Newsletters Archives - Vivosight (International)

Special Edition Q3, 2022

66% of Diagnostic Biopsies for Common Skin Cancer can be Avoided Using Michelson Diagnostics’ VivoSight OCT Laser Scanner

Major Netherlands study shows that VivoSight OCT is non-inferior to and more cost-effective than punch biopsy

A major study published in leading cancer journal The Lancet Oncology [1] has shown in a large, multi-centre, head-to-head randomised clinical trial, that use of Michelson Diagnostics’ VivoSight OCT laser scanner to diagnose the common skin cancer type Basal Cell Carcinoma is as safe and effective as biopsy, and so could avoid diagnostic skin biopsy procedures in as many as 66% of cases, also saving time and money for the health service.

This new publication in The Lancet Oncology reports results from the study performed in the Netherlands at three dermatology centres by a research group led by Professor Klara Mosterd at University of Maastricht. 598 Patients were randomly split into two groups, one group being diagnosed using VivoSight OCT scan and other group with punch biopsy. Treatment decisions were made on the basis of diagnosis of BCC and BCC subtype, and then 12 months after treatment the two groups were compared in terms of the rate of disease recurrence and the costs.

The results were clear: the proportion of patients in the OCT arm with recurrent disease was slightly less than in the biopsy group (6% vs 7%) and furthermore, the overall costs of diagnosis and treatment using OCT was found to be €69 less per lesion than by using biopsy.

The authors concluded “this trial shows that OCT-guided diagnosis and treatment is safe and non-inferior to regular care. In 66% of patients, a biopsy could be avoided, thus minimising treatment delay and avoiding an invasive procedure”

1. 12 months after treatment, 94% of lesions diagnosed with BCC by OCT were free of recurrent or residual lesions, compared to 93% of lesions with punch biopsy;

2. Of the patients who still had recurrent or residual lesions at 12 months, only 9 in the OCT group had malignant recurrent lesions, versus 15 in the biopsy group (the remainder had premalignant lesions);

3. OCT was determined to be ‘non-inferior’ to punch biopsy using a pre-defined non-inferiority margin of -10%. 4. 66% of diagnostic biopsies could be avoided by the use of OCT;

5. The cost of using the OCT for diagnosis and treatment was significantly lower than with punch biopsy. Considering diagnosis alone, OCT cost €233, vs. €308 for biopsy, and then for diagnosis and treatment OCT cost €689 vs €758 for biopsy.

1. Study took place at 3 Netherlands institutions.

2. Eligible participants were adults > 18 years with indication for biopsy of a lesion with basal cell carcinoma in the differential diagnosis

and where doubt remained as to whether lesions is benign, premalignant, malignant, and BCC subtype

3. Excluded were lesions in high-risk H-zone of face, or locally advanced BCC

4. 598 patients were recruited and randomized into 2 arms. One arm received standard of care with diagnostic punch biopsy.

5. Lesions in the other arm were scanned with VivoSight OCT. The observer attempted to identify whether the lesion was BCC and if so what subtype.

6. Any lesion not highly confidently identified as BCC or subtype unclear, was returned to standard of care via punch biopsy. (this resulted to be 33% of lesions)

7. Lesions highly confidently ruled in as BCC and with BCC subtype were considered for non-invasive or surgical treatment according to the subtype and patient preference, and this treatment was scheduled. (this was 66% of lesions)

8. For safety, a punch biopsy was additionally taken of these lesions and checked for potential intervention if the OCT result would compromise patient safety.

9. At 12 months after treatment, a dermatologist blinded to the study arm performed follow-up to identify any possible recurrence or residual lesion; any suspected recurrence or residual lesion was biopsied.

Michelson Diagnostics’ CEO Jon Holmes comments:

This large, thorough, well designed and implemented study clearly demonstrates the potential value of VivoSight OCT in the clinical pathway for low-risk BCC. Previous studies by groups in Germany (Ulrich et al.), USA (Markowitz et al.) and Australia (Cheng et al.) provided solid evidence of the high diagnostic accuracy of OCT, confirming that it is more accurate than clinical or dermoscopic examination alone, and suggested that a proportion of diagnostic biopsies could be avoided.

Prof. Mosterd’s group has achieved the next step, of showing that if OCT is indeed used to rule-in BCC and to identify the BCC subtype, in order to select treatment without biopsy, then the final patient outcome in terms of lesion clearance is non-inferior to using biopsy instead; and furthermore, they found that the OCT pathway is more cost-effective and involves fewer patient consultation visits.

Professor Mosterd’s group has already published several other papers deriving from this work, including a study of value of image markers for BCC [1], patient preference for OCT vs biopsy [2] and of the learning curve for OCT users [3]. All highly recommended reading!

Given the increased publications on VivoSight OCT imaging features for BCC (see Latest News), we’d like to remind on the availability of the course “OCT in Practice” (see also in our July 2021 Newsletter).

The modular course is aimed at VivoSight newcomers and experienced users alike. Presently, 12 main topics are being covered (overview >> here) focusing on when and how to ideally use OCT. You will learn how to assess the most common skin tumors and pathology based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation (Figs. 1a, b). We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz on OCT images of BCCs!

1. lrich, M., von Braunmuehl, T., Kurzen, H., Dirschka, T., Kellner, C., Sattler, E., Berking, C., Welzel, J. and Reinhold, U. (2015), The sensitivity and specificity of optical coherence tomography for the assisted diagnosis of nonpigmented basal cell carcinoma: an observational study. Br J Dermatol, 173: 428-435. https://doi.org/10.1111/bjd.13853.

OCT significantly improved the diagnostic specificity for BCC compared with clinical assessment and dermoscopy alone.

The accuracy of diagnosis for all lesions increased from 65.8 % with clinical evaluation to 76.2 % following additional dermoscopy and to 87.4 % with the addition of OCT.

2. Markowitz O, Schwartz M, Feldman E, Bienenfeld A, Bieber AK, Ellis J, Alapati U, Lebwohl M, Siegel DM. Evaluation of Optical Coherence Tomography as a Means of Identifying Earlier Stage Basal Cell Carcinomas while Reducing the Use of Diagnostic Biopsy. J Clin Aesthet Dermatol. 2015 Oct;8(10):14-20

OCT significantly (p < 0.01) improved sensitivity and specificity over clinical or dermoscopic evaluation. It increased the certainty of diagnosis; clinicians indicated they were certain in 17 percent of lesions examined clinically, in 38.6 percent examined with dermoscopy, and in 70 percent examined with optical coherence tomography.

With the use of Optical Coherence Tomography in the diagnosis of basal cell carcinoma, more than 1 in 3 patients could avoid a diagnostic biopsy.

3. Cheng, H. and Guitera, P. (2015), Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol, 173: 1371-1380. https://doi.org/10.1111/bjd.14042

This systematic review provides an overview of the clinical applications of OCT in the diagnosis and management of BCC. OCT has been suggested to be useful in the diagnosis, treatment planning and treatment monitoring of BCC.

VivoSight OCT is used in many other research areas besides skin cancer & BCC

To spread the utility of VivoSight OCT across more research areas, please see our website and visit our Applications, Publications, Newsletter and Blog webpages. Research applications include:

Autoimmune and Inflammatory Diseases
Aesthetic Medicine, Vascular Lesions and Scars • Wounds & Burns
Nails & Onychomycosis
Melanomas and Pigmented Lesions
Alopecia and Hair Disorders
Other Dermatology Applications

VivoSight has been involved in over 380 publications. Download the publications list from our website here:

https://us.vivosight.com/publications-replacement/

Successful Meeting at ASLMS 2022 for Michelson Diagnostics Ltd. (MDL)

MDL received great attention at the recent annual meeting of the American Society of Lasers in Medicine and Surgery (ASLMS) in San Diego.

VivoSight OCT was well covered during the plenary session by Kristen Kelly, MD highlighting its value for imaging and quantifying vascular lesions in research for new treatments.

In addition, several presentations on VivoSight OCT applications were given by accomplished clinicians and researchers, and shown in this partial list:

Jordan V. Wang, MD, MBE, MBA
CLINICAL AND OCT EVALUATION OF VASCULAR LESIONS TREATED WITH A NOVEL VARIABLE-SEQUENCED LONG-PULSED 532NM LASER

Vascular lesions and conditions often require treatment with lasers that selectively target hemoglobin. More recently, a novel variable-sequenced long-pulsed 532 nm laser was developed, which incorporates variable sequential pulsing with 0.3 ms or 1.5 ms pulses, large spot sizes, and cryogen spray cooling. Dynamic optical coherence tomography (OCT) imaging has also been used to measure vascular characteristics. Here, we use OCT to evaluate treatment outcomes of vascular lesions from this novel laser.

Christopher B. Zachary, MBBS, FRCP
ANALYSIS BY OCT OF PRE/POST Long Pulse 1064 NM LASER TREATMENT OF SUPERFICIAL AND NODULAR BCCs

Treatment of superficial and nodular BCCs by the long pulsed 1064nm laser is used in both Europe and the USA. Imaging by optical coherence tomography (OCT) might objectively improve outcomes following this treatment modality. This two center, IRB approved prospective study examined the quality and usefulness of mapping tumor margins prior to and three months after treatment.

John Wuennenberg, MD
USE OF OPTICAL COHERENCE TOMOGRAPHY AND REFLECTANCE CONFOCAL MICROSCOPY TO GUIDE TREATMENT MARGINS OF BASAL CELL CARCINOMA

Determining the clinical margins of Basal Cell Carcinoma (BCC) is challenging. Noninvasive in vivo images of the skin created by Optical Coherence Tomography (OCT) and Reflectance Confocal Microscopy (RCM) can aid in this endeavor. Interpreting OCT is challenging for the novice user which may result in benign lesions being interpreted as superficial BCC. The use of RCM with higher, near histologic, resolution relative to OCT can help detect the presence of BCC. Since RCM imaging is more time consuming for larger lesions relative to OCT, its utilization as a targeted approach in combination with OCT can be more efficient.

OCT-Guided Laser Treatment of Basal Cell Carcinoma: One Year Follow-Up

Prof. Uwe Reinhold gave an excellent talk on the above topic at the esteemed Derma 2022 annual meeting in Frankenthal, Germany https://www.kongress-derm.de

Topic and results will soon be published in the journal of the J EADV. As conclusion it can be summarized that OCT-controlled 1064 nm Nd:YAG laser treatment of superficial BCC provide for:

High detection rate due to use of OCT
High remission rate
Short treatment time
Potential of treatment of multiple lesions in one session • Good cosmetic outcomes

Elevator Chat with Klara Mosterd, MD – Maastricht, Netherlands

Klara Mosterd is a Professor of Oncodermatology, Mohs Surgeon and Dermatologist at Maastricht University Medical Center

“As we are a center of excellence in the field of skin cancer, we see many patients and are always striving to find ways to improve their care. Few years ago we developed a vision to improve patient care and operational efficiency for BCC using OCT, which we saw had great potential. There had already been some great work published by other groups, but we saw some gaps in the research that needed addressing, and so we set to work!

We have already published several papers towards this goal, and our work now culminates in the just issued Lancet Oncology article. We are very happy with the published results and believe that OCT, using Michelson’s VivoSight OCT scanner, will make a huge difference to patients, saving many of them from invasive biopsies and extra hospital visits, and also saving hospitals money and reducing delays in the BCC clinical pathway.

We know that there is much more to come from VivoSight OCT and are excited to hear that Michelson is already working on Artificial Intelligence algorithms to further aid clinicians in our fight against BCC!

References

1. Adan F, Nelemans PJ, Essers BA, Brinkhuizen T, Dodemont SR, Kessels JP, Quaedvlieg PJ, Dermont GJ, Winnepenninckx VJ, Hamid MA, Kelleners-Smeets NW. Optical coherence tomography versus punch biopsy for diagnosis of basal cell carcinoma: a multicentre, randomised, non-inferiority trial. The Lancet Oncology. 2022 Jul 11.
2. Adan F, Mosterd K, Kelleners-Smeets NW, Nelemans PJ. Diagnostic Value of Optical Coherence Tomography Image Features for Diagnosis of Basal Cell Carcinoma. Acta dermato-venereologica. 2021 Nov 1.
3. Adan F, Mosterd K, Wolswijk T, Kelleners-Smeets NW, Essers BA. Patient Preference for Optical Coherence Tomography versus Punch Biopsy for Diagnosis of Basal Cell Carcinoma: A Labelled Discrete Choice Experiment. Acta Dermato-Venereologica. 2021 Dec 14.
4. Loo E, Sinx K, Welzel J, Schuh S, Kelleners-Smeets N, Mosterd K, Nelemans P. Cumulative sum analysis for the learning curve of optical coherence tomography assisted diagnosis of basal cell carcinoma.
5. Ulrich, M., von Braunmuehl, T., Kurzen, H., Dirschka, T., Kellner, C., Sattler, E., Berking, C., Welzel, J. and Reinhold, U. (2015), The sensitivity and specificity of optical coherence tomography for the assisted diagnosis of nonpigmented basal cell carcinoma: an observational study. Br J Dermatol, 173: 428-435. https://doi.org/10.1111/bjd.13853.
6. Markowitz O, Schwartz M, Feldman E, Bienenfeld A, Bieber AK, Ellis J, Alapati U, Lebwohl M, Siegel DM. Evaluation of Optical Coherence Tomography as a Means of Identifying Earlier Stage Basal Cell Carcinomas while Reducing the Use of Diagnostic Biopsy. J Clin Aesthet Dermatol. 2015 Oct;8(10):14-20.
7. Cheng, H. and Guitera, P. (2015), Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol, 173: 1371-1380. https://doi.org/10.1111/bjd.14042

March 2022 Issue

Authors identify the key OCT image characteristics and terminology for evidence-based, practical use in BCC management in clinical routine

OCT has been used since 2011 to assist in the management of BCC, especially for assessment of suspicious lesions and for monitoring effects of noninvasive treatments. Now, two new papers further underpin the powerful capabilities of VivoSight for BCC.

In the first article, published in JEADV by Fuchs et al.[1], a group of international OCT user experts agreed on a consensus set of BCC OCT image characteristics and terminology by applying the evidence-based Delphi methodology. This expert consensus provides a robust scaffold for the international standardization of the clinical use of OCT for BCC management.

Similarly, in the second article, published in ActaDermatoVeneriologica, by Adan et al. [2], the authors rank specific VivoSight morphologic OCT features in order to accurately discriminate between BCC and non-BCC lesions, and to distinguish between BCC subtypes, and verified by histopathology. The authors then propose an algorithm for diagnosis and subtyping of BCC that could enable the use of a one-stop-shop approach (avoiding biopsy) in patients with a lesion clinically suspected for BCC: If the VivoSight OCT scan then strongly indicated non-superficial BCC, then surgical excision could be planned immediately, or alternatively if the OCT scan clearly indicated superficial BCC, then non-invasive treatment could be planned. The authors state that in their study, 44% of 299 patients, biopsy would be obviated by applying their methodology.

See details in the articles here:

OCT is increasingly being used in nail disease research to:

reduce number of biopsies
assess nail pathology through characteristic morphologic and vascular OCT bio markers
measure and quantify therapeutic efficacies in the treatment of several nail disorders
and predict long term treatment outcomes based on early OCT imaging indicators.

VivoSight enables micrometer resolution, in-vivo, non-invasive imaging of nails and the surrounding skin. It is able to visualize the nail plate, bed and matrix with associated pathologies, as well as blood flow in the nail bed. OCT easily penetrates diseased nail revealing details of underlying pathology, even when the nail is heavily discolored. OCT has a penetration depth of almost 2 mm and is much more accurate than ultrasound. We comment on a number of recent publications that highlight the capabilities and benefits of utilizing OCT in research and clinical practice.

Markowitz et al.: Early Success Indication of Lengthy Onychomycosis Treatment through OCT Biomarkers [3]. Potential for significant cost savings from high predictive value of OCT imaging biomarkers.

A new study by Orit Markowitz, MD and Cynthia Chan, MD is the first to show data supporting VivoSight OCT Onychomycosis markers as early indicators of the success or failure at two months of a 48 weeks regimen of topical efinaconazole.

The authors recommend OCT at 2 months as early indicators of treatment failure. If transferred to clinical practice, this could greatly reduce the cost of Onychomycosis therapy for millions of patients by indicating the need to change the therapy early instead of continuing with one that isn’t working.

Rajabi-Estarabadi et al.: Optical Coherence Tomography in Nail Research and Diagnosis [4]

Excellent new book chapter on the utiliy of OCT. Expert physicians describe visualization of nail psoriasis, onychomycosis, nail hematoma, glomus tumor, and myxoid cysts.

The authors further point out that OCT effectively complements other imaging modalities when higher resolution of structural and vascular morphology is required.

Abignano et al.: Nailfold Microvascular Imaging by Dynamic Optical Coherence Tomography in Systemic Sclerosis (SSc): A Case- Controlled Pilot Study [5]

Through comparison with the standard technique of Nailfold Video Capillaroscopy (NVC), Abignano et al. demonstrate the potential of VivoSight OCT vascular metrics as new objective outcome measures for systemic sclerosis clinical trials and practice.

Nailfold microvasculopathies are included in very early diagnosis of systemic sclerosis. Dynamic OCT (D-OCT) capillaroscopy is able to invivo visualize capillary morphology, the surrounding skin architecture and quantify vascular flow status of capillaries in the nail fold.

In the study, a significant correlation was found between OCT microvascular flow density and NVC scores. Dynamic OCT has the potential to provide a virtual biopsy of the examined skin sample in patients with SSc.

Ortner et al.: Morphometric Optical Imaging of Microporated Nail Tissue: An Investigation of Intermethod Agreement, Reliability, and Technical Limitations [6]

Several techniques, like wide-field microscopy, OCT and RCM (reflectance confocal microscopy) are useful to quantify morphological differences and treatment effects in nails

However intermethod agreement has not been assessed and this study aimed to evaluate and compare aspects of ease of use, measurement speed, nail morphometry, micropore morphometry, repetability and artifact robustness.

Besides OCT demonstrating highest repeatability of all imaging techniques, it also scored highest among the sum of above mentioned aspects.

Ortner et al.: Morphometric Optical Imaging of Microporated Nail Tissue: An Investigation of Intermethod Agreement, Reliability, and Technical Limitations [6]

Several techniques, like wide-field microscopy, OCT and RCM (reflectance confocal microscopy) are useful to quantify morphological differences and treatment effects in nails

Besides OCT demonstrating highest repeatability of all imaging techniques, it also scored highest among the sum of above mentioned aspects.

In summary, the unique capabilities of OCT make it an indispensable instrument in modern nail disease research and exploration of clinical utility. VivoSight OCT also is heavily employed in many other areas of dermatologic research. Please contact us for a demonstration.

OCT is included as an advisory method in the European Guidelines for Diagnosis and Treatment of BCC [8]

To assist clinicians in diagnosing and treating patients with BCC, European Dermatology / Oncology Organizations have developed international Guidelines. The 2019 Guidelines, published in the European Journal of Cancer, make a number of clear statements:

“Histological diagnosis may not be required in superficial and small nodular BCCs (< 1 cm) in low risk areas, if clearly diagnosed clinically and/or with non-invasive techniques”. Level of Evidence 1. Recommendation level A (‘shall’).
“Aided non-invasive diagnosis with dermatoscopy, reflectance confocal microscopy and/or optical coherence tomography can improve the diagnosis accuracy in difficult-to-recognize BCCs”. Level of Evidence 1. Recommendation level B (‘should’).

Taken together, these European Guidelines advise EU physicians that in the case of low-risk, superficial/small nodular BCCs, biopsy is not essential if the non-invasive diagnosis of BCC with OCT is clear, and that OCT further improves diagnostic accuracy over basic clinical examination.

These Europe-centric guidelines allow physicians an effective, efficient and very economic way to care for their patients.

Efficient way to delineate margins of BCC lesion with “Quadrant Mapping” method

In their research, OCT experts have developed a method of mapping the hidden sub-surface lateral extent of a BCC. At University of California Irvine, principle investigator Christopher Zachary, FRCP, and medical student John Soliman employ the mapping protocol. “It is important to use a marking pen that does not significantly absorb the 1064 nm wavelength,” commented Dr. Zachary. “We use a red marker (DERMarker, Viscot #1445) and we are not seeing any sparking or hot spots on our drawn perimeter.”

Mapping Protocol:

Draw the margin around the clinical signs of the lesion, illustrated by a red line. Divide the margin into four quadrants, such as 3, 6, 9 and 12 o’clock positions (Figs. Step 1 – Step 4)
The probing beam of the OCT scanner is illustrated by a black line in the white circle, and live OCT images on the monitor depict whether the BCC lesion is visible inside or outside the margin (red line)
In the example case, BCC features are recognized outside the red marked area at the 12 o’clock position and the margin is extended accordingly
The process is continued until the whole circumference of the margin has been assessed accordingly
Mapping a typical small BCC only takes 3 to 4 minutes

Do you want to experience VivoSight OCT first hand? Scan your own skin, see how easy it is and assess multiple images and metrics displayed immediately on the skin?

Join us at booth #125. Our specialist will be delighted to demonstrate the system, answer your questions and point out how VivoSight could be of benefit to you.

OCT and VivoSight OCT are also covered in many talks at ASLMS 2022. Please filter the program with the search terms “OCT” or “Optical Coherence Tomography” and enjoy the various presentations.

New Brochure about VivoTools, the powerful OCT skin analysis software

To better appreciate the value of VivoTools, a new comprehensive brochure is available. Page by page, purpose, features and benefits of VivoTools are presented with examples. Contact us at info@vivosight.com to get your copy of the VivoTools brochure.

New Brochure about VivoTools, the powerful OCT skin analysis software

Christine Fuchs Jacobsen, MD, PhD is a dermatologist at Bispebjerk Hospital in Copenhagen, Denmark with an interest in non-invasive skin imaging techniques.

“I just defended my PhD thesis successfully on “Preclinical investigation of acne vulgaris using non-invasive in-vivo imaging techniques”. The new imaging modalities, especially latest generation OCT and RCM, allowed me to do research and clinical work that would hardly have been possible just a few years ago.

I like the excitement of discovering something new, not just in unique images, but also coupled with quantifying objective metrics, i.e. hard data. So our group, under the leadership of Prof. Merete Haedersdal, is at the leading edge of insights and we enjoy presenting our latest findings to peers.

Just to mention two examples: firstly, through our work investigating acne vulgaris (AV), it is apparent that we now have a capability to image and quantify AV structural and vascular morphology. And this extends also to subclinical manifestations. This allowed us to define signs or imaging biomarkers that correlate with pathology status and some physiological processes [9]. We were able to:

find high correlation between acne clinical severity and skin imaging features
visualize transfollicular delivery of a microparticulate suspension
quantify a significant increase in epidermal thickness and vessel morphology changes
and identify OCT and RCM subclinical imaging biomarkers that may allow treatment triage.

