VitalCare Announces FDA Approval of Infusion Device Used for iCAT Therapy
National Announcement of FDA Approved Infusion Technology
CARSON CITY, Nev.--(BUSINESS WIRE)--VitalCare Diabetes Treatment Centers, Inc. (NASDAQ: VDTI - News), a Nevada Corporation, today announced the FDA approval (called allowance to market) exists for the infusion devices used by VitalCare for its Intracellular Activation Therapy (iCAT) treatment of Type 1 and Type 2 diabetes. Jimmy McDougald, CEO stated, stated, “This is a major factor in the establishment of our treatment centers, as we begin to move iCAT into the commercial market.”
iCAT Therapy utilizes the special use micro-pulse insulin delivery pump with proprietary software (algorithms) incorporated into its logic. This uniquely designed pump delivers small “micro-doses” of insulin in a pattern which mimics the way a normal pancreas secretes insulin which is used by the liver. iCAT Therapy also uses “real-time” measurements of the patient’s blood sugar levels and bodywide metabolic rate by the use of a metabolic measurement cart. This data is inputted into the pump which automatically adjusts the next insulin dosage to stimulate more normal metabolism. The metabolic cart uses state-of-the-art technology to measure exhaled CO2 from the exhaled breath of the patient, and the result of our iCAT Therapy is the “reactivation” of normal metabolism in the patient. With normalization of liver enzyme functions, the body’s cells begin to utilize glucose, something that people with diabetes cannot do normally. This treatment restores the optimum metabolism bodywide which promotes healing.
By addressing the core problem of diabetes, improper metabolism (fat metabolism), iCAT Therapy is able to achieve unique stabilization of diabetes complications, and in many cases, a reversal of the secondary complications of both Type 1 and Type 2 diabetes has been clinically documented. No other technology or protocol has ever demonstrated this type or level of success.
There are over 20.8 million children and adults in the United States, approximately 7% of the US population, who have diabetes. While an estimated 14.6 million have been diagnosed with diabetes, roughly 6.2 million people (or nearly one-third) are unaware that they have the disease.
In 2007, the total estimated cost of diabetes in the United States was $174 billion in terms of direct medical expenditures and lost productivity. Diabetes is more than a major health crisis - it’s a legitimate national threat to America’s economy. Jimmy McDougald, CEO, further stated, “With the only FDA approved device delivering this treatment, we will expect to sign agreements to start the establishment of iCAT Treatment Centers immediately.”
VitalCare Diabetes Treatment Centers, Inc.
BREAKTHROUGH MEDICAL TECHNOLOGY
VitalCare Diabetes Treatment Centers are leading the way to a healthier life for diabetics—
Understanding diabetes and the role of insulin
Diabetes is a common condition in which the amount of glucose (sugar) in the blood is too high because the body is unable to use it properly. This is because the body´s method of converting glucose into energy as the “primary fuel” for cellular metabolism is not working as it should. In fact, the cells compensate by switching to “fat metabolism” as the primary cellular fuel, since they can’t use glucose due to insulin insufficiency or the liver's desensitization to insulin. Diabetes can lead to serious complications, such as heart disease, strokes, amputations, eye and kidney damage, and premature death. The hormone, insulin, carefully controls the amount of glucose in the blood. Insulin is produced by the pancreas and triggers enzymatic processes within the liver which allows glucose to enter the cells where it is used as the “primary fuel” source throughout the body.
Many people with Type 1 and Type 2 diabetes are dependent on insulin injections and are in jeopardy of persistent fluctuations of their blood sugar. Our micro-pulsed insulin treatment has been developed, tested and shown to be extremely effective. It is without any documented side effects or complications with over 100,000 treatments given to date. This proprietary treatment protocol is precise and only requires one insulin treatment every 7-10 days. VitalCare Technology is working together with its strategic partners to turn this "Medical Miracle" into a diabetic, complication free…"Reality".
VitalCare's Medically accomplished team is moving this patented and FDA approved technology into the commercial market working with Certified Licensed Healthcare Providers who are delivering Intercellular Activation Therapy or “iCAT Therapy” in licensed “VitalCare Diabetes Treatment Centers”. The therapy uses a specially designed micro-dose pulsatile insulin pump that delivers micro-doses of insulin, identical to the way a normal pancreas secretes insulin into the blood stream delivering insulin to the liver during and after a meal, while “real-time” measurements of the patient’s blood sugar level and metabolic rate, using end-tidal CO2 measurements are obtained from the patient using a metabolic cart. This data is inputted into the computer adjusting the insulin dosage. The metabolic cart uses state-of-the-art technology to measure exhaled CO2 thru a small mouth piece. The result of “iCAT” treatment is the “reactivation” of the patient’s metabolism as seen with normalization of liver enzyme function which returns the body cells back to utilizing glucose, to optimize cellular metabolism. The iCAT Treatment leads to the stabilization and in many cases a reversal of secondary complications seen in Type 2 diabetes. Stabilization of Type 1 diabetes is seen, as well. No other technology or protocol has demonstrated this same level of success in clinical trials as iCAT Therapy.
VitalCare Diabetes Treatment Centers, Inc.
Highlights
VitalCare Technology key Issues
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Demand for Insulin Delivery technologies that work is rising
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Effectiveness of traditional insulin treatment showing decline with increasing Diabetic population
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Type II diabetes therapy market is expected to exceed US $15.3 Billion by 2013
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Oral dosing is currently under clinical trials with Insulin inhalers reaching the market in 2007
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VitalCare Technology Enterprises’ Clinical, Medical, Scientific and Executive leaders are poised to create a new standard of care for the treatment of both Type I and Type II diabetes.
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VitalCare signs strategic partnership with CAT Clinics, LLC, BIONICA International, Inc, & MedEdCo, LLC to market, sell, license and open Corporately owned CAT Clinics.
Press - VitalCare In The News
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VitalCare Technology Enterprises is established for development of Intercellular Activation Therapy Diabetes Centers, affiliated with CAT Clinics, LLC, BIONICA International and MedEdCo Corporation.
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“Stock Exchange” Agreements signed between VitalCare Technology, CAT Clinics, LLC, and MedEdCo Corporation, providing a co-ownership relationship between the three companies for the purpose of promotion and expansion of the iCAT Diabetes Center business opportunity Licensing Agreement Signed between VitalCare Technology and CAT Clinics, LLC and BIONICA International.
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Management Service Agreement signed between VitalCare Technology and MedEdCo Corporation for ongoing clinical support, professional education and credentialing, and quality assurance services.
In addition to published research articles in peer reviewed journals featuring iCAT therapy’s clinical success the Company will use its patient testimonials concerning the life-changing benefits they received from iCAT therapy as in the following documented patient testimonials:
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“My neuropathy didn’t allow me to sleep at night. I was in constant pain from the knees down. My husband couldn’t sleep and nothing helped. After several weeks of Cellular Activation Therapy, I noticed changes. Now I take no pain medication at all and have no twinges.” (54, white, woman 28 years Type 1 on iCAT therapy for 8 years)
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“ I am now independent and can go anywhere. I had severe cardiac myopathy. Since I have been on the program, I have lowered my insulin from 150 units per day to 24 units daily. It worked after 3 weeks. I have more energy; before, I slept all the time. I now have a very active life.” (53-year-old woman on a heart transplant list for 3 years; on iCAT therapy for 5 years.)
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The youngest person ever to be treated with iCAT therapy to date started treatments at age 5. Today that little girls of 5 has attained the age of 32 and has become a mother for the third time. Her pregnancies were without any hypoglycemic events or hypertension, throughout each trimester, as she continued on iCAT therapy utilizing the in-home therapy protocol. As the first of the homecare test patients, she delivered healthy normal babies at full term without one side effect or complication and to date has never had any complications or side effects to iCAT therapy. Her picture can be seen on the “portal” website at: www.diabetes.net.
