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Production, validation, and commercialization of MagniLium (hyperpolarized…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85607
Program Year/Program:
2007 / SBIR
Agency Tracking Number:
EB007439
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
XEMED, LLC
16 Strafford Avenue DURHAM, NH -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2007
Title: Production, validation, and commercialization of MagniLium (hyperpolarized helium
Agency: HHS
Contract: 1R43EB007439-01
Award Amount: $172,520.00
 

Abstract:

DESCRIPTION (provided by applicant): Hyperpolarized gas MRI offers unprecedented pulmonary functional diagnostic capability. Pharmaceutical companies require sensitive diagnostic end points to determine the efficacy of COPD therapies they have under devel opment and accelerate their progress through FDA approval and into the marketplace. Individual sufferers of COPD could benefit from improved diagnosis and treatment. The US healthcare budget could benefit if the 35B spent on the 30 million Americans suffe ring from COPD could be directed towards effective treatments through accurate assessments. The primary obstacle to progress has been the availability of high quality hyperpolarization technology and services for both technical and legal reasons. We see a clear path to overcoming those obstacles. We propose to assemble a world-leading 3He polarizer using the low-cost spin-exchange optical pumping technique. New optical pumping technologies, many developed by us only recently and others to be developed in th is proposal, will allow production of 55% polarization at 100 bar-liters per day and as high as 70% polarization at one-third that rate. This phase of the project includes submission of the product gas as an Investigational New Drug (IND) to the US FDA. A subsequent phase will include refinement and duplication of the prototype, utilization of the prototype to partner with clinical and pharmaceutical research centers for human trials, and submission of a New Drug Application (NDA) to the FDA. FDA safe harbo r laws protect drug development as a non-infringing activity.

Principal Investigator:

Jan H. Distelbrink
6038681888
JAND@PHYSICS.UNH.EDU

Business Contact:

William F. Hersman
hersman@xemed.com
Small Business Information at Submission:

XEMED, LLC
XEMED, LLC 16 Strafford Avenue DURHAM, NH 03824

EIN/Tax ID: 201331118
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No