Interventions: Behavioral: RESTORE; Behavioral: Enhanced Usual Care
Sponsors: Massachusetts General Hospital; National Cancer Institute (NCI)
Not yet recruiting
– Rebecca Deusser, MS, MBA and Sanjaya Saxena, MD
“It took me years to find out that what I was dealing with was OCD!”
This is a phrase all too often repeated by people living with obsessive compulsive disorder. Currently, individuals live with OCD for an average of 7 years (Dell’Osso et al, 2019) before they even receive a diagnosis, all while symptoms may intensify and daily life often becomes increasingly constrained.
Clinicians, researchers, and advocates have long raised this concern. What has been missing is clear data behind how many people with OCD in the U.S. are missed in clinical settings or are not receiving the most effective treatment.
When the International OCD Foundation undertook this analysis, the scale of the problem became unmistakable. Millions of people in America are currently struggling with OCD without the most effective treatment.
The challenges we detail in our new white paper, America’s OCD Care Crisis: National Findings on the Failure of Effective OCD Treatment to Reach Patients, are significant, but fixable. They are symptoms of structural oversights that can be changed. Effective, evidence-based treatment for OCD exists, and through intentional action, we can dramatically change these unacceptable outcomes for people with OCD.
Well established prevalence rates for OCD indicate that nearly 10 million people in America — roughly 3% (Ruscio et al, 2010; Stein et al,2025; Ringeisen et al, 2025) — will have OCD at some point in their lives. Yet our findings suggest that 75% of them are never even identified, and up to 95% aren’t receiving the most effective treatment for the disorder.
In our analysis, we discovered significant systemic breakdowns at several key points of a patient’s journey: screening, diagnosis, referral, and treatment.
The breakdowns seen in each step of the care pathway reinforce the focus of IOCDF’s Vision 2030, our five-year strategy to address the systemic barriers that keep effective OCD treatment out of reach.
While the findings are stark, they illuminate many opportunities for change:
Vision 2030 outlines how the IOCDF is committing its resources, partnerships, and expertise toward advancing these priorities — by increasing awareness and community, expanding access to effective treatment, and advancing research. Together, these efforts are designed to work in concert, improving clinical training, implementing screening for early identification, strengthening pathways from diagnosis to care, and increasing the likelihood that people receive evidence-based treatment.
At the same time, the scale of the problem revealed in this report makes clear that progress depends on collective action across the field. Clinicians, health systems, educators, researchers, policymakers, advocates, and people with lived experience all have a role to play. Together, these efforts can help ensure that people with OCD reach effective treatment sooner, reducing years of unnecessary confusion and distress.
Join us in building better access to effective treatment for people with OCD:
The current state of treatment for OCD in the U.S. is sobering, but it is not the end of the story. OCD is treatable, recovery is possible, and change can happen as awareness grows and access expands. With continued effort, the gap between how many are struggling and how many receive effective care can begin to close. A brighter future is possible — and we can build it together.
References
When clinicians have easier access to best practices in OCD diagnosis and treatment, more people can receive effective care. The IOCDF’s Training Institute offers evidence-based programs for clinicians at every stage of practice, including:
The post The Most Effective OCD Treatment Reaches Almost No One: Here’s What We Can Do About It appeared first on International OCD Foundation.
Background: Periodontitis is a chronic gum disease affecting approximately 42% of adults aged 30 years and older in the United States. Training dental students to accurately diagnose and manage periodontitis is a critical component of dental education and clinical care. Recent advances in large language models offer new opportunities to support both domains, yet their performance in periodontal diagnosis remains largely unexplored, particularly for newer models such as GPT-5. Objective: This study conducted an exploratory evaluation of GPT-5’s ability to stage and grade periodontitis. Methods: A total of 25 publicly available clinical cases explicitly reporting periodontitis stage and grade were identified through Google and PubMed searches. Each case description was entered into GPT-5 using a zero-shot prompting approach to assess guideline-based reasoning without exemplar conditioning. The model’s predictions were compared with the published reference diagnoses. Performance was measured using accuracy, 95% CI, unweighted Cohen κ, and weighted Cohen κ. Results: Across these cases, GPT-5 showed marked class-dependent performance and a tendency to overestimate disease severity. Grading performance was notably imbalanced, with high recall for grade C but substantially lower discrimination for grade B. GPT-5 achieved a staging accuracy of 68% (95% CI 48.4%-82.8%) and a grading accuracy of 77.3% (95% CI 56.6%-89.9%), with corresponding Cohen κ values of 0.454 (95% CI 11.0%-75.6%) and 0.179 (95% CI −15.8% to 63.8%), respectively. While staging performance showed fair agreement beyond chance, the low κ for grading indicates poor agreement and limited reliability in distinguishing periodontal disease severity. Conclusions: These findings suggest that although GPT-5 demonstrates potential for guideline-based periodontitis staging and grading, its current diagnostic performance, particularly for periodontitis grading, limits its use in clinical assessment and educational training. Meaningful application in periodontal diagnosis and training will require substantial improvements in reliability and rigorous validation in larger, more diverse, and prospectively collected datasets.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/840839ff7cd91d4050f40346f98235a6" />

Although immunoglobulin G (IgG) normally protects the body against pathogens, it can become problematic in many autoimmune diseases like lupus, rheumatoid arthritis, Graves’ disease, myasthenia gravis, and Sjögren’s disease.
