Nearly a year ago, we published an in-depth look at the origin story and science behind Imaginostics – how a summer in Paris, a PhD in bioengineering, and a shared leap of faith led Valerie and Codi Gharagouzloo to found a company that could fundamentally change what MRI can tell us about the human body. If you haven't read it, start there. A lot has happened since.

Every year, two million patients in the United States face an impossible choice.

They need critical diagnostic imaging, but the contrast agents required to make that imaging useful are toxic to their kidneys. So they are presented with a stark tradeoff: accept potential kidney damage or accept the absence of information their physicians need to make life-saving decisions. For patients already living with kidney disease, this is not a hypothetical dilemma. It is a real, recurring clinical reality.

It is also the kind of problem that Codi Gharagouzloo, PhD, has spent his career working to solve.

As Chief Science Officer & Co-founder of Imaginostics, Codi built the company around a fundamental insight: MRI is a great imaging technology, but it has never fulfilled its diagnostic potential. The images it produces are black and white, qualitative by nature, and dependent on contrast agents that limit who can safely receive them. What clinicians can see is impressive. What they can actually measure and act on at the individual patient level is far more limited.

"I really wanted to get beyond looking inside the body with your eyeballs," Codi says. "As a physicist, how can we move this from qualitative to quantitative?"

That question became the foundation of his doctoral research in 2011, and eventually the foundation of Imaginostics itself.

The technology Codi invented is called QUTE-CE MRI, short for Quantitative Ultra-short Time-to-Echo Contrast-Enhanced MRI, and it does something that no existing imaging approach has been able to accomplish: it creates a quantitative data layer in MRI, enabling the measurement of biology at the level of individual patients rather than statistical populations.

To understand why this matters, it helps to understand the gap it closes.

Conventional MRI can reveal a great deal about the brain and body, but most of what it reveals is visual and qualitative. Techniques like diffusion tensor imaging (DTI) can produce striking images of neural pathways in the brain. Those images are real and meaningful at the group level, where researchers can study populations and identify statistical patterns. But if you want to use an MRI scan to understand what is happening inside a specific person's brain, to render a diagnosis, to track disease progression, to guide a treatment decision, most MRI techniques fall short. The images do not carry individual diagnostic value.

Imaginostics is built to change that.

"A new data layer in MRI" is how Codi describes it. Rather than generating better pictures of the same information, QUTE-CE MRI creates entirely new images that capture quantitative measurements of structure, function, and leakage of small blood vessels at the level of half-millimeter cube volumes throughout the brain and body. Within those tiny tissue volumes, Imaginostics can describe the biology and physiology of the cells living inside, including whether the vessels supplying them are healthy, whether they are leaking, whether they are responding appropriately when the body demands more metabolism.

This is what qualifies Imaginostics' measurements as true biomarkers of aging, meeting the rigorous criteria set by the biomarkers of aging consortium, which requires the ability to describe cellular-level biology within tissue, not just capture images of it.

"Although we can't see the cells inside the brain," Codi explains, "we can start to quantify things within small unit volumes inside the brain. We can start to talk about what their environment is like."

Imaginostics has organized its technology into two complementary platforms, each targeting a distinct dimension of the problem.

The first is ImagiView™,  a software platform that forms part of a combination product currently on the path to FDA approval. ImagiView replaces gadolinium, the toxic contrast agent used in standard MRI, and iodine-based agents used in CT imaging, with an intravenous iron supplement that is safe for patients whose kidneys cannot tolerate conventional agents. The resulting images are not just safer. In head-to-head studies, they have been judged ten times better in quality than standard gadolinium contrast imaging. ImagiView has received FDA Breakthrough Designation for use in patients with kidney disease, validating both its safety profile and its clinical necessity.

The second platform is ImagiSight™, a post-processing analytics layer that takes the enhanced images produced by ImagiView and computes quantitative vascular biomarkers from them. This is where the data layer truly comes to life. ImagiSight is what enables the individual-level precision that makes Imaginostics' technology genuinely distinct from anything currently available.

"A lot of people are putting AI on top of existing data," says Valerie Gharagouzloo, CEO & Co-founder. "We are using AI as well in our product, but we are creating new data. It's not that it's better than anything. It just doesn't exist elsewhere."

That is not a marketing claim. Every investor and clinician who has engaged seriously with the technology has reached the same conclusion: there is no comparable platform in the market. The vascular intelligence that ImagiSight generates is, as Valerie puts it, zero to one. The technology has been recognized twice as a Prix Galien nominee, one of the most prestigious honors in the life sciences, with no other technologies offering this type of data or information in that field.

Codi began this work in academia, in a laboratory, on rats, often late at night. Moving from that environment to a commercial product that can be used in hospitals has taken eight years and required a kind of partnership that most software companies never have to think about.

"We cannot operate in a vacuum," Valerie explains. "We are a radiology imaging startup. Our software needs to integrate on MRI scanners."

