Latest news with #CellTolerance
Business Wire
24-07-2025
- Business
- Business Wire
Mauna Kea Technologies Enters Australian Market with Endotherapeutics Partnership
PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News: Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces its entry into the Australian market by signing a new exclusive distribution agreement with Endotherapeutics Pty Ltd, a leading Australia-based distributor of cutting-edge medical devices, to bring the Cellvizio platform to Australian physicians. This strategic expansion comes as Mauna Kea experiences growing momentum for its CellTolerance application, prompting the company to open new geographic markets with strong growth potential. The three-year agreement grants Endotherapeutics the exclusive rights to distribute and promote the Cellvizio platform in Australia. As part of the market entry, a submission for Therapeutic Goods Administration (TGA) approval for the latest generation of Cellvizio products is underway. Mauna Kea Technologies has already been granted TGA clearance in the past and does not anticipate any hurdles in obtaining it again. The partnership will leverage the upcoming launch of the CellTolerance program with Professor Gerald Holtmann, MD, PhD, MBA, a leading Australian physician at Princess Alexandra Hospital in Brisbane, who is planning to acquire one Cellvizio for food intolerance applications. 'This technology brings hope of change for millions of patients suffering from food-related IBS symptoms,' commented Professor Holtmann. 'Cellvizio is truly unique in its ability to help identify the root causes of patient symptoms, enabling the creation of tailored diets. My entire team is excited to explore its full potential and improve the lives of our patients.' 'We're very pleased to partner with Mauna Kea Technologies to introduce Cellvizio to the vibrant Australian GI market,' stated Rob Curtin, Business Manager for GI at Endotherapeutics. 'The potential for Cellvizio and its key indications, particularly pancreatic cyst characterization and food intolerance detection is very significant.' Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies, added: "We are thrilled to partner with Endotherapeutics, a premier distributor of cutting-edge medical devices and a trusted partner with deep roots in the Australian healthcare system. This partnership marks a key milestone in our international expansion strategy. As we see good momentum in the adoption of our platform, particularly for CellTolerance, we are taking key initiatives to expand our market reach in territories with strong growth potential.' *** About Endotherapeutics Pty Ltd Endotherapeutics is a leading Healthcare Technologies distributor serving customers across Australia and New Zealand, headquartered in Sydney, Australia. Endotherapeutics' mission is to improve healthcare and achieves this by supplying innovative healthcare solutions with the highest levels of service and support. To find out more, visit About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit Disclaimer This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives 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 that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements 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, which is available on the Company's website ( as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, 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 any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
Business Wire
15-07-2025
- Health
- Business Wire
Mauna Kea Technologies Congratulates Stanford Health Care on Completing 100
PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News: Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces the achievement of a key milestone by the clinical care team at Stanford Health Care, which has surpassed 100 cases for CellTolerance tests using the Cellvizio platform for patients with suspected food intolerance. An estimated 12% of the U.S. population suffers from IBS, and in several clinical studies using pCLE, it has been proven that more than 50% of those patients could suffer from food intolerances that can only be characterized by the real-time visualization of the intestinal barrier with Cellvizio during a food challenge. Linda Nguyen, M.D., Interim Chief, Gastroenterology & Hepatology and Clinical Professor of Medicine, Laura Pace, M.D., Clinical Assistant Professor of Medicine, and Sean Spencer, M.D. Ph.D., Instructor of Medicine, are leading the team of health care providers who are helping IBS patients end the circular loop of trying and repeatedly failing to identify and address the cause of their food-related IBS symptoms. 'With every CellTolerance test, we are using this cutting-edge technology to provide our patients with gut-specific, personalized answers. Reaching our first 100 cases is not just a milestone for our team, but a beacon of hope for all of our patients struggling with food intolerances. This program is a game-changer, and I am incredibly proud of our team for leading the charge in this new era of digestive health," said Dr. Sean Spencer at Stanford Medicine. Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, stated:"CellTolerance is bringing answers to the millions of patients seeking resolution of their food-related IBS symptoms, and I extend a huge congratulations to the team at Stanford for their work in implementing CellTolerance on the Cellvizio platform and achieving this fantastic milestone. We are seeing strong growth and adoption of CellTolerance worldwide, underscoring the unique value proposition of the CellTolerance test for physicians and the desire of patients to find a solution that truly addresses their unmet needs." *** About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit Disclaimer This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives 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 that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements 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, which is available on the Company's website ( as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, 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 any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
Business Wire
21-05-2025
- Business
- Business Wire
Mauna Kea Technologies Provides Update on Safeguard Proceedings, Strategic Discussions and Operational Progress
PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News: Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, provides an update on the safeguard proceedings initiated on March 31, 2025 1, as well as on the progress of its strategic discussions and operational developments. This announcement is part of the Company's commitment to maintaining ongoing transparency with its shareholders and partners during the ongoing process. Since the initiation of this safeguard proceedings, the Company has engaged in constructive discussions with its financial partners to identify the most appropriate options for achieving a sustainable solution to the current situation. In parallel, the Company is actively pursuing the exclusive negotiations announced on April 1 st, 2025, with a major healthcare player, aiming to finalize a licensing agreement for Cellvizio® technology in a high-potential therapeutic area. These discussions are progressing constructively and could represent a major strategic milestone for the Company's clinical and commercial development. On the operational front, Mauna Kea Technologies is experiencing strong momentum with its CellTolerance franchise. The symbolic milestone of 1,500 procedures has been surpassed, demonstrating the growing adoption of the technology. Several new accounts have recently been onboarded, including prestigious institutions that form a solid foundation for future growth. Among them, a leading center in the United States has already performed over 100 procedures in just a few months and continues to show an upward trend in usage. The Company plans to continue updating on these clinical and commercial advancements in the coming weeks. Finally, Mauna Kea Technologies is actively engaged with several investors to secure the financial visibility required for the safeguard proceedings and the finalization of licensing agreement. These discussions aim to provide the Company with the resources required to execute its long-term growth strategy. Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, stated: "We are navigating this transition period with full determination and remain strongly committed to equipping the Company for future growth. Our commercial outlook is becoming more tangible each day, both for CellTolerance and our pancreatic cyst application, which are increasingly supported by clinical data and a clear enthusiasm among physicians and patients. The safeguard proceedings provide us with a protective framework ideal for negotiating with our stakeholders and preparing for the Company's redeployment on solid foundations. I am very pleased with the dedication of our teams and am fully committed to shaping a new chapter of strong value creation for the Company. Cellvizio is proving its relevance more than ever today, offering a unique opportunity to improve care for millions of patients while reducing healthcare system costs." *** About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit Disclaimer This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives 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 that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements 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, which is available on the Company's website ( as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, 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 any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
