SBIR and STTR Success Story for
CFD Research Corporation

(Information Posted/Updated on 02/01/2005)

CFD Research Corporation
215 Wynn Drive
Huntsville, AL  35805

Contact:    Ashok K. Singhal
Phone:      256-726-4841
Fax:          256-726-4806
E-mail:      aks@cfdrc.com
Web Site:  http://www.cfdrc.com

Project Title:  Development of Improved Hemodialysis Catheter Designs
Related Award(s):  SBIR Phase I #1R43DK53114-01, SBIR Phase II #1R44DK53114-02
Technology Developed:
CFD Research Corporation has developed and patented a novel and significantly improved hemodialysis catheter (Patent # US 6,409,700 B1). This fixed tip catheter combines ease of insertion with high flow and very low recirculation, delivering the ultimate high efficiency dialysis. The catheter has been designed and optimized with extensive use of advanced computer simulations (computational fluid dynamics (CFD) and coupled fluid-structural interactions) and a complimentary series of experimental investigations.

Key Words:  Catheter, hemodialysis, access recirculation, suction pressure, hemolysis.
Uses of Technology/Products/Service:
The developed catheter has been specifically designed and tested for hemodialysis applications. Its uniquely engineered tip provides outstanding performance with the following characteristics:

- Improved functionality by reductions in occlusion potential, recirculation, and arterial suction pressure.

- Maximum arterial blood flow when the catheter tip contacts the vessel sidewall.

- Reduced red blood cell damage.

- Reduced blood clotting and potential side effects.

- Improved ease of insertion.

Benefits to dialysis patients will include increased safety and comfort level, and possibly a short therapeutic time.

Benefit to Company:
This SBIR program and other NIH funding have enabled CFDRC to broaden its expertise in developing biomedical devices using coupled virtual prototyping and experimental approach. This expertise has been applied to develop other devices and obtain more patents, leading to increased revenues and profitability of the company.

How Product Was Commercialized:
CFDRC patented the new design and, after investigation of several biomedical companies, selected Spire Biomedical Inc. as a commercialization partner for this product. CFDRC granted an exclusive license to Spire, with provisions for: (a) milestone payments, e.g. with FDA approval and launch of product, and (b) royalties based on net sales.

Other Comments Related to Company's Success Story:
The product has been launched recently, (October 27-31, 2004) in St. Louis, Missouri at the American Society of Nephrology Annual Conference.

The catheter sales revenues are expected to be tens of millions of dollars. It is a very competitive market space, and thus will require significant sales effort. The performance of the developed catheter is significantly better than the other catheters currently used. The initial feedback from leading nephrologists and vascular surgeons is very encouraging, and sales are expected to grow steadily.