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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Medical device company in the Diabetes field. |
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| Management |
| Harish Kapoor, BSEE, MSBE, Ph.D. program Senior Fellow -
Rich Pollock, CPA, Chief Financial Officer
Dr. I.P. Rishi, MD, Chief Medical Officer
Dan W, Mattlow, JD. General Counsel
Ashley Chopra, Director, Business Development. |
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| Keywords |
| Obesity, diabetes |
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| Description |
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Company Description – CAL Engineering, is an established 20 years old biomedical technology company headquartered in Ft. Lauderdale, FL. CAL has completed key projects in technological turn-key solutions for IBM, Motorola, Phillips, Coulter, Lucent and several fortune 100 companies. In 1998 CAL spinned off a program into Dr. I-Net Corporation to automate medical records and reduce healthcare cost. In 2008 CAL developed DDM to address the unmet needs of obese and diabetic patients with great commercial opportunity. CAL has completed the design and associated patents with US patents and trademark office for this device, to be sold to consumers directly.
Sales Projection – DDM will provide the therapeutic solution to diabetic and obese population in the comfort of their homes. Even if we target 1% of the market, our revenues in five years will reach over $650 million with shareholders equity of $225 million.
Reimbursement - Three years ago obesity has been classified by Medicare as disease and has started reimbursing for related treatment and therapy. Our research and data warrant us that reimbursement for Diabetic related product epidemic will be procured. |
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| Products / Services |
Product – R&D for DDM has been based upon evidence based techniques driven from quantum medicine widely used in Asian countries for centuries. DDM will therapeutically treat diabetic patients, to increase the relative insulin producing performance of endogenous pancreatic beta cells into insulin producing beta cells, and also regulate pancreatic secretion leading to weight loss. Overall it provides therapeutic solutions that support and improves the quality of life for diabetic and obese patients.
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| Technology / Differentiation |
| Differentiation - Pancreatic therapy will repair and regenerate the cells of islets of langerhans to facilitate hormones that enhance their ability to produce insulin, regulate and treat high blood sugar. The transformation of insensitive or impaired of islets of langerhans results in an increased insulin secretion and increased insulin level in blood plasma. DDM has integrated methodologies driven from bio-mechanics, endocrinology, quantum science and bio-feedback control system to regulate blood sugar and obesity.
Diabetic patient recent frustration from prescription drugs has strengthened their belief in therapeutic treatment. FDA has already red-flagged Actos, Avandia and Byetta for several deaths. This frustration is also coupled with high cost of pharmaceuticals and their long term dangerous side affects. Risk from modern medicine vs. benefit from DDM provides a tremendous market opportunity. CAL’s experience with healthcare and automation has enabled their team to take advantage of this opportunity and subsequently launch DDM. |
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| Market / Customers |
Market - North America and Europe has over 100 million diabetic populations. About 97 million Americans are obese and one third of American kids are destined to be diabetic. Based on the CDC predictions, 45 million to 50 million Americans could have diabetes by 2050. The total annual cost of diabetes in 2007 was estimated to be $174 billion, and for obesity was $140 billion. An average diabetic patient shopping within a pharmacy is spending about $3,200 a year, which is approximately 10 percent more than a non-diabetic patient shopping the OTC category. Data provides a $100 billion market opportunity for this device and associated therapeutic techniques.
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| Competitors / Substitutes / Alternatives |
Competition – DDM does not have any direct competition for external & non-Invasive, therapeutical devices. The Modern drugs does provide indirect competition, however DDM addresses the needs of external therapies to counteract the long term dangerous side effects of these drugs. Stem cells research and its implementation can provide competition in future. Our strong IP position, would offer barrier to other companies to enter this space.
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| Funding |
| Funding - DDM is seeking $7.5 million financing to support staffing, new model development and market launch. We are looking for partners to finance, M&A, licensing, marketing, distribution, strategic, and joint venture opportunity. |
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| Status |
| Status – Clinical Trial/FDA/Development
DDM falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturers are required to register their establishment by submitting Form FDA 2891, "Initial Registration of Device establishment, by submitting Form FDA 2892, "Device Listing." ‘Exempt status’ Notification would allow us to market the equipment for Obese and Diabetic population. |
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Biotech & Specialty Pharma
Healthcare Services
Medical Devices & Tech
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