Motus GI is on track to grow its Pure-Vu endoscopy system in 2021, according to CEO Tim Moran. He spoke on four value-creation drivers — reimbursement, product innovation, clinical data and strategic partnerships — in an earnings call transcribed by Seeking Alpha March 16.
The company recently reported a $19.3 million net loss in 2020 and a $4.4 million net loss in the fourth quarter, a slight improvement from 2019.
Five quotes from Mr. Moran on value-creation drivers and performance:
On reimbursement: "In the fourth quarter, we submitted an application to CMS for a new technology add-on payment. This program could provide reimbursement for Pure-Vu during inpatient colonoscopy. As part of this submission, we also applied for an ICD-10 code … [and] I am pleased to share that they recommended Pure-Vu to be considered for an ICD-10 code. … We also submitted an application for CMS' transitional pass-through payment. This program could provide reimbursement for traditional outpatient procedures."
On product innovation: "Our product development efforts to launch our first Pure-Vu system for use in upper GI endoscopy is on track, and we expect to submit a 510(k) application to the FDA by early third quarter. This would potentially position us with an approved and available product on the market by early fourth quarter.
"We view this as a significant opportunity and believe our technology can potentially address a serious unmet need in the market as it relates to visualization and the treatment of upper GI bleeding, which has an estimated mortality rate of approximately 10 percent."
On clinical data: Mr. Moran said Motus GI began enrollment in a study with Cleveland Clinic to evaluate the clinical and economic benefits of the Pure-Vu system in patients with emergent lower GI bleeding who are treated in an intensive care unit or the rapid inpatient endoscopy suite.
"The outcome we receive from this study could begin to challenge the current standard of care for emergent lower GI bleed patients who are facing urgent need for diagnosis and treatment, but are currently delayed. We expect to have this study fully enrolled before the end of 2021."
On strategic partnerships: "As it relates to our strategic options, we've spent time evaluating a number of potential pathways during the back half of 2020 and into 2021. Our objectives in considering any potential partnership would be aimed at opportunities that could accelerate our commercial efforts and enhance our technology development. Any partnership would also need to unlock clear shareholder value. As we continue to grow awareness and uptake of the Pure-Vu system, we will consider which options best fit our criteria and are actionable."
On contracting with Austin-based Dell Seton Medical Center at The University of Texas and New York City-based NYU Langone: "In both instances, the customer made a commitment to minimum quarterly purchases for our Pure-Vu sleeves and for doing so, we are allowing the early adopters what we are calling centers of excellence to utilize our capital equipment at no additional cost, while these minimums are met or exceeded. We believe deploying this razor blade model works well in instances where capital funding is currently unavailable, as it permits the customer to expand use of the Pure-Vu system, while providing us with more predictable sleeve volumes. Given the current capital environment, we expect to complete additional agreements like these with early adopter hospitals in the first half of the year."