NASAs Jet Propulsion Laboratory, US (NASA-JPL) via California Institute of Technology (Caltech) Grants Non-Exclusive Agreement to K-One Technology Berhad (K-One) to Manufacture & Distribute VITAL Ventilators (Vital Ventilators) Worldwide
K-ONE TECHNOLOGY BERHAD |
Type | Reply to Query |
Reply to Bursa Malaysia's Query Letter - Reference ID | IQL-02062020-00001 |
Subject | NASAs Jet Propulsion Laboratory, US (NASA-JPL) via California Institute of Technology (Caltech) Grants Non-Exclusive Agreement to K-One Technology Berhad (K-One) to Manufacture & Distribute VITAL Ventilators (Vital Ventilators) Worldwide |
Description | NASA's Jet Propulsion Laboratory, US (NASA-JPL) via California Institute of Technology ("Caltech") Grants Non-Exclusive License Agreement To K-One Technology Bhd ("K-One Tech") To Manufacture & Distribute VITAL Ventilators Worldwide |
Query Letter Contents | We refer to your Company’s announcement dated 1 June 2020, in respect of the aforesaid matter.
In this connection, kindly furnish Bursa Securities with the following additional information for public release:-
Please furnish Bursa Securities with your reply within one (1) market day from the date hereof.
Yours faithfully Listing Regulation
Cc : Market Surveillance Dept., Securities Commission (via fax) |
The Board of Directors of K-One Tech wishes to announce the following in response to the queries raised :
1) NASA's Jet Propulsion Laboratory (JPL) is a unique national research facility that carries out robotic space and Earth science missions. JPL is a federally funded research and development center managed for NASA by Caltech as explained in its website - http://www.jpl.nasa.gov
2) The VITAL ventilator is expected to go on pilot manufacturing in 3Q'20.
3) The estimated total capital expenditure incurred to build prototypes and setting up of production lines and test equipment for commencement of manufacturing is expected to be around RM0.5 million which will be funded by internally generated funds.
4) In the event that K-One as a Licensee makes modifications or improvements to the VITAL ventilator, K-One is required to license the modifications and improvements to Caltech and JPL indefinitely.
5) K-One plans to sell/distribute the licensed product worldwide. However, it will initially focus in Malaysia, Indonesia, Philippines, Singapore, India, US, Brazil, Peru, UK, Spain and Italy where COVID-19 cases are high or have not peaked. As for Malaysia, it is neither of the latter's reasons but just that it is home-base for K-One.
6) K-One is required to seek the approval of the medical device authority in the respective country before it can be distributed in the country concerned. In Malaysia, the approval of the Medical Device Authority (“MDA”) is required. As for the US, it has been approved by the Federal Drug & Administration (“FDA”) under Emergency Use Authorization (“EUA”). It will require the approval of similar medical device authorities in the respective countries which K-One intends to distribute.
Apart from US which has been approved by FDA, K-One expects to submit for approvals for each of the initial targeted countries within the next 6 months. It is expected and assumed that each of the target countries shall grant approvals within 3 to 6 months following submissions.
7) The targeted customers for the VITAL ventilators are public and private hospitals. K-One plans to appoint and work with medical/healthcare distributors in the respective indicated countries to sell the VITAL ventilators.
This announcement is dated 3 June 2020.
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Announcement Info
Company Name | K-ONE TECHNOLOGY BERHAD |
Stock Name | K1 |
Date Announced | 03 Jun 2020 |
Category | General Announcement for PLC |
Reference Number | GA1-03062020-00039 |