ARTIDIS First Prospective Study, "NANO”, Evaluating its Nanotechnology Platform Based on a Novel Nanomechanical Biomarker in Breast Cancer Meets Primary Endpoint
Basel, Switzerland, June 22, 2020 – ARTIDIS AG, a clinical stage health-tech company, announced today that its proprietary nanotechnology platform for cancer diagnosis has met the primary endpoint in the “NANO” clinical study. NANO was designed to demonstrate the power of using a nanomechanical biomarker to evaluate breast biopsies within a routine clinical setting. Secondary analysis indicates that the nanomechanical biomarker can be used independently of histopathology to differentiate and further categorize specific molecular subtypes of breast cancer.
Data from this study will be presented as a late-breaking abstract at the virtual Annual American Association for Cancer Research (AACR) Meeting that takes place from June 22-24, 2020.
The primary endpoint of the study was to achieve a sensitivity (proportion of true positive results divided by the total number of patients with a malignant tumor) for cancer diagnosis of at least 90% (CI 95%). The analysis for the primary endpoint was performed on data obtained from 520 patients. Biopsy tissue was categorized as “normal”, “benign” or “malignant” based on a “Nanomechanical Score” as determined by the ARTIDIS nanotechnology platform. After the determination of the “Nanomechanical Score”, histological analysis of the same specimens was performed to serve as a gold standard for comparison with the “Nanomechanical Score".
ARTIDIS was able to detect cancer, including lesions with < 5% neoplastic tissue, with a sensitivity of 96% and a specificity of 78% (CI 95%, AUC = 0.94), meeting the primary study endpoint.
“We are very pleased with the excellent results from this first prospective study conducted in Switzerland. It demonstrates the clinical utility of the nanomechanical biomarker in a routine clinical setting at the patient bedside. We are convinced that this brings us one step closer to providing patients undergoing a biopsy procedure with a same day diagnosis, opening the path to personalized cancer treatment plans guided by the ARTIDISNet platform.” said Marija Plodinec, PhD, CEO of ARTIDIS AG.
ARTIDIS management team
Secondary endpoints evaluated the ability of the nanomechanical biomarker to distinguish and further categorize molecular subtypes of breast cancer based on their aggressiveness and potentially poor treatment response.
While exploratory, secondary analysis indicates that the nanomechanical biomarker can be used independently of histopathology to differentiate and further categorize specific molecular subtypes of breast cancer (sensitivity 83%, specificity 82%, CI 95%, AUC = 0.86). The study includes a long-term follow-up of the same patients after two, five, and ten years.
“Secondary analyses indicate that this novel technology will be able to subclassify the breast cancer subtypes into more or less aggressive subgroups, which could define the patients’ treatment plan and thus reduce over- and undertreatment.” commented Dr. Rosemarie Burian, gynecologist at the Breast Center, University Hospital Basel and lead investigator of the study.
About the “NANO” study
To demonstrate clinical utility of the nanomechanical biomarker as measured by the ARTIDIS nanotechnology platform, a blinded prospective clinical study led by Dr. Rosemarie Burian, was conducted at the Breast Center, University Hospital Basel and at the Biozentrum, University of Basel from 2016 until 2019.
All patients undergoing a core needle or vacuum biopsy of the breast qualified for the study. Within 3 hours, fresh biopsies were analyzed in a physiological solution to maintain their viability for consecutive histological and genetic analysis within the routine clinical workflow. In total, 588 biopsies from N=545 patients were analyzed with a drop-out rate of 4.5%. 61.8% were B1-B4 (normal, benign, of uncertain malignant potential, or suspicious) and 38.2 % were B5a – B5d (malignant). The majority of the B5b lesions were Luminal B, followed by Luminal A, Luminal B-like, Her2 and triple negative breast cancers.
The nanomechanical biomarker measurements of the same patients were comprehensively analyzed in relation to more than 180 structured clinical parameters per patient within the digital ARTIDISNet platform to further categorize molecular subtypes of breast cancer based on their aggressiveness and potential for poor treatment response.
“I am delighted that the “NANO” study met its primary endpoint”, said Dr. Burian. “I would like to thank my radiology colleagues Dr. Sophie Dellas and her team who were essential to the success of the study, Prof. Markus Tolnay’s wonderful team of pathologists, in particular Prof. Ellen Obermann, Sabine Schädelin from the Clinical Trial Unit of the University Hospital, as well as the Biozentrum team led by Prof. Roderick Lim for their continuous collaboration. And, of course, I thank each of the patients who consented to participate in our study and thus supported us in their very personal way”.
The Lead of the clinical study Dr. Rosemarie Burian
About ARTIDIS nanotechnology platform
ARTIDIS introduces a game-changing improvement in the field of cancer diagnostics and treatment by shortening the workflow of bedside biopsy analysis to less than three hours. The ARTIDISNet data platform integrates the mechanical biomarker data with other clinical parameters enabling personalized disease prognosis and aiding with treatment optimization, thereby significantly improving individual patient experience. Its sophisticated AI-powered algorithm allows healthcare professionals to gather insights into rich clinical data sets and supports them in tailoring the treatment of their patients securing better outcomes.
