Fine Needle Aspiration Biopsies (FNAB) are widely performed due to their minimally invasive nature, low cost, and rapid turn around time for the diagnosis of various mass lesions such as cancer and infection. With increasingly, their use is expected to increase further mainly due to the escalating incidence of cancer. In the future, with the prevalence of in s- situ molecular techniques., FNAB will be the predominant and preferred method of tissue retrieval. Currently adapted hypodermic needles used for performing FNAB have many limitations including low reproducibility for adequate sampling A needle device that can overcome these drawbacks, therefore, has worldwide commercial potential. The present device is designed for a significantly higher and reproducible yield of diagnostic material even with minimum technical skill. This research is for finalizing he design to generate a prototype and prepare additional working models of this novel system. Tissue retrieval with these working models will be compared quantitatively and qualitatively with conventional hypodermic needs by performing experimental FNAB on beef liver. Depending on the results of this feasibility study, the molds of the final product will be made during phase II of the clinical trials are preparation towards commercialization (phase III).
This product has a worldwide market and could be easily marketed by many vendors. The average cost per unit would be $5 and is comparable to the cost of material currently used during FNAB procedure with modified hypodermic needle. Apart from the worldwide market, the potential market in United States alone should exceed $1,500,000 per year.
