Member Info for EmeraldCarrots

Genedrive® CYP2C19

Market access routes and reimbursement strategies defined in key initial international target countries, including the Middle East region, with well-positioned and aligned in-country distributors, with required regulatory certification (CE-IVD under IVDR) on track for April 2025

FDA application.

· 510(k) route identified for regulatory submission for US market entry, with initial pre-submission engagement with Food and Drug Administration (FDA) held and feedback positive and with regulatory approach confirmed as appropriate

Genedrive® MT-RNR1

NIHR and OLS Funding Package of c.£500k to address NICE Real World Evidence Generation Requirements for the Genedrive® MT-RNR1 ID Kit across 14 hospitals across the UK (PALOFDAH-UK). Progressing as planned, with nine Group 1 sites live, with***a further five Group 2 sites phased to go-live from May 2025***.

FDA application.

Breakthrough Device Designation received from the FDA. Progressing as planned, with first-engagement with FDA under programme initiated.

Most likely. Could be RNS's to with that to in the next few weeks.

If we get just say 6 or so more Hospitals placing orders in the next say 6 weeks things will be looking very different.

The market will want to see orders snowballing.

Could easily happen.

Fingers crossed.

Up 17.65%.

so here we are, oh and the sp is up 17.65%.

Up 21.32%

Question today/tomorrow. Aspecially with news due MT-RNR1 further 5 hospitals making the total 14.

Up 25%

Off a handbrake turn financially. Last Fridays CE IVD approval the catalyst.

Market may see FDA clearance next for a machine unique to the USA market.

- MASSIVE.

Off a handbrake turn financially. Last Fridays CE IVD approval the antalyst.

Market may see FDA clearence next for a machine unique to the USA market.

MASSIVE.

15,000 more hospitals, now can sell to the EU.

As they can't see that 15,000 more hospitals to sell to is good. LOL!

Because of the CE mark, received last Friday.

That is big news.

Last Friday. See RNS to say CE IVD certified, both machines now. EU has 500 million people and 15,000 hospitals.

Just one of each machine to each hospital would be 30,000 machines.

So I don't think the sp is cheap.

Nuff said!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Country (which seems not a lot) = 310 hospitals. One would have thought say 25 hospitals per country would be conservative.

So 25 x 31 Countries = 775 hospitals, and that assunes just 1 machine per hospital !!!!!!!! Wow!

Hmm. How manu hospitals is the EU?

*****15,000******

They seemed to hint at proviously. Just say 10 hospitals in the whole EU would be a start. 31 new countries......... 10 hospitals per country = 310 hospitals! Hmmmmmmmmmmmmmmmmm!!!!!!!!!!!!!!

CYP2C19 now available for order through NHS........... and has CE IVD clearance so can be sold in the "EU" whatever that is.

That have a population of 500 million (CE IVD mark granted)? It's only 31 Countries after all. What we need is access to new Planets that have populations in the tens of billions, and millions of hospitals. More than one planet too. Several. No a few hundred for starters would be nice to get the ball rolling.

MillonAir

"Not Rns yet..... This looks like 100 % riser when NHS comes"

===================

Is that all? LOL!

Up 4.04%

Used for real life use data for the application. So as far as the MT-RNR1 goes there should be loads of data by now? RNS expected any day to say use of the machine has moved up from 9 hospitals to 14 too. Submitting the FDA application for the MT-RNR1 is key.

All IMHO.