Sensome Announces Positive First-in-Human Study Results for In Situ Tumor Detection Technology for Lung Cancer

Study Showed Smart Stylet Accurately Identified Cancer in the Lung, with Potential Implications for Improving Biopsy Yield

PARIS--(BUSINESS WIRE)--#cancer--Sensome, the pioneer of microsensing technology for real-time, intra-operative tissue analysis, today announced positive results from its first-in-human INSPECT study evaluating its microsensor technology integrated into a smart stylet for bronchoscopic lung biopsy. The study showed that Sensome’s tumor detection technology safely and accurately identified and differentiated between cancerous tissue and healthy tissue. The study was presented today by Amir Hanna, MD, Interventional Pulmonologist and Principal Investigator of the INSPECT study for Marie-Lannelongue Hospital, France at the annual meeting of the American Thoracic Society (ATS) in Orlando, Florida.

Lead author Dr. Hanna commented, “In this early study, the smart stylet accurately identified lesions or cancer amid the complex conditions of in situ lung tissue. With the learning curves of the technology’s algorithm suggesting the potential to exceed 90% overall performance,¹ these results show clear promise for real-time decision support during lung biopsy. By confirming relevant sampling sites and tool-in-lesion, this technology holds promise to significantly boost biopsy diagnostic yield and shorten the path to lung cancer diagnosis and treatment.”

Lung cancer is the most common and deadly cancer in the world, killing almost two million people globally each year. Detection of lung cancer in its early stages dramatically improves the five-year survival rate of patients when compared to late-stage detection. However, lung cancer is challenging to diagnose today with conventional methods, with an up to 58% failure rate in obtaining a successful biopsy,² which causes repeat procedures and treatment delays of up to six months.³

Sensome’s technology is intended to confirm placement of a biopsy tool within a tumor during bronchoscopic biopsy of endobronchial and peripheral tumors without reliance on additional imaging modalities, which are not able to identify cancerous tissue. The novel tool-in-lesion system is designed to guide the bronchoscopist in precisely locating optimal biopsy sites, with the goal of reducing delays in the diagnosis and treatment of lung cancer.

INSPECT Study Results

The INSPECT study is a first-in-human, multi-center, single-arm study of 27 patients across Australia and France. In each case, the smart stylet was placed inside the biopsy needle and tissue readings were taken immediately prior to biopsy of each patient, with histopathology confirming accuracy of the measurement. Results were validated using cross-validation.

In the study, not only was the smart stylet able to differentiate between cancer and healthy tissue, but it also differentiated cancer from other non-cancerous tissue, such as necrotic tissue. With a dataset of only 27 patients, the Sensome technology demonstrated 80.9% accuracy in differentiating healthy from abnormal lung tissue—achieving sensitivity of 88.5% and specificity of 71.4%—and 78.7% accuracy when differentiating cancer from all other types of tissues—achieving sensitivity of 78.3% and specificity of 79.2%.¹

“Lung cancer screening programs have commenced around the world, resulting in an explosion of demand for lung cancer biopsies. It is important that we have the tools that will enable us to respond to this new flood of patients with timely and accurate diagnosis,” 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. “The results from the INSPECT study suggest that Sensome’s smart stylet has the potential to provide this, especially as it integrates well into our existing workflow.”

“We have developed a tool designed to assist clinicians in the moment of action, to ensure they are performing a biopsy of the cancerous tumor and not healthy or other non-cancerous tissue; a biopsy of non-cancerous tissue is not useful in arriving at a diagnosis. Our goal is to eliminate the trial and error associated with mistakenly performing biopsy on tissue that delays cancer diagnosis and treatment,” said Sensome CEO Franz Bozsak. “Our technology works just like a conventional stylet used in biopsy today, except we have made it ‘smart’ with the integration of our sensor into the device, which provides biological intelligence. We are very encouraged by the positive results seen in this feasibility study and expect to see even greater accuracy from our technology in the future as its algorithms learn and improve from the additional patient data we will gather.”

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 detection and 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 microsensor 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.

The Sensome smart stylet technology is considered an investigational device and is not approved for commercial use in the U.S or any other jurisdiction.

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