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Aclarion Announces Achievement of Goal to Enroll 10 Key Opinion Leaders (KOLs) in Spine Surgery to Support Adoption of Nociscan
Recruiting a panel of leading KOL surgeons who believe Nociscan can improve the diagnosis and treatment of discogenic low back pain is a critical step in establishing Nociscan as the standard of care.

Aclarion’s KOL panel represents spine surgeons at some of the largest and most influential academic centers and private practices in the country, including leaders of national associations that advocate for protocols to improve clinical treatments.

The company plans to activate MRIs for every KOL surgeon to expand Nociscan access for their patients and demonstrate improvements in clinical outcomes to payers.

Aclarion will release initial scan volume data before the end of the year and begin reporting on quarterly scan volume in 2024, as increasing scan volume is a measure of increasing revenue and the likelihood of a coverage decision the local payer.

BROOMFIELD, CO, November 8, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that uses biomarkers and proprietary enhanced intelligence algorithms to help physicians identify the location of chronic low back pain, today announced that they have successfully achieved their goal of enrolling ten leading spine surgery KOLs to join the company help bring Nociscan to the standard of care for identifying discogenic low back pain.

“Since executing our IPO last year, Aclarion has consistently delivered value creation catalysts that fall within a very concise framework of technology readiness, clinical evidence and surgeon advocacy and are proven to bring disruptive technological advances to the standard of care in the healthcare industry. said Brent Ness, Chief Executive Officer of Aclarion. “The steps we have taken in a short period of time demonstrate that our actions follow our stated intentions. We are incredibly proud of the KOL panel that has worked to bring Nociscan to the standard of care.”

A cornerstone of the company’s strategy is Key Opinion Leaders (KOL) advocacy. Aclarion has now achieved its goal of engaging 10 leading spine physicians who are deploying Nociscan in their practices to close a major gap with conventional lumbar MR imaging, which cannot distinguish between pain and aging. Our KOL advisors are focused on advancing value-based healthcare through improved outcomes while advocating for societies and payers that leverage patient data and peer-reviewed, published clinical evidence. “KOL’s interest in Nociscan directly reflects the challenge of diagnosing and treating low back pain, and we are pleased that these physicians are advancing spine care with Nociscan,” said Ryan Bond, Chief Strategy Officer of Aclarion.

KOLs, consultants and advisors now include:
- Chris Ames, MD; University of CA San Francisco
- Gregory Basil, MD MBA; University of Miami
- Sigurd Berven, MD; University of CA San Francisco
- George Frey, MD; Advent Health Colorado
- Roger Hartl, MD; Weill Cornell Brain and Spine Center, New York, NY
- Dean Karahalios, MD; Advocate for the Aroura Health System
- James Keller, MD; University of Michigan Health West
- Alpesh Patel, MD MBA; Northwest
- Eric Potts, MD; St. Vincent’s, Ascension Day
- Juan Uribe, MD; Barrow Neurological Institute
- Bob Eastlack, MD; Scripps (surgeon consultant)
- Timothy Ryken, MD; (Consultant)
- Lawrence Tannenbaum, MD; RadNet (MD advisor)
- Jeffrey Lotz, PhD; University of CA San Francisco (Scientific Advisor)
The company will announce expansion of MRI access for each KOL once their MRIs are onboard. Dr. Frey and Hartl already have access to Nociscan and have used it in their clinical practice. As access to MRI increases, so will the potential scan volume, peer-reviewed evidence, and revenue.

For more information about the BEST trial, please visit: www.besttrial.org
For information about BACPAC, please visit: https://heal.nih.gov/research/clinical-research/back-pain
For more information about REACH, please visit: www.bacpac-reach.org
For more information about our published evidence, please visit: www.aclarion.com
For information about accessing Nociscan, please visit: www.aclarion.com

About Aclarion, Inc.
Aclarion is a healthcare technology company that uses magnetic resonance spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers and enhanced intelligence algorithms to optimize clinical treatments. The company is entering the chronic low back pain market for the first time with Nociscan, the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful 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 shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies. For more information please visit www.aclarion.com.

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 management’s current plans and expectations and are subject to a number of uncertainties and risks that could materially affect the company’s current plans and expectations, as well as its future results of operations and financial condition. These and other risks and uncertainties are discussed in more detail in our filings with the Securities and Exchange Commission. Readers are encouraged to read the section entitled “Risk Factors” in the Company’s April 21, 2022 Prospectus as filed with the Securities and Exchange Commission on April 25, 2022 under Rule 424(b)(4), as well as other disclosures. included in the Prospectus and subsequent filings with the Securities and Exchange Commission. Forward-looking statements 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 Advice, Inc.
646.823.8656
ksmith@pcgadvisory.com

Media contacts:
Jodi Lamberti
SPRIG advice
612.812.7477
jodi@sprigconsulting.com
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November 9, 2023
As hospital ASC development continues to accelerate, healthcare systems are seeking larger equity stakes – key findings from the fifth Avanza Intelligence Hospital Leadership ASC survey
Survey available for download; podcast planned with further data analysis

WESTCHESTER, Ill., Nov. 8, 2023 /PRNewswire/ — Avanza Healthcare Strategies, a leading expert in ambulatory surgical centers (ASCs) and outpatient services, has released the results of the 5th Avanza Intelligence Hospital Leadership ASC Survey.

