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Motus GI Reports Fourth Quarter 2020 Financial Results and Provides Corporate Update

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  • Signed new 12-month committed volume contracts with two prominent U.S. medical centers
  • Reported progress on reimbursement for Pure-Vu System in both inpatient and outpatient markets, starting with CMS submissions
  • Preparing to submit a 510(k) application to FDA by Q3 2021 for Pure-Vu System indication expansion for Upper GI endoscopies

FORT LAUDERDALE, Fla., March 16, 2021 (GLOBE NEWSWIRE) — Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today reported its financial results for the fourth quarter ended December 31, 2020, and provided a corporate update.

“We reported a steady increase in commercial momentum during the second half of 2020 compared to the first half of the year. This momentum continued in the fourth quarter despite a resurgence of COVID-19 hospitalizations across much of the United States,” stated Tim Moran, Chief Executive Officer of Motus GI. “While our sales team is still encountering limited access at most hospitals as a result of the pandemic, I am pleased by the continued progress we’ve made expanding our footprint in the market, including the signing of two prominent health systems to new annual agreements that we expect to generate revenues in 2021. We believe that as hospital access returns, GI procedures rebound to pre-pandemic levels and the number of Pure-Vu System placements expand across several hospital networks, our team will be well positioned to drive further Pure-Vu growth over the balance of 2021 and beyond.”

“In addition to our commercial efforts, we are executing towards four value creation drivers, including reimbursement, new product innovation, clinical data, and strategic partnerships. Each of these catalysts offer an opportunity for us to enhance our portfolio, broaden our addressable market, scale our organization and unlock long-term shareholder value. We are already making progress with these initiatives, for example, we just announced the initiation of a new study at a leading non-profit academic medical center in the U.S. evaluating the clinical and economic outcomes using the Pure-Vu System in patients with emergent lower gastrointestinal bleeding. In addition, our team presented a request for an ICD-10 code at a Center for Medicare and Medicaid Services (CMS) meeting on March 9th, which is part of our broader strategy to obtain reimbursement for certain inpatient and outpatient procedures where Pure-Vu System can help facilitate visualization of inadequately prepared colons in high medical need patients,” concluded Mr. Moran.

Fourth Quarter and Recent Business Highlights

  • Reported second sequential quarterly sales growth attributable to disposable sleeve sales for procedures using the Pure-Vu System
  • Announced that two prominent medical centers – the University of Texas Medical Center, and NYU Langone – signed 12-month commitments for minimum disposable sleeve purchase orders, effective for 2021
  • Initiated product evaluations of the Pure-Vu System at several new accounts, most notably the Mayo Clinic in Phoenix and Mass General Hospital in Boston
  • Implemented a strategy to pursue reimbursement for the Pure-Vu System when used during inpatient and traditional outpatient colonoscopies, starting with specific CMS submissions
  • Preparing to submit a 510(k) for a new Pure-Vu Upper GI product to FDA by Q3 2021
  • Initiated a study at a leading US non-profit academic medical center using the Pure-Vu® System in patients with lower GI bleeding, in order to evaluate the clinical and economic benefits of the system with minimal pre-procedural bowel prep
  • Secured an additional U.S. patent for the Pure-Vu System expanding IP portfolio, which includes 31 granted patents and 25 pending patents protecting the Pure-Vu System
  • Strengthened the balance sheet, including executing a warrant exercise agreement with an existing institutional investor in January 2021, raising net proceeds of approximately $11 million dollars that added to the $20.8 million in cash and cash equivalents reported as of December 31, 2020

Financial Results for the Quarter and Full Year Ended December 31, 2020

The Company reported revenue of approximately $36,000 for the fourth quarter of 2020, compared to approximately $99,000 for the same period last year. Revenues are generally from new account and site reorder sales of Pure-Vu single-use sleeves.

For the three months ended December 31, 2020, we reported a net loss of approximately $4.4 million, or a net loss per diluted share of $0.12, compared to $5.9 million, or a net loss per diluted share of $0.21, for the same period last year. During the fourth quarter 2020, net cash used in operating activities and for the purchase of fixed assets was $2.8 million as compared to $5.6 million for the same period of 2019, a reduction of 50% year-over-year.

For the year ended December 31, 2020, we reported a net loss of approximately $19.3 million, or a net loss per diluted share of $0.60, compared to $23.1 million, or a net loss per diluted share of $0.92 for the same period last year. Net cash used in operating activities and for the purchase of fixed assets during the year ended December 31, 2020 totaled $17.1 million as compared to $20.4 million for the same period of 2019. These decreases were primarily attributable to the Company’s cost-cutting measures that were announced on March 30, 2020. These measures reduced the Company’s quarterly cash burn by approximately 50% compared to previously forecasted rates for the second half of 2020.

The Company reported approximately $20.8 million in cash and cash equivalents as of December 31, 2020, compared to cash, cash equivalents and investments of $28.7 million as of December 31, 2019. In January 2021, the Company executed a warrant exercise agreement with an existing institutional investor, raising net proceeds of approximately $11 million dollars.

Conference Call:

The Motus GI management team has scheduled a conference call for today, March 16th, at 4:30 p.m. ET to discuss these results. To access the conference call, investors are invited to dial (877) 407-0792 (U.S. and Canada) or (201) 689-8263 (International). The conference ID number is 13714989. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.motusgi.com or http://public.viavid.com/index.php?id=142994. A replay of the webcast will be archived on the Motus GI website for 90 days following the event.

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 Company’s cost reduction plan, the cost savings and the cash expenses related to the implementation of the plan, risks related to the continued impact of the COVID-19 pandemic, risks inherent in the development and commercialization of potential products, 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 Form 10-K filed on March 30, 2020, 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:
Bob Yedid
LifeSci Advisors
(646) 597-6989
bob@lifesciadvisors.com

Motus GI Holdings, Inc. and Subsidiaries
Consolidated Balance Sheets
(unaudited, in thousands except share and per share amounts)

  December 31,   December 31,
  2020     2019  
Asset          
Current assets          
Cash and cash equivalents $ 20,819     $ 20,528  
Investments         8,203  
Accounts receivable   35       65  
Inventory   805       1,014  
Prepaid expenses and other current assets   448       339  
Related party receivable         18  
Total current assets   22,107       30,167  
           
Fixed assets, net   1,178       1,056  
Right-of-use assets   766       1,021  
Other non-current assets   13       13  
Total assets $ 24,064     $ 32,257  
           
Liabilities and Shareholders’ Equity          
Current liabilities          
Accounts payable and accrued expenses $ 2,333     $ 2,999  
Operating lease liabilities – current   238       321  
Other current liabilities   60       270  
Term debt, net of debt discount of $21 and $246, respectively   7,979       7,754  
Total current liabilities   10,610       11,344  
           
Contingent royalty obligation   1,617       1,872  
Operating lease liabilities – non-current   547       713  
Total liabilities   12,774       13,929  
Commitments and contingent liabilities (Note 9)          
Shareholders’ equity          
Preferred Stock $0.0001 par value; 8,000,000 shares authorized; zero shares issued and outstanding          
Preferred Series A Stock $0.0001 par value; 2,000,000 shares authorized; zero shares issued and
outstanding
         
Common Stock $0.0001 par value; 115,000,000 and 50,000,000 shares authorized; 32,272,309 and
28,811,087 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively
  3       3  
Additional paid-in capital   115,008       102,789  
Accumulated deficit   (103,721 )     (84,464 )
Total shareholders’ equity   11,290       18,328  
Total liabilities and shareholders’ equity $ 24,064     $ 32,257  
           

Motus GI Holdings, Inc. and Subsidiaries
Consolidated Statements of Comprehensive Loss
(unaudited, in thousands except share and per share amounts)

  3 Months Ended December 31,   Twelve Months Ended December 31,
  2020       2019     2020       2019  
Revenue $ 36     $ 99     $ 98     $ 107  
                       
Operating expenses:                      
Cost of revenue- sales   23       71       95       136  
Cost of revenue – Impairment of Inventory   401             401        
Research and development   1,196       2,307       5,555       9,013  
Sales and marketing   578       1,424       3,532       4,897  
General and administrative   2,130       2,308       9,562       9,497  
Total Cost and Expenses   4,329       6,110       19,145       23,543  
Operating loss   (4,293 )     (6,011 )     (19,047 )     (23,436 )
                       
