The MIRA surgical robot's hand. (Craig Chandler/UNL)

That appeared to be the big message out of the Waltham, Massachusetts–based surgical robotics company’s Q2 earnings report yesterday evening.

Vicarious Surgical’s technology uses proprietary human-like surgical robots combined with 3D visualization to transport surgeons inside the patient to perform minimally invasive surgery. CEO Adam Sachs noted during the company’s earnings call that updates to the previous Beta 1 system are focusing on ergonomic changes for surgeon comfort — and improved 3D visualization, sensing and motion capabilities. The idea is to enable the surgeon to move freely within the abdominal cavity with the system, he said.

“With significant and very positive feedback on the initial Beta 2 ergonomic prototypes, we have completed the Beta 2 design, and we are beginning the integration phase of the build,” Sachs said during the call, transcribed by Seeking Alpha. “This is our next step towards bringing our robotics platform to market and ultimately demonstrating its capabilities through a cadaveric eventual hernia procedure in a hospital setting, which we plan to share greater details around later this year.”

A month ago, Vicarious Surgical signed collaborative Center of Excellence agreements with Nashville, Tennessee–based HCA Healthcare and its 182 hospitals across 20 U.S. states and the United Kingdom — as well as University Hospitals Ventures, the innovation and commercialization arm of University Hospitals (UH) in northern Ohio.

Sachs said the agreements go much deeper than mere post-market surgeon training; they represent collaboration throughout the extensive development, clinical, verification, validation and launch phases of Vicarious Surgical’s robotic system.

Despite the strides the company is making, Sachs acknowledged that Vicarious Surgical has experienced limited semiconductor supply and shortages of chips and other hardware in accurate months. “If these challenges continue, they can present a risk to our timeline.”

He added: “We continue to evaluate the details of our supply chain for opportunities to build internal redundancies and multi-source key components and enhance our product design to address constrained supply chain risk.”

For the quarter ended June 30, 2022, Vicarious Surgical saw an adjusted net loss of $19.1 million, or 16¢ per share. It was two pennies behind the 14¢ loss predicted by The Street. The company’s cash burn rate in Q2 was $15.7 million — with a projected full-year cash burn of $65 million to $75 million. The plan is to have roughly $100 million in cash and cash equivalents on hand by the end of the year.

BTIG analyst Ryan Zimmerman kept his Buy rating on Vicarious Surgical stock, even as he called out supply chain challenges as an unnecessary distraction: “We await RBOTs next clinical milestones, which include a potential demo of the system later this year at one of their Centers of Excellence.”

Investors reacted by sending RBOT shares down more than 8% to $4.06 apiece in after-hours trading.

The Research Triangle Park, North Carolina–based surgical robotics and digital surgery company lost $19.6 million, or 8¢ per share, off $994,000 in revenue for the quarter ended June 20, 2022 — versus a loss of $13.2 million, or 6¢ per share, off $1.1 million in revenue for the same quarter a year ago.

Wall Street analysts had expected EPS of –8¢ on $1.25 million in revenue.

During Q2, Asensus announced the installation of a Senhance system at the University Hospital Tübingen in Germany. The company also has two additional orders that have not yet been installed — including one heading toward one of the countries in the Commonwealth of Independent States, the international organization that includes Russia and many other former republics of the Soviet Union.

The company is seeking to expand the use of its Intelligent Surgical Unit (ISU). It plans a full-scale commercial launch of 5 mm articulating instruments and a 510(k) application for pediatric clearance, both during the second half of 2022.

“We delivered yet another strong quarter of global Senhance system utilization growth and made great progress towards the ongoing development of our digital surgery platform with the Intelligent Surgical Unit (ISU) as we seek to make performance-guided surgery (PGS) a reality,” Asensus Surgical CEO Anthony Fernando said in a news release. “Our goal is to enable surgeons to perform safer, more predictable, and better quality procedures. By delivering real-time, data-driven clinical intelligence and guidance, Senhance and PGS will revolutionize surgery, and most importantly, help to Excellerate patient outcomes.”

Investors reacted by sending ASXC shares up more than 4% to 59¢ apiece in after-hours trading.

The Lee Health Surgical Optimization Center, located in the medical office building at Gulf Coast Medical Center, maximizes outcomes for patients undergoing orthopedic (total hip and total knee) surgeries. Based on the American Society of Anesthesiologists’ Perioperative Surgical Home (PSH) model, the Center aims to Excellerate surgical outcomes, use fewer resources, reduce hospital stays and readmissions, and decrease complications for patients referred there.

