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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, Inc. (NASDAQ:AVGR) announced the issuance of three new U.S. patents in March 2022, enhancing its intellectual property portfolio to 187 patents and pending applications. The patents strengthen coverage for Avinger's proprietary OCT imaging platform and its Pantheris and Tigereye devices. This expansion comes as Avinger aims to introduce new products, including the Lightbox 3 imaging console, and file 510(k) applications for two new devices in 2022. Avinger plans to leverage its growing portfolio to secure a competitive advantage in the vascular disease treatment market.
Avinger, Inc. (NASDAQ:AVGR), a medical device firm, announced on March 29, 2022, that it has regained compliance with Nasdaq listing requirements. The Nasdaq notified the company that it has met the minimum bid price rule necessary for continued listing on the Nasdaq Capital Market. Avinger is known for its innovative intravascular image-guided catheter-based systems for the diagnosis and treatment of Peripheral Artery Disease (PAD), which affects millions globally. The company aims to transform vascular disease treatment through its Lumivascular platform.
Avinger, a medical device company, reported a 16% revenue increase in 2021, totaling $10.1 million. Q4 revenue was $2.4 million, impacted by COVID-19. Gross margin improved to 34% for the year. The company received 510(k) approval for Pantheris to treat in-stent restenosis and launched the Lightbox 3 imaging console. Despite challenges from hospital constraints and staffing shortages, they maintained a strong cash position of $19.5 million as of year-end 2021. A reverse stock split occurred on March 14, 2022, for Nasdaq compliance.
Avinger, Inc. (NASDAQ:AVGR) will announce its Q4 and full year 2021 financial results after the market closes on March 22, 2022. The company specializes in treating Peripheral Artery Disease (PAD) with its unique intravascular image-guided, catheter-based system. A conference call will follow at 1:30 PM PT / 4:30 PM ET, which can be accessed via telephone or live webcast on Avinger's investor relations page. A recording will be available post-call on their website.
Avinger, Inc. (NASDAQ:AVGR) announced a 1-for-20 reverse stock split effective March 14, 2022, at 5:00 p.m. Eastern time. This is aimed at meeting Nasdaq's $1.00 minimum bid price requirement for continued listing and fulfilling obligations related to new Series D Preferred Stock and warrants. Following the split, outstanding shares will decrease from approximately 95.6 million to 4.8 million. Proportional adjustments will be made to options and warrants. The common stock will trade on a reverse split basis starting March 15, 2022.
Avinger, Inc. (NASDAQ: AVGR) has announced the deployment of its Lightbox 3 imaging console in four more hospitals across Pennsylvania and New Jersey, enhancing patient treatment for Peripheral Artery Disease (PAD). The Lightbox 3 allows real-time, high-definition intravascular imaging, which has shown improved clinical outcomes. With its portable design, setup is quick and easy, promoting efficiency in treatment. Following FDA clearance, Avinger anticipates full commercial availability in early Q2 2022, opening new revenue opportunities for its innovative medical technology.
Avinger, Inc. (NASDAQ:AVGR) has successfully completed its first cases using the newly launched Lightbox 3 imaging console designed for treating Peripheral Artery Disease (PAD). The Lightbox 3 received FDA 510(k) clearance in January 2022, and its limited rollout is set to expand by Q2 2022. In initial procedures, performed by Dr. Golzar and Dr. Cawich, positive outcomes were reported for all 15 patients treated. The console offers enhanced imaging and a user-friendly interface, promising improved clinical workflows and reduced reliance on contrast dye for patient safety.
Avinger, Inc. (NASDAQ:AVGR) has closed a registered direct offering of 7,600 shares of Series D convertible preferred stock and warrants, raising $7.6 million in gross proceeds. The preferred stock, convertible into 19,000,000 shares of common stock at $0.40, will only convert post a reverse stock split. The warrants allow purchase of up to 16,150,000 shares at $0.48, exercisable after the split amendment. Proceeds will be used for general corporate purposes. A special meeting is expected for stockholder approval of the reverse split.
Avinger, Inc. (NASDAQ:AVGR) announced a registered direct offering of 7,600 shares of Series D convertible preferred stock and warrants to purchase 16,150,000 shares of common stock, targeting gross proceeds of $7.6 million. The preferred shares are convertible into 19 million shares at a price of $0.40 per share, subject to a reverse stock split. With H.C. Wainwright & Co. as the placement agent, the proceeds will be applied to general corporate purposes. A special stockholder meeting is planned to approve the reverse split amendment, affecting the offering's timeline.
Avinger, Inc. (NASDAQ:AVGR) announced 510(k) FDA clearance for its new Lightbox 3 imaging console, enhancing imaging capabilities for treating Peripheral Artery Disease (PAD). The console is notably smaller, portable, and cost-effective, designed to boost account acquisition and streamline technology adoption in PAD centers. Anticipated to launch in early Q1 2022, Lightbox 3 features advanced imaging and a user-friendly interface, promising improved patient outcomes. Avinger is dedicated to revolutionizing vascular disease treatment with its Lumivascular technology.
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