Australia Leads Global Innovation with First-Ever 3D-Printed Skin Clinical Trial

A Milestone Moment in Regenerative Medicine

In a groundbreaking achievement that marks a significant milestone in medical technology, researchers and clinicians at Concord Repatriation General Hospital in Sydney, Australia, have successfully utilized a state-of-the-art 3D bioprinter to create and apply customized skin directly onto a patient’s wound, using cells harvested from the patient themselves. This pioneering approach not only underscores the potential of 3D bioprinting in the medical field but also showcases the remarkable capabilities of personalized medicine. The innovative technology behind this procedure was developed by the Australian biotech company Inventia Life Science, which has been at the forefront of bioprinting advancements. This remarkable achievement represents a revolutionary step forward in the treatment of severe burns and offers new hope for patients suffering from skin injuries. By employing a patient's own cells, the process minimizes the risk of rejection and complications that can arise from using donor skin or synthetic materials. This clinical trial does not merely signify an advancement in the field of bioprinting; it heralds a new paradigm in patient-centered healing that emphasises the importance of individualised treatment plans tailored to the unique needs of each patient. As this technology continues to evolve and undergo further testing, it has the potential to transform the landscape of regenerative therapy, paving the way for new techniques that could be applied to various types of wounds and skin conditions, ultimately improving recovery times and patient outcomes.

Understanding the Technology: The LIGŌ Bioprinter

The technology behind this groundbreaking advancement in medical science is the LIGŌ robotic 3D bioprinter, a cutting-edge device designed by Inventia Life Science. This innovative printer represents a significant leap forward in the field of regenerative medicine, particularly in the treatment of severe skin injuries and burns. Unlike traditional skin grafts, which often necessitate painful and invasive donor-site surgeries that can leave lasting scars and complications, the LIGŌ system offers a revolutionary alternative. It enables clinicians to print autologous (patient-derived) skin cells directly onto the wound site, thereby reducing the need for donor sites and minimising patient discomfort.

Key features of LIGŌ:

• Inkjet-style bioprinting: The LIGŌ printer employs an advanced inkjet-style bioprinting technique, which allows it to precisely print nano-droplets of a specially formulated bio-ink. This bio-ink is a carefully developed mixture that includes the patient’s own skin cells, along with essential biomaterials that promote healing and integration with existing tissue. This method not only enhances the efficiency of the skin regeneration process but also significantly reduces the risk of rejection, as the cells used are derived from the patient themselves.

• On-site usage: One of the standout features of the LIGŌ printer is its compact design, which is specifically engineered for bedside applications. This portability allows surgeons to utilise the device directly in the operating room, enabling them to print skin constructs in real-time during surgical procedures. This immediate application can be crucial in emergency situations, where time is of the essence and rapid wound closure is necessary to prevent infection and promote healing.

• Precision delivery: The LIGŌ printer incorporates sophisticated 3D mapping and imaging technologies, allowing it to accurately assess the depth and geometry of the patient's wound. This capability ensures that the device can create a perfectly contoured, multilayered skin construct that closely mimics the natural architecture of human skin. By tailoring the printed skin to the specific characteristics of the wound, the LIGŌ printer enhances the likelihood of successful integration with the surrounding tissue, leading to better outcomes for patients.

LIGŌ, an innovative biodelivery device designed to transform regenerative surgery. Image courtesy of Inventia.

The Patient Behind the Breakthrough

The first patient in the trial was Rebecca Jane Torbruegge, a young nurse who sustained a burn injury on her leg after a gokart accident. Rather than undergoing a traditional skin graft that would require harvesting tissue from another part of her body, she opted into the clinical trial and became the first human to receive 3D-printed skin during surgery.

Her cells were biopsied, expanded in the lab, and then bioprinted using LIGŌ onto a donor site wound.

“I didn’t expect it to be that easy,” she shared. “I felt no pain in the area. Even the donor site was not sore like I thought it would be.

Dr. Joanneke Maitz with burn patient Rebecca Torbruegge and NSW government representatives at the Concord Burns Unit. Image courtesy of SydneyConnect/NSW Government.

The Clinical Trial: What Makes It Groundbreaking

The ongoing clinical trial is a collaboration between NSW Health, Inventia Life Science, and Concord’s world-renowned burns unit. The trial is being conducted on 10 patients in two phases:-

Phase 1: Donor Site Treatment

The printer was used on surgical wounds created during skin graft harvesting, not the burn wounds themselves ,this was to test safety and integration.

Phase 2: Direct Burn Application (Upcoming)

Once initial safety and healing data are confirmed, the bioprinter will be applied directly on burn wounds, eliminating the need for painful secondary injuries altogether.

A Legacy of Excellence at Concord

Concord’s burns unit is no stranger to global attention, having established itself as a critical facility for the treatment of severe burn injuries. This unit gained significant recognition for its pivotal role in treating victims of the devastating 2002 Bali bombings, where it provided urgent and specialised care to those suffering from life-threatening burns and trauma. The expertise and advanced techniques employed by the staff at Concord have made it a beacon of hope for burn victims not only in Australia but also internationally. Over the years, the unit has become a pioneer in the fields of reconstructive surgery and trauma care, continuously pushing the boundaries of medical science to improve patient outcomes.

According to Dr. Jeremy Rawlins, the lead burns surgeon and principal investigator of the trial, the unit's dedication to innovation and research has led to groundbreaking advancements in treatment protocols. Dr. Rawlins emphasizes the importance of multidisciplinary approaches, combining surgical expertise with psychological support and rehabilitation services to ensure comprehensive care for patients. This holistic model not only addresses the physical injuries sustained by burn victims but also recognises the emotional and psychological challenges they face during recovery.

Furthermore, the burns unit at Concord is equipped with state-of-the-art technology and facilities that enhance the healing process. The incorporation of cutting-edge techniques, such as skin grafting and bioengineered skin substitutes, has revolutionised the way burns are treated. The unit's commitment to research and clinical trials allows them to stay at the forefront of medical advancements, ensuring that their patients benefit from the latest innovations in burn care. Dr. Rawlins and his team are actively involved in numerous studies aimed at improving surgical outcomes and minimising complications, highlighting their dedication to continuous improvement in the field of burn treatment.

In addition to their clinical work, the unit also engages in extensive education and training programs for healthcare professionals, sharing their knowledge and expertise with others in the field. This commitment to education extends beyond local borders, as the unit collaborates with international organizations to provide training and support in burn management to healthcare providers in developing countries. This outreach not only enhances global burn care standards but also reinforces Concord’s position as a leader in the field.

“We’ve gone from skin harvesting — which always causes more injury — to printing skin that matches the patient’s own biology. That’s a game changer.”

 Inventia’s Vision: Bioprinting for All

Inventia Life Science, established in the vibrant city of Sydney, Australia, is rapidly emerging as a pioneering force in the biotechnology sector, particularly in the realm of 3D bioprinting technology. This innovative startup is at the forefront of transforming how we approach tissue engineering and regenerative medicine. With substantial financial backing from the New South Wales Medical Devices Fund, Inventia has successfully secured millions in grants, which are crucial for the expansion and development of their groundbreaking LIGŌ device. This sophisticated bioprinter is designed to revolutionize the way healthcare providers deliver personalized treatment solutions, and the company is on a mission to introduce this cutting-edge technology to hospitals around the globe, thereby enhancing patient care and surgical outcomes.

Their broader goals:

• Extend LIGŌ to other uses: chronic wounds, ulcers, and complex surgical reconstructions. The vision is to adapt the LIGŌ device for a variety of medical applications beyond its initial scope. By focusing on conditions such as chronic wounds and ulcers, which affect millions of patients worldwide, Inventia aims to provide effective solutions that promote faster healing and reduce the risk of infection. Additionally, the capability to assist in complex surgical reconstructions could significantly improve the quality of life for patients requiring intricate surgical interventions, allowing for more precise and tailored approaches to tissue repair.

• Establish bedside bioprinting as a standard protocol in trauma and burn care units. One of the ambitious goals of Inventia Life Science is to integrate bioprinting technology directly into clinical settings, particularly in trauma and burn care units where timely intervention is critical. By making the LIGŌ device readily available at the bedside, healthcare professionals could rapidly produce customized skin grafts and other tissue types on-demand, drastically improving the speed and efficacy of treatment for patients suffering from severe injuries. This innovation could potentially transform the standard of care in emergency medicine, leading to better patient outcomes and reduced recovery times.

• Create automated, scalable bioprinting systems for tissue repair across various organ systems. Looking towards the future, Inventia envisions the development of automated and scalable bioprinting systems capable of addressing a wide range of tissue repair needs across different organ systems. This goal involves not only enhancing the capabilities of the LIGŌ device but also ensuring that bioprinting technology can be implemented efficiently in diverse medical environments. By creating systems that can be easily scaled and adapted, Inventia aims to democratize access to advanced bioprinting solutions, making them available to hospitals of all sizes, from large academic medical centers to smaller community hospitals.

What This Means for the Future of Medicine

This trial represents a significant milestone in the field of regenerative medicine, as it marks the first real-world validation of bedside 3D bioprinting technology. This advancement is crucial because it transitions the concept of 3D bioprinting from mere laboratory hype into tangible clinical action, demonstrating its feasibility and effectiveness in real-world scenarios. The implications of this technology are profound, and it holds the potential to revolutionize the way we approach tissue repair and regeneration. Specifically, it has the potential to:

• Eliminate donor-site injuries, which are often a consequence of traditional grafting techniques. In many cases, patients require skin grafts harvested from other parts of their bodies, leading to additional surgical sites, increased pain, and prolonged recovery times. By utilizing 3D bioprinting, clinicians can create skin and other tissues on-site, thereby avoiding the need for donor sites altogether. This not only enhances patient comfort but also streamlines the surgical process.

• Accelerate healing and minimize complications associated with wound care. The ability to bioprint tissues directly at the bedside means that patients can receive immediate treatment tailored to their specific injuries. This rapid response can significantly reduce the time it takes for wounds to heal, while also decreasing the likelihood of complications such as infections or graft rejection. The personalized nature of the bioprinted tissues allows for better integration with the patient’s existing biological systems, promoting faster recovery.

• Offer personalized tissue engineering solutions with no risk of immune rejection. One of the most significant hurdles in tissue transplantation has been the body's immune response to foreign tissues. However, with 3D bioprinting, it is possible to create tissues that are customized to match the patient's own cellular makeup. This personalized approach minimizes the risk of rejection and eliminates the need for long-term immunosuppressive therapies, which can have severe side effects and increase susceptibility to infections.

• Reduce the cost and logistical burden of treating severe burns, particularly in rural or resource-limited areas. The current treatment for severe burns often requires extensive resources, including specialized medical personnel and facilities. By implementing bedside 3D bioprinting, healthcare providers can offer immediate and effective treatment without the need for extensive transportation or specialized equipment. This innovation could significantly alleviate the strain on healthcare systems, especially in underserved regions where access to advanced medical care is limited.

Watch It in Action

Watch the 9News Sydney video report on the trial here

Dr. Joanneke Maitz with NSW Health Minister Ryan Park and Strathfield MP Jason Yat-Sen Li during a visit to Concord Burns Unit. Image courtesy of SydneyConnect/NSW Government.

The video includes visuals of the LIGŌ printer, clinical procedure, and patient testimony.