UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) Israel Not applicable | --- | --- | |----------- ...

ReWalk Robotics Investor Presentation May 2023 NASDAQ:RWLK 1 Confidential –ReWalk Robotics 2023 Forward Looking Statements ...

ReWalk Robotics Ltd. (NASDAQ:RWLK) Q1 2023 Earnings Conference Call May 11, 2023 8:30 AM ET Company Participants Mike Lawless - Chief Financial Officer Larry Jasinski - Chief Executive Officer Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Martin Pollack - KMTR Operator Good morning and welcome to the ReWalk Robotics First Quarter 2023 Earnings Conference Call. All participants will be in a listen-only mode for the duration of the call. [Operator Instructions] After today’s presentati ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) Israel Not applicable | --- | --- | |---------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT OR SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File Number: 001-36612 | --- | --- | --- | |----------------------------------------------------------------------------------------|------------- ...

PART I - FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) For the nine months ended September 30, 2022, ReWalk Robotics reported a net loss of $14.3 million on revenues of $3.3 million, reflecting a widened loss compared to the prior-year period [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2022, the company's balance sheet shows total assets of $80.8 million, a decrease from $94.8 million at year-end 2021, primarily driven by reduced cash and cash equivalents Condensed Balance Sheet Data (in thousands) | Balance Sheet Item | Sep 30, 2022 (Unaudited) | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $74,027 | $88,337 | | Total current assets | $78,895 | $92,521 | | Total assets | $80,771 | $94,750 | | Total current liabilities | $4,220 | $4,038 | | Total liabilities | $5,181 | $5,367 | | Total shareholders' equity | $75,590 | $89,383 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's revenues for Q3 2022 significantly decreased to $0.9 million from $2.0 million in the prior-year period, leading to a widened net loss Statement of Operations Highlights (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | 9 Months 2022 | 9 Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $886 | $1,972 | $3,332 | $4,724 | | Gross Profit | $221 | $1,140 | $1,232 | $2,574 | | Operating Loss | ($5,433) | ($2,662) | ($14,097) | ($8,824) | | Net Loss | ($5,460) | ($2,675) | ($14,256) | ($8,878) | | Net Loss per Share | ($0.09) | ($0.06) | ($0.23) | ($0.21) | [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operating activities increased to $14.0 million from $8.9 million, resulting in a net cash decrease of $14.2 million Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,978) | ($8,903) | | Net cash used in investing activities | ($25) | ($28) | | Net cash provided by (used in) financing activities | ($183) | $79,808 | | **Increase (decrease) in cash** | **($14,186)** | **$70,877** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, business operations, and financial condition, including revenue disaggregation, commitments, and outstanding warrants - The company has sufficient funds to support operations for more than **12 months** from the issuance date of the financial statements, despite a net loss of **$14.3 million** and negative operating cash flow of **$14.0 million** for the nine months ended September 30, 2022[41](index=41&type=chunk) Disaggregation of Revenues (in thousands) | Revenue Source | Q3 2022 | Q3 2021 | 9 Months 2022 | 9 Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Units placed | $751 | $1,855 | $2,986 | $4,310 | | Spare parts, warranties and other | $135 | $117 | $346 | $414 | | **Total Revenues** | **$886** | **$1,972** | **$3,332** | **$4,724** | - As of September 30, 2022, the company had **19,420,894 warrants** outstanding and exercisable to purchase ordinary shares, with exercise prices ranging from **$1.25 to $9.375**[99](index=99&type=chunk) - Subsequent to September 30, 2022, the company repurchased an additional **719,893 ordinary shares** for an aggregate consideration of **$679,844**[122](index=122&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=30&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management attributes the 55% year-over-year revenue decline in Q3 2022 to lower unit sales, impacting gross margin and increasing operating expenses, while confirming sufficient liquidity [Overview](index=30&type=section&id=Overview) ReWalk commercializes robotic exoskeletons and is actively pursuing broader reimbursement coverage, while the COVID-19 pandemic continues to negatively impact sales and operations - In June 2022, the company submitted a **510(k) application** to the FDA for its ReWalk Personal exoskeleton system, seeking clearance for use on stairs and curbs in the United States[124](index=124&type=chunk) - On September 26, 2022, **CMS** affirmed that **Medicare Administrative Contractors (MACs)** have the discretion to cover and reimburse the **ReWalk exoskeleton**. The company submitted its first case for Medicare coverage in early November 2022[128](index=128&type=chunk) - The COVID-19 pandemic continues to adversely impact sales and operations due to staffing shortages in healthcare, reduced demand, and historical in-clinic restrictions, although some of these trends are reverting to pre-pandemic levels[133](index=133&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) For Q3 2022, revenues decreased 