Penumbra Stock

Penumbra, Inc. (Penumbra) operates as a global healthcare company focused on innovative therapies.

The company designs, develops, manufactures and markets novel products; and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. The company's team focuses on developing, manufacturing and marketing novel products for use by specialist physicians and healthcare providers to drive improved clinical and health outcomes.

The company sells its products to healthcare providers primarily through the company's direct sales organization in the United States, most of Europe, Canada and Australia, as well as through distributors in select international markets.

Markets

The company concentrates on improving treatment outcomes for patients with certain forms of vascular disease and strive to improve the long-term quality of life for patients who could benefit from immersive healthcare applications. Vascular disease refers to any condition that affects the circulatory system and typically manifests as a blockage or rupture of an artery or a vein. When the treatment for vascular disease is performed from within a vessel, it is referred to as an endovascular procedure. Previously, the company classified its end markets according to the anatomic location of the disorder and divided them into neuro, which included neurovascular and neurosurgical, and vascular, which included peripheral vascular and cardiovascular. To better align with the company's strategic priorities, beginning with the three months ended December 31, 2023 the company began to classify its end markets based on the type of procedure being performed, and therefore divide the company's markets into thrombectomy, which includes products that treat conditions, such as pulmonary embolism, deep vein thrombosis, acute limb ischemia, ischemic stroke and coronary disease, embolization and access, which include products to treat aneurysms and to occlude vessels, as well as products to access the vasculature, and immersive healthcare, which includes applications for patients undergoing rehabilitation related to diseases, injuries, or illnesses, as well as applications designed to address mental well-being and cognition.

Thrombectomy Market

The thrombectomy market is consisted of vascular diseases and disorders occurring in vessels throughout the body, including pulmonary embolism, deep vein thrombosis, acute limb ischemia, ischemic stroke, coronary disease and other conditions. Some of the more common conditions the company focuses on are Pulmonary Embolism ('PE'), Deep Vein Thrombosis ('DVT'), Peripheral Arterial Occlusion ('PAO'), Ischemic Stroke, Acute Coronary Syndrome ('ACS'), and Clot associated with Arteriovenous Graft or Fistula.

Embolization and Access Markets

The embolization and access markets are consisted of various diseases and conditions throughout the body, such as aneurysm, hemorrhagic stroke, vessel malformations, bleeding, endoleaks, ovarian veins, varicoceles, and hematomas, as well as products that provide access to the diseased area. These conditions include Aneurysm and Hemorrhagic Stroke.

Immersive Healthcare Market

Immersive healthcare is the use of immersive 3D computer-based technologies to support patient care across a broad spectrum of conditions, including patients recovering from or undergoing physical rehabilitation, and patients with mental well-being and cognition related challenges. Physical rehabilitation can include patients recovering from a range of neuro conditions, including stroke and traumatic brain injury, trauma, sports medicine and other orthopedic conditions. In the case of mental well-being and cognition, patients with a variety of conditions can benefit from distraction, reminiscence, and other therapies to manage symptoms including pain, anxious and depressed moods, age-related challenges, fatigue, and loneliness in a wide range of healthcare settings such as in-hospital settings, skilled nursing facilities, outpatient facilities, senior living facilities and other specialty settings.

Product Portfolio

The company develops a product portfolio that includes 7 product families within the company's major markets.

Thrombectomy Products

The company's thrombectomy products fall into the following broad product families:

Peripheral Thrombectomy Products

Indigo System

The Indigo System was designed for continuous, power aspiration of thrombus in the body, leveraging the success of the Penumbra System in ischemic stroke. Computer-assisted vacuum thrombectomy leverages the power of continuous aspiration to augment the safety, speed and simplicity of thrombus removal, and is suited to a wide range of clot morphology in the peripheral arterial, peripheral venous, pulmonary arteries and coronary vasculature. The Indigo System is consisted of four principal components:

Continuous Aspiration Mechanical Thrombectomy Catheters are robust, durable, trackable and suited for the peripheral and coronary anatomy. The company has introduced multiple sizes of catheters for use in both the peripheral and coronary vasculature. CAT Catheters are available in a wide range of sizes and lengths to address a wide range of vessel sizes and clot locations.

Computer-Assisted Vacuum Thrombectomy (CAVT) Technology combines the company's CAT Catheters with microprocessor-controlled software algorithms that orchestrate the interaction of the company's pump and catheters, enabling physicians to focus on optimizing thrombus removal while helping to mitigate blood loss for arterial and venous applications including the treatment of pulmonary embolism.

