1. Distributor selection: Last
week, L company executives and L company's Americas officials introduced a
video meeting, shared information on entering the Americas, used area ICU,
ambulance, helicopter, highland, PCA, etc. Consultation with distributors
to reflect company expectations and requirements for five to six weeks
(mid-to-end March), contract expectation, contract size, production schedule,
inventory, transportation, A/S, insurance registration, etc. in April. 2. Meeting with investors:
Completed 1st meeting with 3 companies, expected IR during January-February,
requested foreign investors to invest. 3. Progress outside the U.S.:
sales in Spain and Portugal, introduction of Spanish buyers, selection of
partners in the U.S. market, consultant reports important progress next week,
Saudi Arabia finalizes negotiations on February 1, 2023. 4. Domestic: Suggested
equipment committee for code listing of Major Seoul U University A Hospital,
Gyeonggi-do A University Hospital, Daegu K University D Hospital, first
purchase expected around March. 5. Ministry of Food and Drug
Safety, Ministry of Health and Welfare: 1) In the case of being selected for
Breakthroug or STeP as an innovative medical device by the US FDA, review of
regulatory improvement included in the domestic innovative medical device
integrated review and inclusion in the business plan, non-reimbursement or
medical care benefit for 3 to 5 years if selected as an integrated review. 2) It has been verified as a medical device
with significantly improved safety and effectiveness and has been selected as
FDA STeP. It is the duty of the state to prevent patients from being exposed to
the risk of medical accidents at all times due to the use of existing medical
devices with serious safety and effectiveness problems. The government, which
has emphasized the use of selective benefits, neglects the state's obligations
and responsibilities, and prompt conversion of medical care benefits is being
requested and reviewed as a matter of course. 6. HIRA: FDA STeP selection
factor, value for safety and effectiveness, price increase computerized
submission. 7. Significant delays in drug
and medical device certification due to FDA manpower shortage, purchase of PRV
(Priority Review Vouchure) at a cost of $100 million to obtain expedited
approval for drugs, STeP granted priority review.
Thank you. |