Orthocell

What Orthocell does

Orthocell Ltd is an Australian regenerative medicine company headquartered in Perth, Western Australia, founded in 2006 and listed on the ASX under ticker OCC. The company develops and manufactures collagen-based medical devices and autologous cell therapies for tissue repair, organized around its proprietary CelGro collagen platform. Its commercial portfolio includes Remplir (an FDA-cleared collagen nerve repair device for peripheral nerve injuries), Striate+ (a dental bone and tissue regeneration membrane distributed globally by BioHorizons), Ortho-ATI (an autologous tenocyte implantation cell therapy for chronic tendon injuries), OrthoACI (cartilage repair for knee defects), and the pipeline product SmrtGraft (tendon repair). The company has also secured exclusive first right of refusal over global distribution rights for PearlBone, a pearl shell-derived bone substitute developed with Marine Biomedical.

Orthocell manufactures its products at a vertically integrated Perth facility with annual capacity of approximately 100,000 units, supported by research partnerships with the University of Western Australia and the Perron Institute. Revenue is generated through one-time sale of surgical devices to hospitals and specialists, with a hybrid go-to-market combining direct sales for US DoD/VA and major accounts, plus exclusive in-country distributor partnerships internationally (Device Technologies Asia for Australia/NZ/Singapore, MontsMed for Hong Kong, BioHorizons globally for dental products, and specialist nerve distributors in Canada and the US). Uniphar manages US warehousing and logistics. The customer base spans orthopaedic and trauma surgeons, plastic and reconstructive surgeons, urologists (nerve-sparing prostatectomy), dental surgeons and periodontists, sports medicine specialists, and military medical facilities.

In FY2025, Orthocell recorded A$9.19 million in revenue, up 35.8% year-over-year, marking its seventh consecutive quarter of record revenue. The company holds regulatory approvals across eight jurisdictions including the US (FDA 510(k) clearance April 2025), Canada, Thailand, Hong Kong, Singapore, Australia, and New Zealand, with EU and UK CE/UKCA approval pending. Remplir clinical evidence shows an 89.7% real-world treatment success rate across 66 patients and 78 procedures, while Striate+ shows a 98.6% post-market success rate. The company maintains a strong balance sheet with approximately A$27-33 million in cash, no debt, and has raised approximately A$47 million in capital since October 2024 to fund global commercial expansion.

Name

Orthocell

Legal name

Orthocell Ltd

Website

https://orthocell.com

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Orthocell is an Australian regenerative medicine company that develops and manufactures collagen-based medical devices and autologous cell therapies, commercializing the FDA-cleared Remplir nerve repair device, Striate+ dental membrane, and Ortho-ATI tendon cell therapy across orthopaedic, reconstructive, urological, dental, and military surgical markets globally.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841), Dental Equipment & Supplies (3843)

akta.pro primary industry

Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)

akta.pro secondary industry

Bone Graft Substitutes & Orthobiologics (Synthetic/Allograft/DBM) (HLAHAEAG)

Keywords

• Regenerative medicine
• Nerve repair devices
• Collagen medical devices
• Cell therapy products
• Dental bone regeneration

Headquarters

HQ city

Melville

HQ country

Australia

HQ region

Oceania

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Remplir™ Nerve Repair Device Sales: One-time surgical device used during nerve repair procedures. Revenue from direct hospital sales, VA/DoD networks, and through distributor networks in US, Canada, Hong Kong, Singapore, Thailand, Australia. First US sales revenue recorded July 2025.
2. Striate+™ Dental Membrane Sales: Collagen membrane for dental bone regeneration. Distributed globally through BioHorizons partnership. Market-leading product with 98.6% clinical success rate.
3. Ortho-ATI™ Cell Therapy: Autologous cell therapy for chronic tendon injuries. Available in Australia, US and Europe.

Pricing tiers

Go-to-market motion2 records

Distribution channels6 records

Marketing channels7 records

Core offering

Orthocell develops, manufactures, and commercializes regenerative medicine products including FDA-cleared collagen-based medical devices and autologous cell therapies for nerve repair, dental bone regeneration, tendon injury, and cartilage repair. The company's flagship products are Remplir™ (collagen nerve repair device), Striate+™ (dental collagen membrane), and Ortho-ATI™ (autologous cell therapy for chronic tendon injuries). Manufacturing is conducted at a vertically integrated facility in Perth, Australia, with global distribution through specialist distributor networks and direct hospital sales.

Product overview

Orthocell is a regenerative medicine company developing world-leading medical technologies for bone, nerve, and soft tissue repair. The company's product portfolio consists of collagen-based medical devices and cell therapies, including: Remplir™ (FDA-cleared nerve repair device for peripheral nerve injuries), Striate+™ (collagen membrane for dental bone and tissue regeneration), Ortho-ATI™ (Autologous Tenocyte Implantation for chronic tendon injuries), OrthoACI™ (cartilage repair therapy for knee defects), and pipeline products including SmrtGraft™ (tendon repair) and PearlBone™ (bone regeneration via Marine Biomedical partnership). The company manufactures its products in Perth, Australia, with global distribution partnerships for international market expansion.

Differentiator

Problem solved

Functional benefit

Brands

• Remplir™: FDA-cleared collagen nerve repair device for peripheral nerve repair
• Striate+™
• Ortho-ATI™
• OrthoACI™
• SmrtGraft™
• PearlBone™

Products and services

• Remplir™ FDA-cleared collagen nerve repair device designed to support surgical repair and guide the body's natural healing processes for peripheral nerve injuries. Demonstrates 89.7% treatment success rate in real-world studies. Used by orthopaedic, trauma, plastic and reconstructive surgeons, as well as urologists for nerve-sparing prostate surgery.
• Striate+™ Collagen membrane for dental bone and tissue regeneration, used in guided bone and tissue repair procedures. Achieved 98.6% success rate in post-market clinical study. Distributed globally by BioHorizons.
• Ortho-ATI™

Quantifiable outcome

• 89.7% treatment success rate for Remplir nerve repair (66 patients, 78 procedures)
• +5 more outcomes

Named customers4 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Ten partnerships are on record, tiered core, strategic, minor and humanitarian.

