PBC BioMed

What PBC BioMed does

PBC BioMed is a privately-held Irish medical device company founded in 2010 and headquartered in Shannon, Co. Clare. The company operates as a multi-affiliate MedTech group that develops proprietary biomimetic medical devices and delivers end-to-end services — including innovation acceleration, regulatory and quality consultancy, and ISO 13485:2016-certified contract manufacturing — to MedTech clients globally. Its affiliate structure spans Biomimetic Innovations (human bone adhesive), PBC BioVet (veterinary biomaterials), PBC Dermal Care (skin barrier products), and PBC BioHub (innovation accelerator), with operational offices in Ireland, the United States (Memphis), France (Chamonix), the United Kingdom (London), and Australia (Kangaroo Valley).

The company's product portfolio is built on a proprietary biomimetic platform combining calcium phosphate, calcium silicate, and phosphoserine, which provides nanoscale adhesive bonding to bone and metal. OsStic is an injectable, self-hardening synthetic bone void filler that received FDA Breakthrough Device Designation in January 2024 and MHRA approval for first-in-human clinical study in March 2026; OssiVet is the veterinary counterpart of the same chemistry. ReFeel is a bio-absorbable alginate and PGA xerogel sheet for peripheral nerve regeneration. Copper Hawk (veterinary) and Hania (human) round out the dermal care line. The company also acts as Marketing Authorization Holder for Nelsons consumer health products (Arnicare Arnica Cream, Teetha Teething Granules, Teetha Teething Gel).

PBC BioMed monetizes through five channels: (1) sales of its own proprietary devices, (2) contract manufacturing and lyophilisation services for external clients, (3) strategic regulatory, quality, and clinical consultancy engagements, (4) licensing royalties from exclusive distribution agreements such as the Sanara MedTech US license for OsStic, and (5) distribution margins from acting as US importer for Mochida Pharmaceutical's ReFeel and as MAH for Nelsons products. Commercial reach is delivered via direct field sales, exclusive licensee partners (Sanara MedTech), and regional affiliate distributors (PBC BioVet in the EU, PBC Biomed Inc. in the US, and the new Australian office in APAC), targeting orthopaedic and trauma surgeons, peripheral nerve surgeons, veterinary surgeons, and MedTech companies seeking commercialization support.

Name

PBC BioMed

Legal name

PBC Biomed Ltd.

Website

https://pbcbiomed.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

PBC BioMed is a privately-held Irish medical device company that develops proprietary biomimetic bone adhesives, nerve repair xerogels, and dermal care products, while providing contract manufacturing and regulatory consultancy services to MedTech clients across human and veterinary markets.

Ownership category

akta.pro rank

Product category

Orthopaedic and Biomaterial Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391), Scientific Research and Development Services (5417)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Medical Affairs, Scientific Communications & HEOR FSP (HLAGAOAG)

Keywords

• Orthopaedic medical devices
• Biomimetic bone adhesives
• Peripheral nerve repair
• Medical device manufacturing
• Medtech consultancy services

Headquarters

HQ city

Shannon

HQ country

Ireland

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical device product sales: PBC Biomed generates revenue through the sale of its own proprietary medical device products including OsStic (human orthopaedics), OssiVet (veterinary orthopaedics), ReFeel (nerve repair), Copper Hawk (veterinary dermal), and Hania (human skincare). These are sold directly or through distribution and licensing partners.
2. Contract manufacturing services: PBC Biomed operates as an ISO 13485:2016 certified contract manufacturing partner, offering end-to-end manufacturing services specialising in biomaterials, lyophilisation, and complex medical device assembly for external clients.
3. Strategic consultancy services: PBC Biomed provides strategic regulatory, quality, and clinical consultancy services for medical device companies to promote compliance and accelerate commercialisation. Revenue is generated through consulting engagements with global MedTech clients.
4. Licensing and distribution royalties: Through its affiliate Biomimetic Innovations, PBC Biomed earns licensing revenue from exclusive distribution agreements such as the US license with Sanara MedTech for OsStic. Additionally, PBC Biomed serves as US market distributor for ReFeel (importer/distributor role for Mochida), generating margin on product distribution.
5. Marketing authorization holder services: PBC Biomed acts as Marketing Authorization Holder for Nelsons products (Arnicare Arnica Cream, Teetha Teething Granules, Teetha Teething Gel), which generates revenue through this regulatory and distribution relationship.

