17% growth in surgical procedures, with over 2,700 procedures performed globally year to date at September 30, 2023.
手術件数が17%増加し、2023年9月30日現在、全世界で2,700件を超える手術が実施
Two Senhance Surgical programs initiated in the quarter, with two programs initiated subsequent to the end of the third quarter, bringing the year-to-date total to five.
The Company had cash and cash equivalents and short-term investments, excluding restricted cash, of approximately $33.1 million at September 30, 2023.
2023年9月30日現在、制限付き現金を除く現金および現金同等物、短期投資は約3,310万ドル。
“I’m pleased with the progress we’ve made and the strong foundation we are building for the future. We anticipate reaching important milestones in the upcoming quarters,” said Anthony Fernando, Asensus Surgical President and CEO.
“With the LUNA™ Surgical System program progressing as planned, our primary objective continues to be the
completion of our preclinical evaluation planned for December this year with the full LUNA system. Additionally, we are excited to see notable traction in the pediatrics space, a testament to our commitment to advancing surgical technology for all patients and the unique features of the Senhance System.”
During the third quarter of 2023, the Company achieved the following developmental milestones:
2023年第3四半期、当社は以下の開発マイルストーンを達成
Finalized manufacturing strategy with Flex for LUNA Surgical System
LUNA手術システムの製造戦略をフレックス社と最終決定
Finalized strategic relationship with NVIDIA as our graphics hardware provider.
グラフィックス・ハードウェアのプロバイダーとしてエヌビディアとの戦略的関係を最終化
During the last quarter of 2023, the Company continues to expect to achieve the following developmental milestones
2023年最終四半期に、当社は引き続き以下の開発マイルストーンを達成する見込み
Complete integrated system testing for our LUNA Surgical System
Conduct preclinical evaluation for our LUNA Surgical System
Finalize manufacturing partner for the updated Intelligent Surgical Unit™ (ISU™) platform
For the full year 2023, the Company now expects to initiate 8 – 10 new Senhance programs, revised from the previous estimate.
The LUNA System’s development is in progress and is now entering the testing and evaluation phase before regulatory submissions. Preclinical evaluation is on track to be completed in December this year with seven U.S and European surgeons in attendance over a week long period to perform preclinical procedures on porcine models to confirm the performance of the LUNA system. Future milestones include freezing the system’s design in early 2024, followed by verification and validation testing, and pilot manufacturing. The Company is confident in the regulatory pathway for the LUNA System. Ongoing communication with the FDA, along with strong in-house regulatory expertise and past successful submissions for the Senhance System, lead the Company to anticipate using a standard 510(k) pathway in the U.S., rather than the more complex de novo pathway. This streamlined approach is expected to apply globally, offering a quicker market entry compared to new entrants.
Procedure Volumes
Year to date ended September 30, 2023, there was a 17% growth in procedures completed utilizing the Senhance System over the same period in 2022. The main drivers of this expansion were consistent utilization patterns brought on by an increased installed base and an increase of new surgeon users at existing installations.
Year to date, the Company initiated five new Senhance Surgical System placements or sales, which consisted of two in Japan, one in Germany, one in the Commonwealth of Independent States (CIS) region, and one in the United States.
その内訳は、日本2件、ドイツ1件、独立国家共同体（CIS）地域1件、米国1件である。
In August, the Company initiated a program with First Towakai Hospital, in their urology, gynecology, and gastroenterology departments. This initiation in Japan further strengthens the Company’s presence in the region.
In July, Mayo Clinic Hospital, Saint Marys Campus, a leading U.S.-based hospital, became the first hospital in the United States to exclusively utilize the Senhance System for pediatric surgery. The system’s specialized features, including augmented intelligence, machine learning, haptic feedback, and tailored instruments, make it exceptionally well-suited for pediatric procedures.
After the close of the third quarter, the Company placed one additional system and sold a
second system.
第3四半期終了後、当社はさらに1台のシステムを導入し、2台目のシステムを販売した。
Klinikum Idar-Oberstein Hospital in Germany, initiated a Senhance Surgical System in the Clinic for General, Visceral and Minimally Invasive Surgery. The second system was sold to the Company’s distribution partner and is planned for installation in the Commonwealth of Independent States (CIS) region.
For the three months ended September 30, 2023, the Company reported revenue of $1.1 million, as compared to revenue of $2.6 million in the three months ended September 30,2022. Revenue in the third quarter of 2023 included $0.5 million in lease revenue, $0.3 million in instruments and accessories, and $0.3 million in services.
For the three months ended September 30, 2023, total operating expenses were $18.5 million, as compared to $17.2 million, in the three months ended September 30, 2022.
For the three months ended September 30, 2023, net loss was $18.3 million, or $0.07 per share, as compared to a net loss of $18.9 million, or $0.08 per share, in the three months ended September 30, 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 September 30, 2023, the adjusted net loss was $15.6 million, or $0.06 per share, as compared to the adjusted net loss of $16.9 million, or $0.07 per share in the three months ended September 30, 2022, after adjusting for the following non-cash charges: amortization of intangible assets, change in fair value of contingent consideration, and change in fair value of warrant liabilities.
The Company had cash and cash equivalents and short-term investments, excluding restricted cash, of approximately $33.1 million as of September 30, 2023.
In July, a registered direct offering was successfully completed, yielding approximately $10 million in gross proceeds. The infusion of these funds is strategically earmarked to fortify working capital and contribute to ongoing research and development endeavors.
Based on the recent financing and our current operating plan, the Company anticipates that available cash will now sustain operations until the late second quarter of 2024.
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.
デジタル腹腔鏡手術とSenhance®手術システムの基盤に基づき、当社はデジタル手術ソリューションの基盤として、次世代ロボットおよび器具システムであるLUNA™手術システムを開発。
These systems are and 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.
これらのシステムは、インテリジェント・サージカル・ユニット（Intelligent Surgical Unit）を搭載し、外科医のコントロール能力を高め、手術のばらつきを抑える。手術体験全体にマシンビジョン、拡張知能、ディープラーニング機能を加えることで、手術成績と価値に基づく医療を推進する現在の臨床的、認知的、経済的欠点に総合的に対処するつもりです。
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.