Gain on change in estimated fair value of
contingent royalty obligation
  7       13       255       81  
Finance income (expense), net   (116 )     59       (464 )     273  
Foreign currency loss   3       2       (1 )     (4 )
Loss before income taxes   (4,399 )     (5,937 )     (19,257 )     (23,086 )
                       
Net loss $ (4,399 )   $ (5,937 )   $ (19,257 )   $ (23,086 )
Basic and diluted loss per common share $ (0.12 )   $ (0.21 )   $ (0.60 )   $ (0.92 )
Weighted average number of common shares outstanding, basic and diluted   37,795,517       28,801,914       32,120,017       25,133,190  
                               

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Medical Devices

New York Bone & Joint Specialists: New Invention Stops or Delays the Progression of Osteoarthritis of the Knee

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Ping An AskBob Doctor’s Smart Imaging Model for Diagnosis of Pelvic and Hip Injuries is a Breakthrough for Artificial Intelligence

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April 1, 2021

Ping An Insurance (Group) Company of China, Ltd. “Ping An” announced that Ping An AskBob Doctor’s smart imaging model for diagnosing pelvic and hip injuries is the first of its kind to accurately detect all kinds of trauma-related findings simultaneously in X-ray images.

In a research paper published in the international journal Nature Communications, the model is shown to overcome the limitation of other artificial intelligence (AI) systems, which can only detect individual fractures.

The model, a deep learning algorithm, can help physicians make faster, more accurate diagnoses and save lives. Hip fractures mainly occur in elderly people and patients with major trauma. Although they are not directly fatal, complications can lead to a high mortality rate. Reducing the rate of missed diagnoses, improving the comprehensiveness of the detection, and providing accurate diagnoses is critical.

Ping An Health Technology Research Institute, Ping An Smart City, Ping An Good Doctor and the Department of Trauma and Emergency Surgery of Chang Gung Memorial Hospital in Taiwan jointly released the research paper “A scalable physician-level deep learning algorithm detects universal trauma on pelvic radiographs”. The research team gathered the pelvic X-ray data of 1,888 emergency room patients to evaluate the model’s performance in obtain the fracture results and locations. It achieved an overall accuracy of 92.4%. Compared with general clinical diagnoses, the model substantially improves detection accuracy, speeds up the treatment progress, improves the treatment effectiveness on high-risk patients, and reduces the economic cost to patients through earlier detection and treatment.

This is the first AI algorithm to detect all fracture types captured on the X-ray images, including, but not limited to, hip fractures, pelvic fractures, femoral fractures, hip dislocation and artificial joint peripheral fractures.

As of March, 2021, the AskBob Doctor AI pelvic trauma detection technology has been used in the real-life clinical environment in Chang Gung Memorial Hospital in Taiwan for nearly eight months. The results have shown that the misdiagnosis rate has significantly reduced. Since adopting the AI system, the misdiagnosis rate has dropped from 9.7% to 0.7% among emergency physicians, 11.3% to 1.58% among resident physicians and 6% to 0.5% among specialist physicians. The model has performed comparably to radiologists and certain orthopedic specialists in terms of quantitative indicators such as sensitivity and specificity.

The smart imaging model for the diagnosis of pelvis and hip injuries is Ping An’s latest achievement in smart imaging technology. Ping An’s smart imaging technology covers nine major systems of human body — the motor, digestive, respiratory, urinary, reproductive, endocrine, immune, nervous and cardiovascular systems. It supports various equipment including computed tomography (CT,) X-ray, ultrasound and fundus optical coherence tomography (OCT).

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Medical Devices

Sander de Vos Is Appointed Chief Business Officer of IME Medical

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April 1, 2021

Sander de Vos will be responsible for the worldwide roll-out of the company’s medical electrospinning strategy, based on IME’s ground-breaking MediSpin™XL industrial production platform.

Judith Heikoop, CEO of IME Medical Electrospinning said, “We at IME are thrilled to welcome Sander to our fast-growing team of professionals. Sander clearly brings a wealth of well-needed life science experience into the company, that will certainly be of key-value to the further development of our electrospun medical device franchises. Our aim is to become the first partner of choice worldwide for the development of a novel, groundbreaking class of medical devices and pharma products based on nanofibers. Our ever-growing portfolio of customers and partners includes the Medtech and Pharma industry, universities, hospitals, and medical institutes.”

