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Foregut Surgeon, who trained at the Esophageal Institute – West Penn Hospital in Pennsylvania, uses Activ Surgical’s proprietary technology during surgical procedure at Abdali Hospital in Amman, Jordan

BOSTON – January 22, 2024 — Activ Surgical, a digital surgery pioneer, announced that it has completed its first international surgery at Abdali Hospital, a member of the Clemenceau Network, in Amman, Jordan using its ActivSight™ Intelligent Light (ActivSight), which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room. ActivSight is an easy-to-adapt module that seamlessly attaches to today’s laparoscopic and robotic systems and integrates with standard monitors. On December 24, 2023, Mohamad Rassoul Abu-Nuwar, MD, who specializes in general and advanced laparoscopic gastrointestinal surgery, foregut, as well as bariatric surgery, performed a surgical bariatric revision procedure using the ActivPerfusion™ Mode within ActivSight.

Dr. Abu-Nuwar completed a fellowship in Minimally Invasive Foregut Surgery at the AHN Esophageal Institute in Pittsburgh where he trained with Drs. Blair Jobe and Kirsten Newhams on using ActivSight in esophagectomies for cancer patients. At this program, Dr. Abu-Nuwar participated in a clinical study demonstrating that ActivSight’s Laser Speckle Contrast Imaging (LSCI) provides real-time, repeatable, and on-demand perfusion assessment without dyes to help prevent esophageal anastomotic leaks. Ahmad Abu Ghazaleh, Executive Vice Chairman of Abdali Hospital said, “We at Abdali Hospital pride ourselves in being the Middle East’s prime center for healthcare innovation and pioneering technology. The use of ActivSight by Dr. Abu-Nuwar in surgery demonstrates our commitment to patient-centered excellence.”

“West Penn was among the first hospitals where we launched ActivSight in 2022,” said Manisha Shah-Bugaj, Chief Executive Officer at Activ Surgical. “Now, with Dr. Abu-Nuwar championing our technology at Abdali Hospital and the support of one of our lead investors, Hikma Ventures (the strategic venture capital arm of Hikma Pharmaceuticals PLC), we are able to deliver intelligent information to doctors beyond the U.S. to reduce surgical complication rates. As we continue to achieve significant milestones such as this, our vision is to transform the collective surgical experience by leveraging emerging technologies and data into insights that make cutting-edge surgery accessible for all.”

Hikma Ventures led Activ Surgical’s Series B extension round in March 2022 and has made 20 investments to date in global digital health companies. Commenting on this milestone partnership, Lana Ghanem, Managing Director at Hikma Ventures, said, “This is the latest example of Hikma Ventures’ commitment to supporting pioneering companies utilizing cutting-edge technologies to meaningfully improve patients’ lives and treatment journeys and solidifies Hikma’s role in introducing new tools and solutions to patients and hospitals in the MENA region.”

Activ Surgical is transforming the operating room today through its 510(k)-cleared and CE-marked ActivSight device that seamlessly upgrades existing operating room equipment while serving as the “eyes” of their cutting-edge platform. With ActivSight, surgeons can now access critical intraoperative visual data as augmented reality overlays. To date, multiple major hospital networks across the U.S. have purchased ActivSight, and many additional customer sites are planned for 2024.

About Activ Surgical  

Activ Surgical is the pioneering digital surgery company that completed the world’s first autonomous robotic surgery of soft tissue in 2018. The company aims to transform the collective surgical experience by leveraging emerging technologies and data into insights that make world-class surgery accessible for all, and for every surgical imaging system to deliver intelligent information that reduces surgical complication rates, ushering in a new standard of patient care and safety. Activ Surgical is privately held, and backed by Cota Capital, BAM Funds, Hikma Ventures, Mint Ventures, Castor Ventures, Dream One Vision, NVIDIA, DNS Capital, GreatPoint Ventures (GPV), Artis Ventures, Tao Capital Partners, LRVHealth, Rising Tide VC, SONY Innovation Fund, 8VC, Fiscus Ventures, Peak 6 and Reimagined Ventures. Learn more at activsurgical.com and follow us on LinkedIn and X (formerly Twitter).

About Hikma

(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we’ve been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people’s lives. We’re committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,800 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

About Hikma Ventures

Founded in August 2015, Hikma Ventures operates as the corporate venture capital arm of Hikma Pharmaceuticals. Hikma Ventures invests in global start-ups where Hikma’s expertise can accelerate revenue growth and enhance value creation by providing ventures with access to the resources of a multinational pharmaceutical company. For more information, please visit www.hikmaventures.com.

