Hospital for Special Surgery

A study at the Hospital for Special Surgery comparing robot-assisted navigation to the use of augmented reality in spinal surgery found that both techniques demonstrate excellent accuracy and safety for pedicle screw placement. More than 1.2 million spinal surgeries are performed in the U.S. each year, according to the National Center for Health Statistics. Many of these procedures involve implants called pedicle screws to stabilize the spine, and precise positioning is critical for a successful surgery. “Compared to conventional free-hand techniques, both robotic-assisted navigation [RAN] and the use of augmented reality [AR] have demonstrated superior accuracy,” said Dr. Darren R. Lebl. “Our study is the first to directly compare RAN to AR with respect to screw placement precision.” Lebl is a spine surgeon and director of research at HSS, plus the principal investigator of the study. The research was published online in the journal Spine. HSS is a leading academic medical center focused on musculoskeletal health. Founded in 1863, the New York-based healthcare provider claimed it has the lowest readmission rates in the nation for orthopedics, as well as some of the lowest infection and complication rates. In addition to patient care, HSS said it supports research, innovation, and education. The HSS Research Institute includes 20 laboratories and 300 staff members focused on advancing musculoskeletal health through the prevention of degeneration, tissue repair, and tissue regeneration. Robot-assisted surgery and AR offer aid Over the past decade, numerous robot-assisted navigation and augmented reality systems have emerged for spine surgery. “In addition to enhanced accuracy, the potential advantages of both technologies include reduced radiation exposure and provide for improved safety in spine surgery,” noted Dr. Lebl. “A growing number of major medical centers nationwide are using at least one of these technologies.” RAN involves robotic guidance of surgeon-operated instruments. A robotic arm, along with 3D images of the patient’s anatomy and navigation technology similar to GPS, enables the surgeon to perform a minimally invasive procedure that is planned ahead of time on advanced software. AR-assisted spine surgery superimposes 3D images of a patient’s anatomy onto the surgeon’s visual field during surgery via a headset. A preoperative CT scan of the patient’s spine is used to plan and perform the surgery. Study analyzes spinal surgeries The HSS study included 212 adult spine surgery patients who had a total of 1,211 pedicle screws placed between June 2020 and October 2023. It followed 108 people who received 827 screws using robots and 104 patients who received 384 screws with augmented reality. They underwent surgery in the lumbar and/or sacral spine for degenerative spinal conditions. One experienced surgeon performed all of the robotic cases, while two other experienced spine surgeons used the AR system. The position of each pedicle screw was assessed after surgery based on either CT scan or 3D fluoroscopy using the Gertzbein-Robbins classification system, which assigns a grade of A, B, C or D to evaluate accuracy. The HSS researchers considered Grades A and B to be acceptable. The A rating is assigned to screw placement completely within the pedicle, a bony structure on the vertebra that protects the spinal cord. Grade B, still acceptable, is assigned to a screw that is 2mm (1/16 inch) outside of the desired location. In the study, any screw with a Grade C or D would be deemed unacceptable. After surgery, two independent spine surgeons assigned a grade to all the pedicle screws. The study found no significant difference between robot-assisted and AR screw placement in terms of accuracy, with 99.6% of RAN screws rated as Grade A or B, and 98.7% of AR screws classified as A or B. Overall, 92.6% of the screws achieved the top Grade A rating. “Our results confirmed excellent accuracy for both techniques, making both robotics and AR safe tools for accurate positioning of lumbosacral pedicle screws,” Dr. Lebl said. “However, a higher rate of Grade A screws was seen in the RAN group, potentially highlighting superior precision for robotics.”

