BMP2

RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion It is the first product based on RENOVITE®, Renovos' novel nanoclay therapeutic delivery platform for precision regenerative medicine KEELE, England, Jan. 4, 2024 /PRNewswire/ -- Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft tissue, is pleased to announce that its investee company , Renovos Biologics (Renovos), has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its lead product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2). RENOVITE® BMP-2, based on a proprietary synthetic nanoclay gel, is in development as a safer and more effective alternative to currently available bone graft materials. The easy-to-use, injectable gel allows precise, localised bone formation at the target site. It contains BMP-2, a growth factor which promotes in-growth of bone forming cells. The nanoclay gel enables safe, highly-targeted bone fusion, as it does not leach BMP-2, with the gel biodegrading as new bone forms. Dr Agnieszka Janeczek, Chief Executive Officer of Renovos Biologics, said: "We are very pleased with the Breakthrough Device Designation from the FDA, being among just one hundred or so companies granted this designation in orthopaedics since the programme's launch in 2015. This designation is a major milestone in our development journey. The accelerated regulatory feedback and prioritised review will shorten the time to market and allow faster access to expanded treatment options for patients suffering from degenerative disc disease." Michael Harris, Chief Executive Officer of Biocomposites, said: "The granting of FDA Breakthrough Device Designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market RENOVITE® - a next-generation drug carrier. At Biocomposites, our expertise in this field ideally positions us to support and enhance RENOVITE®'s progress towards pre-market approval." The FDA's Breakthrough Device Designation program is intended to help provide patients more timely access to medical devices which have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions, by speeding up the development, assessment and review process. Breakthrough designation is only granted after preliminary evidence has been provided demonstrating a reasonable expectation that the device will provide significant advantages over standard of care. The designation will allow Renovos to have more frequent interaction with the FDA's regulatory experts when preparing its submissions, followed by prioritised reviews. About Biocomposites Biocomposites is an international medical device company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Canada, China and India. Biocomposites is a world leader in the development of innovative calcium compounds and polymers for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry and sports injuries. Biocomposites products are now used in over 120,000 procedures per annum and sold in more than 40 countries around the world. Biocomposites has a minority-share interest in Renovos Biologics. Please visit biocomposites.com to learn more. About Renovos Biologics Renovos is a regenerative medicine company and a specialist developer of RENOVITE® synthetic nanoclay for medical use. Stemming from research at the University of Southampton, UK, Renovos' proprietary RENOVITE® technology greatly improves the performance of a range of regenerative medicine products, with first targets in orthobiologics. RENOVITE® presents a novel mechanism of action, offering unprecedented retention of therapeutic agents at the target site of repair, mitigating their effects to a precisely controlled area, creating a step-change improvement in their efficacy, safety and ease of use, in biodegradable and injectable formulations, suitable for minimally-invasive applications. Please visit renovos.co.uk to learn more. SOURCE Biocomposites