About Abdali Hospital

Abdali Hospital is a 200-bed multi-specialty hospital with the mission to provide best practice patient-centered care and promote research and education. Abdali Hospital was founded by the investment group behind the Clemenceau Medical Center in Beirut, affiliated with Johns Hopkins Medicine International. Our goal is to improve the health of the community locally and internationally, by setting a new standard of excellence in medicine, providing inclusive medical care to prevent, diagnose, manage and treat health problems. For more information, please visit https://www.abdalihospital.com/ .

Media Contact

Michael Sullivan

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503-799-7520

The clinical study, conducted at The Ohio State University Wexner Medical Center, demonstrated that the advanced visualization information from ActivSight impacted intraoperative surgical decision-making in 17.5% of minimally invasive left-sided colorectal cases.

BOSTON, MA – June 5, 2023 — Activ Surgical, a digital surgery pioneer, presented findings today at The American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting from a clinical study conducted at The Ohio State University Wexner Medical Center using the ActivPerfusion™ and ActivICG™ modes within its FDA cleared product, ActivSight™ Intelligent Light (ActivSight). The purpose of the study was to investigate the clinical utility of real-time laser speckle contrast imaging (LSCI) and perfusion quantification in comparison to Indocyanine Green (ICG) in minimally invasive left-sided colorectal surgery. LSCI provides real-time tissue perfusion information by measuring coherent laser light scatter from moving red blood cells.

Results of the study, presented by Garrett Skinner, MD, lead author, surgical resident, and Surgeon Innovator-in-Residence at Activ Surgical, indicate that in 17.5% of cases surgeons changed an intraoperative decision based on additional information provided by ActivSight’s advanced visualization. For cases where a decision was changed, the average discordance between the line of demarcation (LOD) in white light imaging and LSCI was 3.7cm. The ICG and LSCI line of demarcation was concordant in 95% of cases.

“These findings are significant and demonstrate that by using LSCI technology in ActivPerfusion Mode, surgeons were able to assess more precisely and accurately during surgery which regions of resected and/or remaining bowel are well perfused” said Peter Kim, MD, PhD, Founder and Chief Scientific and Medical Officer at Activ Surgical. “More informed real-time decision during surgery using intelligent visualization technology means potentially fewer complications and tissue injuries promising better clinical outcomes.”

In the study titled, “Clinical Utility of Laser Speckle Contrast Imaging (LSCI) and Real-Time Quantification of Bowel Perfusion and Comparison to Indocyanine Green (ICG) in Forty Consecutive Minimally Invasive Left-Sided Colorectal Resections,” Dr. Huang and her co-authors from OSU also found that ActivSight’s perfusion visualization was comparable to that of ICG, with the added benefit of repeatable, precise, dye-less assessment. 

“ActivSight is valuable in my surgical practice because it provides dye-free, real-time tissue perfusion information at critical surgical decision points.” said Emily Huang, MD, Division of Colon and Rectal Surgery at The Ohio State University Wexner Medical Center.

ActivSight is an imaging module that provides enhanced visualization and real-time, on-demand surgical insights in the operating room, all in a laparoscopic form factor.

“We are energized to see the momentum building across the colorectal field. The results from this prestigious group further validate the value of ActivSight for surgeons to see more and subsequently make more informed decisions,” said Manisha Shah-Bugaj, Chief Executive Officer at Activ Surgical. “Less dissection and removal of tissue can improve patient safety and may lead to better surgical outcomes.”

About Activ Surgical  

Activ Surgical is the pioneering digital surgery company that completed the world’s first autonomous robotic surgery of soft tissue in 2018. The company aims to transform the collective surgical experience by leveraging emerging technologies and data into insights that make world-class surgery accessible for all, and for every surgical imaging system to deliver intelligent information that reduces surgical complication rates, ushering in a new standard of patient care and safety. Activ Surgical is privately held, and backed by Cota Capital, BAM Funds, Hikma Ventures, Mint Ventures, Castor Ventures, Dream One Vision, NVIDIA, DNS Capital, GreatPoint Ventures (GPV), Artis Ventures, Tao Capital Partners, LRVHealth, Rising Tide VC, SONY Innovation Fund, 8VC, Fiscus Ventures, Peak 6 and Reimagined Ventures. Learn more at activsurgical.com and follow us on LinkedIn and Twitter.

