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ý
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Nevada
(State or Other Jurisdiction of
Incorporation or organization)
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99-0367049
(I.R.S. Employer
Identification No.)
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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Nasdaq Stock Market LLC
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(Nasdaq Capital Market)
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•
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Drive robotic exoskeleton rehabilitation to become the standard of care for both in-patient and out-patient rehabilitation for patients with some form of lower limb paralysis or weakness in the United States.
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•
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Continue to introduce new indications and features in rehabilitation for our Ekso GT, which could expand access to care to more patients, and for our EksoPulse Analytics, which aids in providing more personalized care in rehabilitation sessions.
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•
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Leverage our market position in exoskeleton rehabilitation by introducing new products and therapies beyond the scope of our existing lower limb devices.
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•
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Expand on our momentum in industrial markets with EksoZeroG for aerial work platforms and scaffolding and EksoVest for overhead work applications by forming strategic partnerships to define and develop new uses for these and potential derivative products.
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•
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Build on our initial success in Singapore and Hong Kong by expanding our reach to additional select countries in Asia.
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•
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Take advantage of the improved cost structure afforded by our joint venture with Zhejiang Youchuang Venture Capital Investment Co., Ltd. and Shaoxing City Keqiao District Paradise Silicon Intelligent Robot Industrial Investment Partnership (Limited Partnership), who we refer to as our Joint Venture Partners for our China JV, to drive unit costs lower for both our medical and industrial products and to develop and serve the exoskeleton market in China and other Asian markets.
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•
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One commercial leader for the Americas and one EMEA-based manager for our distributors;
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•
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U.S. and EMEA sales professionals that pursue new prospects and organizes demonstrations;
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•
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Clinical professionals and physical therapists that provide peer-to-peer demonstrations and trainings;
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•
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Marketing professionals, graphic designers, and consultants to build awareness and generate demand;
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•
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Ambassadors with SCI that provide demonstrations and personal experiences.
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Issuing Status
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||||
License Status
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Issued
Patents
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Pending
Applications
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||
Licensed to the Company
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14
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1
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Exclusively licensed to the Company
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6
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—
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Co-owned with Regents of the University of California, exclusively licensed to the Company
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4
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—
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Co-owned with the Regents of the University of California
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3
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—
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Sole ownership by the Company
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12
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|
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26
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Total: 66
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39
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27
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•
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product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;
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•
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QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
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•
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labeling regulations and FDA prohibitions against the promotion of products for un-cleared, unapproved or off-label use or indication;
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•
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510(k) clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;
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•
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medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;
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•
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post-approval restrictions or conditions, including post-approval study commitments;
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•
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post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;
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•
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the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;
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•
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regulations pertaining to voluntary recalls; and
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•
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notices provision regarding corrections or removals.
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•
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untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
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•
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unanticipated expenditures to address or defend such actions
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•
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customer notifications for repair, replacement, refunds;
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•
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recall, detention or seizure of our products;
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•
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operating restrictions or partial suspension or total shutdown of production;
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•
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refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
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•
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operating restrictions;
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•
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withdrawing 510(k) clearances that have already been granted;
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•
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refusal to grant export approval for our products; or
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•
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criminal prosecution.
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·
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the scope of rights granted under the license agreement and other interpretation-related issues;
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·
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the extent to which our devices, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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·
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the sublicensing of patent and other rights under our collaborative research and development relationships;
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·
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our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
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·
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the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
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·
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the priority of invention of patented or patentable technology.
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·
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a medical device candidate may not be deemed to be substantially equivalent to a device lawfully marketed either as a grandfathered device or one that was cleared through the 510(k) premarket notification process;
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·
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a medical device candidate may not be deemed to be in conformance with applicable standards and regulations;
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·
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FDA or other regulatory officials may not find the data from pre-clinical studies and clinical trials or other product testing date to be sufficient;
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·
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other non-U.S. regulatory authorities may not approve our processes or facilities or those of any of our third-party manufacturers, thereby restricting export; or
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·
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the FDA or other non-U.S. regulatory authorities may change clearance or approval policies or adopt new regulations.
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·
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restrictions on the products, manufacturers or manufacturing process;
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·
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adverse inspectional observations (Form 483), warning letters, non-warning letters incorporating inspectional observations;
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·
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civil or criminal penalties or fines;
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·
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injunctions;
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·
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product seizures, detentions or import bans;
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·
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voluntary or mandatory product recalls and publicity requirements;
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|
·
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suspension or withdrawal of regulatory clearances or approvals;
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·
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total or partial suspension of production;
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·
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imposition of restrictions on operations, including costly new manufacturing requirements;
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·
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refusal to clear or approve pending applications or premarket notifications; and
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·
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import and export restrictions.
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·
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general economic uncertainties and political concerns;
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·
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the introduction of new products or product lines;
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·
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product modifications;
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·
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the level of market acceptance of new products;
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·
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the availability of coverage and adequate reimbursement by third-party payers of services provided using our products;
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·
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the timing and amount of research and development and other expenditures;
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·
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timing of the receipt of orders from, and product shipments to, distributors and customers;
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·
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changes in the distribution arrangements for our products;
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·
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manufacturing or supply delays;
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·
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the time needed to educate and train additional sales and manufacturing personnel; and
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·
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costs associated with defending our intellectual property.
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·
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unexpected changes in regulatory requirements that may limit our ability to manufacture, export the products of these companies or sell into particular jurisdictions or impose multiple conflicting tax laws and regulations;
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·
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the imposition of tariffs, trade barriers and duties;
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·
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difficulties in managing geographically disparate operations;
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·
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difficulties in enforcing agreements through non-U.S. legal systems, including the JV Agreement, which is governed under Chinese law;
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·
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political and economic instability, civil unrest or war;
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·
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terrorist activities that impact international commerce;
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·
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difficulties in protecting our intellectual property rights, particularly in China and other countries where the laws and practices do not protect proprietary rights to as great an extent as do the laws and practices of the United States;
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·
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changing laws and policies affecting economic liberalization, foreign investment, currency convertibility or exchange rates, taxation or employment; and
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·
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nationalization of foreign‑owned assets, including intellectual property.
