PARIS--(BUSINESS WIRE)--Sensome, the pioneer of microsensing technology for instant intra-operative tissue analysis, announced today that the first eight patients have been enrolled in the first-in-human INSPECT study of its novel microsensor technology being developed to instantly detect cancerous tissue during transbronchial biopsy of endobronchial tumors and peripheral lung nodules.
The Sensome technology is intended to be a real-time, in situ system to confirm placement of a biopsy needle within a tumor without reliance on additional imaging modalities. This novel tool-in-lesion system integrates the Company’s impedance tissue microsensor and is designed to guide the bronchoscopist in precisely locating the biopsy site, with the goal of reducing delays in the diagnosis and treatment of lung cancer.
“Lung cancer is the most common and deadly cancer in the world, killing almost two million people globally each year. With the growth of lung cancer screening, it is urgent that we improve the efficiency of diagnosing patients with lung cancer and getting them to treatment, beginning with how biopsies are performed. The earlier we can successfully biopsy and diagnose the disease, the better the outcome for the patient,” said Associate Professor David Fielding, Director of Thoracic Medicine at Royal Brisbane and Women’s Hospital in Australia and principal investigator of the INSPECT study, who performed the first cases.
“Lung cancer is challenging to diagnose today, with an up to 58% failure rate in obtaining a successful biopsy, which causes repeat procedures and treatment delays. An easy-to-use, in situ tool-in-lesion system that can make us better and more successful bronchoscopists would be a paradigm shift in the biopsy of peripheral lung nodules,” added Amir Hanna, MD, coordinating investigator of the INSPECT study at Lannelongue Hospital, France.
The INSPECT study is a first-in-human, multi-center, single-arm study evaluating the ability of the Company’s proprietary in situ tool-in-lesion system to successfully identify lung lesion tissue, and differentiate between healthy and diseased tissue.
“We are excited to be expanding the indications for our microsensor technology platform into interventional oncology with initiation of this clinical study, which follows our successful initial clinical work in ischemic stroke and peripheral artery disease. The prospect of being able to positively affect the trajectory of lung cancer patients with our technology is an exciting one,” said Franz Bozsak, CEO and co-founder of Sensome. “The potential for our microsensor platform is tremendous, as the ability to instantly analyze tissue intra-operatively could transform the success and economics of innumerable minimally invasive procedures throughout the body.”
ABOUT THE SENSOME TUMOR CONFIRMATION TECHNOLOGY
The company’s unique technology is based on electrical impedance spectroscopy, which measures the characteristics of tissue in 360° surrounding the sensor, analyzed by Sensome’s proprietary predictive algorithms. Sensome has miniaturized the sensor technology to enable it to be incorporated in a device that can be introduced through a biopsy needle into a lesion. The Sensome device is being developed to instantly confirm whether or not the tissue is cancerous so the biopsy can be successfully completed. The system is designed to seamlessly integrate with the current transbronchial biopsy workflow.
The Sensome tumor confirmation technology is considered an investigational device and is not approved for commercial use in the U.S or any other jurisdiction.
ABOUT SENSOME
Sensome, a clinical-stage healthtech start-up, has developed a patented, breakthrough microsensor technology that combines the world's smallest impedance-based sensor with predictive algorithms to identify and characterize biological tissues in real-time. The technology is currently being studied in three different clinical indications: clot characterization (ischemic stroke), total occlusion characterization (peripheral vascular disease) and in situ tool-in-lesion confirmation (lung cancer). Sensome intends to partner with leading medtech companies to design, manufacture and distribute smart medical devices integrating its proprietary microsensing technology. The company is partnered with leading guidewire manufacturer ASAHI INTECC for manufacturing of the Clotild® Smart Guidewire System for ischemic stroke, and with Cosmotec for distribution of that device in Japan upon regulatory approval.
