Targeted Remineralization Treatment Using Mineral Loaded Starch Nanoparticles

Dental caries is the most prevalent chronic disease worldwide. The unmet clinical need is noninvasive treatment through subsurface remineralization of enamel, as current fluoride toothpastes & varnishes incompletely repair caries lesions. Our professional-use and direct-to-consumer products treat both dental hypersensitivity and early-stage caries, to reduce discomfort, preserve precious enamel and improve oral health.

We produce tiny positively charged, mineral-loaded starch particles, to target and release inside negatively charged tooth subsurfaces. In-situ degradation forms hydroxyapatite crystals, occluding dentinal tubules and enamel porosities. Our products, CrystLCare™ Biorestorative, Fluoride-Free and Fluoride-Plus, are easy-to-use dissolvable dental strips that release the targeted mineral-loaded particles when placed onto teeth.

Current fluoride products merely seal the extreme upper surface layer of enamel lesions, but targeting the subsurface enables non-surgical treatment of early-stage caries as well as sensitivity relief. Localized concentration of minerals and fluoride facilitates tooth structure regeneration through formation of localized delivery minerals and of apatite crystals, yielding superior treatment compared to currently available products.

The project entered into the ITP program in 2018, and since then, the program has supported verification of the subsurface treatment concept using GreenMark’s patented targeted starch particle technology platform. The ITP program has further supported validation of treatment performance and safety, implementation of medical device requirements and operations, and manufacturing scale-up under a Quality Management System. GreenMark Biomedical, a 2016 “NewCo”, proposed its subsurface treatment based on targeted illumination with the companion LumiCare™ caries detection product. With support from the program, GreenMark established proof-of-concept for Fluoride-Free and Fluoride-Plus product formulations, demonstrated occlusion of dentinal tubules and enamel porosities, validated safety, scaled manufacturing & packaging, implemented Quality systems and a Device Master Record to commercialize two CrystLCare™ products.

• Build intellectual property with broad patents extended globally
• Medical device manufacturing and Quality Management in place
• Manufacturing scaled to 100,000 doses
• Developed a suite of CrystLCare™ Biorestorative products
• Third-party in vitro performance validation published
• Clinical study protocol developed

• CrystLCare Fluoride Free (CC FF) sensitivity product: Class I Medical Device FDA-registered (April 2023)
• CrystLCare Fluoride Plus (CC FP) Pro in-office sensitivity product: Class II 510(k) FDA Clearance (January 2025)
• CC FP OTC product for caries prevention under Fluoride Monograph (Launch targeted Q2 2025)
• CC FP/FF De Novo application for “Enamel Mineral Regeneration” to follow completion of clinical studies (2025-2026)

• Seeking strategic partnership with global dental supply companies and/or distributors
• Raising $4.0 million Series A equity investment round

• Jones et al. Targeted Enamel Remineralization with Mineral-loaded Starch Particles. JADA Foundation Sciences 2024
• Jones et al. Nanoparticle-based targeting and detection of microcavities. Adv Healthc Mater 2017
• Amaechi et al. Evaluation of a Novel Caries Detecting Oral Rinse. BDJ Open 2023
• US10,987,434 Detection and Treatment of Caries and Microcavities with Nanoparticles