• Ontario-based Canadian DistributorcoreChannel Partner/ Reseller/ Distributor · 5 November 2025Second Canadian distributor for Remplir covering Saskatchewan, Manitoba, Ontario, Quebec, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland. Completes national coverage across US$75 million Canadian market.
• MontsMedcoreChannel Partner/ Reseller/ Distributor · 29 October 2025Exclusive in-country distributor for Remplir in Hong Kong. Medical device distributor strengthening Orthocell's presence in Asia. Strategic gateway to Greater Bay Area (~100 million population).
• Marine BiomedicalstrategicStrategic or Co-development Partner · 20 October 2025Strategic partnership for PearlBone bone regeneration technology. Orthocell increased equity stake from 1.7% to 11.7% for AU$1 million, securing exclusive first right of refusal over global distribution rights. PearlBone targeting US$1.6 billion bone substitute market with FDA 510(k) submission expected Q1 2026.
• Global Nerve FoundationminorStrategic or Co-development Partner · 20 June 2025International nerve surgery education and collaboration. Co-sponsored 2026 Nerve Symposium alongside Device Technologies. Faculty included Dr Dominic Power (UK) and Dr Harry Hoyen (US).
• UnipharcoreImplementation/ SI/ Consulting Partner · 1 June 2025US logistics provider handling warehousing, order processing and shipment for Remplir in the United States market. 4,000 Remplir units shipped to Uniphar for US surgical procedures.
• University of Western AustraliastrategicStrategic or Co-development Partner · 1 June 2025Research collaboration on Remplir nerve repair technology. Co-sponsored suturing study demonstrating Remplir superiority over standard suture techniques. Professor Minghao Zheng affiliated researcher.
• Perron InstitutestrategicStrategic or Co-development Partner · 1 June 2025Neurological and Translational Science institute collaboration. Research partnership for nerve repair technology development and clinical evidence.
• Ukraine Crisis AppealhumanitarianGTM or Marketing Partner · 1 April 2025Humanitarian partnership supporting war victims. Pledged AUD $10K to support Remplir nerve repair device distribution to Ukraine. 200 devices donated/purchased for injured soldiers and civilians.
• Device Technologies Asia (DVT)coreChannel Partner/ Reseller/ Distributor · 1 October 2024Exclusive distribution partner for Remplir in Australia, New Zealand, and Singapore. DVT Asia has established relationships with leading plastic reconstructive and orthopaedic surgeons at high quality surgical centres. Singapore first sales achieved December 2024.
• BioHorizonscoreChannel Partner/ Reseller/ Distributor · 1 January 2024Exclusive global distribution partner for Striate+ dental bone and tissue regeneration products. Achieved rapid market expansion to Canada (2024) and Brazil (2025). Comprehensive marketing and medical education program driving strong sales traction.

Scale indicators19 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Axogen: US-listed market leader in peripheral nerve repair (Avance nerve graft, Axoguard, Acroval). Most direct competitor to Orthocell's Remplir in the same surgical nerve repair category and customer base of peripheral nerve surgeons.
• Geistlich Pharma: Swiss-headquartered leader in dental bone regeneration (Bio-Oss, Bio-Gide collagen membranes). Most direct global peer to Striate+ in the dental guided bone/tissue regeneration category.

Broad incumbents

• Integra LifeSciences: Large diversified medical device company with a peripheral nerve repair portfolio (NeuraGen, NeuraWrap) plus regenerative tissue technologies (Integra dermal matrix, DuraGen). Comparable across nerve repair and broader regenerative medicine categories.
• Organogenesis: US-listed regenerative medicine company (Apligraf, Dermagraft, PuraPly) focused on wound care and surgical biologics. Comparable as a publicly traded regenerative medicine commercial-stage company with similar surgeon/hospital GTM and biologics manufacturing model.
• Vericel: US-listed commercial-stage regenerative medicine company (MACI cartilage repair, Epicel). Comparable as a small-cap public regenerative medicine company with a cartilage repair product (OrthoACI) overlapping Orthocell's portfolio.
• Stryker: Global medical device incumbent with orthopaedic, trauma, and surgical product portfolios. Comparable as a broad incumbent whose orthopaedic trauma and extremities fixation products overlap with Orthocell's peripheral nerve repair surgeon customers.
• Coloplast: Global medical device company with restorative therapies and surgical wound care products that address peripheral nerve and reconstructive surgery customers, providing a broad-incumbent comparison to Orthocell's nerve and regenerative surgery portfolio.

Emerging players

• Checkpointsurgical: US-based nerve repair and intraoperative nerve stimulation company. Comparable in targeting peripheral nerve surgeons and competing in select nerve repair indications alongside Orthocell's Remplir.

Others

• BioHorizons (Henry Schein): Orthocell's exclusive global distribution partner for Striate+. A major dental implant and regenerative company within Henry Schein; relevant as the channel through which Striate+ competes against dental bone regeneration peers.

Regional players

• Mesoblast: ASX-listed Australian regenerative medicine company developing cell-based therapies (remestemcel-L, rexlemestrocel-L). Comparable as a fellow Australian listed regenerative medicine peer operating globally with cell therapy technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/results?search_query=orthocell
• LinkedInlinkedin.com/company/orthocell-ltd
• Xx.com/OrthocellLtd
• Facebookfacebook.com/Orthocell

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds2 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Orthocell