Silk Road Medical

Silk Road Medical, Inc. operates as a medical device company with a focus on mitigating the risk of stroke. Founded in 2005 by Tony Chou, MD, and Michael Rosenthal, the company was established to address the shortcomings of existing treatments for carotid artery disease. The founders identified the significant risks tied to traditional surgical options and set out to develop a less invasive, more effective procedure. A significant milestone was achieved in 2015 when the company received FDA 510(k) clearance for its ENROUTE® Transcarotid Neuroprotection System, followed by Premarket Approval (PMA) for the ENROUTE® Transcarotid Stent System the same year. This regulatory clearance was pivotal, enabling the commercial launch of their signature procedure. The company went public in 2019. In June 2024, Boston Scientific announced a definitive agreement to acquire Silk Road Medical for an enterprise value of approximately $1.16 billion, a transaction that was completed in September 2024.

The company's business model centers on the design, manufacture, and sale of its proprietary products used in the TransCarotid Artery Revascularization (TCAR) procedure. Revenue is generated through the direct sale of the disposable devices required for each TCAR procedure, including the ENROUTE® Transcarotid Neuroprotection and Stent Systems. This straightforward monetization strategy is directly linked to the adoption and utilization of the TCAR system by vascular surgeons and other healthcare providers in hospitals and surgical centers. The company has demonstrated consistent revenue growth, reporting $177.1 million in 2023, a 28% increase from 2022. Projections for 2024 anticipated revenues between $194 million and $198 million.

Silk Road Medical's core offering is the TCAR procedure, a minimally invasive method for treating carotid artery disease, which is a major cause of strokes. TCAR combines surgical principles of neuroprotection with endovascular techniques. The procedure involves a small incision at the base of the neck to directly access the carotid artery. A key feature is the temporary reversal of blood flow, which directs any potential debris or clots away from the brain during the stenting process, thereby reducing the risk of a procedural stroke. A stent is then placed to stabilize the plaque and ensure long-term artery openness. The ENROUTE® Transcarotid Neuroprotection and Stent Systems are the only devices specifically designed and commercially available for the TCAR procedure. Initially approved for high-surgical-risk patients, the FDA expanded the indication for the ENROUTE stent in 2022 to include patients at standard surgical risk, significantly broadening the addressable market.

Keywords: TransCarotid Artery Revascularization, TCAR, carotid artery disease, stroke prevention, medical devices, neuroprotection, carotid stent, endovascular surgery, minimally invasive procedure, ENROUTE Transcarotid Neuroprotection System, ENROUTE Transcarotid Stent System, vascular surgery, stroke risk reduction, neurovascular care, Boston Scientific acquisition, high surgical risk patients, standard surgical risk patients, medical device manufacturing, carotid revascularization, vascular intervention