University of Washington Medical Center

Sanofi shared detailed results on Tuesday from a pivotal trial of rilzabrutinib to treat immune thrombocytopenia (ITP), after first revealing in April that the BTK inhibitor met the primary endpoint of the Phase III LUNA 3 study. At the time, the French pharma had announced it was targeting regulatory submissions in the US and Europe by year-end.A win for rilzabrutinib could put two feathers in Sanofi's cap. First, it would justify the company's $3.7-billion purchase of Principia Biopharma to gain the asset in 2020, and second, it would bring a key growth driver to market from its immunology and inflammation (I&I) pipeline, an area the drugmaker is increasingly relying on for revenue as it slims down its oncology portfolio. For related analysis, see Vital Signs: Sanofi builds momentum for its I&I bets.Sanofi has cause to be cautious, however, as the BTK inhibitor has previously fallen short in clinical studies for pemphigus and atopic dermatitis.Boosting platelet countThe LUNA 3 data were unveiled in an abstract ahead of the American Society of Hematology (ASH) meeting in December. The study randomised 202 adults with persistent or chronic ITP to receive rilzabrutinib twice daily or placebo. As promised, the BTK inhibitor met the trial's primary endpoint of durable platelet response, with 23% patients who received the therapy achieving platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy, compared with zero patients in the placebo group. When Sanofi combined data from the double-blind and open-label periods, the durable response rate jumped to 29%. Additionally, rilzabrutinib significantly reduced the need for rescue therapy by 52% versus placebo, and led to significant and clinically meaningful improvements in physical fatigue and bleeding.The experimental therapy also appeared safe and tolerable, as patients in the investigational arm had a similar percentage of adverse events (AEs) as those who received placebo. The most common Grade 1/2 treatment-related AEs for rilzabrutinib were diarrhoea (23%), nausea (17%), headache (8%) and abdominal pain (6%).Sanofi also disclosed that one patient with multiple risk factors who received the BTK inhibitor experienced a treatment-related Grade 3 peripheral embolism. Another participant in the study died due to pneumonia unrelated to treatment.

Earlier this month, Proprio, an artificial intelligence-powered surgical technology vendor, announced that its surgical guidance platform, Paradigm, had reached a significant milestone with 50 successful surgeries completed. Those procedures were performed, along with other surgeons, by Dr. Richard Bransford, director of orthopedics spine quality improvement and a world-renowned spine surgeon at the University of Washington Harborview Medical Center. THE PROBLEM "In the placement of any instrumentation into bone, whether pedicle screws, cortical screws or whatever, there is always the question as to whether anatomical landmarks, classic navigation or whatever is allowing me to place my implants exactly and precisely where I think they should be," Bransford explained. "There also is the issue of how much radiation is acceptable to the patient and the OR staff to have a fine balance of risk and benefit," he said. "The hope was that an AI-powered surgical guidance system would allow for less radiation and still allow for optimal placement of implants." PROPOSAL The proposal behind an AI-powered surgical guidance system was to allow for a more "visual" expert eye to take the anatomy obtained from a CT scan and marry this to a visual intra-operative field to allow for placement of implants and eventually also measure change in alignment as planned pre-operatively. "This would allow for essentially zero radiation intra-operatively while still being able to navigate implant placement," Bransford noted. "The real question was could the infra-red cameras and 'eye' of AI be able to interpret the 'visual' anatomy accurately. "Equally, as the spine was being re-oriented, could the 'eye' track the changes, which classic navigation could not – being static as opposed to AI being dynamic," he added. MEETING THE CHALLENGE The AI-powered guidance platform excelled in what it was able to accomplish, he said "It was able to track motion in real time and adapt to manipulations," Bransford said. "It very accurately navigated placement of implants in the intended position. This was used by myself as the attending surgeon but also equally well with fellows, residents and PAs. "The system is Proprio, being developed in Seattle over the past seven to eight years with stepwise development," he continued. "This worked exceptionally well to accomplish all that was asked and really has taken over from our classic navigation in open cases." RESULTS The hard results the University of Washington Medical Center has achieved include accurately placed implants in the location that was planned pre-operatively with CT-verified confirmation. "This has been hugely successful, has superseded our expectations and has surpassed our utilization of classic navigation," Bransford reported. "Equally, everything is recorded allowing us to measure various aspects of the case in terms of timing of each step. "Also, the screen allows all OR personnel to track and follow what is going on during the case through the Paradigm lens," he added. USHERING IN A NEW ERA "This is truly a revolutionary system, allowing us to take operative navigation to a new level, tracking implants and change in alignment in real time with no radiation with a relatively straightforward camera hovering above the operative field," said Bransford. "Truly, this is moving the needle to a new level of technology for the betterment of patient care." Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication.

Ushers in a new era where surgery is no longer a one-off event but an opportunity to gather data to radically improve the practice of surgery and its role in the healthcare economy. SEATTLE, Sept. 10, 2024 /PRNewswire/ -- Proprio, the global leader in AI-powered surgical technology, announced today that its innovative surgical guidance platform, Paradigm, has reached a significant milestone with 50 successful surgeries completed. These procedures were performed by Dr. Richard Bransford, a world-renowned leader in spine surgery and clinical education at the influential University of Washington Medical Center, along with other leading surgeons. "Since the first-in-human surgery using Proprio less than a year ago, I have witnessed immense progress and benefits from incorporating this technology into spinal surgery," said Dr. Bransford. "This system's unprecedented visualization and data collection capabilities offer a level of precision far beyond previous methods. As this technology becomes widely adopted, I am confident that it will drive better outcomes for patients, revolutionizing the field of spinal surgery and improving the standard of care." The Proprio Paradigm platform is a new sensing modality aiding surgeons in the operating room while recording data to fuel a breakthrough digital twin capability - essentially modeling the potential results of key decisions. Leveraging an array of advanced computer vision sensors, Paradigm captures high-definition views of the surgery and integrates vast amounts of data (e.g., CT, MRI, operative plans) to deliver real-time 3D anatomical mapping – akin to Google Maps for surgery. This intelligent platform adapts to changes in the patient's body, providing surgeons with tools and insights to improve outcomes. In the first 50 surgeries with Paradigm, surgical teams successfully placed hundreds of implants with positive results across a range of challenging surgeries, from scoliosis to collapsed discs. On average, use of Paradigm led to a 10X reduction in radiation-based imaging as highly experienced surgeons and early career residents used the technology to safely and swiftly traverse complex anatomy and accomplish their goals. Proprio's mission is to impact billions of underserved patients globally by enabling skilled surgeons to scale their abilities and address a shortage of millions of clinicians. Throughout eight years of development, the company collected thousands of terabytes of data and ran tens of thousands of simulations and tests. Proprio collected input from hundreds of surgeons across dozens of surgical specialties in the design of Paradigm. The platform is expanding to leading hospitals in the US and abroad throughout 2024 and 2025. "Reaching 50 successful surgeries in a tremendously complex specialty, like spine, is a huge milestone for Proprio. It is just the very beginning for us," said Gabriel Jones, CEO and co-founder of Proprio. "80% of humans do not have access to the healthcare they need. We are immensely motivated to expand the reach of this essential technology to all of surgery, making it accessible to more surgeons and patients globally. Our goal is to extend the boundaries of what humans and computers can do together and to continue to shape the AI-driven future of surgery." For more information, visit . ABOUT PROPRIO  Proprio is the leading medical technology company creating the new way of seeing™ in surgery. Developed out of the University of Washington Paul Allen School of Computer Science, named for the famed co-founder of Microsoft, Proprio uses advances in light field rendering, computer vision and AI to deliver a new 3D sensing modality and digital twin modeling capability for surgery. The Proprio Paradigm platform synthesizes views from multiple inputs for navigating anatomy and surgical environments in 3D. Proprio's goal is to dramatically improve clinical and economic outcomes for patients throughout the world by using advanced data and AI to inform more predictive intelligence in surgery. Proprio is backed by leading healthcare and technology investors, including DCVC, BOLD Capital Partners, Bird B. AG, Intel, HTC, and Alan Frazier, founder of Frazier Healthcare Partners. SOURCE Proprio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED