Inari Medical: A Decade of Leadership in Venous Thromboembolism Treatment with 28.3% Revenue Growth

Compared to arteries, solutions for venous thromboembolism (VTE) have been relatively scarce.

The reasons are twofold: On one hand, the treatment of venous thromboembolism tends to be more conservative, mainly relying on anticoagulant and thrombolytic drugs. Surgical thrombectomy is usually considered only when drug therapy fails or is contraindicated. On the other hand, the anatomical structure of the venous system is more complex than that of the arterial system, with thinner venous walls and slower blood flow, all of which increase the difficulty in developing venous thrombectomy devices.

Although the FDA has approved more than a hundred thrombectomy devices since 2000, most of these devices are designed for arterial systems and are not ideal for treating venous thrombosis. As the main method for treating venous thrombosis, thrombolytic drugs carry a significant risk of bleeding, while anticoagulant drugs can only prevent new clots from forming but cannot eliminate existing ones, resulting in a low cure rate.

To solve this problem, Inari Medical was born.

This medical device company, located in Irvine, California, did not follow the traditional instrument development approach to modify arterial thrombectomy devices. Instead, based on a thorough understanding of venous anatomy and thrombus morphology, it developed a venous-specific thrombectomy device and provided systematic nursing services for patients with venous thromboembolism (VTE).

On January 8, 2021, Inari Medical announced that its FlowTriever system, used for treating pulmonary embolism and right atrial transfer thrombosis, received FDA 510(k) clearance in the United States. Additionally, the ClotTriever system for treating deep vein thrombosis also received FDA 510(k) clearance as well as CE mark certification.

Since then, Inari Medical has continued to strengthen its position in this field and expand its product pipeline. On June 7, 2023, the company launched two new products: the RevCore thrombolytic catheter and the Triever16 Curve catheter. These products address the challenges of removing thrombi within venous stents and improving the trackability of pulmonary embolism and right atrial transfer thrombi, respectively.

With this series of R&D explorations, Inari Medical not only successfully went public but also achieved a revenue of $119 million in the second quarter of 2023, representing a 28.3% increase from the same period last year, driven by the launch of new products, which have gained market recognition.

It is precisely because of this that Inari Medical has earned the reputation as an "expert in vascular interventional therapy" within the industry.

This company has been established for 10 years, so why is it still able to continuously lead the market? First, we can trace it back to FlowTriever, a product independently developed by Inari Medical.

This is a catheter-based system for treating pulmonary embolism, designed to remove thrombus through mechanical and suction mechanisms. It is also the first mechanical thrombectomy device to receive FDA clearance for the treatment of pulmonary embolism.

The system includes two core components: the Triever aspiration catheter and the FlowTriever catheter.

The Trieve Aspiration Catheter is a large-lumen catheter with high trackability that can be used with large-bore syringes to quickly aspirate large amounts of thrombus while minimizing blood loss. It comes in three sizes: Triever16, Triever20, and Triever24.

The FlowTriever catheter is a catheter with three self-expanding nitinol mesh disks, available in four sizes: S (6-10 mm), M (11-14 mm), L (15-18 mm), and XL (19-25 mm). The catheter is designed to lyse thrombus and deliver it to the Triever20.

FlowTriever System Image Source: Inari Medical Official Website

For doctors, the product is extremely easy to use. Simply introduce the guidewire and pass it through the target thrombus tissue in the lungs. After the dilator is in place, advance the Triever20 along the guidewire until reaching the target thrombus tissue. Next, remove the dilator, close the stopcock on the flushing end, pull back and lock the syringe. Then open the stopcock, release the vacuum, generating high-flow volume suction that draws the thrombus into the syringe through a continuous lumen while minimizing blood loss.

If the thrombus has still not been completely cleared, the doctor will introduce a FlowTriever catheter of the appropriate size. As the catheter retracts, the nitinol mesh self-expands, effectively avoiding damage to the blood vessel walls.

Real-world clinical data from Inari Medical's FlowTriever System FLASH indicates high safety, with results previously published in *EuroIntervention*. The study enrolled up to 1,000 PE patients from the U.S. and Europe, showing that mechanical thrombectomy treatment using the FlowTriever system improved hemodynamics in intermediate- to high-risk PE patients and reduced mortality within 30 days.

The ClotTriever system is another core product of Inari Medical, used for treating deep vein thrombosis (DVT). The system can fully conform to blood vessel walls with diameters of 6-16 millimeters, and its key components include the ClotTriever catheter, ClotTriever BOLD catheter, and ClotTriever sheath.

The ClotTriever catheter features a nitinol cutting element and a braided collection bag, designed to cut and collect thrombus from within the ClotTriever sheath. The cutting element is atraumatic, causing no damage to the vessel wall, and can handle thrombi of varying degrees, including newly formed acute thrombi and long-standing chronic thrombi.