Indigo Separators are advanced and retracted through the aspiration catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. In the peripheral vasculature, clots often form in long segments and are more resistant to traditional aspiration techniques. The Indigo System with the Separator enables a practitioner to remove a wide range of clot morphology from both peripheral and coronary vasculature.

Penumbra ENGINE or Penumbra Pump MAX is connected to the company's CAT catheters and CAVT technology, where applicable, and provides the needed aspiration suction force. The company developed its proprietary aspiration source as a fully-integrated system specifically for mechanical thrombectomy by vacuum aspiration.

In 2023, the company launched Lightning Flash, an advanced mechanical thrombectomy system to address venous and pulmonary thrombus using CAVT technology, and Lightning Bolt 7, an advanced arterial thrombectomy system that uses CAVT technology, including modulated aspiration, to address conditions, such as ALI, hibernating thrombus and visceral occlusions.

Neuro Thrombectomy Products

The company's Penumbra System brand of products offers a form of mechanical thrombectomy used by specialist physicians to revascularize blood vessels that are blocked by clots in the intracranial vasculature. These products are aspiration-based. The Penumbra System is a fully integrated mechanical thrombectomy system consisting of reperfusion catheters and separators, the 3D Revascularization Device, aspiration tubing, and aspiration pump.

Penumbra System Reperfusion Catheters are the cornerstone of the Penumbra System and are manufactured using a variety of proprietary processes and materials science innovations for use in revascularization of patients with acute ischemic stroke.

The Penumbra System Reperfusion Catheters, powered by Penumbra ENGINE or Penumbra Pump MAX, are designed for trackability and to maximize thrombus removal force. These design features contribute to improved clinical outcomes and reduced procedure times. Penumbra System Reperfusion Catheters include the Penumbra RED family, JET family, ACE family and MAX families of catheters, designed to address a broad range of occlusions.

In 2021, the company launched its RED family of catheters, which are designed with the latest innovations in tracking and aspiration technology to navigate complex distal vessel anatomy and deliver powerful aspiration, together with Penumbra ENGINE, for the removal of blood clots in acute ischemic stroke patients with large vessel occlusions. In 2022, the company initiated the THUNDER Study, which is an Investigational Device Exemption ('IDE') designed to evaluate the safety and effectiveness of CAVT technology for neurovascular applications. In 2023, the company added to the RED family by launching the RED 43 catheter and RED 72 catheter with SENDit Technology.

Designed specifically for use with aspiration technology, the 3D Revascularization Device is a component of the Penumbra System that offers a technologically-advanced structure designed to treat large vessel occlusion in combination with Penumbra RED, JET 7, ACE, and MAX Reperfusion Catheters.

Either Penumbra ENGINE or Penumbra Pump MAX is connected to the company's reperfusion catheters and provides the aspiration suction force. The company developed its proprietary aspiration source as a fully-integrated system specifically for mechanical thrombectomy by aspiration.

Embolization and Access Products

Peripheral Embolization Products

Ruby Coil System

The Ruby Coil System consists of detachable coils that are specifically designed for peripheral applications. Ruby Coils have a controlled mechanical detachment mechanism that permits the physician to deliver and reposition the coil until the final satisfactory position is reached before detachment.

The Ruby Coil System is used in a variety of clinical applications, including but not limited to, active extravasations, or the escape of blood into surrounding tissue; selective embolization in patients with visceral aneurysms; exclusion of branches prior to chemoembolization and radioembolization; embolization in patients with gastrointestinal bleeding; embolization of branches prior to stent graft procedures; procedures after stent grafting in patients with persistent type II endoleaks and sac enlargement; treatment of patients with varicocele and pelvic congestion syndrome; high-flow arterial venous malformations; post trans intrahepatic shunt placement; balloon retrograde transvenous obliteration; and exclusion of hepatic branches prior to liver resection.

LANTERN

The Penumbra LANTERN Delivery Microcatheter is a low-profile microcatheter with a high-flow lumen that enables large-volume coil delivery. LANTERN features a radiopaque distal shaft for enhanced visibility and dual distal marker bands for precise coil deployment in tortuous anatomy.

