Knee Hurt

Author: Mokhtar

  • Bone Biologics Announces Closing of Registered Direct Offering at Market Prices Under Nasdaq Rules

    Bone Biologics Announces Closing of Registered Direct Offering at Market Prices Under Nasdaq Rules

    Bone Biologics 79

    BURLINGTON, Mass., November 20, 2023–(BUSINESS WIRE)–Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiology products for the spine fusion markets, today announced the closing of its previously announced registered direct offering at market-based prices under Nasdaq rules of an aggregate of 1,139,063 shares of its common stock at a purchase price of $0.64 per share. In a concurrent private placement, the Company also issued and sold unregistered warrants to purchase an aggregate of 1,139,063 shares of common stock. The unregistered warrants have an exercise price of $0.52 per share and are exercisable upon issuance and have a term of five and a half years from the date of issuance.

    HC Wainwright & Co. acted as exclusive placement agent for the offering.

    The gross proceeds to Bone Biologics from the offering were approximately $729,000, before deducting placement agent fees and other offering expenses payable by the Company. Bone Biologics currently intends to use the net proceeds from the offering to fund clinical trials, maintain and expand its patent portfolio and for working capital and other general corporate purposes.

    The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) were offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (Registration No. 333-265872), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on June 28, 2022 and declared effective by the SEC on 11 July 2022. The offering of the common shares issued in connection with the registered direct offering was made only by means of a prospectus supplement forming part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the registered direct offering have been filed with the SEC and are available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained by contacting HC Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or email to placements@hcwco.com.

    The offer and sale of the unregistered warrants in the private placement were made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “ Securities Act “) and/or Rule 506(b) of Regulation D promulgated thereunder and, together with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or the applicable state securities laws. Accordingly, the unregistered warrants offered in the private placement and the underlying common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable government bonds. securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration. or qualification under the securities laws of any such state or jurisdiction.

    About bone biology

    Bone Biologics was founded to pursue regenerative medicine for bones. The company is working with select strategic partners that will build on the preclinical research on the Nell-1 protein. Bone Biologics is currently focusing its development efforts for its bone graft replacement product on bone regeneration in spinal fusion procedures, while also having rights to applications in trauma and osteoporosis. For more information, please visit www.bonebiologics.com.

    Forward-Looking Statements

    Certain statements in this press release, including but not limited to the expected use of proceeds from the offering, as well as statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements.” statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and factors including the Company’s ability to deliver our flagship product to develop NELL-1. and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain necessary financing to develop products and conduct necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval for commercialize any product it may develop in the United States and to obtain any other regulatory approval necessary to market a product in other countries, its ability to commercialize any product it may develop market, its ability to create, sustain, manage or predict its growth; the ability to attract and retain key personnel; changes in the company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized development company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the The Company’s Form S-1, Form 10-K for the year ended December 31, 2022, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

    Contacts

    LHA Investor Relations
    Kim Sutton Golodetz
    212-838-3777
    kgolodetz@lhai.com

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  • Ginger Collagen Latte | GF, DF | BoneCoach™ Recipes – BoneCoach™

    Ginger Collagen Latte | GF, DF | BoneCoach™ Recipes – BoneCoach™

    Craving a comforting drink that’s perfect for any season?

    Try this!

    Our Ginger Collagen Latte recipe is a soothing drink that combines the warmth of a traditional ginger latte with the added benefits of collagen.

    Ginger may be beneficial for digestion, while collagen promotes skin elasticity and joint and bone health.

    Treat yourself to a cup of our Ginger Collagen Latte recipe today!

    Bone Coach Recipes | Ginger Collagen Latte | Bone loss Bone Healthy diet Nutrients Osteoporosis

    SERVES: 1

    TOTAL TIME: 5 minutes

    Ingredients

    1 1/2-inch piece fresh ginger, peeled and broken

    1 cup (250 ml) water

    1 scoop (26 g) collagen peptides

    1/4 teaspoon (1 ml) ground Ceylon cinnamon

    1-2 drops monk fruit sweetener

    1/2 cup (250 ml) non-dairy milk of your choice

    Directions

    1) Mix the ginger and water in a small pot. Bring to the boil and let it simmer for another 10 minutes. Remove the ginger root and whisk in the collagen, cinnamon and monk fruit.

