Lombard Medical Technologies Share Discussion Threads

[roundyg] 07/4/2011 14:25

Becuase this is a modular submission its difficult to say. As I understand it, there are 6 modules, some (4 modules I think) that have already been submitted. The FDA approval process can vary but for any PMA device approval can take up to 180 days, that is a known. One would hope that the exemption in this case for modular review would be to speed up the process but the clock doesn't start until the final part is submitted. One would assume that because of the modular submission, feedback from th eFDA (approval or other) would be relatively quick post that date.

[eddington1972] 07/4/2011 13:28

Does anybody know how far away FDA approval is

[stable] 06/4/2011 17:27

web
I was thinking just that this a.m, Decided 1-10 early 11-20 mid, 21-32 end
this leave this week only for early(dont want friday).
They have a conference soon I was hoping to hear before that and then good comments from conference shortly after and then news as to final submission to States shortly after that.Another dream gone.

[webshares] 06/4/2011 17:22

surely early april would be in the first 7 days!!? any later and we're getting towards the middle aren't we?

[webshares] 02/4/2011 11:43

stable, if we go by your philosophy we could be in for some not so bad news as we made it past friday without results. fingers crossed ay

[nod] 30/3/2011 04:16

The 9% holding by evYsio Medical Devices is an interesting one. evYsio Medical Devices also has a partnership with Endologix.

[nod] 30/3/2011 04:12

Rayrac - yes, i'm sure a takeover is what Invesco will be looking for.
It has ploughed a lot of dosh into LMT over the years. with 44% of shares LMT's fate is in the hands of Invesco's fund managers.

Significant Shareholders
No. of shares % of issued shares
Invesco 967,179,756 44.47%
evYsio Medical Devices ULC 200,000,000 9.20%
Fidelity International Ltd 143,101,185 6.58%
Craig Rennie - a Director 106,237,771 4.88%
Straus Partners Funds 76,068,574 3.50%

[stable] 28/3/2011 15:22

I hope that results are early next week, I always feel that results/news on a friday are on that day so that they can be hidden as all the newpapers business section are put to bed prior to the weekend

[rayrac] 28/3/2011 14:20

Wonder what they will tell us?

[restassured] 28/3/2011 12:30

From company website


Financial Calendar

Results for year ending 31 December 2010 will be announced early April 2011.


Sounds like either friday, or next week.

[rayrac] 28/3/2011 12:15

Endofix?
Do you mean Endologix?


Yes nod, don't know where I got Endofix from!

Reasuring that it's a few years behind. But that's the trouble with having a product that is open to competition from its piers eventually. Aorfix has to be v good and hopefully long term.

A t/o is probably the best here for investors?

[nod] 26/3/2011 01:34

Endofix?
Do you mean Endologix?

Endofix is a bio-degradable screw.

Endologix sells the Powerlink stent for AAA. It's selling well and generating cash.

"For the twelve months ended December 31, 2010, total revenue increased 28% to $67.3 million, compared with $52.4 million for the twelve months ended December 31, 2009."

"For the full year 2011, the Company is reiterating its guidance for total revenue to be in the range of $78 million to $82 million, representing growth of 16% to 22%."

"Total cash and cash equivalents increased by $15.3 million during the fourth quarter and were $38.2 million as of December 31, 2010, compared with total cash and cash equivalents of $24.1 million as of December 31, 2009."




ELGX has a market cap of US$ 372.16M
about 7 times larger than LMT




If Nellix was only worth $15 million to Endologix how good is Nellix and how advanced is it?

In that Med Journal article above, Powerlink was given FDA approval in 2004 - so it is a well established current generation rather than a "next generation"

Nellix doesn't get a mention in Table 3 - next generation "Currently in Trial or Limited Use" - so quite a few years behind Aorfix I would guess.

[rayrac] 25/3/2011 17:12

That caps it, I know where 2BOB is.

Perhaps I should have sold earlier today, Endofix could be our nemesis, but is their product better?

Ah, such is life in this business.

[webshares] 25/3/2011 16:35

damn that 1.6p next week we'll break you

[greynag] 25/3/2011 11:12

--> nod,
It's very early stage but looks like competition? What do you think?

It is a new conceptual approach to the endovascular repair of aortic aneurysms and may provide the opportunity to treat aneurysms with anatomies currently not amenable to treatment with existing FDA-approved endovascular devices. Such anatomies include no-neck or funnel-neck aneurysms, severely angulated and tortuous anatomies, large-diameter aortic necks, and common and
internal iliac aneurysms.

[nod] 25/3/2011 07:57

greynag - i'm a bit confused by your link... are you suggesting that Endologix Nellix is a main competitor to Aorfix?

[stable] 24/3/2011 19:21

webshares
This was known yesterday and I believe it may well have frightened some of the recent speculators to jump because of the doubt it raised by delaying results. Just an idea no proof

[webshares] 24/3/2011 18:21

lombard just changed the eoy release date to early april on the website. rubbish

[greynag] 24/3/2011 13:51

--> nod,

"Zenith appears to be a main competitor to LMT in the med journal reviews"

[restassured] 24/3/2011 12:36

Back on the move after a healthy pull back.
Wonder how long before we retest that 2p area.

[backmarker] 23/3/2011 14:54

I was hoping this rise would carry us back up to 2p, particularly as yesterday's volume was good, but it seems to have run out of puff :-(

the chart must look like one of the stents.

[nod] 23/3/2011 09:49

and from an earlier review in Aug 2010:

CONCLUSION: The rate of early iliac limb occlusion following EVAR in patients with angulated iliac anatomy can be substantially reduced by using the flexible Aorfix stent graft system.




Zenith appears to be a main competitor to LMT in the med journal reviews.

[rayrac] 22/3/2011 22:13

Thank you nod for the link. It appears that the Aorfix is in a very strong position with regard to being able to turn through 90deg............

The two most frequently encountered barriers to EVAR are inadequate or inappropriate proximal neck anatomy and inadequate caliber of iliofemoral access vessels. Hence, the abilities of any device, present or future, to accommodate patients with difficult necks or treacherous access vessels are important, even essential.

Says it all hopefully?

[webshares] 22/3/2011 16:51

fingers crossed results are good and we can shoot past 2p and rerate