The 2023 results continue to illustrate the fluidity of the surgery center industry and how the overall outpatient market continues to mature. Key findings include:
- ASC investments are accelerating and becoming central to the overall health care system strategy. More than seven in 10 hospitals and health care systems plan to continue investing in and joining ASCs.
- Ownership dynamics and equity incentives remain fluid. Hospitals prefer to have an ownership stake of more than 50%, and a growing number prefer to own 100% of their ASC.
- The maturing market continues to impact operational strategies. Hospitals and healthcare systems are considering alternative approaches to external partnerships.
“Investments in ASCs continue to increase and we are seeing increasing attention to outpatient strategies as part of larger strategic planning,” said Avanza founder Joan Dentler, MBA. “The market is experiencing a confluence of events due to price pressure, government regulation and the acceleration of complex business conducted in ASCs. This is a dynamic market and many of our clients are working to stay ahead of these competitive forces by developing a comprehensive, long-term strategy around ASC development.”

The survey, which can be downloaded here, was conducted by HealthLeaders Media on behalf of Avanza, with input from C-suite and board members, as well as financial, operational and clinical leaders from across the country.

Digging deeper into ownership trends, approximately two-thirds of leaders surveyed indicated that when their hospital or healthcare system partners or is considering partnering with physicians for an ASC joint venture, their organization owns or prefers to own a majority stake in the operating room . Centre. The survey found that the number of hospitals owning 100% of their ASCs increased by 61% from the previous survey.

“There is a growing desire to have control over record migration for both clinical and financial reporting purposes,” said Erik Miller, president of Avanza and parent company MedHQ. “Physician partners are increasingly favoring larger equity stakes in hospitals and healthcare systems to leverage contract relationships between payers and clinical operations.”

Later this month, Joan Dentler will elaborate on the study’s findings in a podcast with industry leaders.

About Avanza care strategies

Avanza is an ASC and healthcare consulting organization that supports leading healthcare organizations in planning, developing, executing and executing their ASC and outpatient strategies. Over the past 20 years, Avanza has worked with more than 150 organizations and participated in more than 500 ASC projects, representing more than $200 million in customer revenue. Avanza Healthcare Strategies is a subsidiary of MedHQ, a leading technology-based services provider that leverages expertise in human resources, accounting, clinical staffing and revenue cycles to strengthen outpatient strategies.

For more information:
Phone: 512.479.6700
Email: 368317@email4pr.com
Find Avanza on LinkedIn

SOURCE Avanza Healthcare Strategies
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November 9, 2023
Your Survival Guide for Cold and Flu Season – Bone Talk
It goes by many names: cold and flu season, ‘tripledemic’ season and respiratory virus season are just a few. Whatever you call it, we know that the colder months and more time indoors mean that many of us are coming down with coughs, colds or the flu. If you or your loved ones do get sick and you’re taking over-the-counter medications to treat your symptoms, there are a few things you should keep in mind to keep your family healthy and safe.

Did you know that many commonly used fever reducers and multi-symptom cold and flu medications contain a drug ingredient called acetaminophen? Acetaminophen medicines can be a safe and effective way to control your cough, cold, and flu symptoms, but taking more acetaminophen than prescribed is an overdose and can lead to liver damage. The U.S. Food and Drug Administration has established a maximum daily dose of 4,000 milligrams (mg) of acetaminophen in a 24-hour period.

Follow these four steps to use acetaminophen medicines safely:
- Always read and follow the medicine label.
- Know if your medications contain acetaminophen.
- Only take one medicine that contains paracetamol at a time.
- Ask your healthcare provider or pharmacist if you have any questions about dosing instructions or medications containing acetaminophen.
Visit for more information KnowYourDose.org and follow @KnowYourDose further X/Twitter And Facebook.
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November 8, 2023
AlloSource Announces First Implantation of AceConnex™ Pre-Sutured Fascia Device in Hip Labral Reconstruction Procedure
Pre-sutured fascia allograft designed for hip arthroscopy specialists to help the surgeon increase the efficiency of their procedures and return their patients to an active lifestyle

CENTENNIAL, Colo., Nov. 8, 2023 /PRNewswire/ — AlloSource®, one of the largest allograft providers creating innovative tissue products to help surgeons heal their patients, today announced the first implant of the AceConnex Pre-Sourd Fascia Device for hip-labral reconstruction announced and augmentation. The labral reconstruction procedure was performed by Dr. Winston Gwathmey of University of Virginia Health as part of AceConnex’s limited market launch, marking the next step in the advancement of AlloSource’s products to support hip arthroscopy.