Researchers have discovered a suite of genes that influence head shape in humans. These findings help explain the diversity of human head shapes and may also offer important clues about the genetic basis of conditions that affect the skull, such as craniosynostosis. Researchers at the University of Pittsburgh and KU Leuven have discovered a suite of genes that influence head shape in humans. These findings, published this week in Nature Communications, help explain the diversity of human head shapes and may also offer important clues about the genetic basis of conditions that affect the skull, such as craniosynostosis. By analyzing measurements of the cranial vault -- the part of the skull that forms the rounded top of the head and protects the brain -- the team identified 30 regions of the genome associated with different aspects of head shape, 29 of which have not been reported previously. "Anthropologists have speculated and debated the genetics of cranial vault shape since the early 20th century," said co-senior author Seth Weinberg, Ph.D., professor of oral and craniofacial sciences in the Pitt School of Dental Medicine and co-director of the Center for Craniofacial and Dental Genetics. "We knew from certain rare human conditions and animal experiments that genes play an important role in vault size and shape, but very little was known about the genetic basis for typical features we see in the general population, such as what makes someone's head long and narrow versus short and wide. This study reveals some of the key genes driving variation in this part of the human body." According to the researchers, one application of better understanding the factors that drive natural variation in human head shape is informing paleoanthropology studies, potentially shedding light on the early development of modern humans. Weinberg and colleagues used magnetic resonance (MR) scans from more than 6,000 adolescents to extract 3D surfaces corresponding to the cranial vault. After dividing the 3D vault surfaces into incrementally smaller anatomical subparts and quantifying the shape of these subparts, they tested more than 10 million genetic variants for evidence of statistical association with measures of vault shape. "Previous genetic studies of the cranial vault involved a small number of relatively simple measures," added Weinberg. "While such measures are often easy to obtain, they may fail to capture features that are biologically relevant. Our analysis used an innovative approach capable of describing 3D vault shape in much more comprehensive and nuanced ways. This approach increased our ability to find genetic associations." An important discovery was that many of the strong associations are near genes that play key roles in the early formation of the head and face and regulation of bone development. For example, variants in and near the gene RUNX2, a major player in coordinating development of the skull, were associated with multiple aspects of vault shape. While some genes, including RUNX2, had global effects involving the entire vault, others showed more localized effects that only impacted a specific portion of the vault, such as the central forehead. When the researchers compared the 30 genomic regions associated with head shape across participants with European, African and Indigenous American ancestry, they found that the majority of genetic associations were shared across these different ancestral groups. Although the study focused on healthy participants, the findings may reveal important clues about the biological basis of diseases involving the cranial vault, according to Weinberg. One of these conditions is craniosynostosis, which occurs when the bones of the skull fuse too early while the brain is still growing rapidly. Without neurosurgery, craniosynostosis can cause permanent disfigurement, brain damage, blindness and even death. The team showed that variants near three genes associated with vault shape, BMP2, BBS9 and ZIC2, were also associated with craniosynostosis, suggesting that these genes could play a role in the development of the disease. "This kind of study is possible due to the availability of publicly funded resources," said Weinberg. "The original study that generated these MR scans is focused on understanding brain development and behavior. By creatively leveraging these resources, we have managed to advance discovery beyond that original scope." Other authors on the study were Seppe Goovaerts, Hanne Hoskens, Ph.D., Meng Yuan, Dirk Vandermeulen, Ph.D., all of KU Leuven; Ryan J. Eller, Ph.D., Noah Herrick, Ph.D., and Susan Walsh, Ph.D., all of Indiana University-Purdue University Indianapolis; Anthony M. Musolf, Ph.D., and Cristina M. Justice, Ph.D., both of the National Human Genome Research Institute; Sahin Naqvi, Ph.D., and Joanna Wysocka, Ph.D., both of Stanford University; Myoung Keun Lee, Heather L. Szabo-Rogers, Ph.D., Mary L. Marazita, Ph.D., and John R. Shaffer, Ph.D., all of Pitt; Paul A. Romitti, Ph.D., of the University of Iowa; Simeon A. Boyadjiev, M.D., of the University of California, Davis; Mark D. Shriver, Ph.D., of Penn State University; and Peter Claes, Ph.D., of KU Leuven and Murdoch Children's Research Institute. This research was supported by the National Institute of Dental and Craniofacial Research (R01DE027023, R01DE016886, R03DE031061 and X01HL14053) and the Intramural Research Program of the National Human Genome Research Institute, National Institutes of Health

NOTTINGHAM, England--( BUSINESS WIRE )--Locate Bio, a UK-based orthobiologics company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for LDGraft, currently in development for anterior lumbar interbody spinal fusion (ALIF) procedures at one level from L3-S1 for patients with degenerative disc disease. The FDA Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Degenerative disc disease (DDD) is an irreversible and debilitating disease that has a substantial impact on day-to-day functioning. If left untreated, the condition of a patient with DDD will worsen, causing increasing low back pain and potential radiculopathy, myelopathy, spinal stenosis, degenerative spondylolisthesis, and herniations. It is estimated that there are over 700,000 spinal fusions performed in the U.S. each year i , representing a market approaching $2bn i . LDGraft has been designed to provide both an osteoconductive scaffold and a controlled and extended release of osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2). This extended release is achieved as the product does not contain any liquid phase or surface attached rhBMP-2. Instead, the osteoinductive agent is encapsulated within a proprietary polymer scaffold system which degrades over several weeks, continuously releasing the rhBMP-2 as it does so. John von Benecke, CEO of Locate Bio , said: “According to the World Health Organisation, chronic low back pain is already the leading cause of disability worldwide, with 570 million prevalent cases worldwide ii . With a rapidly ageing global population, there is now an urgent need for next-generation products to relieve suffering and improve the quality of life for millions of patients. We are delighted therefore to have been granted a Breakthrough Device designation from the FDA for LDGraft, our exciting controlled and extended-release rhBMP-2 for spinal fusion. We are proud that the FDA has recognised the potential of LDGraft. Having recently completed our final preclinical work, we are looking forward to progressing LDGraft into human clinical trials later this year and ultimately, regulatory approval. More broadly, today’s announcement is another important milestone for Locate as we seek to achieve our ambition of building a world-leading orthobiologics business that addresses clear unmet needs of both surgeons and patients.” ENDS About Locate Bio Locate Bio is an innovative orthobiologics company with a proprietary, regenerative medicine pipeline, developing a range of exciting orthobiologics products with great disruptive potential. Locate Bio’s ambition is to build a world-leading, orthobiologics business with a diversified suite of best-in-class technologies that address the performance limitations of existing products and enable orthopaedic surgeons to improve the lives of millions of people suffering from debilitating musculoskeletal conditions. Locate Bio is a spin-out from the University of Nottingham. The Company is backed by Mercia Asset Management PLC and BGF. To learn more visit: https://www.locatebio.com/ i DRG Bone Graft Substitutes Market Insights 2019 ii https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions