Author: Mokhtar

  • Research links lower testosterone levels to an increased risk of arthritis

    Research links lower testosterone levels to an increased risk of arthritis

    In a recent study published in Scientific Reports, researchers determined the relationship between serological testosterone levels and arthritis in adults in the United States (US).

    Research: Lower serum testosterone is associated with an increased risk of arthritis.  Image credits: airdone/Shutterstock.comStudy: Lower serum testosterone is associated with an increased risk of arthritis. Image credits: airdone/Shutterstock.com

    Background

    Arthritis is a joint disease that affects the hyaline articular cartilage, surrounding tissues and subchondral bone. Hormonal variables, such as testosterone, have been linked to the growth and development of knee osteoarthritis (KOA).

    Studies have shown that androgens activate non-genetic and non-genetic mechanisms, with the most rapid evidence being a rapid increase in intercellular calcium concentration.

    Physiological testosterone doses have been shown to improve cartilage production in men with advanced osteoarthritis, and treatment with testosterone replacement improves articular cartilage regeneration in affected individuals.

    According to research, androgens are also involved in the formation and development of osteoblasts. However, there is minimal evidence for sex-specific relationships between serological testosterone expression and OA, and the association between plasma testosterone in arthritic individuals and disease progression is not clear.

    About the study

    In the current study, researchers examined the influence of serological testosterone levels on the pathophysiology of arthritis.

    Data from 10,439 adults who participated in the 2013–2016 National Health and Nutrition Examination Survey (NHANES) were analyzed using multivariable logistic regression modeling, performed to determine odds ratios (ORs).

    The model estimates are adjusted for covariates such as age, gender, race, education level, marital status, income, alcohol consumption, smoking status, test reports, laboratory findings, survey responses, and comorbidities (such as diabetes, cardiovascular disease, and hypertension). ).

    In addition, generalized additivity modeling and smoothed curve fitting were performed. The database samples were selected using stratified multistage sampling.

    Data collection methods include home interviews to collect demographic, nutritional and health-related data, and medical examinations to collect laboratory data [including sex hormone binding globulin (SHBG) and estradiol] and physical assessment data [including body mass index (BMI) and waistline].

    Individuals were asked whether they had been diagnosed with arthritis by doctors or other medical professionals, and if so, they were asked to report the type of condition as rheumatoid arthritis, osteoarthritis, or other.

    The Centers for Disease Control and Prevention (CDC) isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS) technique was used to determine TT concentrations.

    Results

    Initially, 20,146 individuals were identified, of whom 5,380 and 4,327 were excluded due to missing data on serological testosterone levels and development of arthritis, respectively. Of the 10,439 study participants, 48% were male, with an average age of 47 years and an average serum testosterone level of 215. Of the participants, 27% developed arthritis.

    Arthritis patients showed lower serum testosterone than their non-arthritic counterparts, in line with previous studies. The findings from linear regression analysis showed a statistically significant negative association between serological testosterone levels and arthritis.

    Similarly, the fourth quarter univariable analyzes using the first quarter as reference showed a significantly lower risk of developing arthritis.

    Specifically, sensitivity analyzes using quartiles of serum testosterone resulted in odds ratios of 1.0, 0.9, 0.5, and 0.5 for the first quartile, second quartile, third quartile, and fourth quartile, respectively, in the fully adjusted model.

    Individuals in the top quartile of serum testosterone levels showed a 51% lower risk of developing arthritis compared to individuals in the lowest quartile.

    Smoothed curve fitting showed a non-linear relationship between the development of arthritis and serological testosterone levels. The subgroup analyzes showed that the negative association between serological testosterone and the development of arthritis was statistically more significant in older female smokers with comorbidities and body mass index (BMI) values ​​of 30 kg per m2 and above.

    Testosterone and estradiol are natural immunosuppressants that suppress antibody and cell-mediated immunity while acting as anti-inflammatory agents. Because women have more active immunity than men, they play a crucial role in lowering men’s susceptibility to autoimmune diseases.

    The primary androgen, testosterone, binds to specialized intracellular receptors to create active forms of testosterone receptor complexes. Androgen and estrogen receptors are present in both male and female osteoblasts, and testosterone binds to both to regulate bone calcium.

    Decreased testosterone levels can affect cartilage metabolism via ion channels and androgen receptors, resulting in cartilage and KOA breakdown. The activation of androgen receptors (AR) and estrogen receptors (ER) has a profound influence on bone metabolism.

    Testosterone increases the glycosaminoglycan content in the extracellular matrix of the chondrocytes, improves the coverage of type II collagen on the cartilage surface and influences the development of the fibrocartilage structures.

    Low testosterone levels may be the cause of obesity rather than its consequence, with BMI having a causal influence on serum testosterone in the hypothalamic-pituitary-gonadal axis.

    Conclusion

    Overall, the study results indicated that lower levels of serum testosterone were associated with an increased risk of developing arthritis.

    The in-depth investigation of the negative and non-linear association between serological testosterone levels and the development of arthritis was related to BMI and sex.

