FORT LAUDERDALE, Fla., March 08, 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, announced today that it will present its request for an ICD-10 code at a Center for Medicare and Medicaid Services (CMS) meeting on March 9th. The request to CMS is part of a broader strategy to obtain reimbursement for certain procedures utilizing the Pure-Vu System to help facilitate the cleaning of a poorly prepared colon during colonoscopy.
During the ICD-10 Code Coordination meeting (the “meeting”), CMS staff will lead a discussion of possible code additions and revisions. Participants are encouraged to ask questions concerning clinical and coding issues and to offer recommendations. All recommendations concerning proposed code additions and revisions discussed during the meeting and followed up in writing before the end of the comment period, will be considered. Final decisions on code additions and revisions are made through a subsequent clearance process within the Department of Health and Human Services. Additional information on the meeting can be found on the CMS website (click here).
“We are pleased to take part in this important meeting with CMS, and to present as part of our request, the significant value we believe our Pure-Vu System provides for patients undergoing colonoscopy procedures. If assigned, an ICD-10 code for our technology would be a key step in our broader reimbursement strategy for the Pure-Vu System. There are a variety of mechanisms to gain both public and private coverage for reimbursement, and we are excited to be working with CMS in an effort to enhance the access of the Pure-Vu System to Medicare beneficiaries,” said Tim Moran, Chief Executive Officer of Motus GI. “Gaining reimbursement for the Pure-Vu System could potentially accelerate our ability to bring this much needed solution to more patients in this underserved market.”
The ICD-10 code decision process is supportive of the New Technology Add on Payment (NTAP) application for the Pure-Vu system, which is currently under review at CMS. The NTAP program is only available to new technologies meeting the definition of newness of the technology, exceeding cost criterion thresholds and demonstrating substantial clinical improvement over existing therapies.
In June 2019, the U.S. Food and Drug Administration (FDA) issued 510(k) clearance for the Pure-Vu GEN2 System.
About the Pure-Vu System
The Pure-Vu System integrates with standard and slim colonoscopes to improve visualization during a colonoscopy while preserving established procedural workflow by irrigating the colon and evacuating debris to provide a better-quality exam. Challenges with bowel preparation for inpatient colonoscopy, particularly patients who are elderly, with comorbidities, or active bleeds, represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care. Motus GI believes the Pure-Vu System may lead to positive outcomes and lower costs for hospitals by safely and quickly improving visualization of the colon for a quality exam the first time. In multiple clinical studies to date, involving the treatment of challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. Motus GI estimates that this year approximately 4.8 million inpatient colonoscopy procedures will take place worldwide.
The Pure-Vu System has received a CE Mark in the EU and is cleared by the U.S. Food and Drug Administration to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure.
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.
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 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.