$MILV here is an early peak at what CCA, who is R/M with $MILV is bringing to the R/M. PR's news, SEC Form 10, 2 websites, 2 years of audited financials by the new auditor 8-K filed with SEC. all in the works. Fast forward to the bottom for the meat folks!!!!
"Every 23 seconds in the United States an individual experiences a traumatic brain injury (TBI), with a fatality occurring once every 7 minutes. TBI touches the lives of an estimated 1.7 million people in the U.S. annually – 52,000 die, 275,000 are hospitalized and 1,365,000, nearly 80%, are treated and released from an emergency department. TBI is a contributing factor to nearly a third (30.5%) of all injury-related deaths in the United States. While these statistics are staggering, the occurrence of traumatic brain injury is likely underestimated and thus has been termed “a silent epidemic.”
Traumatic Brain Injury has become one of the signature injuries of Operation Enduring Freedom and Operation Iraqi Freedom.
According to the Wounded Warriors Project, 320,000 brave men and women who fought gallantly for our nation in the theaters of Iraq and Afghanistan suffered a TBI.
Of all military personnel who experienced injuries because of hostile fire and who were evacuated to Walter Reed Army Medical Center, 28% endured a TBI.
So many of our nation’s heroes have been left with the invisible scars of war; for those who suffered traumatic brain injury, the hidden marks of combat can lead to depression, posttraumatic stress syndrome, and loss of psychosocial skills.
The ubiquitous impacts of traumatic brain injury transcend the arena of combat to the arena of sports. Head impacts and concussions caused by contact sports are a quickly growing epidemic among young athletes. According to reports from the Centers for Disease Control (CDC), the number of reported concussions has doubled in the last ten years.
The American Academy of Pediatrics has reported that emergency room visits for concussions in children ages 8 to 13 years old has doubled, and concussions have risen 200 percent among teens ages 14 to 19 in the last decade. Concussion is simply another name for mild TBI that, left undetected, can result in long-term brain damage and may even prove fatal.
While football tends to dominate discussions concerning TBI and concussions, data from the American Society of Neurological Surgeons suggests riding a bicycle is far more dangerous than hitting the gridiron. Cycling accidents were involved in 86,000 of the 447,000 sports-related head injuries in 2009; football accounted for only 47,000 of those incidents.
Statistics provided by the U.S. Consumer Product Safety Commission (CPSC) reveals the following ten sports/recreational activities contribute to the highest number of head injuries treated in U.S. emergency rooms (ranked in order of highest occurrence and contributory factor):
1. Cycling 2. Football 3. Baseball and Softball 4. Basketball 5. Water Sports (Diving, Scuba Diving, Surfing, Swimming, Water Polo, Water Skiing, Water Tubing) 6. Powered Recreational Vehicles (ATVs, Dune Buggies, Go-Carts, Mini bikes, Off-road) 7. Soccer 8. Skateboards/Scooters 9. Fitness/Exercise Health Club 10. Winter Sports (Skiing, Sledding, Snowboarding, Snowmobiling)
Surprisingly, there are more incidents of treatment for head-injuries sustained while playing golf than competing in hockey, rugby or lacrosse; this demonstrates contact sports are not requisite for TBI.
The CPSC further assorts the top ten head-injury categories among children ages 14 and younger:
1. Cycling 2. Football 3. Baseball and Softball 4. Basketball 5. Skateboards/Scooters 6. Water Sports 7. Soccer 8. Powered Recreational Vehicles 9. Winter Sports 10. Trampolines
In 2002, a rare disease was found in the brain of NFL legend Mike Webster. Nicknamed “Iron Mike” for his legendary toughness, Webster missed only four games over the course of his sixteen year career. Yet his grit could not help him overcome the disease of chronic traumatic encephalopathy (CTE) that was discovered in his brain after his untimely death at age 50. CTE is a progressive degenerative disease of the brain found in people with a history of repetitive brain trauma, including symptomatic concussions as well as subconcussive hits to the head that do not cause symptoms and can manifest into memory loss, impaired judgment, depression, aggression, advanced dementia and in the case of at least eight former football players, suicide.
According to findings published by the Department of Veterans Affairs’ brain repository in Bedford, Massachusetts, the number of cases of chronic traumatic encephalopathy (CTE) has experienced a two-fold increase over the last decade. Researchers there examined the brain tissue of 128 football players who, before their deaths, played the game professionally, semiprofessionally, in college or in high school. Of that sample, 101 players, or just under 80%, tested positive for CTE. The brain bank further examined the brains of 79 deceased NFL players and found evidence of degenerative brain disease in 76 of those players. Recently, the NFL
released estimates that nearly three in ten former players will develop debilitating brain conditions, and that they will be stricken earlier and at least twice as often as the general population. The league expects about 6,000 of the 19,400 retired players, or 28 percent, to develop Alzheimer's disease or at least moderate dementia. Dozens more will be diagnosed with Lou Gehrig's or Parkinson's disease during their lives, according to the data.
The Washington Post, in a February 2015 article, asserts the flood of media attention highlighting damaged brains, dementia and suicides in retired NFL players has made concussions synonymous with football. That attention was greatly needed as the debilitating consequences of brain injuries in football players of all ages has been severely overlooked. But the focus of this controversy has been far too narrow. It is true that young players need better equipment and stricter safety standards on the gridiron. But in many of the most popular sports, boys aren’t the ones most likely to be afflicted by concussions. Girls are.
Recent studies of high school and collegiate athletes have shown that girls and women suffer from concussions at higher rates than boys and men in similar sports — often significantly higher. For instance, in a recent analysis of college athletic injuries, female softball players experienced concussions at double the rate of male baseball players. Women also experienced higher rates of concussions than men in basketball and soccer. Across all sports in the study, the highest rate of concussions was reported not by male football players, but by female ice hockey players. In that sport, a woman experienced a concussion once every 1,100 games or practices, nearly three times the rate experienced in football. The gender disparity exists in high school sports, too. One study, analyzing concussion data for athletes in 25 high schools, found that in soccer, girls experienced concussions at twice the rate of boys.
Whether due to a traumatic brain injury sustained on the battlefield or on the home-front, cognitive impairment is a common consequence of such affliction. Sadly, no United States Food and Drug Administration (FDA) approved treatments for cognitive impairments due to TBI exist. Treatments for posttraumatic cognitive impairments are non-pharmacologic and include education, realistic expectation setting, environmental and lifestyle modifications, and cognitive rehabilitation.
Dietary amino acids, glucagon-like peptides administered in the treatment of Type II Diabetes and even plants used in Chinese and Indian traditional medicine have shown promise in ameliorating injury-induced cognitive damage. Yet their virtue and that of other potentially therapeutic agents (PNA) for cognitive harm and other Central Nervous System (CNS) maladies are impeded by the pathophysiological nature of the Blood-Brain-Barrier (BBB).
More than 100 years ago it was discovered that if blue dye was injected into the bloodstream of an animal, tissues of the whole body EXCEPT the brain and spinal cord would turn blue. To explain this, scientists conceived the notion of a Blood-Brain-Barrier, a biological palisade preventing materials from the blood from entering the brain. More recently, scientists have discovered much more about the structure and function of the BBB.
The BBB is a semi-permeable biological barrier; that is, it allows some materials to cross while preventing others from entering the brain. In most parts of the body, the smallest blood vessels,
called capillaries, are lined with endothelial cells. Endothelial tissue has small spaces between each individual cell so substances can move readily between the inside and outside of the vessel. However, in the brain, the endothelial cells fit tightly together and substances cannot pass out of the bloodstream.
The brain is a highly sensitive and fragile neuronal organ; the Blood-Brain-Barrier ensures it receives its regular supply of fuels, gases, and nutrients essential for maintaining homeostasis and other vital functions while effectively protecting the brain from many common bacterial infections. Yet, this custodial nature of the BBB inhibits delivery of therapeutic agents to the CNS and imposes obstruction for delivery of large numbers of drugs, including antibiotics, antineoplastic agents, and neuropeptides, to pass through the endothelial capillaries to the brain.
The efficacy of a drug designed to mend cognitive damage is predicated upon its successful delivery into the brain and its proper distribution, and while several drug delivery methods and strategies have been developed for injury-induced cognitive impairment and other CNS related disease therapeutics, most of them are proved invasive and lack target specificity. Nanotechnology, more specifically nano-enabled delivery systems, offer a promising solution to improve the uptake and targeted delivery of the drugs into the brain and are proved to be the best method of transferring drugs across the BBB.
