About Ekso Bionics Holdings

Ekso Bionics Holdings, Inc. designs, develops, and markets exoskeleton products that augment human strength, endurance and mobility. The company’s exoskeleton technology serves multiple markets and can be utilized both by able-bodied persons and persons with physical disabilities. The company has marketed devices that enable individuals with neurological conditions affecting gait, including acquired brain injury (ABI) and spinal cord injury (SCI), to rehabilitate, and in some cases, to walk again; provide ambulation assistance in home and community settings for individuals with certain SCI levels; assist individuals with a broad range of upper extremity impairments; and allow industrial workers to perform difficult repetitive work for extended periods. On December 5, 2022, the company acquired the Human Motion and Control (HMC) Business Unit from Parker Hannifin Corporation (Parker), an Ohio corporation (the HMC Acquisition). The assets acquired from the business unit include intellectual property rights for devices which are U.S. Food and Drug Administration (FDA) cleared lower-limb powered exoskeletons that enable task-specific, overground gait training to patients with weakness or paralysis in their lower extremities. For medical applications the company has three main products. EksoNR is a robotic exoskeleton specifically designed to be used in a rehabilitation setting to progress neurorehab patients so they can walk out of the device and back into their communities. As an exoskeleton FDA-cleared for acquired brain injury, stroke, multiple sclerosis (MS) and spinal cord injury, EksoNR offers what the company is the industry’s most natural gait, re-teaching the brain and muscles how to properly walk again. Ekso Indego Therapy is a modular, adjustable, lightweight, lower-limb powered exoskeleton that can be custom-sized and fitted to patients for use in rehabilitation and wellness applications. Ekso Indego Therapy is cleared by the FDA for use with stroke and SCI patients. Ekso Indego Personal is a lightweight powered lower limb orthosis that enables people with mobility impairments the opportunity to walk independently. Ekso Indego Personal is cleared by the FDA for use with SCI patients with injury levels from T3 to L5 in community or home settings. For able-bodied industrial workers, the company has offered three products. Ekso EVO, a wearable exoskeleton for overhead work. EVO is an upper body exoskeleton that elevates and supports a worker's arms to assist them with tasks from chest height to overhead. EVO is intended to reduce worker fatigue and reduce on-site injuries while boosting productivity. Based on extensive customer feedback, the company has engineered EVO to be light weight, have a low profile, allow for minimal contact with the body, and offers a wide range of uninhibited arm motion. EVO is targeted at vertical markets, including aerospace, automotive, manufacturing, and specific construction trades. EksoVest is the predecessor product to EVO and has similar properties and applications. EksoVest was discontinued in 2022. EksoZeroG is a mobile tool support arm that can be mounted on a fixed structure to reduce the load transferred from the tool to the user. EksoZeroG is used primarily in construction and demolition applications. EksoZeroG was discontinued in 2022. EksoHealth - Rehabilitation The company focuses its healthcare business on advanced technology in the rehabilitation market. The company is leveraging its patented exoskeleton technology to develop and market products intended to rehabilitate patients earlier and with better outcomes than the standard of care. As of December 31, 2022, the company had shipped approximately 620 EksoNR and EksoGT units combined to over 400 rehabilitation facilities or customers worldwide. The number of units utilized at a facility varies from one to seven, and is driven by the number of beds and rehabilitation sessions a hospital can offer and that hospital’s adoption of robotics within its rehabilitation protocols. As of December 31, 2022, more than 300 Ekso Indego Therapy and Personal devices have been shipped to over 220 clinical centers or personal end users. The number of units at a center may vary for clinical sites based on the size of the site and ability to assist multiple patients simultaneously using Ekso Indego. Some sites that purchased Ekso Indego technology prior to the release of Ekso Indego Therapy received a 3-piece kit of Indego devices, one each of small/short, medium, and large/tall size configurations. EksoNR EksoNR is a wearable bionic exoskeleton that allows hospitals and other rehabilitation providers to deliver over ground gait therapy and ambulation assistance. EksoNR incorporates hardware and software that can provide varying levels of support and assistance to the patient in real-time, correct issues with the patient’s reciprocal gait. Patients receive therapy