The company has not filed an annual or quarterly report since its Q2 FY2024 10-Q, filed Aug 7, 2024. Its latest SEC filing is a SC 13G/A from Nov 5, 2024.
10-Q for Q2 FY2024, filed Aug 7, 2024
The sections below describe the company as of the FY2023 annual report.
Sells medical devices used in minimally invasive procedures to treat carotid artery disease to hospitals and medical centers.
10-K for FY2023, filed Feb 28, 2024We are a medical device company focused on reducing the risk of stroke and its devastating impact. We believe a key to stroke prevention is…View ↗
TCAR is enabled by our proprietary portfolio of TCAR products designed to provide direct access to the carotid artery, effective reduction…View ↗
We designed our U.S. commercial strategy and built our direct sales force with a particular focus on vascular surgery practices. Vascular…View ↗
Hospitals and medical centers buy products through direct sales representatives; payment terms are short, and revenue is counted when products ship or are delivered.
10-K for FY2023, filed Feb 28, 2024The Company’s revenue is generated from the sale of its products to hospitals and medical centers in the United States through direct sales…View ↗
$177.1M
10-K for FY2023, filed Feb 28, 2024
$177.1M ↗
Hospitals and medical centers typically buy the products through Silk Road’s direct sales representatives.
10-K for FY2023, filed Feb 28, 2024
No. It lost $55.7M in FY2023.
10-K for FY2023, filed Feb 28, 2024
−$59.3MView ↗
10-K for FY2023, filed Feb 28, 2024
−$55.7MView ↗
10-K for FY2023, filed Feb 28, 2024
−$33.5MView ↗
10-Q for Q2 FY2024, filed Aug 7, 2024
−$16.6MView ↗
8-K, filed Sep 17, 2024
Pursuant to the Merger Agreement, at the effective time of the Merger on the Closing Date (the “Effective Time”) each share of Silk Road’s…View ↗
8-K, filed Aug 7, 2024
2024 Financial GuidanceView ↗
Grew. Revenue grew 2.8x in 4 years, from $63.4M in FY2019 to $177.1M in FY2023, about 29% a year.
Broader patient eligibility
The latest report describes TCAR products for both high- and standard-surgical-risk patients; the older report described the stent indication as limited to patients at high surgical risk.
10-K for FY2020, filed Mar 1, 2021 10-K for FY2023, filed Feb 28, 2024The ENROUTE NPS (510(k) K153485) is cleared for transcarotid vascular access, introduction of diagnostic agents and therapeutic devices…View ↗
The safety, effectiveness and clinical advantages of TCAR have been demonstrated in multiple clinical trials, post-market studies and…View ↗
Portfolio expansion
The latest report adds the Enflate balloon to the portfolio, following the older report’s stated plan to add tools and devices for TCAR.
10-K for FY2020, filed Mar 1, 2021 10-K for FY2023, filed Feb 28, 2024Today, our product portfolio consists of the following four single use components. Based on our experience, the full product portfolio is…View ↗
We began commercializing our products in the United States in late 2015. Our products are currently the only devices cleared and approved…View ↗
International distribution
The older report described possible future overseas sales and efforts to obtain clearances in China and Japan; the latest report says Silk Road has distribution agreements in Japan and China, though it still does not sell outside the United States.
10-K for FY2020, filed Mar 1, 2021 10-K for FY2023, filed Feb 28, 2024We manufacture the ENROUTE NPS and distribute our portfolio of TCAR products from our facility in Sunnyvale, California. We market and sell…View ↗
While we do not currently sell our products in markets outside the United States, we have obtained some and are pursuing additional…View ↗
Competes with LeMaitre Vascular, Getinge, Baxter International, Terumo Medical, W. L. Gore & Associates, Edwards Lifesciences, Abbott Laboratories, Medtronic, Boston Scientific, Cordis, Contego Medical, InspireMD, and Cook Medical
10-K for FY2023, filed Feb 28, 2024The major manufacturers of products, such as patches and shunts, used in connection with CEA include LeMaitre Vascular, Inc., Getinge AB…View ↗
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