Anaxiom Reports Initial First-in-Human Clinical Results for Novel Minimally Invasive Obesity Device, Progresses Toward U.S. Early Feasibility Study
Anaxiom Corporation, a clinical-stage innovator focused on developing minimally invasive solutions for obesity treatment, has announced the successful completion of a 12-patient clinical study conducted outside the United States. The early-stage investigation marks an important milestone for the company as it advances its novel, non-surgical therapy toward further clinical validation, including a planned U.S. Early Feasibility Study.
The study represents one of the first clinical evaluations of the company’s proprietary device, designed to address obesity through a fundamentally different approach compared to existing therapies. According to the company, all 12 patients enrolled in the study were successfully treated, with no reported device-related serious adverse events. This outcome underscores a favorable early safety profile, which is a critical benchmark for emerging interventional technologies at this stage of development.
Beyond safety, preliminary findings from the study also suggest encouraging signals of clinical benefit. Patients experienced a noticeable reduction in appetite, alongside improvements in overall health indicators. While the dataset remains small and early, these results provide initial support for the therapeutic concept and lay the groundwork for larger, more comprehensive trials in the future.
The procedures were performed using well-established endovascular techniques, a factor that may help facilitate broader adoption if the technology continues to demonstrate safety and efficacy. Joggy George, an interventional cardiologist affiliated with Texas Heart Institute, participated in several of the cases and highlighted the practicality of the approach. He noted that the procedure integrates smoothly into standard catheter-based workflows commonly used by interventional cardiologists.
According to Dr. George, the familiarity of the technique is a key advantage, as similar catheter-based interventions are already routinely performed in cardiac care settings. This familiarity could potentially reduce the learning curve for physicians and accelerate the integration of the device into clinical practice if it receives regulatory approval. He also emphasized that early patient responses have been promising, suggesting that the therapy could evolve into a valuable non-surgical option for managing obesity.
At the center of this innovation is the AVOS™ system, an implantable device delivered via catheter. Unlike traditional bariatric surgery or pharmacological treatments, this technology targets the physiological mechanisms that regulate hunger. Specifically, the device is positioned endovascularly at the ostium of the celiac artery, a key vessel supplying blood to the stomach.
By modulating blood flow to specific regions of the stomach involved in hormonal signaling, the device is designed to influence the production of Ghrelin, often referred to as the “hunger hormone.” Ghrelin plays a central role in appetite regulation, signaling the brain to stimulate hunger. By reducing ghrelin production, the AVOS™ system aims to decrease appetite, thereby supporting sustained weight loss over time.
This mechanism represents a novel therapeutic pathway in obesity management. Rather than directly altering the anatomy of the digestive system, as in bariatric surgery, or relying on systemic drug effects, as with pharmacotherapy, the device seeks to replicate certain natural physiological conditions associated with reduced hunger and weight loss. This targeted approach may offer a more balanced risk-benefit profile for certain patient populations.
The procedure itself is designed to be minimally invasive. It is performed under conscious sedation, eliminating the need for general anesthesia in most cases. Using standard interventional tools and imaging guidance, physicians can deliver and deploy the device through a catheter-based approach. The company anticipates that, in the future, the procedure could be conducted in outpatient surgical centers, further improving accessibility and reducing healthcare system burden. The expected procedure time is approximately one hour, which is relatively short compared to many surgical weight-loss interventions.
Reynolds Delgado, a cardiologist at Baylor St. Luke’s Medical Center, also provided insight into the clinical significance of the technology. He described the early findings as encouraging evidence supporting a minimally invasive strategy for obesity management. According to Dr. Delgado, the device’s ability to modulate blood flow through the celiac artery in a controlled manner mirrors certain physiological states known to promote weight reduction, reinforcing the scientific rationale behind the approach.
From a broader perspective, the development of this technology comes at a time when the global burden of obesity continues to rise, creating an urgent need for diverse and scalable treatment options. Current interventions, including lifestyle modifications, medications and bariatric surgery, each have limitations. Pharmacologic therapies often require long-term adherence and may carry side effects, while surgical options, though effective, are invasive and not suitable for all patients.
Against this backdrop, minimally invasive device-based therapies are gaining attention as a potential middle ground. By offering meaningful weight loss without the need for major surgery or lifelong medication, such technologies could fill a critical gap in the treatment landscape.
Hakon Bergheim, President and Chief Executive Officer of Anaxiom Corporation, emphasized the broader implications of the study results. He described the early data as highly encouraging and indicative of a significant opportunity to redefine obesity treatment. According to Bergheim, the company’s platform has the potential to transform the current paradigm by providing a non-surgical alternative that avoids the need for continuous drug therapy or invasive procedures.
He also noted that the company is building on this early momentum as it prepares for the next phase of clinical development in the United States. The planned Early Feasibility Study will be an important step in evaluating the device under U.S. regulatory standards and expanding the evidence base needed for future pivotal trials.
While the initial results are promising, it is important to recognize that larger studies with longer follow-up periods will be necessary to fully establish the safety, durability and effectiveness of the therapy. Questions related to long-term weight loss outcomes, potential device-related complications and patient selection criteria will need to be addressed through rigorous clinical investigation.
Nonetheless, the successful completion of this first-in-human study marks a meaningful advance for Anaxiom and highlights the growing role of innovation in addressing complex chronic conditions like obesity. As the company moves forward with its clinical program, stakeholders across the healthcare ecosystem will be watching closely to see whether this novel approach can deliver on its early promise and contribute to a more diverse and effective set of treatment options for patients worldwide.
About Anaxiom Corporation
Anaxiom Corporation (www.anaxiomcorp.com) is focused on developing innovative, minimally invasive therapies to treat obesity and metabolic disease. Its proprietary platform targets physiological pathways involved in appetite regulation using a novel endovascular approach. The company is committed to advancing safe, effective, and accessible solutions to improve patient outcomes worldwide. Anaxiom is a Fjord Ventures portfolio company.
Source Link:https://www.businesswire.com/
