Annuncio • Apr 17
Orthocell Limited Secures Approval for Remplir Nerve Repair Device to Be Used Across United States Department of Defence and Veterans Affairs Hospital Networks Orthocell Limited had secured approval for its Remplir nerve repair device to be used across the United States Department of Defence and Veterans Affairs hospital networks. This approval provides access to approximately 51 DoD military hospitals and 170 VA medical centres across the United States, representing a significant milestone in expanding Orthocell's access to the U.S. market. Orthocell's established U.S. distributor network, which currently covers 17 states, will now target military and VA surgeons operating within these hospital systems. A significant portion of these facilities could be serviced by the Company's existing distribution footprint, supporting efficient market penetration. This expansion into the defence setting follows the recent clinical use of Remplir in 23 surgical procedures on injured soldiers in Ukraine, across both primary and secondary nerve repair applications. The Ukraine experience demonstrates the real-world performance of Remplir in a conflict environment and highlights key attributes of the device, including its portability, ease of use, and suitability for treating major traumatic injuries commonly encountered in military settings. Orthocell believes this validation further supports Remplir's applicability within defence healthcare systems and reinforces its potential to address the needs of military surgeons treating complex nerve injuries. Annuncio • Apr 14
Orthocell Limited to Report Q3, 2026 Results on Apr 20, 2026 Orthocell Limited announced that they will report Q3, 2026 results on Apr 20, 2026 Reported Earnings • Feb 25
First half 2026 earnings released: AU$0.021 loss per share (vs AU$0.006 loss in 1H 2025) First half 2026 results: AU$0.021 loss per share (further deteriorated from AU$0.006 loss in 1H 2025). Revenue: AU$5.42m (up 49% from 1H 2025). Net loss: AU$5.21m (loss widened 302% from 1H 2025). Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has increased by 35% per year, which means it is well ahead of earnings. Annuncio • Nov 20
Orthocell Limited Announces Adoption of Remplir by Australian Urologists Orthocell Limited announced adoption of Remplir™? by Australian urologists is accelerating with the product increasingly being used during prostate cancer surgery in a promising new application aimed at reducing post-surgical complications from peripheral nerve injury. Remplir has now been used in 100 surgical cases to assist in improving recovery of erectile function and urinary continence post-surgery. This estimate is based on ~ 115,000 prostatectomies performed annually in the U.S., the majority of which are conducted automatically. To capitalise on this opportunity, the Company is establishing a commercialisation advisory board and investing in additional research to strengthen the scientific evidence base for this innovative peripheral nerve repair application, ahead of a targeted U.S. product launch in the medium term. Orthocell is also collating clinical data on initial patients who underwent radical prostatectomies with Remplir in Australia. This data will be released once compiled and will support the scientific foundation for formal product launch in existing approved markets. Annuncio • Nov 14
Orthocell Limited has completed a Follow-on Equity Offering in the amount of AUD 30.000001 million. Orthocell Limited has completed a Follow-on Equity Offering in the amount of AUD 30.000001 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 22,846,154
Price\Range: AUD 1.3
Discount Per Security: AUD 0.065
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 230,770
Price\Range: AUD 1.3
Discount Per Security: AUD 0.065
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Recent Insider Transactions • Nov 01
Independent Non-Executive Chairman recently bought AU$57k worth of stock On the 29th of October, John Van Der Wielen bought around 50k shares on-market at roughly AU$1.14 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was John's only on-market trade for the last 12 months. Annuncio • Sep 16
Orthocell Limited Announces Nerve-Sparing Prostate Cancer Surgery Orthocell Limited announced its nerve repair device, Remplir, has been introduced to Urologists in Australia for use in nerve-sparing Robotic-Assisted Radical Prostatectomies (RARP). Remplir has been used in approximately 40 surgical cases to assist in improving recovery of erectile function and urinary continence post-surgery. Orthocell is collating clinical data on initial patients who underwent radical prostatectomies with Remplir in Australia and will release the clinical data once available. The Company will also invest in further clinical studies to build evidence and assist medical education initiatives to drive further adoption of Remplir in this market. Summary Points: Australian urologists are using Remplir during prostate cancer surgery in a promising new application aimed at reducing post-surgical complications due to peripheral nerve injury -- a development with potential for globally significant impact. Currently up to 80% of men experience erectile dysfunction, and up to 35% suffer from urinary incontinence, after radical prostatectomy due to damage of the peripheral nerves in the neurovascular bundle (NVB) surrounding the prostate. Despite procedures aimed at preserving nerve function (i.e. nerve-sparing), and with the enhanced surgical precision offered by robotic assisted radical prostatectomies (RARP), there remains a significant risk of post-surgical erectile dysfunction and/or urinary incontinence. Similar to peripheral nerve repair procedures that restore function to the arms and legs, Remplir can be used to protect the NVB from damage and promote restoration of normal nerve function. Remplir has been used In approximately 40 nerve-sparing RARP by urologists across Australia. Orthocell is currently collaborating with urologists to collect and analyse retrospective outcome data from these nerve-sparing procedures using Remplir, with data to be released once available. The Company also intends to invest in further research to build evidence and assist medical Education initiatives related to this innovative use of Remplir for peripheral nerve repair. The Company believes the use of Remplir in nerve-sparing RARP represents a significant opportunity to expand Remplir's Total Addressable Market. Remplir rollout in the USD 1.6 Billion US market continues to build momentum, with in-country representatives making significant progress working with distributors to gain hospital approvals, on-board surgeons and establish active accounts. Initial US surgical cases continue to build. Nerve repair market sizes estimated using referenced papers from both US and OUS databases and studies. Annuncio • Sep 11