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·
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failure of local laws to provide the same degree of protection against infringement of our intellectual property rights;
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·
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protectionist laws and business practices that favor local competitors, which could slow our growth in international markets;
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·
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the expense of establishing facilities and operations in new foreign markets;
|
|
·
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building an organization capable of supporting geographically dispersed operations;
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·
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challenges caused by distance, language and cultural differences;
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·
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challenges caused by differences in legal regulations, markets, and customer preferences, which may limit our ability to adapt our products or succeed in other regions;
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·
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multiple, conflicting, and changing laws and regulations, including complications due to unexpected changes in regulatory requirements, foreign laws, tax schemes, international import and export legislation, trading and investment policies, exchange controls and tariff and other trade barriers;
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·
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foreign tax consequences;
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·
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fluctuations in currency exchange rates and foreign currency translation adjustments;
|
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·
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foreign exchange controls that might prevent us from repatriating income earned outside the United States;
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|
·
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imposition of public sector controls;
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·
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differing payer reimbursement regimes, governmental payers or patient self-pay systems and price controls;
|
|
·
|
political, economic and social instability; and
|
|
·
|
restrictions on the export or import of technology.
|
|
·
|
delays in delivery or shortages in components that could interrupt and delay manufacturing and result in cancellations of orders for our products;
|
|
·
|
increased component prices and supply delays as we establish alternative suppliers;
|
|
·
|
inability to develop alternative sources for product components;
|
|
·
|
required modifications of our products, which may cause delays in product shipments, increased manufacturing costs, and increased product prices; and
|
|
·
|
increased inventory costs as we hold more inventory than we otherwise might in order to avoid problems from shortages or discontinuance, which may result in write-offs if we are unable to use all such products in the future.
|
|
·
|
test, introduce and develop new products and services including enhancements to our existing products;
|
|
·
|
develop and expand the breadth of products and services offered;
|
|
·
|
develop and expand our market presence through relationships with third parties; and
|
|
·
|
generate satisfactory revenues from such expanded products or services to fund the foregoing requirements while obtaining and maintaining satisfactory profit margins.
|
|
·
|
maintain and evaluate a system of internal controls over financial reporting in compliance with the requirements of Section 404 of the Sarbanes-Oxley Act and the related rules and regulations of the SEC and the Public Company Accounting Oversight Board;
|
|
·
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maintain policies relating to disclosure controls and procedures;
|
|
·
|
prepare and distribute periodic reports in compliance with our obligations under federal securities laws;
|
|
·
|
institute a more comprehensive compliance function, including with respect to corporate governance; and
|
|
·
|
involve, to a greater degree, our outside legal counsel and accountants in the above activities.
|
|
·
|
compliance with the auditor attestation requirements in the assessment of our internal control over financial reporting;
|
|
·
|
compliance with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
|
|
·
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full disclosure and analysis obligations regarding executive compensation; and
|
|
·
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compliance with regulatory requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
|
|
·
|
our ability to grow our revenue and customer base;
|
|
·
|
the announcement of new products or product enhancements by us or our competitors;
|
|
·
|
developments concerning regulatory oversight and approvals;
|
|
·
|
variations in our and our competitors’ results of operations;
|
|
·
|
changes in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts;
|
|
·
|
successes or challenges in our collaborative arrangements or alternative funding sources;
|
|
·
|
developments in the rehabilitation and industrial robotics markets;
|
|
·
|
the results of product liability or intellectual property lawsuits;
|
|
·
|
future issuances of common stock or other securities;
|
|
·
|
the addition or departure of key personnel;
|
|
·
|
announcements by us or our competitors of acquisitions, investments or strategic alliances; and
|
|
·
|
general market conditions and other factors, including factors unrelated to our operating performance.
|
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Revenue
(1)
|
|
$
|
11,332
|
|
|
$
|
7,353
|
|
|
$
|
14,221
|
|
|
$
|
8,661
|
|
|
$
|
5,327
|
|
Loss from operations
|
|
(27,030
|
)
|
|
(31,612
|
)
|
|
(27,586
|
)
|
|
(21,561
|
)
|
|
(16,794
|
)
|
|||||
Gain (loss) on warrant liability
(3)
|
|
1,063
|
|
|
3,909
|
|
|
4,286
|
|
|
2,505
|
|
|
(16,485
|
)
|
|||||
Net loss
(2)
|
|
(26,992
|
)
|
|
(29,122
|
)
|
|
(23,470
|
)
|
|
(19,590
|
)
|
|
(33,769
|
)
|
|||||
Preferred deemed dividend
(3)
|
|
—
|
|
|
—
|
|
|
10,345
|
|
|
4,655
|
|
|
—
|
|
|||||
Net loss per share, basic
|
|
$
|
(0.44
|
)
|
|
$
|
(0.82
|
)
|
|
$
|
(1.87
|
)
|
|
$
|
(1.66
|
)
|
|
$
|
(3.02
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash
|
|
$
|
7,655
|
|
|
$
|
27,813
|
|
|
$
|
16,846
|
|
|
$
|
19,552
|
|
|
$
|
25,190
|
|
Total assets
|
|
17,655
|
|
|
37,988
|
|
|
24,425
|
|
|
32,198
|
|
|
33,474
|
|
|||||
Note payable, net
|
|
4,981
|
|
|
6,969
|
|
|
6,789
|
|
|
—
|
|
|
118
|
|
|||||
Warrant liability
|
|
$
|
585
|
|
|
$
|
1,648
|
|
|
$
|
3,546
|
|
|
$
|
9,195
|
|
|
$
|
—
|
|
(1)
|
In 2016, we commenced recognition of revenue based on a multiple element approach in which revenue is recognized upon the delivery of the separate elements to the customer. As a result of this change, we recognized medical device revenue previously deferred at December 31, 2015 of $6,517 and associated cost of revenue of $4,159, resulting in additional gross
|
(2)
|
The net loss recorded in 2018 included a non-cash gain of $1.1 million associated with the warrants issued in December 2015.
|
(3)
|
The net loss recorded in 2014 included a non-cash charge of $16.5 million associated with the issuance of warrants in conjunction with our Merger and subsequent private placement offering that included an anti-dilution provision. In December 2015, we recorded a non-cash preferred deemed dividend of $4.7 million related to the sale of convertible preferred stock and warrants. During the year ended December 31, 2016, we recorded a $10.3 million non-cash preferred deemed dividend related to the conversion of the preferred stock sold in 2015.
|
•
|
In April 2017, we sold 3,732,356 shares of our common stock and warrants to purchase 1,866,178 shares of common stock with an exercise price of $4.10 per share, or the April 2017 Warrants for aggregate net proceeds of $10.9 million.
|
•
|
In August 2017, we sold an aggregate of 34.0 million shares of our common stock for net proceeds of $33.7 million. In
|
•
|
In August 2018, we announced additional purchase orders by Ford Motor Company for the EksoVest™ as part of an expanded initiative to help reduce the physical toll of repeated overhead tasks among Ford assembly line workers, in which EksoVest™ was supplied to 15 Ford assembly plants in seven countries.
|
•
|
In August 2018, we entered into a Controlled Equity Offering
SM
Sales Agreement, or the ATM Agreement, under which we may issue and sell shares of our common stock, having an aggregate offering price of up to $25.0 million. In the year ended
December 31, 2018
, we sold
2.0 million
shares of our common stock under the ATM Agreement at an average price of
$2.39
per share, for aggregate proceeds of
$4.4 million
, net of commission and issuance costs, to us.
