Addressing Procedural Challenges in Interventional EUS: KOEDA™ Endoscopic Anchor System Featured at Major Congresses

The KOEDA™ System is designed to provide temporary tissue approximation and stabilization during interventional endoscopic ultrasound (EUS) procedures. Its defining innovation is a compact anchor deployed in a single step through a dedicated 19-gauge needle prior to therapeutic device placement. This mechanism is particularly beneficial when mobile organs or tissue structures require precise alignment during critical procedural steps. At recent congresses, prospective applications in EUS-guided gallbladder drainage (EUS-GBD) and EUS-guided gastrojejunostomy (EUS-GJ) drew substantial interest, inspiring discussion on additional clinical scenarios that could benefit from this technology. By securing mobile tissue upfront, the system targets a core vulnerability in complex interventional EUS.

KOEDA's EUS-GJ animal data were presented at DDW and ESGE Days respectively; and the focus at the JGES was on the EUS-GBD development concept;

DDW and ESGE Days: Preclinical EUS-GJ Findings

At DDW, the poster presentation highlighted the EUS-GJ device concept, deployment sequence, and feasibility data. The nitinol anchor—available in 20 mm and 30 mm lengths—was pre-loaded into a dedicated 19-gauge needle. Following puncture of the saline-distended jejunum, stylet advancement deployed the distal arms. Subsequent needle withdrawal achieved approximation of the jejunal and gastric walls prior to placing an electrocautery-enhanced lumen-apposing metal stent. Successful retrieval using a standard polypectomy snare was also demonstrated.

At ESGE Days, the study was presented as a structured scientific abstract. In a five-swine live model, deployment was 100% successful, with anchor retention confirmed upon necropsy. The mean time from needle puncture to anchor deployment was 57 seconds (range: 34–85 seconds).

JGES: Development Focus on EUS-guided Gallbladder Drainage

At JGES, Dr. Okuzono presented KOEDA’s work on EUS-guided gallbladder drainage (EUS-GBD), a procedure where the gallbladder is accessed under EUS guidance for internal drainage. The core development rationale is to approximate and stabilize the gastric and gallbladder walls before subsequent device placement, offering enhanced control when precise tissue positioning is critical.

The presentation introduced this concept to a specialist Japanese audience highly experienced in advanced biliary interventions. A central clinical question addressed was whether controlled fixation can improve procedural reliability without introducing undue complexity or risk.

From a development perspective, the JGES discussion highlighted the rigorous effort required to translate an anchoring concept into a testable medical device—establishing a defined indication, a clear procedural role, and endpoints capable of evaluating safety and efficacy. This targeted approach maintains a precise scientific narrative while demonstrating how a core technical principle can be evaluated across multiple clinical applications.

The congress discussions reinforced the clinical relevance of controlled tissue approximation and identified post-Roux-en-Y anatomy as a promising field for further investigation.

KOEDA Secures Pre-Series A Funding to Advance Pivotal Trials and Commercialization

Funding the Next Stage of Execution

In March 2026, KOEDA secured a pre-Series A capital raise through a third-party allotment. Mitsubishi UFJ Capital (MUCAP) joined as a new investor alongside a JPY 100 million follow-on investment from existing partner Tohoku University Venture Partners (THVP). This funding bridges the gap between early clinical work and the infrastructure required for commercial expansion.

"We would like to extend our sincere appreciation to our investors for their trust and continued support." 

— Mike Yagi, Managing Director and COO, KOEDA Inc.

Advancing Toward a Domestic Pivotal Trial

KOEDA is developing the KOEDA™ Endoscopic Anchor System, designed to stabilize target tissues during interventional EUS procedures such as EUS-GBD and EUS-GJ. Following a successful 2025 first-in-human exploratory trial for acute cholecystitis, the company’s immediate objective is a domestic pivotal trial to generate robust, structured evidence for Japanese manufacturing, marketing approval, and national health insurance reimbursement.

Strengthening Quality and Regulatory Readiness

The project has continued to benefit from complementary expertise and practical perspectives throughout its development, combining clinical understanding with engineering know-how to refine both the device and its intended applications.

Global Expansion and the 2030 Launch

Beyond Japan, the financing funds preparations for U.S. FDA approval, global market entry, and commercialization strategies—including supply chain planning and clinician education—toward a planned 2030 launch.

"We have just closed a new round of investment. The focus now is execution." 

— Yukio Nakajima, Director & Co-Founder, R&D & Global Business, KOEDA Inc.

