Usual preamble on Striate and Remplir, approval geographics etc.
“Own our manufacturing” – against US tariff backdrop
Brief discussion of “[Remplir] clinical uptake” in ANZ mkts.
Keen to emphasize “no debt, no royalties”
DOGE and FDA discussion – “on track for our clearance….late March, early April”
2,500 FDA staff let go and many now re-employed (I did flag this amongst the crap on OCC threads yesterday)
“still on target….for FDA clearance [Remplir]”
“$32 million in the bank….growing interest from institutional investors”
Discussion of personnel….all of which we know….bit of necessary, but mutual smoke blowing up you know where….
Rehash of Striate+ deal.Emphasizing from the same origin (that would be CelGro newbies….go read up), goes on to discuss Remplir and to the delight of many of you at last TGA and Smart Graft!
“Implanted this device 70,000 times so far globally…”.Good safety point! (I didn’t know that figure- or forgot it if they have said before).
Discusses inconsistent outcomes in suturing nerve and patient and clinical frustrations (mentions Axogen and ReNerve problems/issues/lags)
The usual talk you all know on handling and mechanical qualities of Remplir.
“only product designed to mimic the outside of the nerve…shortens procedures and improves outcomes”
Discussing a third amputee application (new I believe) for Remplir and nerve repair.
Clinical results discussion then follows, apparently US Surgeons asking if available in home country (with obvious vindication therein).
“Where are we at?”; completed 510K study, met all key points, positive interactions with FDA, validate submission, positive feedback…reaffirms timeline.
“700,000 peripheral nerve repairs in the US per year”
Discussion of US exec’s/KOP’s as we are aware of.
“Purposely designed product [for Remplir]…not retrospectively fit”. (I’d argue originally it was initially at least developed for ACI, but I digress….
)
“actively engaging distributors…preparing for sales shortly after 510K application comes through”
Didn’t really discuss tendon repair, but clearly a third part of the product suite with Striate and Remplir (the webinar was all about Remplir).
(please excuse me for brevity – I was typing whilst listening)
(PS2: I believe it will be put on the website for shareholders to listen themselves anyway)