“In these conditions, the immune system is creating defective IgGs—called autoantibodies—that are no longer fighting infections,” explained Eric Venker, MD, PharmD, CEO of Immunovant. “Instead, they are attacking a part of your normal functioning body and causing dysfunction.”

Historically, autoimmune conditions have been challenging to treat because therapies like steroids rely on broad immune suppression, noted Leonard L. Dragone, MD, PhD, disease area leader of autoantibody and rheumatology at Johnson & Johnson Innovative Medicine. These non-specific approaches are often inconsistently effective and lead to adverse side effects.
“For many autoimmune diseases, there is a need for more targeted strategies that address disease-causing autoantibodies directly, rather than broadly suppressing the immune system,” emphasized Dragone. Beginning in 1998, the U.S. Food and Drug Administration (FDA) approved infliximab, a tumor necrosis factor (TNF)-α inhibitor, for the treatment of Crohn’s disease. This marked the first approval of a monoclonal antibody for the treatment of a chronic condition. Since then, targeted therapies for autoimmune diseases have expanded to address cytokine signaling pathways (TNF-α, IL-6, IL-17, IL-23), Janus kinase (JAK–STAT) signaling, and immune cell surface markers (CD20).
Another such targeted strategy involves an emerging drug class called FcRn blockers, which are now showing considerable promise in the treatment of certain autoimmune diseases.
FcRn blockers, which typically consist of monoclonal antibodies or antibody fragments, work by blocking the function of a protein receptor called FcRn (neonatal Fc receptor). This prevents IgG recycling, thereby reducing IgG levels in the body.

Venker compares FcRn inhibitors to cholesterol-lowering drugs such as statins. “LDL is the disease-causing agent that healthcare providers target to prevent many cardiovascular diseases. Likewise, in the case of FcRn blockade, we are aiming to lower IgG. We believe that deeper IgG reduction may provide improved results.”
As of early 2026, the FDA has approved three FcRn inhibitors for the treatment of myasthenia gravis, a chronic autoimmune disorder affecting up to 100,000 people in the U.S. Efgartigimod (approved in 2021), rozanolixizumab-noli (approved in 2023), and nipocalimab-aahu (approved in 2025) all work by reducing pathogenic IgGs associated with the disease.

“With FcRn blockers, it is exciting to know that there is now a targeted mechanism for patients around the world with autoimmune diseases caused by an IgG autoantibody,” said Venker.
In Graves’ disease, an IgG autoantibody called thyrotropin receptor antibody (TRAb), which targets the thyroid-stimulating hormone (TSH) receptor of the thyroid, is produced. The condition, which is the most common cause of hyperthyroidism, causes elevated heart rate, shakiness, irritability, muscle weakness, and weight loss.
“TRAb is an IgG antibody, but it is a badly behaving one that is basically hijacking the thyroid system,” noted Venker. “It doesn’t serve any purpose that is normal at all.”

Unfortunately, the toolkit for treating Graves’ disease hasn’t changed much since 1950, when the FDA approved the drug methimazole, said Mark A. Lupo, MD, founder and medical director of the Thyroid & Endocrine Center of Florida.
Methimazole is an anti-thyroid drug that slows down the production of thyroid hormones. Although Graves’ patients benefit from anti-thyroid drugs, Lupo estimates a 50% relapse rate within two years of discontinuing these drugs.
Other options for treating Graves’ disease include surgical removal of the thyroid or the use of radioactive iodine to induce destruction of the thyroid gland. However, these approaches result in permanent hypothyroidism, and patients typically require lifelong thyroid hormone replacement after treatment.
Because TRAb is an IgG, FcRn drugs represent a potential autoimmune solution for Graves’ disease. Like all FcRn blockers, they may work by decreasing TRAb recycling and lowering TRAb levels.
Lupo highlights Immunovant’s recent proof-of-concept study of an FcRn inhibitor for Graves’ disease, the first such study for the condition. “Despite the small number of patients (around 25), the results from this study suggest a potential, durable remission six months off treatment,” said Lupo.