Reference

1. IT Business Today Article

Estimated reading time: 4 minutes

Advancing EUS-Guided Gallbladder Drainage: Insights from the Spanish Pre-Clinical Program

EUS-Guided Gallbladder Drainage Matters

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) creates a drainage route between the GI tract and the gallbladder under ultrasound guidance, serving as an alternative for nonsurgical candidates. Due to its technical complexity, organizations like the European Society of Gastrointestinal Endoscopy emphasize appropriate training, experience, and multidisciplinary expertise. This demanding clinical context makes pre-clinical evaluation essential for exploring new concepts under realistic conditions.

A Two-Day Program for Practical Evaluation

Initiated and led by Prof. Manuel Pérez-Miranda in Spain, a specialized two-day program brought together experienced physicians for lectures and hands-on in vivo sessions to evaluate the KOEDA™ System. This format allowed theoretical discussions and practical observations to directly inform one another, bridging real procedural challenges with technical development.

Assessing Workflow Relevance

The program focused purely on concept evaluation and clinical handling rather than establishing clinical safety or effectiveness. Such pre-clinical work is vital for refining research questions, setting development priorities, and generating structured insights to shape future investigations. Prof. Pérez-Miranda plans to publish the findings, providing a detailed platform for scientific assessment.

Yukio Nakajima

Director & Co-Founder, R&D & Global Business, Koeda Inc.:

"After the hands-on evaluation, how would you describe your overall impression of the KOEDA system?"

Prof. Manuel Perez-Miranda:

“The (KOEDA) stent and anchor clearly perform better than a conventional 5- or 7-French plastic stent with a standard delivery system. Seeing this confirmed in a different endoscopy setting outside of your institution is a significant step forward.”

Clinical Takeaway

The Spanish pre-clinical program provided a valuable, structured setting to test the KOEDA™ System within the EUS-GBD workflow.

Where Clinical Insight Meets Advanced Engineering

From Clinical Challenge to Innovation

For more than 20 years, Toru Okuzono, MD, PhD, Director of Gastrointestinal Medicine at Sendai Kosei Hospital, Sendai, Japan, has dedicated his career to advancing therapeutic endoscopy. Throughout the evolution of endoscopic ultrasound (EUS), he has witnessed the field transform from a diagnostic technique into an advanced therapeutic platform.

The introduction of lumen-apposing metal stents (LAMS) has opened new treatment options for patients requiring minimally invasive procedures such as EUS-guided gastrojejunostomy (EUS-GJ) and EUS-guided gallbladder drainage (EUS-GBD). However, clinical practice has also shown that certain procedural steps remain technically demanding. Achieving stable tissue apposition and maintaining precise control during the critical stages of these interventions can continue to present challenges, even for experienced endoscopists.

Rather than accepting these procedural difficulties as an inherent part of therapeutic EUS, Dr. Okuzono became convinced that a different technical approach was needed.

"I was fascinated by the potential of EUS and LAMS to reduce the burden of surgery for patients. But despite continuous refinement of my own technique, I realized that these limitations were not operator-dependent—but required a technical solution."

This realization marked the beginning of KOEDA.

From Insight to a New Technical Principle

Instead of asking physicians to overcome procedural challenges through greater manual skill, Dr. Okuzono envisioned a dedicated endoscopic anchoring system to ensure precise organ fixation.

Combining clinical insight with advanced engineering, the project utilized nitinol—leveraging its unique shape-memory characteristics and elasticity—to engineer a mechanism small enough for delivery through a standard 19-gauge EUS needle while providing reliable post-deployment fixation.

"I therefore challenged myself to find a better approach and began working on a way to bring more control and precision into organ fixation in these procedures."

The resulting KOEDA™️ Endoscopic Anchor System is designed to support controlled organ fixation during select EUS-guided interventions.

Multidisciplinary Collaboration and Scientific Exchange

Transforming this concept into a medical device required cross-functional expertise. Dr. Okuzono assembled a team of specialists spanning engineering, product development, regulatory affairs, and commercialization.

Furthermore, the system has been continuously refined through rigorous dialogue, critical feedback, and hands-on testing with leading endoscopists across Japan and Europe.

"I was fortunate to find outstanding partners who helped me turn the idea of an endoscopic organ anchoring into reality."

The KOEDA system has been presented at leading scientific meetings, including Digestive Disease Week (DDW), ESGE Days and the Japan Gastroenterological Endoscopy Society (JGES). These meetings provide valuable opportunities to exchange experience with physicians working at the forefront of interventional endoscopy.

Reference

1. Giri S, et al. Adverse events with endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: A systematic review and meta-analysis. United European Gastroenterol J. 2024;12(7):879–890. doi:10.1002/ueg2.12576.