ARTIDIS Launches Groundbreaking ANGEL Study With Over 2,700 Participants: Transforming Breast Cancer Diagnosis & Personalized Therapy Optimization at the Patient's Bedside

ARTIDIS recently announced the launch of its global multicenter clinical trial, ARTIDIS Nanomechanical Generated Measurements for Early Lesions (ANGEL – NCT06085833). Spearheaded by Dr. Alastair Thompson, Olga Keith Wiess, Chair of Surgery and Chief of the section of Breast Cancer Surgery at Baylor College of Medicine, this study aims to revolutionize breast cancer care using tissue nanomechanics to enhance diagnostics and optimize treatments. The study aims to enroll over 2,700 patients, generating comprehensive insights into all breast cancer subtypes.

Drawing on a decade of impactful scientific research and literature, the ARTIDIS Nanomechanical Signature accurately gauges the mechanical properties of fresh tumor tissues to predict malignancy, aggressiveness, and treatment outcomes, while preserving tissue integrity for downstream measurements. Understanding nanomechanics is crucial as it determines cancer cell movement, intravasation, and the development of micro-metastases, often signifying aggressiveness. For instance, nanomechanical properties play a pivotal role in the metastasis process, where breast cancer cells can travel and grow in organs like the liver or lungs.

Integrated seamlessly into standard of care workflows, the ARTIDIS bedside device provides a rapid tool to identify malignant tissue and maintain tissue integrity for further assessments. Furthermore, the state-of-the-art ARTIDISNET combines clinical achievement data with the Nanomechanical Signature to offer a next-generation, integrated approach to personalized patient diagnostics and treatment. The innovative approach of the ARTIDIS Nanomechanical Phenotype platform has the potential to reshape first-line neoadjuvant therapy decisions by identifying malignant lesions capable of forming micro-metastases at the time of diagnosis.

The ANGEL study aims to validate the clinical utility of the Nanomechanical Signature by evaluating ARTIDIS’ ability to assess bedside biopsies and accurately identify breast cancer subtypes as well as predict clinical outcomes and treatment response, especially in the realm of neoadjuvant therapy (NAT). Building on the NANO study at the University Hospital Basel, which confirmed the clinical value of the Nanomechanical Signature in distinguishing benign and malignant breast lesions in 545 patients, the ANGEL study strategically complements ARTIDIS recently established alliances to demonstrate novel treatment-optimization tools for patients with solid tumors in several distinct indications.

Dr. Alastair Thompson said “As a breast surgeon, I believe this study holds immense importance for breast cancer patients. Behind it is the understanding that physical properties of cancer cells contribute to their aggressiveness and response to treatment, a concept that could revolutionize our approach to diagnosis and treatment. Near patient testing in the clinic by the ARTIDIS machine will deliver results almost in real time and support both diagnostic and treatment decisions. This study has exceptional potential to improve patient experiences and revolutionize the standard of care in breast cancer. It is a privilege to be a part of it.”

The first recruitment sites for the global ANGEL study include Baylor St. Luke’s Medical Center and the Harris Health Smith Clinic in Houston, Texas, while the Claraspital in Basel, Switzerland, will be the inaugural European center, with Dr. Rosanna Zanetti as the Lead Site Investigator. The study welcomes patients referred for biopsy or undergoing biopsy of a breast lesion following routine mammography, ultrasound, MRI, and/or clinical evaluation. All histological, imaging, treatment, and clinical outcome data will be integrated into the ARTIDISNET assessment. The study is estimated to complete enrollment within 24 months and includes a 10-year follow-up period.

Dr. Marija Plodinec, CEO of ARTIDIS, added “I am thrilled to have Dr. Thompson as the lead investigator in our groundbreaking clinical study. The ANGEL study specifically addresses the key challenges of personalized diagnosis and treatment decision-making, particularly in the field of neoadjuvant therapy. I am delighted that this clinical validation will enable us to deliver personalized diagnostics and treatment optimization to the patient bedside and help address and improve the entire patient journey.”

The ANGEL study is a significant step forward in realizing ARTIDIS’ vision of revolutionizing cancer care: it will provide patients with additional value without extra burden of cost or procedures and generate measurable patient-focused benefits such as reduced time-to-diagnosis, optimized and right-sized treatment choice and reduce side effects. Ensuring patients receive the best possible treatment from the start is crucial for improving outcomes for breast cancer patients. Learn more about ANGEL (NCT06085833) study at clinicaltrials.gov.

ARTIDIS is at the forefront of transforming cancer care, leading a mission to revolutionize treatment optimization across the entire patient journey, from central lab to patient bedside. By providing swift and precise diagnoses, along with predicting treatment responses from the very first biopsy, ARTIDIS is paving the way for a new era in cancer diagnostics. At the heart of their innovative medical technology lies a remarkable nanotechnology-based imaging modality, granting an unmatched and in-depth view of cancer at the cellular level. This groundbreaking technology centers around a unique Nanomechanical Signature – a tissue biomarker that accurately reflects the tissue phenotype. With a steadfast commitment to becoming the gold standard for tissue analysis and therapy optimization, this clinical stage company, headquartered in Basel, Switzerland, and with offices in Barcelona, Spain, and Houston, USA, aims to deliver substantial benefits to both patients and the healthcare system.