Dilon Technologies Announces the Beginning of Enrollment in its Pivotal Trial of the Next Generation MarginProbe™ 2 Used in Real-Time Margin Assessment
05 Feb 2024
[05-February-2024]
NEWPORT NEWS, Va., Feb. 5, 2024 /PRNewswire/ -- Dilon Technologies Inc. announced today the enrollment of its first patient in the Prospective, Single-Arm, Multi-Center Pivotal Trial for its next generation MarginProbe™ 2 product used in real-time margin assessment. "It is thrilling to witness the development and launch of the MarginProbe™ 2 study. Being actively involved in advancing real-time margin assessment technology remains a significant and ongoing commitment for me," stated Dr. Mehran Habibi, MD, who is the Chief of Breast Surgery of the Western Region of Northwell Health in NY and Director of the Breast Program at Staten Island University Hospital. Dilon has 5 (five) US hospital sites approved and ready to begin enrolling patients. "I have already experienced great results with the current MarginProbe™ technology. Being a part of the trial for a next generation MarginProbe™ 2 that may yield a higher sensitivity may reduce the number of false negatives and help us do even better for our patients," stated Dr. Lori Alfonse, DO, Deputy Physician-in-Chief at the Lehigh Valley Health Network Cancer Institute based in Allentown, PA.
In the learning group , sensitivity in the MarginProbe™ 2 ranged between 75% - >90% sensitivity. Dilon has not seen other technology showing publicly available data with comparable sensitivity rates. "I've already been able to bring re-excision rates down to 4.5% using the current MarginProbe™ in my practice. Participating in a trial for the next generation device is extremely exciting to hopefully improve upon that," said Dr. Vincent Reid, MD, breast surgeon from Mercy Medical Center in Iowa. Dilon Technologies looks to continue building evidence around its MarginProbe™ platform that already has over 12 peer-reviewed publications demonstrating reduction in re-excision rates. "We remain committed to being a leader in women's healthcare by providing technology for patients that will improve their outcomes. MarginProbe™ is beginning to become an integral component of breast surgery for more surgeons across the United States each month," stated George Makhoul, CEO of Dilon Technologies.
About Dilon Technologies® Inc.
Dilon Technologies® Inc., a medical device manufacturer based in Newport News, Virginia, striving to improve the quality of care by providing a wide range of innovative medical device technology that benefits patients around the world. Dilon has a strong medical device portfolio which includes HEMOBLAST Bellows, the only combination powdered surgical hemostat that contains collagen, thrombin, and chondroitin sulfate, MarginProbe™, a groundbreaking technology for accurate, real-time margin assessment in breast cancer surgery, the Navigator System, a surgical gamma probe system for radio-guided lymphatic mapping and tumor localization, TrueView Pro 100, a specimen radiography system (SRS) that uses advanced radiography and automated software to precisely identify tumor lesions in resected or biopsied breast tissue, and the CoPilot, an innovative, portable, and easy to use video laryngoscope.
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