Incisive’s lead technology is BlueCheck, a novel diagnostic for detecting and monitoring the earliest stages of tooth decay. Incisive, formed in 2012, is a spin-out from The University of Melbourne. Intellectual property (IP) was assigned to Incisive and has now been granted in several jurisdictions. Eight cases are pending or in force, including Australia, Brazil, Canada, China, Europe, Japan, Mexico and USA. 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.
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 USA and EU, followed by Australia.
The final product will be a single use application by a dentist, hygienist or orthodontist in the surgery. The conjugate will be applied with an applicator, likely a brush included in a 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 a digital camera. These two industries represent the key strategic partners for Incisive.
The pairing of oral hygiene and prevention is a rapidly growing area, as around the world the focus by patients, dentists and payers on prevention strengthens. In 2018, the global dental consumables market was worth $29.4B (USD), with professional consumables the fastest growing segment of the market (7.1%). The consumer oral care market is even larger ($45.2B USD) but showed the slowest annual growth in 2018, presumably due to a crowded market and low barriers to entry. It is estimated that there are over 480M dental treatments in the US each year, of which 77% related to caries diagnosis and treatment¹. Of those, only 18% are given a remineralisation treatment². The catalyst for applying a remineralisation product is typically identification of a white spot lesion (WSL) which can represent a lesion ten times more advanced than those identified with BlueCheck. It is understood by the market that remineralisation products perform far better with early-stage caries.
It has been demonstrated that BlueCheck allows earlier identification of decay, showing that using White Spot Lesion or WSLs are effectively a lagging indicator of disease. It has been estimated that using an objective tool such as BlueCheck may lead to a 50% increase in the use of remineralisation products and a substantial drop in the need for costly surgical procedures in oral health care, commensurate with an increase in preventative care due to early intervention. BlueCheck will claim applications in both the orthodontic market and general dentistry.
¹Worldwide Offices of Dentists. (2011) Barnes Industry Report.
²Data Research Oral Care USA. (2013) Kline & Company.