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Follow up visual examination three days after the procedures using the LIBERTY Robotic Surgical System, confirms 100% success rate in reaching the targets with no adverse events

BRAINTREE, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY^® Robotic Surgical System, today announces additional updates regarding positive outcomes of its previously announced pivotal pre-clinical study using the LIBERTY Robotic Surgical System.

The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets. In a series of visual testing, preformed 72 hours following each procedure, examination of the animals treated with the LIBERTY Robotic Surgical System showed no visual evidence of vascular injury or any other visual adverse event.

This new data follows the recently announced successful initial outcomes from the pivotal pre-clinical study. A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets. All 6 LIBERTY Systems performed flawlessly based on the initial outcomes, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative.

The Company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the verification and validation (V&V) process, the Company plans on submitting the Investigational Device Exemption (IDE) application to the FDA, in order to commence its pivotal clinical trial in humans.

"We are excited to share additional positive outcomes of our pivotal pre-clinical study. The absence of any visual evidence of vascular injury in the follow-up examination after 72 hours continues to reaffirm the safety and effectiveness of our technology. This milestone, together with the advancement of the verification and validation process, bring us one step closer to the submission of the IDE and commencing our pivotal clinical trial in humans," said Simon Sharon, Microbot’s GM & CTO.

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About Microbot Medical

Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.

The LIBERTY® Robotic Surgical System aims to Improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.
Further information about Microbot Medical is available at http://www.microbotmedical.com.

Safe Harbor

Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of potential products, including LIBERTY, the outcome of its studies to evaluate LIBERTY, whether the Company’s core business focus program and cost reduction plan are sufficient to enable the Company to continue to focus on its LIBERTY technology while it stabilizes its financial condition and seeks additional working capital, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, such as employees of Microbot and its vendors and business partners being called to active military duty, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Investor Contact:

Michal Efraty
+972-(0)52-3044404
IR@microbotmedical.com

A study published in Health Economics revealed insights into medical cannabis patients’ patterns of product choice, cannabinoid product ratios, and doses. The results published in Science Direct highlighted trends in the CBD and THC content of dispensed products and dosing among medical cannabis patients. The researchers examined the qualifying conditions, age, and types of cannabis products used to understand consumption trends. 

The study found that dosages differed by age group. They were also lower than recommended for conditions with Food and Drug Administration-approved products. The findings point to closer monitoring of age-related influences and drug interactions for patients using cannabis products.

University of Minnesota researchers analyzed data from roughly 50% of all registered Minnesota medical cannabis users between June 2016 and November 2019. Patients had one of the 14 qualifying conditions at the time of this study, including cancer, glaucoma, HIV/AIDS, Tourette syndrome, amyotrophic lateral sclerosis, epilepsy, inflammatory bowel disease, and autism. The study revealed significant age-related differences in dosages among patients with the same diagnosis. The study highlighted the need for further research efforts that take into consideration varied dosages and medical cannabis formulations for specific patient populations.  

The researchers used past research as a basis for studying the impact of these factors on cannabis use patterns. Study author Dr. Angela Birnbaum explained, “Our past data shows blood concentrations of CBD and THC can vary widely among patients and according to the fat content in food, indicating possible inconsistent exposure that could lead to variations in response and unanticipated side effects.” The research study indicated a need for closer regulation and research of medical cannabis formulations for particular patient populations.

More research on clinically significant side effects associated with specific CBD and THC dosages is needed to inform policy and practice. In addition, the long-term effects of cannabis and risks for older patients who use multiple medications to minimize adverse drug interactions. 

Source: Health Economics, Science Direct, University of Minnesota

A new study has revealed that the body’s hormone stress response is why some people develop post-traumatic stress disorder following trauma exposure, and others don’t. The finding could lead to more targeted treatments for the condition.

Some people develop post-traumatic stress disorder (PTSD) following exposure to a traumatic event or events, causing notable impairments such as intrusive thoughts, avoiding behaviors, sleep disturbance and hypervigilance.

Crucial to identifying the condition early, and treating it effectively, is understanding why some people, and not others, develop PTSD. Now, a new study by researchers at the Swiss Federal Institute of Technology Lausanne (EPFL) has shown why a subset of people are more vulnerable, and it has to do with the body’s stress hormone response.

“There are considerable differences in the levels of glucocorticoids that individuals release to the bloodstream when stressed,” said Carmen Sandi, one of the study’s corresponding authors. “Low glucocorticoid levels are frequently observed in PTSD patients following trauma exposure and were initially suspected to be a consequence of trauma exposure.”

