Motus GI Announces European Clearance of Enhanced Pure-Vu® GEN2 System to Harmonize with U.S. Configuration

Rhea-AI Summary

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.

Positive

• Received DEKRA certification for Pure-Vu GEN2 System enhances market positioning in Europe.
• Enhancements improve user experience and efficiency in colon cleansing.
• Potential for strategic partnerships in EU to increase market reach.

Negative

• None.

Regulatory approval for enhanced system is a key milestone that supports evaluation of strategic partnership opportunities in the EU
- - -
U.S. commercial rollout of Pure-Vu® GEN2 System enhancements initiated in Q4 2020

FORT LAUDERDALE, Fla., Jan. 15, 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 announced receiving approval from DEKRA (EU Notified Body) for enhancements to the Pure-Vu GEN2 System. The enhancements to the Pure-Vu GEN2 System were introduced to commercial customers in the U.S. during the fourth quarter of 2020.

The enhancements to the Pure-Vu GEN2 System were focused on the continued improvements to the user experience, including software upgrades to increase the efficiency in cleansing the colon and enhanced ergonomics in loading and unloading the device on a colonoscope. In addition, the ability for the system to capture data was improved, allowing it to better understand user preferences and guide future product development efforts.

“We are pleased to receive DEKRA certification for our Pure-Vu GEN2 System in Europe. This certification harmonizes our product configuration in both the U.S. and EU. In addition, this certification is a key milestone that provides for manufacturing efficiencies and serves as a trigger to begin our seeding activities for potential expansion in the EU market,” said Tim Moran, chief executive officer of Motus GI. “As we look to establish the foundation for bringing our innovative Pure-Vu solution to healthcare providers and patients around the world, we've implemented processes that actively collect customer feedback and data which allow us to respond quickly with system updates to enrich the user experience.”

The Company believes this is an important step in its commercialization strategy for the Pure-Vu System in Europe. Motus GI is assessing potential commercial partnerships in the EU with companies that offer proven sales capabilities in the GI space and working knowledge of each country’s regulations. These types of partnerships are expected to be the most efficient and effective method to bring the clinical and economic benefits of the Pure-Vu® System to European physicians and patients.

There were approximately six million colonoscopies conducted in the Europe during 2019¹, making it one of the largest potential markets for the Pure-Vu 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 approximately four million inpatient colonoscopy procedures take place worldwide each year.

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.

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

¹ According to iData Research Inc.

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 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

FAQ

What recent approval did Motus GI receive for the Pure-Vu GEN2 System?

Motus GI received DEKRA certification for enhancements to the Pure-Vu GEN2 System.

How does the DEKRA certification impact Motus GI's operations in Europe?

The certification is a key milestone that harmonizes product configurations between the U.S. and Europe, enabling commercial expansion.

What are the primary enhancements made to the Pure-Vu GEN2 System?

Enhancements include software upgrades for better efficiency in colon cleansing and improved ergonomics for loading and unloading.

How many colonoscopies were performed in Europe in 2019?

Approximately six million colonoscopies were conducted in Europe in 2019.

What is the potential market for the Pure-Vu System in Europe?

The potential market is significant, with around six million colonoscopies performed annually in Europe.