|
•
|
In December 2018, we secured purchase orders for the EksoVest from two global aerospace manufacturers to create and expand pilot programs, respectively. The assistive devices will be piloted by workers on the assembly production lines of commercial and defense airplanes to enhance safety, reduce fatigue and risk of injury.
|
•
|
In January 2019, we entered into the China JV to develop and serve the exoskeleton market in China and other Asian markets and to create a global exoskeleton manufacturing center. In connection with the China JV, one of the Joint Venture Partner affiliates agreed to purchase an aggregate of 3,067,485 shares of our common stock at a price per share equal to $1.63, for aggregate proceeds to us of $5.0 million, which we received in February 2019. In addition, within thirty (30) business days of the China JV delivering its first batch of finished EksoGT products to a buyer, the China JV or the Joint Venture Partner are to invest a further $5.0 million in our Company in accordance with the terms of the JV Agreement.
|
|
|
Years ended December 31,
|
|
|
|
|
|||||||||
|
|
2018
|
|
2017
|
|
Change
|
|
% Change
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Revenue
|
|
$
|
11,332
|
|
|
$
|
7,353
|
|
|
$
|
3,979
|
|
|
54
|
%
|
Cost of revenue
|
|
7,023
|
|
|
5,284
|
|
|
1,739
|
|
|
33
|
%
|
|||
Gross profit
|
|
4,309
|
|
|
2,069
|
|
|
2,240
|
|
|
108
|
%
|
|||
|
|
|
|
|
|
|
|
|
|||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||||||
Sales and marketing
|
|
13,827
|
|
|
13,156
|
|
|
671
|
|
|
5
|
%
|
|||
Research and development
|
|
5,847
|
|
|
9,483
|
|
|
(3,636
|
)
|
|
(38
|
)%
|
|||
General and administrative
|
|
11,700
|
|
|
10,715
|
|
|
985
|
|
|
9
|
%
|
|||
Restructuring
|
|
—
|
|
|
659
|
|
|
(659
|
)
|
|
(100
|
)%
|
|||
Change in fair value, contingent liabilities
|
|
(35
|
)
|
|
(332
|
)
|
|
297
|
|
|
(89
|
)%
|
|||
Total operating expenses
|
|
31,339
|
|
|
33,681
|
|
|
(2,342
|
)
|
|
(7
|
)%
|
|||
|
|
|
|
|
|
|
|
|
|||||||
Loss from operations
|
|
(27,030
|
)
|
|
(31,612
|
)
|
|
4,582
|
|
|
(14
|
)%
|
|||
|
|
|
|
|
|
|
|
|
|||||||
Other income, net:
|
|
|
|
|
|
|
|
|
|||||||
Interest expense
|
|
(600
|
)
|
|
(648
|
)
|
|
48
|
|
|
(7
|
)%
|
|||
Gain on warrant liability
|
|
1,063
|
|
|
3,909
|
|
|
(2,846
|
)
|
|
(73
|
)%
|
|||
Loss on repurchase of warrants
|
|
—
|
|
|
(1,067
|
)
|
|
1,067
|
|
|
(100
|
)%
|
|||
Other (expense) income, net
|
|
(425
|
)
|
|
296
|
|
|
(721
|
)
|
|
(244
|
)%
|
|||
Total other income, net
|
|
38
|
|
|
2,490
|
|
|
(2,452
|
)
|
|
(98
|
)%
|
|||
|
|
|
|
|
|
|
|
|
|||||||
Net loss
|
|
$
|
(26,992
|
)
|
|
$
|
(29,122
|
)
|
|
$
|
2,130
|
|
|
(7
|
)%
|
|
|
Years ended December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Cash, beginning of period
|
|
$
|
27,813
|
|
|
$
|
16,846
|
|
Net cash used in operating activities
|
|
(22,165
|
)
|
|
(31,226
|
)
|
||
Net cash used in investing activities
|
|
(131
|
)
|
|
(456
|
)
|
||
Net cash provided by financing activities
|
|
2,273
|
|
|
42,568
|
|
||
Effect of exchange rate changes on cash
|
|
(135
|
)
|
|
81
|
|
||
Cash, end of period
|
|
$
|
7,655
|
|
|
$
|
27,813
|
|
|
|
Payments Due By Period
|
||||||||||||||||||
|
|
Total
|
|
Less than one year
|
|
1-3 Years
|
|
3-5 Years
|
|
After 5 Years
|
||||||||||
Term loan
|
|
$
|
5,521
|
|
|
$
|
2,632
|
|
|
$
|
2,889
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Facility operating leases
|
|
1,923
|
|
|
541
|
|
|
1,382
|
|
|
—
|
|
|
—
|
|
|||||
Purchase obligations
|
|
1,459
|
|
|
1,459
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Capital lease
|
|
59
|
|
|
37
|
|
|
22
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
|
$
|
8,962
|
|
|
$
|
4,669
|
|
|
$
|
4,293
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Page
Number
|
|
|
|
|
|
|
|
|
|
|
/s/ OUM & CO. LLP
|
/s/ OUM & CO. LLP
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash
|
$
|
7,655
|
|
|
$
|
27,813
|
|
Accounts receivable, net of allowances of $128 and $212, respectively
|
3,660
|
|
|
2,760
|
|
||
Inventories, net
|
3,371
|
|
|
3,025
|
|
||
Prepaid expenses and other current assets
|
281
|
|
|
1,339
|
|
||
Total current assets
|
14,967
|
|
|
34,937
|
|
||
Property and equipment, net
|
2,365
|
|
|
2,249
|
|
||
Intangible assets, net
|
—
|
|
|
491
|
|
||
Goodwill
|
189
|
|
|
189
|
|
||
Other assets
|
134
|
|
|
122
|
|
||
Total assets
|
$
|
17,655
|
|
|
$
|
37,988
|
|
|
|
|
|
||||
Liabilities and Stockholders' Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
3,156
|
|
|
$
|
2,420
|
|
Accrued liabilities
|
3,541
|
|
|
3,503
|
|
||
Deferred revenues, current
|
1,102
|
|
|
1,103
|
|
||
Note payable, current
|
2,333
|
|
|
2,139
|
|
||
Total current liabilities
|
10,132
|
|
|
9,165
|
|
||
Deferred revenues
|
1,495
|
|
|
816
|
|
||
Note payable, net
|
2,648
|
|
|
4,830
|
|
||
Warrant liability
|
585
|
|
|
1,648
|
|
||
Other non-current liabilities
|
67
|
|
|
138
|
|
||
Total liabilities
|
14,927
|
|
|
16,597
|
|
||
