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About Avinger Inc.
Avinger Inc. (NASDAQ: AVGR) is a cutting-edge medical device company revolutionizing vascular disease treatment through its proprietary Lumivascular platform, the only intravascular image-guided system available for therapeutic interventions. Based in Redwood City, California, Avinger designs, manufactures, and markets advanced catheter-based systems that integrate optical coherence tomography (OCT) imaging for real-time guidance during procedures. This innovative approach enhances procedural precision, safety, and outcomes while minimizing radiation exposure for patients and healthcare providers.
Core Products and Technology
Avinger’s product portfolio is built around its Lumivascular platform, which includes:
- Lightbox Imaging Consoles: Portable systems providing high-resolution intravascular imaging in real-time.
- Pantheris Atherectomy Devices: Image-guided tools designed for precise plaque removal in PAD patients.
- Ocelot and Tigereye Catheters: Specialized devices for crossing chronic total occlusions (CTOs) in peripheral arteries.
The company is also expanding into coronary applications, developing an OCT-guided CTO-crossing system aimed at addressing unmet needs in the coronary artery disease market.
Market Position and Strategic Initiatives
Operating in the medical device industry, Avinger addresses significant global health challenges, including Peripheral Artery Disease (PAD), which affects over 200 million people worldwide, and Coronary Artery Disease (CAD). The company differentiates itself through its proprietary technology, which combines imaging and therapy in a single platform, offering unique advantages over conventional methods that rely solely on X-ray imaging and tactile feedback.
Avinger has strategically partnered with Zylox-Tonbridge to enter the Greater China market, a region with an estimated 50 million PAD patients. This collaboration includes technology transfer, manufacturing scale-up, and distribution agreements, positioning Avinger for international growth.
Competitive Landscape and Differentiators
In a competitive landscape dominated by large medical device companies, Avinger stands out with its focus on innovation and intellectual property. The company holds 74 issued and allowed patents in the U.S., covering its OCT imaging systems and therapeutic devices. This robust IP portfolio underscores Avinger’s commitment to maintaining a competitive edge through technological advancements.
Challenges and Opportunities
While Avinger faces challenges such as achieving cost efficiency and navigating regulatory pathways, its focus on coronary applications and strategic cost reductions in its peripheral business highlight its adaptability. The company’s ability to leverage established reimbursement codes for coronary CTO-crossing and OCT diagnostic imaging is expected to accelerate adoption of its coronary solutions.
Conclusion
Avinger Inc. is at the forefront of transforming vascular disease treatment through its image-guided technologies. With a focus on innovation, global expansion, and addressing unmet medical needs, the company is well-positioned to redefine standards of care in both peripheral and coronary interventions.
Avinger, a commercial-stage medical device company, reported a revenue of $2.1 million for Q2 2022, marking a 13% increase from Q1 2022 but a decrease from $2.8 million in Q2 2021. The gross margin improved to 31%. The company launched the Lightbox 3 imaging console, filed a 510(k) for the Tigereye ST catheter, and advanced development of the Pantheris LV. Avinger maintained a cash position of $16 million and raised an additional $5 million in August 2022. The net loss for Q2 2022 was $4.2 million, a reduction from $5.1 million in Q1 2022.
Avinger, Inc. (NASDAQ:AVGR) announced a definitive agreement for a registered direct offering and private placement, totaling approximately $5 million in gross proceeds. The company will issue 1,484,019 shares of common stock and 1,369,864 shares in a private placement at a price of $1.752 per share. Avinger intends to use the net proceeds for working capital, R&D, and potentially acquiring complementary products. The offerings are expected to close around August 8, 2022.
Avinger, Inc. (NASDAQ:AVGR) announced the submission of a 510(k) application to the FDA for its Tigereye ST catheter, an advanced system for treating Peripheral Artery Disease (PAD). This next-gen catheter features an innovative design that enhances crossing capabilities across chronic total occlusions (CTOs). With a working length of 140 cm, the device is compatible with 5 French sheaths, aiming to improve patient outcomes. CEO Jeff Soinski highlights that this device could significantly boost growth, building on a 47% increase the previous year in their CTO business.
Avinger, a medical device company focused on Peripheral Artery Disease (PAD), announced its expansion into the Chilean market with the launch of the Lumivascular product line.
The exclusive distribution agreement with Importadora y Distribuidora Arquimed Ltda will facilitate the sale of Avinger's Lightbox 3 imaging console and associated catheters. The Lightbox 3 is designed to enhance imaging capabilities during procedures, potentially improving patient outcomes without using ionizing radiation.
This move reflects Avinger's strategic growth and commitment to bringing innovative medical technologies to new regions.
Avinger, Inc. (NASDAQ:AVGR) showcased its Lumivascular technology at the Leipzig Interventional Course (LINC) 2022, held June 6-9, highlighting advancements in treating Peripheral Artery Disease (PAD). Key presentations by Dr. Arne Schwindt and Dr. Michael Lichtenberg emphasized the efficacy of the Pantheris OCT-guided atherectomy system in addressing in-stent restenosis with an impressive 93% freedom from target lesion revascularization at six months. A live case demonstrated successful treatment outcomes, reinforcing the technology's role in improving patient care while minimizing radiation exposure.
Avinger, Inc. (NASDAQ:AVGR) announced two podium presentations at the New Cardiovascular Horizons (NCVH) conference, featuring its Lumivascular technology for treating Peripheral Artery Disease (PAD). Key cardiologists highlighted Avinger's OCT-guided systems, demonstrating significant clinical results. Notably, the Pantheris SV showed 93% freedom from revascularization and 94% patency after 12 months. The technology enhances procedural safety and efficacy, reducing radiation exposure for healthcare workers. Avinger aims to revolutionize PAD treatment with its proprietary imaging devices.
Avinger, Inc. (Nasdaq:AVGR) held a significant presentation featuring its Lumivascular technology at the CLI Congress and Masterclass Münster in Germany. Dr. Arne Schwindt highlighted the effectiveness of the Pantheris OCT-guided atherectomy device in treating critical limb ischemia (CLI), showcasing successful patient outcomes. Avinger's platform is designed to provide real-time imaging during procedures, enhancing the precision of treatment for Peripheral Artery Disease (PAD). Avinger aims to reduce amputations through its innovative approach, which currently addresses a significant global health issue affecting over 200 million people.
Avinger, Inc. (NASDAQ:AVGR) reported first-quarter 2022 revenue of $1.9 million, down from $2.6 million in the same period last year, impacted by COVID-19-related hospital staffing shortages. The gross margin decreased to 28%, compared to 35% in Q1 2021. Operating expenses slightly reduced to $5.2 million, while the net loss remained consistent at $5.1 million. The company maintained a cash position of $20.0 million, bolstered by a $7.6 million capital raise in January 2022. Avinger has launched its Lightbox 3 imaging console and is progressing with new catheter developments.
Avinger, Inc. (Nasdaq: AVGR) will announce its Q1 2022 financial results on May 10, 2022, after market close. The company, focused on Peripheral Artery Disease (PAD)Avinger's website.
Avinger, Inc. (NASDAQ:AVGR) announced the full commercial availability of its Lightbox 3 imaging console, designed to enhance vascular disease treatment. Following FDA's 510(k) clearance in January, the product has been used at 12 clinical sites with positive physician feedback. The Lightbox 3 offers high-definition imaging, reducing reliance on contrast dye and improving operational efficiency. Its portability aims to accelerate new user adoption, contributing to increased productivity for Avinger's field teams and promoting device utilization.
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