Current status of business after being selected as Korea's first FDA innovative medical device STeP | |
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Phase 1 business
1. Korea (2023~) 1) Application for adjustment of selective benefit (Patient 8: Corporation 2) to medical care (required) benefit (Patient 2: Corporation 8) (problems with existing product safety and effectiveness - attached file) The FDA, the world's highest medical level, has an Injection Devices Team for special management, and the reason why it continuously recommended development of alternative products is that existing injection pumps and syringe pumps are unsuitable for pharmaceutical injection pumps (attached), and are dangerous and cause death and harm to health. Because it is a technology product. Anyfusion, which perfectly solved the problems of the existing technology, was selected for STeP, a system that allows patients and medical staff to use it quickly as a medical device with significantly improved safety and effectiveness. The drug infusion pump must accurately inject the prescribed quantity based on medical and clinical grounds without stopping in real time for 96 to 168 hours, and play a role in overcoming disease and restoring health through normal treatment. Due to factors such as the FDA and attachments, normal and accurate injection is impossible with existing technology. Only Anyfusion cylinder pump is available. Injecting information into the display with electronic equipment is of course trusted by all medical personnel as accurate and normal injection. Countless patients lose their lives every year due to medical accidents. FDA is not like this for existing products. It encouraged the development of countermeasure technology to overcome the work load and huge medical expenses such as death, deformity, disability, and extended hospitalization by replacing the problem with medical personnel. Anyfusion cylinder pump Despite its high cost-effectiveness due to its perfect safety and effectiveness, restricting it to selective benefit violates the policy that prioritizes the safety of patients, and wastes a large amount of medical expenses, adversely affecting health insurance finances. Economic and industrial values such as prevention of medical accidents, healthy future and medical cost reduction through rapid medical (essential) benefit adjustment, overcoming trade imbalance for more than one year, export, contribution to birth rate, and enhancement of national prestige cannot be converted into money. Just as Anyfusion, which was designated and selected by the US FDA, was eliminated due to differences in domestic innovative medical device designation, pan-ministerial, and innovative medical device company designation and selection standards, Anyfusion's cost effectiveness and economic and industrial effects overcoming serious safety problems such as attachments If it is overlooked and not adjusted to medical care benefit, patients and medical staff must always be exposed to medical accidents and risks, and the medical budget and economic, industrial, and national losses are enormous. 2) Fundraising Up to tens of billions of won at home and abroad Expected around April to May in Series 2 to 3 stages 1), 2) are preparing the following. New product development R&D (domestic and overseas market research and demonstration results): Anyfusion program cylinder pump (Drug library, TCI, Desensitization), customized upgrade cylinder pump, dispensing cartridge, customized ACPi development promotion; American Society of Critical Care, Cancer, Anesthesiology, Domestic and International Exhibitions Recruitment of manpower: CEO, CFO, CTO (by field), research, production, domestic and overseas sales, marketing, etc.
Phase 2 project (2023~) 2. USA: Ongoing 1) Distributor Only USA or Global, USA corporation 2) Other Distributors
Phase 3 business (2023 development completion, 2024 license and permit, 2025 fostering as a core business, excellent stock strategy) 3. Anyfusion ACPi system Compared to dispensing robots, 1/51~1/20 price ACPi system with high cost-effectiveness of 300 or more dispensing volume per day, dispensing range of 90% or more 2 types of automatic and manual 2 types of ACPi cartridge kit set, all-in-one from dispensing to injection. Development of general-purpose equipment that is 1/10 the price of the combined dispensing robot according to dispensing scale As above, the strategy is to pursue an IPO at the end of 2024 or 2025. Thank you. |
Next | Agreement with Italy G and Plan to use Anyfusion at S University new hospital in Cheonan |
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