The OsteoAccess System – Low-Force, Controlled Angled Bone Access for Bone Biopsy and Bone Marrow Aspiration

M.L. Mulvihill, E.D. Ashuckian, J.K. Greaser, H. Hartung, K.M. Erdley, R.B. Bagwell
Actuated Medical Inc,
United States

Keywords: bone biopsy, cancer diagnostics

Summary:

Many medical procedures and diagnostics require penetrating hard cortical bone. For example, biopsies and aspirates taken from within bone are used to diagnose a wide range of cancer and blood diseases. Sampling locations can include the iliac crest (hips), legs, arms, spine, or ribs. Significant force is required to insert the standard needles, and the needle must be inserted perpendicular to the bone surface to avoid slipping from the target. This high force and perpendicular insertion also complicates and limits procedure planning - particularly the starting point and direction from which the doctor will access the target site. In addition, this force often results in inadequate sample collection (samples crushed), clinician fatigue, and increased patient anxiety, discomfort, and healing time. The significant insertion forces also increase the procedure risk when sampling bones in areas with delicate tissue nearby, such as the spine or ribs. The OsteoAccess System is an innovative bone access device that reduces insertion force, improves clinician control, and provides more favorable paths for entry into the target. OsteoAccess’ patented technology oscillates a needle under precise electronic control to enable low-force, angled penetration of rounded, hard surfaces – where traditional needles and drill bits tend to slip dangerously off the surface. The first commercial device will be the OsteoAccess-Biopsy for bone marrow biopsy and bone marrow aspiration. The biopsy system will be followed by systems for bone marrow harvesting and transplants, non-urgent intraosseous access, fracture reduction, scoliosis surgery and pedicle probe placement. OsteoAccess is being developed using a National Institutes of Health / National Cancer Institute (NIH/NCI) Small Business Innovation Research (SBIR) Phase II grant. Pediatric Indication - Actuated Medical, Inc. (Bellefonte, PA) was one of two companies that received a seed grant from the Philadelphia Pediatric Medical Device Consortium (PPDC) (funded by the FDA) - based at the Children’s Hospital of Philadelphia. This funding was awarded to develop OsteoAccess Jr., a device for pediatric bone biopsy and bone marrow aspirations. For children, the procedure is done under general anesthesia and no guidance (CT or other radiation-based imaging) is used. OsteoAccess Jr. offers the reduced force and angled entry, discussed above, to improve sample quality and results in reduced reoperation rates for these fragile patients. AMI is working with Helge Hartung, M.D., Pediatric Hematologist, The Children’s Hospital of Philadelphia on this device. Actuated Medical has spun out OsteoAccess, Inc. to focus on commercializing these low force bone entry medical devices that improve patient outcomes and reduce healthcare costs. Globally, 3.9 million bone marrow biopsies are conducted to diagnose cancer or determine treatment status each year. In addition, 100k percutaneous bone lesion biopsies are performed annually. The bone biopsy market is estimated at $220MM.