Commitments and contingencies (Note 16)
|
|
|
|
|
|
||
Stockholders' equity:
|
|
|
|
||||
Convertible preferred stock, $0.001 par value; 10,000 shares authorized; none issued and outstanding at December 31, 2018 and 2017
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 141,429 shares authorized; 62,963 and 59,943, shares issued and outstanding at December 31, 2018 and 2017, respectively
|
63
|
|
|
60
|
|
||
Additional paid-in capital
|
173,903
|
|
|
165,825
|
|
||
Accumulated other comprehensive loss
|
(92
|
)
|
|
(340
|
)
|
||
Accumulated deficit
|
(171,146
|
)
|
|
(144,154
|
)
|
||
Total stockholders' equity
|
2,728
|
|
|
21,391
|
|
||
Total liabilities and stockholders' equity
|
$
|
17,655
|
|
|
$
|
37,988
|
|
|
Years ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Revenue
|
$
|
11,332
|
|
|
$
|
7,353
|
|
Cost of revenue
|
7,023
|
|
|
5,284
|
|
||
Gross profit
|
4,309
|
|
|
2,069
|
|
||
|
|
|
|
||||
Operating expenses:
|
|
|
|
||||
Sales and marketing
|
13,827
|
|
|
13,156
|
|
||
Research and development
|
5,847
|
|
|
9,483
|
|
||
General and administrative
|
11,700
|
|
|
10,715
|
|
||
Restructuring
|
—
|
|
|
659
|
|
||
Change in fair value, contingent liabilities
|
(35
|
)
|
|
(332
|
)
|
||
Total operating expenses
|
31,339
|
|
|
33,681
|
|
||
|
|
|
|
||||
Loss from operations
|
(27,030
|
)
|
|
(31,612
|
)
|
||
|
|
|
|
||||
Other income, net:
|
|
|
|
||||
Interest expense
|
(600
|
)
|
|
(648
|
)
|
||
Gain on warrant liability
|
1,063
|
|
|
3,909
|
|
||
Loss on repurchase of warrants
|
—
|
|
|
(1,067
|
)
|
||
Other (expense) income, net
|
(425
|
)
|
|
296
|
|
||
Total other income, net
|
38
|
|
|
2,490
|
|
||
|
|
|
|
||||
Net loss
|
(26,992
|
)
|
|
(29,122
|
)
|
||
Foreign currency translation adjustments
|
248
|
|
|
(419
|
)
|
||
Comprehensive loss
|
$
|
(26,744
|
)
|
|
$
|
(29,541
|
)
|
|
|
|
|
||||
Net loss per share, basic and diluted
|
$
|
(0.44
|
)
|
|
$
|
(0.82
|
)
|
Weighted average number of shares outstanding, basic and diluted
|
61,229
|
|
|
35,609
|
|
|
Convertible
Preferred Stock
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2016
|
—
|
|
|
$
|
—
|
|
|
21,894
|
|
|
$
|
22
|
|
|
$
|
121,291
|
|
|
$
|
79
|
|
|
$
|
(114,861
|
)
|
|
$
|
6,531
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(29,122
|
)
|
|
(29,122
|
)
|
||||||
Issuance of common stock under:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
April 2017 equity financing, net of underwriting discount & issuance costs of $662
|
—
|
|
|
—
|
|
|
3,732
|
|
|
4
|
|
|
11,054
|
|
|
—
|
|
|
—
|
|
|
11,058
|
|
||||||
Equipois supply and sales earn-outs
|
—
|
|
|
—
|
|
|
90
|
|
|
—
|
|
|
237
|
|
|
—
|
|
|
—
|
|
|
237
|
|
||||||
August 2017 equity financing, net of issuance costs of $227
|
—
|
|
|
—
|
|
|
34,000
|
|
|
34
|
|
|
33,739
|
|
|
—
|
|
|
—
|
|
|
33,773
|
|
||||||
Equity incentive plan
|
—
|
|
|
—
|
|
|
197
|
|
|
—
|
|
|
46
|
|
|
—
|
|
|
—
|
|
|
46
|
|
||||||
Issuance of common stock upon exercise of warrants
|
—
|
|
|
—
|
|
|
30
|
|
|
—
|
|
|
174
|
|
|
—
|
|
|
—
|
|
|
174
|
|
||||||
Issuance of warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,301
|
)
|
|
—
|
|
|
—
|
|
|
(3,301
|
)
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,414
|
|
|
—
|
|
|
—
|
|
|
2,414
|
|
||||||
Cumulative retrospective adjustment to retained earnings for ASU 2016-09 adoption
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
171
|
|
|
—
|
|
|
(171
|
)
|
|
—
|
|
||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(419
|
)
|
|
—
|
|
|
(419
|
)
|
||||||
Balance at December 31, 2017
|
—
|
|
|
—
|
|
|
59,943
|
|
|
60
|
|
|
165,825
|
|
|
(340
|
)
|
|
(144,154
|
)
|
|
21,391
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(26,992
|
)
|
|
(26,992
|
)
|
||||||
Issuance of common stock under:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
ATM program, net of commission & issuance costs of $274
|
—
|
|
|
—
|
|
|
2,032
|
|
|
2
|
|
|
4,444
|
|
|
—
|
|
|
—
|
|
|
4,446
|
|
||||||
Equipois sales earn-out
|
—
|
|
|
—
|
|
|
18
|
|
|
—
|
|
|
28
|
|
|
—
|
|
|
—
|
|
|
28
|
|
||||||
Equity incentive plan
|
—
|
|
|
—
|
|
|
571
|
|
|
1
|
|
|
(61
|
)
|
|
—
|
|
|
—
|
|
|
(60
|
)
|
||||||
Matching contribution to 401(k) plan
|
—
|
|
|
—
|
|
|
221
|
|
|
—
|
|
|
508
|
|
|
—
|
|
|
—
|
|
|
508
|
|
||||||
In lieu of cash compensation
|
—
|
|
|
—
|
|
|
178
|
|
|
—
|
|
|
291
|
|
|
—
|
|
|
—
|
|
|
291
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,868
|
|
|
—
|
|
|
—
|
|
|
2,868
|
|
||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
248
|
|
|
—
|
|
|
248
|
|
||||||
Balance at December 31, 2018
|
—
|
|
|
$
|
—
|
|
|
62,963
|
|
|
$
|
63
|
|
|
$
|
173,903
|
|
|
$
|
(92
|
)
|
|
$
|
(171,146
|
)
|
|
$
|
2,728
|
|
|
Years ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(26,992
|
)
|
|
$
|
(29,122
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
||||
Depreciation and amortization
|
1,515
|
|
|
1,748
|
|
||
Inventory allowance expense
|
191
|
|
|
73
|
|
||
Provision (recovery) for doubtful accounts
