Author: Mokhtar

  • New Shotel™ medical ankle arthrodesis device significantly improves patient quality of life

    New Shotel™ medical ankle arthrodesis device significantly improves patient quality of life

    Reduces time to weight bearing to two weeks from the current six to eight weeks

    ATLANTA , Nov. 28, 2023 /PRNewswire/ — Shotel Medical today announced its Shotel™ Ankle Arthrodesis Nail System, which utilizes a novel device design for the treatment of end-stage ankle arthritis. It was used for the first time in Florida last month during a procedure in Delray Beach. Two weeks postoperatively, the patient was weight-bearing with the use of a CAM walking shoe, a significant improvement over the six- to eight-week time to weight-bearing offered by traditional ankle arthrodesis systems.

    The patented Shotel Nail System, manufactured and distributed by BioPro Implants, differs from traditional ankle arthrodesis devices because its unique curved design allows for a minimally invasive approach with very small incisions. It is designed to achieve fusion at the tibiotalar joint while allowing unrestricted motion at all other joints. This benefits the patient with faster healing, faster recovery and faster loading. End-stage ankle arthritis is becoming increasingly common and can lead to significant physical disability. There are an estimated 50,000 new cases of ankle arthritis in the US each year1

    “We designed our ankle fusion nail system so that patients have smaller incisions, allowing them to heal faster and function much earlier, giving them a better quality of life. The improvement in time to weight bearing for the patient is meaningful,” said Christopher Weathers, Chief Commercial Officer. “We are pleased to see our Shotel nailing system gaining traction among surgeons across the country. So far, 24 operations have been performed with it.”

    Kevin Palmer, DPM, dual board certified podiatrist from Boca Raton and Delray Beach, FL, who performed the procedure, said, “The patient presented with progressively worsening ankle disease and pre-existing structurally compromised hardware. The new design of the Shotel Nail System gave me confidence that it would be stable and would hold up over the long term. During the procedure, after I removed the patient’s current hardware, the Shotel Nail System was inserted smoothly, with a smaller incision and a much less invasive approach than traditional ankle fusion systems. I also like that it provides multiple layers of compression, which is needed at the fusion site to speed healing.

    “I cannot emphasize enough how important it is that the patient started walking with a CAM walking shoe within two weeks,” added Dr. Palmer added. “This will be a game changer – and life changing – for many patients in the future.”

    For more information about the Shotel™ Ankle Arthrodesis Nailing System or for surgical training, visit www.shotelmedical.com.

    About Shotel Medical
    Shotel Medical is the developer of the Shotel™ Ankle Arthrodesis Nail System, an entirely new device that has the potential to transform patient care and have a significant impact on the healthcare landscape. Developed in collaboration with a team of biomechanical engineers, orthopedic surgeons and industry thought leaders, the device addresses the needs of patients with end-stage ankle arthritis. The unique design allows patients to heal faster, function sooner and improve quality of life compared to current treatment options. Founded in 2017, the company has offices in New Orleans and Atlanta.

    About BioPro
    For more than three decades, BioPro has been at the forefront of orthopedic innovation, focused on improving the lives of patients suffering from orthopedic conditions. The company is committed to developing advanced implants and surgical devices that reduce pain and restore function, providing patients and surgeons with a diverse portfolio of established solutions and emerging technology. For more information, visit https://bioproimplants.com/.

    Media contact:
    Barbara Bikkel
    305-215-2121
    369140@email4pr.com

    ___________________________________
    1 Smyth, Niall A. MD; Dawkins, Brody J.BA; Goldstein, Joshua P.B.S.; Kaplan, Jonathan R. MD; Schon, Lew C. MD; Aiyer, Amiethab A. MD. Consumer prices for surgical treatment of ankle arthritis: limited availability and high variability. JAAOS: Global Research and Reviews 3(7):p e011, July 2019. | DOI: 10.5435/JAAOSGlobal-D-19-00011

    SOURCE Shotel Medical

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  • DISC Surgery Center in Newport Beach is now enrolling patients in a clinical trial of artificial disc replacement

    DISC Surgery Center in Newport Beach is now enrolling patients in a clinical trial of artificial disc replacement

    Drs. Ali H. Mesiwala and Grant D. Shifflett participate in the pivotal two-level study of the safety and effectiveness of the Orthofix M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion.

    NEWPORT BEACH, Calif., Nov. 28, 2023 /PRNewswire/ – DISC Surgery Center of Newport Beach (“DISC”), committed to supporting research vital to the field of spine care, has announced its participation in a clinical trial to artificial disc replacement and is now enrolling qualified patients. Candidates may include patients between the ages of 18 and 75 who have been told they need cervical (neck) surgery at two consecutive levels (among other requirements).

    Drs. Ali H. Mesiwala and Grant D. Shifflett – both board-certified, fellowship-trained spine surgeons at DISC – join other experts at approximately 30 clinical sites participating in this study across the country. The primary objective of the study is to evaluate the safety and effectiveness of the Orthofix M6-C™ artificial cervical disc (already FDA-approved for single-level surgery) in patients with contiguous symptomatic bilevel cervical radiculopathy, with or without umbilical cord compression. The results will then be compared with those in patients undergoing anterior cervical discectomy and fusion (ACDF).

    Artificial disc replacement surgery is very similar to ACDF surgery. Both procedures remove the damaged disk. However, when the damaged disc is removed to replace the disc, the space between the vertebrae is filled with a specialized implant called an artificial disc, instead of a bone graft. The artificial disc is designed to restore the distance between the vertebrae while still allowing some movement.

    With its track record as a national leader in outpatient spine and its team’s extensive experience performing advanced motion maintenance techniques, DISC is ideally positioned to participate in such research.

    “The DISC Surgery Center in Newport Beach has placed more than 3,000 cervical discs since 2018 and we are well versed in the motion-preserving qualities of the surgery,” said Dr. Mesiwala. “I think it is important to stay actively involved in research to improve patient care, so I wanted to be part of a study that will improve our learnings and discoveries.”

    Dr. Shifflett added, “As pioneers in minimally invasive spine surgery and techniques, we always welcome the opportunity to advance the field while informing the treatment options available to patients.”

    Patients who would like to know if they are eligible for this study can visit https://www.discmdgroup.com/adr-clinical-study/.

    About DISC Surgery Center in Newport Beach
    DISC Surgery Center in Newport Beach is a purpose-built outpatient clinic focused on providing patients with the safest, most advanced minimally invasive spine surgery, orthopedic sports medicine, total joint replacement and pain management. DISC is a subsidiary of TriasMD, a portfolio company of Chicago Pacific Founders, and also an official partner of Red Bull Athlete Performance Center. For more information, call 949-988-7800, visit www.discmdgroup.com or follow @DISCMD on Instagram.

    Media contact:
    Kristien Brada-Thompson
    760-274-6393
    369218@email4pr.com

    SOURCE DISC Sports and Spine Center

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  • Non-arthritic hip pain with Keelan Enseki

    Non-arthritic hip pain with Keelan Enseki

    Hip pain is common in athletes, especially in sports such as ice hockey.

    Non-arthritic hip pain includes a variety of intra-articular diagnoses commonly seen in these athletes that are not directly related to osteoarthritis. These include dysplasia, bony changes, femoroacetabular impingement, labral tears, and more.

    A recent clinical practice guideline on this topic was published in JOSPT to help us. In this episode, I talk to the lead author, Keelan Enseki, about the CPG findings.

    Show notes

    Keelan works at the Rooney Center for Sports Medicine at the University of Pittsburgh Medical Center. He currently serves as director of clinical practice innovation and administrative director of physical therapy residency programs. Keelan is also an adjunct professor at the University of Pittsburgh. In these roles, he divides time between clinical practice, teaching, research/writing, and clinical program design. His clinical interests focus on the nonoperative and postoperative care of individuals with injuries to the hip region. These interests are also represented through collaboration with the Orthopedic and Sports Physiotherapy Academies and the International Society of Hip Arthroscopy (ISHA).

