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U.S. troops at Ayn al Asad Air Base in western Iraq hunkered down in concrete bunkers last month as Iranian missile strikes rocked the runway, destroying guard towers, hangars and buildings used to fly drones. When the dust settled, President Trump and military officials declared that no one had been killed or wounded during the attack. That would soon change.

*The NanoDx^™ System has not been evaluated by the FDA or other regulatory agencies. BioDirection^® DBA NanoDiagnostics^™ & NanoDx^™

Former Green Beret Adam Smith had eight concussions during his 17-year career in the National Guard, which included deployments to Bosnia and Afghanistan. To him, traumatic brain injury means more than the short-term memory problems that make him put tracking devices on his keys, phone and other everyday items so he can find them again.

*The NanoDx^™ System has not been evaluated by the FDA or other regulatory agencies. BioDirection^® DBA NanoDiagnostics^™ & NanoDx^™

Enterprise Technology Review Nanotechnology has become increasingly a reality nowadays, and along with it there is a need for discussions related to potential advances, as well as the impacts on the environment and human health that technology can cause. Unprecedented opportunities are arising for re-engineering existing products. For example, clusters of atoms (nanodots, macromolecules), nanocrystalline structured materials (grain size less than 100 nm), fibers less than 100 nm in diameter (nanorods and nanotubes) and films less than 100 nm in thickness provide a good base to develop new nanocomponents and materials. Nanotechnology is rapidly gaining traction across a range of industries, from agriculture to water treatment to energy storage. While nanotechnology was first developed in 1959 as a way of manipulating matter at the atomic and molecular level, it wasn’t until the early 2000s that it really began to flourish. Today, nanotechnology is one of the most innovative, cutting-edge areas of scientific study and it continues to advance at staggering rates.

*The NanoDx^™ System has not been evaluated by the FDA or other regulatory agencies. BioDirection^® DBA NanoDiagnostics^™ & NanoDx^™

Boston, MA - BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other traumatic brain injuries, today announced that Jean-Luc Boulnois has joined the company's Board of Directors. Dr. Jean-Luc Boulnois is the President & CEO of Quadrature Inc., an advisory firm in the medical devices space that provides strategic and operational expertise to early-stage entrepreneurs, as well as CEOs of mid-market commercial stage companies. Dr. Boulnois brings over 30 years of international leadership experience in the medical device industry. He has developed early-stage companies, participated in an initial public offering, and led several mergers, acquisitions, and financing rounds. Dr. Boulnois principally focuses on managing high growth opportunities, either through innovation, unique business models, or strategic and international expansion. Dr. Boulnois was involved with Microline Surgical for over 18 years, first as an investor and later as CEO and Executive Chairman, during which he drove a period of compounded revenue and profit growth exceeding 15% year over year. His previous experience also includes senior level positions at Dover Medical Ventures, Interactive Consulting, Sometec, Technomed International, as well as Arrow International where he served as a Director of...

Boston, MA - BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other traumatic brain injuries, today announced that the company has leased a 9,000 sq. ft. facility in Albuquerque, New Mexico to manufacture a critical component of its proprietary biosensor cartridge. "We anticipate that our new facilty will be fully operational within the next several months," said Sharad Joshi, President & CEO of BioDirection. "The plant is a critical step in our commercialization of the Tbit™ System. We have elected to establish in-house manufacturing to ensure our first product meets all targeted criteria for consistency and reproducible quality. Timing is critical since we anticipate entering the European market in 2020 and the U.S. market by the middle of 2020 following FDA clearance." The company's Tbit System is based on a proprietary nanotechnology biosensor to rapidly detect and accurately measure protein biomarkers that are released from the brain immediately following a head trauma or jolt to the body. The portable system allows for testing to be initially performed in the emergency department and eventually, after receipt of further FDA clearances, at the point of injury. Early diagnosis...