When a patient is referred to the Surgical Optimization Center, the staff assesses their family history, personal medical history, medications, current conditions, and screening or test results to help minimize the unknown risks of surgery. Following the assessment, the care team, often in conjunction with a primary care provider or specialist, provides patients with a personalized plan to prepare them for surgery. The plan may include suggestions for dietary changes, therapy, pain management and treatment for any underlying conditions.

“A good way to understand the process that the care team at the Surgical Optimization Center carries out is by comparing it to a coach preparing an athlete for a marathon,” says John Dunn, D.O., the anesthesiologist on the Lee Health Medical Staff who introduced the PSH model to our health system. “It is unlikely that an individual could run a marathon on a whim and successfully finish the race, so why should patients undergo body-straining, major surgery with no preparation? They shouldn’t, so the care team guides each patient to an optimal condition before surgery, which may take weeks or months of preparation, but ensures the best outcome.”

Created with high-risk surgeries in mind, there are benefits for any patient referred to the Center because the team is dedicated to each patient’s entire surgical journey, from beginning to end. The care team strives to:

• Educate patients on self-care before and after surgery.

• Create an organized discharge plan.

• Minimize patient hospital stays.

• Decrease recovery time for patients.

Story continues

The Surgical Optimization Center is a great, tangible example of Lee Health’s mission of being a trusted partner, empowering healthier lives through care and compassion. I am so proud to have this level of personalized, truly empowering care in our community and available for our patients undergoing total knee and hip surgeries.

To learn more, visit LeeHealth.org and search “Surgical Optimization Center.”

More: Lee Health: New podcast – Be inspired to live a healthy life

More: Lee Health: Illnesses are circulating, care is available from home

Larry Antonucci, M.D., MBA is the president & CEO of Lee Health, Southwest Florida’s major destination for health care offering acute care, emergency care, rehabilitation and diagnostic services, health and wellness education, and community outreach and advocacy programs. Visit www.LeeHealth.org to learn more.

This article originally appeared on Naples Daily News: Lee Health: Surgical care team coaches patients toward safe surgeries

The MarketWatch News Department was not involved in the creation of this content.

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The MarketWatch News Department was not involved in the creation of this content.

Study: Plant-Based Synthetic Organs Prove Effective for Fluorescence-Guided Surgical Training

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Patients

Figure 1. Figure 1. Screening, Randomization, and Follow-up of Study Participants.

Table 1. Table 1. Baseline Characteristics of the Patients (Intention-to-Treat Population).

A total of 897 patients were randomly assigned to a study group: 431 to the chlorhexidine–alcohol group and 466 to the povidone–iodine group (Figure 1). Of the 849 patients who qualified for the intention-to-treat analysis, 409 received chlorhexidine–alcohol and 440 received povidone–iodine. Thirty-six patients were excluded from the per-protocol analysis: 25 underwent clean rather than clean-contaminated surgery, 4 dropped out of the study 1 or 2 days after surgery, and 7 died before completion of the 30-day follow-up (4 in the chlorhexidine–alcohol group and 3 in the povidone–iodine group). Therefore, 813 patients (391 in the chlorhexidine–alcohol group and 422 in the povidone–iodine group) were included in the per-protocol analyses. The patients in the two study groups were similar with respect to demographic characteristics, coexisting illnesses, risk factors for infection, antimicrobial exposure, and duration and types of surgery (Table 1, and Table 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). All patients received systemic prophylactic antibiotics within 1 hour before the initial incision, and there were no significant differences in the type or number of antibiotics given to the two study groups, even when only patients who underwent colorectal surgery were considered (Table 2 in the Supplementary Appendix).

Rates of Infection

Table 2. Table 2. Proportion of Patients with Surgical-Site Infection, According to Type of Infection (Intention-to-Treat Population).

For the patients in the intention-to-treat population, the overall rate of surgical-site infection was significantly lower in the chlorhexidine–alcohol group (9.5%) than in the povidone–iodine group (16.1%, P=0.004) (Table 2). The relative risk of any surgical-site infection among patients whose skin was preoperatively cleansed with chlorhexidine–alcohol versus povidone–iodine was 0.59 (95% confidence interval [CI], 0.41 to 0.85). Similarly, chlorhexidine–alcohol was associated with significantly fewer superficial incisional infections (relative risk, 0.48; 95% CI, 0.28 to 0.84) and deep incisional infections (relative risk, 0.33; 95% CI, 0.11 to 1.01). However, there were no significant differences between the two study groups in the incidence of organ-space infection (relative risk, 0.97; 95% CI, 0.52 to 1.80) or sepsis from surgical-site infection (relative risk, 0.62; 95% CI, 0.30 to 1.29).

Figure 2. Figure 2. Kaplan–Meier Curves for Freedom from Surgical-Site Infection (Intention-to-Treat Population).

