Avinger, Inc. (AVGR): Business Model Canvas [11-2024 Updated]
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Avinger, Inc. (AVGR) Bundle
In the rapidly evolving field of medical technology, Avinger, Inc. (AVGR) stands out with its innovative approach to treating peripheral artery disease (PAD). Leveraging its unique Lumivascular platform technology, Avinger focuses on minimally invasive treatments that enhance procedural success rates for vascular procedures. This blog post delves into the intricacies of Avinger's business model canvas, highlighting their key partnerships, activities, and value propositions that drive their mission to improve patient outcomes in the cardiovascular space.
Avinger, Inc. (AVGR) - Business Model: Key Partnerships
Collaboration with Zylox-Tonbridge for product distribution
Avinger, Inc. has established a strategic collaboration with Zylox-Tonbridge, which includes a License Agreement that grants Avinger rights to commercialize products in the U.S. and Germany. This partnership is structured to provide Avinger with a royalty-bearing revenue stream based on a mid-single to high-single digit percentage of gross revenue, depending on the gross margin of the products sold.
As part of this collaboration, Avinger received approximately $0.2 million and $0.4 million during the three and nine months ended September 30, 2024, respectively, for inventory consumed related to regulatory approvals.
Partnerships with hospitals for product adoption
Avinger focuses on building strong relationships with hospitals and medical centers, which are key customers responsible for purchasing its products. The company’s sales strategy is directed at interventional cardiologists, vascular surgeons, and interventional radiologists, with efforts to engage key opinion leaders in the medical community.
The adoption of Avinger’s products, particularly the Pantheris LV and Tigereye ST, is supported by existing reimbursement codes, facilitating hospital investment in its technology. This strategic focus has been essential in maintaining product utilization among existing users and expanding its market presence.
Relationships with regulatory bodies for product approvals
Avinger actively engages with regulatory bodies to secure product approvals that enable market access. The company received 510(k) clearance from the FDA for the Pantheris device to treat in-stent restenosis, based on clinical trial data. This regulatory achievement expands the addressable market for Avinger’s products, allowing it to cater to high-incidence disease states with limited treatment options.
Additionally, Avinger is pursuing further clinical data programs, such as the IMAGE-BTK study, to evaluate the safety and efficacy of its devices, which is crucial for regulatory approvals and market confidence.
Avinger, Inc. (AVGR) - Business Model: Key Activities
Research and development of medical devices
Avinger, Inc. focuses heavily on research and development (R&D) for innovative medical devices. For the nine months ended September 30, 2024, R&D expenses totalled approximately $3.05 million, a decrease of about 10% from $3.39 million for the same period in 2023. This decline was attributed to the completion of the development of key products such as the Tigereye ST and Pantheris LV, alongside a reduction in headcount. The company’s commitment to R&D is aimed at enhancing its product offerings in the peripheral artery disease (PAD) market, which is critical for sustaining its competitive edge.
Manufacturing catheter-based systems
Avinger manufactures catheter-based systems at its facility in California. The company reported a gross margin of 21% for the nine months ended September 30, 2024, down from 28% in the same period of 2023. Manufacturing costs have seen fluctuations due to labor and material costs, which have increased, impacting the overall cost of revenues that stood at $4.21 million. The company’s strategy includes managing overhead costs effectively, with a focus on increasing production efficiency to improve gross margins in the long term.
| Key Manufacturing Metrics | 2024 (9 months) | 2023 (9 months) |
|---|---|---|
| Cost of Revenues | $4.21 million | $4.12 million |
| Gross Margin | 21% | 28% |
| Stock-based Compensation (Cost of Revenues) | $228,000 | $99,000 |
Sales and marketing to healthcare professionals
The sales and marketing efforts of Avinger are critical for driving product utilization among healthcare professionals. For the nine months ended September 30, 2024, the company reported revenues of $5.36 million, a decrease of 7% compared to $5.75 million in the previous year. This decline reflects a strategic decision made in June 2024 to refocus the sales force on existing high-usage customers rather than expanding into new markets. Additionally, Avinger has reduced its sales personnel from 27 to 18 in its peripheral business, reflecting a 33% cut to streamline operations.
| Sales Performance Metrics | 2024 (9 months) | 2023 (9 months) |
|---|---|---|
| Total Revenues | $5.36 million | $5.75 million |
| Disposable Catheters Revenue | $4.90 million | Decreased by 7% |
| Field Sales Personnel Count | 18 | 27 |
Avinger, Inc. (AVGR) - Business Model: Key Resources
Lumivascular platform technology
The Lumivascular platform technology is a cornerstone of Avinger’s value proposition, providing real-time high-definition imaging for minimally invasive procedures. This platform is designed to enhance the treatment of peripheral artery disease (PAD) through the use of advanced catheter-based systems. The technology enables interventional cardiologists and vascular surgeons to visualize the arterial structure in real-time, improving accuracy and outcomes during procedures.
