Vancouver, Canada and Maidstone, UK, 12 June 2015 – Michelson Diagnostics, a medical device company focused on multi-beam Optical Coherence Tomography (‘OCT’) technology, today announces that data showing significant improvement in the diagnosis of basal-cell carcinoma (BCC) using its VivoSight multibeam OCT scanner will be presented at the World Congress of Dermatology (Vancouver, June 8-13). In addition to being an efficient, non-invasive way to diagnose BCC and other non-melanoma skin cancers, using the VivoSight OCT scanner has the potential to reduce biopsies and surgery, thereby reducing scarring for patients.
Joint lead investigator, Dr Martina Ulrich, CMB Collegium, Berlin, Germany, will outline the results of this independent multi-centre, prospective clinical study into the use of VivoSight and discuss their implications for the diagnosis and management of BCC.
“Based on this pivotal research, we believe that VivoSight scans should become the gold standard for non-invasive diagnosis and monitoring of non-melanoma skin cancer,” stated Andy Hill, Chief Executive Officer of Michelson Diagnostics. “We are now expanding the availability of our new generation VivoSight scanner in Germany and select territories in Europe.”
Data from the study were first published online in the British Journal of Dermatology in April. The BJD paper can be viewed and downloaded from: http://onlinelibrary.wiley.com/doi/10.1111/bjd.13853/abstract.
VivoSight has CE/TGA regulatory-clearance and FDA 510(k) clearance in the United States and is available for sale in Europe, USA and Australia.
The presentation will take place at 14:55 on Saturday, 13 June during session FC50: Dermoscopy and Skin Imaging II in West 205-207.
For further information
Michelson Diagnostics
Tel: +44 (0)20 8308 1695
Andy Hill, Chief Executive Officer
FTI Consulting
Tel: +44 (0)20 3727 1000
Simon Conway / Mo Noonan / Victoria Foster Mitchell
Notes to editors
Study Summary: OCT-assisted diagnosis of BCC
The purpose of the study was to examine the use of OCT in a clinical setting for specificity, sensitive and diagnostic value when compared to clinical and dermoscopic evaluation. The study assessed 164 patients with 256 lesions in a prospective, multi-centre trial across six centres in Germany for the diagnosis of BCC. Patients with Pink lesions (unclear erythematous papule or plaque lesions) which were clinically suspected of BCC and required a diagnostic biopsy were assessed using VivoSight OCT. Each result was compared with standard clinical evaluation with and without dermoscopy. All results were verified by the gold standard of biopsy and histological analysis. All lesions were examined clinically prior to the start of the trial and only those suspected of BCC were selected. 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.
British Journal of Dermatology
The British Journal of Dermatology is one of the top dermatology journals in the world, and publishes papers on all aspects of the biology and pathology of the skin. Originally the Journal, founded in 1888, was devoted almost exclusively to the interests of the dermatologist in clinical practice. However, the rapid development, since the 1950s, of research on the physiology and experimental pathology of the skin has been reflected in the contents of the Journal, which now provides a vehicle for the publication of both experimental and clinical ethical research and serves equally the laboratory worker and the clinician. (http://www.bad.org.uk/journal-information)
Basal Cell Carcinoma
Basal Cell Carcinomas (BCCs) are abnormal, uncontrolled growths or lesions that arise in the skin’s basal cells, which line the deepest layer of the epidermis (the outermost layer of the skin). BCCs often look like open sores, red patches, pink growths, shiny bumps, or scars and are usually caused by a combination of cumulative and intense, occasional sun exposure. In 2010, an estimated 2.8 million cases of BCC were diagnosed in the US, and the figures have continued to climb. BCC is the most frequently occurring form of all cancers. More than one out of every three new cancers is a skin cancer, and the vast majority are BCCs. (http://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma)
About the VivoSight OCT System and Michelson Diagnostics
Michelson Diagnostics develops, manufactures and markets the VivoSight multi-beam Optical Coherence Tomography (‘OCT’) scanner; a point-of-care, real-time tissue imaging device. The patented technology, which has CE/TGA regulatory-clearance and FDA 510(k) clearance in the United States, provides clinicians with continuous images of the epidermis and superficial dermis of the skin that can be interpreted by a medical professional. Given the unprecedented image resolution and image quality, VivoSight OCT has many potential clinical applications beyond the initial focus in dermatology.
The Company’s vision is for the VivoSight OCT system to become the standard-of-care for the non-invasive diagnosis and treatment monitoring of certain diseases and conditions that affect cutaneous and epithelial linings of the body. Michelson Diagnostics currently generates revenues from the first commercial application of VivoSight, in the diagnosis of non-melanoma skin cancer (NMSC).
VivoSight has regulatory clearance in Europe, the USA and Australia, for use by trained clinicians in their assessment of the patient’s medical condition. VivoSight is currently sold in Germany where the scans are reimbursed for patients with private healthcare insurance. Further clinical studies are presently being conducted at leading centres in the United States.
The Company, based in Maidstone, Kent, was founded in 2006 and has 20 employees, and has offices in Germany and USA. It is supported by a syndicate of Venture Capital, corporate and private investors including funds managed by Octopus Investments, Smith and Nephew, Catapult Ventures and Angel Investors.
For more information about Michael Diagnostics and the VivoSight system, see www.michelsondiagnostics.com and www.vivosight.com.
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