Mr. Adrian Mendes reports
HCA HEALTHONE ROSE FIRST IN COLORADO TO ADOPT PERIMETER'S ADVANCED OCT IMAGING TECHNOLOGY FOR USE IN SURGERY
Dr. Kayla Griffith, breast surgical oncologist, and
HCA HealthONE
Rose, part of the HCA HealthONE network of nine hospitals and 17 surgery centres in the Rocky Mountain region and one of the largest health systems in the Denver area, are the first in Colorado to adopt Perimeter Medical Imaging AI Inc.'s
S-Series OCT
(optical coherence tomography) advanced imaging technology for tissue visualization in the operating room. The S-Series is cleared by the Food and Drug Administration for general tissue imaging and is the only wide-field OCT technology used in surgical procedures today.
"HCA HealthONE Rose is highly ranked for its patient care, and its surgical and women's care are well recognized for their excellence. HCA HealthONE Rose's commitment to quality patient care is exemplified in its staff, and evident in its participation in initiatives such as the Colorado Hospital Transformation Project, which aims to improve patient care across communities," said Perimeter chief executive officer Adrian Mendes. "We believe our technology has the potential to enhance surgical care and we are honoured that they have chosen the S-Series. We look forward to a strong partnership."
Unlike the S-Series OCT, traditional technologies such as X-ray, ultrasound or magnetic resonance imaging (MRI) do not have the resolution to see disease at the cellular level. As a result, surgeons must wait up to 10 days for pathology results to either confirm clean margins or indicate positive margins, which typically necessitates patients returning for another procedure. With the S-Series OCT surgeons have advanced imaging to provide additional insights into their decision making.
The S-Series OCT system incorporates Perimeter's wide-field OCT technology to see disease at the cellular level. It is optimized down to two millimetres for identifying regions of interest in tissue microstructures and features such as blood vessels, ducts and glands, making it ideal for visualizing surgical margins.
HCA HealthONE Rose is the most recent major regional medical center to adopt Perimeter's S-Series OCT as the company expands its commercial footprint across the country and awaits a regulatory decision on its next-generation technology, B-Series OCT, which
combines OCT with artificial intelligence.
About Perimeter Medical Imaging AI Inc.
Based in Toronto, Canada, and Dallas, Tex.,
Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with ultrahigh-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the United States, the company's Food and Drug Administration-cleared Perimeter S-Series OCT system provides real-time, cross-sectional visualization of excised tissues at the cellular level. The breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents the company's next-generation artificial intelligence technology that was recently evaluated in a pivotal clinical trial, with support from a grant of up to $7.4-million (U.S.) awarded by the Cancer Prevention and Research Institute of Texas. The company's ticker symbol PINK is a reference to the pink ribbons used during Breast Cancer Awareness Month.
S-Series OCT intended use and unapproved uses
The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization with image review manipulation software for identifying and annotating regions of interest. Perimeter S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by the U.S. FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation and reducing re-excision rates. The safety and effectiveness of these uses has not been established.
We seek Safe Harbor.
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