Orthocell Limited, Annual General Meeting, Nov 06, 2025 Orthocell Limited, Annual General Meeting, Nov 06, 2025. Reported Earnings • Aug 31
Full year 2025 earnings released: AU$0.038 loss per share (vs AU$0.036 loss in FY 2024) Full year 2025 results: AU$0.038 loss per share (further deteriorated from AU$0.036 loss in FY 2024). Revenue: AU$7.55m (up 42% from FY 2024). Net loss: AU$8.57m (loss widened 19% from FY 2024). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has increased by 44% per year, which means it is tracking significantly ahead of earnings growth. New Risk • Apr 03
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (AU$6.3m revenue, or US$4.0m). Reported Earnings • Feb 26
First half 2025 earnings released: AU$0.006 loss per share (vs AU$0.026 loss in 1H 2024) First half 2025 results: AU$0.006 loss per share (improved from AU$0.026 loss in 1H 2024). Revenue: AU$2.41m (up 71% from 1H 2024). Net loss: AU$1.30m (loss narrowed 75% from 1H 2024). Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has increased by 46% per year, which means it is tracking significantly ahead of earnings growth. New Risk • Nov 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.4% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Revenue is less than US$5m (AU$5.3m revenue, or US$3.4m). Annuncio • Oct 31
Orthocell Limited has completed a Follow-on Equity Offering in the amount of AUD 17 million. Orthocell Limited has completed a Follow-on Equity Offering in the amount of AUD 17 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 28,166,667
Price\Range: AUD 0.6
Discount Per Security: AUD 0.03
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 166,666
Price\Range: AUD 0.6
Discount Per Security: AUD 0.03
Transaction Features: Subsequent Direct Listing Annuncio • Oct 25
Orthocell Limited has filed a Follow-on Equity Offering in the amount of AUD 17 million. Orthocell Limited has filed a Follow-on Equity Offering in the amount of AUD 17 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 28,166,667
Price\Range: AUD 0.6
Discount Per Security: AUD 0.03
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 166,666
Price\Range: AUD 0.6
Discount Per Security: AUD 0.03
Transaction Features: Subsequent Direct Listing Recent Insider Transactions Derivative • Oct 16
CEO, MD & Executive Director exercised options to buy AU$190k worth of stock. On the 15th of October, Paul Anderson exercised options to buy 268k shares at a strike price of around AU$0.58, costing a total of AU$157k. This transaction amounted to 3.9% of their direct individual holding at the time of the trade. Since December 2023, Paul has owned 3.79m shares directly. Company insiders have collectively bought AU$232k more than they sold, via options and on-market transactions, in the last 12 months. Annuncio • Oct 04
Orthocell Limited, Annual General Meeting, Nov 29, 2024 Orthocell Limited, Annual General Meeting, Nov 29, 2024. Reported Earnings • Aug 31
Full year 2024 earnings released: AU$0.036 loss per share (vs AU$0.032 loss in FY 2023) Full year 2024 results: AU$0.036 loss per share (further deteriorated from AU$0.032 loss in FY 2023). Revenue: AU$5.32m (up 25% from FY 2023). Net loss: AU$7.18m (loss widened 15% from FY 2023). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Annuncio • Mar 01
Orthocell Limited has completed a Follow-on Equity Offering in the amount of AUD 3.500001 million. Orthocell Limited has completed a Follow-on Equity Offering in the amount of AUD 3.500001 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 9,459,461
Price\Range: AUD 0.37
Transaction Features: Subsequent Direct Listing New Risk • Feb 29
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 5.8% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 5.1% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (5.8% increase in shares outstanding). Revenue is less than US$5m (AU$4.8m revenue, or US$3.1m). Market cap is less than US$100m (AU$88.7m market cap, or US$57.6m). Annuncio • Feb 23
Orthocell Limited has filed a Follow-on Equity Offering in the amount of AUD 3.5 million. Orthocell Limited has filed a Follow-on Equity Offering in the amount of AUD 3.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 9,459,460
Price\Range: AUD 0.37
Transaction Features: Subsequent Direct Listing Annuncio • Dec 22
Orthocell Limited Announces Changes to its Board Orthocell Limited announced that founding Board member and former Chairman, Dr. Stewart Washer, has retired from the Company's Board. Dr. Washer has completed the transition from his previous role as the long-standing Chair and has fully handed over the reins to new Chairman John Van Der Wielen. Stewart made the decision to retire from the Orthocell Board after having served almost 10 years to allow him to pursue other interests. Orthocell Board now has five Directors comprising four Non-Executive Directors and one Executive Director. The recent appointment of Professor Fiona Wood, independent non-executive Director Dr. Ravi Thadhani and Chairman Mr. John Van Der Wielen to the Orthocell Board, has strengthened the leadership team as the Company prepares for the next phase of development and commercialisation of its unique medical devices and cellular therapies. Annuncio • Oct 26
Orthocell Limited Provides Commercial Revenue Guidance for the Full Year 2023 Orthocell Limited provided commercial revenue guidance for the full year 2023. For the period, the company expects commercial revenue to in the range of $51 million to $53 million. Annuncio • Oct 25
Orthocell Limited Announces Board Changes Orthocell Limited announced the appointment of Professor Fiona Wood AM to the Orthocell Board. This coincides with the retirement of Mr. Qi Xiao Zhou, who has served as a Member of Orthocell’s Board since 2012 and the transition of Dr. Stewart Washer from Executive Director to Non-Executive Director. All changes detailed above will be effective 01 November, 2023. The appointment of Professor Wood follows the recent appointment of experienced Chairman Mr. John Van Der Wielen, and independent Non-Executive USA based Director Dr. Ravi Thadhani. Professor Fiona Wood is a well-known and highly respected West Australian, and Australian National Living Treasure, with more than 30 years’ experience as a plastic and reconstructive surgeon. Professor Wood was named Western Australian Citizen of the Year in 2003 and 2004, Australian of the Year in 2005 and Member of the Order of Australia (AM) in 2003 for her contribution to Medicine in the field of burns. Her revolutionary “spray-on skin” treatment of serious burns, invented with colleague