“I appreciated having AceConnex Pre-Surtured Fascia for this labral reconstruction procedure because it made my process in the operating room more efficient compared to the extra time I spent suturing myself,” said Dr. Gwathmey. “I am honored to be the first surgeon in the United States to implant AceConnex. This device will be a true innovation for this procedure as it will allow the surgeon to suture an allograft preoperatively.”

AceConnex Pre-Sutured Fascia is a device intended for use as part of soft tissue surgical procedures where constructs, including those containing allograft tissue, are used for reconstruction, replacement or augmentation of the labrum. The off-the-shelf, sterile device will be available in multiple pre-sutured lengths and diameters, with trimmable areas that allow adjustments of the allograft to match the patient’s anatomy. Additionally, AceConnex Pre-Surtured Fascia is manufactured to ensure consistency and minimize variability compared to allografts that are manually sutured intraoperatively. For many years, fascia allografts have been documented as an effective allograft for labral reconstruction. ^1,2

“The AceConnex Pre-Sutured Fascia allograft device represents a commitment to developing patient-specific solutions for the treatment of hip labral injuries as part of our comprehensive sports medicine and hip arthroscopy portfolio,” said Kevin Whitten, Chief Commercial Officer of AlloSource.

Surgeons have trusted and implanted AlloSource fascia for labral procedures since 2012.

For more information about the new AceConnex pre-bonded fascia, please email info@allosource.org.

About AlloSource
AlloSource, one of the largest suppliers of human tissue, honors tissue donors by creating innovative dermis, cartilage, tendon, fascia, bone and amnion allografts to help patients heal. Since 1994, the Colorado-based nonprofit organization has continued to develop its allografts to improve patient outcomes and serves as a trusted tissue partner to the medical community. AlloSource® is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks. Learn more at allosource.org.

References
1. Carreira DS, Kruchten MC, Emmons BR, et al. Arthroscopic labral reconstruction using fascia lata allograft: shuttle technique and results over at least two years. J Hip conservation surgeon. 2018;5(3):247-58.
2. Rathi R, Mazek J. Arthroscopic acetabular-labral reconstruction with fascia lata allograft: clinical results at a minimum one-year follow-up. Open Orthop J. 2017;11:554-61.
Media contact
Cindy Mason
AlloBron
720. 873. 4744
cmason@allosource.org

SOURCE AlloSource
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November 8, 2023
Deconstruction of the synovium of rheumatoid arthritis defines inflammatory subtypes
- Division of Rheumatology, Inflammation and Immunity, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
  
  Fan Zhang, Anna Helena Jonsson, Aparna Nathan, Nghia Millard, Michelle Curtis, Qian Xiao, Maria Gutierrez-Arcelus, Gerald FM Watts, Dana Weisenfeld, Kathryne E. Marks, Joyce B. Kang, Laurie Rumker, Joseph Mears, Kathryn Weinand, Ellen M. Gravallese, Adam Chicoine, Kazuyoshi Ishigaki, Gregory Keras, Ilya Korsunsky, Zhihan J. Li, Yuhong Li, Yakir Reshef, Saori Sakaue, Zhu Zhu, Katherine P. Liao, Kevin Wei, Deepak A. Rao, Michael B. Brenner and Soumya Raychaudhuri
- Center for Data Sciences, Brigham and Women’s Hospital, Boston, MA, USA
  
  Fan Zhang, Aparna Nathan, Nghia Millard, Michelle Curtis, Qian Xiao, Maria Gutierrez-Arcelus, Joyce B. Kang, Laurie Rumker, Joseph Mears, Kathryn Weinand, Kazuyoshi Ishigaki, Ilya Korsunsky, Yakir Reshef, Saori Sakaue & Soumya Raychaudhuri
- Division of Genetics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
  
  Fan Zhang, Aparna Nathan, Nghia Millard, Michelle Curtis, Qian Xiao, Maria Gutierrez-Arcelus, Joyce B. Kang, Laurie Rumker, Joseph Mears, Kathryn Weinand, Kazuyoshi Ishigaki, Ilya Korsunsky, Yakir Reshef, Saori Sakaue & Soumya Raychaudhuri
- Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA
  
  Fan Zhang, Aparna Nathan, Nghia Millard, Michelle Curtis, Qian Xiao, Maria Gutierrez-Arcelus, Joyce B. Kang, Laurie Rumker, Joseph Mears, Kamil Slowikowski, Kathryn Weinand, Kazuyoshi Ishigaki, Ilya Korsunsky, Yakir Reshef, Saori Sakaue, Katherine P. Liao & Soumya Raychaudhuri
- Broad Institute of MIT and Harvard, Cambridge, MA, USA
  