    2) Froth the milk and pour the ginger tea over it. Sprinkle with extra Ceylon cinnamon and enjoy!

    Recipe created by BoneCoach™ Team Dietitian Amanda Natividad-Li, RD & Chef.

    Medical disclaimer

    The information shared above is for informational purposes only and is not intended as medical or nutritional therapy advice; it does not diagnose, treat or cure any disease or condition; it should not be used as a substitute or substitute for medical advice from physicians and trained medical professionals. If you are under the care of a healthcare professional or are currently taking prescription medications, you should discuss any changes in your diet and lifestyle or possible use of nutritional supplements with your doctor. You should not stop prescribed medications without first consulting your doctor.

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  • Exactech AI platform surpasses 100,000 joint replacement surgeries worldwide

    Exactech AI platform surpasses 100,000 joint replacement surgeries worldwide

    GAINESVILLE, Fla., Nov. 20, 2023–(BUSINESS WIRE)–Exactech, a developer and manufacturer of innovative implants, instrumentation and smart technologies for joint replacement surgery, today announced that its Active Intelligence® (AI) platform has a total of more than 100,000 exceeded joint replacement surgeries around the world.

    “We are proud to reach this incredible milestone of more than 100,000 patients with the support of our surgeon partners worldwide,” said Darin Johnson, CEO of Exactech. “As a leader in orthopedic innovations, Exactech is focused on pushing technological boundaries to deliver a best-in-class platform of enabling technologies and smart solutions. With a commitment to research and transformative technologies, such as a first-to-market surgical guidance system, machine learning-based tools and personalized planning solutions, we are delivering on our vision to unlock data insights through platform-independent, economical innovations that improve clinical outcomes .”

    Active Intelligence was launched in 2021 as a dynamic ecosystem of enabling technologies and smart solutions that provides unparalleled support to surgeons in and outside the operating room. With powerful scheduling software, prediction tools, disruptive surgical technologies and engagement capabilities, Exactech AI provides surgeons with data-rich, low-cost solutions that help improve patient outcomes.

    Some notable achievements of Exactech AI include:

    • Informed by the collective intelligence of thousands of surgeries, powerful tools have enabled more than 2,500 personalized patient predictions by more than 450 surgeons around the world.
    • Personalized preoperative planning software, expanded globally this year, allows surgeons to plan the placement of shoulder components and select implants and sizes for the scapula and humerus based on each patient’s specific anatomy.
    • At no capital cost, more than 500 GPS stations are used by thousands of surgeons in hospitals and ASC centers around the world, and in nearly half of Exactech shoulder cases.
    • Modern alignment philosophies are supported by our ligament-controlled Newton Knee platform, now used in more than half of our guided, personalized knee surgeries.
    • A unique clinical exchange app connects all Exactech surgeons worldwide.

    For more information, visit www.ExactechAI.com.

    ExactechGPS, Equinoxe Planning App and Predict+ are developed by Blue Ortho, a subsidiary of Exactech, and distributed by Exactech, Inc.

    About Exactech

    Exactech is a global medical device company that develops and markets orthopedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies for hospitals and physicians. Headquartered in Gainesville, Florida, Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, Vumedi, YouTube, Instagram and Tweet. With Exactech by your side you have EXACTLY what you need.

    Contacts

    Courtney Adkins
    Director of Marketing Communications
    media@exac.com

    Photo: Business Wire



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  • The effectiveness of phase I cardiac rehabilitation training based on augmented reality on the self-efficacy of patients undergoing coronary artery bypass surgery: a randomized clinical trial | BMC Sports sciences, medicine and rehabilitation

    The effectiveness of phase I cardiac rehabilitation training based on augmented reality on the self-efficacy of patients undergoing coronary artery bypass surgery: a randomized clinical trial | BMC Sports sciences, medicine and rehabilitation

    Trial design

    This controlled pilot clinical study involved 60 patients admitted to Ghaem Hospital of Mashhad, Iran. These patients were specifically from the cardiac surgery intensive care unit and were admitted between May 2020 and January 2021 (Figure 1).

    figure 1
    Figure 1

    CONSORT Flowchart of participants

    Attendees

    The study included patients who met specific inclusion criteria. These criteria required that patients be between 18 and 60 years old and willing to undergo non-emergency coronary transplant surgery. On the other hand, the exclusion criteria included patients who experienced loss of consciousness until the day after surgery, those who did not have a smartphone, individuals with severe postoperative arrhythmias and hemodynamic disorders, and patients who were prohibited by their physicians from participating in rehabilitation.

    Intervention

    Software production

    Prior to the design of the software, extensive research was done to prepare its contents. This involved reviewing various texts, including articles, reference works, and gathering insights from experienced nurses in specialist care units. The content was then submitted to a panel of ten specialists for validation, and their suggested revisions were incorporated.

    The software’s educational content covered a range of topics, including breathing and diaphragm exercises, instructions on physical exercises and their proper performance, discussions and interactions with patients, and encouragement for patients to participate in routine activities. These concepts were presented primarily through instructional videos and engaging animations.

    Once the content was ready, it was handed over to the software development and information technology team for creating the software. After the initial software was developed, a specialized validation process was carried out by ten IT experts to ensure its functionality and effectiveness.

    To validate the software, both white-box and black-box testing methods were used. In black-box testing, users without knowledge of the software’s internal structure enter the desired items and verify the recorded information. The purpose is to ensure accurate data recording. White-box testing, on the other hand, requires users to have knowledge of the software’s internal structure and is typically performed by designers or experts. For example, to assess the speed of the software, several items were selected at different speeds and the accuracy of the selections was examined.

    The next phase included compatibility testing and security testing. Compatibility testing involved installing the application on multiple Android smartphones and tablets to assess performance on each device. In the security testing, a double confirmation method was implemented to ensure accurate recording of each patient’s problems. This required the patient to confirm the selected item by clicking again, which reduced the chance of inadvertent data entry errors.

    The augmented reality software is registered and approved within the electronic services system of the Information Technology Organization of Iran.

    To evaluate patient satisfaction with the augmented reality software, the Mobile Application Rating Scale (MARS) was used.

    This scale evaluates the quality and performance of the application on four dimensions: attractiveness (5 questions), functionality (4 questions), aesthetics (3 questions), information (7 questions) and subjective quality (4 questions). Each item in the scale was rated on a five-point scale. The maximum achievable score was 115, while the minimum acceptable score was set at 23. For a detailed presentation of the results, please refer to (Table 1).

    Table 1 Mean and standard deviation of dimensions of MARS questionnaire

    Phase I cardiac rehabilitation training based on augmented reality

    After establishing the necessary agreements with officials at Ghaem Hospital in Mashhad, Iran, the first author of the study initiated the sampling process. In the intervention group, rehabilitation program training began upon patient entry into the cardiac surgery intensive care unit and continued until the patient’s discharge.

    During several sessions, augmented reality software was used to train patients in physical activities, such as walking around the hospital ward and climbing stairs. These exercises were performed under the direct supervision of the researcher and were taught individually to each patient using the augmented reality software. The duration of physical activity varied depending on the patient’s condition and the length of hospital stay, ranging from 5 to 10 minutes. During the rehabilitation sessions, the ECG and perceived exercise intensity were closely monitored and controlled.

    In the control group, the rehabilitation training program was implemented using a routine method based on the Ministry of Health protocol. The researcher provided face-to-face training within the unit. Both the intervention and control groups completed the cardiac self-efficacy questionnaire upon admission and discharge to the special care cardiac surgery department.

    Results

    The data collection process used two demographic information questionnaires and a cardiac self-efficacy questionnaire.

