Scope: KYNETIC-Power Driven Bone Biopsy Trephine Needle System

With population aging and increasing comorbidity, a growing number of patients develop metabolic bone diseases (MBD) such as osteoporosis and renal osteodystrophy from the associated effects on bone turnover and mineralization. Conditions such as kidney disease, organ transplant, bariatric surgery, cancer, HIV/AIDS, glucocorticoid use and other diseases, result in a significant increase in MBD. Over the past decade, therapeutic options for MBD have expanded rapidly, creating opportunities for targeted treatments. A bone biopsy is the current gold standard for diagnosing the specific type of MBD and facilitates the optimal use of bone-active agents in treatment. It provides information about the mineralized component of bone: turnover, mineralization and microarchitecture. In practice, bone biopsies are performed with trephines that were designed primarily to harvest bone marrow even though both tissues are processed very differently. Qualitative and quantitative histology for a bone biopsy is performed on un-decalcified sections cut from hard resin- or polymer- embedded blocks, preserving the cortical and trabecular microarchitecture. The modern trephines still use a manual technique, and often yield suboptimal bone tissue cores with inadequate preservation of microarchitecture. The manual biopsy technique requires significant training for the operator and is painful to the patient. Power drill modifications, while easier and less painful, yield small cores and produce damage artifacts and debris from an inappropriately designed cutting edge paired with a high-speed drill. These known problems with bone biopsy technology ultimately decrease provider and patient acceptance reducing the accuracy of diagnosis, underscoring the technology gap in meeting the need for appropriate tools.