Motus GI Receives FDA Clearance for Colonoscopy Product

Motus GI’s (NASDAQ:MOTS) latest US Food and Drug Administration (FDA) clearance will strengthen the framework for colonoscopy examinations for more patients than its previously approved product.

On Thursday (September 13), Motus announced that its FDA-cleared Pure-Vu Slim Sleeve, which is an extension of its standard Pure-Vu System, will allow the company access to a wider arange of colonoscopy proceures.

Motus expects to have the new product available for clinical use in the coming weeks. Both products have the same performance, and both work with the company’s Pure-Vu workstation control system.

“From my in vitro testing experience with the Pure-Vu Slim Sleeve on a slim colonoscope, the device had excellent handling and navigation performance,” Dr. Tamas Gonda with Columbia Columbia University Medical Center, said in the press release.

Gonda said the slim device is able to work with patients with unique anatomy needs. Once the product becomes available, the company expects its entry into the market will increase the amount of patients that may benefit from the device.

Mark Pomeranz, CEO of Motus, said the device will better cleanse the colon and reduce insufficent bowl prep that leads to a delayed diagnossis. According to Pomeranz, the system will assist in reducing the amount of repeat preps and procedures and eliminate longer hospital stays.

Pomeranz added the company is working towards a commercial launch in 2019 in the US and parts of Europe. Motus is currently focusing on post-approval clinical trials along with market development programs for US hospitals. The current study is the Reduce study and the upcoming trial will be called Expedite.

The Pure-Vu mixes water and air pressure to safely prepare the colon for these examinations. The system has disposable components and a workstation controller.

Some studies have found that nearly 55 percent of colonoscopies are not properly prepped, which leads to longer hospital stays and additional costs to prepare for the examination, the press release says. The company believes there is an unmet need of 1.5 million procedures in the US and four million worldwide.

Motus has subsidiaries in the US and Israel which are tailored to improve colonoscopy clinical outcomes and enhance cost-efficiency. The Pure-Vu systems are the company’s only set of products, all of which already have received European Commission mark approval in Europe.

Investor takeaway

Motus GI’s stock price increased five percent over the trading period Thursday to US$5.85 as of market close.

TipRanks shows one analyst issued a note to investors on Thursday: Piper Jaffray analyst Matthew O’Brien reiterated his “Buy” rating for the company with a US$8 price target.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.