  Fan Zhang, Aparna Nathan, Nghia Millard, Michelle Curtis, Qian Xiao, Maria Gutierrez-Arcelus, Joyce B. Kang, Laurie Rumker, Joseph Mears, Kamil Slowikowski, Kathryn Weinand, Kazuyoshi Ishigaki, Ilya Korsunsky, Yakir Reshef, Saori Sakaue & Soumya Raychaudhuri
- Department of Rheumatology and the Center for Health Artificial Intelligence, University of Colorado School of Medicine, Aurora, CO, USA
  
  Fan Zhang
- Division of Immunology, Department of Pediatrics, Boston Children’s Hospital and Harvard Medical School, Boston, MA, USA
  
  Maria Gutierrez-Arcelus
- Accelerating Medicines Partnership Program: Rheumatoid Arthritis and Systemic Lupus Erythematosus (AMP RA/SLE) Network, Bethesda, MD, USA
  
  William Apruzzese
- Rheumatology Research Group, Institute of Inflammation and Aging, University of Birmingham, Birmingham, UK
  
  Saba Nayar, Mark Maybury, Ilfita Sahbudin, Hayley L. Carr, Karim Raza, Dagmar Scheel-Toellner & Andrew Filer
- Birmingham Tissue Analytics, Institute of Translational Medicine, University of Birmingham, Birmingham, UK
  
  Saba Nayar and Andrew Filer
- Division of Allergy, Immunology and Rheumatology, Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA.
  
  Javier Rangel-Moreno, Nida Meednu, Darren Tabechian, Jennifer Albrecht, Jennifer L. Barnas, Debbie Campbell, Christopher Ritchlin & Jennifer H. Anolik
- Hospital for Special Surgery, New York, NY, USA
  
  Ian Mantel, Dana E. Orange, S. Louis Bridges Jr., Lionel B. Ivashkiv, Amit Lakhanpal, Anvita Singaraju, Melanie H. Smith, Susan M. Goodman, Vivian P. Bykerk & Laura T. Donlin
- Weill Cornell Medicine, New York, NY, USA
  
  Ian Mantel, S. Louis Bridges Jr., Lionel B. Ivashkiv, Amit Lakhanpal, Anvita Singaraju, Susan M. Goodman, Vivian P. Bykerk & Laura T. Donlin
- Center for Immunology and Inflammatory Diseases, Department of Medicine, Massachusetts General Hospital (MGH), Boston, MA, USA.
  
  Kamil Slowikowski
- Laboratory of Molecular Neuro-Oncology, Rockefeller University, New York, NY, USA
  
  Dana E. Orange
- Department of Rheumatology, Columbia University College of Physicians and Surgeons, New York, NY, USA
  
  Laura Geraldino-Pardilla & Joan M. Bathon
- Department of Rheumatology, University of Colorado School of Medicine, Aurora, CO, USA
  
  Kevin D. Deane, Jennifer A. Seifert, Larry W. Moreland, and V. Michael Holers
- Department of Rheumatology, Allergy and Immunology, University of California, San Diego, La Jolla, CA, USA.
  
  Arnoldas Ceponis, Gary S. Firestein, and David L. Boyle
- NIHR Birmingham Biomedical Research Center and Clinical Research Facility, University of Birmingham, Queen Elizabeth Hospital, Birmingham, UK
  
  Mark Maybury, Ilfita Sahbudin, Hayley L. Carr, Karim Raza, Dagmar Scheel-Toellner & Andrew Filer
- Department of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, CA, USA
  
  Ami Ben-Artzi, Lindsy Forbess and Michael H. Weisman
- Division of Rheumatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
  
  Arthur M. Mandelin II & Harris Perlman
- Center for Experimental Medicine and Rheumatology, EULAR Center of Excellence, William Harvey Research Institute, Queen Mary University of London, London, UK
  
  Alessandra Nerviani, Myles J. Lewis, Felice Rivellese & Costantino Pitzalis
- Barts Health NHS Trust, Barts Biomedical Research Center (BRC), National Institute for Health and Care Research (NIHR), London, UK
  
  Alessandra Nerviani, Myles J. Lewis, Felice Rivellese & Costantino Pitzalis
- Department of Biomedical Sciences, Humanitas University and Humanitas Research Hospital, Milan, Italy
  
  Constantine Pitzalis
- Division of Clinical Immunology and Rheumatology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
  
  Laura B. Hughes
- Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, NY, USA
  
  Diane Horowitz and Peter K. Gregersen
- Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, NY, USA
  
  Edward DiCarlo
- Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY, USA
  
  Brendan F Boyce
- Department of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
  
  Mandy J. McGeachy & Larry W. Moreland
- Department of Radiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
  
  Andrew Cordle and Aaron Wyse
- Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  
  Patrick Dunn
- Northrop Grumman Health Solutions, Rockville, MD, USA
  
  Patrick Dunn
- Division of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA
  
  Joel M. Guthridge and Judith A. James
- Laboratory of Human Immunogenetics, RIKEN Center for Integrative Medical Sciences, Yokohama, Japan
  
  Kazuyoshi Ishigaki
- Department of Surgery, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
  
  James A. Lederer
- Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
  
  Andrew McDavid
- Division of Immunology and Rheumatology, Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford, CA, USA.
  
