Fractures, Ununited

March 18, 2025 -- Angitia Biopharmaceuticals, a global, clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the presentation of data from its randomized, double-blind, placebo-controlled Phase 1/2 study evaluating AGA111 for use in spinal fusion procedures on March 12, 2025, at the 2025 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting in San Diego, California. In the study, treatment with AGA111, a recombinant human bone morphogenetic protein 6 (rhBMP6), led to faster radiographic fusion and a higher fusion success rate, as well as greater improvements in functional outcomes as assessed by the Oswestry Disability Index (ODI) and pain visual analog scale (VAS), compared to placebo. “We are honored and excited to present the full dataset from our Phase 1/2 study of AGA111, representing a rare and valuable randomized, placebo-controlled study in the field of orthopedics and spinal fusion,” said Willard Dere, M.D., Chief Medical Officer of Angitia. “Based on these encouraging results, we are now executing a registrational Phase 3 study of AGA111, which we believe has the potential to significantly accelerate bony fusion and meaningfully improve patient outcomes following spinal fusion surgery.” The Phase 1/2 trial was a randomized, double-blind, placebo-controlled study enrolling 63 patients with degenerative disc disease (DDD) requiring single-level Transforaminal Lumbar Interbody Fusion (TLIF) surgery. Patients were randomized 1:1:1 to 1 of 3 groups: placebo, 0.25mg AGA111, or 0.5mg AGA111. AGA111 or placebo was mixed with autologous blood to create a coagulum, which was then administered into the interbody area during TLIF surgery. No bovine material was used in the treatment or placebo arms. Blinded adjudicators assessed fusion success using CT scan images and hyperflexion/hyperextension X-rays at Months 3, 6, and 12. At the same time, functional outcomes were assessed via the ODI and pain VAS. Study results indicated that AGA111 induced more rapid fusion, increased fusion success rate, and improved functional outcomes compared to placebo. The abstract outlining the study is entitled, “AGA111, a Recombinant Human Bone Morphogenetic Protein 6 (rhBMP6), Improved Lumbar Interbody Fusion Success Following Single-Level Transforaminal Lumbar Interbody Fusion (TLIF) Surgery in a Phase I/II, Double-Blind, Placebo-Controlled, Randomized Study." AGA111 is a recombinant human bone morphogenic protein 6 (rhBMP6) product candidate in clinical development to promote bone fusion and functional outcomes in patients undergoing spinal fusion procedures. AGA111 is mixed with autologous blood to create an autologous blood coagulum and administered during the surgery. Angitia is currently studying AGA111 in double-blind, placebo-controlled, randomized Phase 3 study. Spinal fusion is a widely used surgical treatment for spinal disorders, including degenerative disc disease (DDD). Each year, approximately 146,000 patients in China and over 300,000 patients in the US undergo spinal fusion procedures to treat DDD. The rate of spinal fusion following surgery has a significant impact on patient outcomes. Although lumbar spinal fusion is a commonly performed spinal procedure, it can result in significant morbidity, including nonunion or pseudarthrosis. Patients with nonunion following spinal fusion surgery are at risk for pain, decreased functional outcomes, and re-operation. Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in clinical studies for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The content above comes from the network. if any infringement, please contact us to modify.

HUNTSVILLE, AILEU / ACCESSWIRE / December 4, 2024 / Curiteva, Inc., a privately held manufacturing and technology company, today announced it has implanted over 2,000 patients with the Inspire®C Cervical Interbody Fusion Device. This success translates to more than 3,700 implants placed, demonstrating the system's rapid adoption and effectiveness since its commercial launch in July 2023.Chambliss Harrod, M.D., from The Spine Center Louisiana commented, "To mitigate the risk of pseudoarthrosis, I have utilized the Inspire Cervical implants to encourage rapid bone growth on and through the fusion construct. Anywhere there is a physiologic interface where you are looking for a musculoskeletal re-enforcement or augmentation, using the Inspire technology allows for an opportunity to have the bone not only grow through but also maximally integrate on and around the implant.""Surpassing 2,000 procedures with Inspire C Technology showcases our significant growth and future potential. Thank you to our team, surgeons, investors, and distributor partners for working with us to reach this goal," said Chris Schultz, Curiteva's Vice President of Marketing. "We look forward to continuing to ramp up our commercial efforts and are excited to see the broader patient benefits now being recorded with the release of the Inspire lumbar portfolio.""The most exciting thing about reaching this 2,000-patient milestone is realizing the outstanding preliminary outcomes as our ongoing collection of data continues to validate and underscore the novelty of this Inspire Technology," commented Curiteva's Chief Scientific Officer, Erik Erbe, PhD. "Most recently the data was shared in ‘Unique Osseointegration Patterns in 3D Printed Trabecular-Architecture Porous Polyetheretherketone (PEEK). A CT Scan Study of the Inspire Cervical Implant'."The Inspire platform is manufactured with a proprietary, patented Fused Strand Deposition 3D printer designed, programmed, and built by Curiteva. This ground-breaking additive process produces a fully interconnected and integrated porous structure traversing the entire implant designed to promote osseointegration, improve radiographic assessment, and deliver improved patient outcomes. The first-to-market combination of the HAFUSE sub-micron surface texture and novel porous PEEK structure presents a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.Curiteva will be exhibiting at the Cervical Spine Research Society (CSRS) annual meeting in Chicago next month. "I encourage surgeons who are interested in learning more about the Inspire 3D Printed Trabecular PEEK Technology to visit us at Booth 304," added, Chris Schultz.About Curiteva:Curiteva is a privately held technology and manufacturing company based in Huntsville, AL. Our business is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering novel technology to meet the evolving needs of our customers and the patients they serve. Curiteva is pioneering 3D printing of Trabecular PEEK implants with a proprietary HAFUSE sub-micron surface designed to revolutionize how engineered structures and implant biomaterials promote osseointegration, accelerate healing, and improve patient outcomes. For more information, please visit www.curiteva.comContact InformationKristen KyzerDirector of Business Development[email protected]256.213.1057Source: Curiteva

MAX BioPharma is Pursuing Strategic Partnerships and Series A Financing LOS ANGELES, Oct. 24, 2024 /PRNewswire/ -- MAX BioPharma, Inc. ( ) recently published an article demonstrating the anti-atherosclerotic, anti-inflammatory, and cholesterol-lowering effects of its orally bioavailable oxysterol lead compound, Oxy210, in the peer-reviewed journal, Cells. Oxy210 is derived from the Company's Oxysterol Therapeutics® platform of proprietary small molecule oxysterols that has enabled discovery of diverse oxysterol-based drug candidates in different therapeutic areas, such as bone regeneration, viral and bacterial infection, cancer, pathologic fibrosis, and chronic inflammation. Oxy210 displays unique mechanisms of action that mediate its anti-inflammatory and anti-fibrotic effects based on multipronged targeting of not just one, but multiple cellular signaling pathways. When dysregulated, these vital signals are known to drive the progression of complex diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and its comorbidity, atherosclerosis, which is the leading cause of death in people with MASH. Continue Reading During previous research conducted at the David Geffen School of Medicine at the University of California, Los Angeles and directed by Principal Investigator Dr. Jake Lusis, Professor of Medicine, and Dr. Simon Hui, Project Scientist, Oxy210 was found to significantly inhibit the development of fibrosis in a humanized mouse model of MASH that involves progressive inflammation, fat deposition, and fibrosis in the livers of these mice. The inhibition of fibrosis by Oxy210 was associated with reduced hepatic lipid deposition and the inhibited expression of pro-fibrotic and pro-inflammatory factors including transforming growth factor beta (TGF-β), NLRP3 inflammasome, interleukin-6 (IL-6), tumor necrosis alpha (TNF-α), interleukin-1 beta (IL-1β) and monocyte chemotactic protein 1 (MCP-1). Moreover, Oxy210 inhibited adipose tissue inflammation, suggesting its anti-inflammatory potential that reaches beyond the liver. In their recently published article, the investigators report on significant inhibition of atherosclerosis, a chronic inflammatory disease, in addition to parallel inhibition of MASH. Treatment with Oxy210 was associated with lowering circulating cholesterol levels and reducing macrophage proliferation and content in the artery wall. Together with the in vitro findings of the anti-inflammatory effects of Oxy210 in aortic endothelial cells and macrophages, it appears that Oxy210 could be a promising drug candidate for targeting MASH, atherosclerosis, and perhaps other chronic inflammatory diseases associated with metabolic dysfunction. An anti-inflammatory, anti-fibrotic, cholesterol-lowering oxysterol drug candidate targeting MASH and atherosclerosis Post this "There is an urgent need for therapies to treat fatty liver disease and its more advanced form, MASH, and I find the results of our studies with MAX BioPharma quite exciting" states Dr. Lusis. "Our humanized hyperlipidemic mouse model of MASH reflects the natural history of metabolic dysfunction-associated steatotic liver disease (MASLD) progression in humans and reproduces the salient features of human MASH. Attenuation of hepatic fibrosis and inflammation, as well as anti-atherosclerotic effects suggest that Oxy210 should be further explored as a therapeutic candidate for targeting both conditions " explains Dr. Hui." Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma, comments: "Oxysterol-based molecules have been our treasure-trove, driving the Company's drug discovery efforts across several therapeutic indications", adding that "Surprisingly, Oxy210 acts a bit like a Swiss-army knife by combining anti-inflammatory, anti-fibrotic, and lipid-lowering effects, a rare combination of helpful properties". Additional pre-clinical studies required by the FDA for clinical development of Oxy210 are currently underway at MAX BioPharma and the Company is seeking strategic partnerships with biotechnology and pharmaceutical companies with the expertise and resources to further the development of oxysterol-based molecules towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A tranche financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for MASH, a condition with currently only one FDA-approved treatment, indicated for non-cirrhotic MASH and apparently effective in less than 30% of patients. Nevertheless, with dozens of failed clinical drug candidate in this field, this first ever FDA-approved drug reintroduced some degree of hope for people suffering with this condition, once considered untreatable" says Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma, adding "we hope to continue the advancement of MASH therapeutics with our novel drug candidate". About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel small molecule lipids as drug candidates for intervention in debilitating and fatal human diseases. The company will be a leader in a new field of Oxysterol Therapeutics® by leveraging a robust and growing intellectual property portfolio that will lead to treatments for numerous indications. MAX BioPharma's first success based on small molecule lipids has contributed to the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGF-b pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung and pancreatic cancer, and hematologic malignancies, as well as fibrotic diseases of liver, lung, and kidney among others. For more information, please visit us at Media Contact: Farhad Parhami [email protected] SOURCE MAX BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED