At Fogarty Innovation we are fortunate to have a front-row seat as our companies pioneer innovations that solve meaningful problems in patient care. Our goal is to help them advance through educational programs and support, so it’s truly rewarding to see them make great strides forward as exemplified by the updates below.
Fogarty Innovation company Enspectra Health is leading a digital transformation of skin biopsies with the VIOTM System which non-invasively gathers cellular imaging information in real time. The device is under investigational use in the U.S. The current method of skin biopsy requires invasively removing tissue, then mounting the tissue on slides and viewing it either manually or digitally, which can often take a week or more. The VIO System’s innovative potential is being recognized by the industry which has led to several recent milestones.
Most notably, Enspectra has announced the launch of its VISTA Pivotal Study and its partnership with Golden State Dermatology in support of its application for FDA 510(k) clearance. They were also awarded $1.2 million as a second tranche of its Phase IIB grant of $4 million allocated by the National Institutes of Health’s Small Business Innovation Research (SBIR) Program.
The VISTA Pivotal Study is designed to evaluate Enspectra’s technology on subjects undergoing routine skin biopsies to demonstrate safety and effectiveness of the VIO System. The company will use its technology to non-invasively image patients before a biopsy and then compare the VIO image with resultinghistopathology.
“This is an exciting moment for us as we move into the clinical phase to compile real-world evidence,” said Gabriel Sanchez, Enspectra co-founder and CEO. “We’re eager to get more information and focus on the benefits we can bring patients through the power of non-invasive, real time cellular imaging and share this advance for the field of dermatology.”
The team has recently expanded to support the company’s progress, adding Grace Li as vice president of quality and regulatory to support its development work and FDA application; and Shelley Marwah, vice president of commercial strategy who is working with clinical advisors and developing the go-to-market strategy.
The VIO System generates data-rich images that will serve as the foundation for future AI-based clinical decision support tools, contributing to improved patient outcomes. “The more clinical evidence we can gather, the more we can fully leverage what our technology can do to benefit patients undergoing skin biopsies,” said Gabriel.
Enspectra Health is committed to diversity by including darker skin representation in their study endpoints. They are actively seeking to enroll patients with darker skin color who historically have been underrepresented in dermatological studies to ensure their technology works effectively in all skin types and to also limit racial bias in their data.
Boomerang Medical, a women-led clinical stage bioelectric medicine company that aims to advance the treatment of autoimmune disease, is another Fogarty company reporting significant breakthroughs. In just a little over a year, the company has been granted an Investigational Device Exemption by the FDA to evaluate the company’s implantable bioelectronic medicine therapy for inflammatory bowel disease (IBD), which impacts over three million adults in the U.S. It has raised an impressive $15 million Series A financing round led by Arboretum Ventures and joined by Hatteras Venture Partners.
Heather notes that this was probably the fastest round she has raised in the 20 years she’s been in the industry; in fact, they ended up having more interest from the VC community than space in the round, which speaks to the need they are addressing. “There are very few people who aren’t touched in one way or another by IBD. Addressing the challenges they face is a cause that’s very near and dear to us and our investors,” she said.
Boomerang began its studies in the largest IBD centers in the U.S. and now has more interest from clinical centers than they can accommodate. “We have been overwhelmed and pleased with the degree of interest from the clinical sites, and the consistent feedback we have received is that physicians need more tools at their disposal,” said CEO Heather Simonsen. “They have expressed particularly keen interest in a device-related therapy as the IBD population is very heterogenous and it’s helpful to have a variety of treatment options as most therapies until now have been limited to biologics and pharmaceuticals.”
Heather credits her strong, nimble leadership team for these successes, citing how much they have accomplished in a short time. Because she has been careful to only add positions that are vital to getting Boomerang to its next level, the team has had to streamline their efforts. For example, they set up onboarding calls with study centers rather than conduct time-consuming email correspondence, which decrease the site startup period by 50% to 75%.
Currently Boomerang is focused on enrollment as the sites begin to ramp up, with screening underway. As they begin to conduct the research and collect data, they are prioritizing ongoing communication and education, including providing sites with patient educational materials to aid the investigators and research staff.