Clinical Trials Critical for the Evaluation of Advanced Medical Imaging Tools

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New York, NY – April 14, 2021 – Image-guided surgery offers surgeons greater control of the procedure and real-time feedback, thus providing better outcomes for patients. Accuracy in surgical procedures is critical for serious or life-threatening conditions, such as cancer, and medical technology companies are providing imaging tools to help surgeons deliver better results to their patients. Companies such as Perimeter Medical Imaging AI (TSXV:PINK), Butterfly Network (NYSE:BFLY), ENDRA Life Sciences Inc. (NASDAQ:NDRA), Asensus Surgical Inc. (NYSE:ASXC), and Avinger Inc. (NASDAQ:AVGR) have engaged in the research and development of advanced imaging tools for use in different procedures. In addition to the development of these tools, these companies are seeking regulatory approval and collaborating in clinical studies that provide data on the application of these imaging tools.


Perimeter Medical Imaging Announces Clinical Study Using OCT Imaging System


Perimeter Medical Imaging AI (TSXV:PINK), an early-stage medical device company seeking to transform cancer surgery with ultra-high resolution, real-time, advanced imaging tools, recently announced the FDA 510(k) approval for the company’s Optical Coherence Tomography (OCT) Imaging System, designed to examine tissue microstructures during surgery by providing cross-sectional, real-time margin visualization.


Since the approval of the imaging system, Perimeter Medical Imaging AI has announced a collaboration with Dr. Beth DuPree, a surgeon at Northern Arizona Healthcare Verde Valley Medical Center for a clinical study that will evaluate the use of Perimeter’s OCT imaging system during breast-conserving surgery.


For most breast cancer patients, the complete removal of cancerous tissue while conserving as much healthy tissue as possible is often a challenge. Perimeter’s OCT Imaging System allows surgeons to get clear margins, thus eliminating the need for re-operation and the associated complications and costs.


The goal of this study is to demonstrate the effectiveness of Perimeter’s OCT imaging system during clinical procedures to improve precision when excising tissue during surgery.


Commenting about the study, Dr. Beth DuPree said, “I am excited to lead this study using Perimeter’s OCT Imaging System, which provides ultra-high resolution visualization of a specimen in real-time. The use of this technology in my OR adds to my confidence in the final margin status, for patients, the need to re-operate can cause emotional stress, discomfort, and inconvenience, while potentially delaying other treatment and therapies. This is a non-invasive technology that aims to provide better ‘peace of mind’ for both the patient and surgeon while lowering the likelihood of needing to reschedule another surgery. It is my hope that the data generated from this study will help validate the use of this technology in breast conservation surgery and ultimately create better results for my patients.”


The study is open to patients at the Northern Arizona Healthcare Verde Valley Medical Center.


Perimeter also announced an update to its ATLAS AI Project, which is working on advancing the company’s next-gen artificial intelligence and machine learning tools through clinical development. Perimeter’s proprietary “ImgAssist” AI technology has been tested and trained using an extensive dataset of excised breast tissue images collected during the first stage of the ATLAS AI Project.


Collaborations and Regulatory Approvals Driving the Adoption of Advanced Medical Tools


The president and CEO of Butterfly Network (NYSE:BFLY) in a March 29 conference call with investors outlined the company’s plans to expand in different directions, including creating new uses for its portable ultrasound technology. The company is aiming to forge new collaborations with clinical partners and healthcare organizations that will adopt Butterfly’s technology. Butterfly has already secured partnerships with the American College of Cardiology and Atrium Health to expand the use of its iQ+ whole-body ultrasound device in cardiovascular care. Butterfly also received $584 million as part of its $1.5 billion deal with Longview Acquisition Corp.


Pioneer of enhanced ultrasound technologies, ENDRA Life Sciences Inc. (NASDAQ:NDRA) has been collaborating with key players conducting clinical trials for various conditions using its Thermo Acoustic Enhanced Ultrasound (TAEUS). ENDRA announced a partnership with Inselspital University Hospital in Bern Switzerland for a clinical study of the TAEUS device for assessing Non-Alcoholic Fatty Liver Disease. ENDRA also signed a collaboration agreement with Hepion Pharmaceuticals, a clinical-stage biopharmaceutical company. In this agreement, Hepion will use ENDRA’s TAEUS as an add-on technology in the Phase 2b clinical development of CRV431, which targets non-alcoholic steatohepatitis and other liver diseases.


Asensus Surgical, Inc. (NYSE:ASXC), formerly TransEnterix Inc., is a medical device company at the forefront of Performance Guided Surgery. It recently announced an FDA clearance for its Senhance Surgical System, a laparoscopic platform that uses augmented intelligence to provide unmatched performance and patient outcomes through machine learning. This approval comes after an earlier announcement in January 2021, where the company received the CE mark of approval for its Intelligent Surgical Unit for the Senhance Surgical System use in Europe. “The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” said Anthony Fernando, Asensus Surgical President and CEO. “General surgery is, by far, the largest area of manual laparoscopy which can benefit from the precision and insight of Performance-Guided Surgery… including previous indications granted, the Senhance Surgical System can now be utilized in over 2.7 million general surgical procedures performed in the US annually.”


Avinger Inc. (NASDAQ:AVGR) is a commercial-stage medical device company responsible for the marketing of the first and only intravascular image-guided, catheter-based system for the diagnosis and treatment of patients with peripheral artery disease. The company recently announced that it received 510(k) clearance from the FDA for its Ocelaris, a next-generation image-guided chronic total occlusion crossing system, which will be marketed under the brand name Tigereye. Avinger received the clearance for Tigereye in 2020 and has since launched the CTO crossing system in 30 clinical sites with more than 160 cases successfully performed.


Medical device companies such as Perimeter Medical Imaging AI continue to advance the industry, leading not only to potential breakthroughs that could change how surgeries are performed, but also to better outcomes for the patients.


For more information on Perimeter Medical Imaging AI (TSXV:PINK), click here.


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