Start-up from Auburn’s New Venture Accelerator Drives Dramatic Improvements in MRI Diagnosis
Magnetic Resonance Imaging (MRI) has become one of the most impactful medical advancements ever made to detect a wide range of diseases, conditions and injuries. As MRI technology has evolved over the years into an increasingly indispensable diagnostic tool, one element of the MRI process has remained an obstacle to even more precise and safer procedures. In short, there are serious performance and toxicity issues with the current contrast-enhancing imaging agents injected into many patients that often remain detectable months and even years after the scan.
Nanoxort, an Auburn New Venture Accelerator company, is working to change that, with the help of a recently awarded $1 million Small Business Innovation Research (SBIR) grant from the National Science Foundation.
The Auburn-based company has developed an iron-based MRI contrast-enhancing agent that dramatically improves contrast visibility generated without the toxicity concerns and limitations imposed by current gadolinium-based agents. Gadolinium is a chemical substance with high levels of toxicity that must be quickly removed from the body, reducing the quality of the images produced. Iron, on the other hand, is an essential mineral the human body needs to function, enabling longer, more accurate image capture times for MRIs and rapid clearance from the body for MRI scans using the company’s patented iron-based contrast agent.
The NVA sat down with all four principals of Nanoxort to hear their origin story, what they’ve accomplished so far, and what’s next for these four chemical engineering PhDs and the company they are building.
Dr. Allan David, Dr. Barry Yeh and Dr. Tareq Anani founded Nanoxort in 2018 while working in Dr. David’s chemical engineering lab at Auburn’s Samuel Ginn College of Engineering. Dr. Abhinav Sannidhi joined the company in 2021 as Research & Development Manager and Principal Investigator for the NSF-funded project.
How MRIs Work
MRI machines are highly complex medical diagnostics systems that can non-invasively scan virtually every structure and organ inside the human body using magnets and radio waves to produce 3D images displayed on a high-resolution computer screen. Compared to traditional x-rays and computer tomography (CT) scans, which require ionizing radiation that can cause damage to the patient’s cells and genetic material – DNA – MRIs produce few side effects while greatly enhancing the detailed images they generate.
Roughly 40% of all MRI scans employ a contrast agent – a “dye” that is injected into the patient’s arm intravenously to enhance the image quality, enabling the radiologist to diagnose more accurately what they see. Once the imaging exam is complete, the contrast agent is either absorbed by the body or eliminated through urine.
But there are serious issues with the predominant contrast agent used in MRI systems to help add clarity and decipherability to the MRI image. Due to their high toxicity, gadolinium-based contrast agents must be eliminated from the patient’s body very quickly, which leaves precious little time for MRI machines to view and collect the data produced. This short window limits the accuracy of the resulting diagnoses for a growing number of potential medical indications.
A Focus on Heart Health
In particular, this drawback severely diminishes the capability of MRIs to diagnose a wide range of vascular and heart health issues. The growth of vascular diseases and cardiovascular conditions and the damage they cause calls for a dedicated effort to refine current MRI capabilities to enable broader, more precise and safer diagnoses of vascular and heart health.
Enter Nanoxort
Nanoxort is focusing initial application of its patented contrast agent formulation technology on this growing segment of the MRI market – vascular disease detection.
“Because our iron-based contrast agent is safer and can stay in the body longer,” says David, “we have a much greater design space than current agents, so we’re able to optimize our agent for particular applications such as cardio health. The high level of specificity in vascular imaging our solution provides cannot be achieved with gadolinium-based agents.”
The commercial value of the fundamental research Nanoxort’s founders were conducting came to light when the founders participated in the Southern Regional Cohort of the National Science Foundation Innovation Corps (NSF I-Corps) program at Georgia Tech back in 2016.
It was there that they were introduced to the MRI contrast agent market and how their research might contribute to safer, more effective MRI scans, and where they received an initial $50,000 grant from NSF I-Corps to conduct additional customer discovery in the United States and Europe.
The three then won an Auburn University LAUNCH award that allowed them to conduct further research targeting preclinical studies to address this market opportunity with their patented technology.
David first learned of the NSF I-Corps program through Auburn’s Technology Transfer Office, now known as The Intellectual Property Exchange, or IP Exchange. “We knew the best avenue for initial funding would be through federal grants,” says David, “but to access that funding, we needed to form legal entity, a company. So that’s what we did.”
Nanoxort received its first grant, for $256,000, from the NSF in 2021 to fuel development of what’s called a “minimal viable product,” or MVP. Anani describes an MVP as something that is “good enough to conduct initial in vitro and in vivo testing with enhanced performance over gadolinium” in preparation for more advanced studies to come from a phase two grant, which the company just received.