Another example is the just published international consensus statement on OCT for Basal Cell Carcinoma [1]. This is a major milestone and was especially driven by our group leader Prof. Merete Haedersdal. The need for standardization utilizing OCT for BCC was recognized and Prof. Haedersdal was instrumental in employing the Delphi method to generate expert opinion-based evidence.

A large group of KOLs and experts converged on specific OCT image characteristics and terminology that provide a robust scaffold for the training of staff, standardized reporting of findings and clinical implementation of OCT in dermatology. The generated consensus validates that OCT has arrived and is approved for use in assessing lesions suspicious of BCC.

Non-invasive imaging technologies are profoundly beneficial and the dermatologic community is just at the beginning of the adoption curve. Recall when the telescope or microscope was invented hundreds of years ago and what discoveries followed. I believe it will be similar with OCT.”

References

1. Fuchs, C., Ortner, V., Mogensen, M., Rossi, A., Pellacani, G., Welzel, J., Mosterd, K., Guitera, P., Nayahangan, L., Johnsson, V., Haedersdal, M., Tolsgaard, M. and (2022), 2021 international consensus statement on optical coherence tomography for basal cell carcinoma: image characteristics, terminology and educational needs. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.17969

2. Adan F, Mosterd K, Kelleners-Smeets NWJ, Nelemans PJ. Diagnostic Value of Optical Coherence Tomography Image Features for Diagnosis of Basal Cell Carcinoma. Acta Derm Venereol. 2021 Nov 30;101(11):adv00607. https://doi.org/10.2340/actadv.v101.421. PMID: 34724068.

3. Markowitz, O., Chan, C., Evaluating Onychomycosis Outcomes Two Months into an 11-month-long Efinaconazole Regimen: The Role of Optical Coherence Tomography; https://jcadonline.com/onychomycosis-outcomes-2-months-efinaconazole/

4. Rajabi-Estarabadi A., Williams N.M., Tosti A. (2021) Optical Coherence Tomography in Nail Research and Diagnosis. In: Baran R.L. (eds) Advances in Nail Disease and Management. Updates in Clinical Dermatology. Springer, Cham. https://doi.org/10.1007/978-3-030-59997-3_16

5. Abignano G, Green L, Eng S, Emery P, Del Galdo F, Nailfold Microvascular Imaging by Dynamic Optical Coherence Tomography in Systemic Sclerosis: A Case-Controlled Pilot Study, Journal of Investigative Dermatology (2021). https://doi.org/10.1016/j.jid.2021.08.436

6. Ortner, V.K., Holmes, J., Haedersdal, M. and Philipsen, P.A. (2021), Morphometric Optical Imaging of Microporated Nail Tissue: An Investigation of Intermethod Agreement, Reliability, and Technical Limitations. Lasers Surg Med, 53: 838-848. https://doi.org/10.1002/lsm.23304

7. Conti A, Ciardo S, Mandel VD, Bigi L, Pellacani G. Speckled variance optical coherence tomography for the assessment of nail involvement in acrodermatitis continua of Hallopeau: A case study. J Int Med Res. 2016;44(1 suppl):119-123. https://doi.org/10.1177%2F0300060515593263

8. Peris K, Fargnoli MC, Garbe C, Kaufmann R, Bastholt L, Seguin NB, Bataille V, Marmol VD, Dummer R, Harwood CA, Hauschild A, H ller C, Haedersdal M, Malvehy J, Middleton MR, Morton CA, Nagore E, Stratigos AJ, Szeimies RM, Tagliaferri L, Trakatelli M, Zalaudek I, Eggermont A, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). Diagnosis and treatment of basal cell carcinoma: European consensus-based interdisciplinary guidelines. Eur J Cancer. 2019 Sep;118:10-34. doi: https://doi.org/10.1016/j.ejca.2019.06.003. Epub 2019 Jul 6. PMID: 31288208.

9. Fuchs, C., Ortner, V., Hansen, F., Philipsen, P. and Haedersdal, M. (2021), Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery. J Eur Acad Dermatol Venereol, 35: 1377-1385. https://doi.org/10.1111/jdv.17140

November 2021 Issue

Potential for significant cost savings from high predictive value of OCT imaging biomarkers

The authors recommend OCT at 2 months as early indicators of treatment failure which could tremendously reduce the cost of Onychomycosis therapy for millions of patients by indicating the need to change the therapy instead of continuing with one that isn’t working.

See details in the open article here: https://jcadonline.com/onychomycosis-outcomes-2-monthsefinaconazole/.

“Technologies for assessing skin disease are getting better and are crucial for a modern dermatologic institution” says Emma Guttman, MD, Professor and Health System Chair of the Department of Dermatology at Icahn School of Medicine at Mount Sinai, New York City.

“Right now we are so excited to initiate The Kimberly and Eric J. Waldman Melanoma and Skin Cancer Center that transforms skin cancer care, in which patients will experience state-of-the-art new technologies (many unique only to Mount Sinai), that together with amazing surgical care, oncodermatology and unique research, will bring the best prevention and treatment strategies for our patients with skin cancer.”

“With the new center, latest skin assessment technologies are under one roof which makes Mount Sinai a leader in its field. “The goal is to usher in a new era of patient care and discovery” states Jonathan Ungar, MD, Medical Director, Waldman Melanoma and Skin Cancer Center, Assistant Professor, Dermatology and Medical Education. “VivoSight OCT is part of the high-tech armamentarium through its capability to image skin morphology quickly, precisely and non-invasively. Often we can evaluate suspicious lesions sufficiently without having to revert to skin biopsies”.

The VivoSight system looks 1 mm deep into the skin and provides the following images and measures

Visualization of subsurface pathology, such as basal cell carcinoma nests
Vascular plexus depth, modal diameter of vessels and density of vasculature at this level
Changes in vascular density by depth Epidermal thickness and variability
Quantification of skin surface roughness
Epidermal brightness as a proxy for collagen density

Dr. Guttman continues, “OCT is employed for several dermatologic conditions in our department where its use expedites our research and stimulates new ways of interacting with patients. Specifically, we are a leading center for research in inflammatory and autoimmune skin diseases. OCT is well suited for comparison studies and to objectively quantify treatment effects based on measurable changes in structural and vascular skin morphology. We have active studies in several fields, including Atopic Dermatitis, and collaborate with other sites where VivoSight OCT is also available making the research more efficient”.

Dr. Ungar adds, “interestingly, our patients like being scanned with OCT for their status evaluation, they like the non-invasiveness of the procedure, and many of them take an interest in looking at the images facilitating the physician patient communication. In summary, VivoSight OCT enables us to look 1mm deep into the skin and see more skin morphology including lesions and vascularity which advances our analysis and patient care.”

The renowned German research group of Ruini et al. reports about the latest advances in Optical Coherence Tomography. Abstract included in English language: https://doi.org/10.1007/s00105-021-04905-2.

In this review and summary article, the authors elaborate on new OCT application areas like inflammatory and autoimmune skin disease, teleangiectasia, wound healing, skin ageing and melanocytic lesions.

Furthermore, the purpose of OCT is discussed such as being well suited for comparison studies, quantifying treatment efficacy and for non-invasive monitoring of disease activity.

Nailfold Microvascular Imaging by Dynamic Optical Coherence Tomography in Systemic Sclerosis: A Case-Controlled Pilot Study [3]

Through correlations with the standard technique of Nailfold Video Capillaroscopy (NVC), Abignano et al. demonstrate the potential of VivoSight OCT vascular metrics as new objective outcome measures for systemic sclerosis clinical trials and practice.

See details in Open Access article here: https://doi.org/10.1016/j.jid.2021.08.436

In vivo examination of healthy human skin after short-time treatment with moisturizers [4]

In this study, two novel noninvasive diagnostic techniques, optical coherence tomography (OCT) and confocal Raman spectroscopy (RS), were used to quantify the effects of applying a commercially available moisturizing lotion on the forearm.

As a conclusion, short time moisturizing appears insufficient to provide significant changes in skin morphology and composition, as assessed by OCT and RS. A larger sample size and longer treatment schedules may be needed to analyze skin changes under treatment with moisturizers. https://doi.org/10.1111/srt.13101

BCC Diagnosed with OCT in Germany

In Germany, VivoSight OCT has been in use as a powerful aid for dermatologists for Basal Cell Carcinoma (BCC) for over a decade (since 2011): according to our records over 150,000 patients have been scanned with VivoSight to date, and OCT is now included in the Guidelines for Diagnosis of BCC in Germany [5].

Multiple OCT Metrics Correlate with Age

In several case series, subjects age correlates with distinct OCT metrics. OCT quantification may allow for more targeted therapies. Age is most strongly correlated with dermal brightness, epidermal thickness variation and epidermal contrast, all metrics that can be measured with the VivoTools analysis software.

Compliments to the Sheffield Dermatology Research department under the leadership of Prof. Michael J. Cork (https://sheffielddermatologyresearch.com).

The research team at Sheffield Dermatology is a prime example how advanced imaging technologies can be utilized to gain profound insights into inflammatory skin diseases.

Prof. Cork’s team focuses especially on Atopic Dermatitis (AD) where OCT accelerates their research and enables new innovative patient care. One example is to utilize OCT imaging biomarkers to assess subclinical signs of a developing AD flare-up, and mitigate accordingly, as well as evaluate the effectiveness of a treatment regimen (https://sheffielddermatologyresearch.com/oct).

We’re excited to bring you latest updates, stories and educational materials also in 2022.

In the next year, our newsletter VivoScene will be issued quarterly

Software Update: New Metric of Dermal Brightness

Starting December 2021, the new metric of “Dermal Brightness” is added to the VivoTools analysis software.

Dermal Brightness is the ratio of the dermal OCT signal to the top surface brightness (OCT signal). It is a normalized representation of the dermal OCT signal density and a proxy for collagen density.

Dermal Brightness vs. Age shows a clear downward trend. But these results also show that brightness varies between individuals, likely due to differences in their skin’s collagen content.

Dermal Brightness quantification may help evaluate skin response to therapies targeting collagen (see section “Did You Know?” in Education & Training)

Johann Tillmann is Managing Director of DermoScan GmbH , a manufacturer of high end dermoscopy systems which also distributes the VivoSight OCT system in Germany.

“Our customers want practical, high quality skin imaging solutions that get the job done. Constant contact with dermatologists allows us to understand their needs and also avoid overengineering.

The skin is a fascinating organ and for non-invasive lesion assessment about 3 – 4 distinct imaging products and services will generally be sufficient. We offer dermoscopy devices and systems that physicians use in their everyday work.

Still, innovation doesn’t stand still and in Germany dermatologists are early adopters of new imaging technologies should they prove beneficial. So it is with OCT, which is an excellent upgrade when dermatoscopes reach their limits. The physician or assistant resorts to VivoSight OCT mainly for these reasons:

Higher sensitivity and specificity for many pathologies, especially NMSC suspicious lesions
Need for visualization of structural and vascular morphology up to > 1 mm deep at high resolution
Objective quantification of many relevant skin parameters

It is satisfying to see how practitioners “move around” from just illuminating magnifiers all the way up to VivoSight OCT, and with advanced dermatoscopes and practical software options in between. The spectrum of skin conditions is matched by the spectrum of our imaging solutions. Each device complements the other and the dermatologist feels covered for any patient situation that walks through the door that day.

