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TBI Overview2020-02-26T19:50:32+00:00

News

Sharad H. Joshi Joins BioDirection, Inc. as President and CEO

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...

BioDirection Receives Breakthrough Device Designation from FDA for Tbit™ System

Portable nanotechnology biosensor has the potential to predict positive CT scans following traumatic brain injury

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...

BioDirection, Inc. Announces Exclusive Worldwide License for Tbit™ System to Diagnose and Monitor Sepsis

Proprietary nanowire technology to be evaluated as potential diagnostic platform for measuring inflammatory biomarkers associated with bacterial infection affecting 30 million people worldwide

BOSTON, Aug. 23, 2018 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 acquired traumatic brain injuries, today announced that the company has obtained an exclusive worldwide license for the use of the Tbit™ System to diagnose and monitor sepsis. The Centers for Disease Control and Prevention (CDC) states, "Sepsis is a complication caused by the body's overwhelming and life-threatening response to infection. It can lead to tissue damage, organ failure and death. Sepsis is a medical emergency. Time matters. When sepsis is quickly recognized and treated, lives are saved." Additionally, it is reported that sepsis is the most expensive condition treated in U.S. hospitals, costing nearly $27 billion in 2018. "Our Tbit System is ultrasensitive and provides actionable results within minutes," said Brian McGlynn, founder and chief technology officer of BioDirection. "Healthcare professionals need to identify a sepsis infection quickly and cannot wait days or even hours to begin effective medical treatment. Whether the patient presents with symptoms in the emergency room or acquires the infection during a hospital stay, our flexible platform is uniquely positioned to provide actionable information to support patient management and...

BioDirection, Inc. Announces Appointment of Dr. Harry E. Rubash as Chairman of Medical Advisory Board

Leading orthopedic surgeon to provide medical insight and guidance as company develops the TbitTM System for objective diagnosis of concussions and other traumatic brain injuries.

Boston, MA Mar 6, 2018 — BioDirection, Inc., a privately held medical device company developing novel and rapid point-of-care products for the diagnosis and management of concussions and other acquired traumatic brain injuries, today announced that the company has appointed Harry E. Rubash, MD, FAOA, as chairman of its medical advisory board. "Dr. Rubash is an exceptional medical professional with a broad vision and perspective in new technologies and improving patient outcomes," said Brian McGlynn, founder, executive vice president and chief technical officer of BioDirection. "Most importantly, he is a proven administrator with powerful leadership skills and we are honored to have him join our team." Dr. Rubash has more than 20 years of experience as a leading orthopedic surgeon, researcher, and educator. He is currently emeritus chief of the department of orthopaedic surgery at Massachusetts General Hospital, and the Edith M. Ashley professor of orthopaedic surgery at Harvard Medical School. Dr. Rubash has been recognized with awards and honors by organizations including the American Academy of Orthopaedic Surgeons, the Orthopaedic Research Society, the Orthopaedic Research and Education Foundation, the Hip Society and the Knee Society. He is widely published, authoring nine major textbooks and over 200 papers, and serves in...

Retired Brigadier General Jack Hammond Joins the BioDirection Military Advisory Board

Executive Director of Home Base to provide insights from 30-year military career to support broader relationship between medical device company and U.S. Department of Defense

Boston, MA Jan 17, 2018 — BioDirection, a privately held medical device company developing novel and rapid point-of-care products for the diagnosis and management of concussions and other acquired traumatic brain injuries, today announced the appointment of retired Brigadier General Jack Hammond to the company’s Military Advisory Board. "As co-chairman of our Military Advisory Board, I am excited about working alongside General Hammond to develop and implement strategies for broadening our relationship with the Department of Defense and the U. S. Military," said Stephen Brackett, director of BioDirection. "General Hammond has a passion for the safety and well-being of our military developed over his distinguished career in the U.S. Army. We are indeed fortunate to have a man of his experience on our team." During his distinguished 30-year military career in the U.S. Army, General Hammond commanded troops at the platoon, troop, battalion, and brigade level both at home and abroad, becoming the first Massachusetts officer to achieve the rank of general officer in a combat theater since World War II. Currently, he is the Executive Director of Home Base, a Red Sox Foundation and Massachusetts General Hospital Program that is dedicated to healing the invisible wounds of war affecting service...

NCAA Collegiate Sports Leader Gene DeFilippo and Head Lacrosse Coach at University of Virginia, Lars Tiffany, Join BioDirection Sports Advisory Board

Managing Director of Turnkey Sports and Former Boston College Athletic Director Along with UVA Head Coach Bring Invaluable Sports Expertise to Critical Concussion Protocol Discussion.

Boston, MA Jan 10, 2018 — BioDirection, Inc., a privately held medical device company developing novel and rapid point-of-care products for the diagnosis and management of concussions and other acquired traumatic brain injuries, today announced the appointment of Gene DeFilippo and Lars Tiffany to the company's Sports Advisory Board. "As chairman of the BioDirection Sports Advisory Board, I am very pleased to have Gene and Lars bring their expertise in the field of athletics to the company's development efforts. Their decades of experience in the front office and on the sidelines of some of the country's most prestigious Division 1 institutions will provide invaluable guidance, insight and direction to the company as we develop strategies for launching our Tbit™ System in university, inter-scholastic and youth athletic programs," said Stephen Brackett, director of BioDirection, Inc. Mr. DeFilippo is an American sports executive and former college athletics administrator. He is currently managing director at Turnkey Sports and Entertainment and a member of the Board of the National Football Foundation. Mr. DeFilippo served as the athletic director at the University of South Carolina–Spartanburg—now known as the University of South Carolina Upstate—from 1984 to 1987, at Villanova University from 1993 to 1997, and at Boston...