55% to $0.9 million year-over-year, gross margin contracted to 25%, and operating expenses rose significantly, leading to a wider operating loss Revenue by Product Type (in thousands) | Revenue Type | Q3 2022 | Q3 2021 | 9 Months 2022 | 9 Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Personal unit revenues | $822 | $1,357 | $2,837 | $3,818 | | Rehabilitation unit revenues | $64 | $615 | $495 | $906 | | **Total Revenues** | **$886** | **$1,972** | **$3,332** | **$4,724** | - Gross profit as a percentage of revenue decreased to **25%** in Q3 2022 from **58%** in Q3 2021, and to **37%** for the nine-month period from **54%** in the prior year, mainly due to the impact of fixed production costs on fewer sales and rising production costs[143](index=143&type=chunk) - Sales and marketing expenses increased **42%** in Q3 2022 year-over-year, driven by higher consulting expenses related to CMS reimbursement progress and an increase in tradeshow activities as COVID-19 restrictions eased[148](index=148&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q3 2022 with $74.0 million in cash, confirming sufficient funds for over 12 months despite net loss and negative operating cash flow, while facing a Nasdaq minimum bid price deficiency - As of September 30, 2022, the company had **$74.0 million** in cash and cash equivalents and believes it has sufficient funds to support operations for more than **12 months**[160](index=160&type=chunk) - On October 10, 2022, the company received a deficiency letter from Nasdaq for its closing bid price being below the minimum **$1.00 per share** requirement for **30 consecutive business days**[163](index=163&type=chunk) - A share repurchase program for up to **$8.0 million** was approved, and as of September 30, 2022, the company had repurchased **$183,540** of its ordinary shares[173](index=173&type=chunk)[175](index=175&type=chunk) Contractual Obligations as of Sep 30, 2022 (in thousands) | Obligation Type | Total | Less than 1 year | 1-3 years | | :--- | :--- | :--- | :--- | | Purchase obligations | $1,637 | $1,637 | $— | | Collaboration & License Agreement | $63 | $63 | $— | | Operating lease obligations | $756 | $652 | $104 | | **Total** | **$2,456** | **$2,352** | **$104** | [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company reports no material changes to its market risk during the second quarter of 2022, referring to its 2021 Form 10-K for a full discussion - There have been no material changes to the company's market risk during the second quarter of 2022[185](index=185&type=chunk) [Controls and Procedures](index=41&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2022, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[187](index=187&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, the company's internal controls[188](index=188&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company states there have been no material changes to its legal proceedings from those described in its 2021 Form 10-K - There have been no material changes to the company's legal proceedings from those disclosed in the 2021 Form 10-K[190](index=190&type=chunk) [Risk Factors](index=42&type=section&id=ITEM%201A.%20RISK%20FACTORS) The primary update to risk factors is the company's non-compliance with Nasdaq's minimum bid price requirement, with a deadline of April 10, 2023, to regain compliance or face delisting - On October 10, 2022, ReWalk received a notification letter from Nasdaq indicating non-compliance with the minimum bid price requirement of **$1.00 per share**[192](index=192&type=chunk) - The company has until **April 10, 2023**, to regain compliance by having its stock close at or above **$1.00** for a minimum of **10 consecutive business days**, with failure potentially leading to delisting[193](index=193&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section details the company's stock repurchase activity during Q3 2022, where 184,629 shares were bought back at an average price of $0.99 per share, with $7.8 million remaining for future repurchases Issuer Purchases of Equity Securities (Q3 2022) | Period | Total Shares Purchased | Average Price Paid Per Share | Total Purchased as Part of Plan | Max Value Remaining for Repurchase | | :--- | :--- | :--- | :--- | :--- | | Jul 2022 | — | $— | — | — | | Aug 2022 | — | $— | — | — | | Sep 2022 | 184,629 | $0.99 | 184,629 | $7,815,000 | | **Quarter Total** | **184,629** | **$0.99** | **184,629** | **$7,815,000** | [Exhibits](index=44&type=section&id=ITEM%206.%20EXHIBITS) This section provides an index of the exhibits filed with the Form 10-Q, including employment agreements, RSU awards, and SOX certifications

PART I - FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=5&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20(unaudited)) The company reported **$4.7 million** in revenue and an **$8.8 million** net loss for the nine months ended September 30, 2021, with cash and equivalents significantly increasing to **$91.2 million** [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of September 30, 2021, total assets reached **$98.7 million**, driven by **$91.2 million** in cash, while shareholders' equity significantly increased to **$93.0 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $91,227 | $20,350 | | Total current assets | $96,330 | $25,248 | | Total assets | $98,718 | $28,067 | | **Liabilities & Equity** | | | | Total current liabilities | $4,381 | $4,668 | | Total liabilities | $5,725 | $6,293 | | Total shareholders' equity | $92,993 | $21,774 | | Total liabilities and shareholders' equity | $98,718 | $28,067 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Q3 2021 revenues rose to **$2.0 million** with a net loss of **$2.7 million**, while nine-month revenues reached **$4.7 million** and net loss narrowed to **$8.8 million** Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $1,972 | $747 | $4,724 | $3,175 | | Gross Profit | $1,140 | $392 | $2,574 | $1,787 | | Operating Loss | ($2,662) | ($3,069) | ($8,824) | ($9,223) | | Net Loss | ($2,675) | ($3,336) | ($8,878) | ($10,031) | | Net loss per share, basic and diluted | ($0.06) | ($0.18) | ($0.21) | ($0.71) | [Condensed Statements of Changes in Shareholders' Equity](index=8&type=section&id=CONDENSED%20STATEMENTS%20OF%20CHANGES%20IN%20SHAREHOLDERS'%20EQUITY) Shareholders' equity significantly increased to **$93.0 million** by September 30, 2021, primarily due to substantial capital raised from equity offerings and warrant exercises - The company raised significant capital through multiple offerings in the first nine months of 2021, including a **$36.3 million** 'best effort' offering, a **$28.1 million** 'registered direct' offering, and **$15.1 million** from the exercise of warrants[28](index=28&type=chunk)[29](index=29&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash used in operations was **$8.9 million**, while financing activities provided **$79.8 million**, resulting in a **$70.9 million** increase in cash for the nine months ended September 30, 2021 Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,903) | ($10,131) | | Net cash used in investing activities | ($28) | ($73) | | Net cash provided by financing activities | $79,808 | $11,948 | | **Increase in cash, cash equivalents, and restricted cash** | **$70,877** | **$1,744** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) The notes detail the company's exoskeleton business, COVID-19 impacts, financial position with **$91.2 million** cash, revenue disaggregation, and significant commitments, confirming sufficient liquidity for over 12 months - The company designs, develops, and commercializes robotic exoskeletons (ReWalk, ReStore) and distributes third-party products (MediTouch, MyoCycle) for individuals with mobility impairments[35](index=35&type=chunk)[36](index=36&type=chunk) - The COVID-19 pandemic has negatively impacted sales and operations, and the company expects this to continue as long as the pandemic affects its key markets in Germany and the United States[37](index=37&type=chunk) - Despite a net loss of **$8.8 million** and an accumulated deficit of **$190.3 million** for the nine months ended Sep 30, 2021, the company states it has sufficient funds for more than 12 months, holding **$91.2 million** in cash and cash equivalents[39](index=39&type=chunk) Disaggregation of Revenues (in thousands) | Revenue Source | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Units placed | $1,855 | $522 | $4,310 | $2,583 | | Spare parts and warranties | $117 | $225 | $414 | $592 | | **Total Revenues** | **$1,972** | **$747** | **$4,724** | **$3,175** | - As of September 30, 2021, the company had non-cancelable purchase obligations of approximately **$1.4 million** and a contingent liability to the Israel Innovation Authority (IIA) of **$1.6 million**[68](index=68&type=chunk)[75](index=75&type=chunk) - In September 2021, the company raised capital through a registered direct offering, selling **15.4 million** ordinary shares and various warrants[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses **164%** Q3 2021 revenue growth, improved gross margin, increased operating expenses, and significantly enhanced liquidity with **$91.2 million** cash from recent equity offerings [Overview and Business Highlights](index=29&type=section&id=Overview%20and%20Business%20Highlights) The company focuses on commercializing robotic exoskeletons, pursuing reimbursement, and achieved **$2.0 million** revenue, **58%** gross margin, FDA breakthrough designation, and **$91.2 million** cash in Q3 2021 - The company is pursuing broader reimbursement coverage, noting a policy with the U.S. Department of Veterans Affairs (VA) and progress with German insurers (Barmer, DGUV, TK, DAK); a code for ReWalk Personal 6.0 was issued by CMS, effective October 1, 2020, which may lead to a future coverage policy[128](index=128&type=chunk)[129](index=129&type=chunk)[131](index=131&type=chunk) - Key highlights for Q3 2021 include receiving FDA breakthrough device designation for the ReBoot soft exoskeleton for home and community use by stroke patients[132](index=132&type=chunk) - The company strengthened its cash position to **$91.2 million**, which includes proceeds from a **$32.5 million** registered direct offering that closed in September 2021[132](index=132&type=chunk) [Evolving COVID-19 Pandemic](index=30&type=section&id=Evolving%20COVID-19%20Pandemic) The COVID-19 pandemic continues to negatively impact sales, patient trials, and training, with limited but potential future effects on manufacturing and supply chains - The pandemic has negatively impacted sales by affecting the company's ability to conduct trials for new patients, access clinics, and train users on its products[134](index=134&type=chunk) - Manufacturing has experienced limited impact from supply chain delays and component shortages, but future disruptions are possible[134](index=134&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Q3 2021 revenue increased **164%** to **$2.0 million**, gross margin