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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) announced presentations of its Lumivascular technology at two vascular conferences in Germany, showcasing its impact on treating Peripheral Artery Disease (PAD). Dr. Arne Schwindt emphasized the benefits of onboard OCT imaging for patients treated with Pantheris, noting traditional methods have high restenosis rates. Dr. Michael Lichtenberg highlighted the reduction of radiation exposure during procedures. Avinger's innovative approach allows real-time imaging within arteries, enhancing treatment accuracy and patient outcomes.
Avinger, Inc. (NASDAQ:AVGR) presented its Lumivascular technology at the New Cardiovascular Horizons (NCVH) annual conference from June 1-4, 2021, in New Orleans. Key opinion leaders emphasized its benefits in treating Peripheral Artery Disease (PAD) using proprietary OCT-guided platforms. Dr. Jon George and Dr. Tom Davis highlighted the precision of Avinger's atherectomy catheters, particularly the Pantheris device. With approximately 12 million PAD cases in the U.S., Avinger's innovative Lumivascular system aims to improve treatment efficacy while minimizing patient exposure to ionizing radiation.
Avinger, Inc. (NASDAQ:AVGR) announced on May 25, 2021, the issuance of seven U.S. patents, enhancing its intellectual property portfolio to 182 patents, including 41 in the U.S. These patents primarily pertain to Avinger's proprietary optical coherence tomography (OCT) systems and related catheters for treating vascular diseases. The CEO emphasized that this expanding portfolio underpins their competitive advantage in the market for the first and only intravascular OCT-guided therapeutic catheters, as well as future products like the Lightbox 3 imaging console.
Avinger, Inc. (NASDAQ:AVGR) announced that its management will hold investor meetings on May 26, 2021, during the Oppenheimer MedTech, Tools & Diagnostics Summit. As the first company to offer an intravascular image-guided, catheter-based system for diagnosing and treating Peripheral Artery Disease (PAD), Avinger aims to transform vascular disease treatment through its Lumivascular platform. PAD impacts over 12 million people in the U.S. and more than 200 million globally. Interested institutional investors can schedule meetings through Oppenheimer or by contacting Matt Kreps.
Avinger reported a 13% year-over-year increase in revenue for Q1 2021, totaling $2.6 million, driven by the successful launch of the Tigereye device and growth in Pantheris SV sales. Gross margin improved by 13 percentage points to 35%. The company expanded its commercial reach, opening 8 new accounts in Q1. Cash reserves increased to $30.4 million, sufficient to support growth initiatives through 2022. Avinger also reported a net loss of $5.1 million, a decrease from $5.9 million in Q1 2020.
Avinger, Inc. (NASDAQ:AVGR) is set to release its financial results for Q1 2021 on May 6, 2021, after market close. The company, a leader in intravascular imaging technology for diagnosing and treating Peripheral Artery Disease (PAD), will host a conference call at 1:30 PM PT/4:30 PM ET. The call can be accessed by dialing +1-862-298-0850 or via a live webcast on its investor relations page. Avinger focuses on revolutionizing vascular disease treatment with its Lumivascular platform, impacting over 12 million PAD patients in the U.S.
Avinger, Inc. (NASDAQ:AVGR) announced the publication of two clinical studies supporting the advantages of its OCT-guided therapeutic devices for the treatment of Peripheral Artery Disease (PAD). Conducted at the Einstein Medical Center, the studies indicate a significant reduction in stenosis and target lesion revascularization (TLR) rates after treating patients with the Pantheris SV catheter. Results show stenosis decreased from 85% to 21.5% with a TLR freedom rate of 90.5% at six months. Avinger aims to enroll 60 patients in the IMAGE-BTK clinical study to validate these findings.
Avinger, Inc. (NASDAQ:AVGR) announced that over 100 accounts have purchased its Pantheris SV OCT-guided atherectomy catheters since their launch in Q3 2019, marking a significant milestone. In 2020 alone, Avinger sold over 1,700 Pantheris SV catheters, achieving more than 100% revenue growth from the previous year. The Pantheris SV device enhances treatment options for Peripheral Artery Disease (PAD), particularly in small vessels below-the-knee. Avinger aims to expand its addressable procedures significantly with this product line extension.
Avinger, Inc. (NASDAQ:AVGR) has successfully launched the Tigereye CTO Crossing Catheters for treating Peripheral Artery Disease (PAD). Initiated in January 2021, the full commercial launch has reached 30 clinical sites with over 160 procedures completed. Revenue from Tigereye is projected to increase combined Lumivascular CTO revenue by approximately 60% for Q1 2021 compared to the previous year. The device's advanced imaging capabilities allow for safer and more effective interventions, reducing the need for more invasive procedures.
Avinger reported a strong performance in Q4 2020, with total revenue increasing by 19% sequentially to $2.7 million, the highest in three years. Image-guided CTO revenue surged 38% due to the limited launch of the new Tigereye device. Gross margin improved to 36%, and nine new Lumivascular accounts were opened. Despite a net loss of $4.6 million, Avinger ended the year with $22.2 million in cash, bolstered by an additional $13 million raised in early 2021. The company is set to launch new products and expand into the CAD market in 2021.
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