Education and Training is very important for VivoSight, as it is a more involved technology. For many years we have excellent relationships with the manufacturer (Michelson Diagnostics Ltd.) and expert users, like at the University Hospital of Augsburg, Germany. Together we have created an extensive, interactive online course “OCT in Practice” (overview >> here). The modular course especially covers how to assess the most common skin tumors and pathologies based on typical visual criteria and provides helpful tips and explanations for OCT image interpretation. Our dermatologist customers position themselves to their patients as different and unique offering VivoSight OCT capabilities, and we love seeing them thrive clinically.”

References

1. Markowitz, O., Chan, C., Evaluating Onychomycosis Outcomes Two Months into an 11-month-long Efinaconazole Regimen: The Role of Optical Coherence Tomography; https://jcadonline.com/onychomycosis-outcomes-2-months-efinaconazole/

2. Ruini, C., Daxenberger, F., Gust, C. et al. Neues von der optischen Kohärenztomographie. Hautarzt (2021). https://doi.org/10.1007/s00105-021-04905-2

3. Abignano G, Green L, Eng S, Emery P, Del Galdo F, Nailfold Microvascular Imaging by Dynamic Optical Coherence Tomography in Systemic Sclerosis: A Case-Controlled Pilot Study, Journal of Investigative Dermatology (2021). https://doi.org/10.1016/j.jid.2021.08.436

4. Ruini C, Kendziora B, Ergun EZ, Sattler E, Gust C, French LE, et al. In vivo examination of healthy human skin after short-time treatment with moisturizers using confocal Raman spectroscopy and optical coherence tomography: Preliminary observations. Skin Res Technol. 2021;1-14. https://doi.org/10.1111/srt.13101

5. Lang BM, Balermpas P, Bauer A, Blum A, Brölsch GF, Dirschka T, Follmann M, Frank J, Frerich B, Fritz K, Hauschild A, Heindl LM, Howaldt HP, Ihrler S, Kakkassery V, Klumpp B, Krause- Bergmann A, Löser C, Meissner M, Sachse MM, Schlaak M, Schön MP, Tischendorf L, Tronnier M, Vordermark D, Welzel J, Weichenthal M, Wiegand S, Kaufmann R, Grabbe S. S2k Guidelines for Cutaneous Basal Cell Carcinoma – Part 1: Epidemiology, Genetics and Diagnosis. J Dtsch Dermatol Ges. 2019 Jan;17(1):94-103. doi: 10.1111/ddg.13733. Epub 2018 Dec 28. PMID: 30592557.

September 2021 Issue

Video Blog by Jon Holmes, CEO of Michelson Diagnostics Ltd. (MDL)

Our CEO Jon Holmes is commenting on a recent paper [1] describing a method that offers a new patient-centric, non-surgical option with improved efficacy and cosmetic outcomes for the treatment of Basal Cell Carcinoma (BCC).

Skin cancer treatment pioneer Dr. Orit Markowitz is the first to show that adding VivoSight OCT image guidance for BCC lesion margination and recurrence monitoring leads to one year clearance rates, as determined by clinical, dermoscopy and OCT examination, of 98% excluding immunosuppressed patients and 95.8% including immunosuppressed patients. Most lesions cleared with one Nd:YAG laser treatment.

Learn more in the Video Blog here.

“Advanced skin imaging is imperative for our teaching institution”, says Merete Haedersdal, Professor at the University of Copenhagen and Consultant in Dermatology at Bispebjerg Hospital, Copenhagen, Denmark and further visiting scientist to the Wellman Center for Photomedicine in Boston, USA.

“The practice of dermatology has come a long way and without an adequate assortment of imaging systems, we cannot be at a leading edge in research or modern clinical practice.”

At Bispebjerg University Hospital, the academic team in the department associated with skin imaging consists of professors, physicians, residents, clinical and dermatology research fellows and a good group of medical students. At any given moment, these individuals perform skin imaging procedures other than with the ubiquitous dermatoscope (Figs. 1–2).

Dr. Haedersdal continues, “in many cases we make use of Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT). We just acquired our second VivoSight OCT system and generally use it for the purpose of:

Accelerating Skin Research Projects

See skin microstructures, up to > 1 mm deep, and see skin changes produced by disease and treatments
Obtain objective structural and vascular measurements, like epidermal thickness – superficial vascular plexus depth, vessel diameter and density – surface roughness – blood flow at various depths – epidermal brightness as a proxy for collagen density and more

Providing Advanced Clinical Practice

Quickly see below the surface to better inform treatment decisions
Aids in monitoring treatment response
Effective communication tool with patients

These areas have almost infinite applicability in a university teaching environment, and I’d like to mention just a few recent examples of our group’s work:

Wenande et al: OCT-imaging utilized for low-risk BCC tumor demarcation, treatment and tumor response assessment [2]

For tumor demarcation, imaging appeared beneficial as OCT detected subclinical tumor in 58% of clinical margins, leading to expansion of the treatment area
Evaluation of BCC tumor thickness with OCT
OCT and RCM used to assess treatment response for potential retreatment
OCT utilized to identify best location for post-treatment biopsies

Fuchs et al: Subclinical acne micromorphology and temporal treatment response visualized and quantified [3]

High correlation between acne clinical severity and skin imaging features
Transfollicular delivery of microparticulate suspension visualized
Significant increase in epidermal thickness and vessel morphology changes quantified
OCT and RCM identify subclinical imaging biomarkers that may allow treatment triage

Banzhaf et al: Spatiotemporal closure of fractional laser-ablated channels imaged by OCT and RCM [4]

VivoSight OCT identifies laser channels as black ablation defects in epidermis and upper dermis, surrounded by a characteristic pattern of hyper- and hyporeflective zones
OCT visualizes heterogeneous material in the lower part of open laser channels, indicating tissue fluid
Gradual spatiotemporal closure of laser channel observed over time with in-vivo OCT imaging

Ortner et al: OCT useful for morphometric imaging of microporated nail tissue targeted for drug delivery [5]

Images from various imaging technologies were assessed for nail plate thickness, micropore dimensions and degree of poration
OCT demonstrated the highest repeatability of all imaging techniques
Micropore dimensions correlated strongest between OCT and RCM

Another important reason to have top skin imaging capabilities is the expectation of newly arriving medical students, researchers and clinicians. In today’s interconnected world they want to be part of what’s going on around the globe regarding new insights and best practices. Without proper equipment, they’d be locked out from advances at other international sites and we can’t afford that. As such, not only do we stay on top in this field, skin imaging is part of many PhD programs and a good opportunity for researchers and clinicians to differentiate themselves.

In a similar vein, patients become more knowledgeable and, where appropriate, will want to be evaluated in a most convenient way, a characteristic of non-invasive imaging technologies.

Given our focus on laser-assisted (transdermal) drug delivery and on new ways treating various types of skin cancer, a further good example of keeping up with technology is the increased use of Artificial Intelligence (AI) in medical imaging applications including dermatology. This is a timely development for our work within the Danish Research Center for Skin Cancer. A concentrated effort is underway to understand and manage various manifestations of skin cancer better, from diagnosis to treatment. We are excited to be part of the VivoSight OCT AI Working Group that is specifically working on machine learning algorithms to aid in the evaluation of BCC suspicious lesions (Fig. 3).

In summary, advanced skin imaging capabilities are an indispensable element in our department for research efficiency, making discoveries and assessing patients effectively. VivoSight OCT serves us well and we are excited about the AI initiative as well as making imaging a solid discipline in our dermatology department”.

OCT is a valuable tool in clinical dermatology and dermatologic research.

A comprehensive review article by Psomadakis and Markowitz et al. also covers its utility in diagnosis, monitoring, and grading disease severity in a variety of cutaneous conditions.

Potential of monitoring early disease progression and overall vascular health with OCT [7]

Excellent article by Michael Wang-Evers et al. on importance of visualization and quantification of the skin microvasculature, changes of which correlating with age and blood pressure.

Change in dermal microvasculature after skin compression and immediate release is efficiently imaged and measured by VivoSight OCT (Fig. 4) potentially allowing assessment of overall vascular health and monitoring early disease progression.

VivoSight OCT measures vascular characteristics of port wine birthmarks classified by color [8]

Different color Port Wine Birthmark (PWB) vessel characteristics, such as diameter and depth, may impact presentation and treatment outcomes.

It was found that superficial vessels of purple PWB were significantly closer to the epidermis than pink PWB, which might inform selection of more optimal laser treatment parameters.

How deep is the tattoo?

Accumulations of dark tattoo ink can be well seen with OCT to a depth of about 1 mm. Can measurement of tattoo ink depth help to optimize laser tattoo removal protocols?

Thanks to Brittani Jones for these OCT images. Brittani is a research student for Dr. David Ozog at Henry Ford Health Systems Dermatology Department.

PharmaEd Resources’ Microneedle & Transdermal Delivery Systems Summit 2021 brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

VivoSight OCT is utilized at various research sites to visualize microneedle arrays in the skin, measure insertion depth, monitor swelling or dissolution, as well as skin and vascular changes at the treated site, all of which can help to navigate the clinical and regulatory pathway.

Link to Summit: here

Download Program: here

VivoSight Artificial Intelligence (AI) Project on Track

As mentioned in previous newsletter editions, VivoSight’s AI initiative is ongoing with more capabilities being developed.

We present a sample image that displays a perceived BCC lesion in various colors representing various confidence levels (Fig. 5).

Dr. Giovanni Pellacani is full professor and chairman of the department of dermatology at Sapienza University of Rome, Italy. To date he has published more than 800 peer reviewed articles.

“One of my research interests is noninvasive imaging for skin cancer. Like any multifaceted area, this requires a set of effective tools that have their unique purpose and complement each other.

We use VivoSight OCT when we need to look deeper than the first about 200 μm, as done with RCM (Reflectance Confocal Microscopy). Imaging as deep as > 1 mm affords us good understanding of depth and lateral extent of NMSC (Non-Melanoma Skin Cancer) lesions and as such gives us a quick global overview whether there are (still) suspicious anomalies.

Further we use OCT not only for NMSC. It is also an effective modality to assess stages of inflammatory and autoimmune disease such as atopic dermatitis, psoriasis and bullous disease.

OCT distinguishes micromorphology of the condition and excellent vascular imaging capabilities add another layer to characterize the pathology, often indicating degree of disease severity including subclinical Fig. 5: Yellow to red to blue areas: different confidence levels for AIaugmented BCC imaging biomarkers. manifestations. We have published several papers on OCT imaging biomarkers describing inflammatory skin conditions [9].

A very important issue is the development of skin imaging standards, methods and measures to efficiently compare treatment effects and patient status [10]. In collaboration with other international thought leaders we home in on imaging biomarkers that allow us to share our results more efficiently. This further includes the development of Artificial Intelligence (AI) based algorithms for VivoSight OCT.

Noninvasive skin visualization will become vital in modern dermatology and the integration of imaging standards will add to the common language describing our work.”