VitalCare Diabetes Treatment Centers, Inc. is a Bio-tech company that is commercializing a cutting edge FDA approved technology for treating metabolic disorders specifically targeting Type 1 and Type 2 Diabetes and Secondary Complications of Type 2 Diabetes. The Treatment is known as Intercellular Activation Therapy “iCAT” and uses an FDA approved, US and European patented micro-dose intravenous insulin pump combined with proprietary algorithms and peer reviewed clinical protocols.
Business
Approximately 100,000 treatments spanning over the past 25+ years have been administered. proving the effectiveness of iCAT therapy with not one negative side effect or medical complication reported. There are a number of peer reviewed published articles by top medical researchers in the field of Diabetes, Wound Care and Endocrinology who've determined that iCAT Therapy is by far the most successful adjunct to traditional treatment for Secondary Complications of Type 2 Diabetes and treatment for Type 1 and Type 2 Diabetes.
VitalCare entered into an exclusive Licensing Agreement with the manufacturer of the patented and FDA approved micro-dose intravenous insulin pump and the exclusive developer of the proprietary algorithms and clinical protocols, who provides ongoing clinical oversight, medical training and quality control services to all certified VitalCare Diabetes Treatment Centers and affiliates. These exclusive licenses for North America include the USA, Canada and Mexico with further rights to expand internationally with some exclusions.
VitalCare will seek to open company owned VitalCare Diabetes Treatment Centers, identify and license the technology to healthcare specialists who meet stringent criteria for “Certification”, and license the iCAT Therapy to Insurance Plans and HMO’s under a Disease Management program. iCAT Therapy will initially be introduced to the consumer market as a rescue treatment for “Brittle Diabetic” patients suffering from secondary complications of Type 2 Diabetes, to include; difficult to heal wounds, high blood pressure, heart disease, visual impairment and kidney disease, using the patented and FDA approved micro-dose intravenous insulin pump device.
Currently, there are approximately 30 licensed iCAT clinics operating in North America, including Florida, Arizona, Utah, California, Texas and Nevada. VitalCare has an ownership joint-venture interest in two wound care centers in Indiana and has acquired joint ownership in the iCAT clinic located in Scottsdale, AZ. VitalCare is currently in negotiations for acquisitions with an iCAT clinic in Sacramento, CA and one in Draper, UT. VitalCare anticipates having clinics opened, either Company owned, joint venture or sub-licensed affiliates, in all fifty states by year end 2010.
Medical Devices
iCAT is delivered exclusively with the FDA approved, US and European patented micro-dose intravenous insulin pump device sold via an exclusive purchasing agreement through VitalCare. In addition to licensing and distribution of the insulin pumps, VitalCare will also market and distribute metabolic carts used to measure the patient’s Respiratory Quotient (“RQ”). In the future, VitalCare plans on licensing and marketing the proprietary pre-filled insulin cartridges that will operate only with VitalCare’s insulin pump technology.
iCAT Therapy has been independently proven to be safe and effective for Type 1 and Type 2 Diabetes and most secondary medical complications of Type 2 Diabetes with additional Medical Patents issued for; cardiovascular disease, diabetic wounds, retinopathy, secondary hypertension and kidney disease. In addition, iCAT Therapy has been found to improve all the general maladies of diabetes including lack of well-being, low energy, improving sleep, and there is anecdotal data on improvement in erectile dysfunction. iCAT Therapy has been proven safe and effective on the most difficult and critically ill patients who have failed all conventional therapies commonly referred to as “Brittle Diabetics”. Both patients and their physicians see positive results within a few treatment sessions. There is currently no other therapy known to have this high degree of clinical outcomes at or exceeding iCAT Therapy, with a documented 93%+ clinical outcome for patients between the ages of 5 years to 90+ years of age.
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