FDA Meeting & Status Update

In January, our team had a pre-submission meeting with the FDA to discuss the regulatory process and requirements for our Pink Luminous Breast Device. We're excited to report that the next steps are progressing smoothly. With the support of our regulatory team at Cencora and Alston Bird, we anticipate submitting all necessary documents for another meeting in the coming months. Additionally, we are excited to announce that we are ready for the next clinical trial study. The design and sample size are prepared, and we look forward to advancing this important work.

Expanding Our Patent Portfolio

Our organization has secured patents and successfully signed in multiple European countries, including Ireland, the United Kingdom, Norway, Sweden, Denmark, Spain, France, Italy, Germany, Poland, Switzerland, Turkey, Croatia, and Hungary. This significant milestone allows us to expand our reach and impact across the continent. Thank you for your continued support as we advance our mission and innovation across Europe.

Distribution Contracts and Orders

Our distribution network is expanding rapidly. We have contacts in place throughout the EU/UK. Additionally, we are receiving interest in several Latin American countries, showcasing the growing demand and recognition of our products in these regions.