Marie Stoner, uses a patient’s own skin cells to help restore damaged skin and significantly reduce permanent scarring. This treatment was instrumental in saving many lives in the aftermath of the Bali bombing in 2002. Professor Wood is currently a Consultant Plastic Surgeon at Fiona Stanley Hospital and Perth Children’s Hospital, and the Winthrop Professor of Surgery at the University of Western Australia. Professor Wood is co-founder of the Wood Foundation, which continues her research into the treatment of burns and is a Board member of the Royal Flying Doctor Service, amongst others. Following Professor Woods’s appointment and the resignation of Mr. Zhou, the Orthocell Board has six Directors comprising four Non-Executive Directors and two Executive Directors. With the experienced Board and management team, market leading products and strong balance sheet, the Company is well positioned to grow product sales alongside distribution partners, BioHorizons and Device Technologies, and to execute its US market access program and commercialisation strategies for its breakthrough nerve repair medical device. Board Change • Oct 06
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 8 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Independent Non-Executive Chairman John Van Der Wielen was the last independent director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Annuncio • Sep 22
Orthocell Limited Announces Board Changes Orthocell Limited announced that Professor Lars Lidgren is retiring from the Orthocell Board, effective from 30 September 2023 and Ms Leslie Wise is taking a temporary leave of absence for personal reasons, effective immediately. Annuncio • Sep 05
Orthocell Limited, Annual General Meeting, Oct 31, 2023 Orthocell Limited, Annual General Meeting, Oct 31, 2023. Reported Earnings • Sep 01
Full year 2023 earnings released: AU$0.032 loss per share (vs AU$0.047 loss in FY 2022) Full year 2023 results: AU$0.032 loss per share (improved from AU$0.047 loss in FY 2022). Revenue: AU$4.24m (up 177% from FY 2022). Net loss: AU$6.25m (loss narrowed 31% from FY 2022). Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 3% per year, which means it is significantly lagging earnings. New Risk • Aug 31
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 16% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Revenue is less than US$5m (AU$1.6m revenue, or US$1.0m). Market cap is less than US$100m (AU$79.9m market cap, or US$51.8m). Annuncio • May 30
Orthocell Limited Appoints John Van Der Wielen as Independent Non-Executive Chairman, Effective 1 June 2023 Regenerative medicine company Orthocell Limited announced the appointment of John Van Der Wielen as independent Non-Executive Chairman, effective 1 June 2023. Dr. Stewart Washer, who has served as Executive Chairman since April 2014, will transition to Executive Director. The appointment of Mr. Van Der Wielen follows the recent addition of globally recognised healthcare executive Dr. Ravi Thadhani to the Orthocell Board and will further strengthen the leadership team as the Company prepares for the next phase of development and commercialisation of its unique medical devices and cellular therapies. As a senior financial services professional, Mr. Van Der Wielen has over 35 years' international experience in wealth management, private banking, investments, and insurance, in the UK, Luxembourg, Malaysia and Australia. He has held senior executive positions with several national and global financial services groups. Most recently Mr. Van Der Wielen was the CEO and MD of HBF Health Ltd. for over five years. HBF has revenue of over 1.6 billion dollars and in a recent independent consumer survey was named Australia's most trusted brand in private health insurance. Mr. Van Der Wielen's other previous executive positions include CEO (UK & International) of Friends Life UK, Managing Director (Wealth) of ANZ, CEO of Clerical Medical, Halifax Life & Heidelberger Leben and CEO of Lloyds Banking Group/HBOS Plc. Mr. Van Der Wielen has held numerous directorships and advisory positions, including roles as Senior Adviser to Blackstone. He has served as Chairperson of Kyckr, Non-Executive Director of Partners Life, Non- Executive Director of Friends Provident International and Non-Executive Director of Lombard International Assurance. Mr. Van Der Wielen has significant expertise overseeing and chairing large funds management and investment committees, as well as leading on acquisitions, integration and restructuring programs. Mr. Van Der Wielen is currently Non-Executive Director, of the Blackstone owned Crown Resorts and Chair of Crown Perth, and Non-Executive Director of the Royal Flying Doctor Service WA. He is a Senior Adviser to Appian Capital Advisory LLP and was recently appointed by the Western Australian Government to Chair its Future Health Research and Innovation Fund (FHRI). The FHRI is a sovereign wealth fund, with a purpose is to improve, through research and innovation, the health and prosperity of Western Australians, the sustainability of the health system and to advance the State's standing as a leader in research and innovation. Mr. Van Der Wielen holds an MBA from the University of Western Australia, has studied at London Business School and Oxford University, and is a Fellow of the Australian Institute of Company Directors. Reported Earnings • Mar 03
First half 2023 earnings released: AU$0.021 loss per share (vs AU$0.024 loss in 1H 2022) First half 2023 results: AU$0.021 loss per share (improved from AU$0.024 loss in 1H 2022). Net loss: AU$4.06m (loss narrowed 13% from 1H 2022). Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has increased by 9% per year, which means it is well ahead of earnings. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Non-Executive Director Matt Callahan was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Sep 30
