GMV 0.00% 3.9¢ g medical innovations holdings limited

Ann: Trading Halt, page-109

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    From 28th March 2018

    Dear Hayley
    Response to ASX query

    I refer to the letter from ASX to G Medical Innovations Holdings Ltd (GMV or G Medical) dated 23 March 2018 (QueryLetter). Capitalised terms used in this letter have the meaning given in the Query Letter, unless expressly defined otherwise. On behalf of GMV, I respond to the Query Letter as follows:

    1.Has GMV commenced the product trial referred to in its announcement of 9 May 2017? If not, when does GMV expect the product trial to commence?

    It was agreed between GMedical and SilverLake that the trial was no longer required. A number of G Medical partners, including SilverLake,have received the first released units for internal assessment purposes.

    2.Has SilverLake purchased any units from GMV in accordance with the distribution and co-operation agreement between GMV and SilverLake? If so, please advise how many units and the payments received by GMV. If not, when does GMV expect that SilverLake will purchase units in accordance with the distribution and co-operation agreement with SilverLake?

    SilverLake has not yet purchased any units from GMV. In order for GMV to be in a position to supply its devices to SilverLake for distribution, GMV must first receive the requisite CFDA approvals. As noted below, and previously disclosed through ASX announcements, GMV anticipates receiving CFDA approval in the second quarter of 2018.GMV anticipates that SilverLake will commence purchasing units from GMV within a few weeks of GMV receiving the requisite CFDA approvals.


    3.Has GMV received any payments from MEDTEL pursuant to the exclusive distribution agreement between GMV and MEDTEL? If not, when does GMV expect to receive payments pursuant to the exclusive distribution agreement with MEDTEL?

    Yes we have received US$15,000 from MEDTEL following their receipt of the first commercially ready Prizma Cases. As G Medical intends to manufacture the bulk of its product in China where the costs of production will be cheaper, the distribution of the Prizma medical smartphone remains subject only to the receipt of the CFDA approval. G Medical will provide an update to the market in accordance with its continuous disclosure obligations as and when required.

    4.Has FCL purchased any units from GMV pursuant to the binding memorandum of understanding between GMV and FCL? If so, please advise how many units and the payments received by GMV. If not, when does GMV expect that FCL will purchase units in accordance with the binding memorandum of understanding with FCL?

    No, FCL have not purchased any units from GMV. It was noted in the announcement that:"...the Tier 1 partners of FCL have not yet formalised a definitive arrangement with FCL, and thus FCL have not yet established their "Letter of Credit"... On this basis, the Company cannot categorically state that the full anticipated revenues under this Agreement with FCL can be achieved,until such time as the above have been formalised."These discussions for definitive agreements remain in progress. As noted in GMV's announcement of 10 November 2017, GMV has met with the counter parties and is satisfied that these parties intend to enter into the necessary definitive arrangements with GMV. GMV will release a further announcement in due course once these definitive agreements have been executed.GMV continues to consider that the necessary definitive agreements will be entered into as anticipated. In the event that such agreements are not entered into, and the memorandum of understanding between GMV and FCL is terminated, GMV will make an announcement to ASX in accordance with its continuous disclosure obligations.

    5.Noting that GMV has been granted “green channel” approval by the CFDA, has GMV been granted regulatory approval for the Prizma medical smartphone case by the CFDA? If not, when does GMV expect the regulatory approval for the Prizma medical smartphone case to be granted by the CFDA?

    No, G Medical has not yet been granted regulatory approval for the Prizma medical smartphone case by the CFDA. The Green Channel granting is an acknowledgement by the regulators that G Medical’s submissions will be treated as a priority approval process. All technical tests have been passed which is why the Green Channel was granted. Clinical trials are anticipated tobe finalised within the next few weeks. G Medical’s final submission will then be lodged for CFDA approval. It is on this basis thatG Medical considers it has a reasonable basis to expect to receive CFDA approval in the second quarter of 2018, which it has previously announced.GMV will release a further announcement in due course once it receives updates from the regulator.

    6.Are the Prizma medical smartphone cases commercially ready? If not, please advise when GMV expects the Prizma medical smartphone cases to be commercially ready.

    Yes, the Prizma medical smartphone cases are commercially ready.As G Medical intends to manufacture the bulk of its product in China where the costs of production will be cheaper, the distribution of the Prizma medical smartphone remains subject only to the receipt of the CFDA approval.G Medical will provide an update to the market in accordance with its continuous disclosure obligations as and when required.

    7.Has FCL formalised its arrangements with its Tier 1 Partners? If not, when does GMV expect that FCL will formalise its arrangements with its Tier 1 Partners?

    Refer to the answer to question 4. FCL has not formalised its arrangements with its Tier 1 Partners. These discussions are still on going and G Medical is meeting with FCL in the second quarter of 2018 and will provide an update to the market in accordance with its continuous disclosure obligations as and when required.


    8.Has FCL established its letter of credit? If not, when does GMV expect that FCL will establish their letter of credit?

    Refer to the answer to question 7.

    9.Please provide a breakdown of the receipts received from customers totalling US$22,000. The US$22,000 related to receipts from services provided by G Medical Diagnostic Services (previously CardioStaff) in the US and does not reflect any sales related to our Prizma product.

    10.Please confirm that GMV is in compliance with the Listing Rules and, in particular, Listing Rule 3.1.

    I confirm that GMV is in compliance with the Listing Rules and, in particular, Listing Rule 3.1.

    11.Please confirm that GMV’s responses to the questions above have been authorised and approved in accordance with its published continuous disclosure policy or otherwise by its board or an officer of GMV with delegated authority from the board to respond to ASX on disclosure matters.

    I confirm that the responses set out in this letter have been approved by a resolution of the board of directors of GMV. I trust this letter addresses the Query Letter to the satisfaction of ASX. Please contact me if you have any further queries.

    Again previous questions and relies from 28th March 2018
    Last edited by 61212305: 16/09/19
 
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