Haemek Medical Center

Novo Nordisk continues to list monlunabant in its midstage diabetes and obesity pipeline.\n Novo Nordisk’s cannabinoid CB1 receptor blocker has run into another problem. Months after sharing obesity data that left investors underwhelmed, the Danish drugmaker has reported the failure of a midphase diabetic kidney disease trial of the molecule.CB1 receptor blockade is an old idea—Sanofi won approval for a drug with the mechanism in 2006—but Novo identified Inversago Pharma as a company capable of realizing the potential of the approach. Novo acquired the Canadian biotech in a deal worth up to $1.1 billion in 2023. Since then, a mix of lackluster efficacy and concerning safety signals for monlunabant in obesity have taken the shine off the deal.The program took another hit Wednesday when Novo reported a phase 2 flop. Investigators randomized 254 diabetic kidney disease patients to receive one of two doses of monlunabant or placebo. After 16 weeks of once-daily dosing, people on the study drug did no better than their counterparts on placebo on a measure of kidney function. The result caused the trial to miss its primary endpoint.Reporting of mild to moderate neuropsychiatric side effects was more frequent with monlunabant than placebo. The safety data add to concerns that the molecule suffers from some of the same problems that held back CB1 blockers in the past. European authorities withdrew the approval of Sanofi’s CB1 obesity drug in 2009 after studies found it doubled the risk of psychiatric disorders. Novo is yet to share safety and efficacy data from the kidney disease trial, with the only other snippet in the disclosure being the detail that the most common adverse events were gastrointestinal and the vast majority of cases were of mild to moderate severity.Martin Holst Lange, M.D., Ph.D., the company’s executive vice president of development, told analysts on its financial call Wednesday morning that Novo wasn’t discouraged by the fail, pointing out that “we never did the acquisition of monlunabant to develop it purely for diabetic kidney disease—our focus was on the weight loss potential.”“Second, I just remind you that that that these are small studies, so obviously, we try to see them in the context of the full picture,” he said. “When we look at the safety and tolerability profile, it was comparable, albeit at a slightly lower rate than in the dedicated obesity study, basically indicating that we can still have an aspiration of exploring this further in phase 2b with lower doses, looking at weight loss potential, but obviously also—and this has been the intent from the get-go—ruling out a potential safety concern.”

This next generation robotic surgery innovation utilizes AI-based visual intelligence to provide vital information that is overlaid and presented on the video feed in real-time during surgery JERUSALEM, Israel, Jan. 26, 2023 /PRNewswire/ -- Today, RSIP Neph (part of the RSIP Vision group) announced its new innovative intra-op solution that utilizes advanced Computer Vision and Artificial Intelligence algorithms, to enhance the next generation of robotic surgery. This solution has been under development with the largest urology department in Israel and it will assist surgeons during the surgery itself, by providing additional important information on lesions and body structures which are hidden to the human eye. Continue Reading An overlay image of relevant organs and structures overlaid on a real-time video stream during surgery (RSIP Neph) This new solution includes advanced artificial intelligence algorithms and a deeper understanding of the existing capabilities of the robot to perform these kinds of procedures, allowing it to radically enhance the way this procedure is currently performed. Segmentation, registration, and tracking capabilities provide the surgeon with a new view of crucial information about obstructed unseen tissues and structures. This view will be overlaid on top of the currently available robotic display, allowing the surgeon to perform this task with minimal risks. CT scans are currently taken prior to the operation, to inform the surgeon about the size, shape and location of tumors and other relevant structures. This pre-op information is merged with the intra-op ultrasound, and then fused to the intra-op stereo cameras. With our new technology, this information is overlaid on top of the surgeon's display in 3D, bringing the look and feel to a completely new dimension (watch the video here). Some renal tumors do not require full removal of the organ due to their size and position within the kidney. In such cases, partial removal of the kidney limited to the lesion itself and surrounding areas may be more suitable than total removal of the organ. This partial removal, also known as partial nephrectomy, is preferable to full removal of the organ, as it preserves healthy tissue that can continue to function. This is particularly critical in case of future damage to the second kidney. Until now, partial kidney removal has been performed with some extent of guessing by the surgeon about the optimal cutting location. The gross estimation is due to the limited view that the surgeon has of the lesion which needs to be removed. This may lead to excess removal of healthy tissue or worse, insufficient removal of the lesion. It also limits this procedure, since it can only be performed by very experienced surgeons. "This new technology will alleviate the uncertainties that surgeons experience during partial kidney ablations," said Dr. Arnon Lavi, MD, Senior Urologist at Haemek Hospital in Afula, Israel. "Removing the need for guessing will allow the operating team to avoid critical mistakes and lead to better surgical outcomes, with very significant benefits to the patient." About RSIP Neph RSIP Neph is part of RSIP Vision group and until now, was active in a stealth mode. It develops innovative visual intelligence solutions for the Urological field, through advanced AI and computer vision applications. The solutions address diverse clinical use cases, including Kidney related procedures, PCNL, Lesion ablation, Calix segmentation (4-phased CT) soft tissue tracking and Non-rigid registration. Its technology is based on its founders' extensive track record and years in the field, trusted by the largest, industry leading medical device companies. RSIP Neph is headquartered in Jerusalem, ISRAEL. SOURCE RSIP Vision