Osteoarthritis, Spine

SANTA CLARA, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite® Implant System (Granite) in a smaller (9.5 mm) diameter with both an expanded indication in pediatric patients and an expanded application that includes use in the S1 trajectory. When placed across the SI joint, the Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for multi-segment spinal fusion. This 510(k) clearance follows the initial clearance of the iFuse Bedrock Granite System in May 2022 that included implants of 10.5 mm and 11.5 mm in diameter. The iFuse Bedrock Granite System was also awarded a Breakthrough Device Designation (BDD) by the Food & Drug Administration (FDA) and a New Technology Add-on Payment (NTAP) by the Centers for Medicare and Medicaid Services (CMS). According to Chris Shaffrey, MD, Chief of the Spine Division at Duke University, “The addition of a 9.5 mm diameter implant will seamlessly blend into my workflow, especially with both closed head and open head options. I’m very excited for patients to benefit from this breakthrough spinopelvic technology.” “With the expanded sacral indication and a smaller diameter Granite implant, I can utilize the Granite technology at S1, a segment which published literature has shown to be one of the most challenging segments in the spine, with reported screw loosening rates ranging from 16-41%,”1,2,3 said Brian A. O’Shaughnessy, MD, Reconstructive Spinal Surgeon at Howell Allen Clinic in Nashville, TN. Greg Mundis, MD, Orthopedic Spine Surgeon at Scripps Hospital mentions, “There is increasing interest among the surgeon community to include pelvic fixation in high-risk patients undergoing shorter (2-3 level) lumbar fusions. The addition of a 9.5 mm diameter to the Granite product line now offers surgeons one of the more commonly used sizes to treat these patients.” About SI-BONE, Inc. SI-BONE (NASDAQ: SIBN) is a global leader in technology for surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since pioneering minimally invasive surgery of the SI joint in 2009, SI-BONE has supported over 3,600 surgeons in performing a total of more than 95,000 sacropelvic procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies, including two randomized controlled trials and over 125 peer reviewed publications. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize novel solutions for adjacent markets, including adult deformity, spinopelvic fixation, and pelvic trauma. For additional information on the company or the products including risks and benefits, please visit iFuse Bedrock Granite, iFuse-TORQ and SI-BONE are registered trademarks of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights Reserved. Investor Contact: Saqib Iqbal investors@si-bone.com References Xu F, Zhou S, Zou D, Li W, Sun Z, Jiang S. The relationship between S1 screw loosening and postoperative outcome in patients with degenerative lumbar scoliosis. BMC Musculoskelet Disord. 2022 Feb 28;23(1):186. Kim JB, Park SW, Lee YS, et al. The effects of spinopelvic parameters and Paraspinal muscle degeneration on S1 screw loosening. J Korean Neurosurg Soc. 2015;58(4):357–362. Finger T, Bayerl S, Onken J, et al. Sacropelvic fixation versus fusion to the sacrum for spondylodesis in multilevel degenerative spine disease. Eur Spine J. 2014;23(5):1013–1020. A photo accompanying this announcement is available at: SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application

