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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 (AVGR) reported Q3 2024 revenue of $1.7 million with improved gross margin of 26%. The company implemented cost reductions, reducing headcount by 24% to focus on higher volume accounts and coronary product development. Operating expenses decreased to $4.1 million, leading to a 15% improvement in net loss to $3.7 million. The company filed an IDE pre-submission package with FDA for its coronary CTO-crossing system and launched the Pantheris LV device. Clinical data from IMAGE-BTK study showed strong results with 100% freedom from major adverse events at 30 days.
Avinger (NASDAQ:AVGR), a commercial-stage medical device company specializing in intravascular image-guided catheter-based systems, has scheduled its third quarter 2024 financial results announcement for November 7, 2024, after market close. The company will host a conference call at 1:30pm PT/4:30pm ET. Investors can join via telephone at +1-973-528-0011 using passcode 442577 or through a live webcast available on the company's investor relations webpage. A replay will be available on Avinger's website after the call.
Avinger hosted a webinar featuring key opinion leaders discussing new approaches to treating Peripheral Artery Disease (PAD) Below-the-Knee (BTK). The webinar presented updated data from the IMAGE-BTK study, which evaluated the safety and efficacy of Pantheris SV device in BTK procedures. The study enrolled 51 patients with 58 lesions, with follow-up data on 45 patients at 6 months and 33 patients at 12 months. Results showed 100% freedom from major adverse events at 30 days, 97% freedom from target lesion revascularization, and 94% primary patency at 12 months. The Lumivascular technology incorporates real-time OCT imaging guidance for more accurate navigation during procedures.
Avinger (NASDAQ:AVGR) has announced the issuance of a new U.S. patent and the allowance of five additional U.S. patents, expanding its intellectual property protection for image-guided systems and devices in vascular disease treatment. The newly issued patent, No. 12,089,838, covers an "Atherectomy Catheter with Laterally-Displaceable Tip". The five allowed patents relate to:
- Optical Coherence Tomography for Biological Imaging
- Atherectomy Catheter Drive Assemblies
- Occlusion Crossing Devices
- Atherectomy Catheter with Shaped Distal Tip
With these additions, Avinger now holds 74 issued and allowed patents in the U.S., strengthening its position in the medical device market for vascular disease diagnosis and treatment.
Avinger (NASDAQ:AVGR) has announced the full commercial launch of its Pantheris LV image-guided directional atherectomy system for treating peripheral artery disease (PAD). This follows a successful launch at 16 U.S. clinical centers, involving over 20 interventional physicians. The device features key enhancements including:
- Higher speed plaque excision
- Proprietary jog mechanism for plaque apposition
- Advanced guidewire management system
- Improved tissue packing and removal
Dr. Todd Vogel of University of Missouri Healthcare praised Pantheris LV as the 'interventional tool of choice for most above-the-knee lesions suitable for atherectomy.' Avinger's CEO, Jeff Soinski, highlighted the device's potential to capture market share in above-the-knee procedures, complementing their existing portfolio for PAD treatment.
Avinger (Nasdaq: AVGR) reported Q2 2024 results with revenue of $1.8 million and a gross margin of 20%. The company implemented cost-cutting measures, reducing headcount by 24% to streamline operations. Avinger is progressing with its coronary CTO-crossing system, anticipating IDE submission in Q3 2024. Key financial highlights include:
- Net loss of $4.4 million
- Adjusted EBITDA loss of $3.8 million
- Cash and equivalents of $8.8 million as of June 30, 2024
- Converted $11 million of debt into convertible preferred stock
- Secured up to $24 million in additional growth financing
The company expects improved gross margins and reduced operating costs in H2 2024 due to recent cost-reduction initiatives.
Avinger (Nasdaq: AVGR) has appointed Thomas P. Davis, MD, FACC as Chief Medical Officer for its peripheral business. Dr. Davis, a highly experienced interventional cardiologist and key opinion leader in peripheral vascular space, brings over three decades of expertise to the role. He will work closely with the executive team on clinical strategy and medical affairs initiatives to drive adoption of Avinger's image-guided therapies and foster collaboration with the medical community.
Dr. Davis is a practicing interventional cardiologist focused on peripheral artery disease and non-surgical limb salvage. He also serves as Director of Cardiovascular Research at St. John Hospital and Medical Center in Detroit, Michigan. As a long-time user of Avinger technology, Dr. Davis has witnessed the clinical benefits of real-time image-guidance in terms of safety and long-term efficacy.
Avinger Inc. (Nasdaq: AVGR), a commercial-stage medical device company, has announced it will release its second quarter 2024 financial results on August 8, 2024, after the close of trading. The company will host a conference call at 1:30pm PT/4:30pm ET on the same day. Investors can join the call by dialing +1-848-280-6550 and using the passcode 'Avinger'. A live webcast will be available on the company's investor relations page, and a replay will be posted shortly after the call concludes.
Avinger specializes in marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease.
Avinger announced the closing of a $6 million public offering, with potential gross proceeds of up to $24 million if Series Warrants are fully exercised. The offering included 3,614,457 shares of common stock and Series Warrants (A-1, A-2, A-3) at $1.66 per share. The proceeds will be used for working capital and corporate purposes. H.C. Wainwright & Co. acted as the placement agent. The Series Warrants have varying expiration terms based on FDA approvals. This announcement follows the SEC's approval of the registration statement on June 13, 2024.
Avinger has announced a public offering of 3,614,457 shares of its common stock, along with Series A-1, A-2, and A-3 warrants. Each share and accompanying warrants are priced at $1.66, aiming to raise $6 million upfront. The warrants could generate an additional $18 million if fully exercised, but there are no assurances they will be. The A-1 warrants expire within five years or 60 days post-FDA clearance of a new coronary device. The A-2 warrants expire within 24 months or 60 days post-510(k) clearance, while the A-3 warrants expire within nine months or 60 days post-FDA approval of an IDE application. H.C. Wainwright is the placement agent, and the offering closes around June 17, 2024. Funds will be used for working capital and general corporate purposes.
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