Clinical trials

Results

In two recent papers [1-2], BM presented its Optical Transfer Diagnosis (OTD) method for differentiation between benign and malignant pigmented lesions with the objective to assess its potential by developing, training, and validating a diagnostic indication algorithm for automated discrimination between benign melanocytic lesions and malignant lesions. To that end, using second-generation BM-OTD devices, 712 pigmented lesions were captured and analysed, 415 being clinically and dermoscopically benign and 297 being dermoscopically suspicious or equivocal. All 297 suspicious or equivocal lesions were biopsied and examined histopathologically, and 80 of them were found to be malignant. The BM-OTD diagnostic indication algorithm misdiagnosed one of the 80 malignant lesions as benign (sensitivity, 99%), and the specificity was 93% for the dermoscopically benign lesions, 73% for all lesions included in the study, and 36% for the clinically suspicious but histopathologically benign lesions.

The results presented in [1-2] clearly highlight the potential of the BM-OTD technology. But the results are preliminary since they are based on clinical data recorded by a second-generation R&D prototype instrument, and since the number of lesions included in the study is small compared to the number of lesions included in the studies of our competitors (MelaFind [3-6], 1632 suspicious lesions; Nevisense [7], 2416 suspicious lesions). Therefore, BM will carry out an international pre-clinical testing phase for its third-generation device (the BM-Dermatoscope), after which BM will take its technology through pivotal clinical trials and seek regulatory FDA approval for use by General Practitioners (GPs) in USA. 

CE-marked BM-Dermatoscopes are currently used for tele-dermatology services in pharmacies in France and UK.


References

[1] J. J. Stamnes, G. Ryzhikov, M. Biryulina, B. Hamre, L. Zhao, And K. Stamnes, Biomed. Opt. Expr. 8, 2946-2964 (2017). https://doi.org/10.1364/BOE.8.002946.

[2] D.L. Swanson, R.V. Venneugues, S.Q. Vicensio, J. Garioch, M. Biryulina, G. Ryzhikov, B. Hamre, L. Zhao, F.S. Castellana, K. Stamnes, and J.J. Stamnes, Br. J. Dermatology 178, 541-546 (2018). doi: 10.1111/bjd.15898.

[3] G. Monheit, A.B. Cognetta, L. Ferris, H. Rabinovitz, K. Gross, M. Martini M, et al., Arch. Dermatol. 147(2):188-94 (2011).

[4] MelaFind® - P090012. [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2011 Nov 1. [cited 2014 Feb 21]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P0 90012b.pdf.

[5] Cleveland Clinic [Internet]. Cleveland: Cleveland Clinic. 2012 Oct 31 [cited 2014 Feb 21]. Available from:

http://my.clevelandclinic.org/media_relations/libra ry/2012/2012-10-31-cleveland-clinic-names-top- 10-medical-innovations-for-2013.aspx

[6] MelaFind [Internet]. Irvington (NY); 2014 [cited 2014 Feb 20]. Available from: http://www.melafind.com/patients/aboutmelafind

[7] J. Malvehy, A. Hauschild, C. Curiel-Lewandrowski, P. Mohr, R. Hofmann-Wellenhof, R. Motley, C. Berking, D. Grossman, J. Paoli, C. Loquai, J. Olah, U. Reinhold, H. Wenger, T. Dirschka, S. Davis, C. Henderson, H. Rabinovitz, J. Welzel, D. Schadendorf, and U. Birgersson, Br. J. Dermatology 171, 1099–1107 (2014). DOI 10.1111/bjd.13121


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