Health Care
Orthocell Limited (OCC)
Orthocell Limited is an Australian regenerative medicine company focused on developing and commercialising products for the repair of soft tissue injuries. The company's key products include Remplir™ (formerly CelGro®), a collagen medical device for nerve and tendon repair, and Ortho-ATI®, a first-in-class cell therapy for treating chronic tendon injuries. Orthocell is transitioning from R&D to commercialisation, with products approved for sale in Australia, Europe, and the United States.
Market Cap
A$250M
Shares on Issue
N/A
Price Chart
AI Analysis
With a market capitalisation of around A$250M, Orthocell is an early-stage commercial biotechnology company. Its recent performance has been driven by achieving key regulatory milestones, particularly FDA 510(k) clearance for its Remplir™ nerve repair device, which opens up the significant US market. While revenue from product sales is growing, the company is not yet profitable as it continues to invest heavily in clinical trials, R&D, and establishing global distribution channels. Its financial position is supported by past capital raisings, with the cash balance being a critical metric for investors to monitor against its quarterly operational cash burn.
Orthocell's growth outlook is centred on the successful commercialisation of Remplir™ in the US and Europe, and advancing its Ortho-ATI® tendon cell therapy through clinical trials. Key upcoming catalysts include securing US distribution partners, releasing further data from the Ortho-ATI® rotator cuff trial, and expanding the approved applications for its platform technology. The company's strategic direction involves leveraging its unique technology to capture a share of the multi-billion dollar soft tissue repair and regenerative medicine markets, either through direct sales or strategic licensing and partnership agreements.
Bull Case
- • FDA clearance for Remplir™ provides access to the lucrative US surgical market, representing a major valuation inflection point and commercial opportunity.
- • The versatile CelGro®/Remplir™ collagen platform has multiple applications (nerve, tendon, bone), creating numerous 'shots on goal' and potential licensing deals.
- • Positive clinical data for Ortho-ATI® in treating chronic tendon injuries could establish it as a first-in-class, high-value therapy for a large, unmet medical need.
Bear Case
- • Significant commercialisation risk exists in scaling sales and distribution networks to compete against established players in the US and European medical device markets.
- • As a pre-profitability company, Orthocell will likely require further capital raisings to fund ongoing clinical trials and global expansion, potentially diluting existing shareholders.
- • Potential for clinical trial setbacks or delays in gaining regulatory approvals for new product applications would negatively impact investor confidence and development timelines.
Recent Announcements
US Market and Operational Update
🚨 Price SensitiveOCC, a major Australian mining company listed on the ASX with ticker symbol 'OCC', has released its periodic report detailing significant expansion in U.S. market presence and operational improvements across all sectors of operation as per their latest update for investors to consider potential growth
Orthocell Investor Webinar Details
Quarterly Activity Report & Appendix 4C
🚨 Price SensitiveOCC, a commitments test entity on ASX, has released its quarterly activity report detailing financial performance and compliance status for investors.
Orthocell Finalises Strategic Investment in Marine Biomedica
FAQs
What does OCC do?
Orthocell is a regenerative medicine company that develops and sells innovative treatments for soft tissue repair. Its main products are Remplir™, a collagen scaffold for nerve repair, and Ortho-ATI®, a cell therapy for regenerating damaged tendons.
Is OCC a good investment?
OCC presents a high-risk, high-reward investment profile typical of a small-cap biotech. The potential upside is significant if it successfully commercialises its products in global markets and its clinical trials succeed. However, risks include clinical trial failure, regulatory setbacks, competition, and the need for future funding, which could lead to capital loss.
What drives OCC's share price?
The share price is primarily driven by news flow and key catalysts. These include results from clinical trials, regulatory decisions from bodies like Australia's TGA and the US FDA, announcements of commercial partnerships or distribution agreements, and quarterly reports showing sales growth and cash position.
Key Metrics
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