During the pre-submission process as a usability test for FDA certification of Anyfusion, a cylinder-type drug injection pump, Anyfusion was identified as an innovative technology with significantly improved safety compared to existing products, and was classified as an innovative medical device group.

The STeP (Safe Technologies Program) provides timely access to patients and medical staff through rapid review and certification of 60-day safety enhancement technologies, including senior FDA officials.

If Anyfusion is confirmed as a fast track FDA certified product through STeP, the FDA will verify the safety of Anyfusion.

This is because safer and more effective products can treat patients safely and accurately, quickly recover health, give medical staff high trust with quality medical services, and minimize users' workload.

After UL (Emergo) reviewed Anyfusion data, it was sufficiently confirmed that it was a technology product that conforms to STeP, and UL (Emergo) accepted consulting and contracted with us due to the possibility of STeP.

If the person in charge is assigned and the necessary documents are requested, the consultant in charge will fully understand Anyfusion and communicate with the FDA to improve the safety factors as follows, so it is expected that certification will be possible within this year.

Safety difference between Anyfusion and existing products

1. Due to the limitation of the original technology of the existing product (infusion + syringe pump), errors such as free flow, registration, over, low flow, and Siphoning penomenon occur without alarm.

Anyfusion does not cause these problems at all due to its original technology.

- Errors that occur without alarms develop into medical accident risks because they are not aware of the inaccurate effectiveness due to excessive or under-injection.

2. Since the existing syringe pump has a maximum capacity of 50 to 60cc, the following errors occur when injecting 50 to 60cc or more into the syringe several times.

① Contamination and Infection Risk

② Start up delay (when injecting microdose, the display shows that the drug is injected as soon as it starts, but in reality, the drug is not injected. Startup delay refers to the time it takes for the drug to be injected in the syringe by mechanically pushing the syringe plunger, and the drug is not injected up to 2 hours and 30 minutes.)

③ User error due to frequent resetting

④ Anyfusion doesn't need several injection. In order to prevent contamination and infection, it is not necessary to prepare a unit at a pharmacy.

※ Prediction of a major change in pharmaceutical injection parameters

3. Death volume does not occur due to MCST use.

- Existing products are inevitably wasted in death volume to remove air during priming, but Anyfusion has strength 1) saving expensive medicines and 2) blocking germs and environmental pollutants by throwing them on the floor, trash cans, and sewers.

Just as FDA officials did not understand Anyfusion's mechanical mechanism correctly, it is expected that UL (Emergo) personnel understand Anyfusion's mechanical mechanism correctly, and if they understand the mechanical mechanism, they will easily understand the above safety differences.

Everything goes on paper, and it's important for consultants who understand Anyfusion correctly to make it easier for FDA examiners to understand. We have also signed a confidentiality agreement with Emergo.

If FDA certification is decided by STeP (fast track), we expect to give meaningful massages to the global market as well as Medtech members and major companies in the United States.

The medical market will use Anyfusion, which is safer and more effective for patients, and Anyfusion expects that future health, which is safe for patients, will be a valid drug injection pump for medical staff. I hope that Anyfusion will be quickly certified by the FDA and that it will be a safe and useful drug injection pump for premature babies, underweight children, and critically ill patients.

Thank you.