    The cardiac self-efficacy questionnaire used in this study was the Cardiovascular Management Self-Efficacy Questionnaire, which was developed by Estka of Italy in 2015. This questionnaire consists of 9 questions, each rated on a 5-point Likert scale, ranging from ‘completely confident’ to ‘not at all confident’. The questionnaire consists of three subscales.

    The first four questions assess a person’s belief in their ability to quit smoking, maintain good nutrition, exercise, and avoid stressful situations. This subscale is called cardiac risk factor self-efficacy. Questions 5 and 6 relate to a person’s confidence in remembering to take medications correctly, which reflects self-efficacy for medication adherence. Finally, questions 7 through 9 evaluate a person’s belief in their ability to identify symptoms and signs of disease worsening, indicating self-efficacy in recognizing symptoms.

    Each answer is assigned a score, with ‘not at all confident’ given a score of one, ‘somewhat confident’ given a score of two, ‘somewhat confident’ given a score of three, ‘fairly confident’ given a score of four, and “completely confident” with a score of five. Total scores range from 9 to 45, with higher scores indicating greater self-efficacy in cardiovascular management [21]. Borzou et al. (2017) evaluated the validity and reliability of this tool in Iran [33]. Patients completed the Cardiovascular Management Self-Efficacy Questionnaire both before and after the intervention.

    Sample size and randomization

    The study involved the continuous and purposeful selection of patients who were then randomly assigned to one of two groups. After confirming that they met the inclusion criteria, eligible individuals were divided into intervention and control groups using a random sequence generated by SPSS software. This series was kept in a sealed envelope to ensure confidentiality. Although it was challenging to blind the participants in this study, the outcome assessors and statisticians were unaware of the type of intervention, ensuring a level of objectivity.

    Because no comparable study was found examining the effectiveness of phase I cardiac rehabilitation training based on augmented reality on the self-efficacy of patients undergoing coronary artery bypass surgery, a sample size of 10 participants was determined for each group. The sample size was calculated using the mean comparison formula, with a 95% confidence interval and 80% test power for each group, resulting in a total of 20 participants. To account for the potential dropout rate, an additional 30 participants were added to each group, representing a 10% increase over the values ​​calculated in the formula.

    $$N = \text \left( Z1 – \alpha /2\text + \text Z1 – \beta \right)2\text \left ( S12\text + \text S22 \right)/\left( X1 – X2 \right)2$$

    $$Z_1 – \alpha /2 = \text 196$$

    $$Z_1 – \beta = \text 0.85$$

    $$X_2 = \text 8.3$$

    statistical methods

    After data collection and sampling, the collected data was analyzed using SPSS 21. Various statistical tests were used, including the independent t-test, the Mann-Whitney test, the paired t-test, and the chi-square test. These tests were performed at a 95% confidence level to ensure statistical significance. Descriptive indicators such as mean, standard deviation and frequency were also used to provide a comprehensive overview of the data. Cohen’s d was also used to evaluate the magnitude of the effect size, calculated by standardized mean difference, with g > 0.2 to 0.5 = small effect size, g > 0.5 to 0.8 = medium effect size, and g > 0 .8 = large effect size [38].

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  • PathKeeper Surgical is celebrating the first spine surgery performed with the PathKeeper 3D optical navigation system in Massachusetts

    PathKeeper Surgical is celebrating the first spine surgery performed with the PathKeeper 3D optical navigation system in Massachusetts

    The PathKeeper 3D optical navigation system is used to improve the clinical experience, increase surgical accuracy and eliminate radiation exposure during spine surgery.

    KFAR SABA, Israel, Nov. 16, 2023 /PRNewswire/ — PathKeeper Surgical, a privately held, Israel-based medical technology company, is committed to improving the health of people around the world suffering from all spinal problems requiring surgery. As PathKeeper Surgical celebrates the first use of the PathKeeper 3D optical navigation system during spinal fusion surgery at Southcoast Health’s St. Luke’s Hospital in New Bedford, Massachusetts, PathKeeper Surgical is committed to making navigation-guided surgery available to every patient in all operating rooms.

