Clinical trials - results

We have collaborated with with the globally renowned and leading medical institution, Mayo Clinic (US), for data collection and clinical trials. In two recent papers¹⁻², Balter presented its prototype DermoSight technology based on Optical Transfer Diagnosis (OTD) for differentiation between benign and malignant pigmented lesions with the objective to assess its potential by developing, training, and validating a prototype DermoSight diagnostic algorithm for automated discrimination between benign melanocytic lesions and malignant lesions. To that end, using second-generation DermoSight dermatoscopes, 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 DermoSight 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 in¹⁻² clearly highlight the potential of theDermoSight technology. But the results are preliminary since they are based on clinical data recorded by second-generation R&D prototype DermoSight dermatoscopes, 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 (MelaFind³¯⁶, 1632 suspicious lesions; Nevisense⁷, 2416 suspicious lesions).

DermoSight received US FDA clearance in May 2023 for teledermatology screening of suspect skin cancer lesions. We are ready to enter the US market, having already performed over 200,000 skin lesions assessments in pharmacy and primary care to date in Europe with our CE-marked DermoSight dermatoscope.  Next step is to take DermoSight technology through pivotal clinical trials and seek regulatory FDA approval for use by General Practitioners (GPs) in USA.

References:
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[1] J.J. Stamnes, G. Ryzhikov, M.Biryulina, B. Hamre, L. Zhao, andK. 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. MartiniM, et al., Arch. Dermatol. 147(2):188-94 (2011).

[4] MelaFind® - P090012. [Internet]. Silver Spring (MD): U.S. Food and DrugAdministration; 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, andU. Birgersson, Br. J. Dermatology 171, 1099–1107 (2014). DOI10.1111/bjd.13121

Publications, Presentations, Dissertations

Publications related to the development of the DermoSight technology for tissue diagnostics

1. D.L. Swanson, R.V. Venneugues, S.Q. Vicencio, J. Garioch, M. Biryulina, G. Ryzhikov, B. Hamre, L.Zhao, F. S. Castelana, K. Stamnes, and J.J. Stamnes, Optical transfer diagnosis differentiating benigand malignant pigmented lesion in a simulated primary care practice", Br. J. Dematology 178, 541-546 (2018).

2. J.J. Stamnes, G. Ryzhikov, M. Birryulina, B. Hamre, L. Zhao, and K. Stamnes, Optical detection andmonitoring of pigmented skin lesions, Biomed. Opt. Expr. 8, 2946-2964 (2017).

3. D. Cohen, S. Stamnes, T. Tanikawa, E.R. Sommersten, J.J. Stamnes, J.K. Lotsberg, and K. Stamnes, Comparison of discrete ordinate and Monte Carlo simulations of polarized radiative transfer in two coupled slabs with different refractive indices, Opt. Expr. 21, 9592-9614 (2013). DOI:10.1364/OE.21.009592.

4. Bhandari, S. Stamnes, B. Hamre, Ø. Frette, K. Stamnes, and J.J. Stamnes, Stokes scattering matrix for human skin, Appl. Opt. 51, 7487-7498 (2012).21. D. Cohen, S. Stamnes, T. Tanikawa, E.R. Sommersten, J.J. Stamnes, J.K. Lotsberg, and K. Stamnes, Comparison of discrete ordinate and Monte Carlo simulations of polarized radiative transfer in two coupled slabs with different refractive indices, Opt. Expr.

5. 14549-14567 (2011).19. Ø. Svendsen, M. Kildemo, J. Maria, J.J. Stamnes, and Ø. Frette, Mueller matrix measurements and modeling pertaining to Spectralon white reflectance standards, Opt. Expr. 20, 15045-15053 (2012).

6. A. Bhandari, B. Hamre, Ø. Frette, K. Stamens, and J.J. Stamnes, Modeling optical properties of human skin using Mie theory for particles with different size distributions and refractive indices, Opt. Expr.

7. A. Bhandari, B. Hamre, Ø. Frette, L. Zhao, J.J. Stamnes, and M. Kildemo, Bidirectional reflectance distribution function of Spectralon white reflectance standard illuminated by incoherent unpolarized and plane-polarized light, Appl. Opt. 50, 2431-2442 (2011).

8. D.L. Swanson, S.D. Laman, M. Biryulina, K.P. Nielsen, G. Ryzhikov, J.J. Stamnes, B. Hamre, L. Zhao, E.R. Sommersten. F.S. Castellana, and K. Stamnes, Optical Transfer Diagnosis of Pigmented Lesions, Dermatol Surg. 36, 1979-1986, (2010) DOI: 10.1111/j.1524-4725.2010.01808.x.