“We spent some time talking with multiple radiologists,” says Anani, “and came to realize the potential our patented technology has to solve problems in the MRI marketplace that have been underserved. That’s where our journey began and we’ve been improving the fundamental technology ever since while pulling together what we needed to fund those efforts.”
Next Steps
Nanoxort’s initial product is well beyond the prototype stage, according to Anani. “We believe what we already have is excellent, but we will be spending an early portion of this phase two award to do some final optimization in a few key areas we feel are important in preparation for advanced preclinical studies,” notes Anani. “We’ll be focused on the efficacy of our solution as well as conducting advanced toxicology studies to expand our initial findings.”
Yeh noted that the company’s phase two grant will help bring their technology as close as possible to clinical testing. “We will need a little bit more funding to get through all the preclinical stage steps, and we are pursuing additional financing options to make that happen. All funding to date has been non-dilutive – the three co-founders currently own all the equity in Nanoxort.”
Sannidhi explains that proceeds from the recent SBIR grant must be used for the specific purposes outlined in their application, with a new set of reporting requirements the company must now complete on a six-month basis.
“To qualify for the National Science Foundation grant, we had to submit a budget and we have to stick to that budget as closely as we can – we have to follow certain accounting and financial reporting guidelines.” says Sannidhi. “Any changes to that budget have to be approved by the program officer at the NSF. We provide a work plan, a project scope and the required budget for that scope. But there is flexibility in terms of execution to account for changes we may find necessary along the way.” The NSF SBIR grant money is released in four equal tranches over the two-year period.
The company’s SBIR grants also come with matching funds from the State of Alabama — $100,000 received in September 2022 from the NSF phase one grant and the company is eligible for an additional $250,000 from the State through the second grant just awarded. Some of those funds will be used to explore other promising applications, such as cancer, where gadolinium-based approaches fall short. To do this, the company must prove superiority over gadolinium-based agents in terms of performance, not just safety.
Assigning Responsibilities
On a day-to-day basis, each member of the Nanoxort team wears different hats, although the lines of responsibility aren’t as tightly drawn as one might expect.
“All four of us are steeped in research – we all have PhDs,” says Anani. “That said, we have allocated our respective available time to specific roles, more or less. Abhinav is in charge of day-to-day research activities, planning experiments. My job is writing grant proposals and figuring out how to bring money to the startup to fund our efforts – how can we grow the business? We have other ideas we want to submit grants for, other applications for our technology in the commercial space.”
“I’m mainly in charge of most of the administrative responsibilities of the company,” says Yeh, “making sure we’re properly registered where we need to be – that all the IP and legal issues are addressed. If we’re filing a patent, I’m the one making sure we’re in position to do that.
As a faculty member at Auburn University and the acting associate dean for research for the College of Engineering, David serves in an advisory role both on the business side and when it comes to research. “Fortunately, we have a really strong team here,” says David, “which enables me to continue conducting research while also contributing to some of the grant writing and business development activities.”
Collaboration is King
As the company moves closer to clinical trials, partnering with the “big four” MRI contrast agent manufacturers – GE Healthcare, Bracco Imaging, Bayer, and Guerbet– will be a critical next step.
As a small business, says Anani, Nanoxort needs to leverage the expertise and experience of MRI contrast agent manufacturers as well as suppliers. “We have to be realistic in terms of what we can take on ourselves and where we need to collaborate. As we move towards confirming the value of our new agent through preclinical testing, we’ve begun preliminary discussions with a few of the leaders on what it will take to move through FDA approval, for example. This is typically an expensive and time-consuming process they definitely can help us with. They understand the processes required for commercial introduction, all the logistics involved in distribution channels, for example.”
Getting the Word Out
Visibility is one thing Nanoxort believes will help drive the next phase of the company’s development.
“We don’t know what we don’t know,” remarks Anani, “that’s why we’re speaking with those who do know. The response to our initial discussions with potential partners has been enthusiastic, and we look forward to expanding the universe of experts who can help us further refine our innovative approach to enabling broader, better and safer MRI diagnostic results.”
“That’s how we’ll ultimately succeed,” concludes Anani,” and we couldn’t do it without all the help we have here at the New Venture Accelerator, the IP Exchange, across the Auburn campus and at entrepreneurial organizations around the State of Alabama.”
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To learn more about the New Venture Accelerator visit our website HERE.
Or contact Lou Bifano at loubifano@auburn.edu.