S-1: Avinger Eyes Capital Injection with Proposed Common Stock and Warrant Offering
S-1 Filing
Avinger, Inc. files for a potential offering of common stock and warrants to bolster working capital and general corporate purposes.
Summary
- Avinger, Inc. has filed a registration statement for a proposed offering of shares of common stock, pre-funded warrants, common warrants, and placement agent warrants.
- The offering includes up to shares of common stock, pre-funded warrants to purchase up to shares of common stock, common warrants to purchase up to shares of common stock, and placement agent warrants to purchase up to shares of common stock.
- The company intends to use the net proceeds from this offering for working capital and general corporate purposes.
- The assumed combined public offering price for each share of common stock and accompanying common warrant is $, based on the last sale price of Avinger's common stock on Nasdaq on , 2024.
- The offering will terminate on , 2024, unless Avinger decides to terminate it earlier.
- The placement agent for the offering is .
- Avinger has experienced recurring operating losses and negative cash flows and expects to continue to do so for the foreseeable future.
- The company generated revenues of $7.7 million in 2023, $8.3 million in 2022 and $10.1 million in 2021.
- Avinger has been granted an extension by Nasdaq to regain compliance with the minimum stockholders' equity requirement until May 20, 2024.
Sentiment
Score: 4
Explanation: The document highlights both positive developments (strategic collaborations, FDA clearances) and significant challenges (recurring losses, declining revenue, Nasdaq compliance issues, going concern uncertainty). The need for a capital raise suggests financial strain, leading to a moderately negative sentiment.
Positives
- Avinger has a strategic collaboration with Zylox-Tonbridge for distribution in Greater China and access to peripheral vascular products for distribution in the U.S. and Germany.
- The company has received multiple FDA 510(k) clearances for its Lumivascular platform products, including Tigereye ST and Pantheris LV.
- Avinger has extended its lease agreement for its facility in California through November 2025.
Negatives
- Avinger has experienced recurring operating losses and negative cash flows.
- The company's revenues have declined in recent years.
- There is substantial doubt about Avinger's ability to continue as a going concern.
- Avinger is not currently in compliance with Nasdaq's minimum stockholders' equity requirement.
- The company may need to raise additional funds through future equity or debt financings in the near future to meet its operational needs and capital requirements for product development, clinical trials and commercialization.
Risks
- Investing in Avinger's securities involves a high degree of risk.
- There is substantial doubt about Avinger's ability to continue as a going concern.
- The company will need additional financing to execute its business plan.
- Avinger may not be able to regain and remain in compliance with Nasdaq listing requirements.
- The company may experience future dilution as a result of future equity offerings or other equity issuances.
- The market price of Avinger's common stock may be volatile.
- The company has a significant number of warrants outstanding, which may cause significant dilution to stockholders.
- CRG and Zylox-Tonbridge have the ability to exert significant control over Avinger's business due to their substantial interest in the company.
Future Outlook
Avinger intends to use the net proceeds from this offering for working capital and general corporate purposes and expects its current manufacturing facility in California to be sufficient through at least 2024.
Industry Context
The market for medical devices in the coronary artery disease (CAD) space is highly competitive, dynamic, and marked by rapid and substantial technological development and product innovation.
Stakeholder Impact
- The offering will dilute existing shareholders' ownership.
- The company's ability to continue as a going concern impacts employees, suppliers, and customers.
- The success of the offering will determine the company's ability to execute its business plan.
Next Steps
- Avinger will deliver the Securities to be issued in connection with this offering delivery versus payment or receipt versus payment, as the case may be, upon receipt of investor funds received by us.
- Avinger intends to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and U.S. government securities.
Key Dates
| Date | Description |
|---|---|
| March 8, 2007 | Avinger, Inc. was incorporated in Delaware. |
| September 2011 | CE Marking obtained for original Ocelot product. |
| November 2012 | FDA 510(k) clearance received for original Ocelot product. |
| October 2015 | FDA 510(k) clearance received for Pantheris. |
| March 2016 | FDA 510(k) clearance received for an enhanced version of Pantheris. |
| May 2017 | Data collection completed for VISION clinical trial patients at 12 and 24 months. |
| July 2017 | Final 12and 24-month results released for VISION clinical trial. |
| May 2018 | FDA 510(k) clearance received for next-generation version of Pantheris. |
| April 2019 | FDA 510(k) clearance received for Pantheris Small Vessel (SV). |
| July 2019 | Sales of Pantheris SV commenced. |
| September 2020 | FDA 510(k) clearance received for Tigereye. |
| January 2022 | FDA 510(k) clearance received for Lightbox 3 imaging console. |
| November 2021 | FDA 510(k) clearance received for treating in-stent restenosis with Pantheris. |
| April 2023 | FDA 510(k) clearance received for Tigereye Spinning Tip (ST). |
| Second quarter 2023 | Limited launch of Tigereye ST initiated. |
| June 2023 | FDA 510(k) clearance received for Pantheris Large Vessel (LV). |
| Third quarter 2023 | Full commercial availability of Tigereye ST within the United States; limited launch of Pantheris LV initiated. |
| September 12, 2023 | Reverse stock split (1-for-15) became effective. |
| March 4, 2024 | License and Distribution Agreement and Strategic Cooperation and Framework Agreement entered into with Zylox-Tonbridge. |
| March 5, 2024 | Initial Closing of Private Placement with Zylox-Tonbridge; Series A Preferred Stock Exchange; CRG Loan Amendment. |
| March 6, 2024 | Lease extension agreement signed. |
| May 16, 2024 | Securities Purchase Agreement with CRG for Series H Preferred Stock issuance. |
| May 20, 2024 | Nasdaq extension deadline for compliance with equity requirement. |
| , 2024 | Expected delivery date of the Securities. |
| , 2024 | Offering termination date. |
Keywords
offering, warrants, common stock, Avinger, financing, Lumivascular, Nasdaq, capital, preferred stock, debt
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