We also believe there is a substantial market opportunity outside the United States. Both products are designed to eliminate the need for thrombolytic drugs. 8226; Large market opportunity for patients with unmet needs. Our most important relationships are between our sales representatives and physicians. 8226; Simple, intuitive and easy to use products with minimal training required. In addition, there are multiple ongoing 7 & investigator-initiated studies. Approximately 90% of patients with PTS are unable to work 10 years after diagnosis. PE is often characterized and stratified based on risk to the patient. Anticoagulants do not break down or eliminate existing blood clots. Aspiration alone does not always liberate venous clot from the vessel wall. 8226; Substantial risks of severe bleeding and contraindications. 8226; Eliminate the need for thrombolytic drugs. A guidewire is inserted and advanced through the clot and is positioned beyond the clot. Next, the ClotTriever catheter is advanced over the guidewire and through the sheath. These disks are available in four sizes ranging from 6 to 25 millimeters in diameter. Eligible patients must meet inclusion criteria specified for the registry. Three patients (2.9%) had major adverse events within 30 days of treatment. Points are based on severity and range from 0 (not present) to 3 (severe). 3) Percent of patients with severe PTS (n=65). & & ( Data from the study supported the initial FDA 510(k) clearance for the FlowTriever. Coverage and Reimbursement In the United States, we sell our products to hospitals. The primary ICD-10-CM diagnosis code for PE is I26.9. Third, we are developing solutions beyond thrombectomy to address other unmet needs. The most recent recertification audit was conducted in November 2020.& & As this interest continues to grow, we anticipate that this competition will intensify. The FDA has broad regulatory compliance and enforcement powers. There are also harmonized standards relating to design and manufacture. However, UKCA marking alone will not be recognized in the EU. As of December 31, 2020, we had 456 employees. We have limited experience marketing and selling our products. Fluctuations in quarterly and annual results may decrease the value of our common stock. We do not currently maintain key person life insurance policies on any of our employees. We also store sensitive intellectual property and other proprietary business information. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. We may be unable to obtain necessary licenses on satisfactory terms, if at all. However, third parties may assert infringement claims against our customers. No FDA inspection has been conducted at our current facility in Irvine, California. All affected customers have been notified and have responded to the recall notice. Our actual or perceived failure to comply with such obligations could harm our business.
