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The Dynamic Memory External Fixator (DMEF) Mind Fountain – Medical Technology May 2008 • The Problem Current treatment of fractured long bones, particularly the tibia (lower leg), is expensive, has a long healing time, and can lead to a variety of complications. • Target Population It is estimated that the annual number of lower leg fractures in the U.S. is 225,000; in the U.K. 46,000; in Germany 63,000; in Canada 25,000; in Brazil 141,000; and in Japan 98,000, to mention only a few countries. • The Solution We have developed a smaller, lighter, user- friendly Fixator requiring minimal surgical procedures, thus reducing the risk of infection or knee pain, common following intramedullary nail surgery. The device is ready to market New Features of the Rev. Fixator: •All Metric designed parts (industry standards) •All aluminum parts (weight reduction) •Greater intramedullary pin positioning angle •Greater shaft positioning angle •Collar rotation locking lever (prevents loosening) •Ball spline post pinned to universal joint Highlights • Our device is NOT just another External Fixator, but is a tool that accelerates ossification – the natural formation of the callus (the body’s “bone glue”) at the appropriate healing stage. • Successful clinical trials were conducted at Hadassah Hospital in Jerusalem, which yielded the following astonishing results: – The device almost completely eliminates the risk of bone maladjustment. – The device reduces the treatment time of tibia fracture by 50%, compared to other fixators, thus, allowing for rapid return to normal weight bearing. – The device almost completely eliminates the need for physical therapy, once it is removed. – The device is extremely user-friendly to the orthopedic surgeons, who traditionally dislike external Fixators. • A Money Saver The substantial reduction in treatment and rehabilitation time will save millions of pounds & dollars, respectively, to the British NHS, American HMOs, and rural orthopedic practices. – The device is competitively priced, offering an alternative to the more expensive intramedullary nail surgery. • Patent The device is currently registered in the U.S., Canada, the U.K., France, Germany, Italy, Switzerland, and Israel. – With its new design improvements, we began processing a new patent, adding an additional 20 years of protection. • FDA and CE It is a 510K device ,and we began the process of obtaining CE certification; • Market The device’s estimated market size in the U.S. is $250 million annually, with a similar sized market in Europe; – The above revenue can be doubled by effective marketing aimed at taking over a portion of the current intramedullary surgery nails market of more than $½ billion a year in the U.S. alone. • Company We will establish companies in the U.S. and U.K. with internationally renowned orthopedic surgeons as board members. • Financing To commercialize this device, we seek £1,100,000, while the company’s valuation is conservatively estimated at £4.5 million. Skin Melanoma Detector Mind Fountain – Medical Technology May 2008 The Problem • The current accuracy rate of skin melanoma detection is about 65% among dermatologists and 50% among family and general physicians. Some studies rate the positive predictive value of current evaluations at as low as 20%. • If melanoma is detected in its early stages, the patient is often cured by a wide and deep resection of the tumor. • It would be of great benefit to patients if one could perform a non- invasive analysis prior to lesion surgical removal. The Software Solution • We developed groundbreaking software that already exhibits 87% detection accuracy. • It is part of an inexpensive system that provides immediate evaluation of all new skin lesions. • It provides a precise analysis of changes in dermatologic diagnostic ABCD parameters (asymmetry, border irregularity, colors, & diameter). • It will make the distinction between benign and malignant tumors, thus, significantly reducing unnecessary surgical removal of benign lesions. • It offers navigation capabilities for easy lesion follow-up and excellent body mapping. +5 +1 +6 +2 +7 +8 +3 +9 +4 Dermoscopic Images are sent via e-mail, website upload, CD- ROM, or diskette to the Analysis Center +1 Analysis Center The melanoma detection software makes exact calculations of each of the ABCD parameters for every mole. Imaging Improvement Our system uses dermoscopic imaging that can capture details beneath the dermal layer, based on spectral imaging, originally developed for satellite reconnaissance. Hardware Diagram • Near-Perfection We plan to maximize our software detection accuracy to reach – in combination with the new spectral imaging – up to 99% accuracy, by establishing an online database of prospective melanoma images. • Patents The software is patented in the U.S. and we are in the process of registering an international patent for the integration of the software and the new spectral imaging. The latter is patented in the US and internationally. • Companies We are about to set up an analysis and marketing company in the U.S. and the U.K. • Marketing Since the system is internet-based, the requests for our services could come from the U.S., U.K., Canada, and Australia, and in time from other countries around the world to capture part of the estimated more than £1 billion market. • Savings Our detection system could save tens of millions of pounds & dollars, respectively, to major health care providers such as the British NHS, American HMOs, and rural area medical practices. • Follow-up Since individuals usually have more than one lesion and will require a follow-up, our system will send automatic e-mail and pre-recorded voicemail reminders to the referring physicians and their patients. • Investment We seek £1,250,000 based on the company’s valuation, which is estimated at £4,000,000. Female Incontinence Therapy Device Mind Fountain – Medical Technology May 2008 • The Problem Some women’s pelvic floor muscles weaken, often leading to lack of urinary control. • Target Population The female urinary incontinence problem affects more than 17 million American women and a similar number in Europe. • Traditional Treatment The most commonly recommend method for re-strengthening these muscles is to practice Kegel exercises. However, half of the women affected do not know how to do it properly and the other half tend to stop after a short while. • Our Solution A device that aims to raise the quality of life for women who suffer from this condition by simplifying and improving the efficiency of treatment, thus easing the tremendous discomfort and embarrassment associated with female urinary incontinence. Highlights • Our device generates the desired muscle contractions by localized electrical stimulation, and is designed for optimal interface between the probe’s electrodes and the user’s pelvic floor muscles; • It is elegant, lightweight, compactly designed, user-friendly, self-manageable, simple to operate, painless, and safe for treating the 3 forms of incontinence: stress, urge, and mix; • It eliminates the need for continual readjustments by a physician; • It utilizes a non-irritant, medical grade silicon with superior characteristics, ensuring that it is comfortable, safe, and easy to clean; • Insertion and removal of the electrode probe is made easy due to its flexibility; • The probe’s geometry and flexure allow for optimal anatomical fit and prevent accidental self- extraction, regardless of whether the user is standing, sitting, stationary, or walking; • The probe will be offered in two sizes to fit the range of vaginal anatomies; • Our device’s innovative & discreet design, comfort, and ease of operation will contribute to overcoming the barrier to treatment by moving it out of a hospital and clinic environment and into the privacy and comfort of the user’s home. • Clinical Trials The first round of trials was conducted in Israel that showed an overwhelming degree of user-compliance, cooperation and satisfaction; – We are about to launch the second round of clinical trials at two urogynecological outpatient departments associated with: (1) Harvard Medical School in Boston and (2) Cedar Sinai Hospital – affiliated with U.C.L.A. in Los Angeles. • Regulations It is a 510K FDA device and during this visit to London, I have begun the process of obtaining CE certification. • Patent The device is patented in the U.S. and was just registered in Europe. • Companies We will establish our company in the U.S. and U.K. • Market In treating female urinary incontinence in the U.S., $2.5 billion annually is spent on diapers; $1 billion on surgery; $1 billion on medication; and $1 billion on devices, all which increases by 6% annually. – Our device could, in time, replace a portion of the $4.5 billion diaper, surgery, and medication markets, given that each has drawbacks – The low cost of the device to the end-user will make it affordable to almost all women, making it an attractive competitive alternative to other forms of treatment. • Financing We seek £1,500,000, while the company’s valuation is estimated at more than £5 million.
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