Enspectra Health Catapults to Next Level with FDA Clearance

by | Mar 1, 2024 | Companies, Fogarty Innovation

Enspectra Health’s innovative VIO System recently received its first FDA clearance. VIO is a portable, hand-held device that provides high-resolution images of cellular structures in living skin without the need for incisions. Its compact design allows for direct digitization of pathology from a patient’s skin, offering physicians valuable clinical insights in a matter of seconds. 

“It is especially exciting to be the first new FDA-cleared modality in about 25 years, which is a big advance for the field of medical imaging,” said Gabriel Sanchez, co-founder and CEO of Enspectra, adding that the FDA had been particularly impressed with the startup’s strong clinical data. 

First-of-its kind imaging device 

The multimodal device uses two techniques, reflectance confocal microscopy and multiphoton microscopy. VIO distinguishes itself as the first device cleared by the FDA to employ multiphoton microscopy in any form or application. The second technique, reflectance confocal, is already cleared in the U.S. allowing Enspectra Health to utilize the FDA’s 510(k) pathway.

“We were able to use something that was already proven—reflectance confocal—and combine it with something novel—multiphoton—enabling real-time visualization of skin cells in color.” explained Sanchez. 

During their pivotal clinical study, participants who were already undergoing traditional biopsies were imaged with VIO prior to the biopsy. After building a large dataset of in vivo images from living tissue, they conducted rigorous clinical comparison and blinded readings on features to prove that VIO could identify cellular structures of pathology in both healthy and diseased skin in the same way they are seen on histopathology. “The potential impact that VIO images will have on how dermatologists evaluate skin is immense,” Sanchez said.

Continuing the climb

In addition to Enspectra Health’s focus on skin cancer, the most diagnosed cancer in the U.S., the company is leveraging its existing FDA clearance for unmet needs in the $52B cosmetic industry and $8B topical dermatology drug development market. “There’s a broad underlying need to have immediate access to pathology and cellular information,” Sanchez said.

The company is raising additional funds to pursue a limited commercial release of VIO while expanding its clinical indications and advancing its AI/ML clinical decision support models. Enspectra plans to conduct more clinical studies, focused on pursuing diagnostic applications for skin cancers. The company will also build out digital tools for automating analytics, which would include basic biometrics of skin health that can be applied to a multitude of use cases, such as evaluating general skin health and photoaging; or the efficacy of topical drugs in pigmentation disorders, rashes, eczema and similar conditions. 

“We view VIO as a versatile skin health technology platform that will provide deep insights into a variety of conditions without cutting the skin,” Sanchez said. 

Since VIO can image cellular characteristics non-invasively, there’s a potential to image tissue across the duration of a treatment and track changes over time, rather than being limited to the standard before-and-after photos that are used today. The team intends to use VIO to track aging skin and sun damage to help people protect and preserve their skin health.

“We’ve been very capital-efficient and nimble as we’ve progressed from concept to FDA clearance. Raising additional capital will help us grow the team in the right strategic places and accelerate the execution of these exciting opportunities,” Sanchez said. 

Fogarty provides crucial support framework

Fogarty has played an integral role in the company’s success, says Sanchez. The company took full advantage of all the infrastructure available at the facility, including its testing capabilities. Enspectra also benefited from the expertise and insight of the executive team on multiple levels, including strategizing how to navigate the FDA study design and consulting throughout multiple interaction with the agency.

“We also appreciated the chance to interact with the other Fogarty companies-in-development at FI to share lessons learned and encourage each other when times get challenging,” Sanchez said. “It’s been very fulfilling to be part of the ecosystem here at Fogarty and to work with peers and mentors as we all continue making progress. Thanks to this environment, we’ve been able to keep costs low and accomplish a lot as a small company.”  

Sanchez notes that what really drives the Enspectra team is the patient-first attitude that infuses Fogarty. “We believe it’s imperative to get this technology out and into clinical practice. We have the potential to make a significant impact on people’s health and quality of life with VIO’s broad applications.” 

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