Anyfusion cylinder cartridge consultation with the Health Insurance Review and Assessment Service's Therapeutic Goods Committee to adjust screening benefits to nursing benefits, FDA certification progress, Anyfusion export to Spain

On June 1, 2023, the Health Insurance Review and Evaluation Service (hereinafter referred to as "IRES") Therapeutic Materials Committee held a deliberation to adjust the screening benefit of the Anyfusion cylinder cartridge to a nursing benefit. The result will be notified to the company around mid-June.

Based on the FDA's innovative medical device designation and STeP selection, the company applied for the adjustment in January 2023 and held a hearing on June 1. After reviewing the pre-prepared materials, the applicant's testimony and questions and answers were held. The key issue was the lack of accurate understanding of STeP by the review committee officials who prepared the review, and the price increase case.

The FDA STeP designation recognizes that Anyfusion cylinder pump is an innovative technology that completely overcomes and prevents tens to hundreds of thousands of medical accidents (including unreported medical accidents) per year due to serious safety and efficacy problems due to the original technical limitations of existing pumps, resulting in the loss of life and health. The members of the deliberation committee, as well as all medical professionals and anyone else, testified that no one would tolerate the risk of real-time medical accidents using drug infusion pumps that are not guaranteed to be safe and effective for any kind of patient, including their own family members. We also explained the urgency of quickly adjusting the screening benefit to a nursing benefit, as it is not fair to patients to limit or delay it with any standards or regulations, as it can save huge medical costs caused by safety and efficacy issues of existing products. We explained the need to create added value in the medical frontier by raising the price to reflect the value and cost-effectiveness of the significantly improved safety and efficacy of the cylinder cartridge core technology. We regretted that the review committee members and officials did not experience and accurately understand STeP, which was new to Anyfusion.

With UL Consulting, the paperwork for FDA certification is progressing smoothly and we expect to receive the FDA's opinion 60-70 days after submission this month. Most of the documents required for FDA certification are similar to CE certification.

Anyfusion cylinder pump and Anyfusion ACPi system exports will be shipped today. We would like to thank our Spanish buyers for their cooperation and efforts. We are going to Andalusia(West) from June 12th to 15th and Barcelona(East) from 16th to 20th for multiple hospital use. We expect better results than the domestic multi-hospital real world reference.  Italy will have product demonstrations in the Rome region from the 21st to the 23rd. Unlike the Spanish buyers, the Italian buyers are being introduced to Anyfusion for the first time, and after understanding the product, a successful entry into the Italian market is expected.

Thank you to the jury members and everyone involved for their hard work.