While study participants experienced an increase in total IgG levels following treatment, TRAb levels remained low over a six-month period. The thyroid also decreased in size. “To see TRAb levels down six months off the study drug caught the attention of the endocrine thyroid community,” noted Lupo.
“What was unexpected was that TRAb, the disease-causing antibody, stayed down for many months after stopping the investigational therapy,” added Venker.
“I think we are overdue for a new option in Graves’ disease that could help break some of these methimazole cycles and potentially address not the innocent thyroid gland but the underlying immune system issues,” concluded Lupo.
Venker recalls that safety was an initial concern with FcRn inhibition. After all, these drugs work by reducing IgG, an essential part of the immune system. “Any time you are using an autoimmune drug that potentially suppresses your immune system, you have to think about going too far. Am I going to cause an infection or weaken the immune system?
“So far, this investigational drug has demonstrated a safety profile we expected, and appears positive,” noted Venker. “That makes sense mostly because FcRn blockade is pretty targeted.”
“Although there are no head-to-head comparative safety trials yet, most clinicians and principal investigators view FcRn blockers as relatively safe,” added Lupo. “There are FcRn blockers on the market, and they have demonstrated a good safety record in patients.” The most common side effect tends to involve injection site reactions with either intravenous or subcutaneous delivery.
During pregnancy, maternal antibodies—called alloantibodies—can cross the placenta and attack the organs and tissues of the fetus, explained Dragone.
A distinguishing feature of Johnson & Johnson’s nipocalimab is its pH-independent binding to FcRn. This allows it to bind with high affinity in the placenta, a low-pH environment.
The drug is currently showing potential in the treatment of two alloimmune diseases of pregnancy: hemolytic disease of the fetus and newborn (HDFN) and fetal and neonatal alloimmune thrombocytopenia (FNAIT), said Dragone. These conditions can arise during alloimmunized pregnancies, when the pregnant person’s immune system forms alloantibodies against fetal red blood cells (HDFN) and/or fetal platelets (FNAIT). Importantly, published data on nipocalimab suggest minimal transfer of the drug to the fetus or infant. “Therapies like nipocalimab offer a blueprint for how precision medicine can expand to include pregnant people, a population that has historically been excluded from drug development,” noted Dragone. “Our approach with nipocalimab has the potential to change how we think about treating autoantibody-driven diseases in people of childbearing age.”

The FDA has granted a fast track designation to nipocalimab for both FNAIT and HDFN, and Phase III studies are underway to further investigate the drug in both diseases.
“There are probably 20 trials out there for FcRn blockers, and many are likely to work,” noted Venker. “There are a ton of potential new indications under investigation, including rare diseases that have been ignored historically.”
He notes that Immunovant’s pipeline alone includes potential indications in endocrinology (Graves’ disease), rheumatology (rheumatoid arthritis, Sjögren’s disease, and cutaneous lupus erythematosus), and neurology (myasthenia gravis and chronic inflammatory demyelinating polyneuropathy).
Venker stresses that no FDA-approved solutions exist for Sjögren’s disease, which affects as many as four million Americans. The condition causes severe dry eyes and mouth, fatigue, and joint and muscle pain. Immunovant and Johnson & Johnson are conducting clinical trials to evaluate FcRn blockers for the disease.

Meanwhile, argenx’s FcRn inhibitor efgartigimod has been used in 19,000 people worldwide for myasthenia gravis and other autoimmune conditions, said Hani Houshyar, PhD, FcRn asset strategy lead for argenx.
“However, we believe myasthenia gravis is just the beginning,” she said. As of 2026, the company has active clinical trials to test the drug’s effectiveness in additional autoimmune diseases with high unmet medical need, like myositis, Sjögren’s disease, ocular myasthenia gravis, systemic sclerosis, Graves’ disease, and autoimmune encephalitis.
UCB’s rozanolixizumab was the first FcRn blocker to be approved for the treatment of generalized myasthenia gravis in adults who are positive for anti-AChR or anti-MuSK antibodies, who together account for approximately 90% of cases, said Omar Sinno, MD, UCB’s U.S. medical strategy lead of rare disease. So far, the drug has been approved in the U.S., Canada, the EU, Australia, Switzerland, China, Turkey, and Korea.

Rozanolixizumab is administered via a convenient subcutaneous infusion rather than intravenously. The company’s long-term studies demonstrate robust IgG reductions (up to 75%) with sustained benefit across multiple treatment cycles. UCB is also investigating rozanolixizumab as a potential treatment for a rare autoimmune condition called myelin oligodendrocyte glycoprotein antibody-associated disease.
Finally, Johnson & Johnson’s nipocalimab is in mid-to-late-stage studies for Sjögren’s disease, lupus, warm autoimmune hemolytic anemia, and chronic inflammatory demyelinating polyneuropathy.
