Exhibit 1.01
CONFLICT MINERALS REPORT OF
AVINGER
FOR THE REPORTING PERIOD FROM
JANUARY 1 TO DECEMBER 31, 2022
I. | Introduction |
This is the Conflict Minerals Report of Avinger, Inc. (“we,” “our,” “Avinger,” or the “Company”) prepared for calendar year 2022 in accordance with Rule 13p-1 (“Rule 13p-1”) under the Securities Exchange Act of 1934 (the “Act”). Numerous terms in this Report are defined in Rule 13p-1 of the Act and SEC Release No. 34-67716 (August 22, 2012) under the Act (the “Adopting Release”). The reader is referred to these sources for the definitions of defined terms contained herein.
In accordance with Rule 13p-1, we undertook efforts to determine the presence and source of the conflict minerals within our products. The Company designed its efforts in conformity with the internationally recognized due diligence framework set forth in the Organisation for Economic Co-operation and Development (“OECD”) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (“OECD Due Diligence Guidance”) and related Supplements.
The statements below are based on the activities performed to date in good faith by the Company and are based on the infrastructure and information available at the time of this filing. Factors that could affect the accuracy of these statements include, but are not limited to, incomplete supplier data or available smelter data, errors or omissions by suppliers or smelters, evolving identification of smelters, incomplete information from industry or other third-party sources, continuing guidance regarding the SEC final rules, and other issues. We have not yet received information from certain of the Company’s suppliers regarding smelters and refiners involved in the supply chain for raw materials they provide for our products. We will continue working with such suppliers to identify any additional smelters and refiners.
II. | Overview |
Company Profile
We are a commercial-stage medical device company that designs, manufactures, and sells real-time high-definition image-guided, minimally invasive catheter-based systems that are used by physicians to treat patients with peripheral artery disease (“PAD”). Patients with PAD have a build-up of plaque in the arteries that supply blood to areas away from the heart, particularly the pelvis and legs. Our mission is to significantly improve the treatment of vascular disease through the introduction of products based on our Lumivascular platform, the only intravascular real-time high-definition image-guided system available in this market.
1 The term “conflict mineral” is defined in Section 1502(e)(4) of the Dodd-Frank Wall Street Reform and Consumer Protection Act as (A) columbite-tantalite, also known as coltan (the metal ore from which tantalum is extracted); cassiterite (the metal ore from which tin is extracted); gold; wolframite (the metal ore from which tungsten is extracted); or their derivatives; or (B) any other mineral or its derivatives determined by the Secretary of State to be financing conflict in the Democratic Republic of the Congo (“DRC”) or an adjoining country.
2 OECD (2016), OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas: Third Edition, OECD Publishing, Paris. http://dx.doi.org/10.1787/9789264252479-en
We design, manufacture, and sell a suite of products in the United States and select international markets. We are located in Redwood City, California. Our current Lumivascular platform consists of products including our Lightbox imaging console, the Ocelot and Tigereye family of devices, which are image-guided devices designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion (“CTO”), and the Pantheris family of catheters, our image-guided atherectomy catheters which are designed to allow physicians to precisely remove arterial plaque in PAD patients.
We received CE Marking for our original Ocelot product in September 2011 and received from the U.S. Food and Drug Administration, or FDA, 510(k) clearance in November 2012. We received 510(k) clearance from the FDA for commercialization of Pantheris in October 2015. We received an additional 510(k) clearance for an enhanced version of Pantheris in March 2016 and commenced sales of Pantheris in the United States and select European countries promptly thereafter. In May 2018, we received 510(k) clearance from the FDA for our current next-generation version of Pantheris. In April 2019, we received 510(k) clearance from the FDA for our Pantheris Small Vessel (“SV”), a version of Pantheris targeting smaller vessels, and commenced sales in July 2019. In September 2020, we received 510(k) clearance of Tigereye, a next-generation CTO crossing system utilizing Avinger’s proprietary image-guided technology platform. Tigereye is a product line extension of Avinger’s Ocelot family of image-guided CTO crossing catheters. In January 2022, we received 510(k) clearance from the FDA for our Lightbox 3 imaging console, an advanced version of our Lightbox that allows for easy portability and offers significant reductions in size, weight, and production cost in comparison to the incumbent version.
In January 2023, we submitted a 510(k) application to the FDA for the Pantheris LV device, a next generation image guided atherectomy system for the treatment of larger vessels, such as the superficial femoral artery (“SFA”) and popliteal arteries. Pantheris LV is a line extension of our Pantheris and Pantheris SV family of atherectomy products. This catheter offers higher speed plaque excision for efficient removal of challenging occlusive tissue and multiple features to streamline and simplify user-operation, including enhanced tissue packing and removal, a radiopaque gauge to measure volume of plaque excised during the procedure, and enhanced guidewire management.