BioDirection, Inc. Closes $2 Million Interim Financing

Financing supports clinical development of company's Tbit™ System for objective, point-of-care concussion diagnosis.

Boston, MA — BioDirection, a privately held medical device company developing novel and rapid point-of-care products for the diagnosis and management of concussions and other acquired traumatic brain injuries, today announced that the company has closed a $2 million interim financing to support clinical development of the Tbit™ System, the first technology positioned to deliver a rapid and objective point-of-care blood test for concussion diagnosis. Participants in the financing include Provident Healthcare Capital, a healthcare focused growth-equity fund, MedScience Ventures, LLC, a U.S./Asia-based fund focused on emerging life science and medical technologies, and other globally recognized leaders in medical technology investment. With this financing, total outside funds raised by BioDirection since the company was founded in 2010 are approximately $12 million. "We are very pleased to have this outstanding group of informed investors join our shareholder list," said Eric Goorno, president and chief executive officer of BioDirection. "Their strong interest in our breakthrough technology is further evidence that our Tbit System is positioned to address a significant area of unmet need and target a major commercial opportunity in the diagnosis of concussions. We look forward to accelerating our clinical development program and advancing to the final stages of FDA regulatory review."...

BioDirection Announces Results from Pre-Clinical Study of Tbit™ System for Detection of Traumatic Brain Injury

Data show potential to accurately and rapidly screen TBI patients and reduce number of unnecessary CT scans. Study awarded best overall abstract in neurotechnology at the International Brain Injury Association's 12th World Congress on Brain Injury.

Boston, MA — BioDirection, Inc., a privately held medical device company developing novel and rapid point-of-care products for the objective detection of concussion and other traumatic brain injury (TBI), announced today results from a pre-clinical study show that the company's Tbit™ System for the detection of TBI is sensitive, provides actionable results in point-of-care settings, and has the potential to reduce the number of unnecessary computerized tomography (CT) scans. The study was recognized with the best overall abstract award in neurotechnology among more than 800 submissions at the International Brain Injury Association's 12th World Congress on Brain Injury, the world's largest gathering of clinicians, scientists, and industry representatives focused on brain injury, held March 29 – April 1, 2017 at the Sheraton New Orleans Hotel in New Orleans, Louisiana. "Early, objective diagnostic testing of patients who have experienced head trauma can support more rapid and appropriate treatment decisions while potentially reducing unnecessary head CT scans," said Eric Goorno, president and CEO of BioDirection. "The Tbit System allows for testing to be performed at the earliest stages of a concussion using a single drop of blood. The results from this pre-clinical study, coupled with our meeting with the FDA to review our...

BioDirection to Participate in 12th World Congress on Brain Injury

Diagnostic platform positioned to be first objective point-of-care blood test for concussion able to provide quantitative results in less than 90 seconds from a single drop of blood.

Boston, MA — BioDirection, Inc., a privately held medical device company developing novel and rapid point-of-care products for the objective detection and monitoring of traumatic brain injury (TBI), announced today that the company will participate in the International Brain Injury Association’s 12th World Congress on Brain Injury to be held March 29 – April 1, 2017 at the Sheraton New Orleans Hotel in New Orleans, Louisiana. Sergey Dryga, PhD, MBA, chief scientific officer of BioDirection, will present results from a pre-clinical study of the company’s Tbit™ System for detection of TBI during the Neurotechnology in Rehabilitation session Friday, March 31st from 3:15-4:45pm CT in the Grand Chenier Room. In addition, BioDirection will present a poster titled, "Development of Silicon Nanowire Technology for Biomarker Testing." "We are excited to be able to present the results of our human frozen serum sample study at the World Congress," said Dr. Dryga. "Participants in this conference include many of the leading clinicians in the field, allowing us to demonstrate the potential of the Tbit System to be used as a flexible and objective tool for diagnosing and monitoring brain injury." The Tbit System is based on proprietary nanotechnology biosensors that are capable of providing rapid...

BioDirection, Inc. Holds Pre-Submission Meeting with FDA

Diagnostic platform positioned to be first objective point-of-care blood test for concussion able to provide quantitative results in less than 90 seconds from a single drop of blood.

Boston, MA – BioDirection, a privately held medical device company developing novel and rapid point-of-care products for the objective detection of concussion and other traumatic brain injury (TBI), announced today that the company has successfully completed a meeting with the U. S. Food and Drug Administration (FDA) to review the company’s Tbit™ blood test Pre-Submission Package. During the meeting company representatives reviewed plans for clinical development of the Tbit™ system as a precursor to commencement of a planned pilot trial. “We are grateful for the opportunity to review the Tbit™ system’s mechanism of action, as well as our plans for clinical research and efforts to position our technology platform in the market place, in a productive conversation with the FDA,” said Eric Goorno, president and CEO of BioDirection. “We left the meeting with a strong consensus on the parameters to be used in our upcoming clinical trials, and we look forward to advancing our development program in the months ahead.” The Tbit™ blood test uses a patented nanotechnology biosensor to rapidly detect and accurately measure protein biomarkers that are released from the brain immediately following a head trauma. The portable technology platform allows for testing to be performed at the earliest...