MedNexis, Inc. is a medical device development company that has designed and patented medical devices for production and marketing. A magnetic muscle stimulator/field generator has been designed with input from medical personnel and biomedical engineers. One patent is incorporated initially.

Allopathic Medicine

One market addresses the need for atrophy prevention/treatment in conditions resulting in patient immobilization for over two weeks. After this period, the average muscle loses over 30% of its mass, lengthening the time for complete recovery. The MedStim system has been created to effectively prevent and treat atrophy. Further research on the benefits of pulsed magnetic fields is expected to increase the indications for this device. For instance, studies have shown the accelerated healing of skeletal fractures with pulsed field magnetism.

The market for magnetic stimulation devices in allopathic medicine is in the early stages, but is poised for rapid growth once the technology becomes cost-effective. This potential market includes an estimated 4.2 million patients in the United States. The MedStim system is designed to target this market.

Alternative Medicine

Another market addresses the need for a more powerful and consistent therapeutic magnetic field in alternative medicine. Dynamic magnetic field therapy, which uses variable magnetic pulses, is thought to have positive effects on circulation, immune system function, and wound healing. These effects are proportionate to the strength of the magnetic field generated. The TheraMag system has been designed to address this need. The starting potential for this market is approximately 40 million customers in the United States.

Technology

Patent applications for the company’s first market entries have been filed with a specialized patent agent. MedNexis’ technology utilizes the principle that a current in a coil generates a magnetic field, which in turn generates a current in conductive material within the field. This model is already used in diagnostic studies. Using this model, MedNexis has developed an electromagnetic device that painlessly stimulates human muscles to contract. Initial devices to be marketed include a tailored device for mainstream, allopathic medicine and the TheraMag device for alternative applications.

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Strategy

MedNexis will target two markets: allopathic and alternative medicine. To distinguish the products from any negative connotations associated with alternative medicine in the allopathic field, the devices will have separate names: MedStim for allopathic medicine and TheraMag for alternative medicine. MedStim will be distributed through large distributors, and strategic associations will be key to gaining acceptance. MedNexis will focus on generating randomized, controlled study data for this market. TheraMag will be distributed to alternative medicine centers, with direct sales also possible. This market requires less scientific proof, and entrance will be immediate once the FDA issues an Investigational Device Exemption.

Regulatory Issues

By obtaining an Investigational Device Exemption and labeling the product "For Investigational Use Only," MedNexis will satisfy FDA regulations and expedite market entrance. Acceptance based on successful research results will increase demand and allow for expansion to foreign markets.

Major Milestones

Research and development are underway in the animal stage, and patent coverage will be extended to Australia, Europe, and Canada in the middle of Year One. Human clinical trials will begin in the middle of Year Two, and research studies will be published at the end of Year Two. TheraMag will be available for sale at the end of Year One, and MagnaStim will be available for sale with the label "For Investigational Use Only" at the end of Year Two. Profitability will be established by Year Four.

Competitive Advantage

While existing devices on the market are only partially effective or difficult to use, MedNexis’ MagnaStim and TheraMag devices are user-friendly with multiple home healthcare applications, making them more effective. MedNexis’ patented designs will fill the need for an easier-to-use and more effective magnetic stimulator/field generator.

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Financial

Based on financial projections, if the company receives $750,000 in funding, it will be profitable by Year Three. The company projects $23.5 million in sales in Year Three, with a significant net profit, based on less than 3% market penetration in any segment.

Medical Equipment Business Plan Example

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