Long-term Percutaneous Access Device for Home Therapies

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$966,822.00
Award Year:
2004
Program:
SBIR
Phase:
Phase II
Contract:
9R44HL078294-02A1
Award Id:
46267
Agency Tracking Number:
1R43RR014399-01
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
300 RIVER PLACE, SUITE 6850, DETROIT, MI, 48207
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
ROGER SNYDER
(313) 446-2800
RSNYDER@LVADTECH.COM
Business Contact:
(313) 446-2800
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): The goal of this proposal is to finalize the development and begin the commercialization of an advanced percutaneous access device (PAD) appropriate for use in chronic home treatment modalities that require long-term body access, such as heart assist devices for treatment of chronic heart failure, total parenteral nutrition, drug delivery, and ambulatory peritoneal dialysis. The PAD is pre-seeded with autologous fibroblasts derived from a small sample of the recipient's skin. Cell seeding improves the device's clinical performance, creating a seal impervious to fluids and microorganisms and minimizing the risk from infection. The purpose of this project is to develop a new PAD, improving upon the first generation ViaDerm TM PAD that demonstrated multiyear stability in animal studies and has been used with excellent results in a series of 9 patients receiving a heart assist device for a total of 1054 patient days. The in vitro results of Phase I demonstrated that fibronectin provided for the best cell retention on the surface of the PAD, however, were insufficient to conclude which of 2 substrates, polycarbonate or polyurethane, provided for optimal protection of the device/tissue interface. The work under this phase II SBIR will focus on: 1) optimizing the device by finalizing the selection of the substrate for the new device, 2) optimizing the cell seeding process by pre-coating the surface with fibronectin and minimizing the overall time required for preparation of the device to make it commercially attractive. The specific aims are to improve the instrumentation and techniques for PAD preparation and to test the device in a series of long-term animal studies. To commercialize this product, the company plans to enter into strategic partnerships with, or license to, major corporations selling supplies to patients in each market. The new PAD is likely to be a premium product, but its cost will be outweighed by benefits of reduced hospitalization, disability and loss of earnings and by improved quality of life.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government