    Social tools for COS:
    – Instagram: @keelan_enseki



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  • Aclarion announces major commercial milestone with completion of 1,000 Nociscan exams

    Aclarion announces major commercial milestone with completion of 1,000 Nociscan exams

    Nociscan orders accelerated 2.5x for the last 250 scans compared to the first 250 scans

    Further acceleration in scan volumes is expected as MRIs are activated for the recently completed panel of 10 Key Opinion Leader (KOL) surgeons

    All commercial Nociscans to date have been completed on Siemens MRI scanners, with additional acceleration in volumes expected as Philips scanners come on board

    BROOMFIELD, CO, November 27, 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 it has completed 1,000 commercial Nociscan studies.

    “This milestone in itself is significant, but the pace of our commercial adoption is the most exciting aspect of reaching 1,000 commercial scans,” said Brent Ness, CEO of Aclarion. “For context, 36% of these 1,000 studies were conducted in the last twelve months, demonstrating the adoption our strategy has delivered on our journey to a standard of care. As more imaging locations are added and KOLs continue to access Nociscan, we expect to reach the 2,000 scans milestone even faster.”

    “This achievement reinforces Aclarion’s clear leadership in the evolving field of augmented intelligence and the renaissance in MR spectroscopy,” said Ryan Bond, Chief Strategy Officer at Aclarion. “Nociscan is the first of its kind, evidence-based SaaS platform that turns volumes of complex data into a clear, streamlined report that efficiently communicates individualized biomarker data to help physicians optimize treatment strategies for patients suffering from chronic low back pain. This is an important commercial milestone for our physician customers, their patients and our team.”

    Worldwide, 266 million people suffer from degenerative spinal disorders and lower back pain1. Conventional imaging and diagnostics provide valuable structural information but struggle to identify the source of the pathogenic pain. Low surgical success rates (41-57%)2.3 especially for patients suffering from discogenic chronic low back pain (DCLP). Of all disease conditions, low back and neck pain are responsible for the highest healthcare expenditures in the US1.

    Aclarion’s disruptive innovation, Nociscan, emerged over a decade of development. Aclarion’s patent portfolio includes 22 U.S. patents, 17 international patents, 6 pending U.S. patent applications and 7 pending international patent applications, including patents and patent applications exclusively licensed by Regents of the University of California.

    Nociscan is currently available from imaging facilities using select models of Siemens 1.5T and 3T magnetic resonance spectroscopy. For more information please contact info@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 Annual Report on Form 10-K for the year ended December 31, 2022, as well as other disclosures 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

    [1] Ravindra VM, Global Spine Journal (2018) 8(8): 784-794
    [2] Wei J, Song Y, et al. Comparison of artificial total disc replacement versus fusion for lumbar disc disease: a meta-analysis of randomized controlled trials. Int Orthop. 2013; 37(7):1315-1325
    [3] 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

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  • Researchers develop $1 cancer treatment using engineered bacteria

    Researchers develop $1 cancer treatment using engineered bacteria

    bacteria Sebastian Kaulitzki 46826fb7971649bfaca04a9b4cef3309

    What if a single dollar dose could cure cancer?

    A multi-university team of researchers, supported by federal funding, is developing a highly efficient bacterial therapeutic to target cancer more precisely and make treatment safer via a single $1 dose.

    Traditionally, cancer therapies have been limited in their effectiveness in treating patients. Some, such as radiation and chemotherapy, cause harmful side effects, while others tend to result in low patient responsiveness, not to mention the expense required to receive treatment. Findings from the American Cancer Society’s Cancer Action Network show that 73% of cancer survivors and patients worried about how they would pay for their cancer care, and 51% said they had medical debt due to treatment. For example, state-of-the-art cancer therapy can cost up to $1,000,000.

    Texas A&M University and the University of Missouri are leading the effort to develop a low-cost, safe and controlled cancer treatment. Researchers received a $20 million grant from the Advanced Research Projects Agency for Health (ARPA-H) to fight cancer. The four-year project is part of the current administration’s Cancer Moonshot initiative, an effort to promote and increase funding for cancer research. It is one of the first projects funded by the newly created agency, which aims to accelerate better health outcomes for all by supporting the development of high-impact solutions to society’s most challenging health problems.

    Quickly analyze cells

    $12 million of the grant will go to the Texas A&M Engineering Experiment Station/Texas A&M, where co-principal investigators Drs. Arum Han, Jim Song, and Chelsea Hu develop synthetic programmable bacteria for immune-targeted killing in tumor environments (SPIKEs). The idea is to develop bacteria that help T cells kill cancerous tissue, destroy themselves once the cancer is gone, and leave the body safely as human waste.

