During the Presubmission of the Usability test protocol for FDA 510K certification, the FDA engineer reviewer introduced STeP track modeled after breakthrough devices if Anyfusion is reasonably expected to improve compared to existing products in terms of safety.

If FDA reviwer clearly understands that the mechanical mechanism of Anyfusion core technology improves safety compared to existing products and receives verified data in accordance with STeP track conditions, the STeP process entry request review timeline will proceed as follows.

① FDA Request Received - Day 1

② Substantial interaction by day 30: • Permission or refusal to make decisions • Additional information letter

③ By Day 45 - Interactive Defects If applicable, the sponsor will respond to additional information correspondence.

④ Day 60 - Final Decision

The Safer Technologies Program (STeP) is intended to give patients more timely access to specific medical device and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnoses for underlying diseases or conditions associated with less severe diseases and mortality than subjects.

With the support of innovative device programs by reducing development, evaluation and review time, nine devices were licensed from March 2021 to April 30, 2022.

In Korea's innovative medical device designation system classified as a high-tech group, a medical innovation group, a technology innovation group, and a public medical group, the rest of the group except for the high-tech group belongs to STeP.

The high-tech group is reviewed by the U.S. FDA as a Breaththrough Devices Program with stricter standards than STeP and clinical plans that passed the IRB.

Anyfusion, which was not selected as an innovative medical device in Korea, was classified into the category of innovative medical devices by FDA, the world's top certification agency, and introduced the system and the fast track certification program.

In addition, FDA engineer who reviewed Anyfusion recognized the original technology of Anyfusion as a technology that can manufacture medicines.

As the FDA, which represents worldwide certification, has started this program in March 2021 and has been granted nine devices in about a year and a month, clear evidence and verification data are needed.

• The Breakthrough Devices Program and STeP are designed to give patients and healthcare providers timely access to innovative devices.

• These programs facilitate the development, evaluation, and review of specific devices that meet program eligibility criteria.

* Comparing Programs

Here I attached the original STeP guide line as a pdf file.

If our Anyfusion will be finally FDA approved as STeP, we believe it will help Anyfusion to quickly market globally.

Thank you.