RegenTech Business Plan

Executive Summary

RegenTech is a business aimed to manufacture and distribute a specialized spinal cord regeneration scaffold. Having the resources necessary and having conducted a thorough market analysis to fulfill the requirements of the manufacture, production and distribution of this product, this company is aimed to produce a one of a kind product currently unavailable on the market. This specialized scaffold is designed to assist in the recovery of spinal injuries. This product is set to revolutionize the industry as we now have the technology to help those with paralysis to walk again.

Myself, <My name> having worked for Drager, a medical equipment manufacturer and distributor for over 5 years, bring a good deal of business experience to the company. During this time I worked feverishly collaborating with some of the finest minds in the manufacturing industry and the field of medicine to develop this concept from the drawing board to the production line to customers and individuals suffering from spinal injury. Utilizing a degree in business <my name> is responsible for assembly and execution of the business plan along with the expertise of the following business leaders and innovators joining this venture. Accepting the position of CEO is Devan Ohst former research engineer at Nanofiber Solutions. Accepting the position of Vice-President is Christian Jacobs, who is also a co-founder, is former lead production Manager at Nanofiber Solutions. And finally, assuming the position of CLO is Steven Jechura, also a co-founder of Heart of Gold records and Music.

What We Sell

A specialized spinal cord regeneration scaffold designed to help those with either full or partial paralysis find recovery. Our product is a specialized tissue regenerating scaffold for spinal tissue regeneration comprised of electro spun aligned PCL Nanofiber and co-electrosprayed with a bioactive hydrogel and combined with a specialized growth factor mix.

Who We Sell To

The primary target for RegenTech are individuals who have suffered an acute spinal cord injury which amount to about 273,000 worldwide with about 9,000-12,000 new cases per year. Distribution of this product will be made both directly and proxy via hospitals, surgeon’s, treatment centers, rehabilitation centers and PCP’s (Primary Care Physicians).

Financial Statement

This financial plan was developed based upon current market trends, current growth analysis, and thorough review of the market in terms of all relatable and foreseeable costs to the company. Other factors of financial consideration included material and shipping costs, costs from distributors and vendor rates. The companies cost analysis is set on a 3 year predictive track by management, company accountant and financial analyst. All three worked together on the plan so as to balance out optimism with market reality. The legal department has set forth policy and drawn contracts for predicted sales. First 3 year gross sales predictions are projected above $4.5 million dollars with a gross margin of 91.75%. Profitability is expected after the first 9 months in operation.

Company Overview

RegenTech is a business aimed to manufacture and distribute a specialized spinal cord regeneration scaffold. Having the resources necessary as well as having conducted a thorough market analysis to determine the requirements of the manufacture, production and distribution of this product, this company is aimed to produce a one of a kind product currently unavailable on the market. This specialized scaffold is designed to assist in the recovery of spinal injuries. Our product is set to revolutionize the industry as we now have the technology to help those with paralysis to walk again.

After the company’s inception in Ohio we will pursue and incorporated status. Given the nature of our company as well as the level of financial responsibility involved we have chosen to forgo LLC licensing in lieu of banking and investor considerations.

Additional employment opportunities are foreseen with the company as production increases. It is estimated that at top production within the first 12 months an additional 17 employees will be hired and trained as to production. Training implementation shall be conducted via company training manual. Only supervisors with 5 years plus of experience will be considered for employment, and only candidates with a bachelor degree in management and organization or a related field will be considered.

Products and Services

Currently, the company’s inventory schedule is one item with plan for modifications and readjustments within the next 1.5 years. Our central product is an aligned PCL Nanofiber scaffold integrated with immobilized bFGF (basic Fibroblast Growth Factor) and laminin co-electrosprayed with a HA hydrogel. Laminins are major proteins in the basal lamina, a protein network foundation for most cells and organs and is central to the binding process. Hyaluronic acid (HA) is one of nature's most versatile macromolecules. Being an essential component of the natural extracellular matrix (ECM), HA plays an important role in to the regeneration of spinal cell activity, you could say it behaves much like a stem cell with regards to is generative and regenerative characteristics.

This tissue engineering scaffold device incorporates many components that have been shown to be conductive to neural tissue proliferation, migration, and elongation independently. It also addresses conventional tissue engineering scaffold issues such as porosity and drug delivery, along with macroscopic issues such as production cost and scalability. We believe that this design is the most efficient and provides the best environment for spinal cord tissue generation and recovery.

Competitors

Competition in this field is sparse. However, there are a few that possess the marketing and production capabilities to potentially threaten our sales in the future.

The companies, StemCells, Geron, and NeoStem are taking a cellular approach which has been proven to be less effective than the biodegradable scaffold approach and are deemed less significant than the companies bellow.

There are 5 potentially significant competitors currently in the field of SCI (spinal cord injury) regeneration, StemCells, NeuralStem, InVivo Therapeutics, and Geron. These companies all share a similar production problem: large burn rates and no product shelf life, no tangible marketable product with limited clinical trials, and heavy regulation by both the FDA and the AMA.