9. E.R. Sommersten, J.K. Lotsberg, K. Stamnes, and J.J. Stamnes, Discrete ordinate and Monte Carlo simulations for polarized radiative transfer in a coupled system consisting of two media with different refractive indices, J. Quant. Spectr. Radiat. Transfer 111, 616-633 (2010).

10. D.L. Swanson, S. Laman, M.S. Biryulina, K.P. Nielsen, G.A. Ryzhikov, J.J. Stamnes, B. Hamre, L. Zhao,F.S. Castellana, and K. Stamnes, Optical transfer diagnosis of pigmented lesions: a pilot study, SkinRes. Tech. 15, 330-337 (2009) doi: 10.1111/j.1600-0846.2009.00367.x

11. A. Juzeniene, K.P. Nielsen, L. Zhao, G.A. Ryzhikov, M.S. Biryulina, J.J. Stamnes, K. Stamnes, and J.Moan, Changes in human skin after topical PDT with hexyl aminolevulinate, Photodiagnostics and Photodynamic Therapy 5, 176-181 (2008).

12. K.P. Nielsen, L. Zhao, J.J. Stamnes, K. Stamnes, and J. Moan, The optics of human skin: Aspect important for human health, Norwegian Academy of Science and Letters, In: Solar Radiation and Human Health, E. Bjertnes (ed.), Norwegian Academy of Science and Letters, Oslo 35-46 (2008).

13. K.P. Nielsen, L. Zhao, G.A. Ryzhikov, M.S. Biryulina, E.R. Sommersten, J.J. Stamnes, K. Stamnes, and J.Moan, Retrieval of the physiological state of human skin from UV-Vis reflectance spectra: A feasibility study, Photochem. Photobiol. B93, 23-31 (2008).

14. K. Hestenes, K.P. Nielsen, L. Zhao, J.J. Stamnes, K. Stamnes, Monte Carlo and discrete-ordinate simulations of spectral radiances in the coupled air–tissue system, Appl. Opt. 46, 2333–2350 (2007).

15. K.P. Nielsen, J.J. Stamnes, K. Stamnes, and J. Moan, A Discrete Ordinate Radiative Transfer Model ofHuman Skin Tissue: The Importance of Melanosome Scattering, OSA Biomedical Topical Meeting, Fort Lauderdale, Florida, USA, March 19, 2006.

16. L. Zhao, K.P. Nielsen, J.K. Lotsberg, E. Marken, J.J. Stamnes and K. Stamnes. A new versatile setup for goniometric measurements of spectral radiance, Opt. Eng. 45, 053606 (2006).

17. L. Zhao, K.P. Nielsen, A. Juzeniene, P. Juzenas, V. Iani, L. Ma, K. Stamnes, J.J. Stamnes, J. Moan,Spectroscopic measurements of photoinduced processes in human skin after topical application of the hexylester of 5-aminolevulinic acid, J. Environ. Pathol. Toxicol. Oncol. 25, 307-320 (2006).

18. K.P. Nielsen, L. Zhao, J.J. Stamnes, K. Stamnes, J. Moan, The importance of the depth distribution of melanin in skin for DNA protection and other photobiological processes, J. Photochem. Photobiol. B82, 194-198 (2006).

19. K.P. Nielsen, J. Moan, J.J. Stamnes, L. Zhao, and K. Stamnes, The photoprotective role of melanosome scattering, J. Eur. Acad. Dermatol, Veneorol. 29, 410 (2005).

20. K.P. Nielsen, A. Juzeniene, P. Juzenas, K. Stamnes, J.J. Stamnes, J. Moan, Choice of optimal wavelength for PDT: The significance of oxygen depletion, Photochem. Photobiol. 81, 1190-1194(2005).

21. J. Moan, K.P. Nielsen, L. Zhao, J.J. Stamnes, and B. Hamre, A biophysical phenomenon: Do Africans appear lighter than Europeans to flies?", Fra Fysikkens Verden, 82-85 (2004).

22. K.P. Nielsen, L. Zhao, P. Juzenas, J.J. Stamnes, K. Stamnes, J. Moan, Reflectance spectra of pigmentedand non-pigmented skin in the UV spectral region, Photochem. Photobiol. 80, 450-455 (2004).

23. B. Chen, K. Stamnes, and J.J. Stamnes, Validity of diffusion approximation in bio-optical imaging, Appl. Opt. 40, 6356-6366 (2001).

