CALCIDENT ACTIVE LTD.
A DISPOSABLE DELIVERY PLATFORM FOR PHARMACEUTICALS
AND ORAL CARE
The need
Establishing and maintaining a constant level of additives, mineral ions and drugs in
the oral environment have, so far, been largely unattainable. Oral pathology, such as
fungal infections (common in Cancer and AIDS patients), xerostomia (abnormal
dryness of mouth), caries, aphthosis (painful mouth sores) and halitosis (bad breath)
are currently treated through the agency of toothpastes, mouth rinses, chewing gums
and lozenges. These delivery systems, which are both indeterminable and variable,
provide very short duration therapeutic levels for the delivered active agent ranging
from 10-60 minutes. There is a need to retain the medications locally in the oral cavity
for extended periods of time, especially during sleep.
The Products
Calcident Active Ltd. has developed a disposable platform technology that is placed
and stabilized on the teeth. The platform is based on a container acting as a reservoir
for the slow release of a drug or additive (in the form of a tablet, gel or granules) into
the saliva. The release rate is predetermined through a combination of the reservoir’s
structure and the drug or additive’s chemical formulation. The salivary concentration of
the substance is maintained at the desired level for up to 24 hours, providing maximum
therapeutic efficacy. The system may also be used as a trans-mucosal or gastroretentive delivery system. The platform is user friendly, simple to place and remove by
the patient without professional supervision (similar action to flossing). It is biocompatible, stable in the intra-oral environment, disposable and holds the promise of
improved compliance. Dosage and application are less frequent, fully controllable and
may be of longer duration - factors that may reduce adverse side-effects because of
lessened drug fluctuation.
The Market
Calcident’s strategy is to introduce the innovative, patent-pending platform into 2 major
markets- Oral Hygiene and Pharmaceuticals.
The market potential is huge. Please note the following two examples:
Oral Care- breath fresheners sell annually for over $4.7B. There is a constant demand
for new products and delivery modes.
Pharmaceutics- Clotrimazole (in the form of troches or lozenges), a generic drug which
treats oral thrush (mostly as a result of chemotherapy) sells for over $600M a year.
January 2008
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Contact: Amnon Engelberg, shy_eng@zahav.net.il , +972-77-350-9090
CALCIDENT ACTIVE LTD.
There are many other applications and medications for which Calcident’s platform is
relevant and effective.
January 2008
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Contact: Amnon Engelberg, shy_eng@zahav.net.il , +972-77-350-9090
CALCIDENT ACTIVE LTD.
Status
The company has completed the development of the platform prototype (suitable for
human use), a formulation for the controlled release of Calcium to prevent dental
caries, and an anti-fungal formulation. The Calcium formulation successfully completed
a pilot human test with an average increase of more than 20% in the concentration of
calcium ions in the saliva of those tested. Approval has been obtained for a phase 1
and usability trial of the Clotrimazole controlled release formulation in the platform.
Financing
Calcident is currently raising $2M to finance 2 years of operation in which the company
will finalize engineering, enhance IP, carry through a phase 1 trial of Clotrimazole in its
platform, perform a clinical trial for enhancing Calcium ions in saliva and obtain
regulatory approval for its sale in the US (FDA). With all these, the company will initiate
marketing.
The Team
Calcident Active Ltd. is graduating from Israel’s CSO incubator program, with a
motivated team backed by world renowned specialists.
Amnon Engelberg – CEO Former CEO of retail and manufacturing companies.
Graduate of the Hebrew University Law School, MBA from the University of
Georgia
Dr. Erella Pines Dentist, 17 years experience in pediatric dentistry and serial
entrepreneur
Yoram Sela, Ph.D. 19 years experience in sustained release oral drug delivery. Cofounder of several drug delivery companies
Prof. Michael Friedman Extensive experience in the field of oral drug delivery as well
as industrial pharmaceutics. School of Pharmacy, Hebrew University
Prof. Adrian Becker Specialist orthodontist, Faculty of Dental Medicine, Hebrew
University
January 2008
-ConfidentialPage 3 of 3
Contact: Amnon Engelberg, shy_eng@zahav.net.il , +972-77-350-9090