Key Highlights

  • Orthocell (ASX:OCC) shares were down 12.50% at $0.525 during the Trading session on 22 October 2026.
  • September quarter Revenue was $3.6 million, up 19% on the previous corresponding quarter and down 7% on the June quarter.
  • Funds available were $39.0 million at 30 September 2026, with operating cash outflow of $4.5 million for the quarter.

Orthocell Limited (ASX:OCC) shares fell 12.50% to $0.525 during the trading session on 22 October 2026, while the S&P/ASX 200 stood at 8,792.20, down 0.44%, and the All Ordinaries stood at 8,916.20, down 0.45%. Orthocell is a Perth-based regenerative medicine company that develops collagen medical devices and cell therapies for bone and soft tissue repair. On the same day, the company released its Quarterly Report for the quarter ended 30 September 2026, which showed revenue of $3.6 million and funds available of $39.0 million.

About the Company

Orthocell Limited is an ASX-listed regenerative medicine company with its registered office at Building 191, Murdoch University, 90 South Street, Murdoch, Western Australia. The company describes its focus as regenerating mobility for patients through products that repair a variety of bone and soft tissue injuries.

Business Overview

Orthocell's portfolio centres on a platform of collagen medical devices that support tissue reconstruction and healing in dental and orthopaedic applications. Striate+ was the first product approved for dental guided bone regeneration and is cleared in the United States, Australia, New Zealand, Singapore, the United Kingdom, Europe, Canada and Brazil.

Remplir, used for peripheral nerve reconstruction, is the company's flagship nerve repair product. It has clearance in the United States and approvals in Australia, New Zealand, Singapore, Thailand, Canada and Hong Kong. SmrtGraft, for tendon repair, is available in Australia under the Special Access Scheme, and the company also develops autologous cell therapies for tendon and cartilage tissue.

September Quarter Revenue and Remplir Sales

In its quarterly report dated 22 October 2026, Orthocell reported total revenue of $3.6 million for the September quarter, compared with $3.8 million in the June quarter. Revenue was up 19% on the previous corresponding quarter and down 7% on the June quarter.

U.S. Remplir unit sales rose 25% to 149 units from 119 in the previous quarter, contributing to 20% growth in global Remplir revenue. U.S. Remplir revenue reached $0.40 million, and global Remplir revenue now accounts for more than 40% of total quarterly revenue. The distributor network covers approximately 70% of the U.S. population.

Seventy-nine hospitals were purchasing Remplir, up 13% during the quarter, and 93 surgeons were using the product, up 22%. Value Analysis Committee approvals increased 25% to 55, with a further 59 applications in progress.

Cash Position and Clinical Experience in Prostate Surgery

The 22 October 2026 report showed funds available of $39.0 million at 30 September 2026, made up of $5.2 million in cash and cash equivalents and $33.8 million in securities and term deposits with maturities of three to 12 months. Net cash used in Operating Activities was $4.5 million, or $3.9 million after adjusting for $0.6 million of non-recurring expenditure.

The Appendix 4C estimated 1.2 quarters of funding based on cash and cash equivalents alone. Management stated that the term deposits, classified as investments, are cancellable and mature through 2026 and 2027, and that the $39 million in reserves equates to eight quarters of operational funding.

Orthocell also reported that Remplir has been used in more than 300 Australian prostatectomy procedures. In five patients with advanced prostate cancer undergoing robotic-assisted radical prostatectomy, 80% showed encouraging urinary continence outcomes and 75% of those with erectile function before surgery showed a return of function.

Related Sector Context

Regenerative medicine and medical device companies develop products that repair or replace damaged tissue, and their progress often depends on regulatory clearances, hospital purchasing processes and surgeon adoption.

During the trading session on 22 October 2026, the S&P/ASX 200 was down 0.44% and the All Ordinaries was down 0.45%, so the broader market was lower as Orthocell's shares declined by a larger margin.

Risks to Weigh In

The quarterly report shows total revenue below the June quarter, and the company attributes this to the timing of Striate+ revenue recognition. Operating cash outflow rose to $4.5 million from $3.6 million.

Regulatory approval in the United Kingdom and European Union is expected by the end of calendar 2026 but remains pending. The planned prospective clinical trial in prostatectomy has not yet been run, and the early findings come from five patients. Most funds are held in term deposits rather than cash.

Catalysts on Watch

The company states that regulatory approval for Remplir in the United Kingdom and European Union is expected by the end of calendar 2026, with market access preparation under way alongside UK distributor LEDA Orthopaedics.

Other items include the planned prospective clinical trial of Remplir in robotic-assisted radical prostatectomy, the 59 Value Analysis Committee applications still in progress and the anticipated decline in quarterly cash outflow.

Putting It Together

Orthocell shares were down 12.50% at $0.525 during the 22 October 2026 session as the quarterly report reached the market. The report set out revenue of $3.6 million, rising Remplir adoption in the United States and funds available of $39.0 million, alongside a lower quarter-on-quarter revenue figure and higher operating cash outflow.