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Molecular Heparan Sulfate Delivery in Guided Tissue Regeneration

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85531
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
DE017254
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
AGENTA BIOTECHNOLOGIES, INC.
Innovation Depot 1500 1st Ave. N. BIRMINGHAM, AL 35203-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2009
Title: Molecular Heparan Sulfate Delivery in Guided Tissue Regeneration
Agency: HHS
Contract: 2R44DE017254-02A1
Award Amount: $1,087,460.00
 

Abstract:

DESCRIPTION (provided by applicant): Barrier membranes are an important adjunct to regeneration therapy aimed at restoring the form and function of the mouth. Commercially available barrier membranes are used in dental surgeries to help retain bone graftin g materials, to help exclude epithelium and connective tissue from entering into sites of desired bone and ligament regeneration, or for the combination of these reasons. Whether restoring lost bone around teeth or implants, or in larger areas of the jaws affected by trauma or disease, too often there is inadequate gum tissue to cover the membranes which can lead to membrane exposure, extensive membrane contamination, and procedural failure which is unacceptable. Our data suggests that biologically activati ng membranes made of chitosan (a versatile, biocompatible, resorbable material used in wound bandages) with our proprietary biologic - a small and soluble heparan sulfate-rich co-activator of growth factors - hastens gingival healing over exposed membranes in the mouth. RandD for this project is directed at development of a bioactivated chitosan regenerative membrane that is highly effective in maintaining gingival health and integrity where membranes are unavoidably exposed to the oral environment after pl acement, thereby promoting more predictable outcomes for a wider range of regenerative procedures in the mouth. RandD for this project falls along three lines: biologic development, membrane development, and in vivo testing. More specifically, we will 1) a dvance the prototype biologic used in phase 1 studies, 2) advance our chitosan membrane formulations to incorporate bioactivation with the most clinically appropriate handling characteristics, and 3) test the product candidates in animal models for efficac y. Toxicology and safety testing will be performed with the goal of having product candidate(s) ready for human clinical trials by the end of this phase 2 project. We expect this technology to improve success rates of oral bone regenerative procedures to t reat periodontal disease, to place dental implants, and in cases where maxillofacial reconstruction is needed, therefore meeting patient needs and commercial needs in a large market. There is an absence in today's standard of care for bioactivated regenera tive membranes and this proposed technology addresses that need with a rationally designed RandD plan with an understanding of the existing market, competitors, or potential partners. PUBLIC HEALTH RELEVANCE: Agenta is developing biologically enhan ced regenerative membranes that are used in surgical procedures such as bone grafting. Bone regeneration is often necessary and critical to successful restoration of form and function in the mouth, and procedures called guided tissue regeneration using bar rier membranes are essential to achieving optimal results. Whether restoring lost bone around teeth or implants, or in larger areas of the jaws affected by trauma or disease, too often there is inadequate gum tissue to cover the membranes and the graft sit es which can lead to membrane exposure and procedural failure. Our data suggests that augmenting membranes made of chitosan (an excellent biodegradable material used in wound bandages) with our proprietary biologic improves gingival healing over exposed me mbranes in the mouth. Chitosan is a versatile, biocompatible, resorbable matrix with hemostatic and antimicrobial properties. Our goal is to provide chitosan with the additional biological advantage of enhancing wound closure with our proposed technology. We expect this technology to improve success rates of oral bone regenerative procedures to treat periodontal disease, to place dental implants, and in cases where maxillofacial reconstruction is needed, therefore meeting patient needs and commercial needs in a large market. There is an absence in today's standard of care for bioactivated regenerative membranes and this proposed technology addresses that need with a rationally designed RandD plan with an understanding of the existing market, competitors, or potential partners.

Principal Investigator:

Arthur A. Decarlo
2053076500
ADECARLO@AGENTABIOTECHNOLOGIES.COM

Business Contact:

Arthur Decarlo
adecarlo@agentabiotechnologies.com
Small Business Information at Submission:

AGENTA BIOTECHNOLOGIES, INC.
Innovation Depot 1500 1st Ave. N. BIRMINGHAM, AL 35203

EIN/Tax ID: 631248031
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No