in the device under the supervision of a physical therapist, and typically use an additional assistive device, such as a cane, crutches or a walker. Walking is achieved by a user shifting their weight, requiring the user to achieve balance thereby replicating and reinforcing the movements of a natural gait. Using built-in software, EksoNR's sensors can detect weight shift and initiate steps. Battery-powered motors drive the legs with software determining the appropriate level of assistance necessary for a user to complete the gait sequence. EksoNR is used by customers in both in-patient and out-patient settings. EksoNR includes cloud connectivity through EksoPulse, which gathers and transmits statistics and device information during EksoNR walking sessions. This information can be used to track patient progression and to monitor device utilization. Data is sent securely to the cloud where it is available for customers to view, filter, and export through a secure web portal. This feature enables more thorough patient care while reducing manual data entry. It also enables the company to provide a higher level of service through early identification and thorough reporting of device errors, saving customers the time and expense of unnecessary on-site visits. Ekso Indego Therapy Ekso Indego Therapy is an adjustable, lower-limb powered exoskeleton that can be custom-sized and tailor fitted to patients allowing for swift donning. A comprehensive software suite further enhances training sessions by providing a variety of options, settings, and analytics on patient and device performance that therapists can use to improve treatment plans in real-time. The Ekso Indego Therapy enables therapists to deliver task specific, over-ground and individualized gait training. Ekso Indego Therapy enables individualized gait therapy for patients with lower extremity weakness or paralysis (such as complete/incomplete spinal cord injury and stroke). Ekso Indego's lightweight, modular, and quick-adjust design allows clinicians to offer intensive gait therapy, custom-tailored to patients across the entire continuum of care from inpatient facilities to in-home sessions and everything in between. Ekso Indego Therapy+ software is designed to provide effective gait therapy for patients with lower extremity weakness, such as partially impaired stroke survivors. Patients are required to initiate leg movement and Ekso Indego provides support when necessary while providing auditory, real-time feedback. Ekso Indego Motion+ software allows clinicians to practice task-specific gait therapy with patients through a predictable, guided gait pattern. Powerful motors in the hip and knee, customizable within the Ekso Indego app, enable patients with little to no gait function to stand and walk with postural controls. The patient leans forward to initiate movement, and Ekso Indego responds accordingly. Ekso Indego Personal Ekso Indego Personal is a powered lower limb orthosis, also known as a powered exoskeleton, which enables people with mobility impairments the opportunity to walk independently. Power is provided by sophisticated motors in the knee and hip joints, and combined with advanced sensors and control strategies, the device allows gait impaired individuals to stand and walk again, granting them a new level of independence at home and in the community. Ekso Indego Personal offers a modular quick connect design, which allows its users to put on and take off the device without assistance. At just 29 lb (13 kg), Ekso Indego Personal is a lightweight commercial exoskeleton offering ease of handling, transportation, and storage. Ekso Indego Personal can be used with spinal cord injury levels of T3 to L5 in community or home settings, but is not intended for sports or stair climbing. With its slim profile, Ekso Indego Personal offers a modular quick-connect design, which allows users to put on and take off the device without assistance even while seated in most standard-frame wheelchairs. Rehabilitation clinics with significant stroke, ABI, and SCI populations comprise the primary market for the company’s medical products. The company also serves individual users with Ekso Indego Personal, which is intended to provide overground ambulation in community and home settings. The primary use case for Ekso Indego Personal is for users with certain spinal cord injuries. For this patient population, confinement to a wheelchair can cause severe physical and psychological deterioration. As a result, the secondary medical consequences of paralysis can include difficulty with bowel and urinary tract function, osteoporosis, loss of lean mass, gain in fat mass, insulin resistance, diabetes, and heart disease. Many of the company’s early clinical customers have participated in research focusing on safety and feasibility of exoskeletons and robotics in rehabilitation market development. The Ekso exoskeletons (Ekso1.1, EksoGT, EksoNR, and