Repairing the body with nature in mind
Mr Paul Anderson and Professor Minghao Zheng, Orthocell
As the population ages, the need for treatments that can repair and regenerate damaged material by promoting the body’s natural healing processes is expected to become more prevalent.
Minghao Zheng, Professor of Orthopaedic Science at The University of Western Australia’s School of Biomedical Sciences and Head of Bone and Brain Research at the Perron Institute is a global a leader in the treatment of tendon injuries, osteoporosis, and osteoarthritis using cutting-edge cellular and molecular biology technologies, and an expert in the translation of science to clinical practice.
He pioneered the development of nature derived biomaterials and cell therapy to treat nerve, cartilage, tendon and ligament injury and invented a natural way to treat bone fractures and trauma. Professor Zheng led the pathway to develop patents into stem cell therapy products and biological devices for orthopaedic applications that have been approved by FDA and TGA.
“My goal is to develop technology to help patients. Being an academic pathologist, I learn that what nature has given to us is the best to revitalise the damaged tissues in the body. Synthetic materials for human implant are almost problematic.”
Orthocell
Regenerative medicine uses the body’s own capacity to stimulate growth and healing in the body. In 2006, Professor Zheng connected with entrepreneur Paul Anderson who saw the potential of his work for people suffering from tendinopathy, where issues could not be resolved by physiotherapy.
In 2007, the pair founded the UWA spin out biotechnology company Orthocell and partnered with UWA to use Pathfinder funding to commercialise the regenerative medicine. The partnership has provided a mutual benefit with the use of researchers and world-class facilities, co funding on Australian Research Council grants, royalties, and the funding by Orthocell of academic positions within UWA.
The intellectual property was patented through the UWA commercialisation office. In 2014, Orthocell successfully raised venture capital funding and listed in the ASX, with UWA becoming one of its 20 largest shareholders. In 2024, Orthocell holds over 100 patents internationally, from five patent families.
By 2014 Orthocell had grown the first human tendons in a laboratory and by 2016, employed 23 staff and held 24 patents, of which 16 originated at UWA. By 2021, the number of employees grew to 55 staff with Orthocell recognised as the leading biotech company to increase the global demand for distribution of Australian-sourced medical products.
Since inception, Orthocell’s suite of core products have expanded to include treatments for cartilage injury, dental procedures, and nerve repair.
The need for better medical technologies is growing as the population ages.
Ortho-ACI™ and Ortho‐ATI™
Unlike bone and muscle, damaged cartilage has a limited capacity for self-repair. Whilst tendinopathy usually resolves within 12 months when treated with exercise, some patients are left with chronic and debilitating tendinopathy requiring surgery. Failure rates in surgery on some sites, like the shoulder, are up to 40%. Ortho-ATI® addressed this unmet clinical need in tendon injury. OrthoACI™ uses the patient’s own healthy cartilage cells (chondrocytes) to assist the regeneration of damaged cartilage in the knee and ankle. The technology has been approved by FDA (2016) and TGA (2017) as the first tissue Engineering product for cartilage repair. It is considered the best option for treatment of a cartilage defect in the USA and Australia.
Ortho‐ATI™ is minimally invasive, using a patient’s tendon stem cells to stimulate the formation of collagen and other connective tissue to help regenerate and repair damaged tendons and ligaments. The product can treat tendon or ligament problems for the Achilles, patella, tennis elbow, rotator cuff and hip tendons. Following the procedure, the patient is provided with a rehabilitation program to slowly increase weight bearing and then return to recreational or sporting activities. A randomised control study on Orth-ATI vs surgery on treatment of chronic tendinopathy showed that minimum invasive ATI has achieved earlier recovery in functional improvement.
“These new technologies provide longer durability and better function improvement as compared to current treatment.”
Orthocell uses the body’s own stem cells to stimulate healing.
CelGro™ and Striate+TM premium dental membrane
CelGro™ was developed as a next generation collagen‐based medical scaffold to augment tissue repair of the tendon by supporting and reconstructing the tendon tissue. Orthocell navigated the regulatory pathway required to turn lab bench research into a commercially viable product, which became approved clinically in Europe to guide bone and soft tissue regeneration. In 2008, the team received UWA Pathfinder funding to test Celgro®, which was rebranded to Striate+TM in 2021. StriateTM is a sterile, resorbable collagen membrane used for guided bone and tissue regeneration in dental applications.
European (CE mark) approval for Celgro in 2017 allowed it to be used in a range of dental bone and soft tissue procedures. It also received Australian Therapeutic Goods Administration (ATGA) and Food and Drug Administration approval and ATGA approval for use as a collagen dental regeneration membrane. In 2021, it was included on the Australian Prosthesis list, providing reimbursement to surgeons and patients with affordable access to a premium dental membrane product. In the same year, it received USA FDA approval.