Skilled workforce with medical device expertise
Avinger employs a skilled workforce with extensive experience in medical device development and commercialization. As of September 30, 2024, the company had reduced its total headcount by approximately 24%, resulting in the loss of 17 employees, aiming to streamline operations while maintaining core competencies necessary for product development and clinical initiatives. The workforce is essential for supporting major product development, particularly for innovations like the Pantheris LV and Tigereye ST devices.
Manufacturing facility in Redwood City, California
Avinger operates a manufacturing facility located in Redwood City, California. This facility is responsible for assembling all catheter products, with critical processes such as coating and sterilization outsourced to specialized vendors. The facility is expected to be sufficient to meet production needs through at least 2025, supporting the growing demand for their catheter systems.
| Key Resource | Description | Financial Impact |
|---|---|---|
| Lumivascular Technology | Real-time high-definition imaging platform for PAD treatment | Expected to enhance procedure outcomes and increase adoption rates |
| Skilled Workforce | Team with expertise in medical device development | Reduction of 17 employees to streamline operations; focus on maintaining core competencies |
| Manufacturing Facility | Located in Redwood City, CA; assembles catheter products | Production capacity sufficient through 2025; supports operational efficiency |
Avinger, Inc. (AVGR) - Business Model: Value Propositions
Real-time high-definition imaging for vascular procedures
Avinger, Inc. offers advanced imaging technology through its Lumivascular platform, which provides real-time high-definition imaging during vascular procedures. This innovation allows physicians to visualize the arterial anatomy and the progress of their interventions, enhancing decision-making and improving patient outcomes. As of September 30, 2024, revenues from the Lightbox imaging consoles and related products amounted to less than $0.1 million, indicating a strategic focus on maximizing utilization among existing users rather than expanding to new markets.
Minimally invasive treatment options for PAD
Avinger specializes in minimally invasive treatment options for Peripheral Artery Disease (PAD), specifically through its proprietary Pantheris atherectomy devices. These devices are designed to remove plaque from arteries while preserving healthy tissue, thereby minimizing recovery time and reducing complications. The company received 510(k) clearance from the FDA for Pantheris in November 2021 to treat in-stent restenosis, expanding its market reach. As of September 30, 2024, revenues from disposable catheters related to these devices decreased by 7% to $4.9 million compared to the previous year, reflecting challenges in the competitive landscape.
Enhanced procedural success with innovative devices
Avinger's innovative devices, such as the Pantheris LV and Tigereye ST, are designed to enhance procedural success rates in treating vascular conditions. These devices leverage advanced imaging technology to guide interventions, thereby increasing the precision and effectiveness of treatments. Research and development expenses for the nine months ended September 30, 2024, were approximately $3.05 million, reflecting the company's commitment to ongoing innovation.
| Value Proposition | Description | Financial Impact |
|---|---|---|
| Real-time High-Definition Imaging | Provides clear visualization during vascular procedures, aiding in accurate intervention. | Revenue of less than $0.1 million from imaging consoles as of September 30, 2024. |
| Minimally Invasive Treatment Options | Utilizes atherectomy devices for plaque removal with reduced recovery times. | Revenue from disposable catheters at $4.9 million, a 7% decrease year-over-year. |
| Enhanced Procedural Success | Innovative devices improve treatment outcomes and procedural success rates. | R&D expenses of $3.05 million for innovation efforts in 2024. |
Avinger, Inc. (AVGR) - Business Model: Customer Relationships
Direct engagement with interventional cardiologists and vascular surgeons
Avinger, Inc. focuses its sales and marketing efforts primarily on interventional cardiologists, vascular surgeons, and interventional radiologists. The company identifies and develops strong relationships with key opinion leaders in these fields. As of September 30, 2024, approximately 94% of Avinger's revenues were derived from the United States. In the three months ended September 30, 2024, one customer represented 20% of revenues. This indicates a concentrated customer base, emphasizing the importance of direct engagement strategies.
Educational programs for healthcare professionals
Avinger invests in educational programs aimed at healthcare professionals to enhance the understanding and utilization of its products. These programs are designed to support the adoption of the Lumivascular technology, including the Pantheris and Tigereye devices. As part of its strategy, Avinger has historically faced fluctuations in revenues due to external factors, such as staffing shortages and competitive labor markets affecting hospitals. However, the company continues to prioritize educational initiatives to bolster its market presence and ensure optimal product usage.