Ekso Indego) have been utilized in many of these protocols. The body of research has been carried out by world-renowned institutions and examines a wide variety of diagnoses including ABI, SCI, stroke, MS, and others. In tandem, the company continues to leverage its EksoNR and Ekso Indego customer base to educate and mentor strategic target centers that specialize in stroke, ABI and SCI rehabilitation in specific geographies. Geographically, the priorities have been the U.S. in the Americas, Germany in EMEA (the Europe, the Middle East, and Africa region), and Singapore, Hong Kong, and Australia in APAC (the Asia Pacific region). The company utilizes a direct sales force for customers located in the U.S., Singapore, Hong Kong, Australia, Germany, Austria and Switzerland. The company also has an expanding distributor network in EMEA and APAC. For products sold to hospitals or other rehabilitation clinics, the company offers a range of purchase options. The company sells its medical products through a combination of direct and indirect (i.e., distribution) channels. In the U.S., the company’s hospital and clinical sales are primarily made through its direct salesforce, with the exception of sales to the VA which are handled through distribution. In EMEA, the company sells through a combination of direct and indirect channels, with DACH countries typically handled direct, and other countries and regions served through distributors. In APAC, the company also uses a combination of direct and indirect channels depending on the country. The company has developed a leading clinical capability in robotic rehabilitation, and it provides extensive training and support to its customers to ensure they are successful. All sales or subscriptions include customer training. This consists of both online and in-person training of its customers’ physical therapists. Product Pipeline The company’s medical products broadly target the rehabilitation and mobility spaces. The company’s internal medical product development activities are targeted at a combination of next generation versions of its current products, as well as new applications in both rehabilitation and mobility. In addition to its internal development activities, the company is evaluating complementary external products and services that have the potential to leverage its existing infrastructure and go-to-market capacity to further expand its industry presence. This includes the possibility of pursuing business relationships ranging from acquisitions to licensing activities. EksoWorks - Able-Bodied Industrial Applications The company continues to pursue market and product development opportunities for able-bodied industrial applications. Injuries caused by repetitive tasks and overexertion are leading causes of lost work days due to workplace injuries. The company’s primary product for able-bodied industrial applications is EVO, an upper body exoskeleton that elevates and supports a worker's arms to assist them with tasks ranging from chest height to overhead. EVO builds on nearly a decade of design and development history in upper extremity applications and is based on extensive customer feedback. EVO is a passive, spring-loaded assistive upper-body exoskeleton that is designed to reduce fatigue and shoulder and back muscle strain, with the goal of eliminating work-related injuries to the neck, shoulder, and back. EVO offers five to fifteen pounds of lift assistance in each arm to elevate and alleviate the day-to-day strain on workers across all industries. While EVO is a general purpose product, the company targets specific vertical markets, including aerospace, automotive, general manufacturing, and some construction trades. EksoVest is a shoulder support product targeted at overhead work. EksoVest was superseded by EVO upon its release. The company continued to produce EksoVest and associated accessories for existing customers in 2022. EksoVest was discontinued at the end of 2022. EksoZeroG is a tool holder that can mount on an aerial lift platform or scaffolding. EksoZeroG has been sold primarily through rental companies into the construction market. EksoZeroG was discontinued in 2022. Manufacturing and Service After Sales Service Maintenance and service support, primarily provided under the Ekso Care program for the EksoNR or extended warranty program for Ekso Indego, helps to maximize operational efficiency for the company’s customers and reduces unplanned equipment downtime. The company provides direct service for its customers’ devices at its facilities in San Rafael, California, Macedonia, Ohio and Ratingen, Germany. For some customers in EMEA and APAC, the company utilizes third-party service providers. Beyond its extended warranty and Ekso Care service programs, the company provides a fee-for-service option through which device repairs are fulfilled per quote on demand of the customer and as per its repair price