Tampere, Finland and San Jose, CA--ISO13485:2003 certified laser diode manufacturer Modulight has designed, integrated, and CE certified an OEM medical laser system for PCI Biotech (Oslo, Norway) for a novel cancer therapy process. PCI Biotech developed a patented photochemical drug delivery technology called PCI (PhotoChemical Internalisation) for use in cancer therapy and other diseases for which Modulight delivered a CE certified 7-channel medical laser system solution. The companies have completed a multi-year OEM manufacturing agreement of these systems by Modulight to PCI Biotech.
PCI is a technology for light-directed drug delivery by triggered endosomal release and was developed to introduce therapeutic molecules in a biologically active form specifically into diseased cells. This proprietary technology can provide local enhancement of a range of different drugs, including several cancer drugs currently in clinical use.
"An essential part of our treatment process is the single-wavelength laser source that is used to activate the PCI process," says Per Walday, CEO of PCI Biotech. "The wavelength and the dose of the laser light in the treated tissue must be carefully controlled requiring excellence in designing and building a stable laser system at our desired wavelength. For these reasons we selected Modulight as the system designer and integrator for our demanding application. Their >10 years expertise and references on laser technology along with their in-house laser system design and manufacturing capabilities simply convinced us about Modulight's ability to deliver what we needed in relatively short period of time. We jointly completed CE certification of the laser system from initial spec to certified system in less than 9 months, which was a remarkable achievement and also tells about Modulight team's commitment and ability to cooperate closely with a customer like PCI Biotech."
"We have delivered component and sub-system solutions to global leaders in medical and life-science already over several years, like to PerkinElmer, and this achievement proves our capability to support these and other companies in the field up to complete OEM system design and manufacturing if so desired," says Petteri Uusimaa, president & CEO of Modulight. "This is a result of several years' investment in electronics, software and user interface design capabilities inside Modulight, along with our proprietary laser design and manufacturing knowhow. It has been also very rewarding to our designers to work closely together with the PCI Biotech team and learn more about the use of lasers in a very important field in health care, like cancer therapy."
Modulight is a vertically integrated laser diode manufacturer with design and manufacturing capabilities from chips to complete laser systems over the wavelength range from 630 nm to 1650 nm. The company received ISO 13485:2003 certification from Det Norske Veritas (DNV) in 2011, an internationally recognized quality standard that states the requirements of the Quality Management System (QMS) for the design and manufacture of medical devices.
SOURCE: Modulight; www.modulight.com/press_news60.htm