    SPIKEs can specifically target tumor cells. And because it only targets cancerous tissue and not the surrounding healthy cells, patient safety is increased exponentially. It is a great honor to be on this team and tackle a major health problem that affects many people.”


    Arum Han, the Texas Instruments professor in the Department of Electrical and Computer Engineering

    Han’s laboratory develops high-throughput microfluidic systems that can rapidly process and screen vast bacterial therapeutic libraries, cell by cell, to quickly identify the most promising treatments. These systems are made possible by integrating microfabrication methods and biotechnology to realize a picoliter volume liquid handling system that can accurately analyze single cells with high precision and high speeds, creating devices to rapidly analyze individual cells.

    “The biggest challenge is figuring out how to actually develop these advanced microdevices that allow us to run millions and millions of fully automated tests without manual or human intervention,” Han said. “That’s the technical challenge.”

    Rescuing anti-tumor immune cells

    While Han innovates and designs microdevices, Song -; an immunologist with a background in microbial pathogenesis, T cell biology and T cell-based immunotherapy -; has been working on immunotherapy against bacteria for the past five years. A certain bacteria known as Brucella melitensis can manipulate the human body microenvironment and promote T cell-mediated anti-tumor immunity to treat at least four types of cancer.

    “We are working on improvement Brucella melitensis to more efficiently prevent or suppress tumor growth,” said Song, a professor at Texas A&M School of Medicine. “Our current approach involves figuring out how to engineer bacteria to rescue anti-tumor immune cells, thereby increasing their effectiveness in killing tumor cells.

    ‘That is evident from the data so far BrucellaIts efficiency is dramatically higher than that of other cancer treatments, such as chimeric antigen receptor T-cell therapy and T-cell receptor therapies, with a responsiveness of more than 70%,” said Song.

    Safe and controllable therapies

    While Song continues to test the bacteria’s efficiency using cancer models, Hu, an assistant professor in the Artie McFerrin Department of Chemical Engineering and a synthetic biologist, is working to ensure the live bacterial therapy is safe and controllable.

    “The Brucella The strain we use has been shown to be safe for the hosts because it is an attenuated version, meaning an important gene necessary for bacterial virulence has been deleted,” Hu said. Ultimately, we want to control the speed of the bacteria. growth, where it grows within the tumor environment, and its ability to self-destruct when its mission is complete.”

    To control growth rates, the bacteria’s genes will be adjusted to regulate the population and oscillate around a specific set point. Hu also plans to build biosensors into the bacteria, allowing them to distinguish between healthy tissue and tumor tissue, to ensure they grow only within the tumor microenvironment.

    The bacterium will be engineered to have a receptor that ensures that once the cancer is gone, the patient can take antibiotics that signal the bacterium to cut itself up and be safely removed from the patient’s body.

    “As humans, we are actually covered in bacteria, and many diseases are caused by an imbalance in these bacterial communities,” Hu said. “For example, while some people have incredibly fragile stomachs, others have robust stomachs. The science behind this is that people with a strong immune system and digestive system have a healthy community of bacterial cells in their intestines. There is a lot of potential in living therapies. .”

    “It’s really a great opportunity to have an incredible team that has expertise and can push this technology to the front lines,” Hu said. “So that kind of goal is to reach the clinic and provide patients with effective cancer treatment for less than $1 per dose.”

    Tackling difficult issues using unconventional approaches

    Other collaborators include Dr. Zhilei Chen of the Texas A&M Health Science Center and Dr. Xiaoning Qian of the Department of Electrical and Computer Engineering, along with the principal investigator, Dr. Paul de Figueiredo, of Missouri University.

    “The three main advantages of this work are high safety, low cost and specific targeting of cancer tumors,” Han said. “We are very excited to be one of the first teams to receive support from ARPA-H, a brand new agency created and supported by Congress to really tackle tough problems across broad areas of healthcare. We attack difficult problems. problems using unconventional approaches. High risk and high impact is the hallmark of our approach.”

    And the future applications of technical bacteria that this research opens up are limitless.

