Agluna^®

How Agluna^® Works

During the Agluna^® process, silver is ‘stitched’ into the titanium surface in the form of positively charged ions and is therefore considered to be a surface modification and not a coating. Silver is well known for its bactericidal properties and the use of silver on medical devices has previously been approved by worldwide regulatory bodies on a large number of products. Silver ions at low doses will eliminate bacterial cells with no toxicological effect on the human patient. The Agluna^® treatment enables the steady release of silver ions from the implant’s surface over several months by dissolution into body fluids, eventually leaving a silver-free implant that has long-term durability and biocompatibility. As patients are at highest risk of infection during the initial healing process following surgery the delayed release of silver ions is sufficient to provide a high level of protection.

In vitro testing has shown the Agluna^® surface to have a bactericidal effect against bacteria known to cause post-operative infection, including drug resistant strains. Medical device materials have been shown to be susceptible to rapid colonisation by bacteria, which then produce a plaque or biofilm as protection against the body’s defences. Implants treated with Agluna^® technology have been shown to remain clear of biofilm formation and clinical data from the field of tumour implants has shown a demonstrable reduction in infection rates in patients treated with Agluna^®-treated implants.

Agluna^® Process

The Agluna^® treatment of implants is achieved by an electrochemical process that involves high voltage anodisation (formation of an oxide layer integral with the metal surface) of the titanium implant in dilute phosphoric acid, followed by ion exchange with silver from an aqueous solution. This treatment results in the formation of circular features of approximately 5 µm diameter in the surface of the implant, containing an amorphous titania species within which the bulk of the ionic silver has been stored. In addition to the beneficial integration of ionic silver into the surface, the anodisation of titanium gives the Agluna^®-treated implant a distinctive shiny violet appearance and enhances the durability of the material in laboratory tests.

The concentration of silver ions added to the implant surfaces by the Agluna^® process is carefully controlled and is well below concentrations that would cause any potential toxicological side effects.

Manufacturing and Regulatory

Agluna^® is designed to have beneficial effects in medical devices composed of titanium and other metallic alloys.

These include:

• ○ Orthopaedics and traumatology
• ○ Dentistry
• ○ Spinal surgery
• ○ Cardiology
• ○ Urology
• ○ Neurology
• ○ General surgery

Research and development into the application on other surfaces besides titanium and other metallic alloys is ongoing.

A growing market for Agluna^®

There are approximately 2.5 million hip and knee replacements every year globally, and 1-2% of these currently fail as a result of post-operative infection ^{(Anderson et al, 2009)}. The overall cost to global reimbursement authorities for the revision surgery required is estimated at $5 billion annually. Patient outcome and, therefore, patient experience is also of concern, although the emotional cost is not measurable. There is, therefore, a clear opportunity for a preventative solution to enter the market. Accentus Medical’s Agluna^® technology is the most advanced of its kind and has the support of a significant and increasing volume of clinical data.

Agluna^® will also have beneficial effects in other medical devices where titanium or titanium alloys are increasingly being used as a manufacturing material of choice. These markets include spinal surgery, cardiology, dentistry, neurology, urology and general surgery.

At present Agluna^® is being implemented on titanium and titanium alloy implants, although research and development into the application on other surfaces is ongoing. Global market sales of implantable devices manufactured with titanium are estimated to reach $26 billion by 2020.