Enspectra Health, a Rosenman Innovator and RISE company, recently announced its first patients’ enrollment in its digital skin imaging study. These non-invasive in vivo images have the potential to become a groundbreaking tool for doctors and patients.
From the press release:
MOUNTAIN VIEW, Calif., Oct. 25, 2022 /PRNewswire/ — Enspectra Health, a digital health company pioneering the field of virtual biopsies, announced that the first subject has been enrolled in its VISTA US Pivotal Study. VIO™ Imaging for Skin Tissue Assessment (VISTA) is a prospective, multicenter study designed to demonstrate the safety and effectiveness of the VIO System in subjects planning to undergo routine skin biopsy.
The study will enroll up to 65 subjects, obtaining non-invasive in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and pigment using the VIO System. Following biopsy, images obtained with the VIO System will be compared to the corresponding images procured from the skin biopsy. The study will also assess clinicians’ ability to correctly identify tissue features on images obtained with the VIO System.
“The VIO System has the potential to become a groundbreaking tool for pathological evaluation of the skin, by allowing visualization of skin cells and structures in real time,” said Dr. Michael Wang, Dermatologist and Dermatopathologist with Golden State Dermatology. A leading network of comprehensive dermatology services, Golden State Dermatology will serve as the valued clinical study partner for Enspectra Health for the VISTA Pivotal Study. Subjects will be enrolled at three Golden State Dermatology locations around the greater San Francisco Bay Area.
“The initiation of patient enrollment in the VISTA Study reinforces our commitment to a non-invasive approach to pathology,” said Gabriel Sanchez, CEO of Enspectra Health. “Evaluating the VIO System’s ability to obtain digital color images of cellular structure in live skin non-invasively and in real time is the first step in transforming patient care.”
Enspectra’s device is limited by United States law to investigational use only and is not available for sale.