Viridian Therapeutics is currently investigating two FcRn inhibitors, VRDN-006 and VRDN-008, said Steve Mahoney, president and CEO. Both candidates are designed as subcutaneous products that can be conveniently self-administered by the patient.

VRDN-006 is an Fc fragment in Phase I trials, while VRDN-008 is made up of an Fc fragment and an albumin-binding domain designed to prolong IgG suppression. Mahoney notes that VRDN-008 showed a longer half-life and more sustained IgG reduction than efgartigimod in a high-dose, head-to-head study in non-human primates.
Clinical trial results of VRDN-008 in healthy volunteers are expected later in 2026. “What we believe differentiates VRDN-008 from other FcRn inhibitors is a longer half-life, which has the potential to support less frequent dosing for patients to enhance convenience,” said Mahoney.
Although three FcRn blockers are currently FDA-approved to treat myasthenia gravis in the U.S., Venker notes that Immunovant is continuing to investigate the condition with the company’s follow-on FcRn candidate, imeroprubart (IMVT-1402).
In Immunovant’s proof-of-concept study for Graves’ disease, TRAb stayed low even six months after the investigational treatment was discontinued. But how long will this effect last? “We don’t know that yet because our randomized trials with IMVT-1402 are ongoing,” Venker said. “However, Graves’ disease has given us the first hint that FcRn drugs may be able to put certain autoimmune conditions into permanent remission.”

“A key question for autoimmune disease, the holy grail, so to speak, is whether we can reset the immune system so the person can function normally without medication for the rest of their lives,” he added.
Finally, argenx is developing ARGX-213, a next-generation FcRn inhibitor engineered to extend half-life and sustain IgG reduction.
“Looking ahead, FcRn inhibition represents an increasingly important approach across IgG-driven disease,” noted Sinno. “By selectively reducing pathogenic IgG, these agents enable more targeted autoimmune care. And as clinical experience with FcRn inhibition grows, treatment paradigms may shift toward earlier intervention.”
Tiffany Yesavage, PhD is a freelance writer from Denver, Colorado.
The post FcRn Inhibition in Autoimmune Disease appeared first on Inside Precision Medicine.

As a postdoctoral researcher at the University of Pennsylvania, Haijiao Liu, PhD, helped advance tumor-on-a-chip technology, a feat of bioengineering that mimics the microenvironment of malignant human tumors. Led by Dan Dongeun Huh, PhD, a Penn Engineering professor and trailblazer of organ-on-a-chip technology, Liu and his team explanted lung adenocarcinoma tumors onto the transparent chips to test their perfusion with chimeric antigen receptor (CAR) T cells. Their findings were published in October in Nature Biotechnology, with Liu as first author.
Now on paternity leave in Toronto, Liu spoke with Lindsey Leake about the implications of this work, the challenges inherent to tumor-on-a-chip studies, and his plans to launch a lab of his own this fall.
Q: Walk me through the creation of the tumor-on-a-chip. What went into its design?
Haijiao Liu: It’s essentially inspired by the need for alternative tumor models. This is speaking to the traditionally used animal tumor models and some existing in vitro tumor models, especially for the study of immunotherapies.
For example, when I started at Penn around 2018, Penn Medicine was pioneering this immunotherapy called CAR T-cell therapy, which is basically aiming to harness the patient’s own immune system, specifically the patient’s own T cells, to help fight the cancer. Penn Medicine was demonstrating huge clinical success using this CAR T therapy to treat blood cancers, such as leukemias and lymphomas. In a huge contrast to this, the solid cancer arena has seen a limited response from this new immunotherapy. So there’s this great need to study why this has not been successful, and that comes down to the consensus that the solid tumor has this really complex microenvironment.
In the category called tumor-on-a-chip, people try to control the cultural environment, the biochemical and biophysical environment of tumor cell cultures. We can use this for simple drug testing—see how the tumor growth will be affected or how effectively they can be killed. However, these existing tumor-on-chip or in vitro tumor models are still very simple. They don’t usually recreate or reproduce the complex structure of the human solid tumors that I described, like where they often include complex vessel networks.
I took the lead to address the need and the challenges of reproducing and then investigating, or probing, the dynamic interactions between those CAR T cells and human solid tumors entirely in vitro.
Q: How does the vascularization work on the chip?
Liu: It took several years to start, from the idea of building this more advanced tumor-on-a-chip technology toward proving it’s actually useful. I started by focusing on this one aspect, which is the CAR T-cell trafficking and their functions after they traffic to fight the tumors, and that will involve the recreation of the structural interface between the tumor and this complex vascular network that’s present in human tumors.