That reality is what makes Imaginostics' recent announcement of exploring a commercialization partnership with Siemens so consequential. MRI innovation cannot reach the bedside without the cooperation of the companies that manufacture the machines. The software that powers ImagiView must integrate directly with scanner hardware, and that integration cannot scale without a manufacturer as a partner.

Imaginostics is also in advanced discussions with leading contrast agent manufacturers to finalize partnerships on the agent side of their combination product. With both relationships progressing, the company is building the full stack it needs to bring its technology through the FDA and into clinical practice.

The road to this point has required scientific credibility at every stage. Imaginostics’ technology has received government grants from four federal agencies: the National Institute of Mental Health (NIMH), the National Institute of Aging (NIA), the National Institute on Drug Abuse (NIDA), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). They also received investment from the Alzheimer’s Drug Discovery Foundation (ADDF). That breadth of support reflects the technology's relevance across multiple disease areas and provides the kind of institutional validation that opens doors in health systems and with regulators.

One of the most significant clinical applications of Imaginostics' biomarker platform is also one of the most urgent: blood-brain barrier leakage in the context of cognitive decline and Alzheimer's disease.

Research conducted at the group level has already established that every person presenting with cognitive impairment exhibits blood-brain barrier leakage. The science is clear. What has been missing is the ability to detect and measure that leakage at the individual patient level, where it could actually inform clinical decisions rather than just describe population trends.

Imaginostics is now running a 96-patient study, funded by the ADDF and conducted at AdventHealth's Translational Research Institute with Dr. Kirk Erickson, that aims to do exactly that. The study will examine healthy young and aging adults alongside those developing cognitive impairment, establishing baseline profiles of what healthy brain aging looks like and tracking the progression of vascular changes that accompany decline.

The goal is not just scientific validation. It is the foundation for a clinical decision support tool, one that gives physicians meaningful, individualized information about what is happening in their patient's brain before symptoms become irreversible.

"We know that leakage is present," Codi says. "And so now we need to be able to measure it at the individual level."

Valerie joined Imaginostics as a lawyer, not a scientist. Her path to leading the company reflects something she speaks about openly: the role AI has played in helping her bridge that gap.

"I could not do my job without AI," she says. "I use it every day to understand medical concepts, how to apply technology in different medical applications."

That candor speaks to something broader about how the company operates. At Imaginostics, AI is not only a scientific tool; it also serves as a bridge, helping translate highly complex technology into language and insights that are understandable, accessible, and actionable for a much broader audience.

Imaginostics is not just building for scientists. It is building for the full arc of healthcare, from the individual patient who needs a safer scan, to the pharmaceutical company trying to demonstrate drug efficacy, to the clinician making a real-time decision at the bedside.

The vision Valerie articulates for what this technology could mean for healthcare is expansive. Regular MRI screening with a safe contrast agent, the way some countries already approach preventative imaging, becomes genuinely possible. Biological age, measured not by years lived but by the actual state of a person's vascular system, becomes a trackable, improvable number. Individuals can monitor their own health over time and observe the effect of the choices they make.

"With our technology, when it is fully deployed, we will see symptoms earlier, before symptom onset," she says. "That is how we go with Alzheimer's as well."

The potential extends further still. In drug development, the ability to observe real-time changes in vascular biology after a single treatment dose could compress clinical timelines and reduce the cost of failure. For rare diseases, where population-based trial designs are often economically unviable, individual-level biomarkers could open a new model of therapeutic development entirely. The technology has already attracted interest from leading cancer clinicians at Memorial Sloan Kettering for brain cancer applications, specifically to distinguish true tumor progression from pseudoprogression, and from NYU researchers exploring its use in prostate cancer. Breast imaging is another area Valerie sees as ripe for impact, particularly for women with dense breast tissue who currently require both mammograms and ultrasounds.

Pediatric imaging is also close to her heart. Kidneys in children are particularly sensitive to toxic contrast agents, and the demand for safe, high-quality imaging in pediatric populations represents another unmet need the company intends to address.

Eight years is a long time to believe in something the world is not yet ready to see.

Imaginostics has been explaining vascular health biomarkers and their relevance to Alzheimer's disease since before the broader scientific community had fully embraced the connection. Valerie remembers those early days, when Codi was still working to convince audiences that the vascular angle mattered. The field has caught up considerably since then.

"The world has changed in eight years," Valerie says. "Now people are starting to understand."

What has not changed is what motivates both founders. Codi wants to see the floodgates open, the endless applications in drug development and diagnosis that become possible once the technology is validated and distributed at scale. Valerie wants to see a physician in a hospital reach for the tool and use it for a patient who needs it.

"Seeing this become concrete," she says, "is a dream of ours."

We are proud to have Valerie and Codi Gharagouzloo as members of the StartUp Health community and a driving force within our Alzheimer's and Brain Health Moonshot.