    For our next big project, we will work together to develop bacteria against autoimmune diseases such as type 1 diabetes and rheumatoid arthritis,” Song said. Bacteria-based immunotherapy represents a groundbreaking frontier in medicine and offers the potential to revolutionize the treatment of autoimmune diseases. Now that we have harnessed the power of beneficial microbes to modulate the immune system, we are about to change the future of medicine. Our research and expertise hold the promise of transforming the lives of millions of people, offering them new hope and a healthier future.”

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  • Stronger thigh muscles can prevent knee replacement surgery

    Stronger thigh muscles can prevent knee replacement surgery

    CHICAGO, Nov. 27, 2023 /PRNewswire/ — Stronger quadriceps muscles, compared to the hamstrings, may lower the risk of total knee replacement, according to research presented today at the annual meeting of the Radiological Society of North America (RSNA). Researchers said the findings could inform strength training programs for people with advanced knee arthritis.

    Advanced knee osteoarthritis is a leading cause of pain and disability worldwide. In the US alone, 14 million adults have symptomatic knee osteoarthritis, and more than half of diagnosed patients are expected to eventually undergo total knee replacement surgery.

    Although stronger muscle groups are generally thought to be associated with a lower rate of total knee replacements, their relative importance is not well established. Of particular importance is the relationship between the extensors and the hamstrings, the two main muscle groups in the knee.

    The extensors, the muscles at the front of the thigh, commonly called the quadriceps, are the strongest muscle group in the body and have a vital influence on walking, other activities and biomechanics. The muscles around the back of the thigh, known as the hamstrings, are responsible for the extension of the hip and flexion of the knee, making them equally essential for physical activity.

    “The two muscle groups act as opposing forces, and the balance between them allows for a wide range of activities while protecting the knee joint,” says lead study author Upasana Upadhyay Bharadwaj, MD, of the University of California, San Francisco (UCSF). “An imbalance, among other factors, leads to a change in biomechanics, resulting in the progression of osteoarthritis.”

    Dr. Upadhyay Bharadwaj and colleagues evaluated thigh muscle volume in 134 participants in the Osteoarthritis Initiative, a nationwide study sponsored by the National Institutes of Health. They compared 67 patients who underwent total knee replacement of one knee with 67 control participants who did not undergo knee replacement. The cases and controls were matched on variables such as age and gender.

    The researchers obtained 3T MRI of the thigh at the time of surgery. They also evaluated MRI findings two years and four years before surgery. They used a previously trained deep learning model to segment and calculate the volumes of the muscles of the thigh – measurements that are difficult to calculate manually.

    When comparing patients who had undergone total knee replacement with the control group, a higher ratio of quadriceps to hamstring volume was significantly associated with a lower likelihood of total knee replacement. Higher hamstring and gracilis volumes, a long, thin muscle on the inside of the thigh, were also associated with a lower likelihood of total knee replacement.

    “Our research shows that in addition to strong individual muscles, larger extensor muscle groups – compared to hamstring muscle groups – are significantly associated with a lower likelihood of total knee replacement surgery within two to four years,” said Dr. Upadhyay Bharadwaj.

    The study results have implications for both the interpretation of imaging studies and clinical management. The results suggest that training programs that strengthen the quadriceps in relation to the hamstrings may be beneficial.

    “Although we assume that total muscle volume is important as a surrogate marker of muscle strength, the relationship, and therefore balance, between the extensor and hamstring muscles may be more important and significantly associated with a lower likelihood of total knee replacement,” Dr. Upadhyay Bharadwaj said.

    Although the study focused on people with arthritis, the findings could also help inform strength training for a broader segment of the population.

    “While these results are essential for targeted therapy in a population at risk for osteoarthritis, even the general public can benefit from our results by preventively incorporating appropriate strengthening exercises,” said Dr. Upadhyay Bharadwaj.

    Co-authors are John A. Lynch, Ph.D., Gabby B. Joseph, Ph.D., and Thomas M. Link, MD, Ph.D.

    Note: Copies of RSNA 2023 news releases and electronic images will be available online at RSNA.org/press23.

