SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): April 1, 2016
Ekso Bionics Holdings, Inc.
(Exact Name of Registrant as specified in its charter)
(State or Other Jurisdiction
|(Commission File Number)||
1414 Harbour Way South, Suite 1201
Richmond, California 94804
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(Registrant’s former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
|o||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|o||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|o||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|o||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
|Item 1.01.||Entry Into A Material Definitive Agreement.|
On April 1, 2016, Ekso Bionics Holdings, Inc. (the “Company”) amended that certain Securities Purchase Agreement dated December 23, 2015 among the Company and certain institutional investors (the “Agreement”) to clarify the intention of the parties that compensatory options granted to our employees and directors would not trigger an adjustment of the conversion price of the Series A Convertible Preferred Stock or of the exercise price of the warrants issued pursuant to the Agreement (the “Amendment”).
The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the form of Amendment attached hereto as Exhibit 10.1, which is incorporated herein by reference.
|Item 5.03.||Amendments to Articles of Incorporation; Bylaws; Changes in Fiscal Year.|
On April 4, 2016, the Company filed a Certificate of Amendment to its Certificate of Designation with respect to the Series A Convertible Preferred Stock (the “Certificate of Amendment”). The Certificate of Amendment was filed to clarify the intention of the parties that compensatory options granted to our employees and directors would not trigger an adjustment of the conversion price of the Series A Convertible Preferred Stock.
The foregoing description of the Certificate of Amendment does not purport to be complete and is qualified in its entirety by reference to the Certificate of Amendment attached hereto as Exhibit 3.1, which is incorporated herein by reference.
|Item 7.01.||Regulation FD Disclosure.|
On April 4, 2016, the Company issued a press release announcing that it had received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) to market its Ekso GT robotic exoskeleton. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated by reference into this Item 7.01.
The information contained in this Item 7.01, including the information contained in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
|Item 8.01.||Other Events.|
On or about April 1, 2016, the Company received 510(k) clearance from the FDA to market its Ekso GT robotic exoskeleton for use in rehabilitation centers for the treatment of individuals with hemiplegia due to stroke, individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of T3 to C7 (ASIA D), in accordance with the device’s labeling.
|Item 9.01.||Financial Statements and Exhibits.|
Certificate of Amendment to Certificate of Designation of Series A Convertible Preferred Stock, filed on April 4, 2016
Form of Amendment to Securities Purchase Agreement
|99.1||Press Release dated April 4, 2016|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|EKSO BIONICS HOLDINGS, INC.|
|By:||/s/ Max Scheder-Bieschin|
|Title:||Chief Financial Officer|
Dated: April 7, 2016
FORM OF Amendment to SECUrities purchase Agreement
This Amendment to Securities purchase Agreement , dated as of April 1, 2016 (this “ Amendment ”), between Ekso Bionics Holdings, Inc., a Nevada corporation (the “ Company ”) and the undersigned, amends that certain Securities Purchase Agreement dated December 23, 2015, between the Company and the undersigned (the “ Purchase Agreement ”). Capitalized terms used in this Amendment but not otherwise defined herein shall have the meanings ascribed to such terms in the Purchase Agreement.
WHEREAS, the Purchase Agreement may be amended only by a written instrument signed by the Company and the Purchasers holding in the aggregate at least 75% of the number of shares of Common Stock issued or then issuable upon conversion of Preferred Stock and exercise of the Warrants (in each case without regard to any restriction or limitation on the conversion or exercise thereof and excluding any Common Stock issued or issuable upon conversion of the Preferred Stock or exercise of the Warrants to the extent such Common Stock, Preferred Stock or Warrants have been resold, transferred or are otherwise no longer held by an initial Purchaser) (collectively, the “ Requisite Purchasers ”); and
WHEREAS, the Company and the undersigned desire to amend the Purchase Agreement to clarify the definition of Exempt Issuance.
NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto each agree as follows:
1. Amendment to the Purchase Agreement . The definition of “Exempt Issuance” in Section 1.1 of the Purchase Agreement is hereby amended by deleting clause (a) in its entirety and inserting the following in lieu thereof:
“(a) shares of Common Stock or options to employees, officers, directors, consultants or advisors of the Corporation pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, for services rendered to the Corporation (provided, that (i) any options issued to any consultant or advisor pursuant hereto shall have an exercise price at least equal to the then applicable Conversion Price (such options, “Qualified Advisor Options”), and (ii) a maximum of 100,000 shares of Common Stock (excluding Qualified Advisor Options or shares issued upon exercise thereof) in the aggregate in any rolling 12 month period may be granted to all consultants and advisors pursuant to this provision);”
2. Effectiveness . This Amendment shall become effective upon execution of this Amendment by the undersigned and the execution of substantially identical amendments by the Requisite Purchasers.
3. No Consideration . No consideration has been offered or paid to any person to amend or consent to a waiver, modification, forbearance or otherwise of any provision of any of the Transaction Documents.