Jonathan Noël^a,*, Anya Mascarenhas^b, Chibueze A. Nwaiwu^c,d, Yao Liu^c,d, Marcio Moschovas^e, Vasiliy E. Buharin^d, John Oberlin^d, Saloni Mehrotra^d,f, Alyson F. Dechert^d, Peter C. W. Kim^c,d, Vipul Patel^a

^aDepartment of Urology, AdventHealth Global Robotics Institute, Celebration, FL, USA; ^bHarvard University, Cambridge, MA, USA; ^cDepartment of Surgery, Warren Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI, USA; ^dDepartment of Research, Activ Surgical Inc., Boston, MA, USA; ^eDepartment of Urology, AdventHealth Global Robotics Institute, Celebration, FL, USA; ^fDepartment of Surgery, University of Buffalo, Buffalo, NY, USA

Abstract
Background: When viewed under near-infrared light, indocyanine green (ICG) signal for kidney perfusion can be utilized in partial nephrectomy. Laser speckle contrast imaging (LSCI) uses coherent light to detect perfusion during real-time laparoscopic surgery.

Materials and methods: Laser speckle contrast imaging or ActivSight, an imaging sensor adapter, was used during laparoscopy of an anesthetized porcine kidney model. ActivSight’s “perfusion mode” and “quantification mode” displayed the blood flow as a heatmap and numerical signal intensity, respectively.

Results: After the upper segmental renal artery was clamped, ICG was seen in the lower pole, and LSCI showed low unit (dark color) quantification and perfusion in the upper pole. Indocyanine green was retained in the lower pole after the upper segmental artery was unclamped, and LSCI perfusion was demonstrated in the entire kidney.

Conclusions: Laser speckle contrast imaging is a dye-free, repeatable, real-time adjunct for renal parenchymal perfusion assessment applicable to minimally invasive renal surgery to complement the technology of ICG near-infrared fluorescence and advance digital surgery.

Keywords: Augmented reality; Indocyanine green; Laser speckle contrast imaging; Perfusion; Selective arterial clamping

1. Introduction

Endourology for renal surgery began with Clayman and colleagues’^[1] case description of the laparoscopic approach, with embolization of the renal artery immediately before surgery. Laparoscopic nephrectomy is routinely performed for benign and cancerous kidney conditions. The use of partial nephrectomy (PN) has steadily increased,^[2] given its equivalence in cancer control compared with radical nephrectomy.^[3] Partial nephrectomy can minimize the risk of renal disease progression by sparing nephrons, particularly in patients with comorbidities, single kidneys, or bilateral tumors. However, the increased likelihood of postoperative complications in PN compared with radical nephrectomy^[4] has incited the development of intraoperative imaging technologies to improve surgical outcomes.

Among these innovations is the use of fluorescent contrast agents that emit light that can be captured using a high-resolution endoscopic camera. The most utilized and studied fluorescent agent in urologic surgery is indocyanine green (ICG).^[5] Indocyanine green is administered intravenously and remains intravascular until it is excreted by the liver. It emits photons with a wavelength of 820 to 830 nm,^[6] which are translated to a green color using a near-infrared fluorescence (NIRF) imaging system. The color is visualized in vessels and the renal parenchyma within 1 minute of administration,^[7] allowing for selective arterial clamping and tumor localization during PN.

There is a growing body of evidence that ICG fluorescence angiography can readily identify important vasculature. This is useful in donor nephrectomies and kidney transplantation for recipient assessment of perfusion to the allograft, ureteral reconstruction, and complex reconstruction procedures.^[8–10] Indocyanine green fluorescence angiography has also been used to identify neurovascular bundles and landmark arteries in nerve-sparing radical prostatectomy. Indocyanine green lymphangiography has also been assessed for sentinel lymph node dissection in radical prostatectomy, cystectomy, and penectomy.^[9,11,12] Lastly, ICG may play a role in delineating tumor margins in urological and nonurological radical surgery.^[13,14]

Despite these potential benefits, the pharmacokinetics of ICG limits its usability in certain scenarios. For example, ICG-based visualization sometimes requires multiple timed injections of a contrast agent to visualize tissue perfusion. The accuracy of tissue perfusion is reduced by subjective interpretation based on the degree of fluorescence, as well as the likelihood of false-positive information on repeat assessments, because of capillary leakage and dye retention in interstitial tissue.^[15–17] Furthermore, the lack of standardized dosage, methodology, and quantifiable measurements increases the chance of error due to subjective interpretation.^[16,18]

