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Overview of Avinger Inc
Avinger Inc is a commercial-stage medical device company headquartered in Redwood City, California, that is redefining the treatment landscape for vascular disease. With its innovative image-guided and catheter-based systems, the company focuses on the diagnosis and treatment of peripheral artery disease (PAD) while also developing applications for coronary artery disease. The core of Avinger's technology is its proprietary Lumivascular platform, which integrates advanced optical coherence tomography (OCT) with therapeutic catheter systems to enable real-time, intravascular imaging and precision intervention.
Innovative Lumivascular Platform
Avinger's Lumivascular platform represents a significant evolution in the field of interventional medicine. By combining high-resolution OCT imaging with specialized catheter devices, physicians are empowered to visualize arterial structures from within, ensuring safer navigation and enhanced treatment precision. This unique image-guided approach addresses long-standing challenges in treating chronic total occlusions (CTOs) and complex PAD lesions, reducing the reliance on traditional X-ray imaging and subjective tactile feedback.
Product Suite and Clinical Applications
The company's product portfolio is designed to span the full spectrum of vascular interventions. Key components include:
- Lightbox Imaging Console: A portable, high-definition imaging system that displays real-time OCT images.
- Ocelot and Tigereye Catheters: A family of devices created to penetrate total arterial blockages, particularly targeting chronic total occlusions.
- Pantheris Atherectomy Devices: The first image-guided atherectomy system specifically designed for precise plaque removal in PAD patients.
These devices not only facilitate more predictable procedural outcomes but also streamline the complex workflows typical of vascular interventions. The integration of advanced imaging ensures that physicians have comprehensive, intraprocedural visibility, which is critical when addressing both below-the-knee and above-the-knee lesions.
Competitive Landscape and Market Position
Avinger operates at the intersection of medical imaging and interventional therapy, a niche that requires extraordinary expertise in both engineering and clinical practice. Despite operating in a competitive medical device field, Avinger distinguishes itself through its sole focus on image-guided interventions. Its technology helps physicians achieve better procedural accuracy, potentially reducing operating times and enhancing patient safety. The company's methodical approach to innovation, combined with strategic partnerships and a robust patent portfolio, reinforces its position as a unique entity in the vascular therapy market.
Clinical Impact and Technological Advantages
The image-guided systems developed by Avinger are grounded in a deep understanding of vascular pathophysiology and interventional challenges. By offering real-time visualization during catheter-based procedures, the company addresses critical issues such as imprecise navigation and the risks associated with radiation exposure. This technological advantage provides a more intuitive and evidence-based approach to traversing occlusive lesions, thereby contributing to improved clinical outcomes. Additionally, the use of established reimbursement codes for various procedures facilitates smoother clinical adoption.
Commitment to Quality and Industry Expertise
Avinger's commitment to quality is evident in the rigorous design and development processes that underpin its products. The company continuously seeks to enhance its clinical evidence through robust studies and post-market evaluations. By integrating feedback from leading physicians and leveraging state-of-the-art imaging technologies, Avinger not only meets but often exceeds industry standards, bolstering its reputation for expertise and trustworthiness in the medical device community.
Conclusion
In summary, Avinger Inc offers a transformative approach to vascular disease treatment with its Lumivascular platform. The company's comprehensive suite of image-guided devices is tailored to address some of the most challenging aspects of interventional vascular therapy. Through innovation, strategic market positioning, and a clear focus on clinical excellence, Avinger continues to set new benchmarks in the diagnosis and treatment of both peripheral and coronary vascular diseases.
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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