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

News

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...

BioDirection, Inc. Files Pre-Submission Package With FDA

Diagnostic platform positioned to be 1st objective, point-of-care blood test for concussion providing 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), today announced that it recently filed a Pre-Submission ("Pre-Sub") Package with the FDA as a critical step toward commercialization of its proprietary Tbit™ diagnostic platform. BioDirection's Pre-Sub meeting with FDA to discuss clinical plans and protocols for the company's Tbit™ system, which is a necessary precursor to commencement of clinical trials, has been scheduled for November 2016. "This Pre-Sub filing is a critical milestone in the path to commercialize our game-changing technology," said Eric Goorno, President & CEO of BioDirection. "Tbit™ is truly a disruptive diagnostic platform which has the potential to revolutionize the detection, diagnosis and management of a concussion. We look forward to commencing our clinical trials and advancing to the final stages of FDA regulatory review and product registration." The Tbit™ system 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 system allows for testing to be performed at the earliest stages of medical diagnosis and intervention. Early objective diagnostic testing of patients...

BioDirection, Inc. Closes $4 Million Series B Financing

Financing to support final stages of development program for Tbit™ (traumatic brain injury test) technology, designed to aid in diagnosis of concussions and other brain injuries in less than 90-seconds at point-of-care.

Boston, MA – (PRNewswire) – BioDirection, Inc., a privately held medical device company developing novel and rapid point-of-care products for the objective management of concussion and other traumatic brain injury (TBI), today announced that it has closed over $4 million in a Series B Convertible Preferred Stock financing. With the Series B round, the total funds raised by the company are approximately $10 million. BioDirection expects to use the funding from the financing round to accelerate execution of the final stages of development and plans for commercialization for Tbit™, the company's technology platform designed to provide rapid point-of-care diagnosis of concussions and other TBI. Participants in the financing included Provident Healthcare Capital, a healthcare focused growth-equity fund, and other globally recognized leaders in medical technology investment, some of whom have established associations with some of the largest hospital systems, providers and payers in healthcare today. The Tbit™ system 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 system allows for testing to be performed at the earliest stages of medical diagnosis and intervention. Earlier diagnosis of a concussion can support more rapid and appropriate...

BioDirection Receives SBANE Rising Star Award

Company selected among 175 nominees for its breakthrough point-of-care concussion test.

Boston, MA – May 14, 2015 — BioDirection, Inc. a developer of groundbreaking point-of care technology for the objective diagnosis, prognosis and monitoring of concussions and other traumatic brain injuries (TBI) was named the 2015 “Rising Star” from the Small Business Association of New England (SBANE) Innovation Awards. Its Tbit™ test, currently under development, will objectively diagnose concussions and other brain injuries from a single drop of blood in less than 90 seconds. The Rising Star Award recognizes companies that are in early stages of development but have clearly demonstrated the validity of their business and the potential for significant growth. Approximately 70 independent judges evaluated more than 175 nominated companies. Past SBANE award winners include Staples, Ben and Jerry’s, Genzyme, Nantucket Nectars and KRONOS. “BioDirection is honored to receive this prestigious recognition from SBANE. The SBANE award process is a rigorous, multi-phased and well-regarded one, and we are proud to join SBANE’s ‘Circle of Excellence’”, said Eric Goorno, President & CEO of BioDirection. “In our case, the Rising Star Award recognizes our company’s innovative approach in helping to address the enormous global medical issues surrounding traumatic brain injury.” A TBI occurs every 15 seconds in the U.S. alone: Resulting in...

BioDirection, Inc. Selected to Present at Cavendish Global Health Impact Forum

Forum uniquely brings together leading family offices and their foundations seeking impact investment, grant-giving, and philanthropy opportunities within health and life sciences

Boston, MA – April 15 2015 – an emerging medical device company focused on the development and commercialization of rapid, affordable point-of-care devices for the early identification of mild traumatic brain injury (concussion), announced today it has been selected to present at the Cavendish Global Health Impact Forum taking place May 10th to May 14th in La Jolla, California. The purpose of the Forum is to help family offices and foundations develop and implement their individual pro-social impact investing, grant-giving, and philanthropy programs within health and the life sciences. To accomplish this mission, the Forum showcases presentations and panel discussions by leading research institutions, accomplished healthcare delivery professionals, health-policy experts and private-sector companies engaged in developing innovations with the potential for transformational impact on disease prevention, diagnosis and treatment. A unique gathering of leading family offices, Cavendish Impact Forums are hosted by leading institutions around the world and take place three times each year. The next Forum is being co-hosted by the community of La Jolla, California including The University of California San Diego, The J. Craig Venter Institute, The Scripps Research Institute, The Sanford-Burnham Medical Research Institute, The Sanford Consortium for Regenerative Medicine, and The Institute of the Americas. Michael...

BioDirection, Inc. to Present at 5th Annual Traumatic Brain Injury Conference

Chief Scientific Officer Sergey Dryga to present the Tbit™ system: a new blood test for the rapid identification of concussion and other traumatic brain injury

Boston, MA – (BUSINESS WIRE) – BioDirection, Inc., a privately-held medical device company focused on the development and commercialization of easy-to-use, rapid, point-of-care devices for the objective identification of acquired brain injury including concussion, today announced it will present at the 5th annual Traumatic Brain Injury Conference being held in Washington, DC on April 16, 2015. The company’s Tbit™ system delivers objective information to aid in the diagnosis of a concussion from a single drop of blood in less than 90 seconds. Additionally, this technology provides emergency room physicians with new actionable data that can help in reducing unnecessary head CT scans, thereby saving time and expense while eliminating radiation exposure to the patient. Sergey Dryga, Ph.D., MBA, Chief Scientific Officer of BioDirection, will be presenting on BioDirection’s new Tbit™ system. "This revolutionary blood test will provide new point-of-care information to significantly improve how concussions and other traumatic brain injury are diagnosed today," asserts Dryga. "Our evaluation of the Tbit™ system suggests that the sensitivity and specificity is superior to existing methods while providing results in less than two minutes." Event: The 5th annual Traumatic Brain Injury Conference Presentation: Thursday, April 16, 2015, 11:40 am (EST Location: 10 Thomas Circle N.W. Washington, DC, Washington...

BioDirection, Developer of Concussion Diagnostic Device, Selected as Finalist in Medtech Innovation Competition

New Tbit™ platform, a rapid, point-of-care diagnostic device for concussion, has been selected as a finalist in Startup Showdown Contest

Boston, MA – (BUSINESS WIRE) – BioDirection, Inc. announced today that its new Tbit™ platform, a rapid, point-of-care device for the objective identification of mild traumatic brain injury (concussion), has been selected by the Medical Device and Diagnostic Industry Journal (MDDI) as a finalist in its first ever Startup Showdown Competition. BioDirection's Tbit™ platform utilizes patented bio-nanowire technology that can detect and measure minute levels of "biomarker" proteins released from the brain after a concussion. The technology provides first-in-class critical and objective information to aid in the diagnosis of a concussion from a single drop of blood in less than 90 seconds. "We are honored to be recognized as a finalist in this competition sponsored by MDDI, one of the preeminent trade journals in the medical device and diagnostic industry. This acknowledgment underscores the urgent need for an objective test for concussions and validates BioDirection's pioneering work to fulfill that need," said Eric Goorno, Chief Executive Officer, BioDirection. "Traumatic brain injury has become a widespread concern, and the Tbit™ platform will provide front-line point-of-care personnel new objective information to aid in the immediate diagnosis of a concussion." About MDDI Medical Device and Diagnostic Industry (MDDI) is an online and print resource....