Transbronchial Pressure Vacuum Actuated (TPVA) Micro Biopsy Capsule
Sanovas’ Flexible Transbronchial Pressure Vacuum Actuated (TPVA) Micro Biopsy Capsule overcomes the inherit risks and historic limitations of recovering tissue samples for pathologic analysis from within the airways. The need for minimally invasive methods of tissue diagnosis from lymph nodes as well as solid lesions in the mediastinum has been well established.
Historically, flexible transbronchial needle aspiration (TBNA) biopsy was a method used to obtain cytologic specimens from mediastinal lymph nodes for the diagnosis and staging of bronchogenic carcinoma. However, the dependence on a sophisticated cytologic laboratory along with the skill required to perform TBNA procedures and the inability to obtain enough tissue to diagnose noncarcinomatous processes in the mediastinum by smaller needles limited its use. Recently, real-time endobronchial ultrasound (EBUS) guidance has been entertained as a new method of TBNA to increase operative precision and to obtain larger sample yields of the mediastinal and hilar lymph nodes in determining a diagnosis. While proven to increase effectiveness, the new EBUS TBNA technique has been hampered by low yielding sample sizes, poor access and safety; due to the need to make multiple stabs/insertions of the needle into the target tissue to recover the requisite specimen yield.
This is especially true in the face of growing requirements to recover even larger cytologic specimens to facilitate advanced immunohistochemical (IHC) analysis. The innovations in biotechnology and personalized medicine have increased the diagnostic requirements needed to identify new oncogenes and oncoproteins, such as Anaplastic Lymphoma Kinase (ALK) fusion genes for non-small cell lung cancers (NSCLC). Accordingly, Sanovas TPVA Micro Biopsy Capsule requires only a single stab insertion into the target tissue; creating a fast, efficient and safe mechanism of delivery and action.
The system is expected to overcome the challenges of obtaining a good diagnostic yield from mediastinal and hilar lymph nodes that can be subjected to multimodal analysis of ALK fusion genes in NSCLC. The device further secures the specimen in a hermetically sealed chamber; mitigating sample loss and/or contamination of the specimen upon recovery and exit from the tortuous routes into and out of the airway. Sanovas EBUS - TPVA Micro Biopsy technology is intended to be a safe, practical solution that utilizes proprietary methods of pressure and vacuum actuation to enable IHC Marker Detection in enabling the next generation of Molecular Therapies.