    RSNA is an association of radiologists, radiation oncologists, medical physicists and related scientists who promote excellence in patient care and health care through education, research and technological innovation. The association is located in Oak Brook, Illinois. (RSNA.org)

    Editor’s note: The data in these publications may differ from the data in the published abstract and the data actually presented at the meeting, as researchers continue to update their data up until the meeting. To ensure you are using the most current information, please call the RSNA Newsroom at 1-312-791-6610.

    For patient-friendly information about musculoskeletal imaging, please visit RadiologyInfo.org.

    SOURCE Radiological Society of North America (RSNA)

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  • MCRA Announces Launch of Integrated AI & Imaging Center

    MCRA Announces Launch of Integrated AI & Imaging Center

    Led by former FDA Imaging Experts, MCRA AI & Imaging Center is the first and only integrated solution covering the medical device lifecycle with 24/7 customer support

    WASHINGTON , Nov. 27, 2023 /PRNewswire/ — MCRA, the leading private independent Clinical Research Organization (CRO) and medical device, diagnostics and biologics consulting firm, is pleased to announce the launch of its AI & Imaging Center, the first and only integrated solution, led by former FDA imaging experts, covering the entire medical device lifecycle.

    MCRA’s AI & Imaging Center is designed to better meet the emerging and complex needs of imaging technologies. By combining innovation, expertise and speed, we accelerate customers’ AI/ML needs faster and more efficiently.

    Led by former FDA regulatory and imaging experts, the Integrated AI & Imaging Center provides critical services to medical device customers developing AI/ML-enabled devices and new imaging technologies. The AI ​​& Imaging Center works with an extensive network of radiologists and specialists to provide world-class diagnostic and therapeutic imaging laboratory services.

    MCRA’s AI & Imaging Center services address the entire lifecycle of medical device studies, including regulatory support, study design and design, data collection and aggregation, expert recruitment and training, statistical analyses, performance testing, and project and data management . MCRA’s AI & Imaging Center has already provided services ranging from protocol development to study execution and regulatory submissions for more than 50 imaging clients. As a fully integrated solution, MCRA AI & Imaging Center uses proven zero-print, advanced image analysis and data management software with 24/7 support for customers and network specialists.

    Alex Cadotte, Ph.D., Senior Director, Digital Health and Imaging Regulatory Affairs, said: “As the only fully integrated AI & Imaging Center, our value lies in the expertise of our team, which consists of former FDA experts who have navigated the regulatory landscape to understand. and clinical processes. Our value proposition is to ensure that the study is designed and conducted in a manner that meets FDA expectations and ultimately reduces time to market by conducting the right study the first time.”

    MCRA is excited to continue advancing imaging and digital health innovation in the medical device industry by helping customers navigate the evolving AI/ML imaging landscape. Read more about the MCRA AI & Imaging Center here.

    MCRA customer Richie Christian, Head of Regulatory and Quality at Formus Labs says: “The MCRA AI & Imaging Center has provided our technologies with real insights into how the FDA thinks about best practices for AI MedTech. This deep insight allowed us to be more innovative and deliver a best-in-class product to the AI ​​marketplace.”

    Anthony Viscogliosi, CEO of MCRA said: “The MCRA AI & Imaging Center truly integrates our deep regulatory experience with clinical trial execution, technology and performance testing. This new addition to MCRA will only allow us to improve our customers’ success throughout the entire product lifecycle, with a focus on the main goal: FDA approval.”

    About MCRA, LLC: MCRA is the leading private, independent clinical research organization (CRO) and consulting firm for medical devices, diagnostics and biologics. MCRA delivers its client’s industry experience and integrates its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to deliver a dynamic, market-leading effort from concept of innovation to commercialization . MCRA’s integrated application of these key value-creating initiatives provides unparalleled value to its customers. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 customers worldwide. Key areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dentistry, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery. urology and in vitro diagnostic (IVD) devices. www.mcra.com

    About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. Headquartered in New York City, VB specializes in financing venture capital, private equity and investment banking activities for the neuromusculoskeletal industry. VB is committed to financing healthcare innovation. www.vbllc.com

    For more information please contact:
    Erinn Grable, business development manager
    Phone: 202.552.5821 | Email: egrable@mcra.com

    SOURCE MCRA, LLC

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  • SECRE technology paves the way for new therapies for autoimmune diseases

    SECRE technology paves the way for new therapies for autoimmune diseases

    shutterstock 390538711 6b3c40fdd32742caa54307db3553cab1

    Scientists have developed a potentially transformative new technique that could help in the discovery and development of new therapies for a number of globally prevalent autoimmune diseases.

