Improving quality of life through biomechanics, surgery and industry collaboration

4 minute read

jaw xray

Melbourne-based start-up MAXONIQ has developed a break-through, 3D-printed jaw for debilitating end-stage bone and joint conditions, improving the lives of patients worldwide. Underpinned by this flagship device, the company has a growing suite of bespoke implants for maxillofacial conditions and is advancing the future of personalised surgeries.

Key points

  • The Temporomandibular Joint (TMJ) Prosthetic total joint replacement system is a highly bespoke, 3D-printed device providing a total solution for treating painful end-stage bone and joint conditions
  • The ‘ArthroJaw’ is a close collaboration between MAXONIQ, the University of Melbourne and industry partners
  • MAXONIQ was established to commercialise the device and is now an award-winning company advancing the field of customised surgeries
  • Over 260 ArthroJaws have been implanted in patients, transforming their quality of life
  • Prior to the ArthroJaw, the most accessible option for patients needing a new TMJ was an off-the-shelf implant, which comes in limited sizing and can cause pain and nerve damage.

The outcome

A highly personalised, 3D-printed titanium jaw joint  has been implanted in over 260 patients to treat a range of conditions, including osteoarthritis, bone tumour resection, trauma and congenital abnormalities. It is providing restored, pain-free function and greater quality of life, with many more people set to benefit. MAXONIQ is currently working on FDA (US) and MDR (Europe) approvals for the TMJ Arthrojaw, which should allow exporting from 2023.

This first-of-its-kind device was created through a collaboration between Australian-owned MAXONIQ, the University of Melbourne and industry partners. It brings together biomechanics research, surgical expertise, and cutting-edge 3D-printing technology to provide a safe, efficient and cost-effective solution for complex conditions of the jaw, which may not be treatable otherwise.

The ArthroJaw is also advancing the field of personalised surgeries. Established for the device, MAXONIQ, now has a growing portfolio of world-class custom oral and facial implants for other conditions, with 10 trademarks and over 25 patents and patents pending. Its goal is to be the world leader in custom-made surgical products and devices that will revolutionise oral and maxillofacial surgery.

Associate Professor David Ackland, Australian Research Council (ARC) Future Fellow and Deputy Director of the ARC Centre for Medical Implant Technologies in the Department of Biomedical Engineering at the University of Melbourne, says:

“The ArthroJaw is one of a kind. But it’s not just the implant, it’s the seamless pipeline that has been created. From taking data from medical scans through to a personalised device ready for implantation – from testing, fabrication and sterilization, and critically, navigating the regulatory environment, and carrying out clinical trials. We have an entirely new capacity to develop customised implantable components for a wide range of bone and joint problems. The company is now at a position where they can grow and develop other products.”

Dr George Dimitroulis, Clinical Director and Founder of MAXONIQ, says:

“The work we are doing in collaboration with the University of Melbourne would not have been possible without the co-operation and input from Associate Professor David Ackland and his research team who have nurtured and guided the evolution of the TMJ ArthroJaw device from its inception.

“As a company, we benefit enormously from the ongoing University of Melbourne relationship, which provides us with the confidence and legitimacy we need to promote our devices to discerning clinicians and surgeons who expect solid research backing for each Maxoniq medical device they use."

MAXONIQ won the 2020 Eureka International Innovation & Entrepreneurship Competition Award for Growth and the team was named winner of the 2022 ACGR Award for Excellence in Promoting Industry Engagement in Graduate Research.

The need

For decades, patients needing a new TMJ – usually as a consequence of osteoarthritis or trauma – have had limited options, and would typically receive an off-the-shelf prosthesis manufactured in the US, which requires significant, invasive surgery and presents risk of nerve damage due to limitations in the underlying implant shape and fixation.

A TMJ implant that can be customised to the patient, affordable and quick to make would allow thousands more patients to receive treatment for complex conditions, reducing pain and increasing their quality of life.

The research

The ArthroJaw is based on years of research by Dr Dimitroulis and a team of engineers from the University’s Department of Mechanical Engineering, led by Associate Professor David Ackland, in collaboration with industry.

“The challenge was to create realistic, almost life-like computer models of bones and joints that really represented a patient and their physiological jaw loading. We needed to come up with techniques to take medical images through to a working 3D computer model, with muscles that generate force and load and that we can drive with motion, to be a reasonable approximation of the real-world jaw, and allow assessment of implant functional performance,” says Associate Professor Ackland.

Crucially, biomechanical research came together with surgical expertise – where engineers worked with clinicians, including a maxillofacial surgeon – along with experts in manufacturing, 3D printing, prototyping and sterilizing. BresMedical, for example, helped them adopt additive manufacturing – layering rather than cutting away – as a simpler, more cost effective and efficient way to manufacture.

“It wasn’t just a design engineer. The entire process required a strong understanding of the clinical need, musculoskeletal biomechanics, medical device regulation, and local and international manufacturing landscape. A lot of things had to happen to take the idea through to a product that could safely be implanted into a patient."

The academic underpinning has been crucial for the company and for advancing research more broadly. The validation, assessment, and academic outputs provide credibility for MAXONIQ, while also supporting further research work in jaw and dental biomechanics beyond the ArthroJaw, through research grants, local and international conference presentations and peer-review papers.

Technology development history

The TMJ began with the vision of Dr Dimitroulis to create a new device that would solve the issues associated with existing implants.

In 2012 he approached the University’s Department of Biomedical Engineering to see if they could help him bring it to fruition. Impressed by the innovation, they jumped at the chance to take part and close collaboration began.

The University played a significant role in the early stages of development, first coming up with the concept of the temporomandibular joint replacement. Then creating a generic computer model of the jaw, with all surrounding muscles and bones, as a basis for the design and preliminary modelling and testing.

The next three years saw Associate Professor Ackland and his team – including engineering students – work on developing the computer model and engineering the new jaw prosthesis, working with Dr Dimitroulis to ensure it would meet all the key requirements.

With little funding to begin, as things progressed the team was able to attract research grants and publish work that helped them get to a design they were happy with, and create a prototype.

The prototype was then put into a cadaver for rigorous biomechanical testing and modeling. And they performed a virtual implantation surgery, and simulations to assess the functional performance of the device.

By 2015 they had fabricated a biocompatible titanium joint that could be fitted to the anatomy of each subject. It was comfortable, cost less than existing older technologies to fabricate, and quick to produce – up to two weeks from design to implantation. They had also designed out one of the biggest problems with the old-style replacement joints – the risk of damage to the mandibular nerve.

Approved in 2015 for clinical use in Australia, they completed the first implant in a young adult patient, Richard Stratton. Then in 2016, Dr Dimitroulis established MAXONIQ (formerly OMX Solutions) to commercialise the TMJ Total Joint Replacement System which was also listed on the ARTG prosthesis schedule of medical devices in 2016. Soon after, MAXONIQ began developing other custom oral facial implants and surgical support products.

Refining the design continues. Currently, the team is measuring high accuracy motion data in prosthesis recipients to improve range of motion and assess alternative materials that could have better loading capacity, be easier to install, more lightweight and stronger.

Partners

MAXONIQ

The University of Melbourne

Sabre Medical

Bres Medical

Osteon Medical

Brandwood CKC

OMNI Dental

Materialise

Objective 3D

PartMaker

Funding support

Awards

Australian Council of Graduate Research, Excellence in Promoting Industry Engagement Graduate Research (Centre for Medical Implant Technologies team: Professor Peter Lee, Associate Professor David Ackland, Dr Jia-Yee Lee, Ms Meg Belmonte)

New Investigator Award (Sarah Woodford), 12th Australian Biomechanics Conference, 2021

Outstanding Researcher Award 2017, School of Chemical and Biomedical Engineering, Associate Professor David Ackland

OsseoFrame 2020 Eureka International Innovation & Entrepreneurship Competition (IIEC) - Award for Growth (MAXONIQ)

Publications

Mian M, Ackland DC, Fink S, Wang N, Dimitroulis G. Accuracy of custom temporomandibular joint replacement surgery using a virtual surgical planning protocol. Oral and Maxillofacial Surgery. 25, 367-371, 2021

Dimitroulis G, Austin S, Lee PV, Ackland DC. A new 3D print-on-demand Temporomandibular prosthetic total joint replacement system: Preliminary Outcomes. Journal of Cranio-Maxillofacial Surgery. 46(8), 1192-1198, 2018

Ackland DC, Robinson D, Lee PV, Dimitroulis G. Design and clinical outcome of a novel 3D-printed prosthetic joint replacement for the human temporomandibular joint. Clinical Biomechanics. 56: 52-60, 2018

Ackland DC, Robinson D, Redhead M, Lee PVS, Moskaljuk A, Dimitroulis G. A personalized 3D-printed prosthetic joint replacement for the human temporomandibular joint: From implant design to implantation. J Mech Behav Biomed Materials. 69:404-411, 2017

Ackland DC, Moskaljuk A, Hart C, Lee P, Dimitroulis G. Prosthesis loading after temporomandibular joint replacement surgery: a musculoskeletal modelling study, Journal of Biomechanical Engineering. 137(4) 041001, 2015

Patents

Innovation Patent #2012100561 – The Melbourne TMJ Prosthesis, 30 October 2012

Innovation Patent #1765424 – OsseoFrame Sub-Periosteal Implant System, 23 November 2016

Standard Patent #2016349948 – An improved Temporomandibular Joint (TMJ) Prosthesis, 8 March 2018

United States Patent #US11,364,113 B2 – Anchored Implant for Nasal Prosthesis, 21 June 2021

United Kingdom Patent #GB2585799 – A Procedure and Orbital Implant for Orbit Anchored Bone Affixation of an Eye Prosthesis, 9 February 2022

People

Associate Professor David Ackland

Dr George Dimitroulis

Professor Peter Lee

Dr Jia-Yee Lee

Published August 2022

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