Medical Equipment Producer Business Plan. Home. Business Plans Handbook. Business Plans Volume 1. Medical Equipment Producer Business Plan. BUSINESS PLAN. PREMIUM THERAPY, LLC. Serial Dilution Advantages And Disadvantages' title='Serial Dilution Advantages And Disadvantages' />Miller Street. Cambridge, Massachusetts 0. Premium Therapy, LLC is a medical device company focused on the field of. It has designed and developed a patented. Electro. Magnetic Induction Therapy EMIT in large. EXECUTIVE SUMMARY. COMPANY SUMMARY. TECHNOLOGY. PRODUCTS. COMPETITION. STRATEGY IMPLEMENTATION SUMMARY. MANAGEMENT TEAM. OPERATIONAL PLAN. FINANCIAL PLAN. APPENDIX. International Journal of Engineering Research and Applications IJERA is an open access online peer reviewed international journal that publishes research. Pour plate method is usually the method of choice for counting the number of colonyforming bacteria present in a liquid specimen. In this method, fixed amount of. EXECUTIVE SUMMARY. Premium Therapy, LLC is a medical device company focused on the field of. It has designed and developed a patented. Electro. Magnetic Induction Therapy EMIT in large. Most+Probable+Number+Advantages+Disadvantages.jpg' alt='Serial Dilution Advantages And Disadvantages' title='Serial Dilution Advantages And Disadvantages' />2 Benefits of the fuel cell technology. Stacks and systems. Now moving from the single fuel cell unit to realworld systems, what do we have to add to get them. The terms decubitus ulcer from Latin decumbere, to lie down, pressure sore, and pressure ulcer often are used interchangeably in the medical community. Productivity erythropetin, glycosylation and cell count reply 1 cell lysate colorless reply 1 How to prevent cell aggregation reply 1. Chapter 10 Respiratory System STRUCTURE AND FUNCTION. Morton Lippmann. The respiratory system extends from the breathing zone just outside of the nose and mouth. Technology. Pulsed electromagnetic stimulation is a well established technique with a. The scientific principle. These fields, in turn, have been. When applied to the human body, pulsed electromagnetic stimulation. Harnessing these benefits, the company has developed EMIT as a new and. Using this technology, Premium. Therapy plans to treat a variety of medical conditions. A full utility. patent that provides protection for Premium Therapys technology. U. S. and is currently pending approval. Premium Therapy will target market segments comprised of persons desiring. Together, the several market segments yield an initial. U. S. market of greater than 2. In a recent survey of individuals suffering from these conditions, a large. In fact, almost half of all respondents indicated that they. Based on this data, and Premium. Therapys calculations, over 9. Market Segmentation. It is this group of poorly managed patients that Premium Therapy expects. Premium Therapys new device, the EMIT system, consists of two. Logic Controller LC, which generates the. Array of Overlapping Coils AOC, through which. Premium Therapys novel technology is embodied in the patented form. AOC, which contains a series of overlapping coils encased within an. The ergonomic wraps have been designed for. EMIT and are easily placed by any untrained. For. example, the ergonomic AOC wrap developed for the knee contains. Premium Therapys technology is incorporated into the two models of. EMIT system EMIT MX and EMIT SX. The two models of this system each. The EMIT MX model generates. MX current stimulus sufficient to cause contraction. The EMIT SX model, on the other hand, has. SX stimulus which. The competitive advantages of the EMIT system include. Unique therapeutic application of EMIT. Patented delivery device with multiple user friendly applicators. Two models for multiple applications in the treatment of a variety of. Reduction of healthcare costs with home healthcare applications. Development Status. Research involving the EMIT system has produced encouraging laboratory. Once this approval is obtained, several leading U. S. medical. institutions, including