Empyema

This Clinical Trial will Show the Safety and Probable Benefit of TETRANITE® for Replacing the Use of Metal Plates and Screws LOWELL, Mass.--(BUSINESS WIRE)-- RevBio, Inc., announced that it has received approval from the U.S. Food and Drug Administration to start a 20-patient pilot clinical trial to examine the safety and efficacy of the company’s bone adhesive biomaterial called TETRANITE® to immediately stabilize and fixate cranial flaps following craniotomy procedures associated with brain surgery. This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company. This press release features multimedia. View the full release here: On the left is an image of standard metal fixation hardware consisting of bur hole covers and plates and screw systems that are used to re-affix cranial flaps following craniotomy procedures. On the right is TETRANITE® which fills the missing bone, seals the site from infection, and over time is resorbed and replaced with bone as demonstrated in RevBio’s pre-clinical testing. (Graphic: Business Wire) The clinical trial will be conducted by Timothy R. Smith, MD, PhD, MPH, Director, Computational Neuroscience Outcomes Center and practicing neurosurgeon at Brigham and Women’s Hospital in Boston, Massachusetts, and L. Madison Michael, MD, Co-Director of Cranial Base Surgery for the Methodist Brain and Spine Institute and practicing neurosurgeon at the Semmes Murphey Clinic in Memphis, Tennessee. “We are looking forward to evaluating the efficacy of the product that could provide immediate, rigid fixation that would be preferable to existing plates and screws, which are the current standard of care,” said Dr. Smith. “We’re excited at the potential that this product could provide a biological adherence between the bone flap edges and the skull, as well as an architecture for osteogenesis over time and look forward to the results of the clinical trial.” Craniotomy procedures are required to remove a brain tumor, treat an aneurysm, relieve intracranial pressure, or perform deep brain stimulation. The instruments used to cut into the skull leave a kerf line, which is a continuous gap between the bone flap, which is temporarily removed to conduct the brain surgery, and the surrounding skull bone. As part of the surgical closure process, the cranial flap is secured back into place with plates and screws. The kerf line, however, is typically not sealed, which compromises the ability of the flap to integrate with the surrounding bone. The open kerf line also leaves a channel for leakage of cerebrospinal fluid (“CSF”) that can lead to devastating infections. Infection rates in published literature for certain regions of the skull range up to 21%, which most often results in meningitis, subdural empyema, or cerebral abscesses.1,2 CSF leaks increase the risk of infection by as much as 13 times and are considered the most significant risk factor for post-operative meningitis.3 CSF leakage has been reported to almost double the healthcare cost of the original procedure.4 Furthermore, the use of hardware fixation devices does not provide a scaffold for biological bone healing and also often leads to readmission and secondary surgeries to correct issues associated with pain and protrusion of the metal hardware. The use of TETRANITE could offer an innovative alternative approach for cranial flap fixation that eliminates the use of hardware fixation products and provides a more natural solution that improves bone healing, enhances the conformal contour of the skull, and, at the same time, provides a sealant to resist CSF leaks that frequently lead to infection. “We are truly excited to move this project into the clinical phase of testing,” said Brian Hess, CEO and Founder of RevBio. “We envision that the use of TETRANITE will become the standard of care given all the benefits this biomaterial can provide in comparison to traditional plates and screw systems.” About RevBio, Inc. RevBio, Inc., is a clinical stage medical device company engaged in the development and commercialization of a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial called TETRANITE®. The company is initially developing this technology for use in the dental, cranial, and broader orthopaedic markets as well as applications in the animal health market. RevBio's TETRANITE technology is not yet approved for commercial use. _____________________________ 1 Dashti, S. R.; Baharvahdat, H.; Spetzler, R. F.; Sauvageau, E.; Chang, S. W.; Stiefel, M. F.; Park, M. S.; Bambakidis, N. C. Operative Intracranial Infection Following Craniotomy. Neurosurg. Focus 2008, 24 (6), E10. . 2 Mollman, H. D.; Haines, S. J. Risk Factors for Postoperative Neurosurgical Wound Infection. A Case-Control Study. J. Neurosurg. 1986, 64 (6), 902–906. . 3 Ibid. 4 Piek, J.; Weber, C.; Kundt, G.; Tronnier, V.; Spuck, S.; Hirdes, C.; Kehler, U.; Ditges, C. Pharmacoeconomical Consequences of Postoperative CSF Leaks after Intracranial Surgery--a Prospective Analysis. J. Neurol. Surg. Part Cent. Eur. Neurosurg. 2012, 73 (1), 25–28. .