Orthocell Limited's Rotator Cuff Study Success with Cross-Over Patients Orthocell Limited announced positive results from the crossover patient extension arm of its randomised, multicentre, controlled rotator cuff tendon clinical study. This additional data supports the original randomised controlled RC Study results, which demonstrated that OrthoATITM is a safe and effective treatment for patients suffering from rotator cuff tendinopathy with intrasubstance tendon tear compared directly to the standard of care. Rotator cuff tears lead to considerable pain and disability, and conservative treatment options, do not address the chronic underlying pathology of tendon degeneration. OrthoATITM represents a potential breakthrough treatment option to resolve pain and return functional mobility for this debilitating condition. Watch video here. To be eligible for the RC Study, participants had to have suffered from pain and loss of shoulder function for at least 6 months and had received an average of 4 failed treatments prior to enrolment. Following treatment, assessment of pain and shoulder function showed that the OrthoATITM group had significantly better results compared to the steroid group at all post-treatment time points. Participants in the observational extension study had received at least two corticosteroid injections and had an average symptom duration of 33.1 months, indicating a chronic condition that was unlikely to resolve itself without further treatment. Nine of eleven (82%) participants who received corticosteroid treatment in the RC trial requested subsequent crossover treatment with OrthoATITM due to lack of improvement in their shoulder pain and/or function; On average, participants in the crossover group experienced almost complete resolution of painby month 6 following treatment with OrthoATITM; The crossover group also experienced clinically important improvements in shoulder function at 6 months following OrthoATITM treatment; Results in the crossover group mirror those seen in the OrthoATITM group in the original RC trial; No participants in the crossover group required additional treatment for their shoulder injury within the 12 month follow-up period; and No safety concerns for OrthoATITM were identified. Initial market sizing undertaken by Orthocell suggests that Ortho-ATITM could be applicable to >480,000 rotator cuff patients per year in the US alone, which equates to a market opportunity of approximately US$4-5 billion 1. Ongoing work by Orthocell aims to also assess the savings to the health system that may be delivered by OrthoATITM when accounting for more effective pain relief and return of function, return to work and avoidance of surgical costs. Ortho-ATITM can be used in both pre-surgical and post-surgical applications, not only in treating rotator cuff injuries, but many other tendon injuries and is at the forefront of a significant and increasing market opportunity. The Orthocell team was responsible for the initial development of a similar cell therapy product for the regeneration of cartilage which is now being commercialised by US company Vericel, which currently generates more than $120 million in sales and is only used to treat one target joint in the body. Vericel currently has a market capitalisation of approximately $1.2 billion. Orthocell is in a strong position to advance its US commercialisation strategy to deliver the first injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries. 2 The results of this study demonstrate that OrthoATITM is more effective than steroid injections for treatment of rotator cuff tendinopathy with intrasubstance tendon tear. The Company continues to progress its US plans with the evaluation of technology transfer options, FDA engagement and commercial preparation activities to prepare OrthoATITM for a randomised controlled study under FDA supervision. The observational extension study has been led by Clinical Professor Allan Wang. Dr Jeff Hughes was an investigator in the full RC study. The RC Study was a randomised, multicenter, open-label study designed to assess OrthoATITM, in comparison to steroids as an emerging treatment for patients with rotator cuff tendinopathy with intrasubstance tendon tear. A total of 30 participants verified by MRI with symptom duration >6 months, and who had previously received physiotherapy AND one or more corticosteroid injections were treated. Participants were randomised to receive an ultrasound guided injection of tendon derived cells that had been cultured from a sample drawn from each patient or an ultrasound guided injection into the subacromial space of Celestone Chronodose. Annuncio • Sep 07
Orthocell Limited, Annual General Meeting, Oct 28, 2022 Orthocell Limited, Annual General Meeting, Oct 28, 2022. Reported Earnings • Sep 01
Full year 2022 earnings released: AU$0.047 loss per share (vs AU$0.048 loss in FY 2021) Full year 2022 results: AU$0.047 loss per share. Net loss: AU$9.11m (flat on FY 2021). Annuncio • Jun 07
Orthocell Limited Announces the Completion of Its RemplirTM Nerve Reconstruction Study Orthocell Limited announced the completion of its RemplirTM (previously CelGro®) nerve reconstruction study. Final data read out at 24 months post-treatment for all patients in the trial shows nerve reconstruction with RemplirTM following injury to the spinal cord, brachial plexus and other peripheral arm/hand nerves consistently restores arm and hand function. The results also demonstrate that not only were functional gains maintained between 12- and 24-months post-treatment, but that patients continued to improve over that time. Patients in the clinical trial suffered traumatic nerve injuries following motor vehicle, sporting and/or work- related incidents, resulting in partial or total loss of use of their arms and, in more severe cases, their legs and torso as well (quadriplegia). Patients experienced significant pain and were unable to perform basic activities of daily living (i.e. eating, bathing, dressing and toileting), play sport and/or work. Without surgery they would not have regained normal use of their injured arm and hand. Patients received one or more nerve reconstructions augmented with RemplirTM in one or both upper limbs. Recovery after treatment was assessed by grading the strength of target muscles 1 closest to the site of nerve repair. Follow up data at 12 months was available for 16 of 19 patients involving 33 nerve repairs. Results showed 76% (25 of 33) of nerve reconstructions resulted in functional recovery of muscles controlled by the reconstructed nerve. Follow-up data at 24 months post treatment was available for 14 of 19 patients involving 27 nerve reconstructions. Results showed that 85% (23 of 27) of nerve reconstructions resulted in functional recovery of target muscles closest to the reconstruction site. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Non-Executive Director Matt Callahan was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Dec 29
Orthocell Ordinary Shares to Be Deleted from Other OTC Orthocell Limited Ordinary Shares (Australia) will be deleted from other OTC effective from December 29, 2021, due to Inactive security. Recent Insider Transactions • Sep 25
CEO, MD & Executive Director recently sold AU$552k worth of stock On the 23rd of September, Paul Anderson sold around 1m shares on-market at roughly AU$0.48 per share. This was the largest sale by an insider in the last 3 months. This was Paul's only on-market trade for the last 12 months. Board Change • Sep 22
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Non-Executive Director Matt Callahan was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Sep 14
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Non-Executive Director Lars Lidgren was the last independent director to join the board, commencing their role in 2007. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Sep 13
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Non-Executive Director Lars Lidgren was the last independent director to join the board, commencing their role in 2007. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Sep 09
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Non-Executive Director Lars Lidgren was the last independent director to join the board, commencing their role in 2007. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Sep 06
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Non-Executive Director Lars Lidgren was the last independent director to join the board, commencing their role in 2007. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 29
Full year 2021 earnings released: AU$0.047 loss per share (vs AU$0.036 loss in FY 2020) Full year 2021 results: Net loss: AU$9.04m (loss widened 47% from FY 2020). Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has increased by 18% per year, which means it is tracking significantly ahead of earnings growth. Annuncio • Aug 25
Orthocell Limited Announces CelGro Nerve Study Results Orthocell Limited announced the successful pre-clinical and clinical CelGro® nerve repair study results showing superior nerve regeneration and consistent restoration of upper limb function in people with tetraplegia were presented at the 50th West Australian Branch Australian Orthopaedic Association (AOA) annual scientific meeting. The WA AOA annual scientific meeting is the industry leading state congress and was attended by highly regarded orthopaedic surgeons, researchers and commercial partners. The congress provided an opportunity to build awareness of the surgeon and patient benefits provided by CelGro®, a bestin class collagen medical device. In the pre-clinical study, sciatic nerves in rats repaired with CelGro® exhibited no inflammation, scar tissue formation or fibro-adhesions. CelGro® integrated into the host epineurium (outer layer of connective tissue of the nerve), was remodelled into natural tissue, and at 4 weeks post treatment, resembled the native sciatic nerve in appearance. For full study results, click here; In the CelGro® nerve regeneration clinical study, seventeen nerve repairs were performed with CelGro® in five quadriplegic patients. Patients demonstrated faster and better results in muscle function restoration, compared to published studies of nerve transfer surgery using the standard method (direct suture). In particular, 76.5% of the tetraplegic nerve transfers (13 of 17) resulted in the best-case clinical outcome (MRC Grade 3 or 41) at 12 months post treatment. An MRC Grade 3 or 4 means quadriplegic patients regain a level of independence, enabling them to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of a wheelchair without assistance. For full study results, click The Company believes CelGro® to be an important step forward for improving nerve repair surgery. Its ease of use, consistent and predictable high-quality outcomes which are achieved in a shorter timeframe compared to other methods, will empower surgeons to improve the lives of patients with these complex injuries. CelGro®'s global addressable market in peripheral nerve repair is estimated to be worth more than USD 7.5 billion per annum, with approximately 3,000,000 2 procedures that could use CelGro® completed each year. With positive 12-month data in hand from the CelGro® nerve regeneration trial, Orthocell continues to prepare for discussions with FDA on the approval pathway and also with US insurance companies (or `payers') and key opinion leaders to finalise the commercialisation approach for registration and reimbursement. Annuncio • Jun 22
Orthocell Limited Announces First Interim Data Read Out of All Patients in the Celgro® Nerve Regeneration Trial At 12 Months Post Treatment Orthocell Limited announced the first interim data read out of all patients in the CelGro® nerve regeneration trial at 12 months post treatment. Positive clinical data shows nerve repair with CelGro® following injury to the spinal cord, brachial plexus and other peripheral arm/hand nerves consistently restores arm and hand function. Patients in the clinical trial suffered traumatic nerve injuries following motor vehicle, sporting and/or work- related incidents, resulting in partial or total loss of use of their arms and, in more severe cases, their legs and torso as well (quadriplegia). Patients experienced significant pain and were unable to perform basic activities of daily living (i.e. eating, bathing, dressing and toileting), play sport and/or work. Without surgery they would not have regained normal use of their injured arm and hand. Patients received one or more nerve repairs augmented with CelGro® in one or both upper limbs. Recovery after treatment was assessed by grading the strength of target muscles 1 closest to the site of nerve repair. Follow up data at 12 months was available for 16 of 19 patients involving 33 nerve repairs. Results showed 75.8% (25 of 33) of nerve repairs resulted in functional recovery of muscles controlled by the repaired nerve. Over half of the nerve repairs augmented with CelGro® (17 of 33) were performed in five quadriplegic patients. The results for this challenging condition have been very encouraging. Patients demonstrated faster and better results in muscle function restoration, compared to published studies of nerve transfer surgery using the standard method. In particular, 76.5% of the quadriplegic nerve transfers (13 of 17) resulted in the best-case clinical outcome (MRC Grade 3 or 41) at 12 months post treatment. An MRC Grade 3 or 4 means quadriplegic patients regain a level of independence, enabling them to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of a wheelchair without assistance. Trial participant Adrian Walsh broke his neck in a mountain bike accident in June 2017 and didn't have enough strength to use a wheelchair on his own. Adrian's recovery has been impressive. Annuncio • May 26
Orthocell Limited Announces New Collagen Rope Patent for CelGro Platform Technology Orthocell Limited announced Chinese and Hong Kong patents have been granted for its novel CelGro® collagen rope device, to augment the surgical repair of Anterior Cruciate Ligament (ACL) injuries. The patents entitled "Collagen Construct and Method for Producing the Collagen Construct" are now approved in United States, Australia, Japan, China and Hong Kong, providing additional important intellectual property protection for the CelGro® platform for soft tissue regeneration and repair applications. They are set to expire on or after 12 October 2035. Annuncio • Apr 28
Celgro Study Results Open Up New US Market Access Strategy Orthocell Limited announced positive results from the US 510(k) animal pilot study, indicating that CelGro® faciliates superior nerve regeneration when compared to the market leading nerve repair device - restoring the sciatic nerve to a pre-injured state. As a result of this breakthrough nerve regeneration data, and in light of the previously released interim human clinical data, the company is evaluating the medical device US regulatory pathways to identify opportunities for expedited approval of CelGro® and the ideal route to the highest reimbursement value. Orthocell has completed the pilot stage of its 510(k) animal study titled "Evaluation of collagen nerve wraps used in peripheral nerve repair in a rat sciatic nerve injury model" which was designed to provide evidence of safety and efficacy of CelGro® in peripheral nerve repair, to meet the requirements of the US 510(k) regulatory pathway. The pilot study involved augmenting the repair of severed sciatic nerves in four rats in two separate study groups (CelGro® and an FDA approved nerve repair device) with outcome measures focused on the facilitation of nerve regeneration recorded at four weeks post treatment. The 510(k) animal study results suggest that restoration of the damaged nerve to its pre-injured state can translate to faster and more predictable return of upper arm and hand function. The previously released interim human clinical data, in patients with tetraplegia or paralysed upper limbs showed that nerve repair using CelGro® resulted in more rapid and consistent outcomes. Improvements in muscle power at 12 months were comparable to repair outcomes sometimes achieved at 24 months either with direct suturing or with the use of the comparator device tested in this 510(k) study. In light of these study results and the previously released interim human clinical data, Orthocell believes that CelGro® represents a breakthrough in nerve regeneration and is an important development in nerve repair surgery to return function to paralysed upper limbs. CelGro's® superior ability to integrate into nerve tissue with optimal resorption profile and no adverse reactions, provides the ideal conditions for nerve regeneration. These properties, combined with CelGro's excellent handling characteristics will empower surgeons, and ultimately improve the lives of more patients suffering from complex spinal cord or traumatic nerve injuries. The company is on track to announce further clinical data from its CelGro® nerve regeneration human clinical study in Second Quarter 2021, which focuses on the return of arm and hand function of all trial participants, measured at 12 months post treatment. This data will guide the company's approach with FDA and US payers (Medicare, Medicaid, private payers and the Veteran's Administration) to determine whether an expedited regulatory approval, pursuant to a "De Novo" or "Pre-Market Approval", is possible and what this will mean for reimbursement value for the product. The currently planned 510(k) pathway for CelGro® is underpinned by an assessment of substantial equivalence to a predicate product (i.e a currently approved and marketed device such as that tested in the 510(k) animal study). The 510(k) pathway also essentially caps the potential reimbursement value paid by private insurers, regardless of any additional patient or economic benefits delivered by use of the new nerve repair device. On the other hand, De Novo, Pre-Market Approval pathways and expedited programs allow for increased interaction with the FDA and provide the opportunity for the company to gain a stand-alone approval for a novel nerve repair device, based on the unique clinical benefit delivered by that device. These pathways also allow the company to leverage the evidence generated in the studies to support FDA approval and maximise the value ultimately paid by US payers for the new product, rather than referencing the existing price for currently marketed products. This would potentially allow Orthocell to reap the benefit of the significant patient and economic advantages generated by using CelGro® in nerve repair applications, and take a larger, more profitable share of the nerve repair market. Orthocell continues to assess the approval pathways available for CelGro® and following finalization of the CelGro® nerve regeneration human clinical study in Second Quarter 2021, will engage with FDA to determine whether an expedited regulatory approval is possible and what this will mean for reimbursement value for the product. Annuncio • Jan 28
Orthocell Limited Announces Publication of Successful Case Study Focussing on the Combination of Celgro® Collagen Medical Device and Autologous Tenocyte Implantation for the Surgical Repair of Large Degenerate Tear of the Gluteal Medius Tendo Orthocell Limited announced the publication of a successful case study focussing on the combination of CelGro® collagen medical device and autologous tenocyte implantation (Ortho-ATI®) for the surgical repair of a large degenerate tear of the gluteal medius tendon. The case study was published by internationally recognised orthopaedic hip specialist surgeon Dr John M O'Donnell and sports and exercise doctor A/Professor Jane Fitzpatrick. The case report supports Ortho-ATI® and CelGro® as durable, long term solutions for degenerate, treatment resistant tendons that can be used on their own or in combination. Gluteal tendinopathy can result in severe hip pain and is a common cause of disability affecting up to 23.5% of women and 8.5% of men aged between 50 and 79 years. Gluteal tendinopathy injuries may lead to considerable disability, reduced quality of life, and absenteeism from work, and are a significant burden on healthcare resources. The current standard of care including corticosteroid, platelet-rich plasma (PRP) injections or surgery, either lack an evidence base for long-term efficacy, or suffer from variability in failure rates and full restoration. This case report was designed to assess the role and effectiveness of CelGro® when combined with Ortho-ATI® to treat chronic degenerative gluteal tendinopathy in a 63 year old woman. The patient suffered from chronic right sided hip pain for over 15 years which significantly affected her ability to sleep, work and exercise. The patient underwent numerous conservative treatment options (including physiotherapy, load management, platelet rich plasma and corticosteroid injection therapy) and right hip replacement surgery - all without success. In 