Fractures, Ununited

LOS ANGELES, Feb. 26, 2024 /PRNewswire/ -- Today MAX BioPharma, Inc. ( ) and Metaba, LLC ( ) announced their collaboration in studying the effects of oxysterol drug candidates that target non-alcoholic steatohepatitis (NASH), idiopathic pulmonary fibrosis (IPF), chronic inflammation, and atherosclerosis on metabolic processes using Metaba's state of the art metabolomics platform technology. The two companies will employ their unique expertise and assets to identify changes in metabolites induced by oxysterols that may not only further evaluate the mechanism of action for their therapeutic effects, but also identify potential biomarkers for assessment of the efficacy of the compounds or as diagnostic and prognostic tools. "We are extremely excited about this important collaboration between our companies and scientists that will empower MAX BioPharma in its R&D efforts to develop novel drugs for some of the most debilitating and fatal diseases in humans, especially NASH that currently has no FDA approved therapies, IPF that is only modestly affected by the existing FDA approved drugs, and cardiovascular diseases that remain a huge problem despite the use of cholesterol lowering drugs and lifestyle changes. In addition, as we pursue our goals in developing novel drugs, it is imperative that we also find less invasive ways to assess their efficacy both in preclinical models of the diseases and in future human clinical trials" says Farhad Parhami, President and CEO of MAX BioPharma. Dr. Parhami will be presenting the company's recent developments at the 2024 Biocom Global Partnering & Venture Conference that will take place from February 27th-29th in La Jolla, California. Philip Sell, CEO of Metaba explains: "Metabolomics is a powerful research tool. It fills in the missing gap to complete the multi-omics approach to research and is widely applicable to studying diverse biological systems. Our platform can aid development efforts by helping our scientists to understand the underlying molecular mechanisms of pathogenesis, disease progression, therapeutic action, adjunctive targets, and novel diagnostic or prognostic biomarkers. We are enthusiastic about our collaboration with MAX BioPharma and the value that we can add to their already impressive therapeutic development programs. Our companies synergize elegantly with the unique expertise that each brings to the table. We look forward to combining our efforts to make an impact on debilitating diseases and ultimately improving the patient experience." About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel lipid molecules as drug candidates for debilitating and fatal human diseases. The company has created the Oxysterol Therapeutics® platform, which is applicable across numerous therapeutic indications, and is leveraging a robust and growing intellectual property portfolio. MAX BioPharma's first entry into this area was through 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 orally bioavailable small molecule oxysterols that function as anti-tumorigenic Hedgehog and transforming growth factor-beta (TGF-ß) pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung, blood and pancreatic cancer, as well as fibrotic diseases of liver, lung, and kidney, in addition to those that have antiviral activity against hepatitis B and C viruses and coronaviruses. For more information, please visit us at About Metaba, LLC. Metaba is a privately held biotechnology company based in Santa Monica, California. Metaba has created a novel drug discovery platform that combines a high-powered metabolomics analysis pipeline with computer aided drug design methods to expedite preclinical research and development timelines. Metaba was originally founded to develop an adjunctive therapeutic for treatment of tuberculosis (TB). Building upon the methodological approach that their scientists used to identify a novel drug target in TB and their expertise in metabolomics, the platform was born. Metaba has since expanded their capabilities to address several other indications for drug development including nontuberculosis mycobacteria (NTM), immune response to viral infection (Influenza and Covid-19), metabolism of new drugs, and enhancing multiple development programs of MAX BioPharma. The company has focused on developing novel small molecules as drug candidates and is also interested in exploring use cases of its novel metabolomics analysis platform. For more information, please visit us at View original content to download multimedia: SOURCE MAX BioPharma

