Orthocell

14/11/2025

🔹 ACSEP 2025 🔹

Our team is on the Gold Coast this week for the ACSEP 2025 Annual Scientific Conference, connecting with sport and exercise physicians from across Australia and New Zealand.

This meeting is a key forum for discussing the latest advancements in sport and exercise medicine, including innovative approaches to tendon injury management and repair.

Product Specialist Ellis Taylor and Business Development Manager Trevor Turnbull are on the ground showcasing our tendon cell therapy technology and speaking with clinicians about how our biologic solutions may support improved outcomes for patients with chronic tendon injuries.

If you’re attending ACSEP, drop by to say hello.

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04/11/2025

Orthocell is expanding its presence in Canada, appointing a second distributor for its flagship nerve repair device, Remplir™. The appointment completes national coverage across the US$75 million Canadian market, ensuring access for patients and healthcare providers nationwide.

The newly appointed Ontario-based distributor will manage Remplir™ across all provinces outside of Alberta and British Columbia, which continue to be serviced by Orthocell’s existing distributor.

First Canadian sales are expected this quarter following last month’s successful launch at the American Society for Surgery of the Hand in Vancouver. Rollout activities in Canada will be overseen by Orthocell’s US-based Marketing and Medical Education team.

Orthocell CEO and MD, Paul Anderson said:

“We’re very pleased to expand our Canadian distributor presence beyond Alberta and BC with this new appointment opening up the entire Canadian market.

Each new distributor appointment is an important step, initiating targeted sales and marketing efforts in their territories and bringing us closer to generating new revenue streams.”

🔗 Read the ASX release: https://bit.ly/48Ye5Iv

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03/11/2025

Orthocell has announced the successful completion of the first Remplir™ surgical case in Hong Kong and the official launch of their flagship nerve repair medical device at the Hong Kong Orthopaedic Association (HKOA) 45th Annual Congress.

These achievements mark the start of clinical use and commercial sales in Hong Kong, following the appointment of MontsMed as exclusive in-country distributor. The launch event introduced Remplir to key opinion leaders and specialists in orthopaedic and reconstructive surgery, highlighting its clinical advantages in peripheral nerve repair.

A special shout out to Maier, Orthocell’s Vice President, Global Commercialization & Professional Engagements, who flew out Thursday night to support the launch and went straight to the hospital for the first case.

🔗 Read the ASX release: https://bit.ly/4nFLVWr

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29/10/2025

Congratulations to Professor Minghao Zheng, Orthocell’s Co-Founder and Chief Scientific Officer, on his election as a Fellow of the Australian Academy of Health and Medical Sciences (AAHMS) - one of the nation’s highest honours for leaders in health and medical research.

This Fellowship acknowledges Professor Zheng’s outstanding contributions to regenerative medicine and translational science, and his pivotal role in developing the technologies that underpin Orthocell’s medical device portfolio.

His pioneering research into collagen scaffolds and autologous cell therapies led to the creation of a next-generation collagen medical device platform technology which facilitates tissue reconstruction and healing in a variety of orthopaedic and reconstructive applications , and Ortho-ATI™, a regenerative cell therapy for chronic tendon injury. Together, these innovations continue to shape Orthocell’s mission to deliver advanced solutions for tissue repair and restoration of mobility.

Professor Zheng’s election to the Academy reflects a remarkable career dedicated to improving patient outcomes and advancing Australia’s reputation for world-class medical innovation.

Orthocell extends its warmest congratulations to Professor Zheng on this distinguished honour.

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28/10/2025

Orthocell has appointed medical device distributor as its exclusive in-country distributor for Remplir in the key Asian market of Hong Kong.

The appointment strengthens Orthocell’s presence in Asia and positions the Company to deliver first Remplir™ surgical cases and sales in the near term. Hong Kong also provides a strategic gateway to the Guangdong–Hong Kong–Macao Greater Bay Area, opening access to a population of around 100 million people.

This milestone builds on Orthocell’s progress in Singapore, where sales and surgical case momentum continue to grow, and supports the upcoming launch in Thailand in 2026, with distributor selection currently underway.

