FDA approval and working capital
24 December 2020
TruSpine Technologies plc (AQSE: TSP), the medical device company focused on the spinal (vertebral) stabilisation market, announces that the application for FDA clearance for its Cervi-LOK product which it expected to make by Q4 2020 has been delayed for up to three months. The delay is a result of being unable to secure cadaver lab time and testing due to COVID-19 restrictions. However, the Company have been able to computer model the Cervi-LOK product in situ, and this has enabled the Company to make minor modifications to the Cervi-LOK product.
These modifications should see a significant improvement to the current design and enable the Cervi-LOK product suite to be accessible to a wider range of patients once launched.
Cadaver lab time and testing has been booked for February 2021, pending further COVID-19 restrictions.
Further to the announcement on 12 November 2020, the Company continues to be in dialogue with Evrensel Capital Partners Limited (“Evrensel”) and expects Evrensel’s subscription for 694,444 new ordinary shares in the Company at a price of 36 pence per share to complete by 5 January 2021, providing the Company with an additional £250,000 of gross proceeds.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").
The Directors of the Company take responsibility for this announcement.
|TruSpine Technologies Plc||Tel:+44 (0)20 3638 5025|
|Ian Roberts, CEO|
|Cairn Financial Advisers LLP (AQSE Corporate Adviser)||Tel: +44 (0)20 7213 0880|
|Liam Murray / Ludovico Lazzaretti|
|WH Ireland (Broker)||Tel: +44 (0)20 7220 1666|
|Walbrook PR (Financial PR & IR)||Tel: +44 (0) 20 7933 7870 or +44 (0) 7876 741 001|
|Anna Dunphy||[email protected]|
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identiﬁed by their use of terms and phrases such as ''believe'', ''could'', "should" ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', "expect", ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reﬂect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.