implants, as well as devices to control urinary incontinence and strategies for helping paralyzed muscles to move—have made it to market.

As researchers have learned more about how cells communicate electronically with one another, they are fueling a more sophisticated surge in bioelectronic devices that is delving deeper into more complicated neural networks. Innovations in engineering that are packing chips and other electronic components into tinier and tinier kits to implant in the body, with more power to communicate, charge, stimulate and record, are also expanding the range of diseases that might be treated with a bioelectronic therapy.

In the not too distant future, for example, scientists anticipate that patients with rheumatoid arthritis will no longer suffer from excruciating pain in their joints, but may be able to turn on an implanted electrical device to quiet the immune response that drives their painful inflammation. Or someone with high blood pressure could get an electrical device that would control how well the kidneys filter fluids, alleviating the need to pop pills every day. Or a diabetic could avoid the constant cycle of blood checks and pills or insulin shots, with an electroceutical device at the pancreas that protects their insulin-producing cells. At Massachusetts General Hospital, researchers are working on ways to activate nerves in the eye to restore vision in people with retinal disease, while scientists at Johns Hopkins are convinced that manipulating electrical signals in the brain in just the right way could address conditions from depression to dementia.

That's the vision of the future promised by electroceuticals. Nerves in the body that regulate specific organs—really specific cells in those organs—could be controlled with the precision of an orchestra conductor calling on specific instruments to generate just the right harmony. “The nervous system really uses electricity as its language,” says Robert Kirsch, chair of biomedical engineering at Case Western Reserve University and executive director of the Cleveland FES Center. “So electrical stimulation can be used theoretically just about anywhere in the nervous system. We need to learn how to speak that language.”

Other companies, like SetPoint Medical, which conducted Owens’ trial, are focusing on the vagus nerve. Named after the Latin word for wandering, the vagus is rooted in the brain stem and branches into the neck, chest and abdomen. It controls everything from sensory functions to swallowing, digestion, respiration and heart rate. Scientists are taking advantage of the fact that the vagus serves as something like a volume control for the nervous system, and because of the relative ease in accessing the nerve—it’s the longest one in the body extending from the brain—it’s an obvious target for those eager to wade into the world of electrical stimulation. But researchers are treading carefully to ensure they trace the vagus’ myriad fringelike connections to the right tissue and the right function. While it starts out as a discrete trunk, the vagus, like many of the other large neural networks in the body, eventually dwindles into brush like bundles of nerve endings that tap into different organs, different tissues within those organs, and finally different cells within those tissues. “It’s like trying to make a telephone call by putting the call over every single line that is available,” says Kirsch. “It goes to the right line, but it goes to all the other places too.”

Kyrana Tsapkini, assistant professor of neurology at Johns Hopkins, is relying on that ability to target nerves to tap into complex functions of the brain, from language to memory. For the past decade, she and her team have been building one of the world’s largest databases on the ways electrical stimulation can affect a variety of neurodegenerative disorders, and the results are already encouraging. In a study of 36 people with Alzheimer’s disease, those who received electrical stimulation showed improvement in their ability to remember words, compared with people who did not get the treatment. Tsapkini is building a database of patients with not just Alzheimer’s but also other neurodegenerative disorders to get a better sense of who might benefit most from a bioelectronic strategy to keep their cognitive functions intact. For patients like Owens, the early results have been transformative, and she hopes her experience as one of the first to test her device changes the way diseases like hers are treated. Desperate for more options after she’d exhausted the available treatments, she was scouring Facebook for any advice about new therapies when she came across a video interview with Dr. Kevin Tracey, a neurosurgeon at the Feinstein Institute for Medical Research in Manhasset, N.Y. It was 2017, and he had just published his discovery that the body’s inflammatory response was regulated by the vagus nerve. Tracey had founded Set Point Medical to test the idea that manipulating the electrical signals running along the vagus could control inflammation in auto-immune disorders like Crohn’s.

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Advances in bioengineering and neurology has resulted in a fast-developing way to treat chronic diseases including diabetes, known as bioelectronic medicine.

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An Apparatus for the electro-physiologic Stimulation of the Human Nervous System

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United States Patent and Trademark Office, 2013, U.S. Patent No. 8,457,745, entitled Method, System and Apparatus for Control of Pancreatic Beta Cell Function to Improve Glucose Homeostasis and Insulin Production

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Finding the Essential Link in the Discovery of a Cure for Diabetes

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The United States Patent and Trademark Office, 2014, U.S. Patent No. 8,688,240, entitled Device for Neuro- Physiologic Stimulation

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United States Patent and Trademark Office, 2014, U.S. Patent No. 8,768,468, entitled device for Neuro- Physiologic Stimulation

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cost of diabetes worldwide

Cost of diabetes hits $2.5 Trillion (2,500,000,000,000) By Year 2030

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Why It's Time to Take Electrified Medicine Seriously

Bioelectronic Medicine

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