Inari Medical, Inc. purpose builds a variety of products, including minimally invasive, novel, catheter-based mechanical thrombectomy systems for the unique characteristics of specific disease states.
In addition to the company's purpose-built solutions, the company leverages its capabilities in education, clinical research, and program development to improve patient outcomes. In addition, in November 2023, the company acquired LimFlow S.A. (LimFlow), a medical device company focused on limb sa...
Inari Medical, Inc. purpose builds a variety of products, including minimally invasive, novel, catheter-based mechanical thrombectomy systems for the unique characteristics of specific disease states.
In addition to the company's purpose-built solutions, the company leverages its capabilities in education, clinical research, and program development to improve patient outcomes. In addition, in November 2023, the company acquired LimFlow S.A. (LimFlow), a medical device company focused on limb salvage for patients with chronic limb-threatening ischemia (CLTI). CLTI is an advanced stage of peripheral artery disease that is associated with increased mortality, risk of amputation and impaired quality of life. The LimFlow system utilizes transcatheter arterialization of deep veins (TADV) to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in CLTI patients. Together, the company's devices and systems provide solutions to address the following disease states: deep vein thrombosis, pulmonary embolism, arteriovenous (AV) thrombosis primarily in dialysis fistulas or grafts, acute limb ischemia (ALI), chronic venous disease, and CLTI. The results of operations of LimFlow have been included in the company's consolidated financial statements from the date of the acquisition.
The key pillars of the company's growth strategy include driving the company's solutions towards standard of care in venous thromboembolism (VTE); building momentum with new products in new markets; and expanding the company's footprint internationally.
The Market for the company's Products
The company's product offerings consist of solutions aimed at improving outcomes for patients suffering from venous thromboembolism and other vascular diseases and conditions, including chronic venous disease, small vessel thrombosis, arterial thromboembolism and chronic-limb-threatening ischemia.
Venous Thromboembolism
The company's first two devices, ClotTriever and FlowTriever, were developed to treat the debilitating effects of VTE, and this remains a core focus of the company's business.
Pulmonary Embolism
Through the company's clinical evidence, the company has proven that removing all or almost all of the clot matters. The company purpose builds its clot-removing ClotTriever and FlowTriever systems.
International
The company operates in 22 countries within EMEA, six in LAC, and three in APAC. In these international markets, the company sells products either directly or through distributors, with the practice varying by country.
Solutions
The company's VTE and Emerging Therapy products are transformational.
The company's solutions could be the catalyst to drive the same evolution of treatment for the company's target opportunities, establishing the company's solutions as the standard of care.
Additionally, LimFlow, as one of the company's Emerging Therapy solutions, is the only FDA approved purpose-built system for artery to vein crossing and offers a critical alternative to amputation for no-option CLTI patients, as limb loss is associated with significant complications, mortality, and deterioration of quality of life.
All of the company's systems are designed as single-use, sterile systems, to be deployed over a wire. The company's sales representatives generally target interventional radiologists, interventional cardiologists, and vascular surgeons in selling each of the company's systems.
Venous Thromboembolism (VTE)
ClotTriever System
The ClotTriever system is a comprehensive solution for DVT and peripheral thrombus. The ClotTriever system was designed to core, capture, and remove large clots from large vessels. The ClotTriever is 510(k) cleared for the non-surgical removal of thrombi and emboli from blood vessels, and for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, is intended for use in the peripheral vasculature, including in patients with DVT, and is CE marked for the treatment of DVT. The company began commercializing its ClotTriever system in 2017 and continue to expand the system through indication expansions, component enhancements and new solutions.
FlowTriever System
The FlowTriever is a large bore catheter-based aspiration and mechanical thrombectomy system designed to remove large clots from large vessels in the peripheral vasculature and specifically to treat PE, although it is also used by physicians to treat other complex venous thromboembolism cases. The FlowTriever is 510(k)-cleared by the FDA for the non-surgical removal of emboli and thrombi from blood vessels, and injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, is intended for use in the peripheral vasculature and for the treatment of PE, and is CE marked for the treatment of PE. Triever catheters, a component of the FlowTriever system, are also intended for use in the treatment of clot in transit from the right atrium. The company began commercializing its FlowTriever system in 2017 and continue to expand the system through indication expansions, component enhancements and new solutions.
Emerging Therapies
Chronic Venous Disease Toolkit
The company is designing a toolkit for treating CVD. The first device in the toolkit is the ClotTriever BOLD which also forms part of the company's DVT toolkit. The ClotTriever BOLD is similar to the original ClotTriever catheter and is designed to core, capture and remove large clots from large vessels and address a range of clot chronicity, including chronic clot. The ClotTriever BOLD is 510(k) cleared for the non-surgical removal of thrombi and emboli from blood vessels, and for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, is intended for use in the peripheral vasculature, including in patients with DVT, and is CE marked for the treatment of DVT. The company began commercializing the ClotTriever BOLD in early 2022.
During the second quarter of 2023, the company began commercializing the RevCore thrombectomy catheter, which is the first mechanical thrombectomy device developed to treat acute to chronic in-stent thrombosis. RevCore is 510(k) cleared for the non-surgical removal of thrombi and emboli from blood vessels and for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, and is intended for use in the peripheral vasculature. The device includes a unique diameter-controlled coring element specifically designed to safely engage thrombus within stents. With RevCore, the company has developed a solution for an entirely new patient population not currently addressed by the ClotTriever or FlowTriever systems.
The company is continuing to expand its CVD toolkit to include a recanalization device, crossing device and stent cleaner device among other enhancements and expansions. The company expects the CVD toolkit devices to be packaged separately and sold individually, or as part of the ClotTriever system.
InThrill System
The InThrill system was purpose-built to treat small vessel thrombosis. The InThrill system is 510(k) cleared for the non-surgical removal of emboli and thrombi from blood vessels, and the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, and is intended for use in the peripheral vasculature but not intended for use in DVT treatment. The company began commercializing the InThrill system in late 2022. Each component is packaged separately and sold individually.
LimFlow
The LimFlow system received premarket approval (PMA) from the FDA in September 2023 and is the first and only FDA-approved device for TADV. The LimFlow system is indicated for patients who have CLTI with no suitable endovascular or surgical revascularization options and are at risk of major amputation. The LimFlow system is not intended for use in patients with DVT in the target vein or in patients with uncorrected bleeding disorders or who cannot receive anticoagulation or antiplatelet aggregation therapy. LimFlow launched its system commercially in the United States in the fourth quarter of 2023. The LimFlow system consists of the following six components, which are depicted below and all of which are included in the price of the system: three stent grafts, one arterial catheter (ARC), one venous catheter (V-Ceiver) and one valvulotome (Vector):
Three of the components of the LimFlow system - ARC, V-Ceiver, and Vector - are each independently 510(k) cleared. The LimFlow ARC is a single-use device designed to facilitate placement and positioning of guide wires within the peripheral vasculature. The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature. The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket at its distal tip. The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires. The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for existing or disrupting venous valves.
Sales and Marketing
The company's most important relationships are between the company's sales representatives and the company's treating physicians, which include interventional cardiologists, interventional radiologists and vascular surgeons. The company recruits sales representatives who have substantial and applicable medical device or other relevant sales experience. The company's front-line sales representatives typically attend procedures, which puts the company at the intersection of the patient and physician. The company has developed systems and processes to harness the information gained from these relationships and the company leverage this information to rapidly iterate solutions, introduce and execute physician education and training programs and scale the company's sales organization. The company market and sell the company's solutions to hospitals, which are reimbursed by various third-party payors.
The company has dedicated meaningful resources to building a direct sales force in the United States, with the company's sales force covering over 300 territories as of December 31, 2023. The company continues to actively expand its sales organization through additional sales representatives and territories.
The company sells its solutions to over 1,600 of the approximately 2,000 hospitals in the United States with a cath lab or interventional suite where catheter-based procedures can be performed. Outside of the United States, the company sells its solutions in over 30 countries. As the company expands its network of hospital customers and leverage the company's expanding sales organization, the company seeks to increase awareness within these hospitals and with the company's treating physicians, referring physicians and other stakeholders at the customer account level in order to drive greater adoption of the company's solutions as the preferred first-line choice treatment for patients. This strategy enables the company's sales representatives to have regular and targeted communications to convey the benefits of the company's solutions to non-interventional physicians, such as emergency department physicians and pulmonologists.
Manufacturing and Supply
The company is registered with the FDA as a medical device manufacturer and are licensed by the State of California to manufacture and distribute the company's medical devices. The company is required to manufacture its devices in compliance with the FDA's Quality System Regulation, or QSR.
Competition
For the company's VTE solutions and Emerging Therapy clot removal solutions, the company competes with manufacturers of thrombolytic drugs, such as Roche.
The company's primary medical device competitors are divisions of Penumbra, Boston Scientific, Abbott, Medtronic, AngioDynamics, Becton Dickinson, and Phillips.
Intellectual Property
As of December 31, 2023, the company held 74 U.S. patents, which are expected to expire between March 2025 and October 2024, 54 pending U.S. patent applications, 55 issued foreign patents, and 90 pending foreign patent applications, including 11 pending Patent Cooperation Treaty applications, excluding the company's licensed and sublicensed patents.
As of December 31, 2023, the company had 140 registered trademarks and 61 pending trademark applications worldwide, including trademark registrations for 'Inari Medical', 'FlowTriever', 'ClotTriever', and 'LimFlow' in the United States and other countries.
Government Regulation
The company's products and its operations are subject to extensive regulation by the U.S. Food and Drug Administration, or FDA, and other federal and state authorities in the United States, as well as comparable authorities in foreign jurisdictions. The company's products are subject to regulation as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act, or FDCA, as implemented and enforced by the FDA.
Most of the company's products are subject to premarket notification and clearance under section 510(k) of the FDCA.
Research and Development
For the year ended December 31, 2023, the company's research and development expenses were $87.5 million.
History
The company was founded in 2011. It was incorporated in Delaware in 2011. The company was formerly known as Inceptus Newco1 Inc. and changed its name to Inari Medical, Inc. in 2013.
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