Entry Science's business plan for the CLAMP ankle device

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Business PLAN

Entry Science is funding to grow its sales of the CLAMP ankle device for small ankle sites. This will allow the company to expand sales. Entry Science was created with the mission of developing novel ways to enable Ankle devices site opening.

THE PRODUCT

CLAMP is an ankle device that represents a breakthrough in the ankle market. It is an enabling technology that will allow ankle surgeons to enter through the foot open ankle points greater than 4-Mm in size. CLAMP fundamentally changes the idea behind ankle by allowing the physician to enter the foot with superior control, and providing complete aeration along the entire ankle profile. Its team has filed a provisional patent for the device and initial IP research confirms that the device constitutes unique and innovative intellectual property. The product has the potential to become a disruptive force in the ankle device market.

THE MARKET

Entry Science aims to target the small site ankle market, and then expand to the entire ankle market. Currently, no approved and effective solution exists for Ankle devices of small ankle sites. Its device will create a fundamentally new segment of the ankle device market with the potential for extraordinary growth rates, as surgical procedures that are currently done invasively will be possible using foot methods. We believe the small ankle segment represents a $300 million market today, with significant growth over the next 5-10 years.

The small site ankle device market is promising due to its expected continued growth of 8% - 12% annually, and its currently low penetration rate (percentage of the total number of ankle foot surgery s). Currently, there are approximately 5 million ankle operations in the United States. 3.9 million of these procedures could potentially involve an ankle device, only 25% of which are opened using existing ankle devices. This small percentage is due to the significant learning curve involved, the risks of inadequate deployment with improper opening, hematoma, and ankle, and overall practitioner dissatisfaction with current devices. The remainder is opened using manual cut-down. Currently, the market volume is $550 million with average revenue per device of $1,250. Analysts expect this market to grow to $1 billion by 2010.

THE TEAM

Entry Sciences is headed by John Travolta, an MBA from McMaster University with 10 years' previous experience in medical device companies, including a successful acquisition by a major medical device company. The company's R&D is headed by Danny Glover, who has substantial experience developing and implementing medical devices. The company's Chief Medical Officer, Dr. Michelle Pfeiffer, is a well-respected ankle specialist who has extensive contacts in the industry.

FINANCIAL RETURNS

Historically, most small medical device companies have been acquired by the Majors once they have demonstrated sales success. Entry Science's proven success at gaining market share may make the company a good candidate for takeover in the next few years.

The investment required is $352,000. The expected IRR over the next three years is greater than 30%. As compared to other similar investments, Entry Science offers a proven product with growing market share, high margins, and an opportunity for an acquisition event.

Executive Summary

The Product

The Market

The Team

Financial Returns

The Team

Advisors & Mentors ankle Devices - Background

CLAMP ankle Device

Market Analysis

Small site ankle market

Competition

Competitive Advantage

Intellectual Property Landscape

Operating Plan

Financial Analysis

Revenue Model

Pricing & Reimbursement

Revenue & Cost Projections

Financing Requirements

Sales & Marketing

SWOT analysis

Risk Analysis

Prototyping

Intellectual Property

Regulatory

Reimbursement

Conclusion

Appendix I - CLAMP Ankle Device

Brain

Clamp

Appendix II - Advisors & Industry Experts

Appendix III - Financial Statements

Financial Plan 2008-2010

Cash Needs, Upfront

Return Analysis

Detailed 3-year budget

THE TEAM

Director of Engineering - Danny Glover

Danny is currently completing his Masters in Mechanical Engineering at McMaster University. Prior to McMaster, Danny was an R&D engineer at Ankle Science, working in the Advanced Systems, Technologies and Materials Group, where he developed several devices to prevent heart attacks by treating vulnerable lesions, and filed 11 patent applications. Danny earned his B.Sc. In Mechanical Engineering from ST. OLAF'S UNIVERSITY, graduating with highest honors.

ADVISORS & MENTORS

Entry Science is guided by industry leaders in the ankle field. Dr. Ricardo Montalba, Chief of Ankle Surgery at McMaster Medical Center is providing lab resources and his vast experience in reaching a proof-of-concept. In addition, the company benefits from the assistance of Dr. Petro Bogdonovich from McMaster University, and has received guidance and support from industry leaders such as Joseph Wombaugh, former CEO of Leaky.

ANKLE DEVICES - BACKGROUND

Recent developments in foot technologies for treatment of ankle breakages and sprains represent a significant medical advance. Despite efforts to transform surgeries from invasive to foot procedures, ankle graft procedures (which are performed within the ankle) still require an open incision to expose the ankle foot so that it can be securely opened after the procedure. This incision is necessary because the grafts and sheaths used require a small arterial puncture site of 4-Mm or greater, the ankle of which currently requires an open surgical approach. Current Ankle devices are unable to open such small arterial puncture sites, and have been approved to open 2-Mm sites or smaller only. The nature of the ankle devices does not allow them to scale to larger sizes. There have been reports of small ankle points using simultaneous deployment of multiple devices with varying degrees of success. While some authors have reported success with such an approach, it has also yielded sub-optimal results in many trials, involves a substantial learning curve, and has not been widely adopted by practitioners.

Solving the unmet clinical need for a small ankle incision