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Inari Medical

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Overview

Inari Medical is a pioneering medical device company dedicated to treating and transforming the lives of patients suffering from venous diseases, with a particular focus on venous thromboembolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Mission and Products

The company's mission centers on improving patient outcomes through innovative devices. Their product portfolio includes:

  • FlowTriever System: A large bore catheter-based aspiration and mechanical thrombectomy system for removing large clots from venous vessels, the right heart, pulmonary arteries, and lungs. FDA-approved for Pulmonary Embolism (PE) treatment in 2018 and Right Atrial Clot in Transit in 2021.
  • ClotTriever System: Designed to core, capture, and remove large clots from large venous vessels. Received FDA 510(k) market clearance in 2017 for non-surgical removal of thrombi and emboli from peripheral vasculature.

Clinical Research and Market Presence

Inari Medical demonstrates a strong commitment to clinical data generation through studies and registries such as FLARE, CLOUT, FLASH, FLAME, and PEERLESS. The company operates in multiple countries, including the US, Switzerland, Singapore, Canada, Australia, Brazil, the UK, and Ireland, with a rapidly expanding sales team. The estimated addressable market in the US alone is $5.8 billion, with significant international opportunities.

Financial Performance and Recent Developments

Since its successful IPO in May 2020, Inari Medical has shown robust quarterly revenue growth with gross margins exceeding 80%. Recent developments include:

  • Securing national reimbursement approval in Japan for the ClotTriever Thrombectomy System (December 2024)
  • Entering a joint venture to introduce devices in Greater China
  • Partnering with the American Venous Forum and the National Blood Clot Alliance on the DEFIANCE trial

Commitment to Healthcare

Inari Medical is dedicated to establishing its treatments as the standard of care for VTE and related conditions through innovative solutions, education, clinical research, and program development. Their ethos, "Patients first. Always," underscores their commitment to improving patient outcomes and transforming lives affected by venous diseases.

Leadership Team

Inari Medical's leadership team comprises experienced professionals driving the company's mission to revolutionize venous disease treatment. Key members include:

Executive Leadership

  • Drew Hykes - Chief Executive Officer (CEO): Assumed the role in January 2023, bringing extensive experience from previous positions at Inari Medical, Medtronic, Sequent Medical, and Terumo.

Financial and Operational Leadership

  • Kevin Strange - Chief Financial Officer: Joined in 2020, progressing from VP of Strategy and Business Development to CFO in 2024.
  • Amna Vugdalic - Vice President, Finance

Clinical and Medical Affairs

  • Thomas Tu - Chief Medical Officer: Oversees medical affairs and clinical initiatives.
  • Dr. Andrew Niekamp - Vice President of Medical Affairs: Joined in 2024, bringing expertise in Vascular Interventional Radiology and clinical research.
  • Vic Tapson - Vice President, Medical Affairs

Marketing and Commercial Operations

  • Eric Khairy - Senior Vice President, Marketing: Leads marketing strategies and commercial operations.
  • Tim Benner - Senior Vice President of U.S. Sales: Joined in 2024 with extensive commercial leadership experience.

Product and Business Unit Leadership

  • Tara Dunn - Senior Vice President & General Manager, LimFlow: Oversees the LimFlow business unit.
  • Shon Chakrabarti, MD MPH - Chief Medical Officer, LimFlow: Focuses on improving outcomes for Chronic Limb Threatening Ischemia (CLTI) patients.

Operations and Strategy

  • Paul Koehn - Senior Vice President, Operations: Responsible for operational efficiency.
  • Shawn Flaherty - Vice President US Strategy & Sales

Quality, Regulatory, and Clinical Affairs

  • Mazi Kiani - Joined in 2024 with over two decades of experience in Quality, Regulatory, and Clinical Affairs.
  • Shannon Trevino - General Counsel and Corporate Secretary: Joined in 2023 with over 15 years of legal experience.

Investor Relations

  • Neil Bhalodkar - Joined in 2024 with extensive experience in investor relations and corporate finance. This diverse leadership team combines expertise in medical devices, finance, clinical research, marketing, and operations to drive Inari Medical's growth and innovation in venous disease treatment.

History

Inari Medical, a pioneering medical device company focused on treating venous diseases, has a compelling history marked by innovation and rapid growth. Key milestones include:

Founding and Early Years

  • Founded in 2013 as a spin-out of Inceptus Medical, a medical device incubator
  • Backed by notable investors including Gilde Healthcare, Versant Ventures, and U.S. Venture Partners

Product Development and FDA Approvals

  • Developed two primary mechanical thrombectomy platforms:
    1. FlowTriever System:
      • FDA approval for Pulmonary Embolism (PE) treatment in May 2018
      • Additional clearance for Right Atrial Clot in Transit in January 2021
    2. ClotTriever System:
      • FDA 510(k) market clearance in February 2017 for non-surgical removal of thrombi and emboli from peripheral vasculature

Market Expansion and Growth

  • Completed Initial Public Offering (IPO) in May 2020, raising $156 million
    • Notable as the first non-biotech IPO post-COVID-19 outbreak
    • Shares performed exceptionally well, closing at $42.51 on the first day of trading
  • Expanded commercial organization in the U.S. and internationally
  • Estimated addressable market of $5.8 billion in the U.S. alone, with significant international opportunities

