Incisive, formed in 2004, is a spin-out from The University of Melbourne. Intellectual property (IP) was assigned to Incisive and has now been granted in seven jurisdictions. The lead technology is BlueCheck, a novel diagnostic for detecting and monitoring the earliest stages of tooth decay.
BlueCheck is a diagnostic tool that enables dental specialists to identify early-stage tooth decay when it is not obvious to the eye or by x-ray. The sensitivity of BlueCheck is very high and superior to the sensitivity of the current standard of care. Early diagnosis of tooth decay is key to optimal patient outcomes. The earlier fluoride treatments are administered, the greater the chance of repair and lower the likelihood of painful toothaches and extraction.
The device is a liquid which turns blue on contact with high porosity enamel, i.e. cavities. BlueCheck consists of a protein, linker and dye, synthesized via a two-step conjugation process. The hydroxyapatite-binding property of the protein allows for an electrostatic interaction, such that it remains specifically bound to the porous dental hydroxyapatite, providing a visual representation of tooth decay. BlueCheck is removed following a simple washing step.
The final product will be a single use application by a dentist in the surgery. The conjugate will be applied with an applicator, likely a brush included in the kit. It is possible a remineralisation product will accompany the sale of BlueCheck in a combination pack, and/or detection of the blue dye will be facilitated via an oral digital camera. These two industries represent the key strategic partners for Incisive.
With the trend in cariology towards earlier detection and management, dentists are increasingly adopting new innovative technologies in their surgeries. In the US (2017), the professional dental consumables market is more than $27Bn in annual sales, with CAGR of 4.5-7.1%.
Patents for BlueCheck
Eight cases are pending or in force. Seven granted patents include the following jurisdictions – Australia, Brazil, Canada, China, Europe, Japan and Mexico. The USA case is in prosecution. Incisive’s patent portfolio is managed in consultation with Griffith Hack.
The transient interaction between BlueCheck and the enamel does not rely on a pharmacological, immunological or metabolic action to achieve the intended outcome, and therefore BlueCheck meets the criteria for classification as a medical device.
Nevertheless, prior to commencing human clinical studies, pre-clinical studies will be required. These include confirmation of the mechanism of action and assessment of specificity and sensitivity of the test method, along with safety evaluation. Pre-clinical and clinical studies will be designed to satisfy first market entry into the EU and Australia, followed by the US.
The People & The Plan
Incisive is a privately held company, based at 71 Collins St, Melbourne, Australia. Founding scientist Dr. Jonathan Mangum retains an active role in the company, whilst Dr. Kerry Hegarty leads the overall management. Advisors in Quality Systems, Regulatory and Manufacturing are preparing for manufacturing and safety studies in late 2018, in order to commence clinical studies in 2019.
Incisive seeks to collaborate with a strategic partner in design of the clinical trial, with an option to license the technology. We are presently in active discussion with both digital imaging and remineralisation companies.
For further information, contact:
Dr. Kerry Hegarty at +61 (0)401 188 639,
Dr. Jonathan Mangum at +61 (0)488 586 290