2016, the patient suffered a full thickness tendon tear (rupture) of the gluteus medius from the insertion of the greater trochanter (hip bone), confirmed by MRI of the hip, also noting significant atrophy and degeneration of the tendon. The patient underwent open surgery in April 2017 where the gluteus medius was anatomically repaired. CelGro®, acting as a carrier and scaffold for Ortho-ATI® (patients own cultured tenocytes) was then sutured over the repaired tendon. Both CelGro® and Ortho-ATI® were manufactured at Orthocell's TGA licensed facility prior to surgical implantation. Pain and function improvement was reported by the patient at the 12-week post-implantation review. At 6 months post treatment, and a physiotherapy led strength-based exercise program, the patient reported that pain had settled and was walking without a limp. She had normal function in the hip at 12 months. A structural improvement in the tendon was confirmed by repeat MRI. Orthocell intends to leverage this case report showing CelGro® and Ortho-ATI® results in high quality tissue repair to further position the medical device and cell therapy as best-in-class regenerative medicine products that can be used on their own or in combination. Further performance studies are planned to assist in establishing the effectiveness of the combined product. Annuncio • Jan 15
Orthocell Ltd Receives US Market Clearance Orthocell Ltd. has achieved US 510k clearance to market and supply its collagen medical device Striate+TM in the US dental bone and tissue regeneration market. The US 510(k) clearance now allows Orthocell to supply Striate+TM in the US dental bone and tissue regeneration market, estimated at USD 500 million per annum. The company will now pursue negotiations with multi-national dental companies for US marketing and distribution rights, with Orthocell to retain manufacturing of the finished product. Striate+TM has been approved for use in dental bone and tissue regeneration procedures including, but not limited to, dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets and guided tissue regeneration procedures in intrabony periodontal defects. The 510(k) clearance follows the Company’s application submitted to the FDA in May 2020. The FDA determined that, for the indications above, Orthocell's Striate+ is substantially equivalent to a predicate device and can therefore market Striate+ in the US. Striate+ has, based on surgeon feedback, distinct advantages over other similar products and may assist surgeons to deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and improved bone healing. With US, EU and Australian market approval achieved and key opinion leaders (KOLs) actively engaging with the program, Orthocell is well positioned to secure a distribution partner and establish Striate+TM as the best-in-class dental resorbable collagen membrane. Annuncio • Jan 14
Orthocell Limited Receives First US CelGro Product Approval Orthocell Limited announced that it has achieved FDA 510(k) clearance to market and supply its CelGro collagen medical device for dental bone and tissue regeneration procedures in the US. The FDA 510(k) clearance now allows Orthocell to supply Striate+ in the US dental market, estimated at USD 500 million per annum. Striate+ has been approved for supply in dental bone and tissue regeneration procedures such as dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets and guided tissue regeneration procedures in intrabony periodontal defects. The 510(k) clearance follows the Company's application submitted to the FDA in May 2020. The FDA determined that, for the indications above, Orthocell's Striate+ is substantially equivalent to a predicate device and can therefore market Striate+ in the US. Striate+ has, based on surgeon feedback, distinct advantages over other similar products and may assist surgeons to deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and improved bone healing. Is New 90 Day High Low • Jan 04
New 90-day high: AU$0.49 The company is up 18% from its price of AU$0.41 on 06 October 2020. The Australian market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 2.0% over the same period. Annuncio • Dec 25
Orthocell Limited Receives Australian Market Approval for its Celgro, a Collagen Medical Device Orthocell Limited receives Australian market approval for its CelGro collagen medical device for introduction into the Australian dental bone and tissue regeneration. Inclusion of CelGro Dental in the Australian Register of Therapeutic Goods follows the recent announcement on 17th December 2020 confirming the TGA completed its review of the Company's regulatory application and that the company successfully demonstrated compliance with the requirements of the Medical Device Regulations with respect to the safety and performance of CelGro in dental bone and tissue regeneration procedures. With EU and Australian market approval achieved and key opinion leaders actively engaging with the program, Orthocell is well positioned to gain the key U.S. FDA approval which is targeted for CY2021 and to establish CelGro® as the best-in-class collagen membrane. Use of the product in Australia and the EU will assist with further technical and market validation for CelGro as the U.S. FDA approval approaches. Is New 90 Day High Low • Nov 25
New 90-day high: AU$0.46 The company is up 1.0% from its price of AU$0.45 on 27 August 2020. The Australian market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 9.0% over the same period. Annuncio • Nov 20
Orthocell Limited Announces Patient Enrolment for the Celgro® Nerve Regeneration Trial Is Now Complete Orthocell Limited announced patient enrolment for the CelGro® nerve regeneration trial is now complete, which has to date included the repair of 35 nerves in 19 patients. Positive long term clinical data shows nerve repair with CelGro® results in predictable and consistent restoration of upper limb function. Positive 24 month clinical data; Patients received one or several nerve repairs augmented with CelGro® in one or both upper limbs. Recovery after treatment was assessed by grading the strength of target muscles 1 closest to the site of nerve repair. Assessments were performed before treatment and at 12 and 24 months after treatment. Results from 10 participants (19 nerves) 24 months after treatment with CelGro® showed upper limb
function was restored in 17 of 19 (89%) nerve repairs. These results follow the clinical data of the same ten participants 12 months after surgery ("interim data"), announced on 9 October 2019. Patients ceased, or significantly reduced, prescription pain medication (including opioid-based medications), and in many cases returned to work and participation in recreational activities.
