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Orthocell, Building 191 Murdoch University South Street, Perth (2025)

29/08/2025

Orthocell has today published its Annual Report for FY25.

FY25 key highlights include:

✅ Record annual revenue of $9.23 million, up 36% on FY24, with five consecutive quarters of growth and a peak June quarter of $2.75 million

✅ US FDA 510(k) clearance for Remplir, our flagship nerve repair device, unlocking access to the US$1.6 billion U.S. nerve repair market

✅ First U.S. surgical use of Remplir, supported by a specialist distributor network covering more than 25 states and logistics partner Uniphar

✅ New regulatory approvals for Remplir in Canada, Singapore, Hong Kong and Thailand, extending reach across Asia–Pacific and North America

✅ Expansion of Striate+™ with approvals and launches in Canada, Brazil, Singapore and Europe’s DACH region, in partnership with BioHorizons

Click here to read the full report 👉 https://bit.ly/OCC-FY25-Annual-Report

$OCC

13/08/2025

🇺🇸 US Commercialisation Update

Orthocell has today provided update on the continuing successful commercialisation of its flagship nerve repair product Remplir™ in the US.

Key achievements include:
✅ Ten surgeries have now taken place in the US. Experience in existing markets has demonstrated the importance of these early surgeries in the path towards more widespread adoption.
✅ 36 applications have been lodged to hospital Value Assessment Committees (VACs) with 3 approvals already received. VAC approval is an important and necessary step in achieving widespread surgical adoption in the US hospital system.
✅ 4,000 Remplir units have been shipped to Orthocell’s US logistics provider, Uniphar, for use in US surgical procedures. All units have been manufactured at the Company’s manufacturing facility in Western Australia.
✅ Two new employees have been hired in the US, including a regional sales director with direct experience in the nerve repair product market.

Orthocell CEO, Paul Anderson, said:

“We continue to make excellent progress in the US with surgeons building familiarity through early surgical procedures. We’ve seen the strategic importance of these early procedures in our successful market launches of Remplir in Australia and Singapore.

Our network of distributors remains an important avenue to market and they have been instrumental in identifying key hospitals for us to target VAC approvals. This is the next important step for us in order to achieve more widespread adoption of Remplir, which in turn will drive revenue generation for Orthocell.”

Read the ASX release: https://bit.ly/OCC_Remplir_US_Update

$OCC

25/07/2025

Orthocell has today announced some important changes to its Board of Directors.

The Hon Kim Beazley AC has stepped down from his role as an Independent Non-Executive Director due to health reasons. He will continue to be available in an advisory capacity for US and Defence-related matters.

Mr Michael McNulty will join the Board as a Non-Executive Director and Chair of the Audit Committee, effective from 1 September 2025. Mr McNulty was the Managing Partner of Deloitte’s Perth office for over 10 years and brings significant leadership experience in Board advisory and strategic consulting to the Orthocell Board.

Finally, current US-based Orthocell Independent Director, Dr Ravi Thadhani has been elevated to Lead Independent Director. Dr Thadhani will also lead a newly established committee focused on the US commercialisation of Orthocell’s flagship nerve repair product, Remplir™.

Orthocell Chairman, John Van Der Wielen, said:

“I would like to extend our sincere gratitude to Kim Beazley for his contributions to the Board. Kim’s extensive US experience, garnered from his extraordinary political and diplomatic career and decades of public service, have been pivotal in strengthening Orthocell’s international expansion, particularly in the US, the largest healthcare market in the world.

“We are delighted to welcome Michael McNulty to the Board and as Chair of the Audit Committee. His significant leadership experience as a Director and senior executive across a spectrum of industries, most notably in healthcare and resources, will greatly complement our Board. Meanwhile, Dr Ravi Thadhani’s elevation to Lead Independent Director will bring further collaboration, dedicated to the US market. We look forward to working with Michael and Ravi as we accelerate our global expansion strategy.”

Read the ASX release 👉 https://bit.ly/OCC_Board_Changes

$OCC

10/07/2025

Orthocell has today reached a critical milestone in the commercialisation of Remplir™ in the US$1.6 Billion US market, recording its first sales revenue from the nerve repair product in the US.

This revenue follows first surgical use of Remplir on 26 June in Ohio and subsequent early surgical cases in Florida. Early-stage surgeries conducted in out-patient day surgeries, known as Ambulatory Surgery Centers in the US, play a crucial strategic role in building experience and knowledge amongst the US surgical community.

Orthocell CEO and MD, Paul Anderson, said:

“Translating Remplir’s regulatory clearance in the US to first sales revenue in a little over three months is a testament to the hard work we’ve done with our US roll out plan. This covers everything from our key internal hires in sales, marketing and medical affairs, appointing specialist distributors, Australian manufacturing ramp up and working with our on-the-ground US logistics partner…. We are confident our efforts in the US are on track to drive growth in sales of Remplir during the second half of calendar 2025.”

