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Company Profile
Incisive Technologies’ mission is to equip oral healthcare professionals with the tools they need to address the global challenge of tooth decay. The company formed in 2004, is a spin-out from The University of Melbourne, with assigned Intellectual property (IP) granted in 22 jurisdictions across Americas, Europe and Asia-Pacific. The lead technology is used in BlueCheck, a novel detection aid for detecting and monitoring the earliest stages of tooth decay that received US FDA Clearance in 2023 for use in adults and children and has launched in the US market.

The Product
Certain proteins naturally bind to hydroxyapatite exposed during the demineralization process. This discovery was used to develop BlueCheck, containing a protein based biomolecule designed to reveal changes in enamel – clearly, early and in color. BlueCheck contains a protein, linker and dye, and makes early enamel damage visible — before cavities form. This simple, chairside tool helps clinicians detect issues sooner and clearly show patients where intervention is needed. Porosity is a biomarker of dental decay. BlueCheck reveals porosity with blue color at active sites, making hidden disease visible and easier to identify.

BlueCheck is supplied as a ready to use single application and is fast and easy to use. The device is a paint on technology, applied to the teeth, with a rinse off step (to remove unbound material), with the procedure taking less than a few minutes. BlueCheck utilises the natural hydroxyapatite-binding property of the protein via an electrostatic interaction, it remains specifically bound to the porous dental hydroxyapatite, providing visual evidence of disease and a direct representation of tooth decay. Positive detections can be recorded via camera or an intraoral image, as well as charting into dental records. It utilises a reversible interaction, with temporary binding that is removed by brushing with an SLS-containing toothpaste and/or the action of saliva.

How it helps Clinicians and Patients
BlueCheck is a detection tool that enables dental professionals to easily visualise and thus identify early-stage tooth decay when it is not obvious to the eye or by x-ray. BlueCheck provides sensitive detection (detecting lesions as shallow as ~30µm) compared to current standard of care (radiograph or visual tactile ~200-400µm). It is specific for active caries lesions, binding to surface and sub-surface porosity in active caries lesions, turning them blue. Healthy enamel and inactive (arrested or healed) caries lesions do not turn blue and is a direct measure of disease (due to direct binding to hydroxyapatite, with the darker the colour the deeper the lesion). The blue color can be used to motivate patients, highlighting problem areas as a visual motivator for patients to improve oral hygiene and manage their disease. Early diagnosis of tooth decay is key to optimal patient outcomes, the earlier remineralisation (such as fluoride and other treatments) and regeneration treatments are administered, the greater the chance of repair by healing the natural tooth structure, lowering the likelihood of expensive and painful toothaches, surgical options and extractions. BlueCheck’s blue colour provides objective, visual proof that supports the dentist’s diagnosis and treatment decisions, building trust and fostering patient loyalty.

Global market
Dental caries is the most prevalent, chronic medical condition affecting more than 2.5B people globally, with indirect costs of US $23B pa and more than a third of the world’s population living with untreated caries. With the trend in cariology towards earlier detection and management, dentists are increasingly adopting new innovative technologies in their surgeries to enable a prevention or a Minimally Invasive Dentistry (MID) approach. In the US (2017), the professional dental consumables market is more than $27B in annual sales, with CAGR of ~6% and more than 225M routine dental check-ups pa represents a sizable market opportunity. The US, Europe and developed Asia-Pacific markets, such as Australia has seen the launch and adoption of new paint-on therapies, toothpastes and mouth rinses (such as Hydroxyapatite, new Fluoride treatments, P11-4 peptide, Silver Diamine Fluoride or nano Silver Fluoride, Tooth moose) to support an MID approach to managing early-stage disease.

Regulatory Strategy
The temporary interaction between BlueCheck and the enamel does not rely on a pharmacological, immunological or metabolic action to achieve the intended outcome, therefore BlueCheck meets the criteria for classification as a medical device. Pre-clinical studies included biocompatibility safety studies, confirmation of the mechanism of action and assessment of specificity and sensitivity. Clinical studies have and will assess BlueCheck’s power to identify early-stage disease and monitor lesion arrest (repair) over time. BlueCheck is cleared by FDA in the US and registration plans are underway for Europe, Australia, Canada and other strategic launch markets.

The People and Plan
Incisive is a privately held company, headquartered Level 6, 41 Exhibition St Melbourne VIC 3000, with an R&D and Manufacturing facility in Ferntree Gully in South East Melbourne. The Incisive team encompasses Management, Finance, Regulatory and Quality, Scientific Operations including Manufacturing and R&D and Commercial in the US. Incisive Technologies has a number of strategic partnerships to support the team and support of the growth of the business. The US represents the largest market and a strategic opportunity to launch and prove out the clinical utility of BlueCheck. Incisive Technologies are actively pursuing strategic partnerships and talent with a shared passion to advancing oral healthcare to address the global challenge of tooth decay.

For further information, contact:
Dr. Kerry Hegarty, CEO at +61 (0)401 188 639,
Email: kerry.hegarty@incisive-technologies.com or

Campbell Robertson-Smith, CFO at +61 (0) 490 073 934
Email:campbell.robertson-smith@incisive-technologies.com

Websites
o Incisive Technologies: https://www.incisive-technologies.com/about
o BlueCheck Dental website: https://www.bluecheckdental.com/