LEWISVILLE, Texas--( BUSINESS WIRE )-- Orthofix Medical Inc . (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the publication of new data from a prospective, multicenter study investigating Pulsed Electromagnetic Field (PEMF) stimulation as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis. Published in the International Journal of Spine Surgery 1 , patients treated with the SpinalStim ™ bone growth therapy device demonstrated a high rate of successful fusion with significant improvements in pain, function and quality of life, despite having risk factors for pseudarthrosis. “Patients with risk factors such as a prior failed fusion, the need for a multilevel fusion, nicotine use, osteoporosis or diabetes often have a difficult time healing after lumbar fusion surgery,” said lead author Dr. Marc Weinstein, an orthopedic spine surgeon at the Florida Orthopaedic Institute in Tampa, Florida. “These risk factors contribute to complications and pseudarthrosis, which can prolong pain and ultimately reduce quality of life. This data reinforces the use of PEMF stimulation after lumbar fusion surgery to improve outcomes regardless of the patients’ risk factors.” The prospective study conducted at 10 centers across the U.S. analyzed a total of 142 patients with one or more risk factors for pseudarthrosis. Participants were assigned in-home use of the SpinalStim bone growth therapy device for six months following surgery. Fusion was determined by radiographic imaging at 12 months. Successful fusion for patients with one, two or three or more risk factors was 88.5 percent, 87.5 percent and 82.3 percent respectively. Patient reported outcomes that measure disability, function, pain, quality of life, and overall well-being were also evaluated with significant improvements noted when compared to baseline. “The SpinalStim bone growth therapy device provides a noninvasive and cost-effective means to augment spinal fusion procedures that enables the patient to continue their healing at home,” said Kevin Kenny, President, Orthofix Global Spine. “This new data is important as it adds to the body of evidence supporting the use of PEMF for high-risk patients who face challenges with bone fusion healing.” About the SpinalStim Bone Growth Therapy Device The SpinalStim device is the only bone growth stimulation therapy system that is FDA-approved as both an adjunct treatment for lumbar spinal fusion and as a nonsurgical treatment for spinal pseudarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site 2 and has an overall success rate of 92 percent 3 in treating spinal fusion surgery patients. Use of the SpinalStim device is supported by the North American Spine Society’s coverage recommendation 4 . Weinstein MA, Beaumont A, Campbell P, Hassanzadeh H, Patel V, Vokshoor A, Wind J, Radcliff K, Aleem I, Coric D. Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis. Int J Spine Surg. 2023 Oct 26:8549. doi: 10.14444/8549. Epub ahead of print. PMID: 37884337. Zborowski M, Androjna C, Waldorff EI, Midura RJ. Comparison of therapeutic magnetic stimulation with electric stimulation of spinal column vertebrae. IEEE Transactions on Magnetics, Vol. 51, No. 12, December 2105, 5001009. Erratum in IEEE Transactions on Magnetics, Vol. 53, No. 2, February 2017, 9700101. PMA P850007/S6. February 1990. Spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx . About Orthofix Orthofix is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Its products are distributed in approximately 68 countries worldwide. The Company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo, Brazil. To learn more, visit Orthofix.com. Forward-Looking Statements This news release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other comparable terminology. Orthofix cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6, 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov . You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Orthofix does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Latest Study Published in Journal of Clinical Neurosurgery adds to Robust Body of Evidence Supporting Tissue-Sparing Posterior Cervical Fusion to Treat High-Risk Cervical Fusion Patients PLEASANTON, Calif., Dec. 7, 2023 /PRNewswire/ -- Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, today announced a new publication in the Journal of Clinical Neuroscience. Dr. Michael M. Haglund and colleagues authored the publication on the long-term outcomes of patients undergoing tissue-sparing Posterior Cervical Fusion (PCF) to revise a 1-level pseudarthrosis following a failed Anterior Cervical Discectomy and Fusion (ACDF). A recent clinical publication by Dr. Michael Haglund of Duke University found that patients receiving tissue-sparing posterior cervical fusion for the treatment of pseudarthrosis achieved rates of arthrodesis similar to open posterior cervical fusion. The U.S. market opportunity for high-risk cervical fusion surgery is estimated to be $1.4 billion annually.