PolyNovo

What PolyNovo does

PolyNovo Limited is an ASX-listed (OTC: CALZF) Australian medical device company founded in 1998 and headquartered in Port Melbourne. The company develops and commercializes a proprietary biodegradable polymer technology platform branded NovoSorb, which functions as a synthetic dermal matrix scaffold to support natural tissue regeneration in wound care. Its commercial product portfolio centers on NovoSorb BTM, a synthetic skin substitute used primarily in burn wound management, and NovoSorb MTX, a related product targeting broader wound care applications. PolyNovo is currently preparing a Pre-Market Approval (PMA) submission with BARDA support to expand NovoSorb BTM into the full-thickness burns indication in the United States.

The company generates revenue through direct, sales-led distribution of its medical devices to hospitals and healthcare facilities, primarily in the United States (75.8% of group sales in H1 FY2026, ~USD 51.7M) with a smaller but fast-growing international footprint (USD 16.5M, +28.3% YoY). H1 FY2026 group sales reached AUD 68.2 million, up 26% year-over-year, with adjusted EBITDA of AUD 4.7 million (up 82%) and operating cash flow turning positive at AUD 9 million. PolyNovo added 95 new US hospital accounts in the half, indicating active field-sales expansion. A new Port Melbourne manufacturing facility is in validation and expected to be operational by July 2026, supporting further scale.

The business model is a single-segment medical device manufacturer selling through enterprise field sales to hospitals, surgeons, wound care specialists, and procurement teams. Pricing is not publicly disclosed and is negotiated through hospital procurement. The company employs 51–100 people, operates with no identified parent, and is led by CEO Swami Raote. Near-term strategic priorities are executing the PMA for full-thickness burns, scaling US account coverage, and bringing the new manufacturing capacity online to support demand.

Name

PolyNovo

Legal name

PolyNovo Limited

Website

https://polynovo.com.au

Company type

Public

Founded year

1998

Operating status

Operating

Headcount range

51–100 employees

Short description

PolyNovo Limited is an ASX-listed Australian medical device company that develops and sells the proprietary NovoSorb biodegradable polymer synthetic skin substitutes (NovoSorb BTM and NovoSorb MTX) to hospitals and healthcare professionals for burn and wound care, primarily in the US market.

Ownership category

akta.pro rank

Product category

Wound Care Medical Devices

NAICS

Plastics Product Manufacturing (3261)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE)

akta.pro secondary industry

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG)

Keywords

• Synthetic skin substitutes
• Biodegradable polymers
• Wound care devices
• Burn treatment products
• Regenerative medical devices

Headquarters

HQ city

Port Melbourne

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Revenue generated from sales of NovoSorb synthetic skin substitute products (NovoSorb BTM, NovoSorb MTX) to hospitals and healthcare facilities. H1 FY2026 sales reached AUD 68.2 million with 26% year-over-year growth.
2. International Sales: Sales outside the US market, including rest-of-world markets, accounting for $16.5 million (28.3% growth) in H1 FY2026.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels8 records

Core offering

PolyNovo develops and manufactures synthetic skin substitutes using its proprietary NovoSorb biodegradable polymer technology platform. The company sells medical devices (NovoSorb BTM and NovoSorb MTX) to hospitals and healthcare facilities for the treatment of burns, wounds, and soft tissue reconstruction, enabling natural tissue regeneration through a synthetic dermal matrix scaffold.

Product overview

PolyNovo is a medical device company focused on synthetic skin substitutes and regenerative medicine. The company's product portfolio centers on the NovoSorb technology platform, a biodegradable polymer system that provides dermal matrix scaffolds for wound care. The primary commercial products built on this platform are NovoSorb BTM and NovoSorb MTX, both synthetic skin substitutes designed for different clinical wound care applications. NovoSorb BTM is targeted toward burns treatment, while NovoSorb MTX addresses broader wound care needs. The company is also pursuing regulatory approval (PMA submission) for NovoSorb BTM in full-thickness burns in partnership with BARDA.

Differentiator

Problem solved

Functional benefit

Brands

• NovoSorb: Proprietary synthetic skin substitute technology platform used in NovoSorb BTM and NovoSorb MTX products for wound care and burn treatment applications.
• NovoSorb BTM
• NovoSorb MTX

Products and services

• NovoSorb BTM

Quantifiable outcome

• 26% year-over-year revenue growth in H1 FY2026
• +2 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• BARDA (Biomedical Advanced Research and Development Authority)coreStrategic or Co-development Partner · 20 February 2026BARDA partnership for Pre-Market Approval (PMA) submission for NovoSorb BTM in full-thickness burns indication. BARDA (Biomedical Advanced Research and Development Authority) is providing support for the regulatory submission process, which is targeted for completion by financial year-end. This partnership represents significant strategic value for market expansion into acute burn care in the United States.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• AlloSource: AlloSource is a non-profit tissue processor that provides allograft skin substitutes (e.g., AlloSkin) for burn and wound care—directly competing with PolyNovo in the hospital skin substitute procurement market, particularly for severe burn indications.
• MiMedx Group: MiMedx markets dehydrated amniotic membrane allografts (EpiFix, AmnioFix) used in chronic wound care and surgical applications—competing with PolyNovo in wound care clinics and overlapping with MTX use cases in soft tissue and chronic wound management.
• Vericel Corporation: Vericel develops autologous cell-based therapies for severe burns (e.g., Epicel) and other complex wounds—operating in the same high-acuity burn care segment as PolyNovo's NovoSorb BTM and competing for similar burn center formularies.

Broad incumbents

• Coloplast: Coloplast operates a broad wound and skin care portfolio serving hospitals and specialty clinics globally, making it a competing incumbent in the same end-customer segments that PolyNovo targets with NovoSorb BTM and MTX.
• Smith+Nephew: Smith+Nephew is a global medical device incumbent with a substantial advanced wound management portfolio including skin substitutes and burn care products, competing with PolyNovo across hospitals and wound care specialists in the same end markets.
• Mölnlycke Health Care: Mölnlycke is a global wound care and surgical solutions incumbent with advanced dressings and skin substitute offerings, serving the same hospital burn and wound care customers as PolyNovo with a broader portfolio.
• ConvaTec: ConvaTec is a global medical products company with an advanced wound care franchise (e.g., AQUACEL, InnovaMatrix) that overlaps with PolyNovo's hospital-based wound and burn care end markets and procurement channels.
• 3M Health Care (Solventum/KCI): 3M's health care business (now Solventum) includes negative pressure wound therapy and advanced wound care products widely used in burn and surgical wound management—serving the same hospital procurement channels as PolyNovo.

Direct peers

• Organogenesis Holdings: Organogenesis is a direct competitor with leading skin substitute products (Apligraf, Dermagraft, PuraPly) used in chronic wound care and burn treatment—overlapping with PolyNovo's NovoSorb MTX and BTM indications across hospitals and wound clinics.
• Integra LifeSciences: Integra LifeSciences is a direct competitor in the skin substitute and regenerative tissue space, most notably with Integra Dermal Regeneration Template, a leading dermal matrix used for burn and wound treatment—directly overlapping with PolyNovo's NovoSorb BTM.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/polynovoltd
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• Facebookfacebook.com/PolyNovo
• LinkedInlinkedin.com/company/polynovo-biomaterials-pty-ltd-

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 PolyNovo