POD (Penumbra Occlusion Device) System

POD addresses a specific need in the peripheral embolization market to rapidly and precisely occlude a target vessel, including in high-flow situations. The company's POD device utilizes technology that delivers both variable sizing and variable softness to provide a single device solution for rapid and precise embolization of the target vessel. The technology achieves this range of features through the design of a distal anchoring segment, thereby immediately anchoring the device in a range of vessel diameters. The proximal segment of the POD achieves dense occlusion by packing a softer, smaller diameter segment tightly behind the anchored portion.

The Packing Coil is a complementary device for use with the company's other peripheral embolization products. It is uniquely designed to pack densely behind Ruby Coils and POD to occlude arteries and veins throughout the peripheral vasculature including aneurysms. Both POD and Packing Coil are detached instantly with a sterile detachment handle.

Neuro Embolization Products

Penumbra Coil 400 is a family of detachable coils developed to offer an improved alternative for the treatment of small to large aneurysms and other larger, more complex lesions. The company implemented several proprietary design innovations to enable the coil to maintain shape while achieving biomechanically stable occlusion. Given the size and handling of Penumbra Coil 400, it is able to achieve higher packing density with fewer coils compared to competitive coiling systems.

Penumbra SMART COIL is a family of detachable coils, designed to treat patients with a wide range of neurovascular lesions, including the small and medium sized aneurysms that comprise the majority of the neurovascular coiling market. The design of Penumbra SMART COIL allows the level of softness to be determined not only by the diameter of the platinum filament, but also by a structural component inside the coil itself. This development enables Penumbra SMART COIL to become progressively softer within the span of an individual coil.

Access Products

The Neuron family of guide catheters and the Penumbra distal delivery catheters ('DDC') enable many endovascular procedures in the tortuous anatomy of the neurovasculature. The Neuron delivery catheter is a variable stiffness guide catheter with increased support in the aortic arch, easier access, and trackability into the intracranial vasculature. The design of Neuron enables physicians to position the catheter much higher in the anatomy than conventional guide catheters.

The BENCHMARK catheter features additional improvements in aortic arch support, ease-of-use, and trackability. In addition to improved proximal support in the arch through multi-geometry metal reinforcement, the distal tip is softer and more trackable, while maintaining distal shaft radiopacity for improved visualization. The BENCHMARK also is available pre-packaged with a Select catheter to obviate the need for a neurovascular guide catheter exchange, which may reduce the number of devices needed per procedure and shorten procedure times.

The BENCHMARK family includes the company's BENCHMARK BMX 96 and BMX 81 Access Systems. BMX 96 provides a larger internal diameter without increasing the outer diameter of the delivery catheter, enabling more working room for all neurovascular procedures while maintaining the same size access site as the company's Neuron MAX. BMX 81 utilizes the same technology as BMX 96 but has a smaller diameter and is designed for both radial and femoral access.

Neurosurgical Tools

Artemis Neuro Evacuation Device leverages the company's expertise in thrombectomy and access to offer a minimally invasive approach to surgical removal of fluid and tissue from the ventricles and cerebrum. The Artemis Neuro Evacuation Device works with a neuroendoscope through a sheath to access hematomas. Together with the Penumbra Pump MAX aspiration source, Artemis offers powerful and controlled hematoma evacuation.

Immersive Healthcare Products

The REAL Immersive System is a proprietary, immersive 3D computer-based technology platform that has the potential to benefit patients over a broad range of healthcare applications, including rehabilitation, mental well-being and cognition. This technology builds on the company's experience with neuro and vascular medical device innovation and was initially commercialized for conducting upper body rehabilitation in a clinical setting. Studies have shown that adding virtual reality therapy to conventional therapy is effective in improving patient engagement and outcomes, particularly with systems that are fully immersive, customized for the healthcare setting, and fun and engaging for patients. The company's REAL Immersive System products include the REAL i-Series, which features a virtual reality-enabled headset with intuitive gaze navigation and exclusive experiences and activities designed to address mental well-being and cognition, and the REAL y-Series, which includes upgraded hardware and sensor technology, as well as an expanded content library to include activities that address motor skills, cognition, core and balance, functional tasks, activities of daily living, vision and wellness. In the fourth quarter of 2022, the company introduced the first full body, non-tethered immersive healthcare offering for rehabilitation, which uses upper and lower body sensors that allow clinicians to track full body movement and progress in real time and to support a broad range of physical, cognitive and mental well-being for patients undergoing physical or occupational therapy. The company intends to continue to pursue healthcare applications where the company's immersive 3D computer-based technology platform can improve the quality of life of patients with a variety of conditions.