Laser speckle contrast imaging (LSCI) was developed to decrease the risk of unrecognized ischemia and improve upon ICG using a dye-less, real-time perfusion detection technology. Laser speckle contrast imaging is a technique that uses coherent laser light to detect object movement. The underlying mechanism of LSCI depends on the fact that coherent laser light can interfere with itself. When a target is illuminated by laser light, the image formed is similar to a normal photographic image; however, it has salt-and-pepper “speckles” superimposed upon it. A stationary target has a static field of speckles, and a moving target causes those speckles to twinkle or blink at a rate proportional to the velocity of the underlying target. Thus, when stationary tissue is imaged, the detected movement corresponds to flowing blood.^[19] Image processing on a video stream can convert raw laser speckle images into color maps, where the color corresponds to the computed velocity. The physical mechanism of LSCI is similar to that of laser Doppler velocimetry; however, these systems are probe-based and provide measurements at a single point, whereas LSCI yields a velocity measurement at each pixel in a camera image.^[20] It is hypothesized that LSCI has potential utility in laparoscopic urological surgery. Our objective was to investigate LSCI by comparing it with ICG in displaying renal perfusion changes in a porcine model, taking advantage of the unique imaging module form factor that allows the user to easily switch between modalities (Supplement, https://links.lww.com/CURRUROL/A25).

2. Materials and methods

We utilized a novel imaging module, ActivSight™ (Activ Surgical Inc., Boston, MA), which consists of an infrared-sensitive monochrome imaging sensor adapter and a customized light source with 1 or more coherent laser sources. In LSCI mode, proprietary algorithms detect perfusion using motion in real time, projecting a false color overlay on the standard white light laparoscopic image. This Food and Drug Administration–approved technology has the capacity for both ICG NIRF and LSCI. The imaging module was inserted between a standard laparoscopic system camera head and rigid laparoscope (Fig. 1A). Standard white light and coherent laser were combined with a specialized light guide attached to the module and laparoscope, respectively (Fig. 1B). In accordance with the Animal Welfare Act and hospital ethics, 2 anesthetized porcine models underwent laparotomy on 2 separate days by 2 different teams of surgeons: JN, CN, PK, YL, and SM. The bowel was mobilized to expose the retroperitoneum, with a focus on the left kidney, renal hilar, and great vessel anatomy. The laparoscope and adapter were mounted on a freehand stand that was aimed directly above the surgical field over the kidney. The laparoscopic video display was passed through the accompanying tower. The LSCI mode (ActivPerfusion™) of the adaptor displayed blood flow as a heatmap signature, where red and blue to no color indicated more perfusion and low to no perfusion, respectively. The NIRF mode (ActivICG™) displayed ICG dye concentration as a green intensity map. The investigational quantification mode displayed blood flow on a numerical scale.

Indocyanine green (1.25 mg) was injected into the porcine model, and a control assessment of the extrahepatic biliary tree was performed to ensure green fluorescence. The left-sided upper and lower segmental renal arteries, renal vein, and aorta were isolated with rubber vessel loops, and a Cooley renal artery clamp was applied sequentially.

3. Results

Forty seconds after ICG administration with clamping of the upper segmental artery, ICG fluorescence was observed in the lower pole, with no fluorescence detected in the upper pole (Fig. 2A). When the renal parenchyma and hilar anatomy were visualized using LSCI (Fig. 2B), a red perfusion signal was noted in the lower pole with a perfusion boundary concordant with the boundary identified using ICG, whereas a low perfusion signal (blue color) was noted in the upper pole, corresponding to the lack of ICG fluorescence in the upper pole. After the upper segmental artery was unclamped, ICG was redistributed to the upper pole, as demonstrated by the increased fluorescence signal noted in the upper pole (Fig. 2C). In the LSCI mode, an immediate uniform red color observed over both poles of the kidney confirmed the restoration of the blood supply to the upper pole (Fig. 2D).

Figure 3A shows the left kidney after ICG administration and upper segmental artery clamping, with green demarcation of the lower pole using NIRF. As shown in Figure 3B, the investigational LSCI quantification mode demonstrated low quantification capture of the upper pole, reflected as 16.1 perfusion units. Figure 3C demonstrates an instant numerical increase in the upper pole LSCI units to perfusion 63.5, once the clamp was switched to the lower segmental renal artery. This was visually reflected by the change in the perfusion signal color compared with that in Figure 3B. When the clamps were removed from all arteries, the investigational LSCI quantification mode confirmed visually and numerically (52.1 perfusion units) that the blood supply had returned to the entire kidney (Fig. 3D). No intraoperative adverse effects were observed in any of the animals during the experiments.

