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Medical Device Network Excellence Awards 2023: PolyNovo

PolyNovo is a global medical device company headquartered in Melbourne, Australia. The company is recognised in the Innovation, Business Expansion, and Marketing categories in the 2023 Medical Device Network Excellence Awards.

PolyNovo has developed a unique polymer technology that has marked a significant advancement in biomaterials. Previous investigations of polymer-based synthetic materials found significant challenges in patient immune responses. However, PolyNovo’s technology, NovoSorb®, features distinctive properties that provide excellent biocompatibility, a programmable bio-resorption profile, and can be produced in many formats including film, fibre, foam, and coatings.

NovoSorb patents
NovoSorb technology is protected by over 40 patents regarding its unique polymer and its manufacturing process.

NovoSorb is the recipient of 40+ patents and has led to the development and manufacture of tissue regenerative solutions previously reserved for biologically based products only.

A new class of dermal matrix

The company’s first commercial product, NovoSorb® BTM, is the world’s first fully synthetic dermal matrix featuring a bilayer design for the regeneration of the dermal tissue (a key layer of skin) when lost to trauma, surgery, or other injuries. The matrix is fully resorbable leaving behind only the patients’ newly formed tissue. The product offers a simple, yet effective technique designed to facilitate a wound bed that supports reliable wound closure within a single application.

NovoSorb BTM
NovoSorb BTM is the world’s first synthetic dermal substitute creating a whole new product class.

A synthetic dermal matrix offers significant benefits to existing technologies. It can be easily manufactured at scale and with less variance associated with tissue processing of biologically derived materials. Additionally, a synthetic does not provide any organic material that can be metabolised by bacteria, which can aid clinicians in managing the number one source of product failure, infection. Lastly, the architecture and bio-resorption profile can be designed specifically to meet the needs of its intended use.

As the first fully synthetic dermal matrix, the product has disrupted several markets in the advanced wound care space by providing a scalable and reliable solution to patients and physicians around the world. Surgeons have found it to be easy to use, economically valuable, and able to provide reliable results.

“Our results are a vindication of surgeon recognition of consistent outcomes, better patient experience along with hospital systems’ acknowledgement of lower complexity and cost associated with NovoSorb BTM”, CEO Swami Raote.

Driving towards redefining standard of care

The benefits that NovoSorb technology offers to clinical teams have sparked rapid interest from clinicians around the world. NovoSorb BTM has been clinically investigated in over 200 clinical publications with 94% of these being independent of the company. This has led to rapid adoption and a fiscal year-on-year (YoY) sales growth rate of over 58%.

Patient testimonial NovoSorb
Alan developed a flesh eating infection that required full skin excision of his neck. Image shows his physician, Dr. Wagstaff evaluating the pliability of his new skin.

The company has also received FDA Breakthrough Device Designation and research funding from the US Biomedical Advanced Research and Development Authority (BARDA) providing creditability to the potential impact of NovoSorb technology. PolyNovo is excited about an interim analysis of its ongoing pivotal study investigating NovoSorb BTM against the current leading treatments of third-degree burns, which are expected to be ready in 2024.

“I feel so lucky to have had the [NovoSorb] BTM treatment and I will be forever grateful to the staff for their faultless care and amazing work” – Lowri, Patient.

Customer-driven, patient-focused innovation

A monolayer product, NovoSorb MTX recently received FDA 510(k) clearance and launched in the US. The project was prioritised based on surgeon customer feedback to provide additional versatility and expanded portfolio offering. The launch of NovoSorb MTX marked the establishment of a synthetic regenerative medicine platform that can offer increased versatility and value in soft-tissue reconstruction space. In doing so, PolyNovo expanded its total addressable market in the US alone by an estimated $A500m ($337m approximately).

“The creation of NovoSorb MTX is an exciting example of surgeon-led product development that opens a significant new market for us. We expect clinicians to carry NovoSorb BTM and NovoSorb MTX and provide them with a richer tool kit for patient care.” Swami Raote, PolyNovo CEO.

Swami Raote
Swami Raote, CEO of PolyNovo

PolyNovo stewards a robust development programme covering soft-tissue reconstruction, breast sling, hernia, and orthopaedic applications. The company’s strategic mindset is to provide the benefits of its technology to the most patients, as rapidly as possible. The expansive opportunities NovoSorb technology offers have led the company to partner with other entities in the development of next-generation solutions.

A global reach

Global estimates result in over 150 million people around the world suffering from wounds annually, and only 11% of the world’s population has access to dermal matrices. Given the scalability of a synthetic solution, PolyNovo is focused on providing its technology globally. In 2023, the company expanded its presence in India, Hong Kong, UAE, France, Spain, and Canada and has increased its reach by supporting over 168 new hospitals.

PolyNovo has also partnered with organisations around the world to provide solutions to patients in low-access settings to improve outcomes. After treating over 30,000 patients globally, the company continues to invest in driving growth through geographical expansion, research, and development, and scaling its manufacturing, people, and infrastructure, with a view to reach the millions in need.

Company profile

PolyNovo is a fast-growing, disruptive medical device company which designs, develops, and manufactures regenerative tissue solutions using its patented biodegradable polymer technology, NovoSorb. PolyNovo products are currently distributed in 29 countries. PolyNovo is publicly traded on the Australian Stock Exchange (ASX:PNV).

Contact details

Website: https://polynovo.com/

Email: info@polynovo.com

Links

Patient Testimonials: https://polynovo.com/patient-stories/

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