improved to **58%**, while R&D decreased and sales/marketing and G&A expenses rose, narrowing the net loss to **$2.7 million** Revenue by Product Type (in thousands) | Revenue Type | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Personal unit revenues | $1,357 | $698 | $3,818 | $3,079 | | Rehabilitation unit revenues | $615 | $49 | $906 | $96 | | **Total Revenues** | **$1,972** | **$747** | **$4,724** | **$3,175** | - Q3 2021 revenue increased **164%** YoY, driven by a higher number of personal and rehabilitation units sold in the U.S. and Germany as COVID-19 restrictions eased[140](index=140&type=chunk) - Gross profit margin increased to **58%** in Q3 2021 from **52%** in Q3 2020, mainly due to higher sales volume and higher Average Selling Price (ASP), partially offset by sales mix[142](index=142&type=chunk) - R&D expenses decreased by **17%** for the nine months ended Sep 30, 2021, mainly due to reduced personnel and consulting costs related to the ReStore soft suit exoskeleton[145](index=145&type=chunk) - Sales and marketing expenses increased by **12%** for the nine months ended Sep 30, 2021, driven by increased personnel-related expenses, including higher sales-driven compensation[148](index=148&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company significantly improved liquidity to **$91.2 million** cash by Q3 2021 through equity raises, confirming sufficient funds for over 12 months despite net loss and negative operating cash flow - As of September 30, 2021, the company had **$91.2 million** in cash and cash equivalents and believes it has sufficient funds to support operations for more than 12 months[157](index=157&type=chunk) - The company intends to fund future operations through cash on hand, additional equity/debt offerings, and warrant exercises; primary cash uses will be for sales and marketing, R&D for the 'soft suit' exoskeleton, and general corporate purposes[158](index=158&type=chunk)[159](index=159&type=chunk) - The company fully repaid its loan agreement with Kreos Capital on December 29, 2020, discharging all obligations[164](index=164&type=chunk) - In September 2021, the company closed a registered direct offering and concurrent private placement, raising gross proceeds of approximately **$32.5 million**[179](index=179&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,903) | ($10,131) | | Net cash used in investing activities | ($28) | ($73) | | Net cash provided by financing activities | $79,808 | $11,948 | [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company reports no material changes to its market risk during the second quarter of 2021, referring to its 2020 Form 10-K for further details - There have been no material changes to the company's market risk during the second quarter of 2021[197](index=197&type=chunk) [Controls and Procedures](index=43&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) The CEO and CFO concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[200](index=200&type=chunk) - No changes were identified during the quarter ended September 30, 2021, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[201](index=201&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company reports no material changes to its legal proceedings from those described in its 2020 Form 10-K - There have been no material changes to the company's legal proceedings from those disclosed in the 2020 Form 10-K[203](index=203&type=chunk) [Risk Factors](index=44&type=section&id=ITEM%201A.RISK%20FACTORS) Key risks include product defects, ongoing COVID-19 impacts on sales and supply, and significant challenges with the mandatory FDA post-market surveillance study for ReWalk Personal 6.0 - Manufacturing or design defects, particularly in the software, could lead to user injury or death, resulting in recalls, negative publicity, and product liability claims; a recent correction was initiated for battery thermal runaway events[205](index=205&type=chunk)[206](index=206&type=chunk) - The COVID-19 pandemic continues to adversely affect business through curtailed sales activities, inability to conduct training, repair delays, and supply chain disruptions[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) - The company faces significant risk related to its mandatory FDA post-market surveillance study; despite protocol modifications, enrollment has been substantially below requirements, and failure to satisfy the FDA could result in warning letters or require the company to stop marketing the ReWalk Personal device in the U.S.[219](index=219&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) - Collaborations with third parties like MediTouch, Myolyn, and Harvard University may not result in commercially viable products or significant revenues and could be terminated[216](index=216&type=chunk)[217](index=217&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) No unregistered sales of equity securities or use of proceeds transactions occurred that were not previously reported on a Form 8-K - No unregistered sales of equity securities or use of proceeds transactions occurred that were not previously reported on a Form 8-K[224](index=224&type=chunk) [Exhibits](index=48&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with the Form 10-Q, including recent offering documents and officer certifications - The report includes several exhibits, such as forms of warrants and securities purchase agreements related to the September 2021 offering, and certifications by the CEO and CFO[226](index=226&type=chunk)