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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 U.S. FDA for its next-generation Tigereye ST chronic total occlusion (CTO) crossing system. This device enhances Avinger's image-guided product line with improved tip configuration and catheter shaft design aimed at increasing procedural success in complex lesions. The Tigereye ST features real-time intravascular imaging, user-controlled deflection, and a low crossing profile suitable for treating peripheral vessel lesions. A limited launch is set for the current quarter, with full commercial availability expected by Q3 2023. Avinger's technology allows precise control during procedures, ensuring better patient outcomes while minimizing radiation exposure. The company's commitment to improving treatment for over 12 million PAD patients in the U.S. underlines the significance of this advancement.
Avinger, Inc. (NASDAQ:AVGR) reported its fourth quarter and full-year results for 2022, highlighting a revenue of $2.0 million and a gross margin of 34%. The revenue decreased from $2.4 million in Q4 2021 primarily due to a reduced sales headcount. The company has filed an FDA 510(k) submission for the new Pantheris LV device and is preparing for additional product launches in 2023. Operating expenses decreased by 15% year-over-year, amounting to $4.5 million. The net loss for Q4 2022 was $4.2 million, slightly improved from $5.0 million in Q4 2021. As of December 31, 2022, cash and equivalents stood at $14.6 million.
Avinger, Inc. (NASDAQ:AVGR), a medical device company based in Redwood City, CA, announced it will release its financial results for Q4 and full year 2022 on March 15, 2023, after market close. A conference call will follow at 1:30 PM PT/4:30 PM ET, accessible via telephone at +1-973-528-0011 with passcode 514070, and also via live webcast on the company's investor relations page. Avinger specializes in image-guided, catheter-based systems for diagnosing and treating Peripheral Artery Disease (PAD), estimated to impact over 12 million people in the U.S. and 200 million globally.
Avinger, Inc. (NASDAQ:AVGR) announced the submission of a new 510(k) application for Pantheris LV, a next-generation image-guided atherectomy system designed for larger vessels affected by Peripheral Artery Disease (PAD). This system aims to offer enhanced plaque excision speed and user operation. Avinger expects to launch Pantheris LV in the U.S. by the second half of 2023, pending FDA clearance. Additionally, the technology integrates optical coherence tomography to provide real-time imaging, improving procedural accuracy and reducing reliance on X-ray imaging.
Avinger, a medical device company focused on vascular disease, reported $2.3 million in revenue for Q3 2022, a 6% increase from Q2 2022. The company achieved a 35% gross margin, up from 31% in Q2, driven by stronger capital sales. Avinger expanded its Lightbox 3 imaging console usage, completing over 400 cases in more than 50 clinical sites. The company is preparing for 510(k) submissions for the Pantheris LV and Tigereye ST devices while maintaining a cash position of $17.3 million.
Avinger, Inc. (NASDAQ:AVGR) has announced the issuance of seven new patents aimed at enhancing its intellectual property portfolio for image-guided atherectomy systems. The company received four U.S. patents, two European patents, and one Japanese patent in Q2 and Q3 of 2022. This brings Avinger's total to 197 patents, including 54 in the U.S. The new patents reinforce Avinger's position in a competitive market, supporting its mission to innovate treatment for vascular disease, which affects millions globally.
Avinger, Inc. (NASDAQ:AVGR) announced that it will release its third quarter 2022 financial results on November 9, 2022, after market close. The company, known for its innovative catheter-based system that addresses vascular disease, will host a conference call at 1:30 PM PT / 4:30 PM ET. Interested parties can join by phone or via a live webcast available on their website. A replay will be accessible shortly after the call concludes.
Avinger (NASDAQ:AVGR), a medical device company, will have CEO Jeff Soinski at the LD Micro Main Event XV on October 25, 2022, at 10:00 a.m. PT. The event, held at the Luxe Sunset Boulevard Hotel in Los Angeles, will feature live streaming available at this link. Avinger is focused on innovative solutions for Peripheral Artery Disease (PAD), affecting millions worldwide. They invite investors to schedule meetings during the conference through their investor relations.
Avinger (NASDAQ:AVGR) announced promising interim data from the IMAGE-BTK clinical study for its Pantheris SV device at the AMP conference. The study focuses on patients with below-the-knee (BTK) lesions, a significant cause of critical limb ischemia (CLI). Dr. Thomas Davis reported zero complications in the first 24 patients enrolled, with 100% freedom from target vessel restenosis at 6 months. Patency rates were also high, at 96% after 6 months and 93% after 12 months. Avinger aims to complete the study and believes Pantheris SV has the potential to become the new standard of care for treating PAD.
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