    Conditions such as lupus, rheumatoid arthritis and inflammatory bowel disease (IBD) – as well as malfunctions in transplanted cells – are all caused by altered cytokine secretion from immune cells in the human body.

    To find treatments for such diseases, experts must identify the genetic regulators of secretion so they can explore the most effective ways to inhibit them.

    An international team of researchers has developed a new method called Secretion-Enabled Cell Ranking and Enrichment (SECRE), which is detailed in a study published in Nature Biomedical Technology.

    They have shown that the method is accurate in sorting hundreds of millions of CRISPR-edited cells based on their secretion patterns, and in identifying the genetic regulators of cytokine secretion in an autoimmune disease. In addition, the method takes into account the detailed profiles of approved treatments and treatments in development to determine whether pre-existing therapies can be repurposed in new ways.

    In the study, the researchers describe how they validated their approach against the cells known to play an essential role in the development and severity of IBD, and how they proved that this approach has the potential to find new ways to treat conditions that affect millions of people worldwide. .

    The research is the result of a project lasting about four years between scientists from Great Britain, the United States and Canada, leading experts in the field of developing new tools for the diagnosis and treatment of diseases, led by Professor Shana Kelley, chairman of the Chan-Zuckerberg Institute and professor at Northwestern University.

    This is an incredibly new approach that has the potential to deliver enormous benefits to patients, doctors and pharmaceutical companies working to develop new treatments. It gives us the opportunity to sort large numbers of cells based on their secretion patterns and identify therapeutic targets that can be applied to help people with conditions for which few therapeutic options currently exist. “Through our existing work we have shown that it has the potential to help identify ways to treat various autoimmune diseases, but my work is now also expanding to types of cancer, including some of the most aggressive types of brain tumors.”


    Dr. Mahmoud Labib, a lecturer at the Peninsula Medical School of the University of Plymouth, and the key inventor of the approach

    A possible treatment for inflammatory bowel disease?

    Inflammatory bowel disease (IBD) is a long-term health condition estimated to affect approximately 7 million people worldwide. It is characterized by chronic inflammation of the digestive tract, which can result in severe abdominal pain and diarrhea, and there is currently no known cure.

    As part of their work to validate their approach, the researchers examined the effect of various kinase inhibitors on CD4+ T cells, which are known to produce interferon-gamma, a protein widely implicated in several autoimmune diseases, including IBD. The inhibitors studied included XMU-MP1, a small molecule previously studied as a treatment for heart failure, hair loss and a number of other medical conditions.

    In this case, the researchers used XMU-MP1 to treat mice with a form of colitis that has a similar cell secretion profile to that in people with IBD. They found that the mice experienced significantly less weight loss and reduced symptoms of colitis, while their colons appeared almost normal and showed no significant loss of intestinal stem cells.

    Based on these findings, the researchers say their results suggest that using XMU-MP1 as a means to inhibit the production of interferon-gamma in the intestines may be an ideal means of controlling IBD. They also say it offers a promising future strategy for the therapeutic molecular targeting of the condition, although extensive clinical trials would be needed before it could be considered as a treatment.

    How the SECRE technique works

    The Secretion-Enabled Cell Ranking and Enrichment (SECRE) technique captures the secreted cytokine on the surface of the cell. These cytokines are then labeled with magnetic nanoparticles and sorted at high resolution in a microfluidic device fabricated using scaled three-dimensional printing.

    The SECRE technique allows rapid and rapid sorting of cells based on their secretion patterns, making it amenable to large-scale functional genetic screening. This approach also links the functional signature of the cell to its phenotype, allowing selective sorting of specific subsets of immune cells based on specific cell surface markers and the secretion-specific factors.

    Source:

    Magazine reference:

    Labib, M., et al. (2023). Identification of druggable regulators of cell secretion via a kinome-wide screen and high-throughput immunomagnetic cell sorting. Nature Biomedical Technology. doi.org/10.1038/s41551-023-01135-w.