KIRKLAND, QC, July 21, 2022 /CNW/ - Pfizer Canada ULC announced today that PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.8 Approved by Health Canada, PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),9 10 11 12 13 and have been associated with high case-fatality rates,14 15 16 17 antibiotic resistance,18 19 20 and/or meningitis.21 22 "We are pleased to build on Pfizer's legacy in the innovation and development of pneumococcal conjugate vaccines to help protect Canadians who are most at-risk of pneumococcal disease (PD)," said Fabien Paquette, Vaccines Canada Lead, Pfizer. "PREVNAR 20 is significant in our ongoing fight against pneumococcal disease, including pneumonia in adults, and helps protect against disease-causing serotypes that cause potentially serious respiratory infections. The approval of PREVNAR 20 is pivotal in adult vaccination as it meets a crucial need to expand coverage and protection to address the changing burden of disease." Streptococcus pneumoniae infections are a major cause of illness and death worldwide.23 In Canada, Streptococcus pneumoniae remains as a main cause of bacterial community-acquired pneumonia, with an increased risk in individuals with chronic medical conditions and age (65+). The overall case fatality rate of bacteremic pneumococcal pneumonia is 6.4% and is higher among adults 65+ (12%).24 PREVNAR 20 was approved on May 9, 2022. Health Canada's decision is based on evidence from Pfizer's clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. More than 6,000 adult subjects 18 years and older participated in the three Phase 3 trials, including adults 65 years of age and older, pneumococcal vaccine-naïve adults, and adults with prior pneumococcal vaccination. "Pneumonia remains one of the most lethal infectious diseases in Canada. This vaccine broadens the protection against disease-causing serotypes that lead to Streptococcus pneumoniae infections and marks an important step forward in protecting the health of all Canadians, especially those at higher risk due to comorbidities, immunocompromising conditions, or older age " said Dr. Angel Chu, Vice Chair of Immunize Canada and an infectious diseases physician at the Foothills Medical Centre in Calgary. PREVNAR 20 builds on Pfizer's legacy of more than two decades of experience in developing and supplying innovative pneumococcal conjugate vaccines. INDICATION FOR PREVNAR 20 PREVNAR 20 is indicated for active immunization for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. Clinical efficacy for the prevention of pneumonia was studied with PREVNAR 13 for the shared serotypes, but not for the additional serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F. PREVNAR 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine. About Pneumonia Pneumonia is generally defined based on how or where the disease is acquired. Community-acquired pneumonia (CAP) – pneumonia that is contracted outside of a healthcare setting – accounts for the vast majority of pneumonia cases and is a leading cause of death due to infection in the United States and Europe, with the death rate in older adults often exceeding 10%.25 26 27 About Invasive Pneumococcal Disease (IPD) Invasive pneumococcal disease (IPD) is an acute and serious communicable disease caused by the gram positive bacterium Streptococcus pneumoniae.28 IPD may lead to several syndromes including meningitis and bacteremia.29 In Canada, invasive pneumococcal disease (IPD) is more common in the winter and spring.30 S. pneumoniae can be spread by direct oral contact, respiratory droplets, or indirect contact with respiratory secretions of infected or colonized persons (e.g. sneezing, coughing or talking).31 About PREVNAR 20™ in Canada PREVNAR 20 is the first approved conjugate vaccine that helps protect Canadian adults ages 18 and over against the 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia cases. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

Increasing demand for minimally-invasive surgical procedures are key to driving demand for pleural catheters in advanced healthcare systems. Fact.MR, Rockville MD: Market research company Fact.MR’s ongoing pleural catheter market study has forecasted a promising rate of growth in 2021, as pleural effusion processes gain traction during the coronavirus pandemic owing to the adverse impact of the virus on lung health. The market is expected to be continue growing even post-pandemic, in the upcoming years. Healthcare advances including chemical pleurodesis is generating key opportunities for manufacturers in years to come. According to the Memorial Sloan Kettering Cancer Center, pleural catheters find