To support this next phase of growth, Orthocell has appointed Mr Hamish Thrum as Commercial Director, responsible for managing distributor networks and driving Remplir™ commercialisation across Australia and Asia.

Orthocell CEO and MD, Paul Anderson, said:

“We are approaching the commercialisation of Remplir in Asia on a country-by-country basis in a very deliberate and considered manner. The appointment of MontsMed as our exclusive distributor in Hong Kong is a key step in our Asian commercialisation strategy.”

Read the ASX release: https://bit.ly/4qyq85u

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21/10/2025

The American Society for Surgery of the Hand (ASSH) Annual Meeting in Vancouver earlier this month brought together clinicians, scientists and innovators who share a commitment to improving outcomes in peripheral nerve repair.

For the Orthocell team, it was a valuable opportunity to showcase Remplir™, our next-generation collagen nerve wrap, and engage in focused conversations about Remplir’s science, surgical handling and clinical use across different surgical settings.

A key highlight was our Industry Forum, moderated by Dr Amy Moore and featuring expert panellists Dr Ryan Schmucker, Dr Alex O’Beirne and Professor Ming Hao Zheng. The discussion brought together perspectives from material science, emerging US clinical experience and long-term Australian outcomes, offering insights on how Remplir is being applied in practice and evaluated in evolving surgical decision-making.

In partnership with Mosher Medical, we co-hosted a surgeon reception that created opportunities to share real-world experience with Remplir in US clinical practice, and we were equally proud to support the Women in Hand Surgery event, reflecting our commitment to collaboration, diversity and the exchange of ideas that advance the field.

A sincere thank you to all the clinicians who visited our booth, shared their perspectives or took time to discuss complex cases – your expertise continues to shape how Remplir supports clinical practice.

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19/10/2025

Orthocell has signed Memorandum of Understanding to increase its equity stake in Marine Biomedical - from 1.7% to 12.0% for a total consideration of AU$1.0 million - securing exclusive first right of refusal over global distribution rights their groundbreaking bone substitute product, PearlBone™.

Developed using sustainably sourced pearl shells from the West Australian Kimberley coast, PearlBone is an innovative, next-generation biomaterial with promising applications in bone repair and regeneration in the orthopaedic, trauma and reconstructive surgery market.

Marine Biomedical is well advanced in its path to US regulatory approval of PearlBone, nearing completion of its pivotal study designed to support a U.S. FDA 510(k) marketing submission in 1Q CY26 to commercially distribute PearlBone into the US$1.6 billion bone substitute market.

Orthocell Chair, John Van Der Wielen, said:

“This partnership delivers exactly what we look for — breakthrough science, a clear regulatory path, and immediate commercial synergy. With our strong surgeon relationships and global distribution channels, we are ideally positioned to bring this first-in-class product to market. Marine Biomedical has had significant grant support from the Western Australian Government and has been working for many years on the development of this product.”

🔗 Read the ASX release: bit.ly/48J2MUx

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17/10/2025

Orthocell has today announced that it has received firm commitments for a $30 million capital raising via an institutional placement.

The capital raising received strong international and domestic demand from institutional and sophisticated investors, resulting in the addition of several US institutions to the share register. Canaccord Genuity acted as Sole Lead Manager to the Placement.

Proceeds from the raising will be used to:
✅ accelerate the US roll out of the Company’s flagship nerve repair product Remplir™
✅ undertake clinical studies to commercialise the use of Remplir in the significant prostate cancer surgery market
✅ advance commercialisation of pipeline products in tendon and ligament repair
✅ expand capacity at Orthocell’s existing manufacturing facility
✅ invest in new applications and technologies in the regenerative medicine sector.

Orthocell CEO and MD, Paul Anderson, said:

“We have built significant momentum in the commercialisaiton of Remplir and the funds from the capital raising will be focused on accelerating that process. We greatly appreciate the support we have received from new and existing institutional and high net worth investors and particularly welcome our new investors from the US. We see that as a significant endorsement of our strategy and progress to date as well as the near-term revenue that can be generated from the US market.”

🔗 Read the ASX release: https://bit.ly/4qaKcuJ

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14/10/2025

We are proud to share that Orthocell Founder and CEO Paul Anderson has been named a National Finalist in the 2026 Ernst & Young Entrepreneur of the Year Awards, representing Western Australia in the Technology category.