list. Manufacturing and Supply Chain In addition to its in-house manufacturing capabilities, the company is the process of adding contract manufacturing partners for both EksoNR and EVO. In 2022, the comopany completed the process of transferring sufficient technology and know-how to build EksoNR at a domestic contract manufacturing partner. Starting in 2022, the company also began the process of adding external manufacturing capability for its EVO product line at a contract manufacturing partner located in Malaysia. For 2023, the company expects the majority of its manufacturing output for EVO to be provided by this contract manufacturing partner. The company supports its domestic contract manufacturing partner in the procurement of raw materials for EksoNR. Intellectual Property As of December 31, 2022, 299 applications had issued or had been allowed as patents internationally. The company’s patent portfolio contains 334 cases that has issued or is in prosecution in 21 countries outside the U.S. Licensors include the Regents of the University of California, or UC Berkeley, and Vanderbilt University. The license with UC Berkeley consists of two agreements and one amendment to the agreement covering ten patent cases exclusively licensed to the company, nine of which have issued and one of which remains in prosecution, or the UC Berkeley License Agreements. Inventions covered by a further three patent applications are co-owned by the company and UC Berkeley, with no license agreement between it and UC Berkeley. On October 15, 2012, PH entered a license agreement (Exoskeleton License Agreement) with Vanderbilt University and was granted exclusive license within the HMC field of use to specific licensed patents and licensed software by paying a non-refundable, non-creditable license issue fee and running royalties. On March 1, 2022, Parker Hannifin Corporation entered a license agreement (P-H Knee License Agreement) with Vanderbilt University and was granted exclusive license to specific licensed patents, licensed software and copyrightable technical information by paying a non-refundable, non-creditable license issue fee and running royalties. Included in this agreement was the right to sublicense beginning in March 2024. In addition to the aforementioned agreements, various other subsidized research and development agreements have been entered into with Vanderbilt covering specific work product as articulated in those documents. Intellectual Property Out-Licensing In March 2018, the company entered into a set of agreements with Daydo Co, Ltd., or Daydo, related to distribution and cross-licensing of the EksoVest. Under these agreements, Daydo has exclusive distribution rights for the EksoVest within Japan and rights to modify the EksoVest as needed to address the Japanese market in exchange for royalty payments to it. The company also has rights to use any improvements made by Daydo. Daydo released its localized version of the EksoVest (called Task AR) in January of 2019. These agreements were terminated in 2022, resulting in the recognition of all deferred prepaid royalty revenue. In June 2020, the company entered into a non-exclusive license agreement with HAWE Hydraulik of Germany for rights to develop hydraulic pumps covered by a family of its patents. The agreement additionally includes an exclusivity option. Competition In the industrial business, there are multiple competitors with shoulder devices, including products from Ottobock, Levitate, Skel-ex, and others. Governmental Regulation and Product Approval On April 1, 2016, the company received clearance from the FDA to market its EksoGT robotic exoskeleton for use in the treatment of individuals with hemiplegia due to stroke, individuals with SCI at levels T4 to L5, and individuals with SCI at levels of T3 to C7 (ASIA D), in accordance with the device’s labeling. On July 19, 2016, the company received clearance from the FDA to expand/clarify the indications and labeling to expressly include individuals with hemiplegia due to stroke who have upper extremity function of at least 4 out of 5 strength in at least one arm. On August 25, 2019, the company’s EksoNR device was introduced with the same IFU as EksoGT. On June 15, 2020, the company received clearance from FDA to expand the indications for use, or IFU, and labeling to expressly include individuals with ABI, including traumatic brain injury and stroke who have upper extremity function of at least 4 out of 5 strength in at least one arm. On November 5, 2021, the company received notification from Health Canada that its EksoNR was reclassified from Class I to Class II, and requested that it reapplies for registration under the Medical Device License (MDL) program. Until that license is established, the company is restricted from marketing in that country. History Ekso Bionics Holdings, Inc. was founded in 2005. The company was incorporated in the state of Delaware in 2005.