PARIS — BOSTON: 
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform and TaeWoong Medical USA, a leader in minimally invasive gastrointestinal (GI) diagnostic and therapeutic EUS guided solutions, today announced the signing of an exclusive partnership in the United States to bring physicians and hospitals the industry’s first fully integrated "imaging-to-therapy” solution for pancreatic cystic lesions (PCLs) and related disorders. 

Uniting Cellvizio® needle-based, real-time cellular imaging solution with TaeWoong’s proven EUS-guided therapeutic capabilities will create a cohesive clinical program designed to streamline workflow, enhance clinical accuracy and elevate patient outcomes across pancreatic cyst diagnosis, risk stratification, and treatment, thereby better addressing one of the fastest-growing indications challenges in digestive oncology.

The partnership integrates two highly complementary portfolios, enabling a streamlined and co-branded “Pancreatic Cyst Imaging and Management Program – Powered by Cellvizio®” with key features that include:

• Real-time cellular-level, nCLE imaging from Mauna Kea of pancreatic cysts during EUS procedures
• Advanced EUS-guided diagnostic and therapeutic instruments from TaeWoong Medical for treatment — combining diagnostic clarity and interventional capability in one streamlined workflow
• Clinical onboarding, training and ongoing support for physicians and care teams to adopt the integrated platform safely and effectively
• End-to-end patient management — from initial diagnosis and risk stratification through intervention, reducing diagnostic uncertainty, improving patient selection for therapy, and minimizing unnecessary surgeries
• Support for cost-effective care and optimized resource utilization — thanks to improved diagnostic accuracy and reduction of redundant procedures and avoidable resections

It is expected this unified solution will offer clinicians additional clarity and control at each step of EUS- guided care—from initial assessment to therapeutic intervention.

Sacha Loiseau, Ph.D., Chairman & CEO of Mauna Kea Technologies, commented: "The in vivo evaluation of cysts for patients at risk of pancreatic cancer has been a pillar of demand for Cellvizio, supported by proven clinical outcomes and the advocacy of key opinion leaders internationally. However, the scope of our US sales organization limits our commercial reach until now. Our partnership with TaeWoong Medical USA is expected to meaningfully expand Cellvizio’s U.S. footprint by integrating leading therapeutic products with Mauna Kea’s advanced diagnostic capabilities. Moreover, combining TaeWoong’s US commercial infrastructure with a unified value proposition should allow us to scale smarter together. We are thrilled with this alliance as it further validates that Cellvizio has earned the opportunity to be considered a standard of care in a critical clinical application."

“We are excited to join forces with Mauna Kea Technologies,” said Minsoo Seo, CEO, TaeWoong Medical USA. “Cellvizio’s needle-based microscopic technology is unmatched in its ability to provide real-time cellular-level insights, and its clinical value is recognized by leading centers across the country. Together, we can empower physicians with a complete diagnostic-to-therapeutic solution that elevates patient outcomes and sets a new standard for EUS-driven care.”

RM Global Partners LLC advised Mauna Kea Technologies in connection with the foregoing transaction. Learn more at www.rmglobal.com.

Disclaimer
This press release and the safeguard plan contain forward-looking statements relating to Mauna Kea Technologies, its activities, and the progress of the safeguard proceedings opened for the benefit of the Company. All statements other than statements of historical fact included in this press release and in the safeguard plan, including, without limitation, those regarding the financial position, business, strategies, plans, and objectives of Mauna Kea Technologies' management for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given as to the achievement of the forecasts expressed in these forward-looking statements, which are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies' 2024 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2025, available on the Company's website (www.maunakeatech.fr), as well as risks related to changes in the economic environment, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release and in the safeguard plan are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider significant at this date. The occurrence of some or all of these risks could cause the actual results, financial conditions, performance, or achievements of Mauna Kea Technologies to differ significantly from the results, financial conditions, performance, or achievements expressed in these forward-looking statements. This press release, the safeguard plan, and the information they contain do not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe, for shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of said jurisdiction. Likewise, they do not constitute and should not be treated as investment advice. They do not have regard to the investment objectives, financial situation, or particular needs of any recipient. No representation or warranty, express or implied, is given as to the accuracy, completeness, or reliability of the information contained in these documents. They should not be considered by recipients as a substitute for the exercise of their own judgment. All opinions expressed in these documents are subject to change without notice. This press release has been prepared in French and English. In the event of any discrepancy between the two versions of the press release, the French version shall prevail.