ClotTriever XL Catheter is the "extra-large version" of the ClotTriever Catheter, specifically designed for the efficient removal of various chronic thrombi in the inferior vena cava. The XL catheter is the largest among the ClotTriever catheters and is capable of removing larger or older thrombi within the vena cava. With a collection bag length of only 10cm, it does not compromise the operational stability of the catheter within blood vessels and allows for easier adjustment of the catheter’s position and angle. Its vascular treatment range is between 10-28mm, enabling it to cut and collect thrombi while fully conforming to the vessel walls. Additionally, the effective length of the ClotTriever XL Catheter is 105cm, allowing it to enter from the internal jugular vein and reach the femoral vein, covering most areas where thrombi may occur.

ClotTriever Catheter (Source: Inari Medical Official Website)

ClotTriever BOLD Catheter Has 30% Higher Radial Force Than Ordinary Thrombectomy Devices. This Allows ClotTriever to Apply Greater Force on the Vessel Wall During Expansion, Ensuring Tight Contact with the Vessel Wall, Thereby Reducing Flow Resistance and Thrombus Formation.

ClotTriever BOLD Catheter for Chronic Venous Occlusion Features Advanced Control Design, Allowing the Device to Flexibly Adapt Its Shape and Position Based on Different Chronic Venous Occlusion Conditions to Achieve Optimal Treatment Outcomes. Meanwhile, This Component Enhances the ClotTriever System’s Thrombus Capture Capability, Enabling It to Capture Thrombi of Various Sizes and Hardness Levels and Remove Them from Blood Vessels, Preventing Migration or Re-occlusion.

ClotTriever Sheath is a catheter sheath specifically designed to maximize thrombus removal while minimizing blood loss. Its self-expanding nitinol funnel can fully conform to the vessel wall, enabling 360° thrombus clearance. The device features a one-handed hemostasis valve that minimizes blood loss during insertion and removal.

The lack of standardized care approaches for venous thromboembolism leads to fragmented treatment pathways for patients, with varying triage, treatment methods, and follow-up processes that are difficult to coordinate and track. Scholar Lacey MJ et al. pointed out in the academic paper "Prospective Experience with Pulmonary Embolism Treatment and Outcomes" that 75% of intermediate- to high-risk PE patients did not receive interventional consultation treatment. A single-center retrospective study conducted by Rokosh R et al. showed that in the subject hospital of their research, more than one-third of venous thrombosis patients failed to undergo specific follow-ups, especially those who had already been discharged.

Further research by Rokosh R et al. shows that establishing a referral pathway for a specialized follow-up clinic for venous thromboembolism can significantly improve patient outcomes.

Inari Medical can provide systematic care services for patients with venous thromboembolism. Since 2013, the company has transformed the care standards for this disease through innovative devices specifically designed for venous thromboembolism.

Through the VTE Excellence patient care approach, the company has effectively improved the identification and treatment outcomes of venous thromboembolism. By collaborating with venous disease experts to develop relevant service systems, Inari Medical has successfully addressed the fragmentation of existing patient diagnosis and treatment pathways, ensured that patients who should receive interventional consultations for venous diseases are not overlooked, and enhanced VTE clinical outcomes.

VTE Excellence adopts standardized patient identification and consultation processes, which can promptly identify high-risk groups or confirmed patients of VTE and provide professional evaluations and recommendations. Inari Medical, in collaboration with medical experts, has developed a multidisciplinary tiered treatment algorithm that selects the most appropriate treatment plan based on the patient's condition and risk factors, including medication, interventional procedures, or surgical operations.

At the same time, Inari Medical will assign a full-time VTE coordinator, responsible for the management and follow-up of VTE patients, monitoring treatment outcomes and complication rates, and optimizing treatment processes and quality. In addition, publicity and educational outreach are also one of the company's key focuses. Through comprehensive communication and promotion both inside and outside hospitals, Inari Medical aims to raise awareness and prevention consciousness of VTE among medical staff and the public, reducing the incidence and mortality of VTE.

Inari Medical ranks among the top ten in global medical device R&D investment, with a R&D expenditure of $66 million, accounting for 16.8% of its revenue. In addition, the company successfully made it to the list of the top 100 global medical device companies in 2022.

The reason why the company went public in just ten years and achieved a 28.3% increase in revenue compared to the same period last year lies fundamentally in its dedication to research and development. Looking back on its journey, Inari Medical first broke away from traditional device R&D thinking and pioneered the development of the venous-specific FlowTriever system based on venous anatomy and clot morphology.

Since then, the company has not stopped developing and continues to expand its product pipeline, including the ClotTriever system for treating deep vein thrombosis (DVT), the RevCore thrombolytic catheter specifically designed to address thrombosis within venous stents, and the highly trackable Triever16 Curve catheter, among other product series.

Seizing industry pain points, quickly entering细分 tracks, and consistently focusing on the expansion of product pipelines and technological innovation iterations are the winning strategies of Inari Medical.

In Q2 2023, Inari Medical's operating expenses were $106.7 million, compared to $91.7 million in Q2 2022. The increase in spending was primarily used to expand the workforce, promote commercialization, product development, clinical trial progress, and support the company’s further expansion.

Next, Inari Medical will continue to expand its sales team to increase awareness and adoption of its thrombectomy system products. Meanwhile, the company will promote the iterative upgrading of its products, expand its therapeutic areas and indications, and further increase market size and penetration.