Harvard University, University of California. Berkeley, the Therapeutic Institute, and the University of Arizona, have. Given encouraging results, each has also indicated an interest in. EMIT system. Competition. Currently, the two main technologies competing with the EMIT system are. Electrical Stimulation ES and existing Pulsed Electromagnetic. Stimulation PES. While each of these technologies attempts to treat the. EMIT system, both have severe limitations. ES. devices, for example, are unable to penetrate tissues to reach deep. PES devices, on the. As a result, these devices, while effective in a diagnostic setting, make. Leading products in this field include Rehabilitation Centers ES. Top Line. Stimuluss Model 5. PES device which sells for 1. While. these technologies are currently among Premium Therapys main. Premium Therapy will initially market its technology to healthcare. The. specialty distributors will provide sales, support, and distribution. Premium Therapy will complement the distributors sales. EMIT system in research publications and journals in order. Premium Therapy expects those. EMIT system to be able to. Premium Therapy will also market its technology. EMIT system. Regulatory Issues. Medical devices such as the companys EMIT system are subject to. U. S. Food and Drug Administration. FDA. While it is expected that full FDA approval will be gained quickly. Premium Therapy will seek an. Investigational Device Exemption. IDE and clearly labeling the device For Investigational Use. Only. IDE approvals are typically obtained within an average of 3. This strategy has been successful. Leetonus Lee. Tone, where an IDE was obtained. FDA approval. Despite this accelerated market entrance, Premium Therapy is cognizant of. FDA approval will be necessary in order to claim. EMIT system for each of its indications. Management Team. Premium Therapys management team includes founders with extensive. Credentials include two M. B. A. s, two B. S. E. s in. Biomedical Engineering, two M. D. s and a B. S. E. Electrical Engineering. Furthermore, active consultation is being provided by a serial. FDA specialist, the. Harvard Universitys Physical. Therapy Department, and a patent agent specializing in biomedical devices. Financial. Premium Therapys principals are heavily invested in the. Libros Para Aprender A Leer En Espanol Para Ninos on this page. Assuming a product diffusion that parallels. Premium Therapy anticipates profitable operations. International populations. Financial Highlights. Revenues. 9. 62,7. Cost of Sales. 3. Gross Margin. 5. 79,4. Capital Input. 1,1. Net Profit. 3. 22,8. COMPANY SUMMARY. Premium Therapy will develop biomedical devices, including the EMIT. Premium Therapy has developed patented technology to employ. Electro. Magnetic Induction Therapy EMIT in delivering stimuli to targeted. While this will be Premium. Therapys initial focus, the company expects to leverage its. TECHNOLOGY. Pulsed electromagnetic stimulation PES technologies have been developed. These technologies found relatively early application in the setting of. United States for the diagnosis of nerve and muscle disorders. The results of emerging scientific trials, however, have demonstrated the. PES to painlessly and non invasively treat, rather. Studies have shown. PES to be effective in 1 causing muscles to contract, 2 altering nerve. A number of additional therapeutic effects are. It is on this well established base of research that Premium Therapy has. Electro. Magnetic Induction Therapy EMIT. Premium Therapys. Background. The renowned scientist Michael Faraday first observed the concept of. Faraday was able to. Faradays. experimental setup was simple. He found that by passing strong electric. This pulsed electromagnetic stimulus was able to. In the years since the discoveries of Faraday, pulsed electromagnetic. In 1. 96. 5, the scientists Bickford and Freming demonstrated. Later, in 1. 98. 