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In analyzing the regulatory path forward, timeline, and costs associated with the level of effort required to upgrade the Company’s Quality Management System (QMS), we have decided not to renew our CE mark (required for sales in the European Union) for this year and to consider reapplying in 2 to 3 years to avoid these regulatory fees. Similarly, we will maintain our Quality Management System to be compliant to ISO 13485:2016 but not certify to ISO 13485:2016 by Underwriters Laboratories (UL) which will allow us to avoid fees associated with certification, travel, and hosting audits. Maintaining our QMS to be ISO 13485:2016 compliant will allow us to quickly schedule an audit with UL and become ISO 13485 certified when necessary.


In the current year, the Company separately classified bad debt expense in the statements of operations. For comparative purposes, amounts in the prior years have been reclassified to conform to current year presentations. These reclassifications had no effect on previously reported results of operations or retained earnings.


On January 8, 2019, the Company entered into an auto lease agreement. The term of the lease is 3 years beginning January 8, 2019 with a monthly lease payment of $1,204 due on the 7th day of each month. The total lease commitment including sales tax for the 3 years is $43,338. This lease was terminated on March 10, 2021 and the vehicle was returned to the dealership. No gain or loss resulted from the termination of the lease.


On May 1, 2021, the Board granted options to purchase 1,500,000 shares with an exercise price of $.51 per share to a consultant in China who has a critical role in overseeing the development and manufacturing of the CTLM® in China. The option will vest over a three-year period.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations


The decrease is due to the Company writing off $7,700 of accounts receivable and $11,965 of amounts due from related parties due to their age in fiscal 2020.