In this Phase I NIH SBIR program, PRII will develop the Biopsy Force Reduction (BIFOR) Tool for adult patient Bone Marrow Biopsy. The BIFOR will reduce insertion force, improve biopsy sample quality and sampling rate success, and decrease patient discomfort and healing time. The Phase I feasibility study will determine if the BIFOR can reduce insertion force, improve biopsy sample quality, and is clinically desirable. Over 500,000 bone biopsies are performed every year in the United States. Inspection of the bone marrow is considered one of the most valuable diagnostic tools to evaluate hematologic disorders. Bone marrow biopsies are used to diagnose a variety of conditions including, leukemia, anemia, renal osteodystropy (ROD), tumors, osteoporosis, osteogenesis imperfect, Paget's disease, and other metabolic bone diseases The most commonly used site for the bone marrow biopsy is the anterior iliac crest. The major disadvantage is the force required to penetrate the cortical bone which is tiring to the clinician, often results in poor or crushed samples, and increases patient discomfort and healing time. Bone density and hardness can also vary significantly among patients, making it difficult for the clinician to obtain a suitable core. The Phase I Hypothesis is that an active motion technology device can be developed that reduces the force for penetrating cortical bone and improves bone marrow biopsy sample quality and reduces patient discomfort. The long-term objective of this work is to commercialize BIFOR in partnership with a major OEM. A tool that can reduce insertion force, decrease patient discomfort, and also improve biopsy core quality would generate significant commercial revenue.
This Phase I NIH SBIR will develop and test the Biopsy Force Reduction (BIFOR) Device for adult patient bone marrow biopsy. The BIFOR will reduce insertion force, reduce clinician fatigue, decrease patient discomfort and healing time, improve biopsy sample quality and sampling rate success.