Sales and Marketing

The company sells its products directly in the United States, most of Europe, Canada and Australia, subject to required regulatory clearances and approvals. The company has complemented its direct sales organization with distributors in most international markets.

The company sells its products in the United States through the company's dedicated salesforce. The company's sales representatives and sales managers generally have substantial medical device experience and market the company's products directly to a variety of specialist physicians engaged in the treatment of vascular disorders and healthcare providers who manage patients addressing motor function, cognition and mental well-being, who are the end users of the company's products and significantly influence buying decisions in hospitals and other healthcare settings relating to medical devices and other healthcare products. The company is focused on developing strong relationships with specialist physicians and other healthcare providers and devote significant resources to training and educating physicians and other healthcare providers in the use and benefits of the company's products. The principal specialist physicians and other healthcare providers in the company's target end markets include:

Thrombectomy: Interventional radiologists, interventional neuroradiologists, vascular surgeons, neurosurgeons, interventional cardiologists and interventional neurologists.

Embolization and Access: Neurosurgeons, interventional neuroradiologists, interventional neurologists, interventional radiologists, vascular surgeons and pediatric interventional cardiologists.

Immersive Healthcare: Occupational therapists, physical therapists, nurses, mental health professionals and other healthcare providers.

In addition to the company's direct sales organizations, the company works with distributors in certain geographic areas where the company has determined that selling through distributors is likely to be more effective.

The company has continued licensing the technology to certain of its products to the company's existing distribution partner in China pursuant to a series of licensing arrangements entered into in December 2020, February 2022 and September 2023, which permit the company's partner to manufacture and commercialize such products in China in exchange for fixed payments upon the transfer of the licensed technology and upon the provision of related regulatory support, as well as royalty payments on downstream sales of the licensed products.

The company's direct sales have been, and the company anticipates will continue to represent, a majority of the company's revenues. In 2023, direct sales accounted for approximately 83% of the company's revenue, with the balance generated by independent distributors that sell the company's products outside of the United States and by the arrangements with the company's partner in China, which include licensing royalty and distribution revenue.

Competition

The company's most notable competitors are Boston Scientific, Inari, Medtronic, Stryker, Terumo and several private companies.

Intellectual Property

As of December 31, 2023, the company owned and/or had rights to 117 issued patents globally, of which 57 were U.S. patents. As of December 31, 2023, the company owned and/or had rights to 68 pending patent applications, of which 32 were patent applications pending in the United States. Subject to payment of required maintenance fees, annuities and other charges, 16 of the company's issued patents are expected to expire between 2025 and 2026; 13 of these patents relate to components of the Penumbra System and the Indigo System. Thirty-seven of the company's issued patents, which relate to components of the Penumbra Coil 400, Ruby Coil System and Smart Coil System, are expected to expire between 2029 and 2037. Eighteen patents pertaining to the 3D Revascularization Device are projected to expire between 2032 and 2034. Twenty-one patents related to the company's REAL Immersive System are expected to expire between 2032 and 2042. Some of the company's pending patent applications pertain to components and methods of use associated with commercialized products.

Additionally, the company owns or has rights to trademarks or trade names that are used in the company's business and in conjunction with the sale of the company's products, including 43 U.S. trademark registrations and 214 foreign trademark registrations as of December 31, 2023. Included in the registered trademarks is a mark with the company name and logo.

Government Regulation

The company's products are subject to extensive and ongoing regulation by the United States Food and Drug Administration ('FDA') under the Federal Food, Drug, and Cosmetic Act (the 'FD&C Act') and its implementing regulations, as well as other federal and state regulatory bodies in the United States and comparable authorities in other countries under other statutes and regulations.

The Medical Device Reporting laws and regulations require the company to provide information to FDA. The company is subject to periodic inspections by FDA and other regulatory entities, such as a European Notified Body, related to the regulatory requirements that apply to medical devices designed and manufactured, and clinical trials sponsored, by the company.

The company's medical devices are regulated in the European Union as medical devices per the European Medical Devices Regulation 2017/745, as amended by Regulation 2023/607 ('EU MDR').

Research and Development

The company's research and development expenses were $84.4 million in 2023.

History

Penumbra, Inc. was founded in 2004. The company was incorporated in 2004 as a Delaware corporation.