Presentations related to the development of the DermoSight technology for tissue diagnostics

1. J.J. Stamnes, L. Zhao, D.L Swanson, G. Ryzhikov, M. Biryulina, B. Hamre, and K. Stamnes, Optical Transfer Diagnosis Differentiating Benign and Malignant Pigmented Skin Lesions, Symposium on“Hyperspectral image analysis for skin cancer”, 8 September, 2018, Norwegian Centre for E-healthResearch, Tromsø, Norway.

2. J.J. Stamnes, L. Zhao, D.L Swanson, G. Ryzhikov, M. Biryulina, B. Hamre, and K. Stamnes, Real-time optical detection of skin cancer, Norwegian Electro-Optics Meeting, 2-4 May, 2018. Henningsvær, Lofoten.

3. J. J. Stamnes, Optical Transfer Diagnosis: A novel optical method for diagnosis and monitoring of changes in the physiology-morphology state of human tissue, Norwegian Inflammation Network(NORIN), Oslo, December 2, 2014 (Invited).

4. J. J. Stamnes, Models of radiation transport for dosimetry in coupled systems (atmosphere-ocean and air-tissue), The 1st CERAD workshop on UV and ionizing radiation dosimetry, Oslo, November 6,2014 (Invited).

5. J. J. Stamnes, From Optical Remote Sensing of the Earth to Non-Invasive Diagnostics of Skin Cancer, Seminar, Stevens Institute of Technology, Hoboken, New Jersey, February 14, 2014 (Invited).

6. J. J. Stamnes, From Optical Remote Sensing of the Earth to Non-Invasive Diagnostics of Skin Cancer, Seminar, Imperial College, London, November 19, 2013 (Invited). ( http ://baltermedical.com/) 9.12.2019 Publications - Balter Medicalbaltermedical.com/page/publications/ 4/4

7. J.J. Stamnes, B. Hamre, Ø. Frette, L. Zhao, G. Ryzhikov, M. Biryulina, and K. Stamnes, From optical remote sensing of the Earth to non-invasive diagnostics of skin cancer, The 3rd EOS Topical Meetingon Blue Photonics – Optics in the Sea (Blue Photonics 3), Texel, The Netherlands, March 17-20, 2013 (Invited).

8. J.J. Stamnes, Optical Transfer Technology for Skin Cancer Diagnosis, Co-operation seminar in medical physics and technology, Haukeland University Hospital-University of Bergen, September 20, 2012.

9. J.J. Stamnes and K. Stamnes, From Satellite Remote Sensing of the Earth to Non-Invasive Diagnostics of Skin Cancer, Durham University, May 28, 2012 (Invited).

10. K. Stamnes and J.J. Stamnes, From satellite remote sensing of the Earth to non-invasive diagnostics of skin cancer, Exolife (http://www.univie.ac.at/eph/exolife (http://www.univie.ac.at/eph/exolife)),Vienna, May 22, 2012 (Invited).

11. J.J. Stamnes, Optical Transfer Diagnosis (OTD) for detection of malignant melanomas, Invited Seminar at Haukeland University Hospital, Bergen, 25 November, 2010.

12. J.J. Stamnes, Light and life interactions with emphasis on environmental and medical remote sensing, Invited Seminar at Beijing University of Photonics and Telecommunications, Beijing, May 7, 2010.

13. L. Zhao, D.L. Swanson, S.D. Laman, M. Biryuilin, K.P. Nielsen, G. Ryzhikov, J.J. Stamnes, B. Hamre, E.R.Sommersten, Ø. Frette,, A. Bhandari, F.S. Castellana, and K. Stamnes, Optical Transfer Diagnosis (OTD) technology and its clinical trial on malignant melanomas, Norwegian electro-optics meeting2010, Ålesund, Norway, April 7-9, 2010.

14. A. Bhandari, B. Hamre, L. Zhao, Ø. Frette, and J.J. Stamnes, BRDF of Spectralon white reflection standard illuminated by incoherent unpolarized and plane polarized light, Norwegian electro-opticsmeeting 2010, Ålesund, Norway, April 7-9, 2010.

15. K. Stamnes and J. J. Stamnes, From Satellite Remote Sensing of the Earth to Non-Invasive Diagnostics of Skin Cancer, Department of Physics, Peking University, Beijing, People’s Republic ofChina, October 20, 2009 (Invited).

16. A. Bhandari, K.P. Nielsen, L. Zhao, Ø. Frette, J.J. Stamnes, Goniometric reflectance from spectralon illuminated by linearly polarized light, Norwegian Electro-Optics Meeting, Hurtigruten, Norway, 29-26 March, 2008.

17. E.R. Sommersten, J.K. Lotsberg, K. Stamnes, and J.J. Stamnes, Polarized radiative transfer in a coupled two-media system, Norwegian Electro-Optics Meeting, Hurtigruten, Norway, 29-26 March, 2008.

