Medical Device Business Plan

Medical Device Business Plan-79
The results of emerging scientific trials, however, have demonstrated the dramatic potential for PES to painlessly and non-invasively treat, rather than simply diagnose, a variety of medical conditions.

The results of emerging scientific trials, however, have demonstrated the dramatic potential for PES to painlessly and non-invasively treat, rather than simply diagnose, a variety of medical conditions.

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The competitive advantages of the EMIT system include: Research involving the EMIT system has produced encouraging laboratory results and a formal request to perform human clinical trials has been filed. Given encouraging results, each has also indicated an interest in purchasing the EMIT system.

Currently, the two main technologies competing with the EMIT system are Electrical Stimulation (ES) and existing Pulsed Electromagnetic Stimulation (PES).

The ergonomic wraps have been designed for the multiple applications of EMIT and are easily placed by any untrained user around the lower back, knee, shoulder, and other regions of the body to deliver targeted, therapeutic pulses of electromagnetic stimuli.

For example, the ergonomic AOC wrap developed for the knee contains strategically placed coils designed to produce therapeutic magnetic fields within the knee.

Premium Therapy will complement the distributors' sales force with an internal program focused on highlighting the increased efficacy of the EMIT system in research publications and journals in order to encourage adoption of its technology. International populations were not included in the financial analysis, as global expansion is not anticipated until late in the business plan.

Premium Therapy expects those involved in the distribution and sales of the EMIT system to be able to charge a sustainable premium for providing patients with access to this breakthrough technology. Premium Therapy will develop biomedical devices, including the EMIT system, to aid in the treatment of a variety of medical conditions.

Premium Therapy will also market its technology to patient/consumers once healthcare providers have begun to adopt the EMIT system. While it is expected that full FDA approval will be gained quickly based on the approval of similar devices, Premium Therapy will seek an expedited market entrance by obtaining an Investigational Device Exemption (IDE) and clearly labeling the device "For Investigational Use Only." IDE approvals are typically obtained within an average of 3 months including necessary revisions. Premium Therapy has developed patented technology to employ Electro Magnetic Induction Therapy (EMIT) in delivering stimuli to targeted anatomic regions of the human body.

Medical devices such as the company's EMIT system are subject to regulatory review and approval by the U. This strategy has been successful with a similar device, Leetonus' Lee Tone, where an IDE was obtained and devices were sold prior to full FDA approval. While this will be Premium Therapy's initial focus, the company expects to leverage its medical device expertise in capitalizing on other opportunities as they arise.

When applied to the human body, pulsed electromagnetic stimulation has been scientifically proven to be effective in: 1) causing muscles to contract, 2) altering nerve signal transmission to decrease experienced pain, and 3) causing new cell growth in cartilage.

Harnessing these benefits, the company has developed EMIT as a new and improved, patented delivery technology.

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