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3D-Printed Superhydrophobic-Tipped Optical Fiber for Targeted Periodontal Photodynamic Therapy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DE026083-03
Agency Tracking Number: R44DE026083
Amount: $1,516,255.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCR
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-16
Award End Date (Contract End Date): 2021-08-31
Small Business Information
28 MOREHOUSE PL
New Providence, NJ 07974-2426
United States
DUNS: 079935653
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 QIANFENG XU
 (718) 951-5000
 greer@singleto2.com
Business Contact
 AMY LYONS
Phone: (908) 468-8124
Email: amy@singleto2.com
Research Institution
N/A
Abstract

Eradication of bacteria located in periodontal pockets presents a daunting challenge to dentists and
oral care professionals. The problem is significant; severe periodontitis is the 6th most prevalent
disease worldwide with over 743 million people affected. The global cost of lost productivity from
severe periodontitis is estimated to be $54 billion USD/year. Antibiotics with scaling and root planing
(SRP) have been the mainstays of current treatments but may lead to the development of antibioticresistant
bacteria. Photodynamic therapy (PDT) is a beneficial alternative, however, there are
several challenges to its implantation including staining of tissue and a short penetration depth
because the dye is introduced directly into the periodontal pocket as well as long treatment times
due lack of oxygen in hypoxic pockets. Thus, there is an urgent need for further advances in
periodontal bacteria eradication.
The superhydrophobic fiber optic PDT (SH-PDT) device tip developed by SingletO2 Therapeutics
LLC delivers bactericidal singlet oxygen (1O2, a cytotoxic excited state of molecular oxygen) in a
direct, controllable fashion. This device is a major breakthrough for the precise delivery of reactive
singlet oxygen to kill hypoxic bacteria for treatment of periodontal diseases. Using precision molding
and 3D printing technologies, the device integrates a sensitizer onto the tip of an optical fiber that
can painlessly be inserted between the tooth and gum killing bacteria which are the cause of
periodontitis. Our superhydrophobic design prevents contact between biofluids and the sensitizer,
eliminating staining. Moreover, disinfection of the periodontal pocket will be achieved in a single visit
due to the efficiency of the superhydrophobic system to trap air, which will provide oxygen to
otherwise hypoxic environments. The approach will also not induce bacterial resistance, and it will
be equally effective on gram-negative and gram-positive bacteria.
In this Phase II STTR project, we propose to study the efficacy of the SH-PDT device in two ways.
First we will quantify the ability of the device to kill a bacterial biofilm in vitro that is comprised of
three different bacteria strains associated with periodontitis. Secondly, we will quantify the ability of
the device to kill periodontitis in vivo using a Wistar rat ligature model. A pilot study will be
conducted to determine the appropriate dose, followed by a full study to acquire statistically
significant results. Successful results from these studies will be used to design human clinical trials
in the future.Project Narrative
Precision killing of periodontal bacteria is a critical, longstanding problem. Scaling and root planing
(SRP) with antibiotics, which is the main treatment for periodontitis today, is costly, painful, requires
multiple treatments, and may cause resistant bacterial strains to develop. SingletO2 Therapeutics
LLC (SingletO2) has demonstrated in Phase I the effectiveness of a novel superhydrophobic
photodynamic therapy (SH-PDT) approach for eradication of the bacterial biofilms that cause
periodontal disease without the use of antibiotics. In this Phase II proposal, we will evaluate a
miniaturized device built into the tip of a plastic optical fiber and carry out a proof-of-principle
demonstration of the effectiveness of the approach. SingletO2 will use the SH-PDT devices for in
vitro biofilm studies and for in vivo Wistar rat ligature model studies to guide future human trials. The
device is capable of delivering singlet oxygen in a highly localized and controllable fashion without
direct contact between the sensitizer and tissue. The successful completion of Phase II will
strengthen SingletO2 Therapeuticsandapos; commercialization and business plan.

* Information listed above is at the time of submission. *

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