The Amni-Nik® does not need a formal 'clinical trial'. However we do need to 'prove' the concept and get some useable prototypes into the hands of first users and that is the stage we are at now. We have decided the best way is to make surgical grade stainless Amni-Nik®'s that can be autoclaved. We are excited to see how the Amni-Nik works in the hands of a variety of practitioners in various settings.Our data collection system is in place and we are in contact with clinical sites.
A multi- media business plan blog for the Amni-Nik®
Saturday, October 18, 2014
Where we are now
The Amni-Nik® is a class one medical device.
The Amni-Nik® does not need a formal 'clinical trial'. However we do need to 'prove' the concept and get some useable prototypes into the hands of first users and that is the stage we are at now. We have decided the best way is to make surgical grade stainless Amni-Nik®'s that can be autoclaved. We are excited to see how the Amni-Nik works in the hands of a variety of practitioners in various settings.Our data collection system is in place and we are in contact with clinical sites.
This medical illustration has been very helpful. It inspired the multi-media format of the business plan.This and our logo was done by www.bajemastudios.com
The Amni-Nik® does not need a formal 'clinical trial'. However we do need to 'prove' the concept and get some useable prototypes into the hands of first users and that is the stage we are at now. We have decided the best way is to make surgical grade stainless Amni-Nik®'s that can be autoclaved. We are excited to see how the Amni-Nik works in the hands of a variety of practitioners in various settings.Our data collection system is in place and we are in contact with clinical sites.
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