17.How does this product compare to other existing technologies for margin detection, such as MassPen, Margin Probe, and Confocal Laser Endomicroscopy (CLE), in terms of accuracy and effectiveness? Do you have enough clinical data to compare with other methods/devices?

The below Table provides some information about these four types of margin detection probes. The surgeon can select each of them based on their properties, performance, and application.

Technology Tested Margin numbers/patients Human in vivo/In vitro tests The type of cancer tested Declared Sensitivity /specificity Diagnosis declaration time The cost of the test The cost of the device
Mass Spec Pen

[1], [2]

253  patients In vitro and in vivo on the tumor side margins healthy and diseased thyroid, parathyroid, lymph node, breast, pancreatic, and bile duct tissues 96%-96% 10 sec. 100$ 150,000$
Margin probe

[3]

365 measurement sites In vitro on the tumor side margins Breast 67% – 60% 1 to 5 sec. 995$ 50,000$
Confocal Laser Endomicroscopy (CLE) [4] 709 patients Used by endoscopy channels to get the point and image patients with Gastrointestinal and Pancreatobiliary diseases 89%-75% Real-time Not Found Not Found
CDP 8000 human in-vivo clinical breast samples from more than 600 patients In vitro and in vivo on the cavity side margins Breast 93% – 91% 15 sec. Each head probe 20$ (100$ for each patient) 80,000 $

[1]   J. Zhang et al., “Nondestructive tissue analysis for ex vivo and in vivo cancer diagnosis using a handheld mass spectrometry system,” Sci. Transl. Med., vol, 9, no. 406, p. eaan3968, 2017.

[2]   J. Zhang et al., “Direct molecular analysis of in vivo and freshly excised tissues in human surgeries with the MasSpec Pen technology,” medRxiv, 2020.

[3]   LeeVan, Elyse, Be Thi Ho, Sadie Seto, and Jeannie Shen. “Use of MarginProbe as an adjunct to the standard operating procedure does not significantly reduce re-excision rates in breast-conserving surgery.” Breast Cancer Research and Treatment 183 (2020): 145-151.

[4]  Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastrointestinal endoscopy: technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022 Jan 25;7:7.

 

Apart from the differences in Margin mode, CDP is the only one which can be used in the detection of lymph node involvement in the absence of a frozen section and for non-sentinel lymph nodes based on Electrical Impedance Spectroscopy.