References

1. Markowitz, O, Bressler, MY. Combining Nd:YAG laser with optical coherence tomography for nonsurgical treatment of basal cell carcinoma. Lasers Surg Med. 2021; 1– 8. https://doi.org/10.1002/lsm.23455

2. Wenande, E., Hendel, K., Mogensen, M., Bagger, C., Mårtensson, N.L., Persson, D.P., Lerche, C.M., Husted, S., Janfelt, C., Togsverd-Bo, K., Anderson, R.R. and Haedersdal, M. (2021), Efficacy and Safety of Laser-Assisted Combination Chemotherapy: An Explorative Imaging-Guided Treatment With 5-Fluorouracil and Cisplatin for Basal Cell Carcinoma. Lasers Surg Med, 53: 119-128. https://doi.org/10.1002/lsm.23323

3. Fuchs, C., Ortner, V., Hansen, F., Philipsen, P. and Haedersdal, M. (2021), Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery. J Eur Acad Dermatol Venereol, 35: 1377-1385. https://doi.org/10.1111/jdv.17140

4. Banzhaf, C.A., Wind, B.S., Mogensen, M., Meesters, A.A., Paasch, U., Wolkerstorfer, A. and Haedersdal, M. (2016), Spatiotemporal closure of fractional laser-ablated channels imaged by optical coherence tomography and reflectance confocal microscopy. Lasers Surg. Med., 48: 157-165.https://doi.org/10.1002/lsm.22386

5. Ortner, V.K., Holmes, J., Haedersdal, M. and Philipsen, P.A. (2021), Morphometric Optical Imaging of Microporated Nail Tissue: An Investigation of Intermethod Agreement, Reliability, and Technical Limitations. Lasers Surg Med, 53: 838-848. https://doi.org/10.1002/lsm.23304

6. Corinna E. Psomadakis, Nadeem Marghoob, Brady Bleicher, Orit Markowitz, Optical coherence tomography, Clinics in Dermatology, 2021, ISSN 0738- 081X, https://doi.org/10.1016/j.clindermatol.2021.03.008

7. Wang-Evers, M., Casper, M.J., Glahn, J. et al. Assessing the impact of aging and blood pressure on dermal microvasculature by reactive hyperemia optical coherence tomography angiography. Sci Rep 11, 13411 (2021). https://doi.org/10.1038/s41598-021-92712-z

8. Mehrabi JN, Holmes J, Abrouk M, Wang JV, Pomerantz H, Palma AM, Zachary CB, Geronemus RG, Waibel JS, Kelly KM, Vascular characteristics of port wine birthmarks as measured by dynamic optical coherence tomography, Journal of the American Academy of Dermatology (2021), doi: https://doi.org/10.1016/j.jaad.2021.08.007.

9. Manfredini, M, Liberati, S, Ciardo, S, et al. Microscopic and functional changes observed with dynamic optical coherence tomography for severe refractory atopic dermatitis treated with dupilumab. Skin Res Technol. 2020; 26: 779– 787. https://doi.org/10.1111/srt.12868

10. Ciardo, S., Pezzini, C., Guida, S., Del Duca, E., Ungar, J., Guttman-Yassky, E., Manfredini, M., Farnetani, F., Longo, C. and Pellacani, G. (2021), A plea for standardization of confocal microscopy and optical coherence tomography parameters to evaluate physiological and para-physiological skin conditions in cosmetic science. Exp Dermatol, 30: 911- 922. https://doi.org/10.1111/exd.14359

July 2021 Issue

Innovaderm is one of the leading Clinical Research Organizations (CRO) and research sites in Dermatology. It has an international reputation for the quality of its studies in atopic dermatitis, psoriasis and acne vulgaris.

Innovaderm recently acquired a VivoSight OCT system and went through the first phase of clinical launch. Founder and CEO Robert Bissonnette, MD states, “we need to be on the forefront of providing excellent services to our clients. The subclinical visualization and quantification capabilities of VivoSight are welcome additions to accelerate our research and clinical development work.”

The Innovaderm research site just made first of the ‘Top 10 Research Sites’ with the most completed clinical trials in atopic dermatitis as per TrialHub. The CRO unit has also been recognized for the quality of its work and has been awarded a 2021 CRO leadership award.

If you want to collaborate with Innovaderm on studies managed in North America, Europe and Asia-Pacific, please click here.

Michelson Diagnostics Ltd. (MDL), the UK manufacturer of the VivoSight OCT skin imaging system, collaborates with AI specialist Manchester Imaging Ltd. to develop AI-enhanced BCC detection capabilities.

Artificial Intelligence (AI) applies the latest developments in machine learning, computer vision, neural networks and advanced algorithms to provide practical assistance to clinicians in their use of OCT imaging of BCC. AI could help by rapidly picking out and quantifying ‘biomarkers’ for BCC in the VivoSight images in order to streamline workflow and further optimize sensitivity and specificity.

Our collaborator Manchester Imaging Ltd. already has an AI product on the market for dentistry for use on difficult to interpret radiographic images of X-ray bitewings for enamel-only proximal caries, and has shown that dentists achieved a 76% detection rate when aided by their AI software, compared to only 44% without AI (Figs. 1a, b).

Jon Holmes, CEO of MDL, remarks, “our goal is to use OCT to minimize interventional management of low risk BCC, for both physician and patient. I believe AI has real potential to deliver benefits towards this goal. Easier and earlier AI-enhanced OCT BCC detection, mapping and treatment monitoring dovetails very well with emerging non-invasive, more effective treatment options for low risk BCC lesions, by providing patients and physicians with confidence that the BCC is accurately and effectively treated through to clearance of the tumor.”

Jon Holmes continues, “our work with Manchester Imaging Ltd. is proceeding at pace, and we expect to have a working prototype very soon (Figs. 2a, b); we are now establishing an AI-VivoSight OCT Clinical Working Group with leading dermatologists experienced in VivoSight OCT use and BCC management to help evaluate it, and to provide insights and feedback on how the AI-enhanced OCT tool will be most useful in practical clinical use.”

MDL CEO Jon Holmes concludes “this project, targeting BCC, is just the beginning for AI and VivoSight OCT. VivoSight has a broad range of imaging and clinical applications (see VivoSight Publications Register) and we expect that AI will eventually provide support for many other clinical questions addressable with OCT imaging; we welcome ideas and suggestions from anyone!”.

As mentioned in our previous newsletter, in close cooperation with the University Hospital of Augsburg, Germany and Michelson Diagnostics, our strategic partner DermoScan GmbH has developed a multi-session online course: OCT in Practice.

The modular course is aimed at VivoSight newcomers and experienced users alike. Presently, 12 main topics are being covered (overview >> here) focusing on when and how to ideally use OCT. You will learn how to assess the most common skin tumors and pathology based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation (Figs. 3a, b). We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz on OCT images of BCCs!

“As I am working in a busy practice, it was very practical to attend the course at my own schedule. The learning modules are logically structured, from beginner to advanced level, and they are effective. In a short while I was able to utilize VivoSight for my clinical work with patients, but will also become more experienced over time to get the most out of the system.”

Henrik Mohme, MD, Dermatologist, Porta Westfalica, Germany

The online course is available for a one-time fee of 490 Euros. Interested parties should contact our strategic partner DermoScan at oct@dermoscan.de and will be provided with a quotation and other details.

Optical coherence tomography quantifying photo aging: skin microvasculature depth, epidermal thickness and UV exposure [1]:

Olsen et al. demonstrate the feasibility of dynamic-OCT to evaluate epidermal thickness and blood vessel depth for the assessment of photoaging.

Photoaging predominantly occurs in the face, neck and hands due to UVA and UVB irradiation. Histological studies indicate thinning of the epidermis and elastosis. The group found a significant age-related decrease of epidermal thickness and blood vessel depth as well as a seasonal effect on both epidermal thickness and blood vessel depth.

Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery [2]:

Another stellar paper from Denmark! Fuchs et al. use both VivoSight OCT and RCM to describe subclinical acne treatment effects with in-vivo imaging.

Recent reports on the high correlation between clinical acne severity and optical imaging features substantiated the utility of real-time, noninvasive imaging to obtain quantifiable data on micromorphology and gold microparticle distribution.

The authors conclude that the implementation of OCT and RCM in clinical and research settings permits the assessment of early sub-clinical treatment response and furthers the understanding of effective strategies to enhance transfollicular drug delivery.

Microneedles for gene and drug delivery in skin cancer therapy [3]:

Excellent review paper from Zhi et al. covers two main specialties of VivoSight OCT: imaging of skin cancer and Microneedle patch insertion behavior.

Microneedles (MNs) are an excellent minimally invasive delivery method, as they can bypass the stratum corneum and enter the skin microcirculation to achieve drug and gene delivery. The review summarizes the latest developments in MNs for gene and/or drug delivery, with a focus on their performances as effective MNs for skin cancer treatment. (Note also the many educational assets on our website’s blog page about the use of VivoSight OCT to optimize microneedle performance.)

Comparison Screen Feature

An excellent way to observe morphologic and angiographic changes is the comparison screen feature. Note the clear difference in image and metrics after exposing skin to an irritant. The changes in the lower image take place within minutes.

The comparison screen feature makes it easier to detect and quantify subclinical changes, as such accelerating your research and clinical development work.

VivoSight OCT can effectively characterize the insertion behavior of Microneedles Array Patches (MAPs), and collaborations between industry and academia are being established.

Michigan based TSRL Inc., a preclinical pharmaceutical accelerator company, announced that it has entered into a licensing agreement with The Queen’s University of Belfast for the exclusive use of their patented hydrogel microneedle (MN) technology for the development of a MN patch for treatment of the flu. Future uses of the platform with other therapeutics and vaccines can be optioned (Press Release here).

VivoSight OCT is heavily utilized by Queen’s University’s Prof. Ryan Donnelly and his group to optimize Microneedle Array Patch (MAP) performance. See a number of educational blogs here

Uninterruptible Power Supply (UPS) and New Higher Resolution Camera

VivoSight systems shipped after June 2021 will contain an internal UPS (Uninterruptible Power Supply) that mitigates against power interruptions for up to 70 seconds. This will also be available as a field upgrade to older units.

In addition, new VivoSight units will be fitted with a new, higher resolution probe camera, to further aid accurate probe placement. Older units can also be upgraded at MDL’s factory.

Dr. Barry DiBernardo, MD is a board-certified plastic surgeon and the medical director of New Jersey Plastic Surgery in Montclair. In practice for more than 30 years, he also undertakes a high amount of clinical research.

“In our practice we participate in clinical research with skin tightening technologies to improve skin laxity and wrinkle appearance. With VivoSight we can visualize and quantify skin surface roughness which gives us an objective metric for measuring treatment impact and helps us focus in on the most effective therapies for each patient.

An example of how we use VivoSight is represented in the images below where we are using the VivoSight Skin Roughness Measure to quantify the improvement in the surface texture of the skin in response to treatment.

In addition to this type of application we are also using VivoSight to:

Monitor the treatment of scars
Evaluate skin conditions such as acne to help determine depth
Identify how topicals affect skin texture and vascular density
Image micro-coring and needling to see hole closure in clinical trials
Monitor changes in vascularity over time for certain treatments”.

Dr. DiBernardo concludes, “finally, VivoSight greatly complements my Canfield and other imaging systems. They all have strengths in different areas and with VivoSight I can see surface and subsurface pathology, structural and vascular morphology, to more than a millimeter deep. This allows me to assess the patient’s skin more thoroughly, document treatment results, but also conduct more information based patient consultations”.

References

1. Olsen, J., Gaetti, G., Grandahl, K. et al. Optical coherence tomography quantifying photo aging: skin microvasculature depth, epidermal thickness and UV exposure. Arch Dermatol Res (2021). https://doi.org/10.1007/s00403-021-02245-8

2. Fuchs CSK, Ortner VK, Hansen FS, Philipsen PA, Haedersdal M. Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery. J Eur Acad Dermatol Venereol. 2021 Jun;35(6):1377-1385. doi: 10.1111/jdv.17140. Epub 2021 Mar 5. PMID: 33508886. https://pubmed.ncbi.nlm.nih.gov/33508886/

3. Defu Zhi, Ting Yang, Tingyu Zhang, Mei Yang, Shubiao Zhang, Ryan F. Donnelly, Microneedles for gene and drug delivery in skin cancer therapy, Journal of Controlled Release, Volume 335, 2021, Pages 158-177, https://doi.org/10.1016/j.jconrel.2021.05.009

July 2021 Issue

If you want to collaborate with Innovaderm on studies managed in North America, Europe and Asia-Pacific, please click here.