  William H. Robinson, Paul J. Utz, and Michael H. Weisman
LG-P., KDD, DT, AC, GSF, MM, IS, AB-A., AMM, A. Nerviani, FR, CP, LBH and DH recruited patients and obtained synovial tissues. LWM, SMG, HP, VMH, AF, VPB, and JHA contributed to sample acquisition and processing and design of the AMP study. ED, EMG and BFB performed histological assessment of tissues. DW, KPL, AF, and VPB compiled and analyzed histological and clinical data. WA provided project management and compiled histological and clinical data. K. Wei, AHJ, GFMW, A. Nathan, and MBB designed and implemented the tissue disaggregation, cell sorting, and single-cell sequencing pipeline. AHJ, K. Wei, and GFMW oversaw and executed the tissue disaggregation pipeline. S.N., J.R.-M. and N. Meednu. performed immunofluorescence microscopy and analyzed these data together with MC and AHJKEM and IM performed and analyzed functional cellular assays. MJL, FR, and CP contributed unpublished clinical trial data. FZ, A. Nathan, N. Millard, MC, QX, MG-A., JBK, K. Weinand, JM, LR, and SR performed computational and statistical analyses. AHJ, K. Wei, MBB, JHA, LTD, DAR, FZ, A. Nathan, SR, DEO, JR-M. and AF provided input on cellular analysis and interpretation. DEO, JR-M., AF and JHA provided input for histological analyses. N. Millard and KS implemented the website. SR, MBB, JHA, LTD, and DAR supervised the study. FZ, AHJ, A. Nathan, N. Millard, QX, and SR wrote the first draft. FZ, AHJ, A. Nathan, K. Wei, N. Millard, DAR, LTD, JHA, MBB, and SR edited the draft. Members of the AMP RA/SLE Network contributed to this work by managing patient recruitment, managing clinical data, obtaining and processing synovial tissue samples, managing biorepositories, performing histological or computational analyses, providing software code, providing website support and/or providing input for data analysis. and interpretation. All authors participated in editing the final manuscript.

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November 8, 2023
Stratus® Medical Adds Fifth US Patent and Two Canadian Patents to its 29-Patent Global IP Portfolio for the NIMBUS® Electrosurgical RF Multitined Expandable Electrode

MAGNOLIA, Texas, Nov. 8, 2023 /PRNewswire/ — Stratus^® Medical, a company focused on improving clinical outcomes for chronic pain patients by advancing radiofrequency (RF) technology for the treatment of pain, today announced the issuance of its fifth U.S. patent (U.S. Patent No. 11,806,070 ) and the first two Canadian patents (Canadian patent). Nos. 2,778,997 and 2,799,505) for the NIMBUS^® Electrosurgical RF multitine expandable electrode (“NIMBUS”).

These important patents further protect NIMBUS’ valuable intellectual property for its highly differentiated pain ablation technology. The company now holds 29 issued patents and 11 pending patent applications for its technology and will continue to file additional applications. NIMBUS is rapidly gaining market share in the US and other key markets around the world, where Stratus Medical distributes through both direct sales representatives and distributor partners.

Bret Boudousquie, CEO of Stratus Medical, said: “We continue to invest in our patents, trademark registrations and trade secrets for our valuable RF ablation technologies. We are committed to making NIMBUS the preferred ablation technology for the treatment of pain and are fortunate to work with many of the leading physicians and hospitals in the United States, United Kingdom, Australia, Brazil, Spain and other countries using NIMBUS to improve the quality of life. for patients.”

Amitabh Gulati, MD, a board-certified, interventional pain medicine physician based in New York City and president of the World Academy of Pain Medicine United (WAPMU), noted: “We have used NIMBUS RF ablation technology to treat spine and joint-related problems. to deal with. pain in our practice for the past four years and are satisfied with our clinical results. NIMBUS deployable teeth are unique and provide technical simplicity during placement, reducing overall procedure time. In addition, we are conducting ongoing research that will validate the improved lesion size and shape of the NIMBUS ablation zone compared to standard radiofrequency needling. We believe these qualities support NIMBUS as the preferred RF ablation technology for clinical and educational use.”

About Stratus^® Medical – Stratus Medical’s mission is to improve clinical outcomes for patients with chronic pain by advancing RF technology. The NIMBUS^® Electrosurgical RF Multitined Expandable Electrode (“NIMBUS”), in combination with a radio frequency (RF) generator and thermocouple probe, is intended for use in RF heat lesion procedures for pain relief. NIMBUS is FDA approved and CE marked. NIMBUS is easy to implement into the existing workflow, has demonstrated reduced procedure time and delivers significant savings for many of our customers. Stratus Medical continues to invest in the development of future technologies that align with our mission. Our headquarters are located in Magnolia, Texas.