    The findings could impact the prevention and treatment of arthritis. However, further research is needed to elucidate the mechanisms underlying the impact of serum testosterone on the development of arthritis.

    Source link

  • Study sheds new light on the variety of cellular causes of rheumatoid arthritis

    Study sheds new light on the variety of cellular causes of rheumatoid arthritis

    shutterstock 390538711 6b3c40fdd32742caa54307db3553cab1

    Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation leading to pain, joint damage and disability, affecting approximately 18 million people worldwide. Although RA therapies targeting specific inflammatory pathways have emerged, only some patients’ symptoms improve with treatment, highlighting the need for multiple treatment approaches tailored to different disease subtypes. To more precisely define the cellular causes of RA, an international research consortium, co-led by researchers from the Broad Institute of MIT and Harvard and Brigham and Women’s Hospital, a founding member of the Mass General Brigham health care system, analyzed tissues from RA donors to the at the single-cell level, integrating multiple forms of analysis to stratify RA based on six subtypes of inflammation. Findings, published in Natureshed new light on the variety of cellular causes of RA, which may lead to more targeted, effective and patient-tailored therapeutic approaches.

    “In treating people with rheumatoid arthritis, we struggle to find the right treatment for the right patient,” says corresponding author Soumya Raychaudhuri, MD, PhD, of the Brigham’s Division of Rheumatology, Inflammation and Immunity and the Broad Institute, where he is an institute member. “We wanted to determine why some subgroups of patients do not respond to conventional treatments by looking at the subtypes of inflammation. We did this from many different angles, using multiple advanced, single-cell techniques and by integrating the results in a way that is has not been done before for an inflammatory disease.”

    The study findings represent a major milestone in the Accelerating Medicines Partnership Rheumatoid Arthritis and Systemic Lupus Erythematosus program, a public-private partnership launched in 2014 to advance the understanding of autoimmune diseases at the molecular and cellular levels and identify promising drug targets to identify. Working with researchers and physicians in the US and Britain, the researchers analyzed 79 donor samples of synovial tissue, the inflamed tissue in RA that normally helps soften and support joints. In particular, the researchers examined tissue from patients with new disease and from patients who did not respond to treatment to better identify both the initial causes of RA and those of refractory diseases.

    To ‘deconstruct’ RA pathology at the cellular level, the researchers combined surface protein data and histological analysis with multiple forms of single-cell RNA sequencing and bulk RNA sequencing. Despite the variety of methods used to analyze more than 314,000 cells, the researchers consistently found evidence of six major types of inflammation, which they stratified by associated cell type, called cell type abundance phenotypes (CTAPs). Although some CTAPS, such as those enriched in T and B cells, would be expected to be used for an autoimmune disease like RA, the researchers were surprised to see that CTAPs were associated with structural cells such as fibroblasts and endothelial cells, with relatively few inflammatory leukocytes. They also found that patients’ CTAPs were dynamic and could change over time in response to treatment.

    In the future, the researchers want to expand their knowledge of the cell types involved in RA by studying how interconnections between cells promote disease states. Furthermore, they hope that this work will advance the analysis of synovial tissues in RA patients, which is not currently standard practice. Although blood tests are more common in RA patients, findings from this study and others emphasize that the cellular profile of synovial tissue differs substantially from that of blood.

    What this study shows is that tissue matters. Our findings point to the value of obtaining synovial tissue biopsies to evaluate the nature of the pathological process, which can be so different among patients. Future clinical trials will benefit greatly from assessing tissue characteristics in addition to responses to therapy. By providing this atlas of cell types and pathways involved in RA, we are better able to pursue our goal of precision medicine: being able to select the right drug for the right patient and achieve a high response rate.”


    Michael Brenner, MD, co-senior author, Brigham’s Division of Rheumatology, Inflammation and Immunity

    Source:

    Brigham and Women’s Hospital

    Magazine reference:

    Zhang, F., et al. (2023). Deconstruction of the synovium of rheumatoid arthritis defines inflammatory subtypes. Nature. doi.org/10.1038/s41586-023-06708-y.

    Source link

  • Aclarion Announces Achievement of Goal to Enroll 10 Key Opinion Leaders (KOLs) in Spine Surgery to Support Adoption of Nociscan

    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

    Source link

  • 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

    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

    Source link

  • Your Survival Guide for Cold and Flu Season – Bone Talk

    Your Survival Guide for Cold and Flu Season – Bone Talk

    shutterstock 1868337850

    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.



    Source link

  • AlloSource Announces First Implantation of AceConnex™ Pre-Sutured Fascia Device in Hip Labral Reconstruction Procedure

    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

    rt

    Source link

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.

Source link

  • 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

    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
    https://stratusmedical.com

    SOURCE Stratus Medical

    rt

    Source link

  • The use of TNF inhibitors during pregnancy is not associated with worse fetal or obstetric outcomes

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

    Pregnancy

    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

    Source link

  • 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

    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

    Source link