Enspectra Health Announces First Patient Enrolled in US Pivotal Study

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.

About Enspectra Health

Enspectra Health is an emerging, privately held digital health company pioneering a new field of virtual biopsies to transform the way physicians evaluate a broad spectrum of skin conditions. The Company's novel technology combines reflectance confocal and multiphoton laser scanning microscopy to generate real-time, multispectral images at the cellular level, without the need for an incision. The technology allows for an instantaneous evaluation of rich, digital pathology images of various skin tissues, with the ultimate goal of minimizing unnecessary biopsies and facilitating earlier disease diagnosis.

For more information, please visit www.enspectrahealth.com or contact Investor Relations at ir@enspectrahealth.com.

About Golden State Dermatology
In the midst of health care consolidation, Golden State Dermatology (GSD) was founded to maintain a relatively independent model of practice. GSD is physician-owned and led and is rapidly growing with over 60 providers in the San Francisco Bay Area and California's Central Valley. GSD is led by a team of board-certified dermatologists with a mission to deliver the highest quality care and a great patient, provider, and staff experience. GSD's services include dermatology, cosmetics, Mohs surgery for skin cancer, pathology, and plastic surgery in state-of-the-art medical facilities. For more information about GSD, please visit www.goldenstatedermatology.com.

Disclaimer

Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number 5R44CA221591-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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SOURCE Enspectra Health