Thanks Bedger as always. Here's an AI read that may fill any gaps missed. Excuse the spelling an typesetting it is unedited.
Company Overview and Recent Developments (04:45 - 09:34)
Orthocell is an Australian medical device company with growing international revenue
FDA clearance pending for breakthrough nerve repair device
Products approved in 9 international jurisdictions
StriPlus (first product) received FDA clearance, approved in UK, EU, Australia, New Zealand, Canada
REMPLAR (nerve repair device) approved in Australia, New Zealand, Singapore
Company manufactures own products, owns manufacturing margin and scientific narrative
Three consecutive quarters of record revenue, reporting 2.2 million in December quarter
Board Changes and Financial Position (09:35 - 13:51)
Complete board change in last two years
New chair: John van der Willen
Dr. Ravi Thotani: Former Harvard Medical School professor, FDA consultant
Hon. Kim Beazley: Geopolitical and defence knowledge
Prof. Fiona Wood: Ex-Australian of the Year, plastic reconstructive surgeon
Strong balance sheet: $32 million in bank, no debt, no royalties
Growing interest from institutional investors
Product Portfolio and Manufacturing (13:52 - 17:53)
First product: StriPlus (bone repair), partnered with BioHorizons
Second product: REMPLAR (nerve repair)
Third product: Smart Graft (tendon repair), submitted for TGA approval
Unique manufacturing process producing pure, decellularized collagen
Over 70,000 implantations internationally
REMPLAR Technology and Market Potential (17:54 - 23:33)
REMPLAR redefining nerve repair, mimics nerve's epineurium
Reduces or negates use of sutures, improves clinical outcomes
Three indications: connect, protect, and cap nerves
85% recovery rate in clinical data
Over 180 surgeons in 130+ hospitals using REMPLAR in Australia
700,000+ peripheral nerve repairs performed annually in US
US Market Entry and Global Expansion (23:34 - 31:12)
FDA 510k clearance expected late March/early April
Appointed two US-based executives with Axogen experience
Building US team, engaging distributors, establishing key accounts
Expanding global footprint: submissions in Canada, Thailand, EU, UK, Brazil
$3.5 billion total addressable market
Aiming for 20% market share
Strong commercial phase with validated products and strong balance sheet
(20min delay)