It is intended to be used as a tool by clinicians (prosthetists)during the alignment process and it may be helpful in preventing misalignments and the associated risks in patients.

About

Value Proposition: Users of artificial limbs and their providers are faced with the problem of prosthetic alignment: The optimal angle between prosthesis components is hard to determine and very difficult to document and replicate. Many prostheses are therefore not optimally aligned, which affects safety and comfort. Our product provides an effective and accurate way of measuring the alignment angles of prosthetic componentry. It is intended to be used as a tool by clinicians (prosthetists)during the alignment process and it may be helpful in preventing misalignments and the associated risks in patients who modify their own prosthesis.   Market Opportunity: Approximately 2 million people in the US live with limb loss, a number that is expected to nearly double by 2050. They are being provided with prosthesis by approximately 10,000 prosthetists and technicians. With an estimated price to the professional segment of $500 per unit, this high-margin tool indicates an initial market size of $5M. For the larger consumer market, a simpler, more economical version for direct sale is also planned. In addition our technology, which is classified as a tool and is therefore not subject to regulatory requirements typical for medical devices,could easily be offered in international markets as well.   Competitive Landscape: There are no products that compete on a direct basis. Some manufacturers offer alignment assessment devices that cost between $3,000 and $14,000 and do not offer the simple functionality of our product. Currently, clinicians and end users estimate alignment changes based on the number of setscrew rotations or the visual assessment helped by a plumb bob, an approach that has not changed since 1969.   Technology: The device consists of a compact housing that can be temporarily attached to any prosthesis pylon by a clip mechanism. Integrated are sensors that detect the position of the internal pyramid adapter component, which is translated into alignment angles for display. In the first release angles are merely displayed for documentation by other means. Future releases will allow the storage of pre-settings to support simple alignment changes by non-clinicians creating a new market opportunity. In addition, Wi-Fi connectivity will provide for 1) easier documentation,2) collection of clinical & research data and 3) the data to establish the world’s first prosthesis alignment database.  

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