Post by icemandios on May 11, 2023 23:39:02 GMT
Asensus Surgical, Inc. Reports Operating And Financial Results For The First Quarter 2023
RESEARCH TRIANGLE PARK, N.C., May 11, 2023 (GLOBE NEWSWIRE) -- 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 announced its operating and financial results for the first quarter 2023.
20% year-over-year growth in surgical procedures, with over 900 procedures performed globally during the quarter
Surpassed 10,000 procedures on Senhance® Surgical System
One Senhance Surgical Program was initiated during the quarter
In March 2023, received FDA 510(k) clearance for an expanded indication to treat pediatric patients
First quarter revenue of $1.0 million
The Company had cash, cash equivalents, short-term and long-term investments, excluding restricted cash, of approximately $57.4 million at March 31, 2023
Upcoming 2023 Milestones
For the full year 2023, the Company continues to expect to initiate 10 - 12 new Senhance programs.
During the second half of 2023, the Company continues to expect to achieve the following developmental milestones:
Integrated system testing for LUNA Surgical System
Preclinical evaluation for LUNA Surgical System
Standalone ISU final testing
Designed based on the feedback received from over 10,000 digital laparoscopic procedures performed with the Senhance System, the LUNA Surgical System is the Company’s next generation digital surgery platform. Through a combination of advanced minimally invasive instrumentation, the first ever digital interface between the surgeon and the console, and industry-leading clinical intelligence tools, we believe the LUNA System is poised to revolutionize the way surgery is performed.
The LUNA System is under development, and not currently available for use.
KARL STORZ Collaboration Agreement
The Company previously announced that it had entered into a Memorandum of Understanding with KARL STORZ VentureONE Pte. Ltd. (KARL STORZ), a new wholly owned subsidiary of KARL STORZ SE & Co. KG. As part of the definitive agreements, KARL STORZ intends to market and sell Asensus’ ISU as a standalone device, and the companies intend to jointly collaborate on the development and integration of next-generation instrumentation. The agreement is progressing towards signing and will represent an important step expanding our commercial reach and development capabilities.
U.S. Pediatric Regulatory Clearance
The Company received U.S. FDA 510(k) clearance for pediatric surgeries in the U.S. during the first quarter of 2023. The Senhance System’s unique combination of 3mm instrumentation with a 5mm camera scope combined with haptic feedback make it a unique robotic assisted laparoscopic solution for pediatric surgeries.
Market Development
Procedure Volumes
During the first quarter of 2023, there was a 20% increase in total surgical procedures completed utilizing the Senhance System over the same period in 2022. Strong utilization patterns brought on by an increased installed base, an increase of new surgeon users at existing installations, and a broader market recovery were the main drivers of this expansion.
2023 Senhance Program Initiations
During the first quarter of 2023, the Company initiated one new Senhance Surgical System placement in Japan.
Clinical Validation
During the quarter, a peer reviewed paper was published highlighting early experience of using the Senhance System in pediatric procedures in the United States. Conducted with IRB approval prior to 510(k) clearance, this study highlights the safety and feasibility of using Senhance System in pediatric cases. The surgical team successfully performed surgeries on eight patients ranging from four months to 16 years old, including procedures such as cholecystectomy, inguinal herniorrhaphy, orchidopexy, and exploration for suspected enteric duplication cyst. The successful use of the Senhance System in pediatric surgeries marks an important milestone for the Company in its ongoing mission to advance the field of surgical robotics.
Intelligent Surgical Unit (ISU) Collects Two Industry Awards on the Heels of Passing 10,000 Procedures on Senhance Surgical System
The Senhance System has passed the 10,000 worldwide procedures milestone and the Company recently received two prestigious industry awards. The first award comes from MedTech Breakthrough, where the ISU was named the "Best New Technology Solution” in the surgical category. This achievement is remarkable as the ISU competed against nearly 4,000 nominations from across the globe. This marks the third time Asensus has earned a MedTech Breakthrough win. The MedTech Breakthrough Awards program is an independent program devoted to honoring excellence in medical and health-related technology companies, products, services and people. The second award comes from Juniper Research's Future Digital Awards for Excellence in Digital Health Innovation, where the ISU has been honored as the "Best Medical Robotics Solution" and awarded the Platinum Winner title. The awards program recognizes organizations that have made outstanding contributions to their industry and are positioned to make a significant impact in the future.
First Quarter Financial Results
For the three months ended March 31, 2023, the Company reported revenue of $1.0 million as compared to revenue of $1.1 million in the three months ended March 31, 2022. Revenue in the first quarter of 2023 included $0.5 million in lease revenue, $0.3 million in instruments and accessories, and $0.2 million in services.
For the three months ended March 31, 2023, total operating expenses were $20.4 million, as compared to $18.2 million, in the three months ended March 31, 2022.
For the three months ended March 31, 2023, net loss was $22.2 million, or $0.09 per share, as compared to a net loss of $19.1 million, or $0.08 per share, in the three months ended March 31, 2022.
Adjusted net loss is a non-GAAP financial measure. See the reconciliation of GAAP to Non-GAAP Measures below. For the three months ended March 31, 2023, the adjusted net loss was $22.0 million, or $0.09 per share, as compared to an adjusted net loss of $16.6 million, or $0.07 per share in the three months ended March 31, 2022, after adjusting for the following charges: amortization of intangible assets, and change in fair value of contingent consideration, both of which are non-cash charges.
Balance Sheet Updates
The Company had cash, cash equivalents, short-term and long-term investments, excluding restricted cash of approximately $57.4 million as of March 31, 2023.
Conference Call
To listen to the conference call on your telephone, please dial 1-844-826-3033 for domestic callers and 1-412-317-5185 for international callers, approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link ir.asensus.com/events-and-presentations . The replay will be available on the Company’s website.
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. Based upon the foundations of digital laparoscopy and the Senhance Surgical System, the Company is developing the LUNA Surgical System, a next generation robotic and instrument system as a foundation of its digital surgery solution. These systems will be powered by the Intelligent Surgical Unit 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. The Senhance Surgical System is 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. To learn more about Performance-Guided Surgery, and digital laparoscopy with the Senhance Surgical System visit www.asensus.com.