Quadriplegic patient outcomes; A review of the quadriplegic patient cohort contributing 12 and 24-month data after treatment, involving nine nerve transfers augmented with CelGro® showed:
· Quadriplegic patients regained voluntary muscle movement of previously impaired or paralysed upper limbs within 12 months (MRC Grade 2 or better)1 of treatment. Number of nerve repairs resulting in the best case clinical outcome (MRC Grade 3 or 4) increased from 7 of 9 (78%) repairs at 12 months to 8 of 9 (89%) repairs at 24 months post treatment. MRC Grade 3 or 4 means quadriplegic patients regain a level of independence enabling them to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of a wheelchair without assistance. Is New 90 Day High Low • Nov 02
New 90-day low: AU$0.33 The company is down 6.0% from its price of AU$0.35 on 04 August 2020. The Australian market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 3.0% over the same period. Annuncio • Sep 17
Orthocell Limited Announces CelGro Bone Regeneration in Dental & Orthopedic Applications Orthocell Limited announced publication of positive pre-clinical and clinical results for the use of CelGro® in enhancing repair of critical bone defects in the highly regarded "Tissue Engineering" Journal. The paper is entitled "Collagen Membrane for Guided Bone Regeneration in Dental and Orthopedic Applications". A copy of the publication can be found CelGro GBR Publication. This publication, in conjunction with previous pre-clinical studies published in Biomaterials, demonstrating CelGro dosed with bone growth factors significantly improved the healing of cortical bone, validates that CelGro is an ideal membrane for Guided Bone Regeneration ("GBR") not only in oral maxillofacial reconstructive surgery but also in orthopedic applications such as open tibial fractures and incidences of non-union fractures. CelGro® dental bone regeneration study results published in Tissue Engineering In May 2018, Orthocell announced the results of a clinical study designed to evaluate the performance of CelGro® in dental GBR treatment. Dental GBR is a standard procedure used routinely in clinical practice, to preserve and restore bone volume to facilitate the subsequent placement of dental implants. The clinical study involved a two-stage dental implant procedure with GBR in 10 patients (involving 16 dental implants). Bone defects were covered with the CelGro® collagen membrane after bone void filling. Various assessments related to performance of the CelGro® collagen membrane were evaluated up to 6 months post GBR treatment. Top line data indicated that use of CelGro® resulted in successful bone regeneration within 4 to 6 months of the procedure, enabling the next stage of implant surgery (placement of the crown). Further, the void-filling material was fully integrated into the newly regenerated bone, with no reported complications or adverse events. Pre-clinical study results published in Tissue Engineering The pre-clinical study also reported in this publication was conducted in a large animal model designed to assess the effectiveness of CelGro® to enhance the repair of cortical bone defects, when used in conjunction with autograft bone. The study was performed on 28 skeletally mature whiterabbits. The animals were randomly assigned to one of five treatment groups: no treatment, defect only, autograft only, autograft plus competitor product Bio-Gide®, and autograft plus CelGro. CelGro showed superior cortical bone alignment and reduced porosity at the defect interface, when compared to current market leading GBR product Bio-Gide®. Micro-CT evaluation showed early bridging over the defect area 30 days post-operatively, and nearly complete restoration of mature cortical bone at the bone defect site 60 days post-operatively. Histological analysis at day 60 after surgery, further confirmed CelGro supported the regeneration of higher-quality bone, having a similar thickness and density to normal cortical bone. In addition, use of CelGro in combination with autograft bone, resulted in significantly increased bone formation at the defect - compared to repair without the use of autograft bone. Significance of CelGro bone defect repair results: Positive oral and cortical bone defect repair results using CelGro® in conjunction with bone grafting material published in the highly regarded journal `Tissue Engineering' provides further validation of the development plan for CelGro starting in dental applications, and extending the concept of GBR into critical bone repair within orthopaedic applications. GBR which is commonly used in maxillofacial dental surgery to restore bone volume, has been under- utilized in the repair of cortical bone defects in orthopaedics. GBR in orthopaedics appears to have been limited by the lack of an ideal scaffold that provides sufficient mechanical support to bridge the cortical bone whilst providing a favorable environment to promote the rapid repair and regeneration of high quality bone. Enhancing the rate of repair of the load bearing cortical bone, therefore, could enable patients suffering from serious fractures to return to pre-injury daily activities more rapidly. Next Steps: Orthocell intends to leverage CelGro®'s ability to guide superior quality bone formation to further position CelGro as the best-in-class collagen membrane for bone and soft tissue repair. The performance studies underpins the compatibility and versatility of CelGro as a platform technology and highlights the potential to extend Orthocell's innovative product range into orthopedic bone regeneration.