Health tech veteran Leo Grady believes the microbiome is going to revolutionize healthcare.
Research indicates that the microbiome is related to a range of diseases ranging from gut health to chronic conditions, such as autoimmune diseases, obesity, metabolic health, food allergies and even Parkinson’s Disease.
Several family members suffer from chronic conditions like Crohn's, colitis and celiac disease, Grady said.
"All of them have gotten their microbiome tested, but the results they got were really disappointing. There were different scores that the companies made up and recommendations that weren’t backed up with any science," he wrote in a blog post.
Truly understanding the microbiome will change how people think about health, leading to new diagnostics and whole new classes of treatments, Grady noted.
The former CEO of Paige, a company that develops AI-based applications for pathologists, Grady saw an opportunity to leverage his work in healthcare AI to unlock the microbiome for health. He has built FDA-approved AI applications for many areas of medicine, including radiology, cardiology and pathology that are now incorporated into standard care.
Grady, who's work in health tech includes leadership roles at HeartFlow and Siemens, launched Jona, a startup that provides an at-home microbiome profiling kit and then uses AI to analyze an individual's gut microbiome to deliver actionable, personalized insights. The product is now available to both consumers and providers.
Physicians can keep up with and take action on all the latest science as they treat their patients more comprehensively, according to Grady. For consumers, Jona enables accessibility to the latest science on their personal gut microbiome to understand how the microbiome relates to their health and the concrete actions they can take to improve. Jona's kit costs $385.
"Most of our channel is through concierge medicine, functional medicine, integrative medicine, holistic medicine, any cash pay area of medicine where they tend to do a lot of testing. We also offer it direct-to-consumer," Grady said.
The startup nabbed $5 million in funding led by Breyer Capital and Meridian Street Capital to continue to develop its product.
The gut microbiome is a complex community of trillions of bacteria. Research over the past 15 years has determined that these microbes, both good and bad, are an integral part of human biology.
The startup developed a proprietary large language model (LLM) to interpret an individual's gut microbiome and summarize the scientific literature linking their microbiome to signatures found to be associated with different diseases, conditions, symptoms and allergies.
Jona uses this LLM to generate a personalized interactive report and offers recommendations on food, diet and lifestyle modifications.
"I've been really excited about the microbiome for a long time because I feel that, if you follow the science, the microbiome has been linked to pretty much every chronic disease in one way or another, whether it's GI disorders, autoimmune conditions, diabetes, or even cancer and Alzheimer's, depression and anxiety," Grady said. "The problem though, is that the microbiome is super complex in two ways. One is that the data itself is complex. All the different bacteria, fungus and viruses that can exist in somebody's gut. And the literature is also complex. Every single month, there are more than 2,000 papers published on the microbiome in clinical literature. I thought that AI was really the right technology to make sense of all this research."
He added, "We built a large language model that can read all those papers on the microbiome."
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By leveraging AI, Jona can help make microbiome literature more accessible, interpretable and transparent for consumers and providers, he noted. Jona's platform aims to equip individuals with the latest scientific knowledge to discover root causes and develop effective treatment plans.
Grady is banking on AI as the key technology to build the foundation of microbiome medicine.
"I aspire to build the MRI of the microbiome," he said. "What this will allow us to do is create whole new diagnostics. It also opens up new therapeutic directions and pathways for chronic diseases and it may even impact how we think about processed foods and developing new and better foods for people. There's so much opportunity to really make a difference with chronic disease."
Grady brings to Jona his industry expertise in building "clinical grade AI," he said. "There is a demand or products in the wellness space that are not quite medical devices and not quite true diagnostics. In contrast to the previous companies where we raised hundreds of millions of dollars, we built technology and we did the clinical trial and we went through FDA and we got reimbursement and this was a seven- or eight-year-long journey, the strategy here is to be able to get the product on the market that fits within the wellness space and then use that connection for data and revenue to be able to work through a much longer FDA process to build a true clinical product, which is what we intend to do in the future," he said.
According to NIH research, 60 million to 70 million Americans are affected by GI disorders. In addition, the American Autoimmune Related Diseases Association reports that as many as 50 million Americans are living with an autoimmune disease costing billions of healthcare spending each year.
Many of these individuals struggle to find a diagnosis, relieve symptoms and find effective therapies.
Jona is starting with gut health but Grady sees opportunities to expand into other conditions. "We've been seeing a lot of traction and interest from the longevity community and biohacking as well because microbiome has been shown to be one of the hallmarks of aging," he said.
"We believe that Jona has enormous potential to directly impact patient care. With its innovative use of LLMs and some of the most advanced applications of generative AI we've seen, the company will change how we think about the microbiome and the future of human health," Jim Breyer, CEO and founder of Breyer Capital, said in a statement.
The microbiome therapeutics space is still nascent in the U.S. Just two microbiome-based therapies have been approved by the Food and Drug Administration—Ferring Pharmaceuticals' Rebyota got the first FDA nod last year for the treatment of Clostridium difficile and Seres Therapeutics’ live microbiome capsule Vowst, also to treat C. difficile.
There are other digital health companies in the microbiome medicine market including Viome Life Sciences, which has raised $175 million to date, Seed Health, which sells supplements that target the gut microbiome and Thorne HealthTech, a company that also offers at-home gut microbiome testing.
Venture capitalists have invested $5.9 billion in the microbiome market since 2018, according to data from PitchBook.
Grady points out that Jona does not sell supplements or probiotics but leverages testing services and AI to provide consumers with personalized recommendations to improve their health.