Go-to-market motion2 records

Distribution channels6 records

Marketing channels5 records

Core offering

PBC BioMed develops, manufactures, and commercialises proprietary biomimetic medical devices for human orthopaedics (OsStic injectable bone void filler), veterinary orthopaedics (OssiVet bone adhesive), peripheral nerve repair (ReFeel bio-absorbable xerogel sheet), and dermal care (Copper Hawk veterinary barrier, Hania human skincare). The company also provides ISO 13485:2016 contract manufacturing and strategic regulatory, quality, and clinical consultancy services to MedTech clients through its proprietary AIM innovation framework.

Product overview

PBC BioMed operates as a medical device company with a portfolio of proprietary products and affiliate companies. The core product portfolio includes ReFeel (nerve repair solution), OsStic™ (synthetic bone void filler for human use), OssiVet® (veterinary bone adhesive), Copper Hawk (animal skin barrier), and Hania (human skin protectant). The company also operates specialized divisions including PBC Dermal Care (stabilisation-first dermal technology) and PBC BioHub (accelerator program). Affiliate companies include Biomimetic Innovations (focused on OsStic™ commercialization) and PBC Biovet (veterinary biomaterials). The company provides services in innovation, consultancy, and manufacturing for medical devices.

Differentiator

Problem solved

Functional benefit

Brands

• ReFeel: Bio-absorbable xerogel sheet for peripheral nerve protection and reconstruction, using proprietary alginate and PGA formula.
• OsStic
• OssiVet
• Copper Hawk
• Hania

Products and services

• OsStic Injectable synthetic bone void filler using a proprietary biomimetic formula of calcium phosphate, calcium silicate, and phosphoserine; bonds adhesively at the nanoscale to bone and metal and remodels into natural bone over time as an osteoconductive scaffold. Targeted at orthopaedic and trauma surgeons performing peri-articular fracture fixation in hospitals and surgical centres.
• OssiVet Self-setting calcium phosphate-based bioadhesive bone substitute enhanced with phosphoserine for veterinary use; provides nanoscale adhesive bonding to bone fragments, is osteoconductive, and remodels into new bone with a setting time of 8-10 minutes. Available in low viscosity paste or putty formats for veterinary surgeons treating equine, companion, and agri-health animals.
• ReFeel Nerve Repair Solution Bio-absorbable xerogel sheet using a proprietary biocompatible alginate and PGA (polyglycolic acid) formula to create a bridge for peripheral nerve regeneration; customisable for anatomies challenging to address with preformed conduits or wraps, particularly near joints. Distributed by PBC Biomed Inc. in the US market as importer and market distributor under partnership with Mochida Pharmaceutical.
• Copper Hawk Professional animal skin barrier ointment using a pharmaceutical-grade petroleum base combined with a proprietary blend of herbal extracts; in-vitro studies demonstrate superior anti-inflammatory efficacy versus dexamethasone and immune boosting phagocytic activity. Targeted at veterinary professionals for equine, companion, and agri-health dermal care during early-stage injury, irritation, or environmental damage.
• Hania Irish everyday human skin stabilisation product using controlled barrier systems with botanical actives to protect, calm, and preserve tissue condition. Targeted at consumers for everyday skin management using nature and science.
• Innovation Services (AIM Framework) Innovation acceleration services using PBC BioMed's proprietary AIM framework to bridge the gap between clinical concepts and commercial reality for medical device companies. Targeted at MedTech clients seeking end-to-end innovation support from concept through commercialisation.
• Strategic Regulatory, Quality, and Clinical Consultancy Strategic regulatory, quality, and clinical consultancy services for medical device companies to promote compliance and accelerate commercialisation in today's fast-changing medical marketplace. Targeted at MedTech clients requiring expert regulatory and clinical guidance.
• ISO 13485:2016 Contract Manufacturing Fully certified end-to-end ISO 13485:2016 contract manufacturing services specialising in biomaterials, lyophilisation, and complex medical device assembly for external MedTech clients. Targeted at medical device companies requiring certified contract manufacturing capabilities.

Quantifiable outcome

• OsStic received FDA Breakthrough Device Designation (January 2024), a significant regulatory milestone that qualifies the device for prioritised review and expedited development.
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and supporting.