18. J.J. Stamnes and K. Stamnes, Diffuse imaging in turbid media, EOS Topical Meeting on Advanced Imaging Techniques, Lille, France, September 12-14, 2007.

19. J.J. Stamnes and K. Stamnes, From Optical Space Monitoring of the Ocean to Non-invasive Diagnostics of Skin Cancer, Invited Talk at the Receipt of Simrad’s Prize for Achievements in Electroopticsfor 2007, Annual meeting of the Norwegian Physical Society, Tromsø, August 2007.

20. K.P. Nielsen, B. Hamre, A. Bhandari, L. Zhao, J.J. Stamnes, G.A. Ryzhikov, M.S. Biryulina, L. Rustad,L.A. Akslen, K. Stamnes, and J. Moan, Physiological spectroscopic imaging for diagnosis of skincancer, European Conference on Biomedical Optics, München, June 2007.

21. J.J. Stamnes and K. Stamnes, Optical Remote Sensing for Atmosphere-Water Monitoring and Skin Cancer Diagnosis, Invited talk, Makerere University, Kampala, February 2007.

22. J.J. Stamnes and K. Stamnes, Optical Remote Sensing for Atmosphere/Ocean Monitoring and Skin Cancer Diagnosis, Invited seminar, The University of Vermont, October 6, 2006.

23. J.J. Stamnes and K. Stamnes, Optical Remote Sensing for Ocean Monitoring and Cancer Diagnosis. II.Technical Aspects, Invited seminar, UCLO, Wimereux, France, September 14, 2006.

24. J.J. Stamnes and K. Stamnes, Optical Remote Sensing for Ocean Monitoring and Cancer Diagnosis. I.General Aspects, Invited seminar, UCLO, Wimereux, France, September 6, 2006.

25. D. A. Mohammad, K. P. Nielsen, L. Zhao, Ø. Frette, B. Hamre, J. J. Stamnes, Goniometric measurements of the BRDF of a spectralon calibration standard", Northern Optics Conference,Bergen, Norway, 14-16 June, 2006.

26. L. Zhao, K. P. Nielsen, J. K. Lotsberg, E. Marken, J. J. Stamnes, and K. Stamnes, A versatile setup for goniometric measurements of forward/backwards scattering, Northern Optics Conference, Bergen,Norway, 14-16 June, 2006.

27. K.P. Nielsen, J. Moan, J.J. Stamnes, and K. Stamnes, Optical diagnosis of skin lesions, Annual meeting of Biophysics group of Norwegian Physical Society, Kongsvold, Norway, 15-17 March, 2006.

28. K.P. Nielsen, J. Moan, J. J. Stamnes, L. Zhao, and K. Stamnes, and J.J. Stamnes, The photoprotective role of melanosome scattering, Presented at Eur. Acad. Dermatol, Veneorol. Conference, 2006.

29. J.J. Stamnes, Imaging physiological properties of human skin from spectral reflectance data, Workshop on Imaging from Wave Propagation, Institute for Mathematics and its Applications,University of Minnesota, Minneapolis, October 17-21, 2005.

30. K.P. Nielsen, L. Zhao, J. Moan, K. Stamnes, and J.J. Stamnes, Optical Non-invasive Skin Cancer Diagnosis, Annual meeting of NOFFOF, Oslo, Norway, 17 September, 2004.

31. K.P. Nielsen, L. Zhao, K. Stamnes, J. Moan, and J.J. Stamnes, Modelling of skin reflectance in the visible and ultraviolet parts of the spectrum, Norwegian Electro-Optics Meeting, Tønsberg, Norway,2-5 May, 2004.

32. L. Zhao, K.P. Nielsen, K. Stamnes, and J.J. Stamnes, Experimental test of radiative transfer theory applied to retrieve optical properties of skin, Norwegian Electro-Optics Meeting, Tønsberg, Norway,2-5 May, 2004.

33. J.J. Stamnes, Optical Remote Sensing for Ocean Monitoring and Skin Cancer Diagnosis, invited seminar, Department of Physics and Technology, University of Bergen, April, 2004.

34. K.P. Nielsen, L. Zhao, K. Stamnes, and J.J. Stamnes, Novel approach for imaging of objects embedded in tissue, Norwegian Electro-Optics Meeting, Flåm, 2-5 May, 2002.

Doctoral Dissertations

A novel approach imaging objects imbedded in tissue (Part I), K.P. Nielsen, PhD thesis, University of Bergen, Norway (2005).      

A novel approach imaging objects imbedded in tissue (Part II), L. Zhao, PhD thesis, University of Bergen, Norway (2005).