2 Polson et al. This group of investigators. The ability of pulsed electromagnetic stimulation to induce electrical. Technologic Advances. Since the days of Bickford, Freming, and Polson, magnetic fields have been. Repetitive electromagnetic. Peripherally, magnetic stimulation has been used for. Due to the promise of electromagnetic stimulation in painlessly and. New indications for treatment with electromagnetic. Premium Therapys technology is a further advance in this. The different models of the EMIT system each target a number of different. Together, the several market. U. S. market for the EMIT system of. A recent survey of patients suffering from these conditions found that. These. dissatisfied populations, that are both unable to find relief with current. Side Effects, Interactions, Warning, Dosage Uses. SIDE EFFECTSThe following adverse events are based on the experience of 5. Am. Bisome and 2. B deoxycholate and 9. Am. Bisome and 4. B deoxycholate in Study 9. Am. Bisome and amphotericin B were infused over two hours. The incidence of common adverse events incidence of 1. Am. Bisome compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table Empirical Therapy Study 9. Common Adverse Events Adverse Event by Body System Am. Bisomen3. 43 Amphotericin B n3. Body as a Whole   Abdominal pain 1. Asthenia 1. 3. 1 1. Back pain 1. 2 7. Blood product transfusion react. Chills 4. 7. 5 7. Infection 1. 1. 1 9. Pain 1. 4 1. 2. 8   Sepsis 1. Cardiovascular System   Chest pain 1. Hypertension 7. 9 1. Hypotension 1. 4. Oracle.Dataaccess.Client Dll. Windows Xp Sp3 Arabic Iso here. Tachycardia 1. 3. Digestive System   Diarrhea 3. Gastrointestinal hemorrhage 9. Nausea 3. 9. 7 3. Vomiting 3. 1. 8 4. Metabolic and Nutritional Disorders   Alkaline phosphatase increased 2. ALT SGPT increased 1. AST SCOT increased 1. Bilirubinemia 1. 8. BUN increased 2. 1 3. Creatinine increased 2. Edema 1. 4. 3 1. 4. Hyperglycemia 2. 3 2. Hypematremia 4. 1 1. Hypervolemia 1. 2. Hypocalcemia 1. 8. Hypokalemia 4. 2. Hypomagnesemia 2. Peripheral edema 1. Nervous System   Anxiety 1. Confusion 1. 1. 4 1. Headache 1. 9. 8 2. Insomnia 1. 7. 2 1. Respiratory System   Cough increased 1. Dyspnea 2. 3 2. 9. Epistaxis 1. 4. 9 2. Hypoxia 7. 6 1. 4. Lung disorder 1. 7. Pleural effusion 1. Rhinitis 1. 1. 1 1. Skin and Appendages   Pruritus 1. Rash 2. 4. 8 2. 4. Sweating 7 1. 0. 8. Urogenital System   Hematuria 1. Am. Bisome was well tolerated. Am. Bisome had a lower incidence of chills, hypertension, hypotension, tachycardia, hypoxia, hypokalemia, and various events related to decreased kidney function as compared to amphotericin B deoxycholate. In pediatric patients 1. Am. Bisome compared to amphotericin B deoxycholate had a lower incidence of hypokalemia 3. Similar trends, although with a somewhat lower incidence, were observed in open label, randomized Study 1. Am. Bisome and 6. B deoxycholate. Pediatric patients appear to have more tolerance than older individuals for the nephrotoxic effects of amphotericin B deoxycholate. The following adverse events are based on the experience of 2. Am. Bisome 3 mgkg, 8. Am. Bisome 5 mgkg and 7. B lipid complex 5 mgkg in Study 9. Am. Bisome and amphotericin B lipid complex were infused over two hours. The incidence of adverse events occurring in more than 1. Empirical Therapy Study 9. Common Adverse Events Adverse Event by Body System Am. Bisome. 3 mgkgday n8. Am. Bisome. 5 mgkgday n8. Amphotericin B Lipid Complex 5 mgkgday n7. Body as a Whole   Abdominal pain 1. Asthenia 8. 2 6. 2 1. Chillsrigors 4. 0 4. Sepsis 1. 2. 9 7. Transfusion reaction 1. Cardiovascular System   Chest pain 8. Hypertension 1. 0. Hypotension 1. 0. Tachycardia 9. 4 1. Digestive System   Diarrhea 1. Nausea 2. 5. 9 2. Vomiting 2. 2. 4 2. Metabolic and Nutritional Disorders   Alkaline phosphatase increased 7. Bilirubinemia 1. 6. BUN increased 2. 0 1. Creatinine increased 2. Edema 1. 2. 9 1. 2. Hyperglycemia 8. 2 8. Hypervolemia 8. 2 1. Hypocalcemia 1. 0. Hypokalemia 3. 7. Hypomagnesemia 1. Liver function tests abnormal 1. Nervous System   Anxiety 1. Confusion 1. 2. 9 8. Headache 9. 4 1. 7. Respiratory System   Dyspnea 1. Epistaxis 1. 0. 