Boston, MA - BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other traumatic brain injuries, today announced that the company has leased a 5,000 sq. ft. facility in Southborough, Massachusetts for its new corporate headquarters. The facility will house executive offices as well as finance, marketing, sales, customer service and business development functions. "Our new facilty is now fully operational. We anticipate staffing at this location will reach as many as 30 employees (within the next two years) as we prepare to launch our first product in 2020 pending regulatory clearance,” said Sharad Joshi, President & CEO of BioDirection. “Relocation of the corporate headquarters from Tuscon, Arizona is a critical step in establishing roots in one of the country's leading med-tech center concentrations. Availability of highly trained and experienced medical technology field personnel was a key motivating factor in our decision along with access to leading clinicians and physicians in the field of traumic brain injury and inflammatory disease." BioDirection's new corporate address is: BioDirection, Inc. 144 Turnpike Road, Suite 110 Southborough, MA 01772 Tel: +1 508.599.2400 The company's Tbit System is based on a proprietary...

Boston, MA - BioDirection, Inc., a privately held medical device company developing rapid, whole blood based point-of-care products for the diagnosis and management of concussions and other traumatic brain injuries, today announced that the company has signed a multi-phased technical collaboration agreement with the coordinator (Anwerp University Hospital, Belgium) of CENTER-TBI (Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (www. center-tbi.eu) for the evaluation and development of the Company's proprietary Tbit™ System. CENTER-TBI represents a focused European effort, supported by the European Union (FP7 Grant 602150) to advance the care of patients with TBI within the broader international framework of InTBIR (International Traumatic Brain Injury Research initiative: https://intbir.nih.gov/). The project includes a large scale observational study, which initially involved 65 medical centers in 20 EU countries, later supplemented by non-EU based medical centers in China, Australia and India. The CENTER-TBI Core Study collected detailed clinical and neuroimaging data and blood sample from approximately 4,550 patients in Europe and Israel. Andrew Maas, Co-Chairman of the Center-TBI Management Committee, commented "Although we are an EU supported organization, we have global objectives. First, to improve characterization and classification of TBI with inclusion of emerging technologies, such as biomarkers; and secondly, to identify the most...

BioDirection is excited to be exhibiting at this year's 2019 MEDICA Conference in Düsseldorf, Germany! Please visit us on November 18th - 21st in Hall 3, Booth C36-4 to learn more about BioDirection's Tbit™ System that uses a hand-held analyzer and single-use cartridge to deliver real-time, point-of-care diagnosis of traumatic brain injury in 90 seconds from a single drop of blood. The BioDirection Tbit™ System is currently for investigational use only. Visit us online at http://biodirection.com/

Boston, MA – (PRNewswire) – BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the diagnosis and management of concussions and other acquired traumatic brain injuries, today announced that Sharad H. Joshi has joined the company as President and Chief Executive Officer (CEO). "Mr. Joshi is a proven, entrepreneurial medical device executive with a solid track record of driving global growth and laying strategic foundations for sustained success as CEO of multiple medical technology businesses," said James Wylie, Executive Chairman of BioDirection. "His diverse background includes in-depth experience in research, product development, engineering, sales and marketing, global scaling of distribution channels, operations, quality and regulatory, partnerships and alliances." Prior to joining BioDirection, Mr. Joshi served as CEO for Bio-Chem Fluidics and President and CEO of Microline. He also co-founded Blue Torch Medical Technologies, Inc. and held multiple positions in product engineering, marketing and sales at Uromed, Inc. and Boston Scientific. Mr. Joshi holds an MSME, Mechanical Engineering and Pre-Med with a Biology minor from Northeastern University and an MBA, Entrepreneurship Studies from Babson College's Olin School of Business. "It is a pleasure to join BioDirection at this critical point of time in the commercialization of the Tbit™ System," said Mr. Joshi. "Tbit is...

Boston, MA – (PRNewswire) – BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other acquired traumatic brain injuries, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Tbit™ System for the prediction of positive computerized tomography (CT) scans following Traumatic Brain Injury (TBI). According to the FDA, the goal of the Breakthrough Devices Program (BDP) is to provide patients and health care providers with timely access to designated medical devices by speeding up their development, assessment and review. "We are pleased to receive this FDA designation and believe it is a clear recognition of the potential advantages of the Tbit System over currently available technology," said James Wylie, executive chairman  of BioDirection. "The Tbit System is designed to measure the body's response to trauma and provide a rapid point-of-care test result in less than 2 minutes from a single drop of blood, while current technology may run 3-4 hours or more and require serum testing in a central laboratory." The Tbit System uses a patented nanotechnology biosensor to rapidly detect and accurately measure protein biomarkers that are released...