Study Published in JAMA Dermatology Validates Enspectra Health's Cross-Modal Imaging System for Noninvasive Visualization of Histologic Skin Features

Enspectra Health today announced the publication of pivotal clinical trial results in JAMA Dermatology, demonstrating that its handheld cross-modal imaging system enables physicians to accurately identify key histologic features of skin noninvasively.

MOUNTAIN VIEW, Calif., Nov. 6, 2025 /PRNewswire/ -- Enspectra Health today announced the publication of pivotal clinical trial results in JAMA Dermatology, demonstrating that its handheld cross-modal imaging system enables physicians to accurately identify key histologic features of skin noninvasively. The study, known as the VISTA Trial, was conducted at multiple U.S. dermatology centers and evaluated the system's ability to visualize skin features typically seen only through invasive biopsy and histopathology.

The cross-modal imaging system, VIO, combines reflectance confocal microscopy (RCM) and multiphoton microscopy (MPM) into a compact, handheld device that generates cross-sectional, histology-like images of the skin. In the trial, physicians trained in dermatopathology achieved 96.4% accuracy in identifying primary histologic features and 98.5% accuracy for secondary features, with high inter-reader agreement.

"This study shows that physicians can reliably identify histologic features such as collagen, pigment, hyperkeratosis, atypia, and solar elastosis using VIO's cross-modal imaging," said Dr. Sarah Arron, lead author of the study. "These features are key to understanding skin health, and noninvasive visualization opens new possibilities for both medical and aesthetic applications."

The trial enrolled 65 participants undergoing routine skin biopsy, with cross-modal imaging performed prior to tissue collection. All histologic features identified on cross-modal images were validated against ground truth pathology. The study population included 13.8% Hispanic participants and Fitzpatrick skin types I–V, supporting the system's utility across a range of skin tones.

"During the trial, we imaged a range of common skin lesions across multiple anatomic locations and Fitzpatrick skin types I–V," said Dr. Michael Wang, senior author and principal investigator. "This design allowed us to evaluate the VIO system's ability to capture histologic features in a variety of commonly encountered clinical contexts." 

The cross-modal imaging system has received FDA clearance (510(k) K232789) to:

Acquire, store, retrieve, display and transfer in vivo images of tissue – including blood vessels, collagen, pigment, stratum corneum, hair shafts or follicles, solar elastosis, hyperkeratosis, atypia, and epidermal disarray – in and through epidermis for review by physicians to assist in forming a clinical judgment. Physicians who interpret VIO System images must have dermatology or pathology medical qualifications with skin histology assessment training.

Importantly, the system is not intended to diagnose disease or replace biopsy, but to assist physicians with dermatology or pathology medical qualifications in clinical decision-making by providing histology-like information at the point of care.

Empowering Clinical Teams with Intuitive Imaging

The VISTA Trial also demonstrated the system's ease of use. Medical assistants with less than a day of training successfully captured high-quality images across a wide range of lesion types and anatomical locations. Physicians then interpreted the images using a structured training protocol, achieving high accuracy after just five hours of instruction.

"As a blinded reader, I was impressed by how clear and intuitive the VIO images were to interpret," said Dr. Lilia Correa-Selm, a study author and fellowship-trained Mohs micrographic surgeon. "The cross-sectional format mirrors traditional histology, allowing me to confidently recognize key features like the location of the epidermis and dermis and blood vessels. It images all the structures very clearly in the dermis with the use of colors, which is not achieved with any other non-invasive technique."

Looking Ahead: Aesthetic and Dermatologic Potential

While the VISTA Trial focused on lesional skin, the ability to visualize structural and cellular features noninvasively has broad implications for dermatology, including aesthetics. Cross-modal imaging may support pre-treatment assessment, post-treatment monitoring, and personalized aesthetic planning by revealing changes in cellular structure, collagen integrity, elastosis, and pigmentation.

Enspectra Health is actively exploring future studies in aesthetic and regenerative dermatology paired with automated analysis by artificial intelligence, with the goal of integrating cross-modal imaging into routine workflows for skin health evaluation.

Research reported in this press release was funded by Enspectra Health, Inc and was supported in part by the National Cancer Institute of the National Institutes of Health under award number R44CA221591. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Enspectra Health

Enspectra Health is an emerging, privately held healthtech company pioneering the virtual biopsy to transform the way physicians evaluate a broad spectrum of skin conditions. The Company's novel cross-modal technology combines reflectance confocal and multiphoton laser scanning microscopy to instantaneously digitize cellular images of skin noninvasively. For more information, visit www.enspectrahealth.com.

SOURCE Enspectra Health