Patients who received chlorhexidine–alcohol were significantly more likely to remain free from surgical-site infection than were those who received povidone–iodine (P=0.004 by the log-rank test). In the chlorhexidine–alcohol group, 39 patients had events (9.5%) and data from 370 patients (90.5%) were censored; in the povidone–iodine group, 71 patients had events (16.1%) and data from 369 patients (83.9%) were censored.

The per-protocol analysis yielded similar efficacy results. The Kaplan–Meier estimates of the risk of surgical-site infection (Figure 2) showed a significantly longer time to infection after surgery in the chlorhexidine–alcohol group than in the povidone–iodine group (P=0.004 by the log-rank test).

Table 3. Table 3. Proportion of Patients with Surgical-Site Infection, According to Type of Surgery (Intention-to-Treat Population).

The interaction between treatment group and type of surgery (abdominal vs. nonabdominal) was included in a logistic-regression model with the main effects of group and surgery type and was found not to be significant (P=0.41). When considered separately in a subgroup analysis (Table 3), the rate of infection after abdominal surgery was 12.5% in the chlorhexidine–alcohol group versus 20.5% in the povidone–iodine group (95% CI for the absolute difference [chlorhexidine–alcohol minus povidone–iodine], −13.9 to −2.1 percentage points). For patients undergoing nonabdominal surgery, the rate of infection was 1.8% in the chlorhexidine–alcohol group versus 6.1% in the povidone–iodine group (95% CI for the absolute difference, −7.9 to 2.6 percentage points).

Both the intention-to-treat analysis (Table 3) and the per-protocol analysis showed lower rates of surgical-site infection in the chlorhexidine–alcohol group than in the povidone–iodine group for each of the seven types of operations studied. Although the trial was not powered to compare the rates of infection for subcategories of patients, infection occurred significantly less often in the chlorhexidine–alcohol group than in the povidone–iodine group in the intention-to-treat analysis for patients who underwent small intestinal surgery (P=0.04) or abdominal surgery (P=0.009) or who did not shower preoperatively (P=0.02).

The Breslow–Day tests indicated homogeneity in showing no significant differences between hospitals with respect to the incidence of either any type of surgical-site infection (P=0.35) or individual types of infection (P≥0.19). Even so, we accounted for hospital site in all logistic-regression models by including this term as a random effect through the use of GEE.

Analyses of Risk Factors

The multivariate logistic-regression analysis identified the following risk factors for surgical-site infection in the intention-to-treat population: use of povidone–iodine, abdominal surgery, alcohol abuse, liver cirrhosis, cancer, diabetes mellitus, malnutrition, gastrointestinal disease, longer duration of surgery, longer duration of placement of surgical drain, and preoperative shower with povidone–iodine (Table 3 in the Supplementary Appendix). Since an analysis of risk factors other than the assigned intervention constitutes an exploratory analysis, which involves multiple simultaneous statistical tests, it could inflate the probability of a false positive finding (type II error).

Microbiologic Causes of Infection

Culture of the surgical site in 60 of 61 infected patients yielded growth of organisms (a total of 107 isolates), and similar proportions of infected patients in the two study groups (23 of 39 [59%] in the chlorhexidine–alcohol group and 37 of 71 [52%] in the povidone–iodine group) had an identifiable microbiologic cause of infection (Table 4 in the Supplementary Appendix). Gram-positive aerobic bacteria (63 isolates) outnumbered gram-negative aerobic bacteria (25 isolates) by a factor of 2.5, and 38% of cultures were polymicrobial. There were no significant differences in the frequency of isolating certain categories of organisms or particular organisms in the chlorhexidine–alcohol group (total of 44 isolates) as compared with the povidone–iodine group (total of 63 isolates), with the exception of streptococci, which were less common in the former group (1 of 44 [2.3%] vs. 10 of 63 [15.9%], P=0.03).

Adverse Events

Table 4. Table 4. Clinical Adverse Events (Intention-to-Treat Population).

In the intention-to-treat analysis, adverse events occurred in equal proportions among the patients in the chlorhexidine–alcohol group and the povidone–iodine group (228 of 409 [55.7%] and 256 of 440 [58.2%], respectively), as did serious adverse events (72 of 409 [17.6%] and 70 of 440 [15.9%], respectively) (Table 4, and Table 5 in the Supplementary Appendix). Findings were similar in the per-protocol analysis. Three patients (0.7%) in each study group had an adverse event (pruritus, erythema, or both around the surgical wound) that was judged to be related to the study drugs; however, no serious adverse events were judged to be related to the study drugs. There were no cases of fire or chemical skin burn in the operating room. A total of seven patients died: four (1.0%) in the chlorhexidine–alcohol group who did not have surgical-site infections and three (0.7%) in the povidone–iodine group who died from sepsis due to organ-space infection.