Project title: CARIES AND TOOTH DECAY PREVENTING TREATMENT

Company name : FLUORINEX ACTIVE LTD.

TECHNOLOGICAL FIELD
Medical device, Delivery device,
Preventive medicine

KEY WORDS
Tooth Decay, Caries,
Fluoride, Iontophoresis, Electro-chemistry, Oral Hygiene, Dental
Care

PROJECT SUMMARY
The Mission: Fluorinex Active has declared war on tooth decay
(dental caries). Fluorinex mission is to provide effective means
of protection for the human race from this tantalizing disease
that inflicts over 90% of the population.

The Technology: The breakthrough was achieved through a unique
process that includes a commercial gel compound and a unique
activation of a device, which are being utilized to impose an
efficient ion exchange process through an Electro-chemical
reaction in which Fluor ions (F) displace the Hydroxide ions
(OH-) at the outer layer of the tooth to produce a new mineral
layer (Fluoroapatite) with significantly improved chemical and
physical resistance to the aggressive bacteria and the resulting
acidic environment in the mouth.

Major ADVANTAGES
* Fluorinex treatment provides the most advanced prevention
solution to date: Maximum Fluoride application to the teeth - for
the longest endurance
* The application is direct onto the teeth (topical) as opposed
to binded in some constrains systemic application through
medication and water fluorination, which also turns out to be
less effective
* The treatment will be administered only once in several years
(2 to 5 years)
* Easy and safe procedure at the dentist clinic
* Can be applied to toddlers and young children with no fear of
safety issues
* Can be provided also as a home unit for personal use
* The application tray will be disposable
* The procedure is economically beneficial to all parties
involved: dentists, patients, insurance and healthcare providers
and government
* This technology will be used for teeth whitening and other
applications

ENTREPRENEURS
Mr. Kamal Khawaled - Entrepreneur and R&D
manager, M.Sc. Industrial Chemistry
Dr. Otman Zuab - Medical Director,
DMD, Periodontist and Research fellow at RAMBAM medical center
Mr. David Tavor - CEO, MBA and MA in
Political Science

PROJECT STATUS
Fluorinex Active was established on April 2004.
* Pre-Clinical Trials: Fluorinex collaborated with the Hebrew
University in conducting a comprehensive research on extracted
healthy human teeth. The Fluoride up-take results showed a
significant superiority in Fluoride uptake to Fluorinex
treatment, as compared to other treatments.
* Clinical Trials: The Safety phase of clinical human in-vivo
research which has been approved by the local IRB (Helsinki
Committee) and by Ministry of Health has been conducted in
November 2005. The second phase - an efficacy trial with
follow-up checks over one year for caries incidence, is planned
to start during first quarter of 2006. The subjects will be
chosen from a highly caries and cavity inflicted population to
enable a follow-up within a short time.
* Regulatory: Fluorinex device was pre-ruled by the FDA and
regulated as a 510K class III. No clinical trials needed for
final approval.
* Patents: PCT application was filed and published on July 2005
with priority since 2003. Additional patent using Fluorinex
technology for teeth whitening was filed and registered in July
2005.

COOPERATION REQUIRED
The company is seeking a financial investment of between US $600K
and US $1.5M (at a US $6M company's value, pre-money) and
strategic collaboration, following the FDA pre-ruling and the
successful safety clinical trials.
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WEB: www.fluorinex.co.il

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