The funds will be used for several purposes including expanding VivoSightTM sales in Germany, where the system was launched in mid-2011 and where it is reimbursed for use in the diagnosis of non-melanoma skin cancer (NMSC), the commonest skin malignancy. The Company will also invest further in the development of a compact, more portable second generation VivoSight System with an anticipated lower cost of manufacture and enhanced functionality. Part of the monies raised will be used to initiate US market access with a pilot clinical study planned. The Company believes that the US is the largest single market for the VivoSight system.
VivoSight is a medical imaging system, which uses Michelson Diagnostics world-leading, patented, multi-beam OCT technology to non-invasively view all the layers of the skin in great detail for the first time. VivoSight provides clinicians with real-time, high definition images of the skin through a fast, accurate and reliable imaging system. The Company’s initial focus is in the diagnosis of non-melanoma skin cancer (‘NMSC’), which is the most common skin cancer with approximately 3.5 million new cases in the USA each year.1
VivoSight currently has regulatory clearance in Europe and Australia, and FDA 510(k) clearance in the US. Following the successful launch, use of VivoSight in Germany has grown rapidly, with more than 2,500 scan procedures performed by December 2013 at ten clinics. The Company is now entering the Australian and Swiss markets.
In addition, Michelson Diagnostics is the only Company generating Level 1 Clinical Evidence of the value of OCT in the diagnosis of NMSC. Interim data from the Company’s prospective multi-centre study is very promising. Positive results from the trial are expected to accelerate the adoption of VivoSight as a diagnostic tool and to aid the Company in achieving reimbursement in the US and elsewhere. The trial is expected to complete in the first quarter of 2014 and full results will be presented at the annual meeting of the American Academy of Dermatology, 21-24 March 2014, in Denver, Colorado.
Jon Holmes, Chief Executive Officer of Michelson Diagnostics, commented “I would like to thank our investors for their continued support; the completion of this financing concludes a year in which we have made real progress, especially in our market access in Germany. We now look forward to a very promising 2014 which will include the publication of Level 1 Clinical Evidence in the diagnosis of NMSC”
Simon Andrews, a member of the Ventures team at Octopus Investments, said: “The team at Michelson Diagnostics has really impressed us over the past eighteen months. The market for non-invasive therapy is developing and we are very pleased to see the promising early results of the multi-centre study which should accelerate the adoption of VivoSight. The business has made excellent progress to date and we are excited about the next stage of its growth and development.”
Michelson Diagnostics was advised by Catalysis Capital Partners and Edwards Wildman Palmer UK LLP and Octopus Investment were advised by Shoosmiths LLP.
For further information
Jon Holmes, Michelson Diagnostics – Tel: +44 (0)20 8308 1695
Simon Conway/Mo Noonan/Victoria Foster Mitchell, FTI Consulting – Tel: +44 (0)20 7831 3113
Cordelia Meacher, FieldHouse Ass (for Octopus Investments) – Tel: +44 (0)7961 311 080
1. M. A. Rogers Hw Fau – Weinstock, A. R. Weinstock Ma Fau – Harris, M. R. Harris Ar Fau – Hinckley, S. R. Hinckley Mr Fau – Feldman, A. B. Feldman Sr Fau – Fleischer, B. M. Fleischer Ab Fau – Coldiron, et al., “Incidence estimate of nonmelanoma skin cancer in the United States, 2006,” 20100316 DCOM- 20100413.