|No||2||Date of announcement||2021/10/11||Time of announcement||
|Subject||Oneness has been notified by the US FDA on the acceptance of ON101 medical device 510(k) application|
|To which item it meets||paragraph 10||Date of events||2021/10/09|
1.Product:ON101 Medical Device
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:ON101 Medical Device
(3)Planned development stages：After receipt of the US FDA 510(k) substantial equivalence and clearance, the product can be registered on the US FDA official website for marketing.
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (include interim analysis):510(k) Application
B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:NA
C.After obtaining official approval or the results of statistically significant sense, the future strategy:NA
D.Accumulated investment expenditure incurred: No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies.
(5)Upcoming development plan:
A.Scheduled completion date:After receipt of 510(k) Clearance Letter, Oneness will submit medical device registration for countries where US FDA 510(k) can be referenced for abbreviated registration. The timeline of medical device registration is subject to the review process of the local competent authorities.
B.Estimate responsibilities:After the product is commercialized, Oneness shall pay the royalties the the licensor according to the agreement.
4.Any other matters that need to be specified:
(1)The application has been accepted to be processed according to the US FDA 510(k) regulations. The subsequent review will be under regulatory science
(2)According to Article 2 under Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials or new drug application to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application.
(3)It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.