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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 14, 2024

 

MOTUS GI HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38389   81-4042793
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)

 

1301 East Broward Boulevard, 3rd Floor

Ft. Lauderdale, FL

  33301
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (954) 541-8000

 

Not Applicable
(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):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of Each Exchanged on Which Registered
Common Stock, $0.0001 par value per share   MOTS   OTCQB Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Smaller reporting company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

Motus GI Holdings, Inc. (the “Company”) issued a press release on May 14, 2024, disclosing financial information and operating metrics for its fiscal quarter ended March 31, 2024 and discussing its business outlook. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure.

 

See “Item 2.02 Results of Operations and Financial Condition” above.

 

The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) The following exhibit is furnished with this report:

 

Exhibit No.   Description
99.1   Press Release issued by Motus GI Holdings, Inc., dated May 14, 2024.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

2
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized

 

  MOTUS GI HOLDINGS, INC.
     
Dated: May 14, 2024 By: /s/ Mark Pomeranz
  Name: Mark Pomeranz
  Title: Chief Executive Officer

 

3

 

Exhibit 99.1

 

 

Motus GI Reports First Quarter 2024 Financial Results

and Provides Corporate Update

 

  Successfully ramped up limited U.S. commercial launch of the Pure-Vu® EVS Gastro and Gen 4 Colon system; Doubled the number of active Pure-Vu System customers ordering disposable sleeves with 100% of onboarded customers using Pure-Vu independently
     
  Appointed well-known investment bank. to identify and evaluate strategic alternatives aimed at accelerating commercialization of the Pure-Vu System and maximizing stockholder value

 

FORT LAUDERDALE, FL, May 14, 2024 – Motus GI Holdings, Inc., (OTCQB: MOTS) (“Motus GI” or the “Company”), a medical technology company focused on improving endoscopic outcomes and experiences, today reported its financial results for the first quarter ended March 31, 2024, and provided a corporate update.

 

“We are excited by the initial traction made in the limited U.S. commercial launch of our Pure-Vu® EVS Gastro and Gen 4 Colon system, which was kicked off at the end of 2023. The market acceptance of these two systems has been positive, which is evident by our doubling the number of active customers, reignited interest among several customer accounts that were inactive over the past year, as well as a growing sales pipeline of potential new customers. The most fulfilling aspect of the new system is seeing the device support emergent cases in GI bleeding and seeing how sites can adopt the technology with no onsite support. This enhanced end-user experience has resulted in 100% of fully onboarded customers now using the Pure-Vu system independently, as compared to only 25% of customers using the previous generation system. These types of engagements further show how we are now able to deliver on the potential that we always knew the Pure-Vu system could offer physicians, hospitals, and patients,” commented Mark Pomeranz, Chief Executive Officer.

 

 
 

 

 


First Quarter and Recent Business Highlights

 

At the end of the first quarter of 2024, the Company successfully implemented a limited U.S. commercial launch of the Pure-Vu® EVS Gastro and Gen 4 Colon system. To date, this initial phase of the rollout successfully doubled the number of active Pure-Vu customers, defined as placing an order for disposable sleeves in the six months prior to FDA approval of the new system. In addition, 100% of the established customers onboarded are now using the Pure-Vu independently, which highlights the latest generation’s easy to use design. The new Gen 4 Colon system, which features a sleeveless Flex-Channel design, is also being well-received by early-adopters, who have commented on the system’s improved handling and easy setup.
   
Announced positive data from a colonoscopy study that concluded adequate bowel cleaning can be achieved in patients with a history of inadequate bowel preparation by using the Pure-Vu System. These data were published in the peer-reviewed journal, United European Gastroenterology (UGE).
   
Received approval from the Israeli Ministry of Health, Medical Device Division (known as “AMAR”) to initiate commercial sales of the Pure-Vu® EVS Colon System in Israel, one of the largest markets in the Middle East.

 

Continued to strengthen the Company’s IP portfolio with a key patent issued by the United States Patent and Trademark Office (USPTO) in the first quarter of 2024, which covers the systems and methods for cleaning a colon or other portion of the GI tract, including the optional use of sensors to detect conditions of blockage of flow of materials within an evacuation channel used to remove debris from the body; and devices and methods for purging such blockages from the evacuation channel.
   
The Company’s Board of Directors recently engaged a well-known investment bank. to identify and evaluate strategic alternatives, aimed at accelerating commercialization of the Pure-Vu System and maximizing stockholder value.
   