InVivo Therapeutics is our closest competitor. With a market cap of $335.85 million and was originally planned to launch their similar product to the market in 2010 nothing as of yet and as well they have mentioned problems with their design to investors. InVivo demonstrated that the scaffold approach is indeed an effective approach with tests on a paralyzed monkey later able to walk directly related to the surgery. None of the company’s trials have seen a 100% recovery. Yet InVivo spends $850,000 thousand a year on lost product to burn rates during part of the manufacturing process. InVivo Therapeutics has raised only $38 million to fund the production of their equivalent product.

The other companies not deemed as significant competition have raised significant money but lack the technology to produce the product that RegenTech can. These companies have raised the following amounts from investors and fundraising events.

Target Market

The predominant market for this product is the medical population. This is not limited to hospitals but to rehabilitation clinics, surgeon’s, treatment centers, PCP’s, various medical foundations, medical journals, various magazines and any other organization or institution were tertiary spinal intervention would be of assistance. The nature of this product will not allow for localized advertising.

In part this market remains ‘demand’ driven on a global scale. The level of need sets the precedence as well as the quantity of product shipped. As this is directly related to medical need, direct relations with the aforementioned entities will need to be nurtured and maintained. As far as need and growth our product, being demand driven, is based on those who need it. As long as there individuals either having or facing paralysis, our market segment is assured.

Market Needs & Demand

The specific and directed purpose of this product, developed and designed as a tertiary medical interventional tool, is not yet to a point of modification. Various styles are considered irrelevant, and due to the organic nature of its use is deemed purpose driven thus eliminating the need for modifications just yet. In time, and after clinical trials, it is estimated that various modifications might be necessary. For now it will remain driven by need.

Market Trends

There are only a handful of companies researching and working to develop spinal cord treatment processes. Among those are StemCells, NeuralStem, and InVivo Therapeutics and Geron. None have a tentative date for production release leaving the field wide open.

Market Growth

As the bulk of market growth is negligible as of yet do to the absence of any formal completion it is expected to grow with proper demonstration of product ability. Of course, growth will be slow to start, but given histories inevitable need for medical interventions and considering the fields search for working fixes of this nature, it is expected to drive market need. Cost to start is expected at $6,000.00 per unit. This, however, is expected to drop sharply upon heightened demand to an eventual low of $4,300.00 per unit.

There is an economic factor to consider, one based mainly on insurance companies and their willingness to help aid with consumer cost incurrence’s. As the price is generally considered too high for many to afford, insurance claims might hinder market demand. At the same time market history for medical needs has shown that no matter the price there will always be a high demand for products shown to work.

Strategy and implementation

Our marketing strategy seeks to optimize our advantage of being in both a prime location for distribution. Our location has access to both air and ground freight of all types. Shipping costs can be kept reasonable and market competitive with quick shipping turnaround times. Our name implies our product, the “regeneration of” helping to qualify the psychological aspects of our business strategy. Our company ethic is based upon human dignity, perseverance and the extension of human life. As such we are intent on providing 100% customer service and satisfaction with any and all consumers. Our motto is to strive to provide the quickest shipping times but not at the expense of quality control; our product has no room for error. Our location was chosen for that same reason.

Our general marketing strategy is to use a professionally produced product description flier to places such as rehabilitation clinics, surgeons, treatment centers, PCP’s and medical foundations. Other sources will include medical journals, various magazines and journals and other organizations and institutions were tertiary spinal intervention would be of particular assistance. We will use traditional social networking sources with properly implemented SEO (Search Engine Optimization) via sources such as Facebook, Google+, LinkedIn, Youtube and others. Our website is set to begin production upon tentative business licensing approval and after the award of banking and investment loans.

Position

We are RegenTech, a company passionate about providing our customers only the highest quality product and set to give those in need the best quality life they can have.

Pricing

As this is a product of need it is important to maintain a price that the customer and companies funding can afford. With a few various alternatives on the market either in beta testing or with low to poor success rates, we feel a $6,000.00 asking price is both reasonable and ethical. As the product costs just under $500 per item excess revenue will be used for research and development for product change as well as extending it to the proposed change possibilities. As we offer a better and cheaper product than any of the tentative competition this gives our company the competitive edge it needs to excel in the industry.

Competitive Edge

As we are the first company to produce this form of product we have the market majority to begin with. However as with any product that excel’s, others are sure to come. It would be essential to the survival of our company as well as its growth that we stay ahead of the competition by means of marketing and promotion.

We are already starting with a low production cost using cheap raw materials. We are also positioned to extend the usability of this product through modifications to provide a launch into the peripheral nerve market and later on the osteopathic market. Eventually, we can extend to the veterinary markets.

It is deemed at this point in the business process that our company will have less than 3.5 years of uninterrupted competition. This should provide sufficient time to solidify company operations and prepare to launch into other markets as mentioned previously.

(Strategic Alliancesomitted for preview. Available via download)

(Financial Planomitted for preview. Available via download)

(Sales Forecast Table omitted for preview. Available via download)