Read the ASX release 👉 https://bit.ly/OCC_US_Sales_Revenue

$OCC

09/07/2025

📈 Quarterly Report

Orthocell has today released its Quarterly Report for the period ended 30 June 2025.

This landmark quarter marks a transformational period for the Company following US FDA 510(k) clearance for Remplir™ and our successful entry into the world's largest nerve repair market.

Key highlights for the Quarter include:
✅ Record annual revenue of $9.19m for FY2025 - up 35.8% on the previous financial year
✅ Fifth consecutive quarter of record revenue - $2.73 million in the June '25 Quarter
✅ Strong cash position of $28.7m with no debt
✅ US FDA 510(k) clearance received for Remplir™ opening the $1.6 billion US nerve repair market.
✅ Expanded regulatory approvals for Remplir in key international markets, including Hong Kong, Thailand and Canada.
✅ Continued global roll out of Striate+, with Brazilian regulatory approval received

Orthocell CEO and MD, Paul Anderson, said:

"This was a landmark quarter for Orthocell following receipt of US FDA 510(k) clearance in early April. We were well prepared in advance of receipt of this approval, however once it came through, we were able to accelerate our progress towards first sales in the US. We couldn't be more pleased with the progress achieved through the quarter, which culminated in the first US surgical use of Remplir at the end of June."

Read the ASX release 👉 https://bit.ly/OCC-Quarterly-30June25

$OCC

02/07/2025

🤝 Executive Appointments

has announced the appointment of two experienced executives to drive the Company's global expansion strategy.

Chief Financial Officer Jim Piper brings extensive experience from ASX-listed companies including Pilbara Minerals and senior consulting roles at Accenture. Mr Piper will oversee financial management, investor relations and IT functions as the Company scales.

Adam Wood has been appointed to the newly created role of Chief Commercial Officer. With a proven track record across healthcare and medical technology sectors, including senior roles at Johnson & Johnson, LifeHealthcare and EBOS Medical Technology, he will lead global sales and marketing efforts with a focus on the US market rollout.

Orthocell Chairman, John Van Der Wielen, said:

“I am excited to welcome our two new executives, Jim Piper as Chief Financial Officer and Adam Wood to the newly created role of Chief Commercial Officer. They both bring outstanding experience to the Company which will be invaluable as we extend the commercialisation of our products, particularly Remplir™ in the US. I anticipate that they will play significant roles in driving our Company forward.”

Read today's ASX release 👉 https://bit.ly/OCC-New-Hires

$OCC

30/06/2025

📈 Record Growth Continues

Orthocell has announced record quarterly revenue of $2.73 million for the June quarter – our fifth consecutive quarter of record revenue growth.

This outstanding 22.8% increase demonstrates the exceptional market response to Orthocell’s flagship products, Striate+™ and Remplir™. This was achieved before any contribution from US Remplir™ sales, which are expected to ramp up during the first half of FY26.

Key Highlights:

✅ Record quarterly revenue of $2.73 million (up 22.8% from March quarter)
✅ Fifth consecutive quarter of record revenue
✅ Compound Quarterly Growth Rate of 9.5% over the last 3 years
✅ Strong balance sheet with ~A$28.5 million cash and no debt
✅ Remplir™ now used by >200 surgeons across >165 hospitals in Australia
✅ US market expansion accelerating with 14 specialist distributors across 25 states

Orthocell CEO and MD, Paul Anderson, said:

“We’re seeing our commercialisation strategy in Australia starting to bear fruit and we are confident this will be replicated on a much larger scale in the US.

“With our highly experienced US distributors appointed and our first surgical use completed after achieving FDA clearance, we are well-positioned to accelerate growth in the US$1.6 billion nerve repair market over the coming months.”

📆 Investor webinar

Join Orthocell’s Chairman, Mr John Van Der Wielen, and CEO and MD, Mr Paul Anderson, for an investor webinar this Wednesday 2 July at 10am AWST/12pm AEST to hear an update on the Company’s US expansion strategy.

Read today's ASX release 👉 https://bit.ly/OCC-June-Quarter

$OCC

26/06/2025

🔸 Remplir™ US Milestone 🔸

Orthocell recorded first use of Remplir™ in the US overnight, which is an important step in establishing surgical experience and knowledge of the product.

Our US distributor network now includes 14 specialist nerve distributors with mature, direct-to-surgeon, hospital and other customer relationships across 25 US states.

Orthocell CEO and MD, Paul Anderson, said:

“This first US surgery is a significant milestone for Orthocell and the roll out of Remplir in the US. It signals the start of our commercial journey in the world’s largest healthcare and nerve repair markets, and reflects our commitment to delivering innovative, clinically proven solutions to surgeons and their patients.”

An investor webinar will be held at 10:00am AWST | 12:00pm AEST on Wednesday 2 July 2025 to provide insight into this milestone achievement.