The Discseel Procedure is an outpatient spine treatment that allows patients to return to work and activities within a week. DALLAS, Dec. 4, 2024 /PRNewswire/ -- This study is the World's largest Spine Regenerative Medicine study. Continue Reading 3-year results of the Discseel® Procedure were published in Pain Physician Journal and demonstrate high safety and efficacy in treating chronic low back pain and sciatica (radiculopathy.) The study's Lead Investigator, Kevin Pauza MD, Founding Partner of Texas Spine and Joint Hospital and Pauza Spine Institute, was joined by co-investigators from HSS, MIT, and other US Institutions. (Pain Physician Journal is the official journal of the American Society of Interventional Pain Physicians (ASIPP.) Landmark Spine Study Published: The Discseel® Procedure, Successfully Treats Chronic Low Back Pain, 1-3 Year Results Post this To maintain independence, data for this non-surgical Discseel® Procedure was collected by a research group supported by the American Academy of Orthopedic Surgery, "OBERD." "Independent data collection," Pauza said, "was especially important because it mitigates scrutiny from surgeon-critics." This bears importance because the Discseel® Procedure is the only treatment that's a true paradigm shift in spine treatments over the past 100 years. This is because it is the only spine treatment which (1) identifies the cause of pain, and (2) treats that cause of pain by utilizing a non-surgical, outpatient Regenerative Medicine procedure and an FDA Approved drug; Fibrin. This landmark study demonstrated statistically significant improvement in all outcomes measured at 1-, 2-, and 3-years after undergoing the Discseel® Procedure. 725 subjects were enrolled, suffering with pain for an average of 12 years before undergoing the Discseel® Procedure. Subjects weren't cherry-picked because they were thought to do well, but instead," Pauza said, "subjects enroll only if they first failed a combination of at least four prior treatments including surgical fusion, laminectomy, discectomy, stem cell injection, and other invasive treatments. The Discseel® Procedure is an outpatient procedure that replaces most spine surgeries, including laminectomy, discectomy, and fusion. The US Department of Defense and Office of Veterans Affairs recognized this important fact of the Discseel® Procedure and therefore signed a contract with Discseel Technologies to train physicians to replace most spine surgeries with the Discseel® Procedure. This will benefit over 14 million Veterans and active service personnel by offering the Discseel® Procedure. What is the Discseel® Procedure The Discseel® Procedure is a two-step, outpatient procedure allowing patients to return to activities the following day. The first step identifies all disc tears in the region of symptoms through an Annulargram™ test. The second step immediately treats all disc tears and damage by introducing FDA-Approved Fibrin biologic drug to seal disc damage and stimulate disc growth. No other Spine treatment causes growth of normal disc tissue. The Discseel® Procedure may only be performed by physicians trained and licensed by Discseel Technologies to perform the Discseel® Procedure. For more information regarding the study visit: For more information about Discseel® Technologies and the Procedure, visit: SOURCE Discseel Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BELTSVILLE, Md., Nov. 19, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced the presentation of preclinical data demonstrating that treatment with NC605, a novel anti-Siglec-15 (S15) antibody, resulted in enhanced generation of quality bone with better mechanical properties, in an oral presentation at the Osteogenesis Imperfecta Federation Europe virtual Investigator Meeting on November 15th, 2024. These results demonstrate that NC605 is a highly effective treatment for Osteogenesis Imperfecta (OI), also known as brittle bone disease in a well-established model of disease. OI is a rare disorder that results in high bone turnover, abnormal bone formation, bone fragility and recurrent fractures. There is no cure for OI. Current anti-resorptive treatments inhibit both bone loss and bone formation leading to an increase in bone density, but overall poor bone quality. In contrast, NC605 inhibits bone loss and enhances osteoblast recruitment, to produce new bone, resulting in the generation of quality bone with increased density. Fracture incidence and bone quality were assessed in male and female OI mice (oim) treated with 20 mg/kg of surrogate antibody NP159 (murine mAb parent to NC605) and compared to control groups. Key findings include: In the treated mice, 90% of male oim and 80% of female oim, had no fractures post-sacrifice, compared to 85% and 55% in the control groups, respectively.For the treated oim population, both sexes showed: Increased trabecular and cortical tissue mineral density.Increased cortical bone mineral density.Collectively, all changes resulted in overall enhanced bone quality with better mechanical properties. In contrast, only the treated male oim population showed: Increased trabecular bone volume fraction, including an increase in the number of trabeculae and a decreased separation between trabeculae.Increased cortical thickness.Collectively, the changes resulted in an increase of max load and stiffness, measures of mechanical bone strength. “We have again demonstrated that, NP159, a surrogate murine antibody for NC605, reduces fracture incidence in both male and female OI mice. Given sexual dimorphism seen with OI, we noted improved bone quality in the treated male mice specifically,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer. “We continue to believe that NC605 has the potential to be a transformative agent for both female and male OI patients.” The data were generated in collaboration with Dr. Cathleen Raggio, Hospital for Special Surgery, New York. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. http://www.nextcure.com Cautionary Statement Regarding Forward-Looking Statements Statements made in this press release that are not historical facts are forward-looking statements. Words such as “expects,” “believes,” “intends,” “hope,” “forward” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: our limited operating history and no products approved for commercial sale; our history of significant losses; our need to obtain additional financing; risks related to clinical development, including that early clinical data may not be confirmed by later clinical results; risks that pre-clinical research may not be confirmed in clinical trials; risks related to marketing approval and commercialization; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including NextCure’s most recent Form 10-K and subsequent Form 10-Q. You should not place undue reliance on any forward-looking statements. NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor InquiriesTimothy Mayer, Ph.D.NextCure, Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com