- Initiated limited
U.S. commercial launch of the Pure-Vu® EVS Gastro and Gen4 Colon system, including successful UGI procedures at several leading hospital systems - The Company is engaged in the process to seek strategic partnerships aimed at accelerating commercialization of the Pure-Vu System and maximizing stockholder value
- Recent exercise of certain outstanding warrants provided infusion of
$2.7M in gross proceeds to the Company, which extended its cash runway into the fourth quarter of 2024
“During the past year, we achieved several key milestones that we believe strengthen our position operationally and subsequently initiated a limited
“Over the last six months, we have been able to improve our balance sheet by reducing our debt, eliminating a historical royalty commitment and receiving an infusion of capital. We believe our ability to achieve all these milestones over the past year has created significant value in our business and put us in a strong position to seek strategic partnerships,” concluded
Fourth Quarter and Recent Business Highlights
- Initiated over the last quarter, a limited
U.S. commercial launch of the Pure-Vu® EVS Gastro and Gen4 Colon system. This initial phase of the rollout is targeting existing customers, which is currently on track to be completed by end of the first quarter of 2024. The new device, which features a sleeveless Flex-Channel design, has been well received by early-adopters, who have commented on the system’s improved handling and easy setup. The Company also received positive feedback from customers using the EVS Gastro with patients presenting with a UGI bleed. Also, the system has been used successfully removed stomach contents to support therapeutic upper GI treatments that typically would have otherwise been canceled due to poor visualization. - The Company announced positive data from an international, multicenter colonoscopy study that evaluated if an adequate level of bowel cleansing could be achieved with the Pure-Vu System in patients with previous poor bowel preparation (Boston Bowel Preparation Scale (BBPS)<6). Results from the study met the primary endpoint, showing a median BBPS increase from 1-2-2 (IQR 1–2) to 3-3-3 (IQR) (p < 0.0001), with 31.8% and 88.6% of patients adequately prepared before and after using the Pure-Vu System, respectively (p < 0.0001). The study also met its key secondary endpoints and no serious adverse events occurred. These data were published in a manuscript titled, “An intraprocedural bowel cleansing system for difficult-to-prepare patients—A multicenter prospective feasibility study,” in the peer-reviewed journal, United European Gastroenterology (UGE).
- In
February 2024 , the United States Patent and Trademark Office (USPTO) issued the Company a new patent (patent # 11904085) titled, “Colon Cleaning System with Automatic Self-Purging Feature.” The new patent covers systems and methods for cleaning a colon or other portion of the GI tract include optional use of sensors to detect conditions of blockage of flow of materials within an evacuation channel used to remove debris from the body; and devices and methods for purging such blockages from the evacuation channel. This latest patent application is a continuation ofU.S. patent applications Ser. No. 16/389,955 filed onApril 21, 2019 . - The Company continues its process to seek strategic partnerships aimed at accelerating commercialization of the Pure-Vu System and maximizing stockholder value.
Financial Results for the Quarter and Year Ended
The Company reported revenue of
For the three months ended
For the year ended
During the fourth quarter 2023, net cash used in operating activities and for the purchase of fixed assets was
Net cash used in operating activities and for the purchase of fixed assets during the year ended
The Company reported
About
For more information, visit www.motusgi.com and connect with the Company on Twitter, LinkedIn and Facebook.
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 related to the continued impact of the COVID-19 pandemic, risks inherent in the development and commercialization of potential products, possible or assumed future results of operations, business strategies, potential grow opportunities, 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 quarterly and annual reports filed with the
Investor Contact:
(518) 221-0106
twilliams@lifesciadvisors.com
Condensed Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,958 | $ | 14,042 | ||||
Accounts receivable | 76 | 59 | ||||||
Inventory, current | 245 | 488 | ||||||
Prepaid expenses and other current assets | 478 | 781 | ||||||
Total current assets | 5,757 | 15,370 | ||||||
Fixed assets, net | 992 | 1,325 | ||||||
Inventory, non-current | 251 | 511 | ||||||
Right-of-use assets | 210 | 428 | ||||||
Other non-current assets | 13 | 13 | ||||||
Total assets | $ | 7,223 | $ | 17,647 | ||||
Liabilities and Shareholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 1,842 | $ | 1,969 | ||||
Operating lease liabilities - current | 169 | 245 | ||||||
Other current liabilities | 226 | 53 | ||||||
Current portion of long-term debt, net of unamortized debt discount of | 1,033 | 2,532 | ||||||
Total current liabilities | 3,270 | 4,799 | ||||||
Contingent royalty obligation | - | 1,212 | ||||||
Operating lease liabilities - non-current | 27 | 178 | ||||||
Convertible note, net of unamortized debt discount of | - | 3,892 | ||||||
Long-term debt, net of unamortized debt discount of | 1,239 | 4,589 | ||||||
Total liabilities | 4,536 | 14,670 | ||||||
Commitments and contingent liabilities (Note 9) | ||||||||
Shareholders’ equity | ||||||||
Preferred stock | - | - | ||||||
Common stock | - | - | ||||||
Additional paid-in capital | 156,905 | 144,328 | ||||||
Accumulated deficit | (154,218 | ) | (141,351 | ) | ||||
Total shareholders’ equity | 2,687 | 2,977 | ||||||
Total liabilities and shareholders’ equity | $ | 7,223 | $ | 17,647 |
Condensed Consolidated Statements of Comprehensive Loss (Unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended | Twelve months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenue | $ | 64 | $ | 109 | $ | 319 | $ | 592 | ||||||||
Operating expenses: | ||||||||||||||||
Cost of revenue - sales | 19 | 32 | 81 | 198 | ||||||||||||
Cost of revenue - impairment of inventory | 267 | 439 | 488 | 598 | ||||||||||||
Research and development | 561 | 1,350 | 3,467 | 5,611 | ||||||||||||
Sales and marketing | 244 | 871 | 1,611 | 4,425 | ||||||||||||
General and administrative | 1,445 | 1,444 | 6,579 | 7,611 | ||||||||||||
Total costs and expenses | 2,536 | 4,136 | 12,226 | 18,443 | ||||||||||||
Operating loss | (2,472 | ) | (4,027 | ) | (11,907 | ) | (17,851 | ) | ||||||||
Gain on change in estimated fair value of contingent royalty obligation | - | 577 | 103 | 548 | ||||||||||||
Loss on extinguishment of debt | (284 | ) | - | (284 | ) | - | ||||||||||
Finance expense, net | (54 | ) | (251 | ) | (761 | ) | (1,252 | ) | ||||||||
Foreign currency gain (loss) | 5 | 19 | (18 | ) | (42 | ) | ||||||||||
Net loss | $ | (2,805 | ) | $ | (3,682 | ) | $ | (12,867 | ) | $ | (18,597 | ) | ||||
Basic and diluted loss per common share: | $ | (4.48 | ) | $ | (11.89 | ) | $ | (15.89 | ) | $ | (86.15 | ) | ||||
Weighted average number of common shares outstanding, basic and diluted | 626,313 | 309,788 | 809,506 | 215,863 |
Source:
2024 GlobeNewswire, Inc., source