The modular course is aimed at VivoSight newcomers and experienced users alike. Presently, 12 main topics are being covered (overview >> here) focusing on when and how to ideally use OCT. You will learn how to assess the most common skin tumors and pathology based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation (Figs. 3a, b). We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz on OCT images of BCCs!

Henrik Mohme, MD, Dermatologist, Porta Westfalica, Germany

Optical coherence tomography quantifying photo aging: skin microvasculature depth, epidermal thickness and UV exposure [1]:

Olsen et al. demonstrate the feasibility of dynamic-OCT to evaluate epidermal thickness and blood vessel depth for the assessment of photoaging.

Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery [2]:

Another stellar paper from Denmark! Fuchs et al. use both VivoSight OCT and RCM to describe subclinical acne treatment effects with in-vivo imaging.

Microneedles for gene and drug delivery in skin cancer therapy [3]:

Excellent review paper from Zhi et al. covers two main specialties of VivoSight OCT: imaging of skin cancer and Microneedle patch insertion behavior.

Comparison Screen Feature

The comparison screen feature makes it easier to detect and quantify subclinical changes, as such accelerating your research and clinical development work.

VivoSight OCT can effectively characterize the insertion behavior of Microneedles Array Patches (MAPs), and collaborations between industry and academia are being established.

VivoSight OCT is heavily utilized by Queen’s University’s Prof. Ryan Donnelly and his group to optimize Microneedle Array Patch (MAP) performance. See a number of educational blogs here

Uninterruptible Power Supply (UPS) and New Higher Resolution Camera

In addition, new VivoSight units will be fitted with a new, higher resolution probe camera, to further aid accurate probe placement. Older units can also be upgraded at MDL’s factory.

In addition to this type of application we are also using VivoSight to:

Monitor the treatment of scars
Evaluate skin conditions such as acne to help determine depth
Identify how topicals affect skin texture and vascular density
Image micro-coring and needling to see hole closure in clinical trials
Monitor changes in vascularity over time for certain treatments”.

References

May 2021 Issue

Learn about the capabilities of OCT in clinical and research applications. The CEO of Michelson Diagnostics, Jon Holmes, will present at the upcoming annual, virtual meeting of the American Society for Laser Medicine & Surgery (ASLMS), May 15 – 17, 2021:

10 YEARS OF OPTICAL COHERENCE TOMOGRAPHY IN DERMATOLOGY: A REVIEW OF PROGRESS MADE IN CLINICAL UTILITY AND IN SKIN RESEARCH APPLICATIONS 2010-2020

When: Sunday, May 16, 2021 from 2:32 PM – 2:45 PM CDT

Where: NON-CME Industry White Paper Presentations – Session #2

What: 10 minutes recorded presentation and PDF, followed by Live Q & A

Who: Jon Holmes MA, FInstP, FASLMS – CEO & Co-Founder, Michelson Diagnostics Ltd.

Management choices for Basal Cell Carcinoma (BCC) have been growing due to increased clinical research, treatment technology advances and use of state-of-the-art skin imaging systems. Flexible, efficient options that address each patients’ unique circumstances and preferences are desired. Leading physicians share their experience in the evolution of new management models and how VivoSight OCT plays a crucial role.

Christopher Zachary MD

“Besides established treatment methods for BCC, including Mohs micrographic surgery, new in-office, noninvasive therapies, like laser therapies, have achieved impressive results in recent studies for specific types of BCC lesions [1 – 8]”, says Christopher Zachary MD, Professor and Chair Emeritus of Dermatology at UC Irvine.

He continues, “the integration of OCT skin imaging into treatment algorithms provides real insight into the optimal assessment, treatment and subsequent monitoring of lesions. The result will be increased patient convenience and practice efficiency. Initial cases are showing excellent clinical and aesthetic outcomes. We are studying OCT in combination with lasers to assess, treat and monitor the less aggressive BCC subtypes and see the following benefits:

Pre-Treatment Assessment

Determine peripheral extension and depth of lesion to provide unique and tailored treatment for better efficacy and cosmesis

Aiding Selection of Treatment Method

OCT assessment allows for effective lesion triage for appropriate treatment method selection, in consultation with the patient

Post-Treatment Monitoring

OCT-monitoring of the treated site allows optimal non-invasive postoperative assessment for possible recurrence and development of new tumors

Dr. Zachary concludes, “OCT adds a new layer of confidence about “what is going on & what we can do” due to new objective data and images. In fact, we just published a paper where we used an advanced laser technology (Sciton Inc.) to deliver a controlled hyperthermic dose to the lesion site in a precise fashion, guided by OCT lesion mapping [9] (Fig. 1 – 2).

More work is to be done, but this project is a good illustration of the evolving OCT guided Assess-Treat-Monitor paradigm for the purpose of controlled, local therapy with satisfactory results for both patient and physician. The goal is to achieve high clearance rates with less invasive treatments that should offer superior cosmetic results to surgery.”

Orit Markowitz MD

In several cases new BCC management options are already integrated in real life clinical practice, a prominent example being OptiSkin in New York under the leadership of skin cancer specialist Orit Markowitz MD, the most veterened US pioneer dermatologist in Optical Coherence Tomography and founder of OptiSkin. Dr. Markowitz is also co-chairing the virtual second World Congress of Confocal Microscopy this month. Register here: RCM World Congress

In her newly opened multi-disciplinary center, Dr. Markowitz emphasizes a new model of care for non-melanoma skin cancer under the motto “Cutting Edge Without the Cutting TM”. She remarks, “of course there is room for excision and Mohs micrographic surgery, but I don’t cut, if I can help it. Technologies have come a long way and with them we can offer the latest methods in non-invasive skin cancer diagnosis, treatment and follow-up, a tailored approach our patients want” (Fig. 3).

Dr. Markowitz continues, “I’ve been treating non-melanoma skin cancer non-invasively for more than a decade now and we achieve clearance rates comparable to surgery. In a recent pilot study we achieved BCC clearance rates of over 82% from a single Nd:YAG laser treatment and 100% in up to three treatments [5].

I use RCM (Reflectance Confocal Microscopy) for non-melanoma skin cancer diagnosis, whereas OCT is used for pre-treatment margin assessment, deciding on treatment method based on margin and patient consultation, and monitoring for clearance after treatment. Our imaging modalities give us the information we need to let patients know that their lesions have been cleared, which is their primary concern.”

Dr. Markowitz concludes, “we use OCT also for post-treatment follow-up; if we see a BCC lesion not cleared, we simply re-treat, leading to our very high clearance rates. I’d like to further add that we also treat on the face for which OCT pre-margination is mandatory for targeted laser therapy with desirable cosmetic results. As many of our patient’s lesions are detected early in their evolution, these lesions might be particularly amenable to laser management”.

Julia Welzel MD & Uwe Reinhold MD

Two case examples from Germany, where VivoSight OCT is especially prevalent in dermatology practices: Dermatologists and OCT experts Julia Welzel MD and Uwe Reinhold MD have both independently conducted trials to validate safety and efficacy of OCT-guided scanning Nd:YAG laser treatment of BCC for utilization in clinical practice.

Julia Welzel MD, who is Chief of Dermatology at the University Hospital in Augsburg, Germany, states, “our team started investigating the OCTguided laser approach more than two years ago [12]. After fine tuning technique and parameters, we engaged in a study with positive results about to be published (Fig. 4 – 5). The advantages we see with the OCT-guided scanning Nd:YAG laser approach are:

A simple, potentially just single laser treatment for lesions less than 1 mm thick
Less morbidity than cryotherapy or surgery
More appropriate for elderly, infirm patients
An alternative to surgery
Cost and time savings. Much faster than PDT therapy or topical regimen with imiquimod.

This new approach has good potential to be well adopted in Germany.”

Uwe Reinhold MD is President of the Dermatology Center Bonn, in Bonn Germany, and is also an Executive Officer of the OnkoDerm physician network group focusing on skin cancer guidelines. “We are always on the lookout for new treatment options to provide more choices for our patients”, says Dr. Reinhold. “While it is under additional investigation in the US, we evaluated OCT-guided Nd:YAG laser therapy for appropriate BCC lesions for almost 2 years now and find it to be an excellent modality.” (Fig. 6 – 7).

He continues, “in Germany, treatment of BCC with PDT is very prevalent and achieves very good results especially as a field-directed therapy. However, the evolving scanning Nd:YAG laser from Sciton is attractive in more lesion-directed cases, and also as it is of very short duration compared to PDT. We’re excited to develop algorithms and treatment paths for various BCC presentations, based on our extensive preand post-treatment assessment with OCT, which is done routinely in Germany.”

Robert Stephens MD

Robert Stephens MD and his group at North West Sydney Dermatology & Laser are the first clinic in Australia to offer “OCT-guided skin cancer removal” (https://www.northwestderm.com.au). The team has a special interest in photodynamic therapy, the use of lasers and various types of light in the management of skin disorders, as well as surgical removal of skin cancers. Dr. Stephens has developed the interesting concept of “bi-phasic PDT”. The concept consists of using two types of light source to illuminate the photosensitized tumor. A first phase of conventional red-light activation is immediately followed by second phase delivery of light using an IPL device (Sciton BBL). The IPL is delivered with enough mechanical pressure in order to blanch the skin (to remove the blood).

The hypothesis is that hyperaemia/flushing from PDT can be detrimental as hemoglobin (particularly deoxyhemoglobin) can compete as a light absorber. Flushing can be beneficial though because more oxygen is delivered to tissue. Removing hemoglobin can dramatically augment the passage of light to tumor cells (including stronger yellow and green wavelengths included in the IPL spectrum) thus enhancing activation.

Sufficient free oxygen for the higher fluence second phase (IPL) activation is provided through hyperaemia/flushing from the first phase (red-light) activation. Mechanical pressure may also “squash” certain tumors thereby reducing the distance light has to travel to reach the lower edge.

Much improved outcomes with this method have been observed and first results have been published (there has been no clinical and/or OCT evidence of recurrence in 35 of 36 BCCs of which most tumors were facial and 50% were nodular). The mean follow-up time was 10 months [10]. (Fig. 8 – 11).

For Dr. Stephens in Australia, OCT imaging combined with bi-phasic PDT makes it possible for “BCC diagnosis and removal the same day”. He says, “OCT is instrumental to assess if a skin cancer is suitable for PDT. It is invaluable for lesion selection where we determine depth and subtype of BCC, and further we can identify tumors showing features such as liquefactive necrosis that make them more “squashable” (with the Sciton BBL handpiece). Very important too is that we can verify lesion clearance with OCT.”

Dr. Stephens concludes, “we have an epidemic of BCC in Australia. Our patients want effective, efficient, non-invasive therapy options, as long as the lesion type allows it. For this, OCT serves as a patient qualification and outcome validation tool.”

In summary, a new era has evolved for more personalized, patient-driven management of BCC. VivoSight OCT imaging and measures enable investigators to advance the paradigm of OCT-guided Assessment, Treatment & Monitoring and aid in BCC lesion demarcation, appropriate treatment selection and clearance confidence. Precision skin imaging and innovative treatment methods are inseparable and complement each other for patient and practice efficient BCC management.

US FDA Regulatory Status:

The VivoSight™ topical OCT system is 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. VivoSight is cleared under 510(k) number K153283.

In close cooperation with the University Hospital of Augsburg, Germany and Michelson Diagnostics, our strategic partner DermoScan GmbH has developed a multi-session online course: OCT in Practice. This course we’ll cover in detail in our next newsletter (July).

