Dibotermin alfa

The first Korean developed medical device for spine implantation Expecte to receive faster approval in the U.S. by priority support from the FDA NOVOSIS PUTTY, combining bone-forming proteins and ceramic scaffolds, induces rapid bone formation SEOUL, South Korea, Jan. 2, 2024 /PRNewswire/ -- CGBio (CEO Hyun Seung Yu), a Korean company specializing in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY", has been granted 'Breakthrough Device Designation' (BDD) by the U.S. Food and Drug Administration (FDA). This material incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2). On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff. The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA, 510(k), and De Novo, consistent with the Agency's mission to protect and promote public health. The FDA considers all of these factors to determine whether a device is 'reasonably expected to provide more effective treatment or diagnosis,'" according to the guidance. NOVOSIS PUTTY's designation marks the first case for implantable device in Korea. Despite being a high-risk permanent implant, NOVOSIS PUTTY's efficacy and innovative aspects are recognized internationally. Devices with 'Breakthrough Device Designation' benefit from prioritized FDA support during the approval process. This support includes continuous communication with the FDA, assignment of a specialized review team, and prioritized review of everything from clinical trial design to approval. This streamlined approach speeds up FDA approval, allowing for quicker entry into the U.S. market compared to other devices. According to SmartTrak, the market for growth factor bone substitutes in North America is expected to grow from USD 0.66 billion in 2022 to USD 0.78 billion in 2029, with an average annual growth rate of 4.7%. NOVOSIS PUTTY, a second-generation product, features a ceramic-based synthetic scaffold with superior moldability and osteoconductive properties, and incorporates advanced sustained-release formulation technology (SLOREL™) from its predecessor, NOVOSIS Ortho. A key ingredient in NOVOSIS PUTTY is rhBMP-2, mass-producedx by Daewoong Pharmaceutical Co., Ltd., a leader in the South Korean pharmaceutical industry. This protein plays a crucial role in bone regeneration, transforming stem cells into bone cells in cases of bone defect. Known internationally as 'Nebotermin' and recognized by organizations including the WHO, Daewoong's rhBMP-2 has earned global acclaim for its impact on health. Hydroxyapatite (HA) ceramic material, bone graft substitute that acts as a scaffold of rhBMP-2 at the same time, allows for controlled release of rhBMP-2, reducing the risk of unwanted bone growth and surrounding soft tissue swelling, unlike collagen sponge-based scaffolds. It enables high-density bone formation with lower rhBMP-2 doses. Its synthetic polymer hydrogel component, Poloxamer 407 hydrogel, also allows customizable shaping. CGBio has completed preclinical studies for U.S. confirmatory clinical trials of NOVOSIS PUTTY and is conducting clinical trials to determine the optimal dosage, with plans to apply for U.S. confirmatory clinical trials in the first half of 2024. Hyun Seung Yu, CEO of CGBio, commented, "The breakthrough device designation for NOVOSIS PUTTY is further proof of CGBio's technological prowess, innovation, and potential. With the designation's emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through NOVOSIS PUTTY." Jumi Han, head of CGBio's U.S. Development Center, stated, "The 'Breakthrough Device Designation' for NOVOSIS PUTTY confirms that regulatory authorities are prioritizing support for our product development. We are accelerating U.S. clinical trials to demonstrate its efficacy and safety." About CGBio CGBio began with the mission of 'Pursuing the Improvement of Quality of Life,' specializing in the production and sale of therapeutic materials for reconstructing musculoskeletal tissues damaged by diseases. Expanding its scope, the company now also provides materials for the beauty and plastic surgery sectors. Building on biomaterial-based technology, CGBio collaborates with clinical experts to supply essential products for clinical use and products that are convenient for use in clinical settings. More detailed information can be found at (). About Daewoong Pharmaceutical Daewoong Pharmaceutical, a leading global pharmaceutical company based in South Korea, is dedicated to improving consumer quality of life through its innovative products. Its self-developed NABOTA, a botulinum toxin type-A, is Asia's first FDA-approved botulinum toxin, and Daewoong has also developed novel drugs for GERD, using the active ingredient Fexuprazan, and for diabetes with Enavogliflozin for two consecutive years. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected]. SOURCE CGBio

SCHLIEREN (ZURICH), Switzerland, March 10, 2021 (GLOBE NEWSWIRE) -- Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies and a pioneer in the emerging field of osteoimmunology, today announced that the company will present at two major European conferences in March, both to be held virtually. Joost de Bruijn, Chief Executive Officer, and Michael Grau, Chief Financial Officer, will participate in the 18th edition of BioCapital Europe, the premier life investment venue organized by LSP on March 11. Joost de Bruijn will deliver a corporate presentation at 11.30 CET, and be available, with Michael Grau, for 1x1 meetings with investors. For more info about this event, please visit the meeting website: Kuros will also present real-world clinical data and research on the role of osteoimmunology in bone formation in two presentations at the 11th BritSpine conference, taking place March 10-12. Lukas A. van Dijk will present research that demonstrates the following properties after treatment with Kuros’ MagnetOs: In addition, Dr Kornelis Poelstra MD PhD of the Robotic Spine Institute of Las Vegas will be presenting his findings from a series of patients treated using MagnetOs in his clinical practice. Details for the presentations: For more info about BritSpine 2021, please visit the . MagnetOs bone graft is supported by a growing set of preclinical data demonstrating equivalence to the current gold standard, autograft, with over three years of clinical experience since its first use in the UK in May 2017. For further information, please contact: About Kuros Biosciences AG Kuros Biosciences is a leader in next generation synthetic bone graft technologies for targeted and controlled bone healing. Kuros’s bone graft substitute, MagnetOs, is commercialized in the U.S. and UK for use in posterolateral spinal fusions. Kuros’s lead product in development, Fibrin PTH, a drug-biologic combination for spinal interbody fusion, has started a phase 2 clinical trial in the U.S. Kuros is located in Schlieren (Zurich), Switzerland, Bilthoven, The Netherlands and Burlington (MA), U.S. The Company is listed according to the International Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit for additional information on Kuros, its science and product pipeline. About MagnetOs bone graft MagnetOs bone graft has an advanced submicron surface topography that leads to the formation of bone in spinal fusion defects rather than scar tissue. In preclinical models, MagnetOs preferentially directs the body’s early wound healing response toward the bone-forming pathway, an effect that is so potent that bone can be formed even in soft tissues without the need for added cells or growth factors. This ground-breaking research led to Kuros attaining an osteoinductive claim for MagnetOs in Europe. Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. MagnetOs is not cleared by FDA as an osteoinductive bone graft. US indications statementMagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. EU indications statementMagnetOs is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. MagnetOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. MagnetOs is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. MagnetOs should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, MagnetOs is to be used in conjunction with internal or external fixation devices. Forward Looking Statements This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.