Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

Algernon Pharmaceuticals Regulatory – Medical Devices

Annual Information Form

For The Financial Year Ended August 31, 2018

April 11, 2019

Page 22

Once the Company completes the development of a fully functional prototype device, the device would be ready to move into a RUO phase. Once the RUO development phase is concluded, the device would be ready for researchers who could begin using the device to see if biomarkers can be discovered and validated that would support a screening or diagnostic test for a known medical disease or condition.

Once a new medical test has been developed and validated using the Company’s RUO device, an application would then be made to the FDA in order to determine the best regulatory pathway forward. The device will be assessed by the FDA and will receive a classification of either a class II or class III device. Class I devices are reserved for only the simplest of devices (tongue depressor). There is also a class II de-novo application whereby the device is considered as an improvement over a similar device that is already approved and on the market.

The preference is always to receive a class II designation because class a III designation typically means a company must undertake a larger and more costly human trial and requires a cGMP level of device manufacturing that increases the cost and length of time of the development process.

https://webfiles.thecse.com/sedar_filings/00037722/1904160953176150.pdf

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