Using videos and documents, the course will cover 12 main topics (overview >> here), including, for example, when and how to ideally use OCT. You will learn how to assess the most common skin tumors based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation. We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz. Stay tuned! “OCT in Practice” coming soon to you!

May is Skin Cancer Awareness Month! There are now over 380 peer-reviewed publications covering VivoSight OCT and the most widely studied topic is imaging of Basal Cell Carcinoma. VivoSight serves as an aid to clinical diagnosis, and for measurement of tumor depth and lateral extent of the lesion. These capabilities can not only be helpful in guiding treatment decisions but are unmatched in the non-invasive monitoring of the treated site.

There are many additional publications on other skin cancer types. For a structured list of our publications, please see here

Differentiating Melanoacanthoma from Melanoma with Non-invasive Imaging

Excellent work by Markowitz, Bressler et al.! [13]. As a first, they describe complementary use of RCM and VivoSight OCT for in-vivo evaluation of melanoacanthoma. The notable absence of atypical vasculature, typical of melanoma on dynamic OCT, supported an in-vivo diagnosis of melanoacanthoma with higher confidence.

Video: OCT for Skin Cancer in Australia - Interview with Dr. Pascale Guitera

Dr. Pascale Guitera from the Melanoma Insitute of Australia elaborates on practical utility of VivoSight in an environment characterized by high skin cancer rates.

According to Dr. Guitera, VivoSight is especially appropriate for identifying and triaging BCC lesions followed by margin mapping for suitable treatment. Further on, OCT is employed during the follow-up process to monitor for clearance or eventual recurrances.

Play Video

Microneedle Array Patches for Contraception and HIV Prevention

New article by Paredes et al. on an important topic [14]. Microneedle Array Patches (MAPs) are a novel platform being developed for the delivery of hormonal contraception and antiretroviral drugs. MAPs provide enhanced drug delivery to the systemic circulation via the transdermal route when compared to transdermal patches, oral and injectable formulations.

VivoSight OCT is especially suited to analyze in-vivo the insertion behavior of microneedle patches, such as insertion depth, swelling and dissolution. VivoSight can also quantify and monitor changes to the vasculature and skin surface providing objetive data to help navigate the clinical and regulatory pathways. Note several educational blogs by Prof. Ryan Donnelly and VivoSight’s CEO Jon Holmes on our blog – click here

VivoSight OCT is an excellent modality to aid in the identification of a large number of suspicious lesions, as encountered in conditions like Gorlin Syndrome or Nevoid Basal-Cell Carcinoma Syndrome. The sheer number of lesions makes it impractical to biopsy, but OCT non-invasive assessment and monitoring is an alternative option for disease management

PharmaTher Inc., a specialty life sciences company, has entered into an Exclusive Worldwide Patent and Know-how License Agreement with The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine. [Click here for PharmaTher Press Release] VivoSight OCT is heavily utilized by Prof. Ryan Donnelly and his group to optimize Microneedle Array Patch (MAP) performance. See a number of educational blogs here

A Simulive Virtual Interactive Event May 21 – 23, 2021

Participate in an exciting 3-day continuing medical education (CME) activity about value, complementary functions and limitations of noninvasive cutaneous imaging devices (including dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT)) in various clinical settings.

Congress Co-Presidents: Orit Markowitz, MD and Melissa Gill, MD

Register here: RCM World Congress

Integrating Dermatoscope Images onto VivoSight Screen:

For a more comprehensive patient assessment, VivoSight makes it easy to integrate DermoGenius dermatoscopes from DermoScan GmbH, Germany.

Like the VivoSight handpiece, the dermatoscope can be inserted into the right or left holster of the VivoSight console. Dermatoscope images are then viewable on the VivoSight screen.

For a comprehensive overview of the high-quality DermoScan product line, please visit: https://dermoscan.de/en/

Dermatologist Dr. Bernd Algermissen manages a busy practice on Berlin’s famed Kurfuerstendamm: Avantgarde Lasermedizin. For many years, his VivoSight OCT system is firmly part of practice operations:

“For us, utilizing VivoSight means practicing precision medicine! It provides us with confirmation and confidence for a truly customized patient experience. Take for example the very prevalent condition of AK (Actinic Keratosis), which manifests itself in many different ways. Yes, we all debulk the thick lesion parts first with curettage, medical sandpaper, laser etc.. But how deep really is the pathology of a single lesion or in various areas? Only OCT can tell me lesion involvement for which I adjust the local or field treatment accordingly, rather than use a one size fits all approach.

During follow-up I check whether the pathology is gone, or if subclinical recurrences are beginning to appear over time, something I could never examine without OCT. Again, I can then propose a more subtle, customized therapy for long term, if not permanent, disease control.

For me and my patients, VivoSight plays an important role for personalized diagnosis, treatment selection, follow-up and monitoring if needed. The winner is the patient, getting a tailored approach with informed, efficient therapies.”

References

1. Ortiz, A.E., Anderson, R.R. and Avram, M.M. (2015), 1064 nm long‐pulsed Nd:YAG laser treatment of basal cell carcinoma. Lasers Surg. Med., 47: 106-110. https://doi.org/10.1002/lsm.22310

2. Ortiz, A.E., Anderson, R.R., DiGiorgio, C., Jiang, S.I.B., Shafiq, F. and Avram, M.M. (2018), An expanded study of long‐pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma. Lasers Surg. Med., 50: 727-731. https://doi.org/10.1002/lsm.22803

3. Ahluwalia, J., Avram, M.M. and Ortiz, A.E. (2019), Outcomes of long‐pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma: A retrospective review. Lasers Surg. Med., 51: 34- 39. https://doi.org/10.1002/lsm.23041

4. Ahluwalia, Jusleen; Avram, Mathew M., Ortiz, Arisa E., The Evolving Story of Laser Therapeutics for Basal Cell Carcinoma, Dermatologic Surgery: August 2020 – Volume 46 – Issue 8 – p 1045- 1053, doi: 10.1097/DSS.0000000000002339

5. Markowitz O, Psomadakis CE. Patient-driven management using same-day noninvasive diagnosis and complete laser treatment of basal cell carcinomas: a pilot study. Cutis. 2019;104(6):345- E2.

6. Konstantin Moskalik, Alexander Kozlow, Eugeny Demin, Ernest Boiko . Powerful neodymium laser radiation for the treatment of facial carcinoma: 5 year follow-up data. European Journal of Dermatology. 2010;20(6):738-742. doi:10.1684/ejd.2010.1055

7. Chen CJ, Sierra H, Cordova M, Rajadhyaksha M. Confocal Microscopy–Guided Laser Ablation for Superficial and Early Nodular Basal Cell Carcinoma: A Promising Surgical Alternative for Superficial Skin Cancers. JAMA Dermatol. 2014;150(9):994–998. doi:10.1001/jamadermatol.2013.10225

8. Hibler, B., Sierra, H., Cordova, M., Phillips, W., Rajadhyaksha, M., Nehal, K. and Rossi, A. (2016), Carbon dioxide laser ablation of basal cell carcinoma with visual guidance by reflectance confocal microscopy: a proof‐of‐principle pilot study. Br J Dermatol, 174: 1359-1364. https://doi.org/10.1111/bjd.14414

9. Mehrabi, J.N., Kelly, K.M., Holmes, J.D. and Zachary, C.B. (2021), Assessing the Outcomes of Focused Heating of the Skin by a Long‐Pulsed 1064 nm Laser with an Integrated Scanner, Infrared Thermal Guidance, and Optical Coherence Tomography. Lasers Surg Med. https://doi.org/10.1002/lsm.23377

10. Stephens, R., Holmes, J. and Eadie, E. (2020), Lesion compression during light activation may improve efficacy of photodynamic treatment of basal cell carcinoma: preliminary results and rationale. J Eur Acad Dermatol Venereol, 34: e628-e630. https://doi.org/10.1111/jdv.16503

11. Wenande, E., Hendel, K., Mogensen, M., Bagger, C., Mårtensson, N.L., Persson, D.P., Lerche, C.M., Husted, S., Janfelt, C., Togsverd‐Bo, K., Anderson, R.R. and Haedersdal, M. (2021), Efficacy and Safety of Laser‐Assisted Combination Chemotherapy: An Explorative Imaging‐Guided Treatment With 5‐Fluorouracil and Cisplatin for Basal Cell Carcinoma. Lasers Surg Med, 53: 119-128. https://doi.org/10.1002/lsm.23323

12. Schuh S., Welzel J. (2020) OCT-Guided Laser Treatment and Surgery. In: Bard R. (eds) Image Guided Dermatologic Treatments. Springer, Cham. https://doi.org/10.1007/978-3-030-29236- 2_11

13. Bressler, Moshe; Felice, Skye; Yousefi, Nyousha; Marghoob, Nadeem; Alapati, Usha; Gill, Melissa; Markowitz, Orit; Combining Reflective Confocal Microscopy and Dynamic Optical Coherence Tomography to Diagnose Melanoacanthoma, The American Journal of Dermatopathology: February 16, 2021 – Volume Publish Ahead of Print – Issue – doi: 10.1097/DAD.0000000000001926

14. Alejandro J. Paredes, Inken K. Ramöller, Peter E. McKenna, Marco T.A. Abbate, Fabiana Volpe-Zanutto, Lalitkumar K. Vora, Maggie Kilbourne-Brook, Courtney Jarrahian, Kurtis Moffatt, Chunyang Zhang, Ismaiel A. Tekko, Ryan F. Donnelly, Microarray patches: Breaking down the barriers to contraceptive care and HIV prevention for women across the globe, Advanced Drug Delivery Reviews, Volume 173, 2021, Pages 331-348, ISSN 0169-409X, https://doi.org/10.1016/j.addr.2021.04.002.

March 2021 Issue

Michelson Diagnostics, the UK manufacturer of VivoSight, is excited to issue the first edition of its bimonthly newsletter VivoScene. Every second month we’ll provide latest news, insights and pearls about VivoSight, the world’s leading OCT (Optical Coherence Tomography) skin imaging and measurement system.

VivoScene’s purpose is to enhance the work of its customers, but also to inform non-users how VivoSight can accelerate research projects and advance clinical practices.

In this first edition we feature pioneering physicians who analyze vascular patterns for advanced management of recalcitrant skin conditions. Read on about other topics and sign up to VivoScene to receive future editions on time.

Do you know the depth and diameter of recalcitrant vessels you’re attempting to treat? For what applications can VivoSight vascular images and measures be utilized? Physicians at the forefront of pioneering research and clinical practice investigate the use of new modalities to develop better solutions for difficult to treat vascular conditions.

Drs. Jill Waibel and Kristen Kelly utilized VivoSight in their seminal 2018 paper [1] where they reported that infantile hemangiomas and port wine birthmarks consist of highly variable and heterogeneous vessel sizes, morphologies, and depth distributions, suggesting that laser treatments with uniform pulse durations and standardized parameter sets may not be optimal to treat all lesions.

As they discuss in the paper, “Currently clinicians do not know the vessel characteristics of lesions they are treating. We speculate that more complex treatment protocols are required, tailored to individual vessel diameters and depths in a lesion, which can be observed using OCT”.

Dr. Roy Geronemus also added VivoSight to his practice. “We are enthusiastic about the results we are seeing with our VivoSight OCTguided treatments of Port Wine Stain birthmarks”, said Dr. Geronemus. “This new technology has great potential to change therapies for vascular conditions. The first results are very encouraging, and we are evaluating the technology to guide treatment of other conditions beyond Port Wine Stains.”