Sander de Vos (46) is an accomplished executive with more than 15 years of leadership experience across healthcare and biotech commercial and business development positions. Prior to joining IME, Sander worked at Mimetas, an innovative Dutch start-up company providing novel human cell biology models for improved therapies, where he played a key role in expanding the collaborations with its pharma and biotech partners.

In previous roles, Sander led the commercial team of Isogen Life Science and acquired experience as an entrepreneur growing a private business. His commercial career started at Westburg Life Sciences and for more than 10 years he shaped and directed the sales strategy and commercial development of part of their life science business.

Sander has a background in molecular biology, co-developed a molecular diagnostic test for simultaneous detection of tick-borne pathogens, and contributed to the development of a vaccine against ticks at the Faculty of Veterinary Medicine of the Utrecht University.

Sander de Vos, Chief Business Officer of IME Medical Electrospinning, said: “With the potential of becoming the global leader in large-scale production of best-in-class nanofiber based medical devices and drug delivery solutions, I’m proud, gratified and delighted to become a member of the IME management team. The company’s technology enables faster and better recovery of tissues and body structures, and therefore IME is uniquely positioned to make a meaningful difference in the lives of patients.”

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Medical Devices

Dipti Itchhaporia, MD, FACC: New American College of Cardiology President

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April 1, 2021

Dipti Itchhaporia, MD, FACC, today begins her term as president of the American College of Cardiology.

During her one-year presidency, she will lead the over 54,000-member global organization in its mission to transform cardiovascular care and improve heart health.

“From the moment I became a Fellow of the ACC, I’ve been excited about being a part of this community and contributing to advancing the field of cardiology and the patients we serve,” Itchhaporia said. “I’m looking forward to connecting the cardiovascular community over the next year, as we emerge from a mostly virtual world, to make strides in our strategic priorities and improve the lives of heart disease patients. We must be prepared as a profession to embrace and move to center stage our solutions and vision of digital transformation and health equity.”

Itchhaporia is an interventional cardiologist who is the Eric and Sheila Samson Endowed Chair in Cardiovascular Health, director of disease management for Hoag’s Jeffrey M. Carlton Heart and Vascular Institute in Newport Beach, California, and associate professor of medicine at the University of California, Irvine. She has been a leader in the College for over 20 years, previously holding positions both nationally and in the ACC California Chapter.

Most recently, Itchhaporia held the position of ACC vice president. She previously served as a member of the ACC’s Board of Trustees and the Board of Governors, secretary of the ACC as chair of the Board of Governors, and president of the ACC California Chapter. She has also served on multiple ACC committees and helped to advance the College’s education, science and innovation efforts, including as a member of the ACC Lifelong Learning Oversight Committee, Science and Quality Committee, Governance Committee, Practice Administrator Workgroup and as an advisor for the ACC’s Innovation Program.

Itchhaporia’s professional interests include quality measurement and improvement in cardiovascular disease, focusing on emerging risk factors and medical and lifestyle interventions to prevent coronary heart disease. She is also extensively involved in advancing technology and innovations that will advance the digital transformation of cardiovascular medicine to ultimately improve the lives of patients and clinicians, while helping to achieve health equity.

Itchhaporia’s professional passions have led to leadership roles in advancing the ACC’s strategic priorities, including serving as chair of the ACC Board of Trustees Health Equity Task Force, which addresses issues of health disparities, the social determinants of health and improving access to care for underserved patients. Further work toward health equity will be at the forefront of her presidential year.

“Health equity has been a priority for the College for a long time and for the first time we are feeling like this could be actualized,” Itchhaporia said. “In cardiology we need to have the mindset to prioritize health equity issues, and I’m excited that this is in our reach.”

She received her medical degree from St. Louis University School of Medicine and completed her residency in internal medicine at Stanford University Medical Center. She then joined the general medicine faculty at the University of California, San Francisco (UCSF), ultimately pursuing a cardiology fellowship at Georgetown University and an interventional cardiology fellowship at Stanford University.

Other ACC officers for 2021-2022 are Vice President Edward T. A. Fry, MD, FACC; Board of Governors Chair Joseph Marine, MD, FACC; and Treasurer Christopher M. Kramer, MD, FACC.

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