Dilon Technologies Inc. has announced the U.S. Food and Drug Administration approval and U.S. launch of its MarginProbe 2 system, a next-generation device for real-time intraoperative margin assessment in breast cancer surgery. MarginProbe 2 aims to help surgeons achieve greater precision during breast-conserving surgeries, reducing the need for additional procedures and improving patient outcomes.

MarginProbe 2 builds on the success of the original MarginProbe, the only real-time margin assessment device on the market with a robust library of published data shown to reduce re-excisions by more than 54% on average, the company claims. Developed by Dilon’s team in Israel, the new system provides increased sensitivity on all tumors with an array of miniaturized sensors, enhanced detection algorithms, and seamless integration into the operating room workflow, allowing surgeons to make critical decisions with confidence while in the O.R. 

“MarginProbe 2 is a game-changer for breast surgery,” Dilon Technologies CEO George Makhoul stated. “By providing surgeons with immediate, reliable margin information, we’re helping reduce re-excision rates and improve the overall surgical experience for both patients and healthcare providers. No one wants to have to come back for a reoperation. Our goal is to make sure surgeons can get it the first time.”

The product’s sensitivity has increased to more than 76% on all specimens, which was reported in a U.S. pivotal study.  Surgeons can now select an option to have MarginProbe detect cancer by choosing DCIS (ductal carcinoma in-situ) or Invasive.  DCIS accounts for 31% of re-excisions in women ages 18-64 and 24% in women over the age of 65, according to a recent study published in the Annals of Surgical Oncology.¹ MarginProbe’s workflow is compatible with any hospital setting and the simple-to-use interface is maintained in this next-generation iteration. 

“Within three to five minutes I have immediate, binary results of positive or negative margins on my specimen. I can make a decision for my patient in real time, which has helped me maintain my 4.6% re-excision rate,” noted Dr. Vincent Reid from Mercy Hospital (Cedar Rapids, Iowa).

MarginProbe 2’s U.S. launch reflects Dilon’s commitment to advancing patient-first technologies that support more precise care and improved clinical outcomes, company bigwigs said. Dilon’s commercial team will now showcase the technology nationwide. 

“MarginProbe is straightforward to use in the O.R. and adds minimal time to the procedure. The device provides results that are easy to interpret and apply in real time for intraoperative lumpectomy margin assessment. The learning curve is short, and the MarginProbe can be utilized in any practice setting to support breast conserving surgery,” stated Dr. Freya Schnabel (NYU Langone).

“The changes made in this system to improve the sensitivity without sacrificing specificity are impressive,” added Dr. Jaime Alberty (NYC Health and Hospitals System). “DCIS is a major pain point in our re-excisions and anything we can reliably use to reduce that will be used.”

Newport News, Va.-based Dilon Technologies Inc. provides a range of medical solutions for patients worldwide. Dilon’s medical device portfolio includes: HEMOBLAST Bellows, the only combination powdered hemostat that contains collagen, thrombin and chondroitin sulfate; the Navigator 2.0 System, a surgical gamma probe for radio-guided lymphatic mapping and tumor localization, the MarginProbe, a groundbreaking technology for accurate margin assessment in breast cancer surgery, and the CoPilot, a portable, easy-to-use video laryngoscope.

Reference
¹ Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024 Feb 6. doi: 10.1245/s10434-024-14902-z.