Ann: Exceptional Results in Second Valve-in-Valve Case, page-22

First 22 Last

Share
Profile

Follow
codeai

348 Posts.

34

14/08/23

15:48

Post #: 69328997
Share

Originally posted by synaphai: ↑

It's extremely difficult to get a HDE. Only 10 cardiovascular devices were given the designation 1997-2015 and 2016-2022 only 5 high-risk devices have gotten the distinction for any illness in adults.

And it takes a lot of time as everything with the FDA does:

First we must generate enough data by doing ViV procedures (how many is unknown but, from my experience, the FDA does not like companies jumping the gun on these things). Then the company must apply for a Humanitarian Use Device designation, which could take as little as 45 days but often takes longer in practice.

Only then can a Humanitarian Device Exemption submission be made and getting an approval typically takes forever. The average wait time in 2015, the last year I can find data for, was 815 days. The mean wait time 2012-2016 was 671 days. Seastar Medical submitted their HDE application for acute kidney injury in pediatric patients in late July 2022 and it took the FDA until early May just to let them know that their application was lacking and needed to be submitted again.

Again, I'm not trying to be a downer, just realistic based on what I know.

https://www.meddeviceonline.com/doc/does-the-humanitarian-device-exemption-process-work-and-is-it-worth-pursuing-0001

Expand

Firstly I don’t think HDE is the ultimate pathway Anteris is looking for as there is an annual quota how many devices can be sold for profit each year if I read it correctly.

Secondly, if VIV is not something Anteris is looking for PMA ultimately then why are they making it available for the Special Access Program in Canada?

I suspect VIV might be incorporated in the EFS or pivotal study somehow?

Not advice, DYOR

Last edited by codeai: 14/08/23

AVR Price at posting: $21.00 Sentiment: None Disclosure: Held
Upvote

0 Great analysis

Reply

Top Stories

Listen: HotCopper Wire Podcast 014 – Abu Dhabi wants to buy our 'true' oil and gas gem

MPK

Many Peaks accelerating gold hunt in Côte d'Ivoire after assay 'justification'

BRK

Bullish Brookside expands with fifth DSU at 'highly sought after' American oil and gas field

SPN

Sparc opens small-scale green H2 plant in SA, but liquidity dried up

CKF

Profits after tax down -88%, and shares rocket – what's going on with Collins?

First 22 Last

Add to My Watchlist

What is My Watchlist?

A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.

(20min delay)
Last $6.00		Change 0.000(0.00%)		Mkt cap ! $92.99M

Open	High	Low	Value	Volume
$6.00	$6.06	$6.00	$12.63K	2.093K

Buyers (Bids)

No.	Vol.	Price($)
1	83	$6.00

Sellers (Offers)

Price($)	Vol.	No.
$6.09	1690	1

View Market Depth

No.	Vol.	Price($)
1	83	6.000
2	342	5.860
2	625	5.850
1	857	5.830
1	344	5.800

Price($)	Vol.	No.
6.090	1690	1
6.100	927	2
6.140	1490	1
6.150	218	1
6.160	92	1

Last trade - 11.30am 24/06/2025 (20 minute delay)

AVR (ASX) Chart

Ann: Exceptional Results in Second Valve-in-Valve Case, page-22

Listen: HotCopper Wire Podcast 014 – Abu Dhabi wants to buy our 'true' oil and gas gem

Many Peaks accelerating gold hunt in Côte d'Ivoire after assay 'justification'

Bullish Brookside expands with fifth DSU at 'highly sought after' American oil and gas field

Sparc opens small-scale green H2 plant in SA, but liquidity dried up

Profits after tax down -88%, and shares rocket – what's going on with Collins?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: Exceptional Results in Second Valve-in-Valve Case, page-22

Top Stories

Listen: HotCopper Wire Podcast 014 – Abu Dhabi wants to buy our 'true' oil and gas gem

Many Peaks accelerating gold hunt in Côte d'Ivoire after assay 'justification'

Bullish Brookside expands with fifth DSU at 'highly sought after' American oil and gas field

Sparc opens small-scale green H2 plant in SA, but liquidity dried up

Profits after tax down -88%, and shares rocket – what's going on with Collins?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News