Media contact
Cody Jorgensen
Director, Marketing
Stratus Medical
346-703-0642
cody@stratusmedical.com

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SOURCE Stratus Medical

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November 8, 2023
The use of TNF inhibitors during pregnancy is not associated with worse fetal or obstetric outcomes

According to new research at ACR Convergence 2023, the annual meeting of the American College of Rheumatology (ACR), use of tumor necrosis factor inhibitors during pregnancy is not associated with worse fetal or obstetric outcomes and may reduce the risk of serious maternal infections during pregnancy ( Abstract #0477).

Tumor necrosis factor (TNF) inhibitors such as adalimumab and infliximab are often prescribed for inflammatory forms of arthritis that have not improved with other treatments. Although research shows the drugs are safe during pregnancy, many women stop taking them for fear of harming the fetus. Unlike other medications used for inflammatory arthritis, such as methotrexate, which can cause serious fetal complications, TNF inhibitors are not known teratogens (an agent that causes abnormalities after fetal exposure during pregnancy).

To further test the safety of persistent TNF inhibitors during pregnancy, Anna Molto, MD, PhD, HDR, a rheumatologist and researcher at Cochin Hospital in Paris, France, and her colleagues used data from a nationwide French health insurance database to create a to emulate a randomized database. clinical trial (RCT). This type of research relies on observational data to conduct a study when a gold standard RCT may not be ethical or feasible.

The researchers identified more than 2,000 women treated with TNF inhibitors for rheumatoid arthritis (579 patients) or spondyloarthritis (1,503 patients) between 2008 and 2017. Each had a singleton pregnancy, with 1,497 (72%) stopping treatment when they learned they were pregnant. The average age of the women at the start of pregnancy was 31 years±5 years and the average duration of illness was 4 ±5 years.

The results showed no statistically significant difference in poor obstetric, fetal or infant outcomes, including spontaneous abortion (a loss of pregnancy naturally before twenty weeks of gestation), medical termination of pregnancy, preeclampsia or eclampsia, gestational diabetes, premature birth, small birth weight or serious birth defects.

Interestingly, women who continued to use TNF inhibitors were less likely to be hospitalized for serious infections during pregnancy during six weeks postpartum compared to those who stopped treatment (0.2 versus 1.3 percent, respectively). Molto says this finding was the most surprising.

“Although we had assumed that pregnancy outcomes would be at least comparable in both groups, we did not expect that there would be a lower risk of maternal infections in patients who continued TNFi, as the risk of infection is known to be higher with these treatments” , she says. She speculates that the finding may be due to lower concomitant use of corticosteroids, but does not yet have results to confirm her theory.

Regarding the overall study results, Molto says: “These data add to the increasingly reassuring data on the use of TNFi during pregnancy. And most importantly, if a rheumatologist is considering stopping a TNFi during pregnancy because of the risk of infection, this study suggests that this may not be justified.”

Molto acknowledges the limitations of relying on claims data, noting that disease activity cannot be measured, but also points out that the use of a national database ensures that “all French participants are included, [thereby avoiding] selection bias.”

The next step, Molto says, is to test the hypothesis in a randomized controlled trial.

This study was carried out thanks to the funding program of the French Ministry of Health.

Source:

American College of Rheumatology

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November 8, 2023
$Research shows that there is a doubled risk of fractures in patients with acute calcium pyrophosphate crystal arthritis$

Research shows that there is a doubled risk of fractures in patients with acute calcium pyrophosphate crystal arthritis

Researchers will present the first-ever study on fractures and calcium pyrophosphate deposition disease at ACR Convergence 2023, the annual meeting of the American College of Rheumatology (ACR). They report a doubled risk of fracture in patients with acute calcium pyrophosphate crystal arthritis compared with those without the disease (Abstract #0235).

Calcium pyrophosphate deposition disease (CPPD) occurs when calcium pyrophosphate (CPP) crystals form near cartilage cells, sometimes leading to joint inflammation, pain, and swelling. It is often called pseudogout because of its clinical similarity to gout, yet much less is known about CPPD than about gout and other forms of inflammatory arthritis.

Rheumatologist Sara Tedeschi, MD, MPH, her colleagues at Brigham and Women’s Hospital in Boston, and fellow at the Medical College of Wisconsin, wanted to expand the knowledge base by investigating whether patients with CPPD disease are at increased risk for fractures. Previous studies had shown a link between low bone density and CPPD. Recent data from experimental models suggest that increased formation of osteoclast (cells that break down old bone) due to loss of function of osteoprotegerin (a protein that normally inhibits bone resorption) may contribute to the pathogenesis of the disease.

To find out more, Tedeschi and her team conducted a matched cohort study using electronic health records (EHR) from Mass General Brigham’s health care system. The study included more than 1,100 patients who had at least one episode of acute CPP crystal arthritis; the acute inflammatory form of CPPD – between 1991 and 2017. They were compared with more than 3,300 comparison researchers who did not have acute CPP crystal arthritis, although they could have other types of arthritis. The average age in both groups was 73 years, and more than half were women.