|
(50
|
)
|
|
105
|
|
||
Loss on disposal of property and equipment
|
126
|
|
|
—
|
|
||
Amortization of debt discount and accretion of final payment fee
|
152
|
|
|
179
|
|
||
Gain on change in fair value of contingent liabilities
|
(35
|
)
|
|
(213
|
)
|
||
Common stock contribution to 401(k) plan
|
212
|
|
|
509
|
|
||
Stock-based compensation expense
|
2,868
|
|
|
2,414
|
|
||
Change in fair value of warrant liability
|
(1,063
|
)
|
|
(3,909
|
)
|
||
Loss on repurchase of warrants
|
—
|
|
|
1,067
|
|
||
Unrealized loss (gain) on foreign currency transactions
|
381
|
|
|
(500
|
)
|
||
Changes in operating assets and liabilities
|
|
|
|
||||
Accounts receivable
|
(850
|
)
|
|
(1,085
|
)
|
||
Inventories
|
(1,655
|
)
|
|
(2,096
|
)
|
||
Prepaid expense and other assets, current and noncurrent
|
1,046
|
|
|
(862
|
)
|
||
Accounts payable
|
752
|
|
|
77
|
|
||
Accrued liabilities
|
559
|
|
|
105
|
|
||
Deferred revenues
|
678
|
|
|
284
|
|
||
Net cash used in operating activities
|
(22,165
|
)
|
|
(31,226
|
)
|
||
Investing activities
|
|
|
|
||||
Acquisition of property and equipment, net
|
(131
|
)
|
|
(456
|
)
|
||
Net cash used in investing activities
|
(131
|
)
|
|
(456
|
)
|
||
Financing activities
|
|
|
|
||||
Principal payments on notes payable
|
(2,174
|
)
|
|
(54
|
)
|
||
Proceeds from issuance of common stock, net
|
4,446
|
|
|
42,463
|
|
||
Proceeds from exercise of stock options
|
1
|
|
|
46
|
|
||
Proceeds from exercise of common stock warrants
|
—
|
|
|
113
|
|
||
Net cash provided by financing activities
|
2,273
|
|
|
42,568
|
|
||
Effect of exchange rate changes on cash
|
(135
|
)
|
|
81
|
|
||
Net (decrease) increase in cash
|
(20,158
|
)
|
|
10,967
|
|
||
Cash at beginning of the period
|
27,813
|
|
|
16,846
|
|
||
Cash at end of the period
|
$
|
7,655
|
|
|
$
|
27,813
|
|
|
|
|
|
||||
Supplemental disclosure of cash flow activities
|
|
|
|
||||
Cash paid for interest
|
$
|
457
|
|
|
$
|
429
|
|
Cash paid for income taxes
|
$
|
18
|
|
|
$
|
20
|
|
|
|
|
|
||||
Supplemental disclosure of non-cash activities
|
|
|
|
||||
Transfer of inventory to equipment
|
$
|
1,118
|
|
|
$
|
554
|
|
Share issuance for common stock contribution to 401(k) plan
|
$
|
508
|
|
|
$
|
—
|
|
Share issuance for in lieu of cash compensation
|
$
|
291
|
|
|
$
|
—
|
|
Share issuance for vesting of restricted stock
|
$
|
1
|
|
|
$
|
—
|
|
Equipois sales earn-out
|
$
|
28
|
|
|
$
|
47
|
|
Equipois supply earn-out
|
$
|
—
|
|
|
$
|
189
|
|
April 2017 warrant issuance
|
$
|
—
|
|
|
$
|
3,301
|
|
Repurchase of April 2017 warrants and share issuance
|
$
|
—
|
|
|
$
|
2,245
|
|
Cumulative retrospective adjustment to retained earnings for ASU 2016-09 adoption
|
$
|
—
|
|
|
$
|
171
|
|
Reclassification of warrant liability to equity upon exercise of warrants
|
$
|
—
|
|
|
$
|
62
|
|
|
Foreign
Currency
Translation
|
||
Balance at December 31, 2017
|
$
|
(340
|
)
|
Current period other comprehensive income
|
248
|
|
|
Balance at December 31, 2018
|
$
|
(92
|
)
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Raw materials
|
$
|
2,055
|
|
|
$
|
1,737
|
|
Work in progress
|
331
|
|
|
—
|
|
||
Finished goods
|
1,351
|
|
|
1,463
|
|
||
|
3,737
|
|
|
3,200
|
|
||
Less: inventory reserve
|
(366
|
)
|
|
(175
|
)
|
||
Inventories, net
|
$
|
3,371
|
|
|
$
|
3,025
|
|
|
Years ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Numerator:
|
|
|
|
||||
|
|
|
|
||||
Net loss
|
$
|
(26,992
|
)
|
|
$
|
(29,122
|
)
|
Adjusted net loss used for dilution calculation
|
$
|
(26,992
|
)
|
|
$
|
(29,122
|
)
|
|
|
|
|
||||
Denominator
|
|
|
|
||||
Weighted-average number of shares outstanding
|
61,229
|
|
|
35,609
|
|
||
Dilutive weighted-average number of shares outstanding
|
61,229
|
|
|
35,609
|
|
||
|
|
|
|
||||
Net loss per share
|
|
|
|
||||
Basic
|
$
|
(0.44
|
)
|
|
$
|
(0.82
|
)
|
Diluted
|
$
|
(0.44
|
)
|
|
$
|
(0.82
|
)
|
|
Years ended December 31,
|
||||
|
2018
|
|
2017
|
||
Options to purchase common stock
|
6,466
|
|
|
3,156
|
|
Restricted stock units
|
278
|
|
|
616
|
|
Warrants for common stock
|
3,396
|
|
|
3,396
|
|
Total common stock equivalents
|
10,140
|
|
|
7,168
|
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net
|
|
Estimated
Useful Life
|
||||||
Developed technology
|
$
|
1,160
|
|
|
$
|
(1,160
|
)
|
|
$
|
—
|
|
|
3 years
|
Customer relationships
|
70
|
|
|
(70
|
)
|
|
—
|
|
|
3 years
|
|||
Customer trade name
|
380
|
|
|
(380
|
)
|
|
—
|
|
|
3 years
|
|||
|
$
|
1,610
|
|
|
$
|
(1,610
|
)
|
|
$
|
—
|
|
|
|
•
|
Level 1
—Quoted prices in active markets for identical assets or liabilities. The Company considers a market to be active when transactions for the asset occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
|
•
|
Level 2
—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
•
|
Level 3
—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The valuation of Level 3 investments requires the use of significant management judgments or estimation.
