Sensome Reports Encouraging First-in-Human Clinical Results for Its Innovative In Situ Lung Tumor Detection Technology
Sensome has announced positive results from its first-in-human INSPECT clinical study evaluating the company’s microsensor-enabled smart stylet technology for bronchoscopic lung biopsy procedures. According to the company, the investigational technology successfully demonstrated the ability to safely and accurately distinguish cancerous tissue from healthy tissue during lung biopsies performed in real time.
The findings were presented at the annual meeting of the American Thoracic Society held in Orlando, Florida. The presentation was delivered by Amir Hanna, an interventional pulmonologist at Marie-Lannelongue Hospital and principal investigator of the INSPECT study.
Sensome is developing microsensing technologies designed to provide biological intelligence during minimally invasive medical procedures. The company’s smart stylet system integrates a proprietary sensor into a biopsy stylet, enabling physicians to analyze tissue characteristics during procedures without relying exclusively on imaging technologies or post-procedure pathology review.
The INSPECT study marks the first clinical evaluation of the company’s technology in human patients for bronchoscopic lung biopsy applications. According to the company, the results suggest the platform may help physicians improve biopsy accuracy, reduce non-diagnostic sampling, and accelerate the diagnosis of lung cancer.
Lung cancer remains the most common and deadliest form of cancer globally, accounting for nearly two million deaths each year worldwide. Medical experts consistently emphasize that early detection and treatment significantly improve survival outcomes. However, diagnosing lung cancer in its early stages continues to be a major challenge due to difficulties in obtaining accurate biopsy samples from suspicious lung lesions.
Current biopsy techniques often depend on imaging guidance methods such as fluoroscopy, computed tomography, or ultrasound. While these imaging systems help physicians navigate biopsy tools toward lesions, they do not directly identify whether tissue at the biopsy site is cancerous. As a result, clinicians may unintentionally sample healthy tissue, necrotic tissue, or non-diagnostic areas, leading to failed biopsies and delays in diagnosis.
According to data referenced by Sensome, conventional lung biopsy procedures can fail to obtain a successful diagnostic sample in as many as 58% of cases. These failures frequently result in repeat procedures, prolonged patient uncertainty, increased healthcare costs, and treatment delays that may extend for months.
Sensome’s smart stylet technology is designed to address this challenge by enabling real-time tissue characterization during bronchoscopic biopsy procedures. The device is intended to confirm whether the biopsy needle is positioned within cancerous tissue before tissue collection occurs, potentially improving diagnostic yield and reducing the need for repeat procedures.
The system functions as a “tool-in-lesion” confirmation platform intended to guide bronchoscopists toward optimal biopsy locations within both endobronchial and peripheral lung tumors. Unlike imaging systems that primarily visualize anatomical positioning, Sensome’s microsensor technology provides biological information about the tissue itself.
Dr. Hanna explained that the early study results demonstrated the smart stylet’s ability to accurately identify cancerous lesions amid the complex biological environment of lung tissue. He noted that the technology’s performance appears likely to improve further as the underlying algorithms continue learning from additional clinical data.
According to Hanna, the study suggests the technology may eventually exceed 90% overall performance as algorithm training expands. He stated that the findings support the potential value of the system as a real-time decision-support tool capable of helping physicians confirm proper sampling locations during lung biopsy procedures.
Hanna added that accurate confirmation of biopsy location could significantly improve diagnostic yield while helping shorten the timeline from initial suspicion to definitive lung cancer diagnosis and treatment initiation.
The INSPECT study was conducted as a first-in-human, multi-center, single-arm feasibility study involving 27 patients across clinical sites in Australia and France. During each procedure, the smart stylet was inserted into the biopsy needle, and tissue measurements were collected immediately before biopsy sampling occurred.
The resulting tissue classifications generated by the device were subsequently compared against histopathology findings to evaluate accuracy. Study data were also validated using cross-validation methodologies.
According to the study findings, the smart stylet successfully differentiated cancerous tissue not only from healthy lung tissue but also from other abnormal non-cancerous tissue types, including necrotic tissue. This distinction is clinically important because necrotic or damaged tissue may appear suspicious on imaging but does not provide useful diagnostic information when biopsied.
Within the relatively small dataset of 27 patients, Sensome’s technology achieved an overall accuracy rate of 80.9% in differentiating healthy tissue from abnormal lung tissue. The device demonstrated sensitivity of 88.5% and specificity of 71.4% for this classification task.
In distinguishing cancerous tissue from all other tissue categories, including non-cancerous abnormal tissue, the technology achieved an overall accuracy rate of 78.7%, with sensitivity measured at 78.3% and specificity at 79.2%.
While the study was limited in scale, Sensome believes the results provide strong evidence supporting continued development and larger clinical evaluations of the platform.
David Fielding, Director of Thoracic Medicine at Royal Brisbane and Women’s Hospital and principal investigator in the INSPECT study, highlighted the increasing importance of efficient lung biopsy technologies as global lung cancer screening programs continue to expand.
According to Fielding, broader adoption of lung cancer screening is leading to a substantial increase in the number of patients requiring diagnostic biopsy procedures. He noted that healthcare systems need improved diagnostic tools capable of supporting timely and accurate evaluations as screening volumes rise.
Fielding stated that the INSPECT study results suggest Sensome’s smart stylet may help address this growing clinical demand while integrating effectively into existing bronchoscopic workflows already used by pulmonologists and thoracic specialists.
Franz Bozsak, CEO of Sensome, explained that the company’s goal is to provide clinicians with actionable biological information during procedures so they can confirm they are sampling cancerous tissue rather than healthy or non-diagnostic tissue.
Bozsak emphasized that biopsies of non-cancerous tissue do not contribute to accurate diagnosis and often force patients to undergo additional procedures, increasing delays and anxiety. He said the company aims to eliminate much of the trial-and-error process currently associated with bronchoscopic biopsy procedures.
According to Bozsak, the smart stylet is designed to function similarly to conventional biopsy stylets already familiar to clinicians, but with the addition of integrated sensing technology capable of delivering real-time biological intelligence during the procedure.
He added that the company is highly encouraged by the positive findings from the feasibility study and expects future versions of the technology to achieve even greater levels of accuracy as machine learning algorithms continue to improve using larger patient datasets.
The INSPECT study represents an important step in Sensome’s broader effort to develop real-time sensing technologies capable of transforming minimally invasive procedures across multiple clinical specialties. By integrating biological sensing directly into procedural tools, the company aims to improve physician decision-making, procedural efficiency, and patient outcomes.
As lung cancer screening programs continue expanding globally, demand for reliable diagnostic procedures is expected to increase substantially. Technologies capable of improving biopsy accuracy and reducing delays in diagnosis may therefore become increasingly important components of future pulmonary care pathways.
With encouraging first-in-human data now presented at the American Thoracic Society meeting, Sensome plans to continue advancing its smart stylet technology through additional clinical studies aimed at validating performance across larger patient populations and more diverse clinical settings. The company believes its microsensing platform could eventually help establish a new standard for real-time tissue analysis during minimally invasive diagnostic procedures.
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.