Read the ASX announcement 👉 https://bit.ly/OCC-First-Surgery

Register for Investor Webinar 👉https://us02web.zoom.us/webinar/register/WN_LXvxwljLQhiEKaqxPu-hKQ

$OCC

24/06/2025

📖 Australasian BioTechnology Journal – out now

Orthocell has been prominently featured in the latest issue of Australasian BioTechnology journal, showcasing our journey from Perth startup to a global leader in regenerative medicine.

The article highlights the power of strategic planning – how our Company has maintained manufacturing sovereignty in Australia while scaling globally, building deep relationships with key opinion leaders to drive clinical adoption.

With FDA clearance now achieved for our groundbreaking Remplir™ nerve repair device, we're seeing real patient impact - helping to restore crucial movement and even function to paralysed limbs. Transforming lives.

Here's an excerpt:

‘[Orthocell] stands as an exemplar of Australia’s capacity to develop and commercialise sophisticated medical technologies that address critical healthcare needs globally.

With manufacturing anchored in Western Australia and driven by a culture of clinical excellence and KOL collaboration, Orthocell’s journey presents a compelling blueprint for Australian medical innovations striving to reach global scale.

‘We distribute to major jurisdictions globally, including the United States, Europe, Singapore, Canada, and soon Brazil, Thailand and other jurisdictions. In anyone’s language, this is an extremely successful story that has seen Orthocell develop and translate world-leading techniques, technologies, and treatments into effective clinical products that are now earning export dollars and providing us with the ability to expand the local innovation ecosystem in this country.’

Well worth a read 👉 https://bit.ly/AusBiotechJournal_May25

$OCC $innovation

18/06/2025

🔹 Breakthrough Study 🔹

Orthocell has today announced interim results from a new study demonstrating that Remplir™ delivers superior nerve regeneration, earlier return to function, and higher quality tissue restoration compared to current surgical suture techniques.

The Suturing Study, conducted in collaboration with Orthocell’s Chief Scientific Officer and highly regarded physician, Professor Minghao Zheng, and the The University of Western Australia, was commissioned by Orthocell to evaluate the impact of sutures on nerve regeneration and functional recovery in surgical repair of severed peripheral nerves.

🔍 Interim Study Findings

Use of Remplir™ in nerve repair results in:
✅ Earlier return to nerve function compared to suture-only repair
✅ Superior regeneration of high-quality nerve tissue with better cellular alignment
✅ Faster restoration of protective nerve structure and blood vessel establishment
✅ No inflammatory response, and reduced scarring that can block nerve regeneration across repair sites

Critically, the study provides the scientific evidence for Orthocell's US market expansion.

Orthocell CEO Paul Anderson said:

"These study results provide the scientific foundation to transform nerve repair surgery in the US market. With our sales teams now in market and first sales imminent, this clinical evidence positions us to rapidly establish Remplir™ as the new gold standard among US surgeons."

The study results will form the cornerstone of Orthocell's US medical education strategy, supporting rapid adoption in the US$1.6 billion US nerve repair market.

Read the ASX Release 👉 https://bit.ly/OCC-Suture-Study

$OCC

18/06/2025

📄 New study

A new peer-reviewed study published in BMC Oral Health provides compelling evidence of the superiority of Orthocell’s Striate+™ collagen dental membrane to promote good bone formation and to prevent unwanted epithelial infiltration in guided bone regeneration procedures.

The study compares the effectiveness of Striate+ against an established market competitor, and control (no membrane), across 4, 8, and 12-week timepoints, using a number of assessment methods to evaluate bone and tissue regeneration.

Key outcomes included:
✅ Use of a collagen membrane resulted in significantly improved bone formation compared to the control group.
✅ Superior bone quality – Striate+ resulted significantly higher trabecular density and improved microarchitecture
✅ Accelerated healing – bone-to-implant contact achieved with Striate+ at 8 weeks, 4 weeks earlier than competitor and control
✅ Enhanced barrier function – superior prevention of epithelial infiltration compared to competitor and control

This research provides valuable scientific validation of Striate+'s performance characteristics and supports its continued development as an advanced solution for guided bone regeneration procedures.

Read the journal article 👉 https://bit.ly/OCC_BMC-OralHealth

$OCC

16/06/2025

🏆 2025 WA Premier’s Science Awards – now open

As a Bronze sponsor of the 2025 Premier's Science Awards, Orthocell is proud to support scientific excellence in Western Australia.

Now in their 24th year, the Premier's Science Awards celebrate diversity and innovation across all areas of science, and at every stage - from students to established scientists.

At Orthocell, we know firsthand how important it is to support talent in biotechnology. If you know an outstanding Western Australian researcher doing ground-breaking work in science, technology, engineering and/or mathematics, consider nominating them today.

Applications for the 2025 Premier’s Science Awards are now open, with up to $140,000 to be won.

To learn more or apply, visit: https://bit.ly/OCC-ScienceAwards2025

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