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
December 31, 2018
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
585
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
585
|
|
Contingent success fee liability
|
$
|
34
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
34
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2017
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
1,648
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,648
|
|
Contingent consideration liability
|
$
|
42
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
42
|
|
Contingent success fee liability
|
$
|
39
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
39
|
|
|
Warrant
Liability
|
|
Contingent
Consideration
Liability
|
|
Contingent
Success Fee
Liability
|
||||||
Balance at December 31, 2017
|
$
|
1,648
|
|
|
$
|
42
|
|
|
$
|
39
|
|
Gain on revaluation of 2015 warrants
|
(1,063
|
)
|
|
|
|
|
|||||
Gain on revaluation
|
—
|
|
|
(30
|
)
|
|
(5
|
)
|
|||
Reclassification to accrued liabilities
|
—
|
|
|
(12
|
)
|
|
—
|
|
|||
Balance at December 31, 2018
|
$
|
585
|
|
|
$
|
—
|
|
|
$
|
34
|
|
|
December 31, 2018
|
|
December 31,
2017 |
||||
Deferred extended maintenance and support
|
$
|
2,114
|
|
|
$
|
1,763
|
|
Deferred royalties
|
300
|
|
|
—
|
|
||
Deferred device revenues
|
70
|
|
|
31
|
|
||
Customer deposits and advances
|
62
|
|
|
52
|
|
||
Deferred rental income
|
51
|
|
|
73
|
|
||
Total deferred revenues
|
2,597
|
|
|
1,919
|
|
||
Less current portion
|
(1,102
|
)
|
|
(1,103
|
)
|
||
Deferred revenues, non-current
|
$
|
1,495
|
|
|
$
|
816
|
|
|
December 31, 2018
|
||
Beginning balance
|
$
|
1,919
|
|
Deferral of revenue
|
2,230
|
|
|
Recognition of deferred revenue
|
(1,552
|
)
|
|
Ending balance
|
$
|
2,597
|
|
|
Medical
|
|
Industrial
|
|
Other
|
|
Total
|
||||||||
Device revenue
|
$
|
6,403
|
|
|
$
|
2,360
|
|
|
$
|
—
|
|
|
$
|
8,763
|
|
Service, support and rentals
|
2,100
|
|
|
—
|
|
|
—
|
|
|
2,100
|
|
||||
Parts and other
|
323
|
|
|
118
|
|
|
—
|
|
|
441
|
|
||||
Collaborative arrangements
|
—
|
|
|
—
|
|
|
28
|
|
|
28
|
|
||||
|
$
|
8,826
|
|
|
$
|
2,478
|
|
|
$
|
28
|
|
|
$
|
11,332
|
|
|
Estimated
|
|
December 31,
|
||||||
|
Life (Years)
|
|
2018
|
|
2017
|
||||
Company owned fleet
|
3-4
|
|
$
|
3,794
|
|
|
$
|
2,890
|
|
Machinery and equipment
|
3-7
|
|
289
|
|
|
760
|
|
||
Computers and peripherals
|
3-5
|
|
77
|
|
|
572
|
|
||
Computer software
|
3-5
|
|
818
|
|
|
877
|
|
||
Leasehold improvement
|
5-10
|
|
631
|
|
|
631
|
|
||
Tools, molds, dies and jigs
|
5
|
|
69
|
|
|
50
|
|
||
Furniture, office and leased equipment
|
3-7
|
|
555
|
|
|
637
|
|
||
|
|
|
6,233
|
|
|
6,417
|
|
||
Accumulated depreciation and amortization
|
|
|
(3,868
|
)
|
|
(4,168
|
)
|
||
Property and equipment, net
|
|
|
$
|
2,365
|
|
|
$
|
2,249
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Salaries, benefits and related expenses
|
$
|
2,446
|
|
|
$
|
2,850
|
|
Device warranty
|
307
|
|
|
232
|
|
||
Severance
|
270
|
|
|
—
|
|
||
Clinical trials
|
227
|
|
|
136
|
|
||
Capital lease obligation
|
35
|
|
|
34
|
|
||
Other
|
256
|
|
|
251
|
|
||
Total
|
$
|
3,541
|
|
|
$
|
3,503
|
|
|
Warranty
|
||||||
|
2018
|
|
2017
|
||||
Balance at beginning of the period
|
$
|
232
|
|
|
$
|
204
|
|
Additions for estimated future expense
|
362
|
|
|
207
|
|
||
Incurred costs
|
(287
|
)
|
|
(179
|
)
|
||
Balance at end of the period
|
$
|
307
|
|
|
$
|
232
|
|
|
|
|
|
||||
Current portion
|
295
|
|
|
232
|
|
||
Long-term portion
|
12
|
|
|
—
|
|
||
Total
|
$
|
307
|
|
|
$
|
232
|
|
Period
|
Amount
|
||
2019
|
$
|
2,333
|
|
2020
|
2,333
|
|
|
2021
|
440
|
|
|
Total principal payments
|
5,106
|
|
|
Less final payment fee, discount and issuance cost
|
125
|
|
|
Long-term debt, net
|
$
|
4,981
|
|
|
|
||
Current portion
|
2,333
|
|
|
Long-term portion
|
2,648
|
|
|
Long-term debt, net
|
$
|
4,981
|
|
Period
|
|
Operating
Leases |
||
2019
|
|
$
|
541
|
|
2020
|
|
554
|
|
|
2021
|
|
566
|
|
|
2022
|
|
262
|
|
|
2023
|
|
—
|
|
|
Total minimum payments
|
|
$
|
1,923
|
|
Source
|
Exercise
Price
|
|
Term
(Years)
|
|
December 31, 2017
|
|
Issued
|
|
Expired
|
|
Exercised
|
|
December 31, 2018
|
|||||||
Information Agent Warrants
|
$
|
1.50
|
|
|
3
|
|
200
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
200
|
|
2015 Warrants
|
$
|
3.74
|
|
|
5
|
|
1,604
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,604
|
|
2014 PPO and Merger warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Placement agent warrants
|
$
|
7.00
|
|
|
5
|
|
426
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
426
|
|
PPO warrants
|
$
|
14.00
|
|
|
5
|
|
1,078
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,078
|
|
Pre-2014 warrants
|
$
|
9.66
|
|
|
9-10
|
|
88
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
88
|
|
|
|
|
|
|
3,396
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,396
|
|
|
December 31, 2018
|
December 31, 2017
|
||||
Current share price
|
$
|
1.24
|
|
$
|
2.13
|
|
Conversion price
|
$
|
3.74
|
|
$
|
3.74
|
|
Risk-free interest rate
|
2.48
|
%
|
1.98
|
%
|
||
Expected term (years)
|
1.99
|
|
2.99
|
|
||
Volatility of stock
|
104
|
%
|
95
|
%
|
|
Shares Available For Grant
|
|
Available as of December 31, 2017
|
4,838
|
|
Granted
|
(4,279
|
)
|
Forfeited
|
523
|
|
Expired
|
185
|
|
Available as of December 31, 2018
|
1,267
|
|
|
Options
Outstanding
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Life (Years)
|
|
Aggregate
Intrinsic
Value
|
|||||
Outstanding at beginning of year
|
3,156
|
|
|
$
|
4.96
|
|
|
|
|
|
||
Granted
|
3,925
|
|
|
$
|
1.93
|
|
|
|
|
|
||
Exercised
|
(1
|
)
|
|
$
|
1.13
|
|
|
|
|
|
||
Forfeited
|
(429
|
)
|
|
$
|
4.67
|
|
|
|
|
|
||
Expired
|
(185
|
)
|
|
$
|
7.91
|
|
|
|
|
|
||
Outstanding at end of year
|
6,466
|
|
|
$
|
3.05
|
|
|
8.34
|
|
$
|
58
|
|
Vested and expected to vest
|
6,466
|
|
|
$
|
3.05
|
|
|
8.34
|
|
$
|
58
|
|
Exercisable at year end
|
2,149
|
|
|
$
|
5.22
|
|
|
6.07
|
|
$
|
37
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
Range of
Exercise
Prices
|
|
Number of
Shares
|
|
Weighted-Average
Remaining
Contractual Life
(Years)
|
|
Weighted
Average
Price
|
|
Number of
Shares
|
|
Weighted
Average
Price
|
||||||
$0.49 - $1.59
|
|
688
|
|
|
8.44
|
|
$
|
1.17
|
|
|
272
|
|
|
$
|
1.13
|
|
$1.76 - $1.79
|
|
1,824
|
|
|
9.50
|
|
$
|
1.76
|
|
|
68
|
|
|
$
|
1.79
|
|
$1.82 - $2.85
|
|
2,422
|
|
|
9.09
|
|
$
|
2.16
|
|
|
381
|
|
|
$
|
2.54
|
|
$3.22 - $15.33
|
|
1,532
|
|
|
5.80
|
|
$
|
6.85
|
|
|
1,428
|
|
|
$
|
6.89
|
|
|
|
6,466
|
|
|
8.34
|
|
$
|
3.05
|
|
|
2,149
|
|
|
$
|
5.22
|
|
|
Years Ended December 31,
|
||
|
2018
|
|
2017
|
Dividend yield
|
—
|
|
—
|
Risk-free interest rate
|
2.68% - 3.0%
|
|
1.83% - 2.37%
|
Expected term (in years)
|
5.27-10
|
|
5.27-9.23
|
Volatility
|
88%-106%
|
|
77%-88%
|
|
Number of
Shares
|
|
Weighted
Average Grant-
Date Fair Value
|
|||
Unvested as of January 1, 2018
|
617
|
|
|
$
|
1.65
|
|
Granted
|
354
|
|
|
$
|
1.78
|
|
Vested
|
(599
|
)
|
|
$
|
1.46
|
|
Forfeited
|
(94
|
)
|
|
$
|
2.78
|
|
Unvested as of December 31, 2018
|
278
|
|
|
$
|
1.83
|
|
|
Years Ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Sales and marketing
|
$
|
611
|
|
|
$
|
485
|
|
Research and development
|
426
|
|
|
439
|
|
||
General and administrative
|
1,831
|
|
|
1,304
|
|
||
Restructuring
|
—
|
|
|
186
|
|
||
|
$
|
2,868
|
|
|
$
|
2,414
|
|
|
Years Ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Domestic
|
$
|
(24,787
|
)
|
|
$
|
(26,434
|
)
|
Foreign
|
(2,205
|
)
|
|
(2,688
|
)
|
||
Loss before income taxes
|
$
|
(26,992
|
)
|
|
$
|
(29,122
|
)
|
|
Years Ended December 31,
|
||||
|
2018
|
|
2017
|
||
Federal tax at statutory rate
|
21.0
|
%
|
|
34.0
|
%
|
State tax, net of federal tax effect
|
—
|
|
|
—
|
|
R&D credit
|
1.3
|
|
|
1.2
|
|
Change in valuation allowance
|
(21.1
|
)
|
|
18.9
|
|
Deferred tax impacts of the Tax Act
|
—
|
|
|
(59.1
|
)
|
Unrealized (gain) loss on warrant
|
0.8
|
|
|
3.1
|
|
Foreign
|
1.0
|
|
|
(0.4
|
)
|
Other
|
(3.0
|
)
|
|
2.3
|
|
Total tax expense
|
—
|
%
|
|
—
|
%
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Deferred tax assets:
|
|
|
|
||||
Depreciation and other
|
$
|
248
|
|
|
$
|
242
|
|
Net operating loss carryforwards
|
36,970
|
|
|
31,590
|
|
||
Unused R& D tax credits
|
1,769
|
|
|
1,359
|
|
||
Accruals & reserves
|
480
|
|
|
524
|
|
||
Deferred Revenue
|
221
|
|
|
253
|
|
||
Stock Compensation
|
1,888
|
|
|
2,277
|
|
||
Other
|
55
|
|
|
42
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Prepaid expenses
|
(49
|
)
|
|
(314
|
)
|
||
Less: Valuation allowance
|
(41,582
|
)
|
|
(35,973
|
)
|
||
Net deferred tax asset (liability)
|
$
|
—
|
|
|
$
|
—
|
|
Balance at December 31, 2016
|
335
|
|
|
Increase of unrecognized tax benefits taken in prior years
|
33
|
|
|
Increase of unrecognized tax benefits related to current year
|
119
|
|
|
Balance at December 31, 2017
|
487
|
|
|
Increase of unrecognized tax benefits taken in prior years
|
51
|
|
|
Increase of unrecognized tax benefits related to current year
|
90
|
|
|
Balance at December 31, 2018
|
$
|
628
|
|
|
Payments Due By Period
|
||||||||||||||
|
Total
|
|
Less than
one year
|
|
1-3 Years
|
|
3-5 Years
|
||||||||
Term loan
|
$
|
5,521
|
|
|
$
|
2,632
|
|
|
$
|
2,889
|
|
|
$
|
—
|
|
Facility operating lease
|
1,923
|
|
|
541
|
|
|
1,382
|
|
|
—
|
|
||||
Capital lease
|
59
|
|
|
37
|
|
|
22
|
|
|
—
|
|
||||
Total
|
$
|
7,503
|
|
|
$
|
3,210
|
|
|
$
|
4,293
|
|
|
$
|
—
|
|
|
EksoHealth
|
|
EksoWorks
|
|
Other
|
|
Total
|
||||||||
Year ended December 31, 2018
|
|
|
|
|
|
|
|
||||||||
Revenue
|
$
|
8,826
|
|
|
$
|
2,478
|
|
|
$
|
28
|
|
|
$
|
11,332
|
|
Cost of revenue
|
4,932
|
|
|
2,055
|
|
|
36
|
|
|
7,023
|
|
||||
Gross profit
|
$
|
3,894
|
|
|
$
|
423
|
|
|
$
|
(8
|
)
|
|
$
|
4,309
|
|
|
|
|
|
|
|
|
|
||||||||
Year ended December 31, 2017
|
|
|
|
|
|
|
|
||||||||
Revenue
|
$
|
5,831
|
|
|
$
|
1,484
|
|
|
$
|
38
|
|
|
$
|
7,353
|
|
Cost of revenue
|
4,164
|
|
|
1,106
|
|
|
14
|
|
|
5,284
|
|
||||
Gross profit
|
$
|
1,667
|
|
|
$
|
378
|
|
|
$
|
24
|
|
|
$
|
2,069
|
|
(a)
|
Financial Statements and Schedules:
The following financial statement documents are included as part of Item 8 to this Form 10-K:
|
(b)
|
Exhibits.
