Clinical Trials

Balter Medical’s OTD Melanoma technology has been clinically tested and developed over several years.

The first generation OTD device was tested at the Bergen Hospital Trust (BHT) and other major hospitals in Norway during 2006.

One such published study included 149 scanned pigmented skin lesions of which 5 were histo- pathologically diagnosed as Cutaneous Melanoma and 1 was a clinical Lentigo Maligna.  OTD dnalysis of this clinical data showed that the Balter technology was capable of making a clear separation between melanomas and non-melanomas with a sensitivity of 100% for a specificity of 97%.

This compelling proof of concept data lead to the development of a second generation OTD Melanoma device. This machine is a much smaller hand held device more suitable for extensive clinical trial use.

Many additional clinical studies have been completed using this device in Norway, USA and UK. The purpose of these studies is to gain clinical experience for training the diagnostic algorithms and to obtain user insight into the optimum clinical application once the technology and device is commercialized.

Several studies using this prototype have been carried out at MAYO Clinic Arizona USA. In 2009 Dr David Swanson, published once study which included 137 pigmented skin lesions of which 13 where clinically diagnosed as MELANOMA. The Balter OTD diagnostic device accurately diagnosed 100% of the Melanomas and only reported 11 false positives.

To date Balter has clinically analyzed hundreds of suspicious pigmented skin lesion from hundreds of patients and consistently accurately identifies all Melanomas with very few false positive readings.

Balter Medical AS has now developed additional prototype devices and has extended its clinical testing program to include research sites in UK and EU.

Following the international pre clinical testing phase, Balter will take its Melanoma OTD device in to pivotal clinical trials and seek regulatory approval for medical use.