XLV Diagnostics is a startup company based in Thunder Bay, Ontario that is developing and commercializing its XLV technology. XLV Diagnostics’ innovation has the potential to disrupt mammography markets by enabling the development of affordable x-ray detectors for digital radiology machines that will give broader access to screening for early detection of breast cancer for millions of women worldwide.
CIMTEC designed and built XLV Diagnostics’ proof-of-concept prototype scanner, which demonstrated the superior functionality of the original concept. The company returned to CIMTEC for its mechanical expertise and contracted with it to design and build the first, product grade scanner in order to move the device farther along the commercialization pathway. After completing the clinical machine and obtaining its regulatory approvals, XLV Diagnostics plans to start selling the XLV mammography system to hospitals around the world.
Need or Opportunity:
Globally, breast cancer is the most common cancer and principal cause of death among women. In 2014, it was estimated that 24,400 Canadian women would be diagnosed with, and 5,000 would die from, breast cancer. Early detection of breast cancer is the most important factor in increasing survival rates; if a breast cancer tumour can be detected and treated in its early stages, the likelihood of a successful outcome is greater and the cost of the treatment is reduced.
Providing a cost-effective solution will increase access to breast cancer screening worldwide, effectively improving early breast cancer detection and increasing the treatment efficacy. “One-third of deaths caused by breast cancer could be decreased if detected and treated early. In a worldwide context, this means nearly 400,000 lives could be saved every year.”
The proof-of-concept prototype performance helped XLV Diagnostics to attract $3 million of Series A investment which is used for completing the digital mammography development and filing for regulatory approvals. Says Sorin Marcovici, president and CEO of XLV Diagnostics, “The financing supports multiple key milestones along the path to installing the first XLV clinical mammography machine at Thunder Bay Regional Health Sciences Centre and in obtaining Canadian, U.S., and European regulatory approvals in preparation for taking the product global.”
Previous knowledge of the technology combined with mechanical engineering expertise made CIMTEC an easy choice for designing and building the clinical prototype according to XLV Diagnostics’ specific requirements. “It’s much easier working with people who already understand the technology and have the engineering expertise in medical imaging,” says Peter Oakham, Chief Engineer at XLV Diagnostics.
CIMTEC is designing improvements to the proof-of-concept prototype which include hardware for a custom detector enclosure and linear motion system that performs image scanning off the panel.
XLV Diagnostics and CIMTEC worked together to establish the necessary components and requirements of the design for the clinical prototype. This multi-faceted project involves improving the scanning plate and scanning bed mechanism, as well as designing the XLV system to the size of a typical mammography unit.
CIMTEC is working with XLV to manufacture the prototype and move it into testing to facilitate design optimization.