Dr. Geronemus’ group has already published two papers where VivoSight was instrumental. The first, a case report, focused on treating port wine stains using dynamic OCT-guided laser settings [Christman et. al., 2]:

“Matching PDL settings to vessel depth and diameter at each visit using dynamic OCT might increase the odds of clinical improvement, and lower the total number of treatments necessary for an optimal outcome for PWS birthmarks.”

The second paper examined the vasculature in melasma and measured vessel response from treatment with tranexamic acid [Pomerantz et. al., 3]:

“Dynamic-OCT imaging of melasma demonstrated increased blood flow and vessel diameter in both papillary and reticular dermis. Oral TXA reduced vascular flow and vessel diameter, most remarkably in the superficial dermis affected by melasma. D-OCT can potentially be used in measuring response to treatments targeting melasma, given the potential relationship between melasma and aberrant blood vessels.”

Dr. Kelly presented some of her work with VivoSight OCT at the recent “Controversies and Conversations in Laser & Cosmetic Surgery” Dec 2020 meeting and further mentioned collaboration with Dr. Lisa Arkin of the University of Wisconsin, who has acquired a VivoSight system within the Department of Dermatology.

Dr. Arkin comments, “We are enthusiastic to begin this research. Dr. Kelly and I are hopeful that use of the Vivosight system will provide granular quantitative data on Port Wine Stains that can be integrated with deep clinical phenotyping including genotype and age to help optimize precisionbased treatments for these patients.”

The VivoSight team is equally excited to be working with these renowned thought leaders. Being able to visualize and quantify vascular structures objectively, non-invasively in real-time and invivo, allows acceleration of research timelines, and helps to inform therapy options and monitor treatment effects. We’ll keep you posted here on VivoScene.

Check out our blogs on our website. A number of educational videos will help you to get more out of VivoSight and learn about latest pearls and pitfalls.

The American Society for Laser Medicine and Surgery (ASLMS) has made our paper Editor’s Choice!

In their recent article [4], Mehrabi et. al. used VivoSight OCT imaging to observe vascular changes when investigating parameters for treatment of Basal Cell Carcinoma (BCC) lesions with various long pulse (LP) Nd:YAG laser settings.

Their original understanding was that LP 1064 nm laser treatment of BCCs relied upon hemoglobin absorption as its primary target to eradicate the underlying vasculature of these skin cancers. However, immediately after laser administration OCT images and measures of treated tissue revealed increased blood flow and vasodilation resembling an erythematous response when compared with untreated skin. If the improvement of BCCs is related to a vascular event, it is not an immediate process.

On the other hand, weeks after treating with more aggressive settings, the treatment site revealed avascularity with progressive surrounding angiogenesis. VivoSight was well able to visualize and quantify both different vascular events.

Blood Vessels in Malignant Melanoma

New research by international melanoma experts [5]: J. Welzel et. al use VivoSight OCT to describe vessel patterns in malignant melanoma and correlate them with disease stage for risk estimation prior to surgery

It seems that as the melanoma lesion progresses through stages I-IV, the blood vessel density increases, vessel pattern becomes more irregular and there are more atypical vessels; all observable by VivoSight Dynamic OCT. The authors suggest this could improve melanoma risk estimation prior to surgery and may be a completely new way of assessing melanoma risk.

Vascular Fingerprint of Melasma

A first in Melasma research! Pomerantz et. al. [3] from the group of Roy G. Geronemus, MD utilized VivoSight OCT to examine the vasculature in melasma and measure vessel response from treatment with tranexamic acid. The preliminary finding is that OCT can potentially be used in measuring response to treatments targeting melasma, given the potential relationship between melasma and aberrant blood vessels.

Vivosight is covered in more than 380 peer-reviewed articles. For a structured list of our publications please click here

Michelson Diagnostics, the UK manufacturer of VivoSight, teams up with AI Specialists Manchester Imaging to develop Machine Learning Algorithms for VivoSight OCT Skin Imaging System. Learn how we stay at the forefront of latest capabilities to help our customers: https://us.vivosight.com/2020/12/14/aimanchesterimaging/

Free Online VivoSight Demo

Want to experience VivoSight OCT live in action from the convenience of your home or office? We’d love to show you real time scanning and discuss how VivoSight might be of value to you. Please sign up for an online demo here: https://us.vivosight.com/how-to-order/

New Website

Our new website is growing, please check us out. It is easy to navigate among the various categories and see that we have much more going on besides vascular imaging. Make sure you download our comprehensive, informative brochure, visit our blog page and sign-up for the VivoScene newsletter.

Website & Brochure: https://us.vivosight.com
VivoScene sign-up:

VivoSight Posts on LinkedIn and Twitter

We post every week relevant content on Social Media, especially LinkedIn and Twitter. Don’t miss out on the latest, please connect and follow us on:

LinkedIn: https://www.linkedin.com/showcase/vivosight/
Twitter: https://twitter.com/VivoSight
Instagram: https://www.instagram.com/vivosight/

Michelson Diagnostics Ltd. is proud to introduce VivoTools, a new advanced image analysis software for the VivoSight OCT system to measure vascular and structural tissues of the skin and quantify treatment effects. See here for details: https://us.vivosight.com/vivotools/

3-Axis Precision Probe Stand

For those users who are interested in using VivoSight for scanning samples ex-vivo, the new 3-axis precision probe stand is an ideal addition to their armory. The VivoSight probe can be strapped into the stand in a moment, and fine adjust knobs control the height and x-y position for a perfectly stable and precisely controlled OCT scan of the sample. The probe stand simplifies probe handling for bench top work and will save lots of time when scanning multiple samples.

Your satisfaction, helping to advance your research and clinical efforts, and providing the best possible experience with VivoSight is our top concern. Please let us know what we could do better and how we can improve your experience with VivoSight and Michelson Diagnostics.

References

1. Waibel, J.S., Holmes, J., Rudnick, A., Woods, D. and Kelly, K.M. (2018), Angiographic optical coherence tomography imaging of hemangiomas and port wine birthmarks. Lasers Surg. Med., 50: 718-726. https://doi.org/10.1002/lsm.22816

2. Christman MP, Feng H, Holmes J, Geronemus RG, Treating port wine stain birthmarks using dynamic optical coherence tomography-guided settings, Journal of the American Academy of Dermatology (2019), doi: https://doi.org/10.1016/j.jaad.2019.08.028.

3. Pomerantz, H., Christman, M.P., Bloom, B.S., Lederhandler, M., Feng, H., Holmes, J. and Geronemus, R.G. (2021), Dynamic Optical Coherence Tomography of Cutaneous Blood Vessels in Melasma and Vessel Response to Oral Tranexamic Acid. Lasers Surg Med. https://doi.org/10.1002/lsm.23345

4. Mehrabi, J.N., Kelly, K.M., Holmes, J.D. and Zachary, C.B. (2021), Assessing the Outcomes of Focused Heating of the Skin by a Long‐Pulsed 1064 nm Laser with an Integrated Scanner, Infrared Thermal Guidance, and Optical Coherence Tomography. Lasers Surg Med. https://doi.org/10.1002/lsm.23377

5. Welzel, J., Schuh, S., De Carvalho, N., Themstrup, L., Ulrich, M., Jemec, G., Holmes, J. and Pellacani, G. (2021), Dynamic optical coherence tomography shows characteristic alterations of blood vessels in malignant melanoma. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.17080

Special Edition Q3, 2022

Feature

Key results from the study:

Michelson Diagnostics’ CEO Jon Holmes comments:

Education & Training

More on Sensitivity and Specificity of VivoSight OCT for BCC Assessment

Did You Know?

News

Events

The VivoWay

References

March 2022 Issue

Latest News: Two Seminal Recent Articles Confirm Value of OCT for Basal Cell Carcinoma

Authors identify the key OCT image characteristics and terminology for evidence-based, practical use in BCC management in clinical routine

Feature: VivoSight OCT Increasingly Utilized in Nail Disease Research

VivoSight’s deep penetration, vascular and structural imaging capabilities are ideal to aid in assessment of nail pathology, treatment effects and treatment outcome predictions

Education & Training

“OCT in Practice” Training Course

Did you know?

OCT is included as an advisory method in the European Guidelines for Diagnosis and Treatment of BCC [8]

Efficient way to delineate margins of BCC lesion with “Quadrant Mapping” method

News & Events

VivoSight OCT Exhibiting at ASLMS 2022 in San Diego

Product Updates

New Brochure about VivoTools, the powerful OCT skin analysis software

New Brochure about VivoTools, the powerful OCT skin analysis software

The VivoWay

Elevator Chat with Christine Fuchs Jacobsen – Copenhagen, Denmark

Christine Fuchs Jacobsen, MD, PhD is a dermatologist at Bispebjerk Hospital in Copenhagen, Denmark with an interest in non-invasive skin imaging techniques.

References

November 2021 Issue

Latest News: Early Success Indication of Lengthy Onychomycosis Treatment through OCT Biomarkers

Potential for significant cost savings from high predictive value of OCT imaging biomarkers

Feature: Mount Sinai Icahn School of Medicine Department of Dermatology Invests in Latest State-of-the-Art Skin Imaging Technologies

VivoSight OCT part of a multi-technology approach for skin cancer and beyond

The VivoSight system looks 1 mm deep into the skin and provides the following images and measures

Education & Training

Advances in Optical Coherence Tomography [2]

Insights of the Month

Nailfold Microvascular Imaging by Dynamic Optical Coherence Tomography in Systemic Sclerosis: A Case-Controlled Pilot Study [3]

In vivo examination of healthy human skin after short-time treatment with moisturizers [4]

Did you know?

BCC Diagnosed with OCT in Germany

Multiple OCT Metrics Correlate with Age

News & Events

VivoSight OCT in Use at Sheffield Dermatology, UK

VivoScene Quarterly in 2022

Product Updates

Software Update: New Metric of Dermal Brightness

The VivoWay

Elevator Chat with Johann Tillmann – Regensburg, Germany

References

September 2021 Issue

Latest News: On recent Markowitz et al. article: 98% Clearance at 1 Year with Nonsurgical In-office Treatment of Basal Cell Carcinoma (BCC)

Video Blog by Jon Holmes, CEO of Michelson Diagnostics Ltd. (MDL)

Feature: Merete Haedersdal, MD, PhD: On a Mission to Accelerate Discoveries and Modernize Clinical Practice

Learn how VivoSight OCT is an indispensable tool for Dr. Haedersdal and her group to advance their translational research

Accelerating Skin Research Projects

Providing Advanced Clinical Practice

Education & Training

Optical Coherence Tomography – History, Types and Applications [6]

Insights of the Month

Potential of monitoring early disease progression and overall vascular health with OCT [7]

VivoSight OCT measures vascular characteristics of port wine birthmarks classified by color [8]

Did you know?

How deep is the tattoo?

News & Events

Microneedle & Transdermal Delivery Systems Summit 2021, October 5 – 6

VivoSight Artificial Intelligence (AI) Project on Track

The VivoWay

Elevator Chat with Giovanni Pellacani, MD – Rome, Italy

References

July 2021 Issue

Latest News: Innovaderm acquires VivoSight OCT Skin Imaging System

Feature: Adding Artificial Intelligence (AI) to Delineate Basal Cell Carcinoma (BCC)

Advanced detection of BCC imaging biomarkers has the potential to make faster, easier and more accurate diagnostic decisions.

Education & Training

“OCT in Practice” Training Course

Henrik Mohme, MD, Dermatologist, Porta Westfalica, Germany

Insights of the Month