Fogarty CAP Company Melio Poised to Revolutionize Neonatal Care with Innovative Platform

by | Mar 1, 2024 | Companies, Fogarty Innovation

Determining if someone has a bloodstream infection shouldn’t take days. That’s the premise behind Melio, a pathogen identification diagnostic platform for infectious diseases that can identify pathogens in mere hours, rather than the current standard of care with its suboptimal delays. This speed and accuracy hold tremendous potential for addressing the global threat of antibiotic resistance. 

“If there is an infection, you want to start the patient on the appropriate antibiotic or antimicrobial immediately. Otherwise, you increase the chances for poor outcomes, which leads physicians to start the patient on broad-spectrum antibiotics when they are not sure what they are treating,” explains founder and CEO Mridu Sinha, Ph.D. “It’s almost like treating patients in the dark with a trial-and-error approach as you try to guess which antibiotic or course of treatment to give.”

Making a big difference in small lives

While the problem is widespread across all healthcare settings and age groups, the neonatal population is most affected because babies tend to display non-specific symptoms—typically lethargy—when something is wrong. It’s hard to know whether the issue is severe, but rather than risk the consequences of delay, doctors start the babies on broad spectrum antibiotics as they await the blood culture. Ultimately, however, only one baby out of 150 who are given antibiotics truly needs them. 

The practice can potentially have numerous negative short-and long-term effects. These include impacts during the hospital stay, as neonates are separated from their mothers, which can affect bonding and breastfeeding, as well as lifelong effects as the antibiotics target and alter the immature gut microbiome. These babies may be at higher risk for conditions like asthma, allergies, compromised GI health and even neurodevelopmental disorders, which all have been linked to the microbiome.

Neonatologists recognize the issue and are actively looking for solutions that can help them improve the care they provide by ensuring only the babies with an infection are treated. “Overtreatment not only has profound consequences on the babies’ emotional and physical wellbeing, but it has immediate practical consequences in that these babies occupy precious NICU beds just to rule out an infection,” said Sinha. 

Melio’s blood test could help revolutionize this care by providing a fast, three-hour turnaround from patient sample to results while identifying frequently encountered and medically critical infections in a single test.

Curiosity drives groundbreaking research 

Sinha received her Bachelor of Science in electrical and electronics engineering from Manipal Institute of Technology in India, then moved to the United States to get her master’s in electrical engineering from the University of Wisconsin-Madison. As an intern engineer at Boston Scientific working on IC design for implantable defibrillators and pacemakers, she realized she wanted to be closer to patient care, which led her to pursue her Ph.D. in bioengineering at UC San Diego. 

“The whole idea of design thinking was very appealing to me, where you get to discover a challenge and then come up with a solution for the problem, not the other way around,” said Sinha. 

She started by shadowing in the neonatal ICU, which held great personal interest as she was aware that the neonatal death burden in India is disproportionate to the healthcare system’s capabilities.  Her first project involved babies with a certain brain injury caused by a lack of oxygen. If diagnosed and transferred to a neonatal intensive care unit within six hours, the babies can receive therapeutic hypothermia, which can slow the injury process and potentially minimize additional damage. Sinha began working with community hospitals in California to develop a tool that would allow providers to swiftly identify these high-risk babies so they could be quickly transferred for treatment. (The resulting resource is being used by the California Perinatal Quality Care Collaborative today.)  

This work led to another discovery. As she was performing manual retrospective chart review of each newborn to gather data, she noticed that the babies were not only diagnosed with brain injury, but also with “rule out sepsis;” in other words, they didn’t have a diagnosis of sepsis, but were given antibiotics because the doctors couldn’t tell whether the baby had brain injury or an infection.

That’s how she first became aware that many babies may needlessly be on antibiotics for seven days, which illuminated the lack of proper diagnostic tools.

“I was intrigued, which led me to research existing technologies. We are all now familiar with ‘PCR’ because of COVID, and I thought maybe we could use some of these molecular diagnostic tools to quickly identify infection-causing pathogens in blood. As an engineer, I had to teach myself all these nuances of diagnostics and molecular biology to try to understand where the gap or solution was, and the benefits or downsides of existing technologies,” she says.

Because no one was able to answer her many questions, she ended up writing a review paper on how dissecting existing technologies may yield a solution, which became the 18th most cited paper in the Journal of Clinical Microbiology that year. 

Next she delved into finding a diagnostic that would work, which was when she met Stephanie Fraley, Ph.D., who ultimately became a Melio co-founder. Fraley had just become a professor at UCSD and was working on a bare-bones version of the startup’s current technology. Today, Melio is on the cutting edge of next generation of DNA melting technology—identifying pathogens by capturing their unique DNA melt curves and classifying them using advanced artificial intelligence.

An experienced team steers the company, with support from Fogarty’s CAP program

The current Melio team is made up of eight full-time employees with deep competencies in relevant areas—including expertise in IP, startups and molecular biology—supported by a highly knowledgeable and experienced scientific advisory team. 

“Our seasoned team averages 25+ years in the space, with each of them having already attained great success in their respective technical careers,” Sinha says. “The fact that they joined Melio really speaks to the caliber of the technology we are developing and the vision we are realizing.”

To date, they’ve already raised about $3 million, including grant funding, and are currently raising an equity round.

Becoming a member of Fogarty Innovation’s Company Accelerator Program (CAP) has been a game-changer for Sinha, who learned about Fogarty from her networks early in her career and believes Melio is aligned with the organization’s vision of improving patient care globally. This short term program supports early-stage companies in developing a comprehensive, cross-functional approach and achieving specific goals. 

“Our passion is not just in creating a solution; it’s about ensuring it makes a real difference,” said Sinha. “Being part of the Fogarty ecosystem allows us to deeply engage with the clinical community and understand the nuances of clinical workflows. This collaboration is key to ensuring our technology not only fits seamlessly into patient care but also catalyzes meaningful change in diagnostics and treatment practices.” 

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