Orthocell
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.
- Company typePublic
- Founded2006
- HeadquartersMelville, Australia
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Orthocell firmographics
Firmographics- 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
Orthocell industry classification
Industry- 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
Where Orthocell is headquartered
LocationHeadquarters
- HQ city
- Melville
- HQ country
- Australia
- HQ region
- Oceania
Offices3 records
Markets served
Orthocell business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- 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.
- Striate+™ Dental Membrane Sales: Collagen membrane for dental bone regeneration. Distributed globally through BioHorizons partnership. Market-leading product with 98.6% clinical success rate.
- Ortho-ATI™ Cell Therapy: Autologous cell therapy for chronic tendon injuries. Available in Australia, US and Europe.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Humanitarian pricing for Ukraine aid |
Go-to-market motion2 records
Distribution channels6 records
Marketing channels7 records
Orthocell product offering
Product offeringCore 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
Companies that use Orthocell
Customer profileNamed customers4 records
Segments6 records
Ideal customer profiles5 records
Orthocell technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Orthocell partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core, strategic, minor and humanitarian.
- Ontario-based Canadian DistributorcoreSecond 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.
- MontsMedcoreExclusive 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 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 FoundationminorInternational nerve surgery education and collaboration. Co-sponsored 2026 Nerve Symposium alongside Device Technologies. Faculty included Dr Dominic Power (UK) and Dr Harry Hoyen (US).
- UnipharcoreUS 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 AustraliastrategicResearch collaboration on Remplir nerve repair technology. Co-sponsored suturing study demonstrating Remplir superiority over standard suture techniques. Professor Minghao Zheng affiliated researcher.
- Perron InstitutestrategicNeurological and Translational Science institute collaboration. Research partnership for nerve repair technology development and clinical evidence.
- Ukraine Crisis AppealhumanitarianHumanitarian 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)coreExclusive 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.
- BioHorizonscoreExclusive 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
Orthocell competitors and assessment
Company assessmentDirect 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
Orthocell social profiles
Digital presenceOrthocell compliance and trust
Trust signalCompliance10 records
Orthocell financial estimates
Financial estimateRevenue estimate
Valuation estimate
Orthocell leadership team
Management profileNumber of profiles
Profiles9 records
Orthocell subsidiaries and ownership
Company hierarchySubsidiaries1 record
Orthocell funding detail
Funding detailFunding overview
Funding rounds2 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Orthocell M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Orthocell
What does Orthocell do?
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.
Is Orthocell a public or private company?
Orthocell is a public company. It is classified as public and is currently operating.
When was Orthocell founded?
Orthocell was founded in 2006. It employs 11 to 50 people.
Where is Orthocell based?
Orthocell is headquartered in Melville, Australia, in the Oceania region.
How does Orthocell make money?
Three revenue lines are on record. Remplir™ Nerve Repair Device Sales are the primary driver. The others are striate+™ Dental Membrane Sales and ortho-ATI™ Cell Therapy.
Who are Orthocell's main competitors?
Direct peers on record are Axogen and Geistlich Pharma. Broad incumbents are Integra LifeSciences, Organogenesis, Vericel, Stryker and Coloplast. Checkpointsurgical is listed as an emerging player. BioHorizons (Henry Schein) is listed as an others. Mesoblast is listed as a regional player.
Does Orthocell have an API?
No public API is recorded for Orthocell.
What industry is Orthocell in?
Orthocell's product category is Regenerative Medicine Medical Devices. Its primary akta.pro industry code is HLAAAGAH, Cartilage, Bone & Musculoskeletal Regeneration, with a secondary code of HLAHAEAG, Bone Graft Substitutes & Orthobiologics (Synthetic/Allograft/DBM). Its NAICS code is 339113 and its SIC code is 3842.