Avinger Increases Focus on Coronary Development, Reduces Operating Costs of Peripheral Business
Avinger (NASDAQ:AVGR) announced a strategic shift to focus on its coronary artery disease program, leveraging its proprietary image-guided technology. The company aims to address unmet needs in the coronary market by developing an innovative therapeutic system. As part of this move, Avinger will reduce operating costs in its peripheral artery disease business by cutting headcount by 33%, expecting significant cost savings in the second half of 2024. Avinger plans to file an IDE application with the FDA later this year and start a clinical trial post-approval. The company supports its strategic partner's efforts for product registration in China and expects a U.S. launch of the Pantheris LV catheter in Q3 2024.
- Strategic focus on coronary artery disease program.
- Development of an innovative image-guided therapeutic system.
- Expected cost savings from a 33% reduction in peripheral business headcount.
- Planned IDE application to FDA by year-end.
- Clinical trial initiation post-FDA approval.
- Support for product registration in China.
- Anticipated U.S. launch of Pantheris LV catheter in Q3 2024.
- Reduction in headcount for the peripheral artery disease business.
- Potential risks and delays in obtaining FDA clearance for new products.
Insights
Avinger's strategic shift towards focusing on its coronary artery disease (CAD) program and reducing the operating costs of its peripheral artery disease (PAD) business has significant financial implications. By cutting headcount by
Moreover, the move to concentrate resources on the CAD program aligns with Avinger's goal to address a larger and potentially more lucrative market. The coronary market is known for its high barrier to entry, characterized by complex and costly procedures. Should Avinger’s new image-guided therapeutic system succeed in improving the chronic total occlusion (CTO) crossing success rates and reducing procedure times, it could capture significant market share. This strategic focus might also lead to higher valuation multiples, given the favorable market dynamics and anticipated higher margins in the coronary segment.
However, while these actions are promising, they come with inherent risks. The success of the program hinges on FDA approval, which can be unpredictable and time-consuming. Furthermore, Avinger’s revenue from the PAD business may face temporary disruption due to reduced operational focus. Investors must weigh these factors carefully.
Avinger’s increased focus on the coronary program, especially its image-guided therapeutic system for CTO procedures, is noteworthy from a medical perspective. The coronary artery disease market is immense, with many patients suffering from complex lesions that current technologies struggle to address effectively. Avinger’s portable Lightbox 3 platform, combined with their proprietary imaging technology, could revolutionize how CTO procedures are conducted, potentially improving patient outcomes significantly.
The anticipated FDA IDE (Investigational Device Exemption) application later this year marks a critical milestone. If approved, it would allow Avinger to begin clinical trials, which are essential for validating the effectiveness and safety of their new system. This step not only fuels optimism but also brings the company closer to commercializing a potentially groundbreaking technology.
However, the shift in focus raises questions about the continuity of innovation and service in the PAD area. While cost-cutting in the peripheral business might streamline operations, it can also slow down advancements or reduce the company's ability to cater to existing PAD patients, which is something stakeholders should monitor closely.
REDWOOD CITY, CA / ACCESSWIRE / June 5, 2024 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease, today announced that it will increase focus on its coronary artery disease program, where it is developing an innovative new image-guided therapeutic system to address unmet coronary market needs, while reducing the operating costs of its peripheral artery disease business. As part of this strategic prioritization, Avinger has reduced headcount dedicated to its peripheral business by
"Our coronary product development program represents an opportunity to establish a leading position in a large addressable market currently characterized by complex, expensive and often unsuccessful procedures," said Jeff Soinski, Avinger's President and CEO. "By leveraging our proprietary image-guided technology and portable Lightbox 3 platform, we believe we can significantly improve CTO-crossing success rates and safely reduce procedure times, while accessing established reimbursement codes for coronary CTO-crossing and OCT diagnostic imaging following FDA clearance. We remain on track to file an IDE application with the FDA later this year and are excited to initiate a clinical trial following approval.
"We are streamlining operations for our peripheral business to reduce operating costs while ensuring this important therapy remains available to physicians who use our proprietary image-guided devices to address critical medical conditions," said Soinski. "We continue to support our strategic partner's efforts to achieve regulatory registration of our image-guided products in the greater China market and anticipate the U.S. commercial launch of our new Pantheris LV image-guided atherectomy catheter in the third quarter of this year."
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first image-guided, catheter-based system for the diagnosis and treatment of patients with vascular disease in the peripheral and coronary arteries. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye® family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices for the treatment of peripheral artery disease (PAD), estimated to affect more than 200 million people worldwide. Avinger is developing its first product application for the treatment of coronary artery disease (CAD), an image-guided system for CTO-crossing in the coronary arteries, which provides the opportunity to redefine a large and underserved market. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
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Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the potential success of our coronary artery disease programs, our anticipated timing of launching new products, our expectations regarding filing an IDE application and initiation of clinical trials, the outcomes of clinical trials and our ability to establish a leading position in the market; the expected cost savings from our headcount reduction; and our ability to expand our portfolio of peripheral devices. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our ability to manage our company with fewer employees, dependency on a limited number of products; the resource requirements related to Pantheris, Tigereye and our Lightbox imaging console; the outcome of clinical trial results; the adoption of our products by physicians; our ability to obtain regulatory approvals for our products; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2024, and Quarterly Reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward- looking statements.
Investor Contact:
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com
Public Relations Contact:
Phil Preuss
Chief Marketing Officer
Avinger, Inc.
(650) 241-7942
pr@avinger.com
SOURCE: Avinger, Inc.
View the original press release on accesswire.com
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