In April 2023, we received 510(k) clearance from the FDA for Tigereye Spinning Tip (“ST”), a next-generation image-guided CTO crossing system. Tigereye ST is a line extension of our Ocelot and Tigereye family of CTO crossing catheters. This new image-guided catheter incorporates design upgrades to the tip configuration and catheter shaft to increase crossing power and procedural success in challenging lesions, as well as design enhancements for ease of image interpretation during the procedure. The low-profile Tigereye ST has a working length of 140 cm and 5 French sheath.
We are subject to this rule as we have determined that, during 2022, conflict minerals were likely necessary to the functionality or production of products we manufactured or contracted to manufacture. The Company, as a purchaser of component parts, is many steps removed from the mining of conflict minerals. We do not purchase raw ore or unrefined conflict minerals and we conduct no purchasing activities directly in the DRC or adjoining countries.
Conflict Minerals Policy
The Company developed a policy statement to support the goals expressed by Congress in enacting Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The policy highlights the Company’s commitment to complying with the reporting and due diligence obligations required by the SEC rule and the Company’s expectations from its suppliers. In addition, the policy includes language encouraging suppliers to source responsibly. The policy resides on our corporate website at https://irdirect.net/AVGR/corporate_governance.
Reasonable Country of Origin Inquiry Information
We have conducted a good faith reasonable country of origin inquiry (“RCOI”) to determine whether the necessary conflict minerals originated in the DRC or an adjoining country or came from recycled or scrap sources.
The Company’s RCOI process included reviewing the products manufactured or contracted to be manufactured during the Reporting Period to identify products that should be deemed in-scope as described by the Adopting Release and conducting an inquiry of our direct suppliers of the in-scope products using the Responsible Minerals Initiative’s (“RMI”) Conflict Minerals Reporting Template (“CMRT”). Based on the results of our RCOI which indicated sourcing from the DRC or an adjoining country, we exercised due diligence on the source and chain of custody of the conflict minerals in accordance with the OECD Due Diligence Guidance. Our due diligence efforts are discussed further in this Conflict Minerals Report.
Due Diligence Program Design
The Company designed its conflict minerals program to conform, in all material respects, with the five-step framework of the OECD Due Diligence Guidance, the Supplement on Tin, Tantalum, and Tungsten, and the Supplement on Gold, specifically as they relate to our position in the minerals supply chain as a “downstream” company:
Step 1: | Establish strong company management systems |
Step 2: | Identify and assess risks in the supply chain |
Step 3: | Design and implement a strategy to respond to identified risks |
Step 4: | Carry out independent third-party audit of smelter/refiner's due diligence practices |
Step 5: | Report annually on supply chain due diligence |
III. | Due Diligence Measures Performed by The Company |
The following describes the measures taken to reasonably determine the country of origin and to exercise due diligence in the mineral supply chain in conformance with the OECD Due Diligence Guidance.
Step 1: Establish strong company management systems
a. | Conflict minerals team – The Company established a conflict minerals team that includes individuals from the relevant business units and departments, including Quality, Operations, Finance, procurement, and legal. The team was structured to include the involvement from those in upper management roles, including the VP Finance, VP of Quality and Director of Operations and Service, to ensure that critical information, including the Company’s conflict minerals policy, reached relevant employees and suppliers. |
b. | Conflict minerals policy – The Company adopted and published a policy establishing expectations for our suppliers. The policy resides on our corporate website at https://irdirect.net/AVGR/corporate_governance. |
c. | Internal engagement – We developed a training program to educate employees on our conflict minerals process, the goals of our program, and our reporting obligations as a supplier and a public filer. |
d. | Supplier engagement – The Company communicated its conflict minerals policy and provided educational materials to our in-scope suppliers. Suppliers were informed when the request for information was initiated on the conflict minerals disclosure requirements as well as recommendations for developing, implementing, and documenting a conflict minerals compliance program. |
e. | Records management – The Company will maintain records relating to our conflict minerals program in accordance with the recommended record retention guidelines of five years. |
Step 2: Identify and assess risks in the supply chain
We performed the following steps as part of our risk assessment process:
a. | Identified products in scope – Our conflict minerals team conducted a detailed review of the products manufactured or contracted to be manufactured during the Reporting Period to identify products that should be deemed in-scope as described by the Adopting Release. |
b. | Conducted RCOI – The Company utilized the industry-developed CMRT to query our suppliers for conflict minerals information. We requested this information from the Tier 1 suppliers who provide materials and components for the products deemed in-scope by our conflict minerals team. We evaluated the responses from the templates submitted by our suppliers to determine our reporting obligation based on this RCOI. We have not yet received information from certain of the Company’s suppliers regarding smelters and refiners involved in the supply chain for raw materials they provide for our products. We will continue working with such suppliers to identify any additional smelters and refiners. |
c. | Completed additional follow-up – The Company contacted 5 direct suppliers with all providing the requested information prior to our filing. We also worked to clarify and validate the accuracy of information provided by our suppliers. We are also continuing to work with certain suppliers to identify any additional smelters and refiners. |
d. | Identified smelters or refiners (“SORs”) – The Company compiled a list of SORs in our supply chain using our suppliers’ responses in their CMRTs. The Company reconciled this list to the list of smelter facilities designated by the RMI’s Responsible Minerals Assurance Process (“RMAP”). The RMAP completes independent, third-party audits of smelters and refiners to determine which can be validated as having systems in place that ensure the minerals are responsible sourced according to the OECD Due Diligence Guidance. The Company works with a third party expert in the area of Conflict Minerals to reconcile suppliers’ smelters lists to the list of RMI SORs. We have provided the list of SORs in our supply chain in this report within section IV – Product Description; Processing Facilities. We also have provided the country of origin details for the smelters in use by our suppliers in Appendix 1. |
Step 3: Design and implement a strategy to respond to identified risks
We performed the following steps as part of our risk management plan:
a. | Reporting results to senior management – The Conflict Minerals team reports to the results of our RCOI to upper management which included the team’s plan to respond to risks identified in the due diligence processes. |
b. | Identified SORs – As part of the risk mitigation process, the Company reconciled the list of SORs collected from suppliers to the list of smelter facilities validated by the RMI. |
Step 4: Carry out independent third-party audit of smelter/refiner's due diligence practices
The Company is using information provided by independent third party audit programs, including the RMI, London Bullion Market Association (LBMA), and Responsible Jewelry Council (RJC), to confirm the existence and verify the OECD-conformance status of SORs identified during our due diligence.
