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Antimicrobial Biodegradable Bone Graft for Craniofacial/Maxillofacial Application

Award Number: R43DE023287
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2013
PERIOD OF PERFORMANCE END DATE: 12/31/2015

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Antimicrobial Biodegradable Bone Graft for Craniofacial/Maxillofacial Application - DESCRIPTION (provided by applicant): The incidence of traumatic facial injuries relative to injuries at the other anatomic locations has risen sharply during combat operations in Iraq and Afghanistan compared to previous military conflicts. Evan in the civilian population, traumatic craniofacial bone injury is often accompanied by injury or loss of surrounding soft tissues. There are reports of local complications and wound infection rates as high as 100% in civilians suffering gunshot wounds to the face. In the cases of open fractures that involve bone defects, the surgeon must find a way to quickly repair the wound while reducing the risk of chronic infection or osteomyelitis. In the Phase I program, we propose to develop a superior local antibiotic delivery system (in the form of beads) that also possesses resorbable and osteoinductive properties. The beads would be made of biodegradable magnesium. The beads will be coated with hydroxyapatite (HA) incorporated with gentamycin. The HA coating will be applied using Spire's commercial TPA process which produces a thin (5-10¿m) layer at a low temperature, thereby retaining the original chemical composition and phase of the HA source material. HA is well-known to initiate and expedite bone growth. We propose a system in which the HA will initiate bone growth; as the HA starts to dissolute slowly, the Mg will also degrade allowing the antibiotic to be distributed locally, preventing infection. Most importantly, there wil be no need for a subsequent operation to remove any implant or bead from the site.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2015 ( Subtotal = -$569 )
2015	2013	N2 BIOMEDICAL LLC	ONE PATRIOTS PARK	BEDFORD	MA	01730	MIDDLESEX	USA	Oral Diseases and Disorders Research	000	2	4/15/2015	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$569
														Subtotal = -$569

Issue Date FY: 2014 ( Subtotal = -$13,142 )
2014	2013	SPIRE CORPORATION	PATRIOTS PARK	BEDFORD	MA	01730	MIDDLESEX	USA	Oral Diseases and Disorders Research	000	1	9/19/2014	NEW	-$216,334
2014	2013	N2 BIOMEDICAL LLC	ONE PATRIOTS PARK	BEDFORD	MA	01730	MIDDLESEX	USA	Oral Diseases and Disorders Research	001	2	9/22/2014	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$203,192
														Subtotal = -$13,142

Issue Date FY: 2013 ( Subtotal = $216,334 )
2013	2013	SPIRE CORPORATION	PATRIOTS PARK	BEDFORD	MA	01730	MIDDLESEX	USA	Oral Diseases and Disorders Research	000	1	9/19/2013	NEW	$216,334
														Subtotal = $216,334

Grand Total All Awards = $202,623

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Antimicrobial Biodegradable Bone Graft for Craniofacial/Maxillofacial Application

Award Number: R43DE023287

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2013

PERIOD OF PERFORMANCE END DATE: 12/31/2015

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