Clinical Research and Studies

  • Invested heavily in clinical research, including studies and registries such as FLARE, CLOUT, FLASH, FLAME, and PEERLESS
  • Focused on generating real-world evidence to drive device adoption and improve patient outcomes

Recent Developments

  • Secured national reimbursement approval in Japan for the ClotTriever Thrombectomy System (December 2024)
  • Entered joint venture agreement to introduce devices in Greater China (December 2024)
  • Partnered with American Venous Forum and National Blood Clot Alliance on the DEFIANCE trial

Mission and Culture

  • Committed to treating and transforming lives of patients with venous diseases
  • Emphasizes patient-first approach, innovation, and a culture valuing diversity and inclusivity Inari Medical has established itself as a leader in venous thromboembolism treatment, driven by innovative products, robust clinical research, and a steadfast commitment to patient care.

Products & Solutions

Inari Medical Inc. specializes in developing innovative catheter-based technologies for treating venous thromboembolism (VTE). Their key products include:

ClotTriever System

  • Designed for deep vein thrombosis (DVT) treatment
  • Uses mechanical coring, collection, and retrieval of emboli and thrombi
  • Components include ClotTriever Thrombectomy Catheter and associated sheaths

FlowTriever System

  • Treats pulmonary embolism (PE) and other vascular thrombi
  • Employs mechanical and aspirational disruption, fragmentation, maceration, and retrieval
  • Includes various catheters: FlowTriever, FlowTriever2, Triever16, Triever20, and Triever24

Artix Thrombectomy System

  • Dual mechanical and aspiration solution for arterial thrombus cases
  • Features covered funnel catheter and MT thrombectomy device
  • Used for nonsurgical removal of emboli and thrombi

Additional Products

  • Protrieve Sheath: Used with Inari's thrombectomy systems
  • InThrill Sheath and Catheter: Part of the thrombectomy portfolio
  • FlowStasis Suture Retention Device: For suture retention
  • FlowSaver Blood Return System: Enables autologous blood transfusion

Clinical Application

Inari Medical's products are utilized by interventional radiologists, cardiologists, and vascular surgeons in catheterization laboratories and interventional suites for treating conditions like DVT and PE.

Core Technology

Inari Medical's core technology focuses on innovative solutions for venous thromboembolism (VTE) and other venous diseases. Key aspects include:

Mechanical Thrombectomy Devices

  1. FlowTriever System
    • First FDA-cleared mechanical thrombectomy device for pulmonary embolism (PE)
    • Enables single-session, thrombolytic-free removal of thrombi from pulmonary arteries
    • Improves patient hemodynamics without thrombolytic-associated risks
  2. ClotTriever System
    • Treats deep vein thrombosis (DVT)
    • Features atraumatic nitinol coring element and mesh collection bag
    • Extracts large thrombi in a single session without thrombolytics or ICU monitoring
  3. RevCore Thrombectomy Catheter
    • Specifically designed for venous in-stent thrombosis
    • Unique diameter-controlled coring element for safe thrombi engagement within stents
  4. Triever16 Curve Catheter
    • Versatile for both PE and peripheral thrombectomy
    • Pre-shaped curve for targeted aspiration
    • Compatible with FlowSaver blood return system

Key Technologies and Features

  • HyperClear Technology: Reduces clot adhesion in collection bags
  • Nitinol Coring Element and Mesh Collection Bag: Facilitates thrombi removal
  • Self-Expanding Nitinol Funnel: Ensures optimal clot extraction

Clinical Performance

  • High rates of thrombus removal
  • Minimal blood loss
  • Improved patient quality-of-life measures
  • CLOUT registry: 100% thrombus removal in most patients, near-complete removal in 85.2% Inari Medical's technologies aim to provide safe, efficient, and effective VTE treatments, often in a single session without thrombolytics, potentially reducing complications and improving outcomes.

Industry Peers

Inari Medical operates in the medical device industry, specializing in venous and related diseases treatment. Key industry peers and competitors include:

Direct Competitors

  1. Retriever Medical
    • Focus: Vascular disease treatment
    • Products: Aspiration catheters, mechanical thrombectomy devices, blood filtration systems
  2. Ceretrieve Ltd.
    • Specialization: Neurointerventional devices
    • Offerings: Distal access catheters, thrombectomy devices
  3. Imperative Care
    • Focus: Stroke and vascular diseases
    • Solutions: Interventional tools, robotic technologies for thrombectomy
  4. Route 92 Medical
    • Specialization: Neurovascular intervention
    • Key Product: FreeClimb catheter systems

Broader Industry Peers

  1. Penumbra: Neuro and vascular healthcare technologies
  2. Teleflex: Global provider of critical care and surgical medical devices
  3. AngioDynamics: Vascular and oncology medical devices
  4. LeMaitre Vascular: Peripheral vascular disease and cardiovascular disease solutions

Publicly Traded Peers

  1. Boston Scientific Corporation: Wide range of medical devices
  2. LivaNova PLC: Cardiovascular and neuromodulation solutions
  3. iRhythm Technologies, Inc.: Cardiac arrhythmia diagnostic and monitoring devices
  4. QuidelOrtho Corporation: Diagnostic and medical device development and manufacturing These companies operate within the broader medical device and healthcare equipment industry, often targeting similar or adjacent markets to Inari Medical.

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