Ongoing support and training for product users
The company provides comprehensive support and training to users of its medical devices, ensuring they can maximize the benefits of the technology. For the nine months ended September 30, 2024, Avinger reported revenues of $5.356 million, a decrease of approximately 7% compared to the same period in 2023. This decline was influenced by a strategic decision to focus on driving utilization among existing customers rather than expanding into new markets. The support and training programs are crucial for maintaining relationships with existing users and enhancing customer satisfaction.
| Metric | Value |
|---|---|
| Revenues (Q3 2024) | $1.650 million |
| Gross Margin (Q3 2024) | 26% |
| Customer Concentration (Top Customer, Q3 2024) | 20% |
| US Revenue Percentage (2024) | 94% |
| Training and Support Initiatives | Ongoing for all product users |
| Revenue Decrease (9 months 2024 vs 2023) | 7% |
Avinger, Inc. (AVGR) - Business Model: Channels
Direct sales force targeting hospitals and clinics
Avinger, Inc. employs a direct sales force that focuses on establishing relationships with hospitals and clinics. This strategy is essential for promoting its catheter products, particularly the Lumivascular technology, which includes the Pantheris and Tigereye systems. The sales force has been strategically reduced, with personnel dedicated to peripheral business decreasing from 27 to 18 as of March 31, 2024, a reduction of 33%. This realignment aims to concentrate efforts on existing high-volume users and enhance utilization within their current customer base, reflecting a shift in focus due to operational adjustments and market conditions.
Online platforms for product information and education
Avinger utilizes online platforms to disseminate product information and provide educational resources to healthcare professionals. This digital engagement is crucial for supporting the adoption of their innovative catheter solutions. The company’s website serves as a central hub for product details, clinical data, and training materials, facilitating informed decision-making among interventional cardiologists, vascular surgeons, and interventional radiologists. In 2024, Avinger is expected to leverage these platforms further to enhance customer engagement and drive product utilization.
Trade shows and medical conferences for visibility
Participation in trade shows and medical conferences is a key channel for Avinger to increase visibility and promote its products. These events allow the company to showcase its advancements in catheter technology and engage directly with potential customers and industry stakeholders. In 2023, Avinger generated revenues of $7.7 million, reflecting the impact of these marketing efforts amidst ongoing market challenges. The company anticipates that continued participation in such events will be vital for sustaining awareness and driving sales growth in a competitive landscape.
| Channel | Details | Impact on Sales |
|---|---|---|
| Direct Sales Force | Targeting hospitals and clinics, personnel reduced to 18 from 27 | Focus on existing high-volume users, aim to increase utilization |
| Online Platforms | Website for product information and education | Enhances customer engagement and supports adoption |
| Trade Shows | Participation in medical conferences | Increases visibility and promotes product advancements |
Avinger, Inc. (AVGR) - Business Model: Customer Segments
Hospitals and medical centers
Avinger, Inc. primarily serves hospitals and medical centers, which are critical customers in the healthcare sector. These institutions are responsible for purchasing Avinger’s devices, particularly the Lumivascular platform products, which include various catheter technologies used in the treatment of peripheral artery disease (PAD). In the nine months ended September 30, 2024, revenues derived from hospitals and medical centers were approximately $5.4 million, reflecting a decrease of 7% compared to the same period in 2023, attributed to a reduction in sales personnel and strategic realignment efforts.
| Customer Segment | Revenue (9 months ended Sept 30, 2024) | Revenue Change (%) | Key Products |
|---|---|---|---|
| Hospitals and Medical Centers | $5.4 million | -7% | Catheters, Lumivascular Platform |
Interventional cardiologists and vascular surgeons
Avinger targets interventional cardiologists and vascular surgeons as key users of their products. These professionals utilize Avinger’s devices during minimally invasive procedures to treat patients with PAD. The company focuses its marketing and sales efforts on building relationships with these healthcare providers, aiming to enhance the adoption of its technologies. For the three months ended September 30, 2024, Avinger reported that revenues from sales to interventional cardiologists and vascular surgeons were approximately $1.65 million.
| Customer Segment | Revenue (3 months ended Sept 30, 2024) | Key User Group | Focus Areas |
|---|---|---|---|
| Interventional Cardiologists and Vascular Surgeons | $1.65 million | Healthcare Providers | Minimally Invasive Procedures |
Patients with peripheral artery disease (PAD)
Patients suffering from PAD represent a crucial segment for Avinger, as the company’s products are designed to improve their quality of care. The total addressable market for PAD treatments is significant, with millions of patients affected globally. In 2024, Avinger anticipated challenges in expanding its market share due to competitive labor markets and reduced sales personnel, which could affect patient access to its technologies. The estimated number of patients with PAD in the U.S. is approximately 8 million, highlighting the potential for growth in this segment.