The index date for patients with CPP crystal arthritis was either the first mention of pseudogout in their chart or the first synovial fluid analysis with the finding of CPP crystals. The period from registration of the EPD to the index date was at least 180 days. The index date for the matched comparators was a medical encounter within 30 days of the matched pseudogout patient’s index date.

The primary outcome of the study was the first fragility fracture (fractures resulting from a fall from standing height or lower) at the humerus, wrist, hip or pelvis. Secondary outcomes were the first fracture at each of these anatomic locations. For patients with more than one fracture, only the earliest fracture was used. Fragility fractures were identified using published algorithms with a positive predictive value of greater than 90%.

The researchers estimated the incidence rates and incidence ratios for each type of fracture and for fractures at each individual body location. They used Cox models (a statistical technique that can be used to measure time-to-event results on one or more predictors) to estimate adjusted risk ratios for fractures. Patients who had rheumatoid arthritis (RA) or were prescribed corticosteroid or osteoporosis treatment were excluded from the sensitivity analyzes in an attempt to rule out the influence of these diagnoses/medications, which are known to increase the risk of fracture.

The researchers found that the fracture rate was twice as high in the acute crystal CPP arthritis cohort as in the comparison group, after adjusting for traditional fracture risk factors: 11.2 per 1,000 person-years versus 5.6 per 1,000 person-years. The disparity between the two groups increased over time and the sensitivity analyzes yielded similar findings.

Tedeschi says the increased risk of fractures wasn’t particularly surprising, but the difference was large. Also surprising, she says, was “that differences in fracture risk were seen, of similar magnitude, after excluding patients who had used corticosteroids in the 90 days before the index date.” [Moreover]Fracture rates varied within the first months of follow-up, indicating a pre-existing difference in bone health between cohorts.”

Tedeschi notes that the study does not indicate whether patients with acute CPP crystal arthritis had repeat episodes or used corticosteroids after the index date, either of which could influence the findings. She adds that they could not assess falls, which would affect fracture risk and may have differed between CPPD and comparators. She concludes by noting: “The analysis did not assess vertebral fractures as they may be asymptomatic and not captured in diagnosis codes.”

Yet the findings are clear: patients with acute CPP crystal arthritis have a doubled risk of fragility fractures.

“At the very least, we hope that physicians will consider assessing bone mineral density in patients with CPPD to determine whether osteoporosis treatment is necessary,” says Tedeschi.

This research was supported by grants from the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Source:

American College of Rheumatology

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November 8, 2023
Orthofix announces the full commercial launch of the WaveForm L Interbody System for lateral lumbar fusion procedures
LEWISVILLE, Texas, November 6, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch in the U.S. of the WaveForm^®L Lateral lumbar interbody system. Designed for lateral lumbar interbody fusion (LLIF) procedures, the 3D printed WaveForm L features a porous structure that prioritizes strength and stability to provide a robust fusion environment.

“Designed to safely and reproducibly treat the spine via indirect decompression and sagittal alignment restoration, the WaveForm L features a large core opening for the placement of bone graft material to optimize bone fusion throughout the body,” said Dr. Donald Blaskiewicz, director of Spinal Malformation at St. Luke’s Boise Medical Center in Boise, Idaho, and faculty at UCSD in San Diego, CA. “The WaveForm L also has enhanced imaging properties to assist with radiographic visualization during intra- and postoperative imaging. These combined features make it one of the best 3D printed interbodies available.”

WaveForm interbodies are uniquely created with a primary focus on structure, surface and stability. Constructed from a repeating wave-like structure, WaveForm L is designed to efficiently distribute compressive loads and provide high porosity for optimized stiffness without compromising strength.^1,2 With an 80 percent body porosity, WaveForm L provides improved imaging properties and greater graft packability, while the optimized 65 percent endplate porosity of the wave-like structure provides bone ingrowth and early mechanical stability.^3,4,5

“We are committed to delivering a comprehensive portfolio of innovative, procedurally focused products that are strategically designed to work together to drive fusion,” said Kevin Kenny, president of Orthofix Global Spine. “WaveForm L represents the latest developments in patented spinal implant technology, which is designed to address the many nuances of spinal pathology to meet the individual needs of patients, providing both clinical and economic value to patients, surgeons and hospital systems.”

