TGA listed Australian allografts now available for use in dentistry

The increasing interest and adoption of dental implants as a treatment modality has lead to a commensurate increase in practitioners completing related surgical procedures. Implants rely on the availability of adequate bone volume and as a result, the popularity of bone augmentation products to correct defects and deficiencies is likewise on the increase.

A full range of synthetic, bovine and porcine derived augmentation products have been listed on the TGA's Australian Register of Therapeutic Goods (ARTG) for some time. However, up until recently, human tissue allografts have not met the TGA's strict criteria for listing on the ARTG. This has principally been due to all allografts being harvested and processed offshore, making it cost-prohibitive to fulfil the TGA's oversight requirements for these Class II Biologic materials.

To date, practitioners who favoured allografts over animal and synthetic grafting materials would need to initiate a request through the TGA's Special Access Scheme, an instrument that allows patients to request treatment with unregistered products. While the Special Access Scheme application process has recently been streamlined, a better alternative has now become available.

Sydney-based Australian Biotechnologies Pty Ltd has commenced offering a full range of ARTG listed allografts derived from human tissue donors in Australia that is now available through Henry Schein Halas.

"The core focus of Australian Biotechnologies to date has been supplying allografts for use in orthopaedic surgery," said Simon Berry, CEO of Australian Biotechnologies. "We ship these nationally to over 100 hospitals packed in dry ice. The catalyst for now being able to supply allografts for the dental market was the TGA approving freeze-drying as a method of preserving our products. This has meant that we can supply a range of allografts that do not need to be refrigerated and can be stored at a dental surgery.

"We received this approval 18 months ago and in that time, we've formed a distribution partnership with Henry Schein Halas and have been developing grafts that are packaged specifically for dentistry under the Oravance brand. To date, we have sold more than 1000 Oravance grafts."

Australian Biotechnologies is based at Frenchs Forest in Sydney's north. The large facility houses extensive refrigeration facilities and laboratories for processing the grafts.

"The allografts used in dentistry are produced from the long bones of deceased donors and also from tissue extracted from live donors during hip replacement surgery," Mr Berry said. "The tissue is supplied by NSW Health, ACT Health and the Australian Tissue Donation Network.

"Ensuring the safety of our products is paramount and the multi-stage process starts with exhaustive donor screening. Tissue is only accepted if the donor fulfils stringent criteria. Donors with tattoos, for example, are rejected, as are donors who lived in the UK during certain periods. The socio-medical history of every donor is carefully reviewed and if any of the criteria fail, the donor tissue is rejected.

"Tissue that meets this initial criteria then goes through a five stage process that meets the strict standards of the TGA. At each stage, the tissue is sent for independent laboratory testing to ensure the efficacy of the preceding step.

"We have developed proprietary processes that remove all blood and fats from the bone. The result is clean, pure bone. It does not contain DNA. It's a natural scaffold for your body to use for regeneration. The final step in the process is sterilisation by irradiation."

Oravance is a bone and collagen matrix that has a low inflammatory response from the body, resulting in bone remodelling in 28-60 days. It's freeze dried, sterile and packaged for single patient use.

Founded in 2000, Australian Biotechnologies is a specialist in allograft tissue processing, catering to a wide range of patient needs and surgical procedures. The company supplies allograft solutions for orthopaedic, spinal, dental and oral-maxillofacial surgeries both nationally and internationally.

During its 17-year history, Australian Biotechnologies has successfully introduced and launched numerous new allograft and biologic products and to date has supplied over 50,000 allografts to the Australian community.

Unlike the much publicised allograft recalls in the USA, Australian Biotechnologies has never had a product recall.

"The Oravance range includes pure cortical bone granules, pure cancellous bone granules and a combination of cortico-cancellous bone granules that can be used to fill deficiencies," Mr Berry said. "In addition, we also produce blocks and dowels for when a larger, rigid graft is required.

"One of the more unique products in the range are cortical sheets and plates. These are supplied moist and flexible. But once dry, they become rigid. So if you're filling an extraction site with granules, for example, a cortical sheet can be used instead of a synthetic membrane. It can be molded to the site while moist and it then becomes rigid when it dries.

"The range is quite versatile and we're working with dental clinicians to create grafting products that are specific to their needs."

The Oravance Allograft Range

Cortical Sheets
Cortical Plates
Pure Cortical Bone Granules
Pure Cancellous Bone Granules
Cortico-Cancellous Bone Granules
Cancellous Dowels
Cortical Blocks
Cortico-Cancellous Blocks