Asensus Surgical Provides Preliminary 2021 Year-End Corporate Update
Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today provided a preliminary 2021 year-end corporate update.
Fourth Quarter Highlights
"Digital transformation is occurring in many sectors and it's a critical time to bring it to the OR to elevate surgery in ways that matter. Last year was a strong one for the company as we continued to empower surgeons around the globe with new tools and Clinical Intelligence for increased control, less variability, and consistently superior outcomes. Driving greater than 42% growth in global Senhance procedure volumes and initiating ten new Senhance programs is encouraging and points to the continued growing demand for Senhance and the clinical utility it delivers to surgeons and hospitals," said Anthony Fernando, Asensus Surgical President and CEO. "We look forward to leveraging the momentum we generated to accelerate adoption of Senhance and continuing to make progress on the promise of Performance-Guided Surgery."
2021 Senhance Program Initiations
During the fourth quarter of 2021, the Company initiated six programs, one in the US, three in EMEA, and two in Asia. Included in this are two previously unannounced program initiations which occurred in December of 2021, at hospitals in Germany and Ukraine, respectively.
During 2021, there were 21 peer-reviewed clinical papers published providing further support for the clinical utility of the Senhance System across a variety of surgical specialties. In particular, there were four milestone papers published:
Performance-Guided Surgery (PGS)
Historical advances in surgery have largely focused on bringing tools and techniques into the OR to reduce the invasiveness of procedures and improve the execution of discrete tasks. Unlike many other industries, very little focus has been on improving the decision-making aspects of the surgical process, which is crucial in the high-pressure, highly variable situations which happen repeatedly during any surgery.
PGS is the first surgical paradigm focused on a holistic solution for the entire surgeon workflow to drive consistently superior outcomes. We believe PGS can deliver real-time clinical decision support to boost surgeon capabilities to perceive complex environments, make decisions, and perform the desired tasks with increased precision, safety, and efficiency to mitigate surgical errors and complications.
Expanded Global ISU Machine Vision Capabilities
Articulating Instrument Clearance
General Surgery Indication Expansion
CE Mark for Intelligent Surgical Unit
Fourth Quarter and Full Year 2021 Revenue
For the quarter ended December 31, 2021, the Company estimates preliminary unaudited revenue of approximately $2.1 - $2.5 million. For the full year, preliminary unaudited 2021 revenue is expected to be approximately $7.9 - $8.3 million, representing revenues from the sale of three Senhance Systems, system leasing, and related revenues from instruments and accessories, and services.
As of December 31, 2021, the Company had preliminary unaudited cash, cash equivalents, short-term and long-term investments, excluding restricted cash, of approximately $135.8 million, and there were approximately 235.2 million shares of common stock outstanding.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. This builds upon the foundation of Digital Laparoscopy with the Senhance Surgical System powered by the Intelligent Surgical Unit (ISU) to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. Learn more about Performance-Guided Surgery and Digital Laparoscopy with the Senhance Surgical System here: www.senhance.com. Now available for sale in the US, EU, Japan, Russia, and select other countries. For a complete list of indications for use, visit: www.senhance.com/indications. For more information, visit www.asensus.com.
This press release includes statements relating to the Senhance System and our preliminary 2021 results. These statements and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether we will be able to continue to progress our strategic plan in 2022; whether final 2021 fourth quarter and full year revenue will meet expectations; whether the momentum we have generated will drive accelerated adoption of the Senhance System and whether we will continue to make progress towards on the promise of Performance-Guided Surgery; whether Performance Guided Surgery can deliver real-time clinical decision support to boost surgeon capabilities to perceive complex environments, make decisions, and perform the desired tasks with increased precision, safety, and efficiency to mitigate surgical errors and complications; whether we can continue to increase Senhance System placements and sales, and whether we can continue to add foundational sites and receive regulatory clearances and approvals that we seek. For a discussion of the risks and uncertainties associated with the Company's business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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