11.18.22
Hello all MARCo friends and followers,
We are very excited to share that we are taking the first steps towards our ultimate goal of an FDA cleared MARCo product. We recently engaged with an FDA consultancy firm - FDA Consultants - with over 30 years of experience in successfully navigating companies through FDA medical device applications from start to finish. Our first project with them will be completing an FDA Q-Submission, which we believe we can submit and have our first formal meeting with an FDA panel of experts by the end of this calendar year.
The results of that Q-Submission will cement our path forward to bringing MARCo to regulatory clearance in the U.S. We believe the results of the meeting and feedback from the FDA will enable us to identify whether MARCo has enough of a predicate to go for a traditional classification, if it is so cutting edge that it would go through a DeNovo pathway and forge its own classification, or if it can earn breakthrough device status - a status which would open up additional government funds for our company. Given previous research on existing classifications, we currently believe we have a path to breakthrough device status.
Based on previous work the FDA Consultants have done, as well, we believe that we can achieve FDA clearance in 12-18 months from now. This is based on previous successes of the consultancy firm as well as industry standards.
Why is FDA clearance needed if we're on the market?
While we will continue to sell our wellness & support version of MARCo, we believe FDA clearance will be key to unlocking MARCo's ultimate growth potential. First, FDA clearance is a required step to get MARCo covered by insurance and other medical payment plans. Second, it would enable us to bring MARCo to higher risk customers and larger institutions whose focus is on high risk individuals - a core part of our mission. Combined, we believe that the increase in target market size and insurance coverage abilities will enable us to grow sales and build a more legitimate brand.
We will keep you all posted as we continue on this FDA clearance journey!
And to all our backers, I want to say again, thank you for joining our mission. If you want to see your impact and investment go even further, please make sure to share our company and campaign with anyone and everyone you may know who may be interested. And even if you are just following for now, a share can go a long way, so please do consider sharing and spreading the word.
Thank you all and stay tuned for the next latest and greatest update in MARCo's journey!
Sincerely,
Jacob Boyle
CEO - MARCo Health Inc.
Website: https://www.marcohealthtech.com
Facebook: https://www.facebook.com/marcohealthtech
Instagram: @marcotherobot
TikTok: @marcotherobot
LinkedIn: https://www.linkedin.com/company/marco-technologies-llc/