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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 the expansion of its limited launch for the Tigereye™ image-guided chronic total occlusion (CTO) crossing system in the U.S. and Germany. After receiving FDA clearance, Avinger successfully completed over 40 cases across 10 clinical sites as of December 2020. The company anticipates a full U.S. commercial launch in January 2021, citing positive clinical results and strong user confidence in the device. Tigereye features advanced imaging technology, enabling better navigation during procedures, and aims to significantly enhance treatment options for Peripheral Artery Disease (PAD).
Avinger, Inc. (NASDAQ:AVGR) has been granted an extension until May 19, 2021, to meet Nasdaq's minimum bid price compliance requirement. The company aims to achieve compliance either through stock price growth or a proposed reverse stock split, with a ratio between 1-for-5 and 1-for-20. Avinger's management urges shareholders to vote FOR this proposal during the December 10 annual meeting. The company highlighted progress in 2020, including FDA clearance of new products and a strong balance sheet, positioning Avinger for growth despite challenges posed by the COVID-19 pandemic.
Avinger, Inc. (NASDAQ:AVGR) has launched its Lumivascular products in Israel, marking its entry into the Israeli healthcare market. The company signed an exclusive distribution agreement with Neopharm Medical Supplies for its Pantheris atherectomy and Ocelot CTO devices. Regulatory registration was completed in July, with initial patient cases successfully carried out in October. Avinger's CEO emphasized the advancement in treating Peripheral Artery Disease (PAD) through the unique imaging capability of their devices, aiming to reduce complications compared to traditional therapies.
Avinger, Inc. (NASDAQ:AVGR) will release its Q3 2020 financial results on November 10, 2020, after market close. A conference call is scheduled for 1:30 PM PT (4:30 PM ET) where details will be discussed. Avinger specializes in catheter-based systems for diagnosing and treating Peripheral Artery Disease (PAD), impacting over 12 million people in the U.S. The company aims to transform vascular disease treatment through its Lumivascular platform. A live webcast will be available on their investor relations page.
Avinger, Inc. (NASDAQ:AVGR) has announced that physicians in three U.S. centers successfully treated patients using the TIGEREYE™ image-guided chronic total occlusion (CTO) crossing system. The device, part of a limited launch at up to 10 top clinical sites, offers enhanced imaging and steerability, promising improved outcomes for patients with Peripheral Artery Disease (PAD). Avinger anticipates a full commercial rollout in Q1 2021, aiming to significantly expand their position in the CTO segment.
Avinger, Inc. (NASDAQ:AVGR) announced FDA clearance for its TIGEREYE system, an innovative next-generation image-guided chronic total occlusion (CTO) crossing device. This launch, expected in early 2021, enhances the company's offerings in treating Peripheral Artery Disease with real-time imaging capabilities. CEO Jeff Soinski emphasized TIGEREYE's potential to drive growth in their CTO-crossing business, bolstered by a robust financial position with over $25 million in cash. This advancement follows the company's recent product launches and seeks to expand their market presence.
Avinger, Inc. (NASDAQ:AVGR) has announced the full exercise of the underwriter's option to purchase an additional 1,000,000 shares of common stock at $0.47 per share. This results in total gross proceeds of approximately $5.67 million, before any deductions. The offering was made under a previously filed shelf registration statement with the SEC. Aegis Capital Corp. acted as the sole bookrunner for this offering. Avinger, which focuses on innovative treatment solutions for Peripheral Artery Disease (PAD), remains committed to advancing its Lumivascular platform.
Aegis Capital Corp. has acted as the Sole Bookrunner for a $5.2 million follow-on offering for Avinger Inc. (NASDAQ:AVGR). Avinger is a medical device company focusing on image-guided systems for the diagnosis and treatment of Peripheral Artery Disease (PAD), which affects over 12 million people in the U.S. Avinger's Lumivascular platform comprises the Lightbox imaging console, Ocelot CTO catheters, and Pantheris atherectomy devices, aiming to revolutionize vascular disease treatment.
Avinger, Inc. (NASDAQ: AVGR) announced the closing of an underwritten public offering of 11,063,830 shares of common stock at $0.47 per share, resulting in gross proceeds of approximately $5.2 million. An additional 1,000,000 shares may be purchased by underwriters for overallotments. These shares were offered under a previously filed shelf registration statement with the SEC. The proceeds aim to support the development of Avinger’s Lumivascular platform, designed for treating Peripheral Artery Disease (PAD).
Avinger, Inc. (NASDAQ:AVGR) announced that underwriters exercised their option to purchase an additional 2,368,421 shares at $0.38 per share, raising total gross proceeds to approximately $6.9 million. This follows a prior underwritten public offering. The shares were offered under a shelf registration declared effective by the SEC. Aegis Capital Corp. served as the sole bookrunner. Avinger is committed to innovating treatment for Peripheral Artery Disease (PAD), affecting over 12 million people in the U.S.