Step 5: Report annually on supply chain due diligence
Accordingly, this Conflict Minerals Report has been filed with the SEC and is available on our website at https://irdirect.net/AVGR/sec_filings.
IV. | Product Description; Processing Facilities |
Product Description – Our business is managed and reported on a product basis as follows:
Our current products include our Lightbox imaging console and our various catheters used in PAD treatment. All of our revenues are currently derived from sales of our various PAD catheters in the United States and select international markets, Lightbox consoles, as well as related services. Each of our current products is, and our future products will be, designed to address significant unmet clinical needs in the treatment of vascular disease.
Processing Facilities – Based on our due diligence process and the information received from our suppliers, the following facilities were identified by the Company’s suppliers as the smelters and refiners of the tin, tantalum, tungsten and/or gold present in and necessary to the functionality of products manufactured by the Company in the calendar year ended December 31, 2022. The information from our suppliers is still evolving and may contain company-level declarations. We have not yet received information from certain of the Company’s suppliers regarding smelters and refiners involved in the supply chain for raw materials they provide for our products. We will continue working with such suppliers to identify any additional smelters and refiners. As such, this smelter list is presented in good faith as the best information we have to date. This list may contain smelters that are not in our supply chain and/or there may be other smelters not yet identified in our due diligence process. We will continue to update the list as our information and the relevant third-party data from RMI, LBMA, and RJC improves.
Metal | Smelter Name | Country | Smelter ID |
Gold | Royal Canadian Mint | CANADA | CID001534 |
Gold | Metalor USA Refining Corporation | UNITED STATES OF AMERICA | CID001157 |
Gold | Umicore S.A. Business Unit Precious Metals Refining | BELGIUM | CID001980 |
Gold | United Precious Metal Refining, Inc. | UNITED STATES OF AMERICA | CID001993 |
Tin | Minsur | PERU | CID001182 |
Tin | Thaisarco | THAILAND | CID001898 |
Gold | Zhongyuan Gold Smelter of Zhongjin Gold Corporation | CHINA | CID002224 |
Gold | Yunnan Copper Industry Co., Ltd. | CHINA | CID000197 |
Tin | Yunnan Tin Company Limited | CHINA | CID002180 |
Tin | Yunnan Chengfeng Non-ferrous Metals Co., Ltd. | CHINA | CID002158 |
V. | Future Due Diligence |
We will continue to communicate our expectations and information requirements to our direct suppliers. We are also continuing to work with certain suppliers to identify any additional smelters and refiners. Over time, we anticipate that the amount of information available globally on the traceability and sourcing of these ores will increase and improve our knowledge. We will continue to make inquiries to our direct suppliers and undertake additional risk assessments when potentially relevant changes in facts or circumstances are identified. If we become aware of a supplier whose due diligence needs improvement, we may continue the trade relationship while that supplier improves its compliance program. We expect our suppliers to take similar measures with their suppliers to ensure alignment throughout the supply chain.
In addition to those above, the Company will undertake the following steps during the next compliance period:
● | Review the conflict minerals policy statement and update if necessary. |
● | Continue to collect responses from suppliers using the most recent revision of the CMRT. |
● | Engage with suppliers and continue to facilitate a timely response while ensuring completeness and accuracy of the information provided to enhance our data collection for calendar year 2023, if any. |
● | Monitor and track performance of risk mitigation efforts. |
● | Compare and validate RCOI results to information collected via independent third-party audit programs, such as the RMI, and through our Company’s own coordinated outreach to smelters. |
● | Encourage responsible sourcing from the DRC and adjoining countries. |
APPENDIX I – Countries of Origin
The information provided in this Appendix is based on the information collected from the Company’s suppliers.
BELGIUM |
CANADA |
CHINA |
PERU |
THAILAND |
UNITED STATES OF AMERICA |