    The PathKeeper system was used to create a comprehensive surgical plan and accurately navigate the single-level lumbar degenerative spinal fusion surgery at Southcoast Health’s St. Luke’s Hospital.

    “The PathKeeper system addresses many of the complexities of spine surgery and adapts to the patient’s individual needs with a high degree of accuracy and without radiation during a critical part of the surgical procedure,” said Matthew Philips, MD, chief of Brain & Spine Services, Southcoast Health Neurosurgery, Dartmouth, MA. “We have already experienced the clinical benefits of integrating the PathKeeper system into our spinal fusion surgeries at St. Luke’s Hospital.”

    The PathKeeper system is designed to replace traditional navigation technology with a 3D optical navigation system that provides comprehensive surgical planning; active, independent submillimeter registration and tracking of patient anatomy and surgical instruments; establish precise accuracy of device implantation; more efficient surgical workflow; elimination of radiation exposure during the surgical procedure; and a more affordable price point so that both hospital operating rooms and ambulatory surgical center operating rooms can integrate this new technology.

    “We are very pleased with the adoption of the PathKeeper system at Southcoast Health, which continues our expansion of the PathKeeper system to hospitals and surgery centers across the United States,” said Ryan LeBlanc, Chief Commercial Officer of PathKeeper Surgical. “The PathKeeper system is a game changer in driving improved clinical outcomes and economic value for patients and healthcare providers.”

    PathKeeper Surgical received FDA 510k clearance for the PathKeeper System earlier this year. The name PathKeeper effectively describes the essence of the system: a 3D optical navigation system that ‘keeps’ the surgical ‘path’ on course throughout the operation.

    About PathKeeper Surgical
    PathKeeper Surgical is an Israel-based medical technology company that has developed a solution to combat the high failure rates in spine surgery. PathKeeper was founded in 2018 by Erez Lampert, a top expert in medical 3D imaging with more than 20 years of experience in the healthcare and aerospace industries, and a proven track record in 3D imaging. Erez previously served as R&D leader for the Itero Element Intraoral Scanner for Align Technology (Invisalign), the world’s leading 3D dental scanner. Josh Schroeder, MD, director of Spinal Deformities at Hadassah Medical Center and an HSS fellow, has been on board as a clinical advisor since the company’s founding. Erez and Josh’s combined knowledge enabled the company to develop an innovative navigation system that outperforms existing solutions. More information can be found at path-keeper.com.

    About Southcoast Health
    For more than 25 years, Southcoast Health has served communities in southeastern Massachusetts and Rhode Island as the region’s largest provider of primary and specialty care. The nonprofit charity system includes three acute care hospitals – Charlton Memorial in Fall River, St. Luke’s in New Bedford (a Level II Trauma Center) and Tobey in Wareham – as well as a network of more than 700 physicians, hospitalists and mid-level practitioners.

    Southcoast Health has established six urgent care centers, two cancer centers, a Visiting Nurse Association and numerous outpatient facilities that ensure convenient access to services for 725,000 residents in 33 communities covering 900 square miles. Additionally, the system has partnered with Acadia Healthcare to provide expanded resources at Southcoast Behavioral Health in Dartmouth.

    Southcoast Health has been consecutively recognized as a Newsweeks World’s Best Hospital of 2019-2023, in addition to being ranked as a High Performing Hospital for Maternity Care during the calendar years 2021-2022 and 2022-2023 by American news and world report.

    With more than 7,500 employees, Southcoast Health is the largest employer in southeastern Massachusetts and one of the largest employers in the Commonwealth, according to the Boston Business Journal. More information is available online at www.southcoast.org.

    US Media Contact:
    Ryan LeBlanc
    head of marketing
    ryan.leblanc@path-keeper.com

    Photo – https://mma.prnewswire.com/media/2279117/PathKeeper.jpg

    SOURCE PathKeeper

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  • The assessment of atlantoaxial joint involvement in patients with rheumatoid arthritis is the result of an observational ‘real-life’ study

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  • Part 2 (Alignment) — Bone Talk

    Part 2 (Alignment) — Bone Talk

    shutterstock 614185925

    Training Your Bones: Part 2 (Alignment)
    By Rebekah Rotstein, NCPT

    Last month we went exploring how exercise benefits your bones, noting the importance of consistency, progression, and enjoyment in your routine. We identified the three methods of building bone tissue: weight-bearing movement, resistance exercise and impact activities.

    But focusing only on these elements overlooks an important part of essential training programming for bone health: body alignment, and more specifically, joint positioning.

    Suppose you are used to standing with your ribs pressed forward, and think that this is how you should present with good posture so that you do not slouch. This altered torso placement changes the muscle activation of your core muscles, recruiting the back and often inhibiting the abdominal muscles, causing both weakness and potential back strain over time. Adding heavier weight loads to that forced postural presentation can leave your body vulnerable to injury.

    From a bone health perspective, the beneficial forces from the weights may not be transmitted evenly through the spine and body in that distorted postural presentation. The better your skeleton is in a standing, weight-bearing position, the better its ability to optimize the loading forces of both gravity and external resistance. In other words, body alignment plays a role in bone strengthening.

    ALIGNMENT 101

    So how can you improve your body alignment? A great place to start is unloading your skeleton. If you have osteoporosis or osteopenia, and even more so if you have had a fracture in the past, decompress your spine daily by lying on your back with your knees bent. This is known as constructive rest position. Focus on your breathing here, spending anywhere from a few minutes to, say, 10 minutes a day. Make sure you provide proper head support if necessary to prevent neck strain.

    Then try the following exercises:

    Lying shoulder press
    -to improve posture and decompress the spine

    Lie on your back with your knees bent. Inhale with palms facing up, next to your hips. Exhale and gently press your shoulders into the mat for a few seconds. Inhale and release, then exhale and press again. Repeat several times.

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  • CMA clarifies collaboration on combination therapies to accelerate patient access to essential treatments

    CMA clarifies collaboration on combination therapies to accelerate patient access to essential treatments

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    The Competition and Markets Authority (CMA) today issued a statement clarifying that certain types of agreements between competing pharmaceutical companies working on ‘combination therapies’ will not be prioritized for research – making it easier for pharmaceutical companies to work together to deliver essential to develop treatments for use in NS. The CMA’s statement comes in response to concerns that the CMA could intervene to stop these types of collaborations under competition law.

    Combination therapies combine two or more individual drugs into one treatment and have become increasingly important for the treatment of a range of serious conditions, most commonly cancer. They can produce better health outcomes than individual medications because, in combination, these medications can target the disease more effectively.

    These combination therapies can only be approved for use on the NHS if they are shown to be ‘cost-effective’. The Association of the British Pharmaceutical Industry (ABPI) told the CMA that since 2017, half of combination therapies for cancer treatments with branded medicines submitted for review to the National Institute for Health and Care Excellence (NICE) have withdrawn from the list . fully processed or were not assessed as cost-effective.

    In some cases, a combination will only be ‘cost-effective’ and commercially viable if there is some form of collaboration between pharmaceutical companies, and companies have expressed concerns that such collaboration could be investigated by the CMA. That’s why the CMA is playing its role in clarifying where and how competing drug manufacturers can work together to give them a better chance of meeting the cost-effectiveness threshold and bringing these essential medicines to market.

    The CMA has worked closely with the ABPI, NHS England (NHSE) and NICE to make this public statement, and has worked with relevant bodies in all four countries of Great Britain to ensure that patients can benefit where they are also located. By meeting the conditions set out in the CMA’s statement, pharmaceutical companies will be able to enter into a commercial agreement with the comfort that the CMA will not prioritize this conduct in investigations. However, the information exchanged between pharmaceutical companies must be limited to what is strictly necessary to reach a commercial agreement, and pharmaceutical companies cannot share the confidential price of their individual medicines.

    Ann Pope, CMA Senior Director of Antitrust, said:

    Tens of thousands of NHS patients are missing out on innovative combination therapies. Competing pharmaceutical companies’ concerns that they will fall foul of competition law if they work together are not the only reason why more of these therapies are unavailable to NHS patients, but the CMA is playing its role in explaining how companies can negotiation and avoidance are explored.


    Our statement is intended to provide clarity and comfort to businesses following the rules, and ultimately aims to help more people access essential treatments. It is not a ‘free pass’ and any companies engaging in anti-competitive behavior will be thoroughly investigated by the CMA.”

    Fiona Bride, Director of Medicines Value & Access at NHS England, said:

    NHS patients are already benefiting from access to combination cancer therapies, but it is clear that industry concerns over competition law could act as a barrier to a wider range of combination treatments reaching patients who could benefit.


    This crucial step by the CMA now provides a clear position that, in specific circumstances, commercial deals involving multiple medicines approved by different companies can be struck so that NHS patients can benefit from the latest combination therapies for a range of conditions at a fair price . taxpayers.”

    Helen Knight, Director of Medicines Evaluation at NICE, said:

    NICE is seeing an increasing number of combination therapies coming through its health technology assessment pipeline, so it was important for us to support the CMA in issuing this statement.


    We believe that if companies can work together in these very specific circumstances, the opportunity for these therapies to progress through NICE evaluation will increase. This has the potential to get better treatments to patients faster.”

    As well as the benefits to patients that come from having more combination therapies available on the NHS, there are also wider benefits for growth and innovation in the pharmaceutical sector. More companies should have the confidence to invest in and bring combination therapies to market, ultimately delivering better value for money to the NHS. These targets align with the CMA’s annual plan for 2023 to 2024, which puts people, businesses and the UK economy at the heart of its work.

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  • Boston Scientific Completes Acquisition of Relievant Medsystems, Inc. off

    Boston Scientific Completes Acquisition of Relievant Medsystems, Inc. off

    Recent coverage of Intracept in the healthcare plan® system expands access to vertebrogenic pain treatment to tens of millions of patients

    MARLBOROUGH, Mass., Nov. 17, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced the completion of its acquisition of Relievant Medsystems Inc., a company offering the only U.S. Food and Drug Administration-approved Intracept system® Intraosseous nerve ablation system, a therapy for the treatment of vertebrogenic pain, a form of chronic low back pain. The Intracept System, a basivertebral nerve ablation therapy, will complement Boston Scientific’s chronic pain portfolio, which includes spinal cord stimulation, radiofrequency ablation and an interspinous spacer procedure.

    Relievant recently secured national coverage from Anthem Blue Cross Blue Shield and Humana, both of which are now effective and expanding access to the Intracept system. These national payers join Cigna Healthcare and local Medicare1 plans that allow greater access to treatments for people with vertebrogenic pain. This policy expands access to more than 150 million lives.

    “Relievant’s revolutionary therapy has tremendous potential to help even more people with chronic pain,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “The completion of this acquisition further differentiates our position in advanced interventional chronic pain, providing physicians with the broadest selection of evidence-based treatment options that address multiple pain targets and transform patients’ lives.”

    The acquisition includes an upfront cash consideration of $850 million and undisclosed additional contingent payments based on sales performance over the next three years. On an adjusted basis, the transaction is not expected to be material to adjusted earnings per share in 2024, increasing slightly in 2025 and increasing thereafter. On a GAAP basis, the transaction is expected to have a greater dilutive effect due to depreciation and acquisition-related costs.

    About Boston Scientific

    Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global leader in medical technology for more than 40 years, we advance science for life by providing a broad range of high-quality solutions that address patients’ unmet needs and reduce healthcare costs. To learn more, visit www.bostonscientific.com and get connected Tweet and Facebook.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by words such as “anticipate,” “expect,” “expect.” project”, “believe”, “plan”, “estimate”, “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates based on information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding the financial and business impact of the transaction, expected net sales and related growth rates, product launches and product performance and impact. If our underlying assumptions prove incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the expectations and projections expressed or implied in our forward-looking statements. These factors have in some cases (along with other factors) affected our ability to implement our business strategy and could cause actual results in the future to differ materially from those contemplated by the statements contained in this press release. As a result, readers are cautioned not to place undue reliance on our forward-looking statements.

