Medicsight Interim Results For the Six Months Ended 30 June 2008
Medicsight PLC, industry leader in the development of Computer-Aided Detection (CAD) and image analysis software to assist in the early detection and diagnosis of disease, is pleased to announce its Interim Results for the six months ended 30 June 2008.
Highlights- Preliminary Agreement with the Systems Integration (PACS) Division of Toshiba Medical Systems
- Global Partnership Agreement with INFINITT Company Limited ("Infinitt")
- Received Chinese State Food and Drug Administration (SFDA) regulatory approval for MedicRead Colon
- Received Brazilian National Health Surveillance Agency (ANVISA) regulatory approval for MedicRead Colon and ColonCAD
- Signed an exclusive CAD clinical research agreement with leading American CT colonography (CTC) radiologists Dr Perry Pickhardt and Dr David Kim
David Sumner, Chief Executive of Medicsight PLC commented: "We are delighted with the progress the Company has made during the first half of 2008. We continue to bolster our contract pipeline adding the Toshiba PACS division and Infinitt to our list of distribution partners. Approvals continue to be received from regulatory bodies in China and Brazil who have recently cleared the MedicRead Colon and ColonCAD products for sale. In addition we are on track with the regulatory processes in Japan and the US. Finally and in line with expectations, Medicsight expects to launch its online MedicRead Colon solution and Lung and Liver applications at RSNA this year."
For further information, please contact:
Medicsight plc
David Sumner
+44 (0)20 7605 7950
www.medicsight.com
Nomura Code Securities Limited
Juliet Thompson
Managing Director
+44 (0)20 7776 1200
Jon Senior
www.nomuracode.com
Media enquiries:
Abchurch
Heather Salmond
heather.salmond@abchurch-group.com
Tel: +44 (0) 20 7398 7700
Mob: +44 (0) 7855 018 606
Stephanie Cuthbert
stephanie.cuthbert@abchurch-group.com
Tel: +44 (0) 20 7398 7700
Mob: +44 (0) 7843 080947
www.abchurch-group.com
Chief Executive's Review
I am pleased to report our interim results for the six months ended 30 June 2008, Medicsight has achieved a number of key milestones and is making progress in line with the Company's expectations.
Commercial Partnerships
In February 2008, Medicsight signed a Preliminary Agreement with the Systems Integration (PACS) Division of Toshiba Medical Systems ("Toshiba") for the resale of MedicRead ColonCAD throughout Japan. The Company believes that this heralds the beginning of an on-going partnership with Toshiba, a leading global provider of diagnostic medical imaging systems and comprehensive medical solutions.
In April 2008, Medicsight signed a Partnership Agreement with INFINITT Company Limited ("Infinitt"). Infinitt has agreed to integrate Medicsight ColonCAD into its Colon solution for global distribution. As well as being South Korea's leading PACS supplier, Infinitt also has a growing presence in both the USA and Japan with a global network of offices, partners and sales channel representatives in 26 countries.
In addition to the agreements already signed, Medicsight is working to secure further contracts with other medical imaging companies to achieve wider distribution of its products.
Regulatory Approvals
In the six months ended 30 June 2008, Medicsight was granted regulatory approval for MedicRead Colon from the Chinese State Food and Drug Administration (SFDA) and the Brazilian National Health Surveillance Agency (ANVISA). More recently, the Company received Brazilian ANVISA regulatory approval for its ColonCAD product.
The Company is currently working to obtain Japanese Ministry of Health, Labour and Welfare (MHLW) regulatory approval for its MedicRead Colon product. Medicsight has engaged a team of experts to prepare the Company's application to secure US Food and Drug Administration (FDA) clearance. The Company is confident that it will shortly be in a position to file a 510(k) submission for review by the FDA.
Clinical Progress
In May 2008, the Company signed an exclusive CAD clinical research agreement with leading American CT colonography (CTC) radiologists Dr Perry Pickhardt and Dr David Kim from the University of Wisconsin Medical School, USA. In 2004, Dr Pickhardt's group was the first to establish a third-party reimbursed CT colonography colorectal cancer screening programme. Since then Drs Pickhardt and Kim have both played an instrumental role in building the clinical evidence base that has proven the comparable effectiveness of CTC for the detection of colorectal neoplasia within an asymptomatic population in relation to optical colonoscopy. Their specialist advice and experience of CTC practice will enhance the clinical validation of Medicsight's Colon CAD products set in the context of the world's largest healthcare market.
In June 2008, data presented at the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) 2008 Conference found that Medicsight's ColonCAD technology assisted radiographers in identifying 100% of the cancers within the study group.
Product Development
The Medicsight product roadmap continues on track enabling 2008 launches of MedicRead Colon 3.0, MedicRead Lung 1.0 and MedicRead Liver 1.0 as well as an online CTC software solution based on MedicRead Colon. Medicsight is continuing to improve the performance of its ColonCAD product with a new version planned for 2009. In addition, the company has initiated the development of a CO2 insufflation device for CTC (MedicCO2lon) and is exploring new image processing and analysis tools for optical colonoscopy. These additions will bolster the existing CTC portfolio.
Financial Review
Revenue for the six months ended 30 June 2008 was £44,000 compared with £nil for the six months ended 30 June 2007.
In the six months ended 30 June 2008, the Company spent a total of £4,892,000 on operating costs compared with £3,566,000 for the six months ended 30 June 2007, which is in line with company expectations.
Medicsight remains in a strong financial position with the funds available to execute the business plan.
Conclusion
Medicsight continues to make progress in line with the Company's expectations. In the first half of 2008, we have achieved a number of significant milestones and laid the foundations for further successes. With significant financial resources at the Company's disposal, Medicsight is well positioned for the product rollout in 2009 and beyond.
David Sumner
Chief Executive Officer
8 August 2008
NOTES TO INTERIM FINANCIAL STATEMENTS
1. Basis of preparation of interim financial information
These interim consolidated financial statements are for the six months ended 30 June 2008. The interim financial report, which is unaudited, has been prepared in accordance with the recognition and measurement criteria of International Financial Reporting Standards and IFRIC interpretations adopted for use in the European Union ("IFRS"). The accounting policies and methods of computation used are consistent with those used in the Group annual report for the year ended 31 December 2007 and are expected to be used in the Group Annual Report for the year ended 31 December 2008. The six month period figures have not been audited as subject to review by the company's auditors.
The financial information for the year ended 31 December 2007 does not constitute statutory information. A copy of the statutory accounts for that year has been delivered to the Registrar of Companies. The auditors' report on these accounts was not qualified and did not contain statements under section 237(2) and (3) of the Companies Act 1985.
The interim consolidated financial statements are presented in pounds sterling because that is the currency of the primary economic environment in which the group operates. All values are rounded to the nearest thousand pounds (£000) except when otherwise stated.