Orthocell Rockets to Record $2.21M Revenue, Eyes US FDA Approval for Remplir™
Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.
- Record quarterly revenue of $2.21 million, up 9% sequentially and 46% year-over-year
- Received regulatory approval and achieved first sales of Remplir™ in Singapore
- Submitted US FDA 510(k) application for Remplir™, targeting $1.6 billion US nerve repair market
- Completed $17 million capital raise to fund US commercial launch and global expansion
- Appointed experienced US executives to lead Remplir™ market entry and sales
Strong Revenue Momentum Amid Market Expansion
Orthocell Limited (ASX: OCC) has delivered a robust performance in the December 2024 quarter, reporting a record $2.21 million in revenue. This marks a 9% increase from the previous quarter and a striking 46% rise compared to the same period last year, underscoring sustained growth momentum following the launches of Striate+™ in the US and Remplir™ in Australia in late 2022.
The company’s compounded quarterly growth rate of 9% over the past nine quarters reflects growing adoption of its collagen-based medical devices by surgeons, with Striate+ and Remplir gaining traction across multiple markets. Notably, the traditionally slower December quarter saw exceptional performance, signaling strong underlying demand.
Regulatory Milestones and Market Penetration in Asia
Orthocell achieved a significant regulatory milestone with the Health Sciences Authority (HSA) approval of Remplir™ in Singapore, a strategic gateway to ASEAN markets. The company swiftly capitalized on this approval, securing an exclusive distribution agreement with Device Technologies Asia and recording first sales ahead of the planned Q1 2025 market launch. This early commercial success highlights the product’s appeal and the distributor’s effectiveness in engaging key surgical specialists.
US FDA Submission and Leadership Appointments
In a pivotal development, Orthocell submitted its US FDA 510(k) application for Remplir™ in December 2024, targeting clearance to enter the $1.6 billion US nerve repair market. The company anticipates FDA approval by late March or early April 2025, following the standard 90-day review period. To spearhead the US launch, Orthocell appointed John Walker, a seasoned sales executive with a track record in nerve repair device growth, and Phillip Edmondson, an award-winning medical affairs professional, signaling a well-prepared commercial strategy.
Capital Raise Fuels Growth Ambitions
Orthocell bolstered its financial position with a $17 million placement at $0.60 per share, attracting strong support from institutional and high-net-worth investors. With approximately $31 million in cash reserves at quarter-end and an expected R&D grant of over $3 million, the company is well-funded to execute its US market entry and ongoing global regulatory submissions. This financial strength provides a solid runway for scaling operations and accelerating revenue growth.
Outlook and Strategic Positioning
CEO Paul Anderson expressed optimism about Orthocell’s trajectory, emphasizing the transformative potential of the US market for Remplir™ and the company’s ambition to become a key player in the $4.5 billion global medical device sector it targets. The ongoing expansion of Striate+™ through BioHorizons in the US and Europe, alongside the growing adoption of Remplir™ in Australia, New Zealand, and Singapore, positions Orthocell for a multi-regional growth phase.
Orthocell’s proprietary collagen medical devices and advanced cellular therapies continue to underpin its innovation pipeline, with the tendon cell therapy OrthoATI™ progressing towards US FDA registration and strategic partnerships. The company’s integrated approach to tissue repair and regeneration, combined with strong commercial execution, sets a compelling growth narrative.
Bottom Line?
Orthocell’s record revenue and strategic US FDA submission set the stage for a potentially transformative 2025.
Questions in the middle?
- Will Orthocell secure US FDA clearance for Remplir™ within the anticipated timeline?
- How quickly can Orthocell scale Remplir™ sales in the US following regulatory approval?
- What are the prospects and timelines for regulatory approvals in other key international markets?