I was inspired by in vivo tumor transplantation, where traditionally, people take human tumors and then transplant them in a bulk, intact format into animal models. So my idea was, if we want to focus more on the human biology, if we want to engineer this entirely in vitro, how about we design a vascular bedding, like a miniature living model?
We basically took advantage of the self-assembly capability of human-sourced endothelial cells, combined with certain stromal fibroblasts, or stromal cells. With a bit of optimization, engineering, tweaking, then we can allow them to form capillary-like vascular networks in our engineered models.
Q: What are the advantages of recreating the tumor microenvironment in this way? That is, is the Petri dish becoming obsolete in cancer research?
Liu: The unique advantage of this way of engineering is to have a higher level of control over the structures of the tissue-tissue interface that we can build. For example, we can engineer different culture chambers. We can engineer different access windows with this model. That allows us to construct, step by step, the vascular bedding and then the tumor transplantation. Also, by forming these perfusable vessels—by the way, we can provide the infusion and flow of the CAR T cells, just like they are infused and flow in the patient—that gives us the leverage to reconstruct, probe, and then control these tissue functions in a highly precise manner.
Q: How did you and your colleagues at Penn explore CAR T-cell activity on the chip?
Liu: We first used different functional assays, like immunostaining and ELISA (enzyme-linked immunosorbent assay) assays, to characterize how the CAR T cells are doing and how they are interacting with the tumors in our engineered model. Then we disassembled this engineered tissue to extract all the cells for flow cytometry, to further characterize their functional phenotypes.
With the help of our collaborators and other people in the lab, I took advantage of this engineered model of vascular tumors interacting with CAR T cells for multi-omics analysis. For example, I was able to extract all the cells and send them for single-cell RNA seq[uencing]. We were able to look at the gene expressions of each individual cell from all the cell types that we included in this model. In this way, we have almost like a superpower to probe and read into how each cell—including the CAR Ts and tumors and the vessels—how they are responding and interacting with each other at the molecular gene levels. This is so powerful that it helped me to discover novel interactions between these parties and also new druggable targets.
The message is that through the development of this more advanced tumor-on-a-chip technology—combined with advanced multi-omics analytics and advanced computational analysis—we were able to provide this powerful in vitro technology to apply to accelerate the development of cell therapies, such as the CAR T immunotherapies for cancer, but also other complex diseases.
Q: What are the overall implications of this latest research?
Liu: With a growing understanding of human biology at the cellular and tissue levels, I think we’re seeing that our ability to engineer and design biological systems is also growing. More than ever, we have these advances in the ability to precisely construct, investigate, and then eventually control very complex tissue functions, and even organ functions. For example, our demonstrated tumor-on-a-chip technology is like presenting a miniature sandbox; we can literally see and predict the battlefield of CAR T therapy in cancer.
If we combine these advanced engineering technologies with emerging technologies in spatial multi-omics and the unprecedented productivity of the AI revolution, we will be able to accelerate the understanding of more complex human biology and extract more biological insights, and then apply that to accelerate the development of safer and more efficacious drugs and therapies, such as immunotherapies in cancer.
Q: What are the limitations of organ-on-chip technology that need to be overcome?
Liu: I think there are challenges on two fronts. The first limitation is the lack of complexity. We’re claiming that what we just published is a sufficiently complex system for us to deeply probe and understand the dynamics of CAR T tumor interactions. Still, if we’re speaking next level of translational power or potential, then we need to pursue a higher complexity that incorporates the missing but critical components from in vivo.
The other side of the coin is that if you make this engineered model more complex, you make it more challenging to reproduce or to scale up or to translate to other labs. But also, that points to an opportunity and growing room for translation, to standardize every single step, from the construction to the analysis of these engineered models, and to automate these processes as much as possible.
Q: What do you envision for your new lab?
Liu: I have a lot of things I want to do. I’m eager to establish my own team. The overarching and the unifying theme of the new lab will be to develop the next generation of in vitro complex tissue models, or I call it assembloid tissue models. Assembloid basically means there’s a stem cell-based, three-dimensional complex tissue model that intentionally incorporates different cell types, to emulate the critical tissue-tissue interactions that determine the tissue- and organ-level functions. I still need to make a big decision where the lab could be; it could be in Canada and it could also be in China.
Q: What impact might tumors-on-a-chip have on the future of precision medicine?
Liu: It’s attracting a lot of attention from biologists and clinicians who are heavily focused on using the traditional tissue models—animal models, for example, or the simple dish cultures—for their studies of interest. So the biggest impact I can foresee with our technology is that now it’s more mature. I can see it being gradually, and maybe quickly, adapted into more traditional biological labs, to help them dissect the complex biological questions they’re asking, or to accelerate the evaluation of the exciting new drugs or therapies they’re developing. Overall, I can see that accelerate this development pipeline of new drugs and therapies in precision medicine.
