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Commercialization Timeline
Commercialization Timeline
Regulatory Pathway
Regulatory Pathway
Our device will seek a 510k exemption as a Class I medical device.
There are many predicate devices on the market for low vision diseases that make use of proprietary software and a VR headset. We intend to leverage this when applying for the exemption.
Investment Merit
Investment Merit
The competitive price for our device ($1300) was set to be 30% less than the Peli-Lens, which has a base cost of $2000.
According to the World Health Organization 15 million people have a stroke yearly. According to clinical data, 10% of all stroke patients have permanent HH. We hope to conservatively capture 1% of this population.
As stated in our commercialization timeline, once our product launches we plan to provide software support and address any user concerns with our device, setting aside $3 million. We plan to taper that off after each year our device has been on the market. This model assumes we do not add any features or new low vision solutions.
With this projection we plan to be receiving a return on investment and start acquiring net income around year 5.
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