Iridex Announces First Patient Enrollment in MicroPulse® TLT Clinical Study Conducted in Collaboration with Imperial College Healthcare NHS Trust
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Insights
The initiation of the MicroPulse Transscleral Laser Therapy study by Iridex Corporation in collaboration with Imperial College Healthcare NHS Trust represents a significant step in advancing the treatment of glaucoma. Glaucoma is a leading cause of irreversible blindness globally and the development of minimally invasive treatment options is critical. This study's focus on MicroPulse TLT, a form of laser therapy that aims to lower intraocular pressure without the tissue damage associated with traditional laser treatments, could offer a substantial improvement in patient outcomes if proven effective.
From a medical research perspective, the structured approach to expanding participation across the UK is pivotal. It will not only increase the data pool but also enhance the statistical power of the study's findings. The adherence to NICE IPG692 guidelines ensures that the research meets the highest standards of care, which is crucial for eventual clinical adoption. Furthermore, the custom-designed database management system provided by Iridex could streamline data collection and analysis, potentially accelerating the path to peer-reviewed publication and clinical application.
The strategic partnership between Iridex and Imperial College Healthcare NHS Trust could have substantial implications for the business landscape of ophthalmic medical devices. Iridex's investment in the study underscores its commitment to expanding its clinical portfolio and could position the company as a leader in innovative glaucoma treatments. If the study yields positive results, it may drive demand for Iridex's Cyclo G6 Laser and the MicroPulse P3 Delivery Device, potentially increasing the company's market share and revenue.
In the broader context, the laser therapy market for glaucoma is competitive and innovation is a key differentiator. The success of this study could also catalyze further research and development within the industry, leading to improved treatment modalities. For healthcare providers, the availability of a new, minimally invasive treatment option could enhance patient care and satisfaction, while also potentially reducing the long-term costs associated with more invasive glaucoma surgeries.
The financial implications of this clinical study for Iridex Corporation hinge on the outcomes of the research. Positive results could lead to increased adoption of MicroPulse TLT, driving up sales of the associated medical devices. This would be a boon for Iridex's financial performance, particularly given the company's role in funding and supporting the study. The initial costs may be substantial, but the long-term return on investment could be significant if the treatment becomes a new standard for glaucoma care.
Investors should monitor the progress of the study closely, as interim results could influence the company's stock performance. Moreover, the involvement of Iridex in providing a database management system indicates a strategic move to integrate technology and services, potentially opening additional revenue streams. However, it is essential to consider the risks involved, as the study's duration and the regulatory path to market approval can affect the timing and magnitude of any financial benefits.
MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Iridex Corporation, headquartered in Mountain View, California, and Imperial College Healthcare NHS Trust in London, today announced the first patient enrollment in a collaborative medical research study and registry evaluating the treatment of glaucoma with MicroPulse® Transscleral Laser Therapy (TLT) using Iridex’ Cyclo G6® Laser and the MicroPulse P3® Delivery Device. This partnership establishes a large-scale enrollment platform to advance clinical research.
David I. Bruce, President and CEO of Iridex, shared: "The first patient enrollment in this partnership with Imperial College Healthcare NHS Trust is the first step toward multicenter participation enabling a large-scale view and significant in-country impact of our MicroPulse® technology.”
The study, titled "MicroPulse Transscleral Laser Therapy: A Prospective UK Study," is set to expand Iridex’s global clinical portfolio, through its commitment to funding essential components of the 3-year study and providing a custom-designed and secure database management system.
Professor Philip Bloom, Consultant Ophthalmic Surgeon at Imperial College Healthcare NHS Trust, emphasized the importance of rapid expansion: “We are delighted at Imperial to be able now to offer this minimally invasive treatment for glaucoma. Expansion to include other units will be crucial in advancing glaucoma treatment in the UK. Our partnership with Iridex is key to enhancing this study's reach and impact.”
The Western Eye Glaucoma Department of the Imperial College Healthcare NHS Trust is the first to implement MicroPulse® TLT as part of this clinical research registry, adhering to NICE IPG692 guidelines. The registry and study is structured for expanded participation from other UK providers to join the program and build enrollment for large patient cohorts.
Both Iridex and Imperial College Healthcare NHS Trust are dedicated to conducting this study in accordance with the strictest ethical and regulatory standards and look forward to welcoming additional sites to join the program. The collaboration symbolizes the company’s shared vision for advancing medical science with MicroPulse® TLT. It promises significant insights and advancements in glaucoma laser therapy, potentially revolutionizing treatment approaches and enhancing patient care.
Iridex would like to thank and acknowledge Carleton Optical Equipment Ltd, located in Chesham, England, for providing clinical trial training, service, and support.
About Iridex Corporation: In 2024, Iridex Corporation celebrates its 35th anniversary as a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. The Company’s proprietary MicroPulse® technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions. Iridex’s current product line is used for the treatment of glaucoma and diabetic macular edema (DME) and other retinal diseases. Iridex products are sold in the United States through a direct sales force and internationally primarily through a network of independent distributors into more than 100 countries. For further information, visit the Iridex website at www.iridex.com.
Iridex, and MicroPulse® are registered trademarks of Iridex Corporation, Inc. © 2023 Iridex Corporation. All rights reserved.
Safe Harbor Statement: This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical expectations and commercial trends, market adoption and expansion, demand for and utilization of the Company's products and results and expected sales volumes. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 20, 2023. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
Media Contact
Steven Koufos
skoufos@iridex.com
FAQ
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