Verisante Technology, a leader in cancer imaging technology, has engaged StarFish Medical Inc. to provide engineering services and expertise to develop the Company's initial product, Verisante Aura, for manufacturing.
Verisante Aura is a novel, multimodality imaging and spectroscopy system designed to aid in the early detection of skin cancer. This system provides valuable information about the chemical composition of the skin quickly and non-invasively. Verisante Aura scans for 21 biomarkers instantly, providing immediate, accurate results on benign and malignant lesions. The Aura requires the use of a disposable end cap to be replaced after each use for health and sanitary reasons. Therefore, in addition to revenue from initial sales of the device, Verisante will also have a recurring revenue stream.
Thomas Braun, CEO of Verisante Technology, Inc. says: "We are very pleased to have StarFish Medical Inc. as a strategic partner to facilitate the development of our lead product, Verisante Aura. StarFish has a proven track record in medical device development and manufacturing and has established strong compliance with all industry standards, including compliance with ISO 13485:2003, CE Mark, and FDA GMP regulations."
Last week, Verisante announced that it has successfully completed the certification process for ISO 13485:2003, an internationally recognized quality management standard. The certification is a confirmation of the Company's ability to design and manufacture medical devices.
Operational Update for the Aura
"Our next major milestones for the Aura are to apply for regulatory approvals in Canada, the European Union and Australia," Braun says. "With our strategic partner preparing for manufacturing over the next several months, we will be increasing our focus on marketing the Aura in the territories where we obtain regulatory approvals. Skin cancer is the most common cancer and there are 21,000 dermatologists and 500,000 GPs in Europe. We see a large unmet need for a device like the Aura that can assist doctors with early detection."
The statistical analysis of the Aura clinical study pursuant to a Collaborative Research Agreement between the Company and the University of British Columbia Department of Dermatology has been completed. The study on clinical trial data collected during the past six years by the Aura clinical prototype will be submitted by the research team to a peer reviewed journal and the results will be announced in conjunction with publication. At this time the publication date is not known.
The Company will have seven fully functioning Aura prototypes in early Q4 that will be available for demonstrations and clinical studies. Verisante currently has nine engineering and scientific personnel working out of the Company's technical office in Richmond, BC.
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