Notice

Business Status

1. Domestic hospitals address FDA concerns regarding existing drug infusion pumps. Clinical risks and serious issues stem from poor environments and practices caused by government healthcare policies, preventing proper pre-service education and training for new medical staff. Pumps are used without proper understanding, leading to unreported human errors causing severe medical accidents and skyrocketing healthcare costs due to increased workload. Anyfusion cylinder pump fundamentally resolves these issues with real-world clinical efficacy, enhancing reliability and expanding its opportunities.

2. Demonstration and Real-world Usage Effects at Major Domestic Hospitals

1) Two hospitals affiliated with Korea's top National S University College of Medicine and private S Hospital will conduct government-supported clinical trials and demonstrations focusing on the cost-effectiveness of actual usage, building on the foundation of point 1 above.

2) Effects

① Expansion of usage in domestic hospitals

② Overcoming poor domestic medical policies, culture, and environment; verifying cost savings and cost-effectiveness; enabling price adjustments

3. Investment Intentions from Three Major Domestic Investment Firms

Following a high evaluation of the company's technology and marketing status at a Gyeonggi Province business support event, Company P (pre-IR meeting with Bio sector executives) announced that major firms P, A, and I will jointly review a large Series B investment.

4. Progress on U.S. Market Entry

① Support from the U.S. Embassy in Korea

The U.S. Embassy in Korea has committed to introducing and supporting efficient, rational, and economical consulting agencies for identifying the optimal market and region for establishing a U.S. corporation.

② Through the U.S. Embassy, global company D, known for successful accelerator and incubator programs, has agreed to provide business proposals for successful U.S. market entry, including initial investment.

③ We were also introduced to Company C as a consulting firm specializing in identifying optimal medical professionals, institutions, and methods for corporate establishment and medical insurance registration.

④ The U.S. Healthcare Insurance System and the Necessity of Registration

The U.S. healthcare insurance system, a dual-payment system where hospitals and physicians are paid separately, is becoming the global market standard. The registration of procedure fees (including consumables and equipment usage fees) is understood to be critical to the success or failure of Anyfusion and the company.

Not only in the U.S. but as a standard for the global market, U.S. healthcare insurance requires contracts with private insurers that vary by state. It integrates public insurance programs like Medicare, Medicaid, and Obamacare (Affordable Care Act), with the Center for Medicare and Medicaid Services (CMS) determining the listed prices and coverage for medical supplies and procedure fees. CMS listing will also impact contracts with private insurers in each state. Price increases during additional cost-effectiveness verification; Anyfusion ACPi Pro is subject to the same.

Listing on U.S. public and private insurance is influenced by clinical data from influential physicians and academic societies within the U.S. Significant costs are anticipated.

5. Two-step process for universalizing the Anyfusion cylinder pump: Significance of the bulk order quote request from Cheonan S University's new hospital

① Confirm via demo that it completely resolves the serious leakage and fluid retention issues of existing pumps.

② Purchase a small quantity (approx. 10 units) for long-term (approx. 1+ year) practical use to verify quality, performance, and A/S.

② If other hospitals do not require a large-volume order reference (case) due to university (large) hospital references showing no long-term usage issues as in ①, proceed with a small-volume order; if many require it, proceed with a large-volume order from the start.

③ Reference from major hospitals is particularly necessary. Although pursued as a demonstration project at Ajou University, limitations arose due to medical personnel shortages during the healthcare crisis. Pursue references from Samsung Seoul Hospital, Seoul National University Hospital, and Seoul Asan Hospital.

④ Rapid domestic hospital expansion through academic presentations, exhibitions, and promotional activities using evidence from references ①-④

⑤ Paradigm shift in drug infusion pumps to Anyfusion cylinder pumps through replacement across all domestic university hospitals

⑥ Same process required for global market

⑦ Need for U.S. entry as global standard: Evaluate all data using U.S. hospital data (↑funding required) → Preliminary preparation: 1) Maximize efforts domestically before establishing U.S. subsidiary 2) Establish subsidiary (eligible for U.S. government support programs; U.S.-based cost data for manufacturing, etc., determines insurance reimbursement pricing) → Secure investment → Series C or IPO (listing). Mass orders are the first step. This constitutes Series B level.

6. We will refrain from announcing information that could serve as a reference for emerging industrial nations, including China, which are pursuing early modification and copying, regarding the successful market expansion of Anyfusion (pump, ACPi, M-CSTD) and other important news. While various international patents have been filed, shareholders and authorized personnel should contact the company directly.

Thank you.

Next (November 28–29) The Korean Society for Hospital Quality Management conference
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