CytoVeris and AdventHealth Central Florida Join Forces for Clinical Study to Improve Prostate Cancer Outcomes

Study will explore how MarginASSURE, CytoVeris’ AI-powered imaging device, can help surgeons detect cancer in near real-time

CytoVeris, a medical device company developing AI-powered cancer imaging technologies to enable more precise surgical decision-making and improve patient outcomes, today announced the start of a new clinical research study to investigate the precision of using an AI-powered imaging device during surgery to improve prostate cancer margin assessment. This device, called MarginASSURE, is expected to provide more precise surgical decision-making in real-time while also improving patient outcomes.

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The study, a collaboration between CytoVeris Inc. and AdventHealth Central Florida, will focus on CytoVeris’ multispectral imaging capability for the intraoperative assessment of cancer margin during robotically assisted radical prostatectomy (RARP) surgery.

The study will only involve U.S.-based surgeries at the AdventHeath Celebration facility and will be led by Vipul Patel, M.D., founder and medical director of the Global Robotics Institute at AdventHealth Celebration, and his team. Patel is world-renowned for his contribution to the field of robotic-assisted surgery and is one of the most experienced robotic surgeons in the world, having personally performed over 16,000 robotic prostatectomies.

“We are very excited to extend our technology to help surgeons and their patients undergoing prostatectomy in collaboration with one of the world’s leading surgeons in Dr. Patel and the outstanding team at AdventHealth,” said Patrick Curry, COO of CytoVeris. “Having demonstrated the technology in bladder and breast cancer surgery, this is the next impactful indication for our platform.”

Why it matters:
According to the American Cancer Society, prostate cancer is second only to skin cancer among the most common cancers in American men. This year, it is estimated that the U.S. will see 288,300 new cases of prostate cancer resulting in 34,700 deaths. Among men diagnosed with prostate cancer this year, approximately 90,000 will undergo RARP surgery [1]. Post-surgical positive margin rates are generally only in the 20% range which can lead to complications and poorer patient outcomes [2].

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How the device will be used in the study:
During the course of the multi-year study, Patel will collaborate with CytoVeris in adapting and developing its imaging platform for prostate cancer margin assessment.

“In the operating room, every move is critical. Robotic devices are changing the way we (surgeons) operate by providing more precision, therefore better patient outcomes,” Patel said. “This study will attempt to demonstrate the capability of MarginASSURE and its ability to detect cancer in near-real time in a label-free manner through the development of advanced tissue characterization technologies that can identify cancer tissue, assess margins, and identify critical tissue structures.”

The CytoVeris system is based on proprietary Multi-Spectral Tissue Auto-Fluorescence (AF) Imaging technology that analyzes the “optical fingerprint” of tissue due to its intrinsic biomolecular and morphological characteristics, without the use of dyes or imaging agents.

The prostate imaging device, named MarginASSURE, is designed to provide rapid margin assessment of excised prostate specimens and deliver to the surgeon actionable data to help guide the surgical steps required to better optimize patient outcomes, while also optimizing nerve sparing.

The project work will incorporate and correlate pre-operative MRI imaging of tumors with the MarginASSURE imaging of RARP specimens suspect of extraprostatic/extracapsular extension of cancer into the periprostatic soft tissues.

“CytoVeris was founded on the vision that, by leveraging advanced optical imaging and artificial intelligence, surgeons will have the ability to visualize cancer when it matters most – in the operating room,” said Dr. Alan D. Kersey, Ph.D., president & CEO of CytoVeris. “This clinical research study aims to demonstrate and validate our technology in prostate cancer, opening doors to further optimize patient outcomes.”

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