This prestigious program celebrates visionary leaders who challenge convention, create opportunities and shape the future – qualities that have defined Paul’s leadership from Orthocell’s earliest days.

Paul has guided Orthocell from its origins as a university spin-out to becoming a globally recognised regenerative medicine company. Under his leadership, Orthocell has developed and commercialised world-first medical devices that are transforming patients’ lives and strengthening Australia’s manufacturing and biotechnology capability.

National judging takes place today in Sydney, with winners announced at tomorrow night’s Gala event.

A cornerstone of Paul’s leadership is to take calculated and creative risk to not only innovate, but to do so with a commitment to sustainable business principles and unwavering care for the clinicians and patients that Orthocell exists to support.

The whole Orthocell team and our wide community of supporters wish to congratulate you Paul, and to share our appreciation to EY for continuing to champion Australian innovation and entrepreneurship.

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10/10/2025

Orthocell has today released its Quarterly Report for the period ended 30 September 2025, outlining a period of continued growth and strong commercial progress.

Key highlights for the quarter include:
- Record revenue for the quarter of $3.0 million driven primarily by Remplir’s growing market pe*******on in Australia and Singapore
- Orthocell maintains robust cash reserves of $27 million in cash as at 30 September 2025 and is well-positioned for continued commercial expansion
- Remplir rollout in the US$1.6 Billion US market ahead of schedule, with Distribution networks now spanning 25 states and reaching 40% of the US population, and first surgeries complete
- First distributor appointed for Remplir in US$75 million Canadian market, with first sales targeted for December 2025 Quarter
- Remplir used in nerve-sparing prostate cancer surgery
- Remplir study results deliver compelling 81% success rate
- Strengthened leadership with Executive and Board appointments

Orthocell CEO and MD, Paul Anderson, said:

“We have continued to build strong commercial momentum in the September quarter with another record quarter of sales revenue delivered primarily from Remplir sales in our existing markets in Australia and Singapore.”

Read the ASX release: https://bit.ly/46Koaap

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07/10/2025

Did you catch Chairman John Van Der Wielen’s recent interview on Proactive?

Following Orthocell’s outstanding revenue announcement, he reflected on the Company’s record $3 million quarter — marking six consecutive quarters of growth across Australia, New Zealand and Singapore.

John also highlighted the accelerating U.S. rollout and the Company’s expanding global footprint, with its first Canadian distributor appointed, progress underway in Thailand and Hong Kong, and strong growth potential as these markets come online.

“It's the sixth quarter in a row that we've displayed growth, and for investors, we're very confident that will continue. The most important part about the result is it mainly relates to Australia, New Zealand and Singapore, with some early activity in the US, but a lot more to come.”

Take a look 👉 https://bit.ly/4pSj3fL

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Orthocell Non-Executive Chairman and Director John Van Der Wielen talked with Proactive about the company’s record-breaking quarterly results, achieving reve...

01/10/2025

📈 Record Growth Continues

Orthocell has announced record quarterly revenue of $3.0 million for the September quarter – our sixth consecutive quarter of record revenue growth.

This outstanding 9.1% increase reflects the strong market uptake of Remplir™ in Australia and Singapore, with the US rollout now gaining momentum and Canada coming online in the December quarter.

Key Highlights:
✅ Record quarterly revenue of $3.0m (up 9.1% from June quarter)
✅ Sixth consecutive quarter of record revenue
✅ CQGR of 9.5% since Q2 FY23 launch
✅ ~$27.0m cash and no debt
✅ US rollout accelerating with >100 surgeons introduced & 11 hospital approvals secured
✅ First Canadian distributor appointed – initial sales targeted for December quarter

Orthocell CEO & MD, Paul Anderson, said:

“The record revenue result for the September quarter is a particularly pleasing result, given it has largely been achieved from our existing markets in Australia and Singapore. It’s a tangible confirmation that surgeons are growing increasingly comfortable using Remplir in nerve repair procedures.”

Read today’s ASX release 👉 https://bit.ly/4gUQ6fd

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