Nociscan cost-effectiveness abstract poster highlights dominance over provocative discography. The 45th Annual Society for Medical Decision Making (SMDM) Meeting is being held October 22-25, 2023. Founded in 1979, SMDM promotes scientific and methodological rigor in health care decision research and its application to health policy and clinical care. Highlighting the importance of the cost savings and improved outcomes associated with Nociscan, SMDM represents the third society meeting, showcasing the Economic Value Analysis of Low back pain (EVAL) study in 2023 BROOMFIELD, CO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Aclarion, Inc. (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today their Nociscan cost-effectiveness poster will be showcased at the 45th Annual Society for Medical Decision Making meeting, October 22-25, 2023. The cost-effectiveness study comparing Nociscan to provocative discography was performed at the Center for Disruptive Musculoskeletal Innovations (CDMI) through a National Science Foundation (NSF) grant and sponsored by Aclarion. The abstract highlights that Nociscan statistically dominates provocative discography (PD) because PD is both more costly and less effective. "An evidence-based process for accurate identification of a source for low back pain is valuable to improve cost-effectiveness of operative and non-operative management strategies," said Leslie Wilson, PhD, Professor in the Department of Medicine and the Department of Clinical Pharmacy at University of California San Francisco. “The economic model includes a decision-tree comparing Nociscan with PD based on a comprehensive set of peer-reviewed data. The incremental cost-effectiveness ratio (ICER) confirms that Nociscan dominates PD, with a Monte Carlo sensitivity analysis illustrating Nociscan dominates from 40-85% over a wide willingness-to-pay range. In total, Nociscan can save the US healthcare system from $283M to $441M annually.” Chronic low back pain (cLBP) is a global healthcare problem, with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. Conventional imaging and diagnostics provide valuable structural information but struggle to identify the source of the pathogenic pain. Low surgical success rates (41-57%)1,2 are common especially for patients suffering from Discogenic Chronic Low Back Pain (DCLP). “We are pleased with the compounding interest in the Nociscan cost-effectiveness research,” said Ryan Bond, Chief Strategy Officer at Aclarion. “SMDM serves a leading role at the nexus of policy, health economics, and clinical decision making, three areas of interest to Aclarion and our physician customers. Moreover, SMDM joins other leading societies – ISASS for spine surgery and ASPN for pain and neuroscience – who showcased similar Nociscan cost-effectiveness research at their annual meetings earlier this year. Combined with our published clinical evidence, Aclarion is proud of this important evolving research and the clear results – Nociscan shows clinical benefit vs PD while reducing cost-of-care.” In June 2023, a Nociscan cost-effectiveness abstract was presented by Dr. Wilson at the International Society for the Advancement of Spine Surgery (ISASS) annual meeting. In July 2023, a Nociscan cost-effectiveness poster was presented at the American Society for Pain & Neuroscience (ASPN) annual meeting. Wei J, Song Y, et al. Comparison of artificial total disc replacement versus fusion for lumbar disc disease: a meta-anaylsis of randomized controlled trials. Int Orthop. 2013; 37(7):1315-1325 Ibrahim T, Tieyjeh IM, et al. Surgical versus nonsurgical treatment of chronic low back pain: a meta-analysis of randomized trials. Int Orthop. 2008; 32(1):107-113 About Aclarion, Inc. Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes" and "expects" or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company's current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contacts: Kirin M. Smith PCG Advisory, Inc. 646.823.8656 ksmith@pcgadvisory.com

SALT LAKE CITY, Utah, Sept. 26, 2023 /PRNewswire/ -- DiscGenics, Inc., a privately held, late-stage clinical, biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that Flagg Flanagan, Chief Executive Officer and Chairman of DiscGenics will present at the following conferences: East-West BioPharma Summit being held October 2-4 in Cambridge, Massachusetts and livestreamed globally. Organized by BioCentury and BayHelix in collaboration with McKinsey & Company, the East-West BioPharma Summit brings together industry leaders and investors to debate global development strategy, and to network with peers from both the East and West. Virtual attendance is available, which includes access to a recording of DiscGenics' company presentation. For more information, please visit: . 2023 Cell & Gene Meeting on the Mesa being held October 10-12 in Carlsbad, California and livestreamed globally. Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 120 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers. Virtual attendance is available, which includes a livestream of DiscGenics' presentation and the ability to view all conference sessions on-demand. For more information, please visit . About DiscGenics DiscGenics is a privately held, late-stage clinical, biopharmaceutical company developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics's first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, mild to moderate lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. IDCT has been granted regenerative medicine advanced therapy (RMAT) and Fast Track designations by the U.S. Food and Drug Administration. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain. For more information, visit discgenics.com. SOURCE DiscGenics, Inc.