application in interventional radiology and pulmonology image-guided processes. Pleural effusion occurs in more than 300 persons for a population of 100,000. Ease of use and maintenance for patients with professional guidance allows for home care applications as well generating growth prospects in the industry. Introduction of automated and semi-automated products are also likely to gain attention among healthcare practitioners in years to come. “Widespread application of pleural catheters for minimizing damage from pleural effusions arising from multiple conditions are key factors driving demand. Healthcare procedures for blood vessel blockages, heart failure, lung infections, lung cancer, kidney ailments, leukemia, cirrhosis, and pulmonary embolism will support applications of pleural catheters, for emergency and pre-planned procedures,” says the Fact.MR analyst. Request a report sample to gain comprehensive insights at Key Takeaways from Fact.MR’s Pleural Catheter Study Minimally-invasive transduative effusion treatment procedures will account for relatively faster growth owing to applications in congestive heart failure treatments. Growing awareness about metastatic disease treatment options are likely to drive demand in malignant pleural effusion applications. Ambulatory surgical centers will generate increased demand, driven by use in emergency surgical procedures. China, and India are high growth markets for pleural catheter procedures owing to investments in infrastructure advancements and medical tourism. The United States will hold the lead, driven by sophisticated healthcare infrastructure and research centers for heart-related diseases. Germany and UK will drive market with pleural catheter device production and the prevalence of cardiovascular disease. Pleural Catheter Market- Prominent Drivers Technology advancements in terms of automation in pleural drainage systems are supporting market growth. Favorable reimbursement scenarios for pleural catheter procedures, particularly in emerging economies will aid market demand. Rising prevalence of lifestyle ailments such as obesity and the resultant impact on cardiovascular health is generating growth opportunities. Pleural Catheter Market- Key Restraints Lack of awareness about plural effusion treatment procedures especially in developing economies is a key factor holding back adoption. Strict regulations associated to product development in the industry and limits market growth prospects. Discover more about the pleural catheter market with figures, data tables and the table of contents. You will also find detailed market segmentation on Competitive Landscape Smiths Medical, Pixel Energy, Bicakcilar Medical Equipment AS, HEYER Medical AG, OAKWORKS Medical, Biometrix, B. Braun Melsungen AG, and Redax are some of the leading players operating in the global pleural catheters market. Key manufacturers are primarily looking towards entering product development and commercialization agreements within the industry in addition to product launch strategies. For instance, in August 2020, Bearpac Medical LLC announced the launch of the Passio Pump Drainage System, comprising a disposable collection kit and Passio catheter, and handheld control unit for draining symptomatic pleural effusion. PleurX has also unveiled its new catheter system, aimed towards the management of malignant ascites and recurring pleural effusion incidences for home care settings. The system comprises a supplemental insertion kit to minimize fluid leakage and air entrance during the placement process. More Insights on the Pleural catheter Market In its latest report, Fact.MR offers unbiased analysis of the global pleural catheter market. In order to understand the global market potential, its growth, and scope, the market is segmented on the basis of indication (malignant pleural effusion, non-malignant recurrent effusions, chylothorax, empyema, and haemothorax), and end user (hospitals and ambulatory surgical centers), across seven regions (North America, Latin America, Europe, East Asia, South Asia, Oceania, and Middle East & Africa) Request more information about Report Methodology About Fact.MR Market research and consulting agency with a difference! That’s why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range – from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Reach out to us with your goals, and we’ll be an able research partner. Contact: US Sales Office: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 E: sales@factmr.com Corporate Headquarter: Unit No: AU-01-H Gold Tower (AU), Plot No: JLT-PH1-I3A, Jumeirah Lakes Towers, Dubai, United Arab Emirates Source: Fact.MR