Lindsey Leake is an award-winning, independent health reporter based outside Washington, D.C. She spent 15 years as a staff journalist at outlets including Fortune, the USA TODAY Network and Sinclair Broadcast Group. She holds an MA in Science Writing from Johns Hopkins University, an MA in Journalism and Digital Storytelling from American University and a BA from Princeton University.
The post In Conversation with Haijiao Liu, PhD appeared first on Inside Precision Medicine.
Studying sexually transmitted infections (STIs) has long been constrained by a fundamental problem: the available models fail to fully capture the complexity of the human body. Traditional cell cultures oversimplify biology, while animal models often do not accurately reflect human infection dynamics.
Now, scientists at the University of Maryland School of Medicine and collaborators have developed the first immune-capable “cervix-on-a-chip,” a microengineered system that recreates the human cervical environment with unprecedented realism. The work, published in Science Advances, could significantly accelerate the development of new treatments and prevention strategies for STIs.
STIs remain a major global health burden. According to the World Health Organization, nearly one million new infections occur every day worldwide, with chlamydia alone accounting for roughly 129 million cases annually. In the United States, chlamydia and gonorrhea together generate an estimated $1 billion in direct medical costs each year.
Beyond their prevalence, these infections can lead to serious complications, particularly in women, including infertility, pelvic inflammatory disease, and adverse pregnancy outcomes.
Despite this, researchers have struggled to study how infections develop and progress in the human cervix, a key site of infection, under realistic conditions.
“This new model will revolutionize how scientists study STIs,” said Jacques Ravel, PhD, co-lead author of the study. “By integrating engineering, microbiology, immunology, and microbiome science, we were able to build a model that more closely reflects human biology and the complexity of the cervical microenvironment.”
The newly developed system belongs to a class of technologies known as organ-on-a-chip models, or microphysiological systems. These platforms are designed to mimic the structure and function of human tissues using living cells and controlled physical environments.
In this case, the researchers constructed a miniature model of the cervix using human cervical epithelial cells layered on a porous membrane, with supportive tissue cells beneath. Fluids flow across both sides of the membrane, replicating the dynamic conditions found in the body.
The model also incorporates immune cells and microbial communities, allowing scientists to study how these components interact during infection.
“A key goal was to develop a complex model system that is both practical and accessible,” said Jason Gleghorn, PhD, who led the model development. “The need for this model was particularly critical for studying the vaginal microbiome, which we know plays an important role in susceptibility to STIs.”
One of the defining features of the cervix-on-a-chip is its ability to include different types of vaginal microbiomes, something that has been difficult to replicate in previous models.
The researchers tested the system using two of the most common STIs: chlamydia (Chlamydia trachomatis) and gonorrhea (Neisseria gonorrhoeae). They found that the outcome of infection depended strongly on the type of microbiome present.
In models dominated by Lactobacillus crispatus, a bacterial species commonly associated with vaginal health, infections were significantly limited. In contrast, when less protective microbiomes were introduced, infections became more severe.
“One of the most exciting findings was that just like in women, protective microbiomes dominated by Lactobacillus crispatus limited infection in the model,” Ravel said. “In contrast, when we introduced ‘nonoptimal’ microbiomes, infections worsened.”
These results reinforce growing evidence that the vaginal microbiome plays a central role in determining susceptibility to STIs.
Beyond improving understanding, the new model provides a practical platform for testing potential therapies.
Because it closely mimics human biology, the cervix-on-a-chip can be used to evaluate new treatments under realistic conditions. This includes not only traditional antimicrobial drugs but also emerging approaches such as probiotics and live biotherapeutics designed to restore protective microbiomes.
“This model provides a powerful new tool to develop faster, more effective, and personalized treatments,” Ravel said. “For the first time, we can simulate what happens in the human body rather than relying solely on petri dish systems or inadequate animal models.”
The implications of the technology extend beyond the infections tested in the study. The cervix-on-a-chip could be adapted to study a wide range of pathogens, as well as broader questions about reproductive health, inflammation, and host–microbe interactions.
The researchers emphasized accessibility in the model’s design, aiming to make it usable by scientists outside of specialized bioengineering labs. This could accelerate adoption and expand its impact across the field.
The development of immune-capable organ-on-a-chip systems represents a broader shift in biomedical research toward more human-relevant experimental models. By integrating multiple components of human biology—cells, tissues, immune responses, and microbiomes—these systems offer a more accurate view of disease processes.
In the context of STIs, where subtle interactions between host and microbes can determine outcomes, such realism is particularly valuable.
As researchers continue to refine these platforms, they may help bridge the gap between laboratory studies and real-world biology—ultimately enabling earlier, more precise, and more effective interventions.
For now, the cervix-on-a-chip marks a significant step forward, providing scientists with a tool that captures the complexity of the human cervix in a way that was previously out of reach.
The post ‘Cervix-on-a-Chip’ Brings STI Research Closer to Real Human Biology appeared first on Inside Precision Medicine.
Central nervous system (CNS) treatments are having a major comeback. These five precision medicine players plan to ride the resurgence.
After a decade of stagnation, the CNS space is seeing a revival in sales and R&D spending as the market was last year projected to surpass $80 billion for the first time since 2013 and hit around $127 billion.
Recent landmark approvals have brought attention back to the CNS, including the U.S. Food and Drug Administration (FDA)’s greenlight of Eisai/Biogen’s lecanemab (Leqembi) for the treatment of Alzheimer’s disease in 2023, and the FDA approval of Bristol-Myers Squibb’s schizophrenia treatment xanomeline/trospium chloride (Cobenfy) in 2024.
At the same time, Johnson & Johnson’s depression treatment, esketamine (Spravato), is on its way to blockbuster status, showcasing the growth potential of the CNS market.
These successes accompany an emerging shift in psychiatry clinical trials from subjective rating scales to more objective endpoints, including digital and physiological measures, with the potential to better tailor treatments to a patient’s biological makeup.
Startups and scaleups are attracting increasing investor attention for their potential to change the way we treat CNS conditions. Check out our list of the most exciting companies that have netted the biggest investor dollars.
Founded: 2025 | Headquarters: Dublin, Ireland
Aerska’s name is derived from an Irish proverb stating that people survive in each other’s shelter, emphasising the strength of its team.
This team includes co-founder Jack O’Meara, previously co-founder of the liver-focused RNA interference (RNAi) biotech Ochre Bio, who is driven by the experience of loved ones suffering from Alzheimer’s disease.
Aerska is developing RNAi therapies for neurodegenerative conditions, including Parkinson’s and Alzheimer’s disease.
While there are already FDA-approved RNAi therapies on the market, such as Alnylam’s patisiran (Onpattro), these are typically focused on liver and cardiometabolic conditions rather than the CNS.
Aerska’s technology consists of antibody “brain shuttles” that bind to proteins on the blood-brain barrier (BBB). They then carry a payload RNA into the brain.
The payload, which is designed based on data-driven patient stratification and disease biomarkers, then silences specific genes driving the disease.
Aerska has already raised $60 million since its launch, including a $21 million seed round in October 2025 and a $39 million Series A round in February 2026, co-led by EQT Life Sciences and age1.
The company, which has research operations in the U.K., is using the latest funding to drive its pipeline programs toward clinical testing.
Founded: 2019 | Headquarters: Boston, Massachusetts, U.S.
Beacon Biosignals was co-founded by a team including its CEO—MIT neuroscientist Jacob Donoghue, MD, PhD—and its CTO, the machine learning researcher Jarrett Revels.
Boasting more than 100 employees, the company’s goal is to provide objective biomarkers in drug development that neurology and psychiatry have traditionally lacked compared with other areas of precision medicine.
Its FDA-cleared Waveband device measures the brain’s activity, known as electroencephalography (EEG), while patients sleep at home. The EEG data is then stored, quality-controlled, and fed into AI models that can guide the design of clinical trials.
For example, Beacon’s EEG data can identify patients with Alzheimer’s disease who have worse outcomes and might need a more targeted treatment or a different clinical trial than other patients.
Beacon raised $27 million in a Series A round in 2021 and an oversubscribed Series B round worth $86 million in November 2025.
The B round, which included investors such as Innoviva, Google Ventures, and Nexus NeuroTech, will help the startup to accelerate the discovery of neurobiomarkers and broaden clinical adoption of the technology.
Beacon acquired the French sleep monitoring company Dreem in 2023 to access its monitoring data and headband technology. Beacon then acquired the Ohio-based CleveMed in April 2025 to harness technology measuring breathing, oxygen, and other signals.
Founded: 2010 | Headquarters: Oxford, U.K.
Brainomix was founded by a team including CEO Michalis Papadakis, PhD, who was scientific director of the preclinical stroke lab at the University of Oxford.
Brainomix is dedicated to speeding up patient care in cases of stroke, where speedy treatment is key.
Brainomix’s flagship product, Brainomix 360 Stroke, is designed to harness AI to interpret brain scans and detect blood clots in patients with stroke, speeding up clinical decision-making.
The product involves a group of tools that automatically analyze images, including results from computed tomography (CT), CT angiography, magnetic resonance imaging (MRI), and CT perfusion.
Brainomix’s technology doubled the rate of thrombectomy treatment in patients with stroke and reduced hospital triage and transfer delays, according to a 2025 study.
