Mauna Kea's Global Push: New Strategy Targets Growth Beyond the U.S.

PARIS & BOSTON – February 04, 2026 – Following a year of record-breaking sales acceleration in the United States, medical device innovator Mauna Kea Technologies is turning its sights to the global stage. The company, known for its groundbreaking Cellvizio® cellular imaging platform, has announced a significant new commercial organization designed to drive aggressive growth outside the U.S., focusing on two high-potential clinical areas: pancreatic cyst characterization and food intolerance diagnosis.

The strategic reorganization builds directly on the momentum from a successful U.S. commercial restructuring in early 2025, which yielded sustained sales growth throughout the year. Now, Mauna Kea is sharpening its international strategy to replicate that success in Europe, the Middle East, Australia, and beyond. This move signals the company's transition from a U.S.-focused turnaround to a new phase of global expansion, leveraging its clinically validated technologies to capture a larger share of the international diagnostics market.

A Two-Pronged Attack on International Markets

At the heart of the new strategy are two major growth drivers where Cellvizio® has demonstrated significant clinical value. The first is the notoriously challenging field of pancreatic cyst characterization. Differentiating between benign and potentially cancerous pancreatic cystic lesions (PCLs) is a critical diagnostic hurdle. Mauna Kea's needle-based Confocal Laser Endomicroscopy (nCLE) technology provides physicians with real-time, in-vivo cellular images during endoscopic procedures.

Recent landmark achievements have bolstered the company’s position in this area. A multi-center study presented at Digestive Disease Week® 2024 highlighted Cellvizio's impressive diagnostic accuracy of 97% in classifying PCLs—a significant improvement over conventional methods. This clinical validation was further solidified by the recent inclusion of Cellvizio® in the technical guidelines of the European Society of Gastrointestinal Endoscopy (ESGE), a major endorsement that paves the way for wider adoption across Europe. The company is also awaiting a decision from France’s national health authority, the Haute Autorité de Santé (HAS), on reimbursement, a move that could unlock a key European market.

The second pillar of the international strategy is CellTolerance®, a platform for detecting food intolerances in patients suffering from conditions like Irritable Bowel Syndrome (IBS). After achieving €1 million in sales in 2025, CellTolerance® has proven its market traction and is now poised for a major scaling effort. The platform addresses a vast and growing market; the global food intolerance test market was valued at over $14 billion in 2023 and is projected to more than double to nearly $32 billion by 2032. With millions of people worldwide suffering from food-related sensitivities, CellTolerance® offers a direct, visual method to identify trigger foods, which some users have already described as an "essential technology" for their patients.

The 'Fractional CCO' and an Outsourced Playbook

To spearhead the CellTolerance® expansion, Mauna Kea has made a strategic and somewhat unconventional leadership appointment. Benoit Chardon, who has served as a Senior Strategic Advisor since 2024, has been named Fractional Chief Commercial Officer, dedicated exclusively to the CellTolerance® business. This "fractional" leadership model allows Mauna Kea to leverage top-tier executive talent with a highly specific and proven track record without the overhead of a full-time, C-suite position for a single product line.

Chardon brings over two decades of experience scaling high-growth businesses in the healthcare, weight loss, and medical aesthetics sectors. His resume includes pivotal roles in some of the industry's most notable success stories. He was instrumental in the international marketing and growth of CoolSculpting®, which was acquired by Allergan for $2.5 billion, and played a key role at FILORGA, which Colgate Palmolive acquired for €1.5 billion. More recently, as Chief Commercial Officer at Allurion Technologies, he helped grow the company's revenue from $3 million to $64 million in five years.

Under Chardon’s leadership, a dedicated, outsourced commercial and marketing team will execute the CellTolerance® rollout. This model offers agility and access to specialized expertise while allowing the core company to focus on R&D and its other commercial priorities. Chardon’s priorities for 2026 include accelerating lead generation, securing partnerships with leading clinics, and rolling out standardized frameworks to ensure a consistent, high-quality patient experience.

“CellTolerance® has proven strong clinical relevance and market traction globally,” said Benoit Chardon. “We are now entering the execution phase to replicate proven scalable models I have successfully deployed before. Our goal is disciplined, high-quality scaling to make CellTolerance the go-to solution for food intolerance diagnosis in Europe and key international markets.”

Building on a Foundation of U.S. Success

The confidence behind this ambitious international push is rooted in the company's robust performance in 2025. After restructuring its U.S. sales operations, Mauna Kea saw its strategy pay off handsomely. The second quarter of 2025 saw U.S. sales jump 23% at constant currency compared to the prior year, a period of acceleration that contributed to a total revenue of nearly €8 million for the full year. This growth was particularly impressive as it was achieved with a smaller, more productive sales force, validating the company’s new commercial model.

Financially, the company appears poised to support this new chapter. In late 2025, Mauna Kea successfully completed a financial restructuring and raised €6 million in new capital, providing the resources needed to fund its expansionary plans. This combination of proven commercial strategy, strong financial footing, and validated clinical technology creates a powerful foundation for the international initiatives.

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, framed the recent moves as a pivotal moment for the company. “2025 marked a turning point with record U.S. momentum in pancreatic cysts and CellTolerance emerging as a true second pillar,” he commented. “To seize the international opportunity ahead, we are adapting our organization with clear focus and the right expertise. Benoit’s proven track record in scaling high-growth healthcare businesses makes him the right leader to structure and accelerate CellTolerance globally. 2026 will be the year we move from the CellTolerance pilot phase into meaningful, recurring growth alongside building pancreatic cyst momentum outside the U.S.”

The new organization and targeted strategy represent a calculated effort by Mauna Kea Technologies to transform its real-time cellular imaging platform from a niche technology into a global standard of care across multiple, high-impact specialties.