    Factors that could cause such differences include: future economic, political, competitive, reimbursement and regulatory conditions; production, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other events related to climate change; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; demographic trends; concluding and integrating acquisitions; intellectual property rights; dispute; conditions in the financial markets; the execution and impact of our business strategy, including cost savings and growth initiatives; future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), which we may update in Part II, Item 1A – Risk factors in the Quarterly Reports on Form 10-Q that we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement applies to all forward-looking statements contained in this press release.

    CONTACTS:
    Jessica Sachariason
    Media relations
    +1 (415) 730-2310
    jessica.sachariason@bsci.com

    Lauren Tengler
    Investor Relations
    +1 (508) 683-4479
    BSXInvestorRelations@bsci.com

    1 Data on file. Local Medicare coverage includes Blue Cross Blue Shield Michigan and Palmetto GBA is a Medicare Administrative Contractor covering Medicare patients in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia and West Virginia.

    SOURCE Boston Scientific Corporation

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  • Bone Biologics Announces Registered Direct Offering at Market Prices Under Nasdaq Rules

    Bone Biologics Announces Registered Direct Offering at Market Prices Under Nasdaq Rules

    BURLINGTON, Mass., Nov. 17, 2023–(BUSINESS WIRE)–Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiology products for the spine fusion markets, today announced that it has entered into a definitive agreement to issue and sell a aggregate of 1,139,063 shares of common stock at a purchase price of $0.64 per share in a registered direct offering that will be priced at the market under Nasdaq rules. In a concurrent private placement, the company also agreed to issue and sell unregistered warrants to purchase an aggregate of 1,139,063 shares of common stock. The offering is expected to close on or about November 20, 2023, subject to the satisfaction of customary closing conditions.

    HC Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The unregistered warrants have an exercise price of $0.52 per share, become exercisable upon issuance and have a term of five and a half years from the date of issuance.

    The gross proceeds to Bone Biologics from the offering are expected to be approximately $729,200, before deducting placement agent fees and other offering expenses payable by the Company. Bone Biologics currently intends to use the net proceeds from the offering to fund clinical trials, maintain and expand its patent portfolio and for working capital and other general corporate purposes.

    The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a shelf registration statement. on Form S-3 (Registration No. 333-265872), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on June 28, 2022 and declared effective by the SEC on July 11, 2022. The offering of the common shares to be issued in the registered direct offering will be issued only by means of a prospectus supplement forming part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained by contacting HC Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856- 5711 or email placements@hcwco.com.

    The offer and sale of the unregistered warrants in the private placement are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “ Securities Act”). Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, together with the common stock underlying such unregistered warrants, are not registered under the Securities Act or applicable state laws the field of effects. Accordingly, the unregistered warrants offered in the private placement and the underlying common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable government bonds. securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration. or qualification under the securities laws of any such state or jurisdiction.

    About bone biology

    Bone Biologics was founded to pursue regenerative medicine for bones. The company is working with select strategic partners that will build on the preclinical research on the Nell-1 protein. Bone Biologics is currently focusing its development efforts for its bone graft replacement product on bone regeneration in spinal fusion procedures, while also having rights to applications in trauma and osteoporosis. For more information, please visit www.bonebiologics.com.

    Forward-Looking Statements

    Certain statements in this press release, including, but not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions relating to the offering and the anticipated use of proceeds therefrom, as well as statements containing the words “believes ” contain. “anticipates,” “expects” and words of similar meaning constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and factors including the Company’s ability to deliver our flagship product to develop NELL-1. and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain necessary financing to develop products and conduct necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval for to market any product it develops in the United States and to obtain any other regulatory approval necessary to market a product in other countries, its ability to market any product it develops to market, its ability to create, support, manage or predict its growth; the ability to attract and retain key personnel; changes in the company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized development company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the The Company’s Form S-1, Form 10-K for the year ended December 31, 2022, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

    Contacts

    LHA Investor Relations
    Kim Sutton Golodetz
    212-838-3777
    kgolodetz@lhai.com

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