The exhibits filed with this Report are set forth in the Exhibit Index.
|
Exhibit
Number
|
|
Description
|
|
|
|
1.1
|
|
|
|
|
|
2.1
|
|
|
|
|
|
3.1
|
|
|
|
|
|
3.2
|
|
|
|
|
|
3.3
|
|
|
|
|
|
3.4
|
|
|
|
|
|
3.5
|
|
|
|
|
|
3.6
|
|
|
|
|
|
3.7
|
|
|
|
|
|
4.1
|
|
|
|
|
|
4.2
|
|
|
|
|
|
4.3
|
|
|
|
|
|
4.4
|
|
|
|
|
|
4.5
|
|
|
|
|
|
4.6
|
|
|
|
|
4.7
|
|
|
|
|
|
4.8
|
|
|
|
|
|
4.9
|
|
|
|
|
|
4.10
|
|
|
|
|
|
4.11
|
|
|
|
|
|
4.12
|
|
|
|
|
|
4.13
|
|
|
|
|
|
10.1
|
|
|
|
|
|
10.2†
|
|
|
|
|
|
10.3
|
|
|
|
|
|
10.4†
|
|
|
|
|
|
10.5†
|
|
|
|
|
|
10.6†
|
|
|
|
|
|
10.7
|
|
|
|
|
|
10.8
|
|
|
|
|
|
10.9
|
|
|
|
|
|
10.10 **
|
|
|
|
|
|
10.11 **
|
|
|
|
|
|
10.12 **
|
|
|
|
|
|
10.13†
|
|
|
|
|
|
10.14†
|
|
|
|
|
|
10.15
|
|
|
|
|
|
10.16†
|
|
|
|
|
|
10.17†
|
|
|
|
|
|
10.18†
|
|
|
|
|
|
10.18†
|
|
|
|
|
|
10.19
|
|
|
|
|
|
10.20
|
|
|
|
|
|
10.21
|
|
|
|
|
|
10.22
|
|
|
|
|
|
10.23
|
|
|
|
|
|
10.24
|
|
|
|
|
|
10.25
|
|
|
|
|
|
10.26
|
|
|
|
|
|
10.27
|
|
|
|
|
|
10.28
|
|
|
|
|
|
10.29
|
|
|
|
|
|
10.30
|
|
|
|
|
|
10.31†
|
|
|
|
|
|
10.32†
|
|
|
|
|
|
10.33†
|
|
|
|
|
|
10.34
|
|
|
|
|
|
10.35
|
|
|
|
|
|
10.36*
|
|
|
|
|
|
21.1*
|
|
|
|
|
|
23.1*
|
|
|
|
|
|
31.1*
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
32.2*
|
|
101 §*
|
Interactive Data Files of Financial Statements and Notes.
|
101.ins §*
|
Instant Document
|
101.sch §*
|
XBRL Taxonomy Schema Document
|
101.cal §*
|
XBRL Taxonomy Calculation Linkbase Document
|
101.def §*
|
XBRL Taxonomy Definition Linkbase Document
|
101.lab §*
|
XBRL Taxonomy Label Linkbase Document
|
101.pre §*
|
XBRL Taxonomy Presentation Linkbase Document
|
**
|
Confidential Treatment has been requested as to certain portions of Exhibit. Such portions have been omitted and filed separately with the Securities and Exchange Commission.
|
|
By:
|
/S/ Jack Peurach
|
February 28, 2019
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/S/ Jack Peurach
|
|
President and Chief Executive Officer
|
|
February 28, 2019
|
Jack Peurach
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/S/ John F. Glenn
|
|
Chief Financial Officer
|
|
February 28, 2019
|
John F. Glenn
|
|
(Principal Accounting and Financial Officer)
|
|
|
|
|
|
|
|
/S/ Steven Sherman
|
|
Chairman of the Board
|
|
February 28, 2019
|
Steven Sherman
|
|
|
|
|
|
|
|
|
|
/S/ Marilyn Hamilton
|
|
Director
|
|
February 28, 2019
|
Marilyn Hamilton
|
|
|
|
|
|
|
|
|
|
/S/ Charles Li
|
|
Director
|
|
February 28, 2019
|
Charles Li
|
|
|
|
|
|
|
|
|
|
/S/ Thomas A. Schreck
|
|
Director
|
|
February 28, 2019
|
Thomas A. Schreck
|
|
|
|
|
|
|
|
|
|
/S/ Stanley Stern
|
|
Director
|
|
February 28, 2019
|
Stanley Stern
|
|
|
|
|
|
|
|
|
|
/S/ Ted Wang
|
|
Director
|
|
February 28, 2019
|
Ted Wang
|
|
|
|
|
A.
|
The Company engages in the research, development and manufacture of wearable exoskeletons and robotic-assist devices.
|
B.
|
Consultant has extensive trading and investment and capital market experience has particular expertise in business development in Asian markets.
|
1.
|
Consulting Services.
|
(a)
|
Consultant shall provide advice with respect to the Company's strategic positioning in the Asia Pacific region;
|
2.
|
Representations and Warranties of the Company.
|
3.
|
Representations and Warranties of Consultant.
|
(j)
|
Consultant will not engage in any solicitation activities with respect to the Company
.
|
4.
|
Fees.
|
5.
|
Indemnification.
|
6.
|
Confidentiality.
|
7.
|
Survival.
|
8.
|
Term.
|
9.
|
Notices.
|
10.
|
Governing Law.
|
11.
|
Miscellaneous.
|
Name
|
|
Jurisdiction of Incorporation
|
Ekso Bionics, Inc.
|
|
Delaware
|
Ekso Bionics GmbH
|
|
Germany
|
Ekso Bionics (Asia) Pte. Ltd.
|
|
Singapore
|
(1)
|
I have reviewed this annual report on Form 10-K of Ekso Bionics Holdings, Inc.;
|
(2)
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
(3)
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
|
(4)
|
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
|
(5)
|
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
|
/s/ Jack Peurach
|
Jack Peurach
|
Principal Executive Officer
|
(1)
|
I have reviewed this annual report on Form 10-K of Ekso Bionics Holdings, Inc.;
|
(2)
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
(3)
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
|
(4)
|
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
|
(5)
|
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
|
/s/ John F. Glenn
|
John F. Glenn
|
Principal Financial Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.
|
/s/ Jack Peurach
|
Jack Peurach
|
Principal Executive Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.
|
/s/ John F. Glenn
|
John F. Glenn
|
Principal Financial Officer
|