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Avinger, Inc. (NASDAQ: AVGR) is a commercial-stage medical device company committed to transforming the treatment of Peripheral Artery Disease (PAD) through innovative, image-guided, catheter-based systems. Founded and headquartered in Redwood City, California, Avinger designs, manufactures, and sells its proprietary Lumivascular platform, which includes the Lightbox imaging console, the Ocelot family of catheters for penetrating chronic total occlusions (CTOs), and the Pantheris family of atherectomy devices for removing arterial plaque.
Avinger's mission is to significantly improve clinical outcomes for PAD patients by offering precision and real-time imaging that enhances both diagnosis and treatment. The company's groundbreaking products are developed to address the needs of over 200 million PAD patients worldwide.
Key highlights of Avinger's product lineup include:
- Lightbox Imaging Console: An advanced system providing real-time intravascular imaging.
- Ocelot Catheters: Designed for crossing chronic total occlusions with precision.
- Pantheris Atherectomy Devices: The first-ever image-guided devices for the removal of arterial plaque.
- Tigereye ST CTO-Crossing Catheter: Launched to significant market enthusiasm, providing enhanced performance for complex procedures.
Recent financial disclosures indicate that Avinger is actively expanding its commercial footprint. The company recently reported financial results for the third quarter of 2023, with total revenue of $1.8 million and notable developments including the launch of the Tigereye ST and Pantheris LV systems. Despite a net loss of $4.5 million, Avinger continues to invest in product development and sales expansion, primarily in the United States.
A key strategic move for Avinger has been the newly formed partnership with Zylox-Tonbridge, a leading Chinese medical device company. This collaboration is set to provide up to $15 million in equity funding and facilitate Avinger's entry into the Greater China market. The partnership also aims to enhance manufacturing efficiency and explore new revenue opportunities through product distribution in the U.S. and Germany.
In addition to advancing its peripheral products, Avinger is making strides in the coronary space. The company is developing a new image-guided system for treating coronary artery disease (CAD), with plans to file an Investigational Device Exemption (IDE) application with the FDA by mid-2024. This development emphasizes Avinger's commitment to addressing unmet medical needs across both peripheral and coronary segments.
For the most current updates and detailed information on Avinger, Inc., their products, financial reports, and more, please visit their official website at www.avinger.com.
Avinger, Inc. (NASDAQ:AVGR) has received 510(k) clearance from the FDA for its Pantheris system, allowing it to treat in-stent restenosis (ISR)real-time intravascular imaging combined with precise control to effectively target ISR lesions. The opportunity in this market is significant, as an estimated 30-40% of stents face restenosis within three years after placement.
Avinger, Inc. (NASDAQ: AVGR) reported a revenue of $2.4 million for Q3 2021, reflecting a 3% increase year-over-year. The gross margin remained steady at 34%. The company opened 8 new Lumivascular accounts despite challenges from COVID-19. Avinger announced a 510(k) submission to expand Pantheris' indications to include treatment of in-stent restenosis and a new Lightbox 3 imaging console. Operating expenses rose to $5.3 million, leading to a net loss of $6.0 million. Cash reserves stood at $23.1 million as of September 30, 2021.
Avinger, Inc. (NASDAQ:AVGR), a medical device company, is set to release its third quarter 2021 financial results on November 11, 2021, after market close. A conference call will follow at 1:30 pm PT / 4:30 pm ET, accessible via phone or live webcast on the company’s investor relations page. Avinger specializes in intravascular imaging systems for diagnosing and treating Peripheral Artery Disease (PAD), which impacts millions globally. The company aims to transform vascular disease treatment through its Lumivascular platform.
Avinger has announced positive results from its INSIGHT study for the Pantheris system, aimed at treating in-stent restenosis (ISR) in lower extremity arteries. Presented at the VIVA conference, the study followed 85 patients, showing an 82% luminal gain post-procedure, with 93% freedom from target lesion restenosis at 6 months and 89% at 12 months. Notably, there were no amputations reported. The results support a pending FDA 510(k) submission for an ISR indication. With ISR affecting up to 40% of stents placed annually, the data position Pantheris as a potential frontline therapy.
Avinger, Inc. (NASDAQ:AVGR), a medical device company, will engage in investor meetings from September 13-15, 2021, at the H.C. Wainwright 23rd Annual Global Investment Conference. The company specializes in the diagnosis and treatment of Peripheral Artery Disease (PAD), which impacts over 12 million people in the U.S. and 200 million globally. Avinger is known for its innovative Lumivascular platform, including its imaging console and catheter systems. Interested investors can contact H.C. Wainwright for scheduling inquiries.
Avinger, Inc. (NASDAQ:AVGR) presented its Lumivascular, OCT-guided technologies at the AMP conference, focusing on critical limb ischemia treatment. Dr. Jaafer Golzar shared insights on Avinger’s Pantheris SV and Tigereye catheters, emphasizing ongoing clinical trials that could enhance their efficacy in treating Peripheral Artery Disease (PAD). CEO Jeff Soinski highlighted the growing acceptance of their technologies in the medical community. Avinger aims to transform PAD treatment, impacting over 12 million patients in the U.S. alone.
Avinger reported a 91% year-over-year revenue growth for Q2 2021, reaching $2.8 million, driven by strong Pantheris and Tigereye sales. The Pantheris SV revenue increased significantly due to market adoption in below-the-knee treatments, while image-guided CTO revenue surged 114% following the Tigereye launch at over 40 sites. The gross margin improved to 36%, and the company maintains a robust cash position of $26.7 million, expected to support future growth through 2022.
Avinger (NASDAQ:AVGR) announced the submission of a 510(k) application to the FDA for its new Lightbox 3 imaging console, which aims to revolutionize the treatment of Peripheral Artery Disease (PAD)
The new console features significant reductions in size and weight, improving portability and user experience, while enhancing imaging capabilities. President & CEO Jeff Soinski highlighted the potential of Lightbox 3 to accelerate new account acquisition and enhance existing user engagements. The console embodies Avinger's commitment to advancing medical imaging technology, which could lead to improved outcomes for PAD patients.
Avinger, Inc. (Nasdaq:AVGR), a medical device company, will release its Q2 2021 financial results on August 10, 2021, after market close. The company offers the first intravascular image-guided system for treating Peripheral Artery Disease (PAD), impacting over 12 million people in the U.S. A conference call will be held at 1:30 PM PT / 4:30 PM ET, which can be accessed via phone or webcast. A replay will also be available on Avinger's website.
Avinger, Inc. (NASDAQ:AVGR) has submitted a 510(k) application to the FDA for a new clinical indication of its Pantheris system to treat in-stent restenosis (ISR) in lower extremity arteries. The application is supported by data from the INSIGHT trial, highlighting the device's safety and efficacy. With 200,000 stents placed annually, 30%-40% of which may develop ISR, this presents a significant market opportunity. The Pantheris system offers advantages over existing treatments by enabling targeted blockage removal while minimizing risks associated with stent damage, potentially improving patient outcomes.
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