(Alliance News) - TruSpine Technologies PLC on Friday said it has obtained a GBP30,000 loan agreement with former Non-Executive Director Annabel Schild, and said the US Food & Drug Administration is seeking further clarification on its application for Cervi-LOK.

The London Gatwick Airport-based medical device company said the loan will be used to repay a portion of its outstanding fine from the Aquis Stock Exchange.

This comes after AQSE said in August that it had sanctioned TruSpine with a fine after it said it had breached the rules of the exchange.

The fine includes GBP20,000 to be invoiced immediately; GBP30,000 deferred until the earlier of the completion of a fundraise or the period ended 12 months from the publication of the penalty notice; and a GBP165,000 balance.

At the start of January, TruSpine had announced GBP200,000 bridging loan facility alongside a non-binding letter of intent for GBP2.4 million in staged equity funding over three tranches of GBP800,000. It noted that the GBP200,000 would be available immediately.

Then, at the start of February, the company said its loan transfer had experienced delays.

Consequently, Aquis said: "The market had a false impression of the company's financial position from 3 January 2023 until 1 February 2023."

Then, on February 28, TruSpine announced that it had secured a new loan of GBP200,000 from a third party.

Two months later, at the end of April, a charge over the company's assets was filed at Companies House in favour of the Hub 2021 Ltd, the entity which had provided the loan announced on February 28. No reference to the charge was made in the company's announcement of February 28.

On May 9, TruSpine released a correction to its announcement of February 28 adding details of the charge over its assets

As a result of the failure to announce the charge at the time of entry into the loan, Aquis said the market had a "false impression of the company's financial position and risk profile" between February 28 and May 9.

TruSpine added that the loan will also be used to progress the due diligence on the proposed appointments of Victoria Sena and Samuel Ogunsalu as non-executive directors.

In addition, TruSpine said on Friday that the US FDA is seeking further clarification regarding its 510(k) application for Cervi-LOK, which it said it could provide "in the near future".

In October, the FDA confirmed it had completed the technical screening of TruSpine's 510(k) submission, which was submitted in late July, but sought further clarification on certain matters.

The application was placed on technical screening hold "until such time the relevant information requested has been provided to the FDA", adding that the submission could remain on hold until March 25 next year. Cervi-LOK is a screw free spinal stabilisation system.

Shares in TruSpine were untraded at 1.25 pence each on AQUIS on Friday morning.

By Sabrina Penty, Alliance News reporter

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