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BRAINBox Solutions Announces New U.S. Patent Allowance, Strengthening Biomarker Portfolio for Multi-Modal Mild Traumatic Brain Injury Test

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BRAINBox Solutions, Inc announced today that the U.S. Patent & Trademark Office (PTO) issued a notice of allowance for a patent covering methods for detection of mild traumatic brain injury (mTBI), also known as concussion, using Brain Derived Neurotrophic Factor (BDNF). BDNF is an important component of the biomarker panel in the multi-modal diagnostic prognostic and prognostic solutions the company is developing for mTBI.

“BRAINBox’s test is the first to integrate blood biomarkers with functional testing for both the diagnosis and prognosis of mild TBI,” said Donna Edmonds, BRAINBox Solutions’ Chief Executive Officer. “The new BDNF patent is an important addition to our broad, worldwide portfolio of patents covering biomarkers related to various aspects of diagnostic use. Incorporating BDNF into our TBI biomarker panels enhances the competitive advantage of our algorithms to generate an objective TBI score to help guide healthcare decision making.” She noted that BRAINBox Solutions’ current intellectual property portfolio includes 17 issued patents protecting a portfolio of more than 30 proprietary TBI biomarkers and 18 pending applications directed to other novel TBI biomarkers.

The newly allowed patent is based on BRAINBox Solutions’ discovery that a decrease in blood levels of BDNF alone are sensitive and specific in the detection of mild TBI. The claims in the new patent also protect the BDNF discovery alone, and in combination with other biomarkers, including GFAP, S100B, NSE, MT3, and NRGN. The new patent covers both diagnosis of TBI and patient monitoring post-injury, particularly for determining return to work or play. The company’s pending patents also cover patient risk stratification based upon TBI symptoms and the correlation with specific neuroimaging features in CT and advanced MRI. In this context, the results of the TBI biomarker test may be used to justify a more definitive neuroimaging test such as MRI. The work underlying the discoveries in the company’s patent portfolio established important relationships to guide clinical care decisions at multiple steps in the care pathways of TBI, and aid eligibility decisions in clinical trials for treatments for TBI.

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Stephen Liu, M.D., joins Board of Directors

Separately, the company announced that Stephen Liu, M.D., a been appointed to the board of directors. Dr. Liu is a Partner at Uptick Health Advisors and IFG Health Fund, and he serves as an advisor to BioVentures Investors.

“Stephen brings more than 25 years of experience as a physician-entrepreneur, academic orthopedic surgeon specializing in sports medicine and senior clinical advisor to several medical device companies and financial organizations in the U.S. and Asia,” said Ms. Edmonds. “We welcome his insights and guidance as the BRAINBox TBI test nears final clinical development and commercialization.”

The BRAINBOX TBI test is currently undergoing a pivotal clinical trial, HeadSMARTII, in the U.S. and Europe designed to support applications for regulatory clearance and marketing.

Stephen is Chairman/Founder of Forme®. Forme is a smart wearable technology company focused on posture and back health. He has served as a Senior Advisor to OPKO Health and a Senior Advisor to Landenburg Thalman. He also served as a Member of the Board of Directors of Cardo Medical, a publicly traded medical device company that was acquired by Arthrex and served as a clinical advisor to major MedTech companies including J&J and Stryker.

Previously, Stephen was a faculty member at the UCLA School of Medicine and Director of the school’s Bio-skill Laboratory. He and his team commercialized several medical device R&D projects which were later acquired. He has also co-authored seven books, published more than 40 peer reviewed articles and lectured in over 25 countries.

Stephen holds a B.A. in Biology and Psychology and an M.D. from the University of Southern California.

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