TruSpine Technologies PLC Deutsche Boerse AG

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9Q7

GB00BMZCKL55

Delayed Deutsche Boerse AG Other stock markets 02:04:38 2021-07-06 EDT			5-day change	1st Jan Change
0.0617 ^EUR	-24.29%		-.--%	-.--%

05-07	TruSpine Technologies says CEO Laurence Strauss resigns	AN
03-21	TruSpine Chair Miller buys GBP375,000 in shares	AN

TruSpine notes US FDA requires more info on 510k application

October 03, 2023 at 10:18 am

TruSpine Technologies PLC - London Gatwick Airport-based medical device company - Says the US Food & Drug Administration has confirmed it has completed the technical screening of TruSpine's 510k submission for Cervi-LOK, which TruSpine submitted in late July. Says the FDA is seeking further clarification on certain matters, which TruSpine believes it can provide "in the near future". Says the application has been placed on technical screening hold "until such time the relevant information requested has been provided to the FDA". Says the submission can remain on hold until March 25 next year.

Chief Executive Officer Laurence Strauss says: "On behalf of the TruSpine board we are pleased to report progress with our 510k FDA application. Our technical team and advisers are working to provide the requisite clarifications to the FDA. I look forward to reporting on progress."

Current stock price: 1.05 pence

12-month change: down 76%

By Greg Rosenvinge, Alliance News reporter

Comments and questions to newsroom@alliancenews.com

Latest news about TruSpine Technologies PLC

TruSpine Technologies says CEO Laurence Strauss resigns	05-07	AN
TruSpine Chair Miller buys GBP375,000 in shares	03-21	AN
EARNINGS AND TRADING: Cykel and Mustang push back takeover deadline	03-15	AN
TruSpine Technologies raises GBP290,000 through share issue	03-14	AN
Plant Health eyes Mexico Saori launch; NARF wins deal	02-23	AN
TruSpine submits info to US FDA over Cervic-LOK applictaion	02-19	AN
TruSpine Technologies enters GBP50,000 loan note agreement	02-14	AN
TruSpine secures loan to pay fine; FDA needs Cervi-LOK clarification	01-05	AN
Loss-making TruSpine expects to raise equity or debt soon	12-28	AN
EARNINGS AND TRADING: Celebrus swings to profit; Aquila revenue flat	11-27	AN
Digital 9 dismisses call for strategic review	23-10-30	AN
TruSpine submits further documentation to FDA for Cervi-LOK	23-10-12	AN
TruSpine notes US FDA requires more info on 510k application	23-10-03	AN
EARNINGS: Eden Research loss widens on GBP5 million impairment	23-09-29	AN
TruSpine accepts Aquis findings after investigation	23-09-18	AN
TruSpine Technologies plans to appeal GBP215,000 Aquis fine	23-08-17	AN
TruSpine Technologies raises GBP50,000 through subscription	23-08-15	AN
Truspine finally files US FDA 510k submission for Cervi-LOK	23-07-25	AN
Vertu Motors "optimistic"; Atrato in Ovo Energy deal	23-06-29	AN
TruSpine Technologies takes out GBP100,000 loan from non-exec director	23-04-26	AN
TruSpine terminates services agreement, names new CEO	23-04-05	AN
Downing Renewables acquires two hydropower plants	23-03-02	AN
TruSpine Technologies inks GBP200,000 loan; CEO Ian Roberts steps down	23-02-28	AN
TruSpine says bridge loan funding yet to be received, expects to soon	23-02-20	AN
Diversified plans fundraise; Highcroft ends sale	23-02-08	AN

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