4. Miscellaneous . Except as expressly amended by this Amendment, the Purchase Agreement shall remain in full force and effect and is otherwise unchanged. The Purchase Agreement shall, together with the amendments thereto set forth in this Amendment, be read as a single document. This Amendment may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.
[Signature Page Follows]
IN WITNESS WHEREOF, each of the Parties has caused this Amendment to be executed in the manner appropriate for each, and to be dated as of the date first above written.
|EKSO BIONICS HOLDINGS, INC.|
[Signature Page to Amendment to Securities Purchase Agreement]
Ekso GT™ Robotic EXOSKELETON Cleared by FDA for Use with Stroke and Spinal Cord Injury Patients
First robotic exoskeleton cleared for use with stroke and spinal cord injury levels to C7
RICHMOND, Calif., April 4, 2016 – Ekso Bionics Holdings, Inc. (OTCQB: EKSO), a robotic exoskeleton company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Ekso GT robotic exoskeleton for use in the treatment of individuals with hemiplegia due to stroke, individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of T3 to C7 (ASIA D), in accordance with device’s labeling. The Ekso GT is the first exoskeleton cleared by the FDA for use with stroke patients.
Ekso GT is a wearable robotic exoskeleton that enables individuals to stand up and walk over ground with a full weight bearing, reciprocal gait in a clinical setting. The Ekso GT with smart Variable Assist* software, which was designed for rehabilitation institutions, provides adaptive amounts of power to either side of the patient’s body, engaging the patient throughout his or her continuum of care. The technology provides the ability to mobilize patients early in their recovery, frequently, with a significant number of high intensity steps. To date, the Ekso has helped patients take more than 41 million steps in over 115 rehabilitation institutions around the world.
“This clearance marks a major milestone towards our goal of establishing exoskeletons as standard of care in the rehabilitation clinic," commented Thomas Looby, president and interim chief executive officer of Ekso Bionics. “Our strategy has been to concentrate on the rehabilitation clinic, with a focus on ease of use, rapid turn over between sessions, and efficacy for a range of patients. Clinics using the Ekso GT are able to offer exoskeleton therapy to the widest patient population among all exoskeletons on the market, which we believe will translate into broader adoption of exoskeletons by hospitals and rehabilitation clinics and better outcomes for patients.”
Each year, an estimated 375,000 people suffer a spinal cord injury globally and an estimated 17 million people suffer a stroke. 1 Over 60% of acute stroke survivors are unable to walk or need intervention in walking. Impaired ambulation is greatly associated with fall risks, dependency, limited participation in social activities, and poor quality of life. As a consequence, assisting with ambulation in the clinical environment may aid in the recovery of ambulation that is one of the most desired goals for stroke survivors undergoing rehabilitation. 2
"We appreciate the collaboration with the leading rehabilitation institutions who helped contribute to our submission” added Mr Looby.
"I congratulate Ekso Bionics for being the first exoskeleton to receive clearance for stroke,” said W. Zev Rymer, Director, Research Planning and Sensory Motor Performance Program, Rehabilitation Institute of Chicago, " When we partnered with Ekso at the beginning of 2012, they had the first exoskeleton that was uniquely optimized for the rehabilitation clinic . We have seen the clinical value of the technology, and Ekso Bionic's continued innovation now brings us the ability to provide this advanced technology to a broader patient population."
1. Feigin VL et al. Lancet
2. Psychometric Comparisons of 3 Functional Ambulation Measures for Patients With Stroke Jau-Hong Lin et al.
* Marketed as SmartAssist outside of US
About Ekso Bionics®
Ekso Bionics is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical, industrial and defense applications. Founded in 2005, the company continues to build upon its unparalleled expertise to design some of the most cutting-edge, innovative wearable robots available on the market. They are the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe, to providing research for the advancement of R&D projects intended to benefit U.S. defense capabilities.
The company is headquartered in the Bay Area and is listed on the OTCQB under the symbol EKSO. For more information, visit: www.eksobionics.com .
About Ekso™ GT
Ekso ™ GT is the first FDA cleared exoskeleton cleared for use with stroke, and spinal cord injury levels to C7. The Ekso GT with smart Variable Assist™ (marketed as SmartAssist outside the U.S.) software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of the patient’s body, challenging the patient as they progress through their continuum of care. The suit’s patented technology provides the ability to mobilize patients earlier, more frequently and with a greater number of high intensity steps. To date, this device has helped patients take more than 41 million steps in over 115 rehabilitation institutions around the world.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) a projection of financial results, financial condition, capital expenditures, capital structure or other financial items, (iii) the Company's future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing to fund the Company's operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company's products, the Company's failure to achieve broad market acceptance of the Company's products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company's medical device products, the failure to obtain or maintain patent protection for the Company's technology, failure to obtain or maintain regulatory approval to market the Company's medical devices, lack of product diversification, existing or increased competition, and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC. To learn more about Ekso Bionics please visit us at www.eksobionics.com . The Company does not undertake to update these forward-looking statements.
Heidi Darling, Director of Marketing Communications
Phone: 510-984-1761 x317