| Customer Segment | Estimated Affected Patients (U.S.) | Market Potential | Challenges |
|---|---|---|---|
| Patients with PAD | 8 million | High | Competitive Market, Staffing Issues |
Avinger, Inc. (AVGR) - Business Model: Cost Structure
Research and Development Expenses
For the three months ended September 30, 2024, Avinger, Inc. reported research and development (R&D) expenses of $1.086 million, compared to $1.044 million for the same period in 2023. This reflects an increase of approximately 4% year-over-year. The R&D expenses for the nine months ended September 30, 2024, were $3.052 million, down from $3.388 million in 2023, indicating a decrease of about 10%.
Stock-based compensation within R&D amounted to approximately $42,000 for the three months ended September 30, 2024, compared to $24,000 in the same period of 2023. For the nine months, stock-based compensation was $397,000 in 2024 versus $158,000 in 2023.
Manufacturing and Operational Costs
Cost of revenues for the three months ended September 30, 2024 was $1.224 million, down from $1.429 million in the same period of 2023, representing a decrease of approximately 14%. For the nine months ended September 30, 2024, the cost of revenues was $4.209 million, slightly up from $4.117 million in 2023.
The gross margin for the three months ended September 30, 2024 increased to 26%, compared to 21% for the same period in 2023. For the nine months, gross margin decreased to 21% from 28% year-over-year, influenced by production volume fluctuations and rising material costs.
Selling, General, and Administrative Expenses
Selling, general, and administrative (SG&A) expenses for the three months ended September 30, 2024, were reported at $3.009 million, a decrease of 11% from $3.377 million in the same period for 2023. For the nine months, SG&A expenses were $10.980 million, up from $10.261 million in 2023.
Stock-based compensation within SG&A totaled $145,000 for the three months ended September 30, 2024, compared to $159,000 for the same period in 2023. The increase in SG&A expenses for the nine months was attributed to higher third-party professional services and quality assurance expenses.
| Expense Type | Q3 2024 (in thousands) | Q3 2023 (in thousands) | 9M 2024 (in thousands) | 9M 2023 (in thousands) |
|---|---|---|---|---|
| Research and Development | $1,086 | $1,044 | $3,052 | $3,388 |
| Cost of Revenues | $1,224 | $1,429 | $4,209 | $4,117 |
| Selling, General, and Administrative | $3,009 | $3,377 | $10,980 | $10,261 |
Avinger, Inc. (AVGR) - Business Model: Revenue Streams
Sales of catheter-based systems and accessories
Avinger, Inc. generates revenue primarily through the sales of its catheter-based systems and related accessories. For the nine months ended September 30, 2024, revenues from disposable catheters amounted to approximately $4.9 million, reflecting a 7% decrease compared to the same period in 2023. For the three months ended September 30, 2024, sales of disposable catheters were reported at $1.5 million, a decline of 9% year-over-year. The overall revenue trend has been affected by staffing shortages, competitive pressures, and strategic shifts in the sales force's focus.
Service agreements for imaging consoles
Avinger also earns revenue from service agreements associated with its Lightbox imaging consoles. For the nine months ended September 30, 2024, revenues from Lightbox imaging consoles and related services were less than $0.1 million, indicating a slight decline compared to the previous year. The company’s strategy has shifted towards enhancing utilization rates among existing customers rather than expanding the customer base, which has also impacted service agreement revenues.
Potential licensing agreements with partners
While Avinger has not yet fully capitalized on licensing agreements, there is potential for future revenue from partnerships. The company is exploring various collaborations that could lead to licensing opportunities, which would provide an additional revenue stream. Avinger’s innovative technologies, including the Lumivascular platform, position the company favorably for potential licensing agreements in the medical device sector.
| Revenue Stream | Revenue (Q3 2024) | Revenue (Q3 2023) | Revenue Change (%) |
|---|---|---|---|
| Catheter Sales | $1.5 million | $1.65 million | -9% |
| Lightbox Imaging Services | Less than $0.1 million | Less than $0.1 million | Decreased slightly |
| Potential Licensing Revenue | Not yet realized | Not applicable | N/A |
Overall, Avinger’s revenue streams are under pressure due to market dynamics and internal strategic shifts. The focus remains on existing products while exploring new opportunities for revenue generation through licensing and enhanced customer engagement.
Updated on 16 Nov 2024
Resources:
- Avinger, Inc. (AVGR) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Avinger, Inc. (AVGR)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Avinger, Inc. (AVGR)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.