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  • Stratasys is collaborating with Siemens Healthineers in a Landmark Research Project to advance medical imaging

    Stratasys is collaborating with Siemens Healthineers in a Landmark Research Project to advance medical imaging

    The use of 3D printing can improve outcomes by providing 3D modeling to physicians with real-world scenarios to practice and reference.

    EDEN PRAIRIE, Minnesota & REHOVOT, Israel, November 27, 2023–(BUSINESS WIRE)–Stratasys Ltd. (NASDAQ: SSYS), a leader in polymer 3D printing and additive manufacturing solutions, today announced it is partnering with Siemens Healthineers to conduct a groundbreaking research project designed to develop new state-of-the-art solutions develop for the advancement of medical imaging phantoms for computed tomography (CT) imaging.

    CT phantoms are a crucial tool in medical imaging and a nearly universal resource in hospitals around the world. They are specialized devices used to evaluate and ensure the performance of CT scanners. Phantoms are designed to simulate certain characteristics of the human body and enable the assessment of several key metrics, including radiation dose and image quality, facilitating calibration and ensuring consistent scanner performance. The joint development uses Stratasys’ PolyJet™ technology in combination with Siemens Healthineers’ unique RadioMatrix™ technology and advanced algorithm, aimed at translating scanned patient images into specific radiopacity material characteristics of the human anatomy. The solution enables custom phantom production and the creation of ultra-realistic human anatomy characteristics with complete radiographic accuracy of patient-specific pathology that was previously not possible.

    This joint project will transform the way phantoms can be used in the medical field, and in some cases even allow device manufacturers and academic institutions to replace human cadavers with 3D printed structures. Having this capability enables critical efficiency and minimizes unavoidable human variability. This work will also generate a critical amount of research data, providing important insights for advancing CT system algorithms, driving materials development and unlocking potential new application areas – and identifying future research opportunities.

    “The current limitations of phantoms have long been a challenge for the radiology community,” said Erez Ben Zvi, Vice President of Medical at Stratasys. “This collaboration with Siemens Healthineers will allow us to jointly explore the tremendous potential of our radiopaque materials and 3D printing technologies to overcome these barriers.”

    Starting with the production of 3D printed phantoms for smaller scale anatomies of the head and neck region, the research will include the production of increasingly larger and more complex anatomies – leading to the Phase One endpoint of 3D printing a heart model and a complete human torso with full radiographic accuracy.

    “The knowledge gained from this project represents a breakthrough in medical imaging that will open new possibilities for 3D printing and imaging applications,” said Lampros Theodorakis, Head of Computed Tomography Product & Clinical Marketing at Siemens Healthineers. “We are excited about the opportunities that await us as a result of this collaboration and believe it will have long-term implications for medical and academic applications.”

    About Stratasys

    Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products, healthcare, fashion and education. Through smart and connected 3D printers, polymer materials, a software ecosystem and on-demand parts, Stratasys solutions deliver competitive advantages at every stage of the product value chain. The world’s leading organizations turn to Stratasys to transform product design, make manufacturing and supply chains more agile, and improve patient care.

    For more information about Stratasys, visit www.stratasys.com, the Stratasys blog, X/Twitter, LinkedIn or Facebook. Stratasys reserves the right to use any of the foregoing social media platforms, including the Company’s websites, to share material, non-public information pursuant to the SEC’s Regulation FD. To the extent necessary and required by applicable law, Stratasys will also include such information in its public disclosure filings.

    Note to editors: High-resolution images and additional information are available upon request from the appropriate media contacts listed.

    Contacts

    Investor and media contacts

    Stratasys Business &
    North America
    Chris Reese
    chris.reese@stratasys.com
    +1 6651 357 0877

    Investor Relations
    Jonah Lloyd
    Yonah.Lloyd@stratasys.com
    +972 74 745 4919

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    Jonathan Wake / Samantha White,
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    Stratasys Corporate & Israel
    Erik Snider
    Erik.Snider@stratasys.com
    +972 74 745 6053

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    Kalyani Dwivedi
    Kalyani.Dwivedi@stratasys.com
    +91 80 6746 2606



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