Lateral lumbar interbody fusion (LLIF) procedures represent approximately 20 percent of the interbody device market. The number of these procedures is expected to continue to increase based on the rapid growth of titanium-coated PEEK devices and 3D printed metal devices. According to 2022 data, the LLIF market in the US is estimated at over $350 million.⁶
1. Data available, TM-0043-22
2. Kelly, Cambre N., et al. “Design and structure-function characterization of 3D printed synthetic porous biomaterials for tissue engineering.” Advanced Healthcare Materials 7.7 (2018): 1701095.
3. Data available, TM-0071-23
4. Data available, D0006845
5. Kelly, C.N., Wang, T., Crowley, J., Wills, D., Pelletier, M.H., Westrick, E.R., Adams, S.B., Gall, K., & Walsh, W.R. (2021). High-strength, porous, additively manufactured implants with optimized mechanical osseointegration. Biomaterials, 279, 121206. https://doi.org/10.1016/j.biomaterials.2021.121206
6. Data on file. Market estimates based on iData 2022 US Market Report Suite for Spinal Impants and MIS.
About Orthofix

Orthofix and SeaSpine merged in January 2023 to form a leading global spine and orthopedics company with an extensive portfolio of biologics, innovative spine hardware, bone growth therapies, specialty orthopedic solutions and a leading surgical navigation system. The products are distributed in approximately 68 countries around the world.

The company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and corporate offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy. with an emphasis on product innovation, production and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil. For more information, visit Orthofix.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects” , ‘intends’, ‘predicts’, ‘potential’, ‘continue’ or other similar terminology. Orthofix cautions you that statements in this press release that are not descriptions of historical facts are forward-looking statements based on the company’s current expectations and assumptions. Any forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including due to the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s annual report. on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6. , 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Orthofix does not intend to revise or update any forward-looking statement contained in this press release to reflect events or circumstances occurring after the date of this press release, except as may be required by law.

Contacts

Media relations
Denise Landry
DeniseLandry@orthofix.com
214.937.2529

Investor Relations
Louisa Smith, Gilmartin Group
IR@orthofix.com
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November 8, 2023
Salivary gland abnormalities in primary Sjögren’s become more serious over time, research shows
New research at ACR Convergence 2023, the annual meeting of the American College of Rheumatology (ACR), shows that ultrasound-detected salivary gland abnormalities in primary Sjögren’s become more severe over time and that the slowly progressive disease likely begins long before it reaches the is first. detected (summary #1371).

Sjögren’s disease, also called primary Sjögren’s syndrome, is a systemic autoimmune disease. It is characterized by inflammation of the tear and salivary glands, leading to chronic dry eyes and mouth. Fatigue is common and about a third of patients have complications affecting the lungs, skin, kidneys and joints. Up to 60% of patients may develop systemic symptoms.

Salivary gland ultrasound (SGUS) is a safe and non-invasive method for diagnosing and monitoring Sjögren’s disease. Still, it’s unclear whether the abnormalities it detects become more notable over time. Valérie Devauchelle-Pensec, M.D., Ph.D., professor of rheumatology in the Department of Clinical Immunology and Rheumatology at the University of Brest Occidentale and Cavale Blanche Hospital in Brest, France, designed a cross-sectional international study to find out.

I have been caring for patients with Sjögren’s disease for years and I am always surprised that when I see them at the beginning of their disease, their first ultrasound scan of the salivary gland shows severe lesions. I also have many patients with rheumatoid arthritis. In rheumatoid arthritis, the joints are destroyed, but not at the onset of the disease. Sjögren’s seems different. I wondered, ‘When does the disease really start and do the lesions evolve over time or not?’ Many of my colleagues, who are experts in Sjögren’s and ultrasound, agreed to participate [in the study].”

Valérie Devauchelle-Pensec, MD, Ph.D., professor of rheumatology, department of clinical immunology and rheumatology at the University of Brest Occidentale

Between May 2019 and February 2022, 247 patients from 11 international centers consecutively participated in the study. Most were women, with an average age of 58 years. Nearly 100% of patients reported dry mouth; 75% had abnormal saliva production and 85% were positive for anti-SSA autoantibodies, a hallmark of Sjögren’s. The median EULAR Sjögren’s disease activity score (ESSDAI) was 3, indicating low disease activity.

Ultrasound-detected functional abnormalities of the parotid and submandibular gland were classified according to the most recent Outcome Measures in Rheumatology (OMERACT) score, a four-grade semiquantitative scoring system. The patients were then grouped according to the duration of illness from the onset of dry mouth symptoms.
- Group A: less than five years (47 patients)
- Group B: five to nine years (69 patients)
- Group C: 10 to 20 years (78 patients)
- Group D: More than 20 years (53 patients)
When the researchers looked at the most serious node for each patient, they found a significant association between disease duration and the OMERACT score. The odds ratio for progression over a five-year interval was 1.23.

There was no statistical difference between the groups with regard to the various ultrasound parameters, with the exception of the proportion of hyperechoic bands, which are associated with damage in established Sjögren’s patients.

“We hypothesized that hyperechoic bands represent the slow fibroadipose evolution of the disease,” says Devauchelle-Pensec. “To me, this means that Sjögren’s disease starts long before we find it, so it is important to treat patients early.”

She adds that the study highlights the importance of adding ultrasound findings to the classification criteria for Sjögren’s syndrome and the need for a better understanding of when the disease begins.

Source:

American College of Rheumatology
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November 8, 2023