Nanoparticles are tiny molecules made up of natural or artificial polymers that interact with and easily traverse biological barriers, allowing for effective drug targeting and bio-distribution of pharmaceuticals in a controlled manner. These tiny particles range in size from between 10 and 100,000 nanometers – To put the size of a nanometer in context, the thickness of a sheet of paper is 100,000 nanometers while the thickness of a strand of human hair is 80,000 nanometers; nanoparticles become invisible to the human eye at 130 nanometers.
Compelling Competitive Advantage, LLC (CCA) owns a versatile and widely applicable biotechnology asset base. Its Nanoscale Particle Complex (NPC) technology represents the leading edge of nano-encapsulation delivery systems (less than 100 nanometers in diameter; mean diameter of 40 nanometers in current liquid product samples with the capability to engineer significantly smaller nano-carrier particles) that create instant delivery of therapeutic payloads into the blood stream, beginning through the membranes of the mouth. This mean diameter of 40 nanometers equates to 40 nanoparticles of therapeutic agents crossing the BBB into blood brain tissue. Small equals fast! This instant delivery aspect functions as an “Oral IV;” providing the patient with instant gratification and effect upon consumption of the product utilizing the NPC delivery mechanism.
While nanoparticles may be composed of natural AND artificial polymers, CCA’s technology is categorized as a food product by the FDA being comprised of lecithin from soy bean sources, water and small amounts of denatured alcohol. As a point of fact, many individuals produce a product with a small component of particles similar in size to the company’s NPC technology everyday – shakes and smoothies. The process of adding soy bean lecithin into water with other food materials and juices followed by subjecting the mixture to a blender or food processor yields a nutritional “drink” containing macro particulates, and even a small amount of nanoparticles. Individuals consuming these drinks have, in fact, been consuming a product
similar to CCA’s without any reported deleterious effects or warnings and regulation by the FDA.
CCA’s organic nanoparticle design is of utmost importance as toxicity is an extremely important factor and limitation of drug delivery studies and a major area of interest in research on nanoparticle delivery to the brain.
Although solid nanoparticles may be used for drug targeting, when reaching the intended diseased site in the body, the drug carried needs to be released. Thus, for drug delivery, biodegradable nanoparticle formulations are needed as it is the intention to transport and release the drug in order to be effective.
However, model studies to the behavior of nanoparticles have largely been conducted with non-degradable particles comprised of nonbiological components such as metals like iron or cadmium.. Most data concerning the biological behavior and toxicity of particles comes from studies on inhaled nanoparticles as part of the unintended release of ultrafine or nanoparticles by combustion derived processes such as diesel exhaust particles. Research has demonstrated that exposure to these combustion derived ultrafine particles/nanoparticles is associated with a wide variety of effects including pulmonary inflammation, immune adjuvant effects and systemic effects including blood coagulation and cardiovascular effects. Since the cut-off size for both ultrafine and nanoparticles (100 nanometers in size) is the same, now both terms are used as equivalent. Based on the adverse effects of ultrafine particles as part of environmental pollution, engineered nanoparticles may be suspected of having similar adverse effects.
The company’s technology, validated by top scientists within the biotechnology stratum at the University of Pennsylvania, led the university to execute an agreement for the conduction of codevelopment activities with CCA and its NPC technology;
specifically, the creation of an effective delivery mechanism to the bloodstream and transmission across the Blood-BrainBarrier.
CCA is working together with the university and the Children’s Hospital of Philadelphia (CHOP) on the co-development of a new treatment for cognitive impairment resulting from TBI.
The university and children’s hospital have successfully validated the use of certain amino acids in the repair of brain tissue in the context of TBI;
CCA’s NPC technology shall provide a fast and effective, orally administered delivery mechanism across the BBB for this promising therapeutic. In simplest terms, CCA’s nanoparticle delivery complex acts as a guardian, shepherding a safe and controlled passage for healing drugs across the Blood-Brain-Barrier. Significant market potential for this co-owned technology is expected in the treatment of brain injuries from accidents and military injuries, and from the aging population, especially those with adult dementia.
Nanoparticles have enormous medical applications, beyond assisting in the treatment of TBI, providing massive advantages regarding drug targeting, delivery, and release over conventional drug delivery techniques. Nanoparticles are proved to be the best delivery systems for the treatment of a variety of neurodegenerative and virus generated diseases and potentially may be used in anti-tumor therapy, gene therapy, AIDS therapy and radiotherapy. More specifically, nanoparticles have wider application in brain tumor therapy, cancer treatment and Alzheimer’s disease.
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