• Leeds University Teaching Hospital (NHS Trust)coreStrategic or Co-development Partner · 2 March 2026Leeds University Teaching Hospital in the UK serves as the clinical trial site for the first-in-human MHRA-approved study of OsStic injectable synthetic bone void filler in tibial plateau fracture fixation. Professor Peter Giannoudis serves as Principal Investigator. The study marks a significant clinical milestone for the biomaterial.
• Colorado State University Translational Medicine InstitutesupportingStrategic or Co-development Partner · 1 January 2025PBC Biomed partnered with the C. Wayne Mcilwraith Translational Medicine Institute at Colorado State University to advance veterinary orthopaedic research. Chief Medical Officer Dr Russell, R&D Director Paul Dorrell, and R&D Engineer Antzela Tzagiollari visited the Institute to kick off the partnership focused on bringing innovative veterinary medical devices to market.
• Mochida Pharmaceutical Co., Ltd.coreStrategic or Co-development PartnerPBC Biomed has partnered with Mochida Pharmaceutical for over four years to develop and commercialise ReFeel Nerve Repair Solution. PBC Biomed serves as strategic design and development partner as well as US market distributor for ReFeel. The partnership has expanded to cover trauma, tendon & ligament, and cavernous nerve projects, with Mochida positioning biomaterials as a key growth pillar.
• Sanara MedTech Inc.coreOEM/ Whitelabel/ Licensing PartnerBiomimetic Innovations Ltd (PBC Biomed affiliate) entered into an exclusive license and distribution agreement with Sanara MedTech Inc for OsStic synthetic injectable bone void filler in the United States. Sanara holds exclusive rights to commercialise OsStic in the US market.
• STERISTechnology or IntegrationPBC Biomed has partnered with STERIS for over a decade for product sterilisation services. The partnership involves STERIS's sterilisation facility in Tullamore, Ireland, as a critical stage of PBC Biomed's supply chain and product lifecycle management.
• GP Bio LtdcoreStrategic or Co-development PartnerBiomimetic Innovations Ltd was founded following a decade-long collaboration between GP Bio Ltd and PBC Biomed Ltd, combining deep expertise in biomaterials and bone repair. This collaboration led to the development of the OsStic biomimetic bone adhesive technology.
• NelsonssupportingChannel Partner/ Reseller/ DistributorPBC Biomed is the Marketing Authorization Holder for Nelsons products including Arnicare Arnica Cream, Teetha Teething Granules, and Teetha Teething Gel. This relationship allows PBC Biomed to leverage its regulatory and market access expertise to commercialise consumer health products.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Sanara MedTech: Sanara MedTech is PBC BioMed's exclusive US licensee for OsStic and operates in adjacent orthopaedic and wound care segments, making it both a partner and a closely aligned commercial peer in US orthopaedic biologics distribution.
• BoneSupport: BoneSupport is a Swedish orthobiologics company that develops injectable bone substitute products (Cerament) for fracture and bone infection indications, directly competing with OsStic in the synthetic bone void filler category.
• Cerapedics: Cerapedics commercializes i-FACTOR peptide-enhanced bone graft for cervical spine and orthopaedic applications, making it a direct competitor in the synthetic bone graft substitute market where OsStic is positioned.

Broad incumbents

• Integra LifeSciences: Integra LifeSciences is a broad medical device incumbent with significant orthopaedic, neurosurgical, and regenerative tissue portfolios, including nerve repair products (NeuraGen, NeuraWrap) directly comparable to PBC's ReFeel offering.
• Stryker: Stryker is a global orthopaedic and medical device incumbent with extensive trauma, extremities, and biologics portfolios, representing the largest commercial competitor that OsStic would face upon launch.
• Zimmer Biomet: Zimmer Biomet is a major orthopaedic device incumbent whose trauma, sports medicine, and biologics portfolios overlap directly with the orthopaedic indications PBC targets with OsStic and OssiVet.

Emerging players

• CollPlant Biotechnologies: CollPlant is an emerging regenerative medicine company developing recombinant human collagen-based and bioengineered products for orthopaedic and tissue repair applications, sharing PBC's biomaterial-based approach to musculoskeletal indications.
• Locate Bio: Locate Bio is an emerging UK orthobiologics company developing bone graft substitutes and tissue engineering products, representing a directly comparable peer in the European bone substitute innovation landscape.
• Carmell Therapeutics: Carmell Therapeutics is an emerging regenerative medicine company developing plasma-based bioactive materials for bone and cartilage healing, representing a peer in the novel orthobiologics category where PBC's biomimetic adhesive technology is positioned.

Others

• DSM Biomedical (dsm-firmenich): DSM Biomedical supplies biomaterials (including collagen and bioresorbable polymers) used in orthopaedic and tissue engineering applications, serving as both a potential supplier and an enabling peer for companies like PBC operating in the biomaterials space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/pbc-biomed

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries4 records

Funding overview

Funding rounds

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 PBC BioMed