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BREAST PROSTHESES FOR SUBRADICAL SURGERY

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
14234
Program Year/Program:
1990 / SBIR
Agency Tracking Number:
14234
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
WHALEN BIOMEDICAL, INC
11 MILLER ST SOMERVILLE, MA 02143-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 1990
Title: BREAST PROSTHESES FOR SUBRADICAL SURGERY
Agency: HHS
Contract: N/A
Award Amount: $460,732.00
 

Abstract:

THE OBJECTIVE OF THIS PROJECT IS TO DEVELOP PROSTHESES FOR SUBRADICAL SURGERY AND RADIATION THERAPY COSMESIS. THE PROSTHESES EMPLOY AN INTEGRALLY TEXTURED SILICONE RUBBER SURFACE AT THE TISSUE INTERFACE THAT PROMOTES TISSUE ATTACHMENT TO THE PROSTHESIS AND MINIMIZES TISSUE CAPSULE FORMATION AROUND THE IMPLANT. THE PROSTHESES ARE FILLED WITH A READILY METABOLIZED, NONTOXIC LIQUID TO DIMINISH ANY COMPLICATIONS RELATED TO LEAKAGE. THEY ARE ALSO PERCUTANEOUSLY ADJUSTABLE IN VOLUME IN ORDER THAT AN OPTIMALCOSMETIC RESULT CAN BE ACHIEVED AFTER HEALING OF THE PERI- IMPLANT TISSUES. THE FIRST TASK IS THE MANUFACTURE OF HARDWARE TO FABRICATE THE DEVICES USING VACUUM MOLDING METHODS. A SERIES OF EXPERIMENTS USING ADULT RABBITS WILL THEN BE EMPLOYED TO (1) EVALUATE THE PERFORMANCE AND SAFETY OF THE PERCUTANEOUS FILLING PORT USED TO ADJUST THE VOLUME OF THE IMPLANTED DEVICES, AND (2) CHARACTERIZE THE EFFECTS OF VOLUME ADJUSTMENTS ON TISSUE CAPSULE STRUCTURE. SUSCEPTIBILITY OF THE IMPLANT SITES TO INFECTION WILL BE INVESTIGATED, AS IT IS LIKELY THAT HEALED TEXTURED SURFACE IMPLANTS ARE MORE RESISTANT TO BACTERIAL COLONIZATION THAN IDENTICAL SMOOTH SURFACE DEVICES, POSSIBLY MAKING THEM LESS SUBJECT TO CAPSULAR CONTRACTURE. FINALLY, A SERIES OF EXPERIMENTS TO DETERMINE THE EFFECTS OF RADIATION THERAPY ONTISSUE CAPSULE MORPHOLOGY WILL BE CONDUCTED USING A REGIMEN TYPICALLY FOLLOWED FOR LUMPECTOMY PLUS RADIATION. THESE STUDIES ARE DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF THE PROSTHESES FOR SUBSEQUENT CLINICAL TRIALS. AWARDEE'S STATEMENT OF THE POTENTIAL COMMERCIAL APPLICATIONSOF THE RESEARCH: SEGMENTAL MASTECTOMY (LUMPECTOMY) PLUS RADIATION IS BEING UTILIZED WITH INCREASING FREQUENCY IN PREFERENCE TO RADICAL MASTECTOMY. THESE DEVICES FILL THE NEED FOR AN IMPLANTABLE PROSTHESIS TO ACHIEVE A MORE DESIRABLE COSMETIC RESULT AND OFFER THE UNIQUE FEATURE OF MINIMALLY INVASIVE POSTOPERATIVE ADJUSTMENT.

Principal Investigator:

Robert L Whalen
6176613693

Business Contact:

Small Business Information at Submission:

Whalen Biomedical Inc.
5 Howland St Cambridge, MA 02138

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