These aspects will be further examined in a multicenter study at centers in Switzerland, Germany, and the US. This will ensure that the current data is evaluated in an international setting and confirm its clinical validity across a wider cohort of patients.
“We are also expanding our clinical program to include the diagnosis of lung and pancreatic cancers and to identify its potential for treatment optimization in collaboration with centers in Barcelona, Spain, and the Texas Medical Center in Houston, US”, commented Dr. Marija Plodinec.
About breast cancer
Breast cancer is the number one cancer among women worldwide. Each year, 7.5 million women rely on accurate and fast diagnosis and personalized advice when undergoing routine biopsy. Existing diagnostic procedures are complex and can take up to a week or longer resulting in high anxiety and negative patient experience. Out of all biopsies analyzed, approximately 25% will render a cancer diagnosis. These patients will benefit from a reliable biomarker supporting much faster, accurate disease prognosis and treatment optimization.
About ARTIDIS AG
ARTIDIS AG is a clinical stage health-tech company located in Basel, Switzerland, that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNet digital platform, allowing physicians to significantly shorten the current diagnostic process bringing benefit to both the patient and the healthcare system. ARTIDIS applications are not limited to oncology, and its nanotechnology platform can be used to analyze any kind of living tissue. For more information please visit www.artidis.com
Abstract #9677: First clinical validation of the physical biomarker based on the nanomechanical tissue profiling for rapid breast cancer diagnosis, prognosis and prediction of treatment outcome
Poster Session Title: Late-Breaking Research: Clinical Research 2
Poster Number: LB-273
Additional information on the meeting can be found on the AACR website: https://www.aacr.org/meeting/aacr-annual-meeting-2020/aacr-virtual-annual-meeting-ii/
For further information please contact:
Dr. Marija Plodinec, CEO
Phone: +41 61 633 29 95
ARTIDIS Gains Strong Momentum in 2019 Raising CHF 8.8 Million in Seed Financing
Basel, Switzerland, December 5th, 2019 – ARTIDIS AG ("ARTIDIS"), a privately held healthtech company, announced today the successful closure of a CHF 8.8 million seed financing in two rounds securing early clinical validation and the next development phase towards market entry in 2021.
The funding will be used to advance the company’s healthtech platform into a large multi-centre clinical study together with the University Hospital Tuebingen (Germany), University Hospital Barcelona (Spain), and Texas Medical Center (Houston, US). The study will aim at providing further evidence verifying the value ARTIDIS is bringing for diagnosing breast and lung cancer, as well as for personalizing and optimizing cancer treatment. The results will support the regulatory submissions to the FDA and the European Notified Body to gain approval for the ARTIDIS medical device and data platform. This is one of the major prerequisites for ARTIDIS to enter the diagnostic market world-wide in 2021, thus, changing the standard of care for cancer patients.
Dr. Marija Plodinec, CEO of ARTIDIS commented: "The closure of this financing round and the successful recruitment of 545 patients in our first clinical study at the University Hospital Basel this year is a huge success. We are thankful for the support and trust of all our shareholders – together, we are opening a new chapter towards personalizing the patient journey."
The round was supported by family offices and private individuals from Switzerland and EU including BERNINA Bioinvest, Zurich and SMD MedicalTrade AG, Taegerwilen.
"We are extremely happy for the opportunity to invest in this promising company and support the great team of ARTIDIS on their mission to deliver fast diagnosis and personalized treatment to cancer patients." – stated Philipp Looser from SMD Medical Trade AG.
The management of BERNINA BioInvest commented: "ARTIDIS brings the future of cancer diagnostics and treatment to the patients and clinicians. We support ARTIDIS, because their approach will significantly optimize the diagnostics workflow and has the potential to revolutionize the way treatment decision-making is done, improving not only the personal patient journey but benefiting the whole healthcare ecosystem. We are confident that Marija Plodinec and her team have the expertise, the passion, and the drive needed to realize this vision."
Martin Gertsch, Chairman of the Board says: "We are very glad that we could also strengthen our Board of Directors during this year: Owing to their significant industry experience and diverse subject matter expertise, Ms Trudi Haemmerli, Board Member Innosuisse, and Dr. Reinhard Ambros, former Global Head of Novartis Venture Fund, were both elected as Board of Directors this year."
About ARTIDIS AG
ARTIDIS AG is a spinoff from the Biozentrum, University of Basel, Switzerland, that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNet digital platform, allowing physicians to significantly shorten the current diagnostic process and bringing benefit to both the patient and the healthcare system. ARTIDIS enables professionals to design personalized cancer treatment plans tailored to the individual patient needs and desired outcomes. For more information, please visit www.artidis.com.
For further information please contact:
Dr. Marija Plodinec, CEO
Phone: +41 61 633 29 95