Glucocorticoids are steroid hormones produced by the adrenal glands, which sit atop each kidney. The essential glucocorticoid the body produces is cortisol, the primary stress hormone that works with certain parts of the brain to control mood, motivation, and fear. Following the fight-or-flight response, if the brain continues to perceive something as dangerous, it triggers a pathway that results in the release of cortisol.

While low glucocorticoid levels and a smaller hippocampus, the area of the brain involved in long-term memory formation and memory retrieval, were originally thought to result from trauma, they’re currently viewed as potential risk factors for PTSD. However, establishing their causal role in the condition has proven difficult.

“The possibility that this could be a trait constituting a preexisting PTSD risk factor has been an outstanding open question for many years, but tackling it has been challenging due to the difficulties of both collecting biological measures before trauma exposure and having access to relevant animal models in which the causal role of these traits can be investigated," said Sandi.

To examine how a reduced hormonal response to stress might be linked to PTSD symptoms, the researchers used rats that had been genetically modified to mimic humans with a blunted response to cortisol. They measured the volume of different brain regions, trained rats to associate a cue with fear, recorded their sleep patterns, and measured their brain activity.

The researchers discovered that decreased responsiveness to glucocorticoids led to several pivotal PTSD vulnerability traits, including impaired fear extinction (in male rats), reduced hippocampal volume, and rapid-eye-movement sleep (REMS) disturbances. Fear extinction is a process by which a conditioned fear response diminishes over time; problems with fear extinction mark PTSD. REMS is crucial for memory consolidation, and people with PTSD often experience REMS disturbances. From this, the researchers concluded these traits are biologically interconnected and not independent risk factors.

Next, the rats were given the equivalent of cognitive behavioral therapy to reduce their learned fears and then administered corticosterone, the murine version of cortisol. The researchers noted that both excessive fear and REM sleep disturbances abated. In addition, increased levels of the fight-or-flight neurotransmitter norepinephrine in the brain returned to normal.

“Our study provides causal evidence of a direct implication of low glucocorticoid responsiveness in the development of PTSD symptomatology following exposure to traumatic experiences, i.e., impaired fear extinction,” Sandi said. “In addition, it shows that low glucocorticoids are causally implicated in the determination of other risk factors and symptoms that were until now only independently related to PTSD.”

The study’s findings open the door to potential treatment for people with PTSD.

“Our research illuminates previously elusive aspects of PTSD, revealing that blunted corticosteroid responsiveness not only predicts but may also contribute causally to core PTSD symptoms,” the researchers said. “This suggests potential benefits of glucocorticoid treatments for patients with diminished glucocorticoid responsiveness.”

The study was published in the journal Biological Psychiatry.

Source: EPFL

A new study has found a link between high blood insulin levels, frequently seen in people with obesity and type 2 diabetes, and pancreatic cancer. The researchers say their findings may lead to new cancer prevention strategies and targeting treatments to slow or prevent the progression of the cancer.

Obesity and type 2 diabetes (T2D) are among the risk factors for pancreatic cancer, and pancreatic ductal adenocarcinoma (PDAC) is one of the most prevalent, aggressive, and lethal pancreatic cancers. However, the mechanisms by which T2D and obesity contribute to PDAC have remained unclear.

Now, a new study by researchers at the University of British Columbia in Canada has shed light on the role that insulin and its receptors play in the development of PDAC.

“Alongside the rapid increase in both obesity and type 2 diabetes, we’re seeing an alarming rise in pancreatic cancer rates, said James Johnson, one of the corresponding authors of the study. “These findings help us understand how this is happening and highlight the importance of keeping insulin levels within a healthy range, which can be accomplished with diet, exercise and, in some cases, medications.”

The pancreas performs exocrine and endocrine functions. Acinar cells (exocrine) synthesize, store, and secrete enzymes into the small intestine that help digest food, whereas beta cells (endocrine) make the hormone insulin, which regulates blood glucose levels. Insulin is thought to bind to its own receptor on the acinar cell, stimulating enzyme secretion.

T2D results from a combination of ineffective and insufficient insulin, leading to insulin resistance and high blood insulin (hyperinsulinemia) as the body produces more of the hormone to bring down high blood glucose levels (hyperglycemia). It’s commonly accepted that in obesity, elevated free fatty acid levels cause insulin resistance, which, because of the resulting hyperglycemia, also leads to hyperinsulinemia.

Using mice models, the researchers examined what was happening in the pancreatic acinar cells when the animals were hyperinsulinemic.

“We found that hyperinsulinemia directly contributes to pancreatic cancer initiation through insulin receptors in acinar cells,” said Anni Zhang, the study’s lead author. “The mechanism involved increased production of digestive enzymes, leading to heightened pancreatic inflammation.”

The researchers propose that this inflammation leads to the development of precancerous cells. Their findings may pave the way for new cancer prevention strategies and therapeutic approaches that target insulin receptors on acinar cells.

“We hope this work will change clinical practice and help advance lifestyle interventions that can lower the risk of pancreatic cancer in the general population,” said Janel Kopp, co-corresponding author. “This research could also pave the way for targeted therapies that modulate insulin receptors to prevent or slow the progression of pancreatic cancer.”

The researchers also say their findings may have implications for other cancers associated with obesity and T2D, where elevated insulin levels may also play a contributing role.

“Colleagues in Toronto have shown similar connections between insulin and breast cancer,” Johnson said. “In the future, we hope to determine whether and how excess insulin might contribute to other types of obesity- and diabetes-driven cancers.”

The study was published in the journal Cell Metabolism.

Source: University of British Columbia

Medicare Advantage plans — which currently face significant regulatory scrutiny for inflating healthcare costs and denying seniors’ care — are driving better outcomes for their beneficiaries than traditional Medicare, a new study suggests.

Researchers from health data company Inovalon and Harvard Medical School compared outcomes data for beneficiaries in MA and original Medicare, and found MA members had fewer hospital readmissions, fewer preventable hospitalizations and lower rates of high-risk medication use.

In MA, the government contracts with private payers to manage the care of Medicare seniors. Multiple studies have found enrollment in MA is associated with lower healthcare utilization, including for post-acute care. 

However, past research has generally found a more modest association than the new analysis.

The Harvard and Inovalon researchers argued prior studies have often been “restricted to narrow sets of quality measures and limited trial populations.”

They said their study instead evaluates a broad set of measures for a nationally representative group — and adjusts for underlying population differences between traditional Medicare and MA, which is more likely to include socioeconomically disadvanted people.

“Previous comparisons of quality under MA vs. [fee-for-service Medicare] may have underestimated outcomes in MA by not fully accounting for the greater socioeconomic disadvantages faced by MA members,” the researchers wrote.

Enrollment in MA has increased dramatically to more than 30 million people — over half of all Medicare beneficiaries. Nearly six in 10 beneficiaries are expected to be MA members by 2030.

The plans are popular in part because they can offer more supplemental benefits than traditional Medicare, like dental and hearing services, or subsidized transportation and gym memberships.

Yet as MA grows, there is a debate raging in the health policy world over the future of the program, which is increasingly weighing on Medicare’s financial solvency.

Spending on MA has snowballed: Plans were overpaid almost $10 billion a year from 2017 to 2020, according to one study. Another piece of research estimates the U.S. could be on the hook for $75 billion in overpayments this year.

Critics blame factors like insurers upcoding the disease severity of their members and inflated bonus payments in quality programs.

Proponents of MA point to research, like the new study, finding that plans result in better health outcomes than traditional Medicare. For their analysis, Harvard and Inovalon researchers analyzed beneficiary data in the year after seniors joined either traditional Medicare or MA, and controlled for patient characteristics.

They found seniors in traditional Medicare had a 3.8 times higher rate of readmission to the hospital after 30 days than seniors in MA. Traditional Medicare had a 1.7 times higher rate of avoidable hospitalization overall. Rates of high-risk medication usage were 1.4 times higher in traditional Medicare.

MA and traditional Medicare had similar rates of medication adherence.

The researchers said the results boost findings from their earlier report that found MA had lower overall utilization than traditional Medicare, and that lower utilization was driven by fewer inpatient visits.

Other health policy researchers say lower utilization in MA raises red flags, due to health plans curbing medical costs by delaying or denying needed healthcare. Such care restrictions could be contributing to MA beneficiaries with greater health needs disenrolling at higher rates than healthier seniors.

The Harvard and Inovalon researchers argued their findings suggest the reduction in inpatient visits comes from reduced preventable and readmission visits. That would mean lower MA utilization is due to improved care quality, rather than care rationing on the part of plans.

Lawmakers on the Hill have grown increasingly skeptical of MA payment denials. During a May hearing of the Senate Permanent Subcommittee on Investigations, senators expressed bipartisan support for paring back the use of prior authorizations to restrict care, especially payers’ use of algorithms in coverage determinations. Government watchdogs found last year that 18% of MA payment denials should have been approved under Medicare coverage rules.