World’s first intra-operative molecular imaging system LightPath™ obtains CE Mark Approval

October 19, 2015

Cambridge, UK – 19 October 2015 – Sagentia, a leading international science, product and technology development company, announced today that its client Lightpoint Medical has obtained CE Mark approval for the LightPath™ Imaging System, the world’s first intra-operative molecular imaging system developed in partnership with Sagentia.

Cancer surgery is often unsuccessful because surgeons fail to remove all of the cancerous tissue. The LightPath™ Imaging System is designed for use in the operating room to help surgeons ensure they have removed all cancerous tissue in a single operation. Experts believe the device may have the potential to reduce the number of repeat operations for breast cancer, where up to 40%* of patients are faced with additional surgery. As well as reducing the need for reoperation, it is believed it could help reduce likelihood of recurrence, patient anxiety and enormous cost to health services.

The system detects Cerenkov Luminescence, a faint light produced by PET imaging agents widely used in cancer diagnosis. Although the science behind the LightPath™ system has been known for many years, this is the first time that it has been utilized in this way and the LightPath™ Imaging System is the first approved medical device for intra-operative molecular imaging in the world. The technology provides the potential for optical imaging of numerous cancer types.

Working with Lightpoint from the outset to translate this technology from theory to reality has been hugely exciting. This technically challenging program has required world-class science and engineering to deliver. 

Sagentia worked as Lightpoint’s product and technology development partner, collaborating on all aspects from the core science to system design.

“We are delighted to have achieved the major landmark of a CE mark for Lightpoint’s first product offering: the LightPath™ Imaging System,” said Dr David Tuch, CEO of Lightpoint Medical. “Bringing LightPath™ to market is an important milestone in our efforts to transform cancer surgery. It's been an absolute pleasure to have Sagentia as our R&D partner. Their expertise in advanced sensors and optics has been instrumental in our project's success. We look forward to working with them in the future for our product development.”

Commenting on this news, Alistair Fleming, Head of Surgical and Diagnostics at Sagentia noted “Working with Lightpoint from the outset to translate this technology from theory to reality has been hugely exciting. This technically challenging program has required world-class science and engineering to deliver. It is rewarding to see this first product now reach market. We congratulate Lightpoint on reaching this milestone, and look forward to supporting them in the future.”

LightPath™ is now commercially available in Europe having been launched at the biennial congress of the European CanCer Organisation (ECCO) in Vienna on 25-29 September 2015. The organization represents the interests of over 60,000 oncology professionals and promotes the multidisciplinary nature of the field with the aim of improving the prevention, diagnosis, treatment and care of cancer patients. Commercial launch in the United States is planned for 2016.

Development of the LightPath™ Imaging System was made possible by Collaborative R&D and Smart grants from Innovate UK, the UK’s innovation agency.

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