TUE AM News: RadUnity gets FDA clearance for medical imaging platform; UW-Madison researchers find placenta treatment is safe in monkeys

December 3, 2024

— Madison-based RadUnity has received FDA clearance for its time-saving medical imaging product, clearing the way for commercial distribution.

The startup company recently announced the federal agency approved its 510(k) Class II Medical Device application, which founder Tim Szczykutowicz says will help secure additional funding and expand the team.

He launched the company in 2023 based on research patented through the Wisconsin Alumni Research Foundation, and holds a position as associate professor of radiology at UW-Madison.

“With this clearance, we’ve made a significant leap toward turning an academic concept into a practical clinical solution … It brings us closer to fulfilling my goal of providing a solution that the community will embrace and use to improve patient care,” Szczykutowicz said in a statement.

The company aims to address the “problem of inconsistency” in medical imaging by centralizing management of certain medical images, before radiologists or AI networks interpret them. Its approach involves ensuring consistent formatting and image processing for these images, such as computed tomography or CT scans.

While CT scans are widely used for diagnosis and pre-surgical assessment, many CT scanners provide varying information for the same procedure, the company says, which can affect patient care. The inconsistency it aims to address is linked to various factors, such as vendors prioritizing “visually pleasing” imagery over uniformity.

RadUnity’s website says its team has identified “numerous sources” of inconsistency at imaging centers, from rural outpatient sites to large academic institutions.

While these differences can pose a problem for the radiologists who interpret CT scan results, they can also throw a wrench in the burgeoning field of AI medical image processing, the company says. AI vendors are challenged with building AI networks that can assess a wide array of varying medical images, rather than a standardized set of results.

RadUnity’s software platform controls the image creation process to provide a consistent “look and feel” for doctors interpreting them, creating continuity in images created for a single patient over time, and between patients. The company says this can cut down on the time radiologists spend assessing results, reduce the implementation time for certain AI medical image interpretation tools, and “eliminate” AI processing errors linked to image compatibility issues.

After creating its tools for CT scans, RadUnity plans to develop “harmonization methods” for magnetic resonance imaging, or MRI scans — another type of widely used medical imaging.

See more at Madison Startups.

— A UW-Madison study demonstrated a placenta treatment approach is safe in monkeys, advancing the therapy toward potential use in humans.

The study, published in the journal Molecular Human Reproduction, focused on a gene therapy meant to address “placental insufficiency,” which can limit growth for developing fetuses and possibly lead to premature delivery.

This condition results in “poor nutrient and oxygen transport” to the fetus as well as low birth weight, according to Jenna Schmidt, a scientist and research assistant professor with the university’s Wisconsin National Primate Research Center.

“The placenta, although transient and typically discarded after pregnancy, is an organ that is so critical to ensuring healthy babies,” she said in the release, but added “there is currently no way to treat the placenta.”

Schmidt worked with University of Florida researcher Helen Jones on a new method for doing so, which involved using AI to identify treatment targets. They created a “nanoparticle” that contained a small piece of DNA linked to a protein called IGF-1 that’s important for normal placenta development. UW-Madison says pregnancies where fetal growth is restricted have lower levels of this protein.

To test the nanoparticle, the scientists injected it into placentas of pregnant monkeys at the research center in Madison. They found the DNA was “successfully taken up and expressed” within 24 hours with no harmful side-effects, the release shows.

Jones says earlier studies in mice and guinea pigs are “very encouraging,” and with the more recent pilot study showing no issues in primate pregnancies, “we are excited to continue to optimize and further target this therapy.”

Schmidt notes the implanted gene’s expression was seen 10 days after treatment in the monkeys.

“Maybe that could translate into a nanotherapy infusion every two weeks in humans after mid-pregnancy,” she said in a statement. “That is usually when doctors see that the fetus is smaller than normal through ultrasound diagnoses. But there is a lot more work to do before we can move this into human trials.”

After publishing the latest results, researchers next will work to extend the therapy through the third trimester of pregnancy, with a goal of measuring the impact on both the fetus and mother through the birth process. Ultimately, Schmidt aims to “improve placental function, extend pregnancies, and see more healthy babies and adults.”

See more in the release.

For more of the most relevant health care news, reports on groundbreaking research in Wisconsin, links to top stories and more, sign up today for the free daily Health Care Report from WisPolitics and WisBusiness.com.

Sign up here.

— KI has been accepted into the Wisconsin Sustainable Business Council’s Green Masters Program at the highest level, recognizing the Green Bay furniture company’s sustainability efforts.

The Green Master tier shows the recipient has “identified and is effectively managing” material sustainability issues and performance in a comprehensive way, the council’s release shows.

The announcement notes KI achieved a 23.1% reduction in greenhouse gas emissions and 20.7% decline in energy consumption compared to 2017 baseline levels, while also diverting 4.7 million pounds of material from landfills. Of that total, 3.1 million pounds was taken to recycling centers, a 33.9% increase in waste reduction over the year.

“We believe that sustainability is about people and doing right by them and future generations,” KI Sustainability Manager Robin Kunstmann said in a statement. “Our commitment to reducing our environmental impact is evident in our continuous efforts to improve our processes and products.”

See the release.

— A recent pitch contest in Sheboygan County featured several software-focused startups being developed by local entrepreneurs.

The contest was held in November by Accelerate Sheboygan County, Sheboygan County Economic Development Corp., the Sheboygan County Innovation Council and New North, giving startup leaders an opportunity to showcase their early-stage ideas.

The first place winner, Alex Suscha, has created an AI software-as-a-service platform called Sourcer AI. The technology uses artificial intelligence to fact-check online articles, with a goal of fighting misinformation. Suscha, a student at UW-Stevens Point, received $3,000 from the contest.

Meanwhile, Plymouth resident Tyler Heilberger got $1,500 for his second-place idea called Rosebud. This family travel software aims to help users find unique experiences that match their personal preferences, according to the release.

A third entrepreneur, Tyler Razacheck, got the People’s Choice award and $500 for his business, Hi-Ho Soda. The company has done an initial launch and can distribute its soda products throughout the state.

Don Hammond, chair of the SCEDC, touts the “incredible talent” demonstrated by the pitch contest winners.

“Their innovation is a prime example of how Sheboygan County competes on a global scale, and how we continue to recruit and retain talent,” he said in a statement.

See the release.

Despite state restrictions, Wisconsinites are receiving abortions via telehealth

UW faculty fear ‘massive seizing’ of their work under proposed policy

TOPICS

AGRIBUSINESS

– Join the 2025 Wisconsin Ag Forum at UW–Madison Jan 21

CONSTRUCTION

– Johnny V, Cobalt Partners team up on $90M Wauwatosa apartment development

ECONOMY

– Wisconsin Physicians Service, Molson Coors cut jobs in November

EDUCATION

– Wisconsin education leader urges more state funding for special ed, 4K