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Motus GI Holdings, Inc. (NASDAQ: MOTS) is a medical technology company headquartered in the United States with subsidiaries in the U.S. and Israel. The company is committed to enhancing endoscopy outcomes, reducing costs, and improving patient experiences. A primary focus of Motus GI is the development and commercialization of the Pure-Vu® System.
The Pure-Vu® System is a medical device designed to improve the colonoscopy experience by aiding in the early detection and prevention of colorectal cancer and other diseases of the colon and rectum. This innovative system, which has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval in Europe, integrates with standard colonoscopes. It facilitates cleaning of a poorly prepared colon during the colonoscopy procedure while maintaining the standard workflow and techniques.
Recent achievements of Motus GI include strengthening their market presence through strategic partnerships and ongoing projects aimed at enhancing the Pure-Vu® System’s functionality and reach. The company continues to focus on securing additional regulatory approvals, expanding its market base, and improving its financial performance.
Motus GI Holdings has submitted a 510(k) application to the FDA for a new version of the Pure-Vu System, compatible with gastroscopes for upper GI endoscopy. This innovation aims to improve efficiency in treating upper GI bleeds, which affect approximately 400,000 patients annually in the U.S. The product enhances visibility by removing blood and debris during procedures, potentially expanding Motus GI's market share and operational synergies. CEO Tim Moran expressed optimism about the application, as it aligns with the company's growth strategy.
Motus GI Holdings, Inc. (NASDAQ: MOTS) has signed new 12-month contracts with the University of Texas Medical Center and NYU Langone, anticipating revenue generation in 2021. The company reported a revenue of approximately $36,000 for Q4 2020, down from $99,000 in Q4 2019, and a net loss of approximately $4.4 million. Cash and equivalents totaled $20.8 million as of December 31, 2020. Motus GI is preparing a 510(k) submission for the Pure-Vu System to expand its indications and improve market presence during a COVID-19 recovery.
Motus GI Holdings, Inc. (NASDAQ: MOTS) announced the enrollment of the first patient in a pilot study for the Pure-Vu® System, aimed at improving clinical outcomes for patients with emergent lower gastrointestinal bleeding. The study will enroll up to 20 patients and assess bowel preparation success during urgent colonoscopies using minimal prep. The Pure-Vu System, FDA-cleared, enhances visualization and is expected to lower costs while expediting diagnoses. The company anticipates that over 4.8 million inpatient colonoscopies will occur globally in 2021, underlining the system's potential impact.
Motus GI Holdings (NASDAQ: MOTS) is set to present its request for an ICD-10 code on March 9, 2021, at a CMS meeting to secure reimbursement for its Pure-Vu System. This system enhances colonoscopy procedures by improving bowel cleanliness. CEO Tim Moran emphasized that acquiring an ICD-10 code is crucial for expanding access to this technology for Medicare beneficiaries. The Pure-Vu System has FDA clearance and a CE Mark in the EU, showing promise in achieving over 95% cleanliness rates in clinical studies, thus enhancing patient outcomes.
Motus GI Holdings, Inc. (NASDAQ: MOTS) will announce its fourth quarter and full year 2020 financial results on March 16, 2021, after the market closes. The company specializes in endoscopy solutions aimed at improving clinical outcomes and cost-efficiency in diagnosing gastrointestinal conditions. Following the release, management will host a conference call at 4:30 p.m. ET to discuss results and recent developments. A replay will be available on the company's website for 90 days post-event, emphasizing transparency and shareholder communication.
Motus GI Holdings, Inc. (NASDAQ: MOTS) announced its participation in two virtual investor conferences in March 2021. The H.C. Wainwright Global Life Sciences Conference is set for March 9, 2021, where management will engage in meetings. Additionally, Motus GI will present at the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 9:20 a.m. ET. The presentation can be accessed live via webcast and will be archived on the Company's website. Motus GI specializes in endoscopy solutions that enhance clinical outcomes and cost-efficiency in gastrointestinal care.
Motus GI Holdings, Inc. (NASDAQ: MOTS) announced the issuance of U.S. Patent No. 10,925,466, enhancing IP protections for its Pure-Vu System. This system improves colonoscopy visualization and efficiency, addressing unmet needs in bowel preparation, especially for high-risk patients. The Pure-Vu System has shown over 95% bowel cleanliness rates in clinical studies and has received CE Mark approval in the EU, along with FDA clearance.
Motus GI Holdings, Inc. (NASDAQ: MOTS) announced a warrant exercise agreement with an institutional investor, expected to yield up to $11.0 million. The investor will exercise approximately 8.0 million existing warrants at $1.30 per share, and will receive up to 6.0 million new warrants at a $2.12 exercise price, valid until January 27, 2026. Funds will support commercialization and R&D for the Pure-Vu System, along with working capital needs. A.G.P./Alliance Global Partners acted as the financial advisor for this transaction.
On January 15, 2021, Motus GI announced receiving DEKRA certification for enhancements to its Pure-Vu GEN2 System, marking a significant milestone in its commercialization strategy in Europe. The enhancements focus on user experience and data capture to improve colon cleansing efficiency. This regulatory approval aligns both U.S. and EU product configurations and sets the stage for potential strategic partnerships in the EU market, which had approximately six million colonoscopies in 2019. Motus GI estimates four million inpatient procedures annually.
Motus GI Holdings has received additional patent protection for its Pure-Vu® System in the U.S. and Europe, enhancing its market position. The U.S. Patent Office issued patent 10,881,277, while the EPO granted patent number 3128893 for fecal waste evacuation technology. CEO Tim Moran highlighted the growing commercial potential and increased awareness among gastroenterologists. The Pure-Vu System boasts a 95% bowel cleanliness rate in clinical studies, addressing significant unmet needs in colonoscopy procedures and showcasing potential cost savings for hospitals.
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