The intervention provides surgeons with significant improvements in efficiency in dental applications including with extraction sites, grafting, guided bone regeneration and periodontic defects, and delivers improved patient recovery through its superior handling characteristics, tissue integration qualities and improved bone growth and healing. In 2024, over 40,000 patients have had Striate+TM applied as part of dental implants.
In 2022 the collagen product for guided bone regeneration attracted an AUD $21.46 million licencing fee and market sale from BioHorizons to Orthocell Ltd. The product has now been given an exclusive global marketing and distribution license to sell globally.
“Unlike other devices, CelGro/Striate does not cause inflammatory reaction and provides faster bone ingrowth on implant.”
Striate is a collagen-based scaffold for use in dental applications.
Remplir™ revolutionising nerve repair
Millions of people suffer from peripheral nerve injury due to sporting or work-related incidents or from a motor vehicle accident. The damage caused can have a significant effect on a person’s ability to carry out daily tasks. Whilst surgery to re-connect nerves that have been cut or crushed may be an option, it is complicated, can leave scar tissue, and results are inconsistent.
Based on their existing collagen technology, in 2022, Remplir™ was invented as a collagen nerve wrap to provide protection to the injured nerve while it heals. The surgical technology is used in peripheral nerve damage and reduces the need for suturing by offering a barrier of protection for the nerves that need to be conjoined. It creates an ideal environment to support regeneration which dissolves over 3-6 months, resulting in consistent and predictable return of muscle function and reduced healing time for patients. Remplir™ gained Australian ATGA regulatory approval and reimbursement for use of peripheral nerve reconstruction in 2022.
The use of RemplirTM in nerve reconstruction has achieved successful clinical outcomes for patients with cervical spinal cord injury or paralysed upper limbs. More than 130 surgeons are using the technology to help over 3000 patients with nerve injury. The innovation has resulted in operations becoming shorter and simpler, with improved recovery in patients. RemplirTM has featured in Channel 9 national innovation program.
“Remplir has revolutionised the way of nerve repair in patients. This has attracted much attention and resulted in research collaborations with UWA. We have now collaborated with many top hospitals globally including Massachusetts General Hospital, Barnes-Jewish Hospital in USA and Royal Orthopaedic Hospital.”
RemplirTM is revolutionising peripheral nerve damage.
PearlBone™
Osteoporosis, osteoarthritis and traumatic fracture are major health issues where bone implants and grafts are required for the surgical treatments of these conditions.
About 20% of bone trauma require surgical graft intervention through orthopaedic, trauma and reconstructive surgery to heal. Often synthetic bond materials are used however this can cause an inflammatory reaction. To address this challenge, Professor Zheng and his team turned to the marine environment for a way to heal bone naturally.
A study in 2018 led by Professor Minghao Zheng and Dr Rui Ruan showed that nacre (mother of pearl) possesses potent osteogenic properties and could potentially be suitable as a source for bone substitute material for fractures or trauma.
Subsequently, in 2021, Professor Zheng expanded the scope of his research to develop medical products and devices using nacre as a natural bone substitute. The nacre is sustainably certified from silver-lipped pearl oysters in Broome, Western Australia and is an opportunity to save nacre, a by-product of existing pearl farming and turn the material into a sustainable new product.
In 2021, Professor Zheng set up the UWA spin out company Marine Biomedical in Broome, and in partnership with Broome pearling business Willie Creek Pearls. The local marine Biologist Mr Patrick Moase is the co-founder of the company. The Western Australian biotech company is dedicated to developing and manufacturing innovative and life-changing medical products sourced from marine resources. The manufacturing process adheres to the Australian Therapeutic Goods Administration good manufacturing practice guidelines and is the first medical manufacturing company in the region, providing education and research opportunities to the region.
Their flagship technology PearlBone™ is a patented bone substitute created at UWA to fulfil a vital need in the orthopaedic, trauma, and reconstructive surgery space. To support Marine Biomedical in developing the technology, the team received funding through Marine Biomedical in 2023 as well as RED Grant (Regional Economic Development Grant) funding from the Western Australia Government. Economic calculations indicate that production of PearlBone™ increases the value of nacre by 2000 times. PearlBone has also featured as part of the Channel 9 national innovation program.
“This is the first time that natural bone substitute can be made using pearl shell for orthopaedic application. All current products are synthetic.”
Mr Paul Anderson, Minister Stephen Dawson, and Prof Minghao Zheng with PearlBoneTM.
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