6 8. Hypoxia 7. 1 6. 2 2. Lung disorder 1. 4. Skin and Appendages   Rash 2. The following adverse events are based on the experience of 2. Am. Bisome 3 mgkg, 9. Am. Bisome 6 mgkg and 8. B deoxycholate 0. Study 9. 4 0 0. HIV positive patients. The incidence of adverse events occurring in more than 1. Cryptococcal Meningitis Therapy Study 9. Common Adverse Events Adverse Event by Body System Am. Bisome 3 mgkgday n8. Am. Bisome 6 mgkgday n9. Amphotericin B 0. Body as a Whole   Abdominal pain 7 7. Infection 1. 2. 8 1. Procedural Complication 8. Cardiovascular System   Phlebitis 9. Digestive System   Anorexia 1. Constipation 1. 5. Diarrhea 1. 0. 5 1. Nausea 1. 6. 3 2. Vomiting 1. 0. 5 2. Hemic and Lymphatic System   Anemia 2. Leukopenia 1. 5. 1 1. Thrombocytopenia 5. Metabolic and Nutritional Disorders   Bilirubinemia 0 8. BUN increased 9. 3 7. Creatinine increased 1. Hyperglycemia 9. 3 1. Hypocalcemia 1. 2. Hypokalemia 3. 1. Hypomagnesemia 2. Hyponatremia 1. 1. Liver Function Tests Abnormal 1. Nervous System   Dizziness 7 8. Insomnia 2. 2. 1 1. Respiratory System   Cough Increased 8. Skin and Appendages   Rash 4. Infusion Related Reactions In Study 9. Day 1. Am. Bisome treated patients had a lower incidence of infusion related. Day 1 as compared to amphotericin B deoxycholate treated patients. The incidence of infusion related reactions on Day 1 in pediatric and adult. Incidence of Day 1 Infusion Related Reactions IRR By Patient. Age  Pediatric Patients 1. Adult Patients 1 6 years of age Am. Bisome Amphotericin B Am. Bisome Amphotericin B Total number of patients receiving at least one dose of study drug 4. Patients with feverIncrease 1. C 61. 3 2. 2 4. Patients with chillsrigors 4 8 2. Patients with nausea 4 8 4 9 3. Patients with vomiting 2 4 71. Patients with other reactions 1. Day 1 body temperature increased above the temperature taken within. Cardiorespiratory events, except for vasodilatation flushing, during all study drug infusions were more frequent in amphotericin B treated patients as summarized in the following table Incidence of Infusion Related Cardiorespiratory Events Event Am. Bisomen3. 43 Amphotericin Bn3. Hypotension 1. 2 3. Tachycardia 8 2. Hypertension 8 2. Vasodilatation 1. Dyspnea 1. 6 4. 7 2. Hyperventilation 41. Hypoxia 1 0. 3 2. The percentage of patients who received drugs either for the treatment or prevention of infusion related reactions e. Am. Bisome treated patients compared with amphotericin B deoxycholate treated patients. In the empirical therapy study 9. Day 1, where no premedication was administered, the overall incidence of infusion related events of chillsrigors was significantly lower for patients administered Am. Bisome compared with amphotericin B lipid complex. Fever, chillsrigors and hypoxia were significantly lower for each Am. Bisome group compared with the amphotericin B lipid complex group. The infusion related event hypoxia was reported for 1. B lipid complex treated patients compared with 0 of patients administered 3 mgkg per day Am. Bisome and 1. 2 of patients treated with 5 mgkg per day Am. Bisome. Incidence of Day 1 Infusion Related Reactions IRR ChillsRigors Empirical Therapy Study 9. Am. Bisome Amphotericin B lipid complex 5 mgkgday 3 mgkgday 5 mgkgday BOTH Total number of patients 8. Patients with ChillsRigors Day. Patients with other notable reactions Fever 1. C increase. in temperature   Nausea 2. Vomiting 91. 0. 6 7 8. Hypertension 5 5. Tachycardia 4 4. Dyspnea 2 2. Hypoxia 4 4. 7 8 9. Day 1 body temperature increased above the temperature taken within 1. Patients were not administered premedications to prevent infusion related reactions. Day 1 study drug infusion. In Study 9. 4 0 0. Am. Bisome and amphotericin B deoxycholate as initial therapy for cryptococcal meningitis, premedications to prevent infusion related reactions were permitted. Am. Bisome treated patients had a lower incidence of fever, chillrigors and respiratory adverse events as summarized in the following table Incidence of Infusion Related Reactions Study 9. Am. Bisome 3 mgkg Am.