The Company’s common stock was approved for quotation on the OTCQB market starting Monday, May13, 2024, under the symbol “MOTS.”

 

 
 

 

 

Financial Results for the Quarter Ended March 31, 2024

 

The Company reported revenue of $64,000 for the first quarter of 2024, compared to $56,000 for the same period last year. Revenues were primarily derived from reorders and new customer orders of disposable sleeves.

 

For the three months ended March 31, 2024, the Company reported a net loss attributable to common shareholders of $7.6 million, or $0.88 per basic and diluted share, compared to a net loss attributable to common shareholders of $4.4 million, or $13.81 per basic and diluted share, for the same period last year.

 

During the first quarter of 2024, net cash used in operating activities and for the purchase of fixed assets was $2.0 million as compared to $4.8 million for the same period of 2023.

 

The Company reported $4.9 million in cash and cash equivalents as of March 31, 2024. This balance includes the fully funded credit facility with Kreos Capital, which has approximately $2.3 million due and outstanding as of March 31, 2024.

 

 
 

 

 

About Motus GI

 

Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions.

 

For more information, visit www.motusgi.com and connect with the Company on Twitter, LinkedIn and Facebook.

 

Forward-Looking Statements

 

This press release contains certain forward-looking statements. Forward-looking statements are based on the Company’s current expectations and assumptions. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms, including without limitation, risks related to the continued impact of the COVID-19 pandemic, risks inherent in the development and commercialization of potential products, possible or assumed future results of operations, business strategies, potential grow opportunities, uncertainty in the timing and results of clinical trials or regulatory approvals, maintenance of intellectual property rights or other risks discussed in the Company’s quarterly and annual reports filed with the Securities and Exchange Commission, and its other filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

Investor Contact:

 

Troy Williams

LifeSci Advisors

(518) 221-0106

twilliams@lifesciadvisors.com

 

 
 

 

 

Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Unaudited, in thousands, except share and per share amounts)

 

   March 31,   December 31, 
   2024   2023 
    (unaudited)      
Assets          
Current assets:          
Cash and cash equivalents  $4,944   $4,958 
Accounts receivable   81    76 
Inventory, current   228    245 
Prepaid expenses and other current assets   497    478 
Total current assets   5,750    5,757 
           
Fixed assets, net   897    992 
Inventory, non-current   251    251 
Right-of-use assets   155    210 
Other non-current assets   13    13 
Total assets  $7,066   $7,223 
           
Liabilities and Shareholders’ Equity          
Current liabilities:          
Accounts payable and accrued expenses  $1,495   $1,842 
Operating lease liabilities - current   116    169 
Other current liabilities   66    226 
Current portion of long-term debt, net of unamortized debt discount of $4 and $108, respectively   1,632    1,033 
Total current liabilities   3,309    3,270 
           
Long-term debt, net of unamortized debt discount of $91 and $16, respectively   669    1,239 
Operating lease liabilities - non-current   21    27 
Total liabilities   3,999    4,536 
           
Commitments and contingent liabilities (Note 9)          
           
Shareholders’ equity          
Common stock $0.0001 par value; 115,000,000 shares authorized; 5,210,876 and 1,547,042 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively   1    - 
Additional paid-in capital   159,397    156,905 
Accumulated deficit   (156,331)   (154,218)
Total shareholders’ equity   3,067    2,687 
Total liabilities and shareholders’ equity  $7,066   $7,223 

 

 
 

 

 

Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited, in thousands, except share and per share amounts)

 

   Three Months Ended
March 31,
 
   2024   2023 
         
Revenue  $64   $56 
           
Operating expenses:          
Cost of revenue - sales   12    9 
Cost of revenue - impairment of inventory   -    165 
Research and development   455    1,454 
Sales and marketing   151    842 
General and administrative   1,472    1,945 
Total costs and expenses   2,090    4,415 
Loss from operations   (2,026)   (4,359)
           
Gain on change in estimated fair value of contingent royalty obligation   -    220 
Finance expense, net   (80)   (239)
Foreign currency loss   (7)   (8)
           
Net loss  $(2,113)  $(4,386)
Deemed dividends from warrant issuance   (5,508)   - 
Net loss attributable to common shareholders  $(7,621)  $(4,386)
           
Basic and diluted loss per common share:          
Net loss  $(0.25)  $(13.81)
Net loss attributable to common shareholders   (0.88)   (13.81)
Weighted average number of common shares outstanding, basic and diluted   8,613,204    317,547 

 

 

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May 14, 2024
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