Orthocell Ltd

📺 VIDEO REPLAY #Orthocell CEO and MD, Paul Anderson, hosted a webinar this morning to provide an important update on Orthocell's clinical and commercial plans. For those who were unable to attend or would like to review the information presented, a recording of the webinar is now available online. Watch the replay 👉 https://lnkd.in/gFQBPtz9 $OCC #Orthocell #innovation #nerverepair #regenerativemedicine #global

💻 Investor Webinar Orthocell CEO & MD, Paul Anderson, will deliver a comprehensive update to investors on the Company's global commercialisation push at 11am AEST on Wednesday 26 February. Participants must register to attend. Register to attend 👉 https://lnkd.in/gD2KUJu7 $OCC #Orthocell #innovation #nerverepair #regenerativemedicine #global

🇹🇭 𝐓𝐡𝐚𝐢𝐥𝐚𝐧𝐝 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 Orthocell Ltd has submitted a regulatory application to the FDA of Thailand to commence sales of our groundbreaking nerve repair device Remplir™, with clearance expected in Q3 CY2025. Remplir™ is now gaining record sales traction in Australia, New Zealand and Singapore, with all sights set on US FDA clearance in March/April 2025. Read the ASX Release 👉 https://lnkd.in/gUd2-7Xq $OCC #Orthocell #Remplir #nerverepair #regenerativemedicine #global

⚕️ 𝐉𝐨𝐢𝐧 𝐮𝐬 𝐚𝐭 𝐭𝐡𝐞 𝟐𝟎𝟐𝟓 𝐀𝐎𝐀 𝐕𝐢𝐜𝐭𝐨𝐫𝐢𝐚𝐧 𝐁𝐫𝐚𝐧𝐜𝐡 𝐀𝐒𝐌 | 𝟐𝟏-𝟐𝟑 𝐅𝐞𝐛𝐫𝐮𝐚𝐫𝐲 𝟐𝟎𝟐𝟓 We're thrilled to be attending the 2025 AOA Victorian Branch ASM in Lorne this week, where our team will be showcasing our advanced regenerative medicine technologies. If you're visiting the conference, stop by our stand to meet the Orthocell team and learn more about our innovative cellular therapies and unique collagen medical device platform. Discover how our cutting-edge solutions can enhance your practice in regenerative medicine. Unable to attend? We'd still love to connect. Visit www.orthocell.com to learn more about our transformative technologies. $OCC #regenerativemedicine #cellulartherapies #conference #healthcare #Orthocell

🇨🇦 Canada submission update Orthocell Ltd has announced it has submitted an application to Health Canada for a Medical Device Licence (MDL) to sell its leading nerve repair product Remplir™ into the US$75 million Canadian nerve repair market. Health Canada is the regulatory authority responsible for regulating the importation, manufacture, export, and supply of medical devices. Evaluation of Orthocell’s application is now in progress with clearance expected in the second half of 2025. Read the ASX Release 👉 https://lnkd.in/gV6umKdD $OCC #Orthocell #Remplir #nerverepair #regenerativemedicine #global

In case you missed it... #Orthocell CEO & MD, Paul Anderson, spoke with Proactive's Tylah Tully about the Company's record-breaking performance in 2024, plans for global expansion, and the ambitious goal to capture 20% of the $3.2B global nerve repair market. Take a look 👉 https://lnkd.in/g4UT6mHM

🔍 Stockhead Report #Orthocell's plans to broaden its commercial footprint in existing and new markets drove the company's share price up 13.8% this week, according to a special report in Stockhead. The rise followed news of Orthocell plans to accelerate efforts to enter several key markets across CY25 including Thailand, Canada, the UK, Brazil and European Union, building on a third quarter of record revenue. Here's an excerpt: "Perth-headquartered Orthocell was a hero of the ASX healthcare sector in 2024. The company is up more than 265% in the past year and ~20% over the past month. Orthocell sits among the top five performing ASX healthcare stocks of the past year." Take a look 👉 https://lnkd.in/gVRRKgND $OCC #innovation #nerverepair #medicaldevice #regenerativemedicine #global

🌎 Five New Country Regulatory Submissions Planned in 2025 On the back of outstanding early sales traction for Remplir™ in Australia, New Zealand and Singapore, Orthocell has announced that it is accelerating its global expansion into multiple key jurisdictions. Orthocell has recently submitted its US FDA 510(k) regulatory application for clearance to commercially distribute Remplir into the US$1.6 billion U.S. market, with approval expected in March / April 2025 A further five applications across Canada, Thailand, the United Kingdom, the European Union and Brazil are in progress for 2025. Expansion into these markets will significantly increase the revenue opportunity for the Company to circa US$3.2 billion, where the Company is targeting a 20% market share. Read the ASX release 👉 https://lnkd.in/gpbYKW6M $OCC #Orthocell #innovation #nerverepair #regenerativemedicine #global

💰 R&D Tax Refund #Orthocell has announced that it has received a $3.18 million R&D Tax Incentive Refund for the 2023/2024 financial year. The R&D Tax Incentive is an Australian Government program to support Australian companies to undertake R&D activities in Australia, under which eligible companies can receive cash rebates of up to 48.5% of expenditure on R&D activities. Orthocell CEO and MD, Paul Anderson, said: “We are in a very exciting phase at Orthocell. We hold a strong cash position of circa $33 million, are royalty free, have rapidly growing revenues, and are on track to achieve U.S. market clearance to start selling Remplir in the US$1.6 billion U.S. market in late March or early April 2025. With our experienced team, sales growth in existing markets showing clear traction and the significant potential for exponential revenue growth that the US market can deliver, we look forward to this next phase with great enthusiasm, and believe we are on track to become a key player in the US$4.5 billion[1] global medical device market.” Read today’s ASX release 👉 https://lnkd.in/gZgB2rbF $OCC #ASX #regenerativemedicine #biotech #medtech #innovation #global

📈 Quarterly Report Orthocell has today released its Quarterly Report for the period ended 31 December 2024. Key highlights for the Quarter include:   ☑️ Third consecutive quarter of record revenue at $2.21 million reported in the December 24 Quarter ☑️ Global market expansion of Remplir™ continued with the first major international regulatory approval, appointment of an exclusive distributor and achievement of first sales in the key market of Singapore ☑️  Submission of US FDA 510(k) regulatory application for clearance to commercially distribute Remplir into the US$1.6 billion U.S. market ☑️ Preparations underway for US commercialisation of Remplir, with the appointment of two key US-based Executives ☑️ Completion of a $17 million placement to fund US launch of Remplir and drive further growth Read the ASX release 👉 https://lnkd.in/gkAdXV9W $OCC #Orthocell #innovation #regerativemedicine #medtech #medicaldevice #global