The University of Oxford spinout is at a commercial stage, with operations in more than 20 countries, and is expanding into the U.S.
Brainomix raised a $21.2 million Series B round in 2021 and extended its Series C round from $6.5 million in March 2025 to $25.4 million in February 2026, with leading investors including Parkwalk Advisors and Hostplus. The proceeds will fuel the company’s expansion into the U.S. market.
Brainomix has also partnered with heavyweights, including Nvidia, Boehringer Ingelheim, Medtronic, and GE Healthcare.
Brainomix also has a product dedicated to disease monitoring in pulmonary fibrosis.
Founded: 2021 | Headquarters: San Diego, California, U.S.
Circular Genomics was spun out of the University of New Mexico, with its founders including CSO Nikolaos Mellios, PhD, and Alexander Hafez, PhD.
The company later moved its headquarters from Albuquerque to San Diego in March 2025 to access scientific and operational know-how from Eli Lilly at Lilly Gateway Labs.
Circular Genomics aims to equip medical professionals with a blood test to detect CNS conditions early, in addition to stratifying and guiding the treatment of patients.
Its technology involves using a polymerase chain reaction (PCR) test of a patient’s blood sample to screen for specific circular RNA molecules produced in the brain that can cross into the blood and be measured as a biomarker of disease in the CNS.
Commercially launched in 2024, Circular Genomics’ MindLight SSRI Antidepressant Response Test predicts whether a patient will benefit from common antidepressants called SSRIs with around 77% accuracy. This is designed to predict a patient’s most suitable antidepressants without needing months of trial-and-error approaches.
The company is applying its technology in Alzheimer’s disease, where the approvals of disease-modifying therapies such as Leqembi have led to demand for tests that can detect the disease at earlier stages than traditional tests.
Circular Genomics raised $15 million in a Mountain Group Partners-led Series A round in December 2025 to finance the development of its technology and expansion of its technology in Alzheimer’s disease.
The company also has its sights on other CNS conditions, including multiple sclerosis and Parkinson’s disease.
Founded: 2019 | Headquarters: Sydney, Australia
Omniscient (o8t)’s founders include CMO Michael Sughrue, MD, a neurosurgeon aiming to improve anatomy maps for other surgeons, and machine learning expert Stephane Doyen, PhD.
o8t’s FDA-approved product Quicktome involves using a patient’s MRI brain scans and AI models to map out a patient’s brain circuitry. These maps, accessible from an electronic tablet, can guide surgery to minimize the risk of brain damage compared to using a generalized anatomical diagram.
Quicktome is already in use at major hospitals around the world, including major centers in the U.S. Its partners include U.S. surgical support firm META Dynamic and the U.S. medical device innovation center, The Jacobs Institute.
o8t has raised more than $60 million, and bagged $14 million (AUD 20 million) in January 2026 as part of a Series D round targeted to reach $25 million (AUD 36 million). The round was led by Australia’s National Reconstruction Fund (NRFC) and OIF Ventures, with the aim of keeping the company based in Australia.
The funding is earmarked to fuel the development and commercialization of Quicktome, and grow o8t’s Australian workforce by more than 40. The company also has operations in Atlanta, Georgia, U.S.
o8t also plans to expand the technology into high-growth markets, including brain computer interface targeting, stroke and traumatic brain injury.
Jonathan Smith, PhD, is a freelance science journalist based in the U.K. and Spain. He previously worked in Berlin as a reporter and news editor at Labiotech, a website covering the biotech industry. Prior to this, he completed a PhD in behavioral neurobiology at the University of Leicester and freelanced for the U.K. organizations Research Media and Society of Experimental Biology. He has also written for medwireNews, Biopharma Reporter, and Outsourcing Pharma.
The post Top 5 Firms Engineering Healthcare in the CNS Space appeared first on Inside Precision Medicine.
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on cups of stimulation. Our choice today is laced with traces of cocoa. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today and, of course, do keep in touch. …
In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the U.S. Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late, STAT explains. The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.
Americans starting weight loss medicines for the first time want lower cost and greater convenience as they consider pills from Novo Nordisk and Eli Lilly, Reuters says, citing seven doctors who specialize in obesity. Novo’s Wegovy pill has been on the market since January, while Lilly’s newly approved Foundayo joins the fray this week. Interviews with the specialists show a promising landscape for oral weight loss drugs as the companies compete for share in the fast-changing obesity treatment market that is seen topping $100 billion a year in the next decade. All seven doctors said they had begun prescribing oral Wegovy, and three said they have prescribed the pill to about 10% of their patients. Of those patients, most are taking a GLP-1 for the first time, rather than switching from injectables, and have not yet reached the highest dose.