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ORTHOCELL LIMITED — Investor Relations & Filings

Ticker · OCC ISIN · AU000000OCC6 ASX Manufacturing
Filings indexed 780 across all filing types
Latest filing 2025-04-13 Interim / Quarterly Rep…
Country AU Australia
Listing ASX OCC

About ORTHOCELL LIMITED

https://orthocell.com/

Orthocell Limited is a regenerative medicine company focused on the development and commercialization of innovative technologies for the repair and regeneration of human soft tissue. The company’s core product portfolio includes the CelGro platform, a naturally derived collagen medical device designed to facilitate tissue repair and reconstruction in applications such as dental bone and soft tissue regeneration, nerve repair, and tendon repair. Orthocell also specializes in advanced cellular therapies, notably Ortho-ATI (Autologous Tenocyte Implantation) for treating chronic tendon injuries and Ortho-ACI (Autologous Chondrocyte Implantation) for cartilage repair. These therapies utilize a patient's own cells to restore function and structure to damaged tissues. The company aims to provide restorative solutions that improve clinical outcomes and offer alternatives to traditional surgical interventions.

Recent filings

Filing Released Lang Actions
Quarterly Activity Report & Appendix 4C 10 pages 704.9KB
Interim / Quarterly Report Classification · 95% confidence The document is titled 'Quarterly Report – March 2025' and contains detailed financial and operational information for the quarter ended 31 March 2025. It includes revenue figures, cash position, regulatory updates, product launch details, and market expansion activities. The content is comprehensive and substantive, covering financial performance and business developments for a period shorter than a full fiscal year. This matches the definition of an Interim / Quarterly Report (IR). The document is about 15,000 characters long, indicating it is a full report rather than a brief announcement or certification. Therefore, the appropriate classification is IR with high confidence.
2025-04-13 English
Remplir Regulatory Application Submitted for Hong Kong 2 pages 186.8KB
Capital/Financing Update Classification · 95% confidence The document is a press release announcing the submission of a regulatory application to commence sales of a medical product (Remplir™) in Hong Kong. It discusses the company's commercial expansion, market opportunities, and financial position but does not contain any financial statements, detailed financial results, or regulatory filings such as annual or quarterly reports. The document is an update on capital and commercial activities rather than a formal financial report or regulatory filing. It fits best into the category of Capital/Financing Update (CAP) because it provides information about the company's funding status and expansion plans related to its product sales and market growth.
2025-04-09 English
Regulatory Approval for Striate in US$65M Brazilian Market 3 pages 238.5KB
Regulatory Filings Classification · 95% confidence The document is a press release announcing that Orthocell has received regulatory approval from the Brazilian Health Regulatory Agency (ANVISA) for its product Striate+. It discusses market opportunities, product features, and future commercial plans. There are no financial statements, quarterly or annual results, or detailed financial data presented. The document is primarily an update on regulatory approval and market expansion, not a financial report or earnings release. It is also not a report publication announcement since it does not mention the release or availability of a report. The content fits best under a general regulatory announcement category, as it informs about regulatory approval and commercial plans without detailed financial data or management discussion. Therefore, the most appropriate classification is Regulatory Filings (RNS).
2025-04-08 English
Remplir Cleared to Commence Sales in US$1.6B US Market 3 pages 217.8KB
Capital/Financing Update Classification · 90% confidence The document is a press release announcing that Orthocell has received FDA 510(k) clearance for its nerve repair product Remplir, enabling commercial distribution in the US market. It discusses the market opportunity, company strategy, manufacturing capacity, and future plans. There are no financial statements, detailed financial performance data, or comprehensive management analysis typical of annual or interim reports. The document is primarily an announcement of a regulatory clearance and commercial update rather than a financial report or detailed investor presentation. It does not fit categories like 10-K, IR, ER, or IP. It is not a regulatory filing in the sense of compliance documents or certifications, nor is it a legal proceeding or M&A related. The document is a corporate announcement about a significant regulatory milestone and commercial readiness. Therefore, the best fitting category is Capital/Financing Update (CAP), as it relates to a significant regulatory clearance that enables commercial sales and impacts company capital and revenue prospects.
2025-04-03 English
Investor Presentation - US FDA 510(k) Clearance for Remplir 21 pages 1.9MB
Investor Presentation Classification · 95% confidence The document is a detailed presentation by Orthocell Ltd about the US FDA 510(k) clearance for its flagship Remplir nerve repair product. It includes market opportunity, manufacturing capacity, logistics, sales and marketing plans, clinical results, and strategic outlook. The content is structured as a presentation with slides, forward-looking statements, and detailed business and commercial information. There are no financial statements, audit opinions, or regulatory certifications. The document is not an earnings release or a regulatory filing but a comprehensive investor-focused presentation on the company's product and market strategy. Therefore, it fits the definition of an Investor Presentation (IP). The document length is substantial (15,000 characters), indicating it is the full presentation, not just an announcement or summary.
2025-04-03 English
Orthocell Webinar Details - Remplir US FDA 510(k) Clearance 2 pages 200.6KB
Investor Presentation Classification · 85% confidence The document is a press release announcing a webinar about the US FDA 510(k) clearance for Orthocell's Remplir product. It includes details about the webinar, contact information, and a company overview. There is no financial data, no detailed investor presentation content, no report attached or referenced as being published, and no regulatory filing or certification. The document is primarily an announcement of an event related to a regulatory milestone (FDA clearance) and an investor presentation that has been separately announced. Given the nature of the content, it fits best as an Investor Presentation (IP) announcement or related communication. However, since the investor presentation is separately announced and this document is about the webinar discussing the clearance, it is not the presentation itself but an announcement of an event. The document is not a report publication announcement (RPA) because it does not mention a report being attached or published. It is not a regulatory filing (RNS) because it is not a compliance or certification document. The best fit is Investor Presentation (IP) as it is focused on investor communication about a significant company event and product milestone, even though the presentation itself is separately announced, this document serves as an investor communication about the event.
2025-04-03 English

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