4. Discussion

We report the first use of the LSCI investigational quantification mode in a laparoscopic form factor for the real-time, dyeless, repeatable assessment of renal perfusion. Laser speckle contrast imaging perfusion signals demonstrated visual concordance with ICG for perfusion assessment of the kidney. In addition, the investigational LSCI quantification mode had higher perfusion units over perfused areas of the kidney and lower perfusion units over areas with limited perfusion. Our findings agree with those of other published findings that showed that the use of LSCI for perfusion assessment in the neural cortex and intestine was feasible.^[21–23] Furthermore, LSCI has been assessed in research trials in cholecystectomy and colorectal and bariatric surgery settings (ClinicalTrials.gov identifier NCT04633512). A recent study that compared LSCI measurement of renal cortical microperfusion with total arterial renal blood flow and side-stream dark-field imaging demonstrated that LSCI was significantly correlated with both techniques. However, the correlation of renal blood flow with stream dark-field imaging was superior to that with LSCI in 1 study.^[24]

Because LSCI is a dyeless visualization technology, it can be used in its different modes multiple times during the same procedure without any interference to its field of view. It also provides an objective relative quantification of flow and perfusion. In ICG-based visualization systems, dye retention in the tissue may affect the specificity of subsequent visualization of tissue, yielding various shades of green color that are subjectively interpreted by the user. This lends such systems false-positive results. Moreover, ICG-assisted visual systems do not provide quantification of blood flow or tissue perfusion.

Although LSCI avoids false-positive results from dye retention and allows for real-time measurement of tissue perfusion, it introduces a limitation in that ICG lacks motion artifacts. The laser speckle signal is generated by the motion of either tissue or blood. To accurately measure the blood flow, it is necessary for the target tissue to be relatively stationary. We observed that optimal use of the imaging module required adequate user stabilization during target organ analysis as motion tremor during adjustment of the LSCI image display resulted in motion artifacts in the order of milliseconds while switching among the different modes. Therefore, we hypothesize that motion stabilization or tremor elimination in robot-assisted laparoscopic surgery would further improve the utilization of this implementation of LSCI. In addition, algorithms may be used to minimize the motion sensitivity of LSCI technology.

The role of LSCI technology in urology is similar to that of the more widely used NIRF/ICG, where a focus on both laparoscopic and robotic renal surgery^[25] exists for complex vascular anatomy cases. The clinical advantage of LSCI is the avoidance of drug administration along with a real-time adjunct for qualitative and quantitative renal parenchymal perfusion assessment. This approach seems reproducible and can hasten intraoperative decision-making on vascularity, particularly in PN. Digitally activated surgery will enhance augmented reality’s aim to impact perioperative outcomes.^[26] A limitation of our study was the small sample size (n = 2). However, for the purposes of our study, it was necessary to use more than 2 porcine models to assess and demonstrate the feasibility of this new technology (LSCI) in detecting renal cortical microperfusion and comparing it with ICG.

Future work includes urology-led clinical trials using the dual-mode ActivSight Imaging Module, assessing its feasibility and safety evaluation during partial and radical nephrectomy, nerve-sparing prostatectomy utilizing the landmark artery,^[27] and postoperative follow-up on their respective pentafectas.^[28,29] Such trials should compare LSCI to standard white light with NIRF/ICG-enhanced laparoscopic and robotic surgery.

5. Conclusions

Laser speckle contrast imaging is a dye-free, repeatable, real-time adjunct for renal parenchymal perfusion assessment. Its applicability in minimally invasive renal surgery can complement the technology of ICG NIRF, improving visualization, and advancing digital surgery.

Acknowledgments

None.

Statement of ethics

Institutional Review Board approval to undertake this pre-clinical study was granted. Informed consent was obtained from all patients included in this study. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000.

Conflict of interest statement

No conflict of interest has been declared by the authors. VP is an advisor for Activ Surgical Inc. YL, VEB, JO, SM, AFD, and PCWK are employees of Activ Surgical.

Funding source

No funding was received funding for the preparation and work reported in this manuscript.

Author contributions

JN, PK, VP: Study concept and design;

AM, CAN, YL, VEB, JO, SM, AFD, PCWK: Data acquisition;

CAN, VEB, JO: Data analysis;

JN, AM, CAN: Drafting of the manuscript;

JN, CAN, VP: Critical revision of the manuscript.

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