The Memo: NIMBLE Diagnostics Bringing Visibility to Vascular Implants

Under the direction of Co-Founder and CEO Dr. Oriol Iborra Egea, NIMBLE Diagnostics is creating a new frontier in implant monitoring and vascular care. With a non-invasive, microwave-based diagnostic device designed to monitor implanted stents in real time, NIMBLE is solving a long-standing blind spot in cardiovascular care: knowing what’s happening inside a stent without having to go back inside the body.

“We implant a stent, we send the patient home, and we assume everything’s fine—until it’s not,” said Iborra. “We’ve built a way to monitor that stent non-invasively, quickly, and safely—before a serious event occurs.”

From a research project in Barcelona to a fast-moving medtech startup with international ambitions, NIMBLE Diagnostics is on a mission to redefine how clinicians follow up with patients after stent implantation—and to prevent life-threatening complications before they happen.

Origin Story

NIMBLE Diagnostics was born from a collaborative research effort among several investigators from the Germans Trias i Pujol Hospital and affiliated universities. From this joint initiative, cardiovascular researcher Dr. Oriol Iborra Egea and telecommunications engineer Susana Amorós took the lead and spearheaded the creation of the startup to make the technology a clinical reality. The two first crossed paths at a public hospital in Barcelona, where they collaborated on early research to improve stent monitoring technologies. Combining Iborra’s background in translational cardiovascular science with Amorós’s engineering expertise, they set out to solve a critical clinical challenge: how to monitor stent performance non-invasively and in real time.

Their early concept—using microwave signals to assess stent integrity and patency—showed promise in simulations and in vitro studies. However, initial animal trials with a probe-based design were unsuccessful due to limited tissue penetration. That challenge led to a key breakthrough: replacing the probes with external antennas. Amorós played a central role in refining this technical pivot, which dramatically improved the system’s performance and opened the door to clinical feasibility.

Encouraged by the results and united by a mission to improve patient care, Iborra and Amorós co-founded NIMBLE Diagnostics in March 2022. Together with a multidisciplinary team, they’re translating a promising research concept into a clinically impactful solution.

The Current Landscape

Today’s standard of care for monitoring stents is surprisingly limited. After implantation, most patients receive just a few follow-up visits in the first year, usually consisting of a clinical conversation rather than imaging.

“If the patient says they’re feeling fine, we assume the stent is working. But up to a third of patients will have complications in the first couple of years, and we often don’t catch it until it’s too late,” Iborra said.

The gold-standard diagnostic tools—like intravascular ultrasound (IVUS) or optical coherence tomography (OCT)—require catheterization and/or contrast agents, meaning they’re invasive, expensive, and only used once a patient is already showing symptoms.

NIMBLE is eliminating that gap. By offering real-time data on whether a stent is blocked, fractured, or compromised, their device can optimize care pathways, enabling early intervention when needed and avoiding unnecessary procedures when not. This is for any type of stent and any patient, regardless of where the stent is located.

“We’re helping two kinds of patients: those with a silent problem that needs urgent attention and those with symptoms unrelated to their stent who can avoid invasive diagnostics altogether.”

Inside the Innovation

NIMBLE’s device uses two antennas—placed on the skin near the implant site—to transmit and receive microwave signals. The stent reflects those signals, which are then analyzed by proprietary algorithms to determine its condition.

“It’s like scanning a barcode,” Iborra said. “In less than five seconds, we can tell whether a stent is open, partially blocked, or fractured—and even quantify the degree of obstruction and identify the type of fracture.”

This precision fills a critical diagnostic void. For instance, Iborra noted that stent fractures—where the metal structure begins to break down—are frequently underdiagnosed due to limitations in current imaging methods.

“Our system can detect not only if a fracture exists, but what type it is—whether it’s a full break or just a nick on one side of the stent,” he said. “That kind of insight just isn’t available non-invasively today.”

The technology is designed to integrate easily into clinical workflows and doesn’t require a specialized imaging technician. “We want this to be used at the point of care—quickly, affordably, and by any trained professional.”

And this is just the beginning; NIMBLE’s technology has the potential to be used with any metallic implant, from stents to valves, prostheses, sensors, or even vascular calcifications, and their team is planning to tackle these applications further in the coming years.

Progress and Milestones

NIMBLE has moved at a remarkable speed. Though the company was officially incorporated in 2022, meaningful development only began in early 2023 following their seed round. Since then, the team has:

• Completed preclinical testing in 15 swine models.
• Built and refined a human-compatible prototype.
• Successfully completed a first-in-human clinical trial in 11 patients, demonstrating 100% diagnostic accuracy per clinical guidelines and strong concordance with OCT and angiography results.
• Detected a full stent fracture in one patient that was initially missed by standard angiography and later confirmed via IVUS.
• Expanded its clinical trial as a pilot study in Barcelona to enroll 120 patients.
• Initiated preparations for a pivotal trial in late 2025 across Europe and the United States.

In parallel, NIMBLE is raising a €12M Series A round to fund its regulatory trials and commercialization roadmap. As of April 2025, €9M has been committed, and the company is actively seeking a lead investor to close the round by September.

The company’s primary goal is to replicate these promising results in a pivotal trial, leveraging long-standing relationships with leading institutions specializing in coronary artery disease across the U.S., Germany, and Spain. This effort aims to support both CE marking and U.S.

FDA approval, with an application for Breakthrough Device Designation already underway.

“Our goal is to bring this to patients worldwide,” Iborra said. “We think of it as the next ultrasound—a new standard in how we monitor metallic implants.”

Market Insights

In 2024, more than 7.2 million stents were implanted worldwide. This figure is projected to continue to increase at a CAGR of 5.7% from 2024 to 2029. By 2030, more than 10 million stents will be placed each year.

It’s easy to understand why. The average number of stents placed per procedure is 1.2 to 1.6, depending on how conservative your estimates are, as well as the clinical literature being reviewed. Combine this with a rapidly increasing global burden of cardiovascular disease, and you have a recipe for millions of stents being placed each year that might benefit from some level of routine monitoring of complications. 

Looking beyond the company’s beachhead indication, there are over 11 million implant-related procedures performed worldwide that could benefit from routine monitoring.

Join Us at LSI Europe ‘25

Iborra has been selected to present at LSI Europe ‘25 this September 7th-11th in front of hundreds of global medical technology companies. Join us in welcoming Iborra to the event in London, where he will share the latest updates on NIMBLE Diagnostics’ technology and development.