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MICHELSON DIAGNOSTICS OCT FOR SKIN IMAGING D. Woods See what we can see… Introduction • Michelson Diagnostics Ltd • Established 2006 • ~15 FT employees in UK, USA and German subsidiaries • Clinical research collaborations in Germany, UK, USA, Denmark, Australia, Switzerland, Italy. • Level 1 Clinical Evidence for NMSC identification See what we can see… Michelson Diagnostics • 2006 aim: “To develop MultiBeam OCT technology into a viable medical imaging tool” See what we can see… Optical coherence tomography OCT • OCT non-invasively captures tomographic images “OPTICAL ULTRASOUND” y x See what we can see… Optical Coherence Tomography 1991 2002 2010 1st generation Ophthalmology Cardiology Fourier-domain OCT 2nd generation 1996 Time-domain OCT See what we can see… Dermatology Fourier-domain focussing Michelson Diagnostics trade-off MultiBeam OCT • MultiBeam OCT gives • Large depth-of-focus gives poor • Lateral resolution which is resolution. spatially invariant and > 2x better • Great resolution gives limited depththan traditional single beam OCT of-focus • Better contrast uniformity lower speckle noise and better penetration in skin. Tomlins, P H, Ferguson, R A, Hart, C, Woolliams, P D “Point-spread function phantoms for optical coherence tomography,” OP 2, August 2009; ISSN: 1754-2944 See what we can see… VivoSight Topical OCT • Low-power eye-safe 1300 nm laser • Patented MultiBeam probe for increased performance • < 7.5 µm lateral resolution • < 5.5 µm axial resolution • Up to 2 mm depth penetration • 2D or 3D – 6 x 6 x 2 mm • Real time • Non-invasive • Non-ionising See what we can see… Healthy glabrous skin 2 mm See what we can see… Pathology? Basal Cell Carcinoma Image: Dan Siegel See what we can see… Application #1 • Avoid biopsy • Excellent correlation of diagnostic features in OCT and histology 1,2 • 7-center trial publication summer 2014 enabled a statistically significant 250"VivoSight patientsOCT with clinically improvement in the for specificity andscanned Negative Predictive Value suspicious lesions BCC were (NPV) of BCC diagnosis over both clinical and dermoscopy in ™ VivoSight OCT diagnosis this cohort of challenging pink compared patches. Sowith many biopsies can standard unnecessary, clinical diagnosis and OCT, patients can be rendered withwith VivoSight without dermoscopy instead be treated non-invasively." Results verified by biopsy and histological analysis Dr. med. Martina Ulrich, Berlin, Germany http://www.vivosight.com/clinical-dermatology/ See what we can see… Superficial BCC http://www.vivosightatlas.com/ See what we can see… Mohs surgery • • • • Time consuming Expensive Accurate – great cosmetic results Low recurrence See what we can see… Mohs mapping See what we can see… Mohs mapping • “Breadslice” sampling creates a flythrough • Reconstruction of multiple views See what we can see… Mohs mapping See what we can see… Mohs Mapping • Typically adds just 5 minutes to a procedure • Lowers residual tumour requirement for second slice (by 0.8 slices in USA) • Time- and cost-saving Hurdles remaining • Specific training • Clinical studies See what we can see… VivoSight The VivoSight OCT imaging system has been developed with the support of clinicians. It is compliant with European CE mark directives and has FDA 510(k) clearance for use in the USA. For more information please contact: Daniel Woods Michelson Diagnostics Tel. +44 208 144 9836 Email: [email protected] For clinical use in the US FDA 510(k) K093520 applies: VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions. US Federal law restricts this device to sale by or on the order of a physician. See what we can see… Key papers Banzhaf, C. & Jemec, G. B. (2012) "Imaging granulomatous lesions with optical coherence tomography" Case Rep Dermatol, 4(1), pp. 14-18. Coleman, A. J., et al. (2013) "Histological correlates of optical coherence tomography in non-melanoma skin cancer" Skin Res Technol, 19(1), pp. e10-19. Schmitz, l., et al. (2013) "Optical coherence tomography: its role in daily dermatological practice" German Society of Dermatology. Wang, K. X., et al. (2013) "Optical Coherence Tomography-Based Optimization of Mohs Micrographic Surgery of Basal Cell Carcinoma: A Pilot Study" Dermatol Surg. Selected Other Papers Arielle Kauvar, et al. (2013) In American Academy of Dermatology "Study of a Novel Non-invasive Topical Under-eye Contouring Technology," Miami Donnelly, R. F., et al. (2011) "Design, optimization and characterisation of polymeric microneedle arrays prepared by a novel laser-based micromoulding technique" Pharm Res, Chan, C. & Rohrer, T. (2012) "Optical Coherence Tomography and Its Role in Mohs Micrographic Surgery: A Case Report" Case reports in dermatology. Pomerantz, R., et al. (2011) "Optical Coherence Tomography Used as a Modality to Delineate Basal Cell Carcinoma prior to Mohs Micrographic Surgery" Case Rep Dermatol, 3(3), pp. 212-218. Seyed Arash Alawi, et al. (2013) "Optical coherence tomography for presurgical margin assessment of non-melanoma skin cancer – a practical approach" John Wiley & S Clark, C., et al. (2013) "Confirmation of Squamous Cell Carcinoma Clearance using Optical Coherence Tomography Imaging". Pelosini, L., et al. (2013) "In vivo optical coherence tomography (OCT) in periocular basal cell carcinoma: correlations between in vivo OCT images and postoperative histology" Br J Ophthalmol, 97(7), pp. 890-894. Schmitz, L., et al. (2013) "Optical Coherence Tomography Imaging of Erythroplasia of Queyrat and Treatment with Imiquimod 5% Cream: A case report" Karger. Themstrup, L., et al. (2012) "Cryosurgery Treatment of Actinic Keratoses Monitored by Optical Coherence Tomography: A Pilot Study" Dermatology. Messer, D. (2013) "Revolutionary changes in the treatment of onychomycosis; laser-Foot PinPointe ". Messer, G., et al. (2013) "Die Revolutionierung der Behondlung der Onychomykose". Aydin, S. Z., et al. (2011) "Optical coherence tomography: a new tool to assess nail disease in psoriasis?" Dermatology, 222(4), pp. 311-313. PSA NailAydin, S. Z., et al. (2013) "Potential Use of Optical Coherence Tomography and High-Frequency Ultrasound for the Assessment of Nail Disease in Psoriasis and Psoriatic Arthritis" Dermatology. Abignano, G., Aydin, S. Z., Castillo-gallego, C., Liakouli, V., Woods, D., Meekings, A., et al. 2013. Virtual skin biopsy by optical coherence tomography: the first quantitative imaging biomarker for scleroderma. Ann Rheum Dis. Buckland, J. (2013) "Imaging technology acts as a ‘virtual skin biopsy’ in SSc" Nature Reviews Rheumatology. Babalola, O., et al. (2013) "Optical coherence tomography (OCT) of collagen in normal skin and skin fibrosis" Arch Dermatol Res. Banzhaf, C. A., et al. (2013) "In vivo Imaging of Sarcoptes scabiei Infestation Using Optical Coherence Tomography" Case Rep Dermatol, 5(2), pp. 156-162. Ring, H. C., et al. (2013) "Optical coherence tomography imaging of telangiectasias during intense pulsed light treatment: a potential tool for rapid outcome assessment" Arch Dermatol Res. Welzel, J. (2013) In AADO "OCT for monitoring and quantification of treatment effects," Miami. See what we can see…