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

News

NanoDx Announces Licensing Collaboration with IBM Research for the Design and Manufacturing of Nanoscale Sensors for Rapid Diagnostic Testing

NanoDx System pursuing FDA Emergency Use Authorization to expand rapid COVID-19 testing

Boston, MA - NanoDx, Inc., a privately held medical device company developing breakthrough, point-of-care diagnostic solutions, today announced a licensing agreement with IBM Research for use of its metal-oxide semi-conductive ("CMOS") compatible nanoscale sensors to enhance and expand accurate, rapid testing for several indications, including COVID-19, Traumatic Brain Injury (TBI), Sepsis and Stroke. NanoDx is pursuing an Emergency Use Authorization from the U.S. FDA for rapid, two-minute, point-of-care COVID-19 testing. "The field of diagnostics has changed rapidly during the past year with the emergence of COVID-19," said Sharad Joshi, President and Chief Executive Officer of NanoDx. "This global pandemic has further highlighted the need for a convenient, fast and accurate diagnostic so proper treatments can be delivered to patients as quickly as possible with the goal of shortening recovery times. As we move forward, our access to IBM's technology in the in vitro diagnostics and biosensor fields will enable us to pursue developing a high throughput diagnostics platform at a significantly lower cost." NanoDx is commercializing a real-time, point-of-care diagnostics platform capable of detecting and quantifying biomarkers (analytes) from a small fluid specimen in less than two minutes. The company has built an extensive intellectual property portfolio around its nanosensor...

NanoDx Announces Collaboration with the Home Base Program

Focused on identification and management of the long-term issues associated with Traumatic Brain Injury in both active and retired military personnel.

Boston, MA - June 15, 2021 – NanoDx, Inc., a privately held medical device company developing cutting-edge and rapid, point-of-care diagnostic products for the objective diagnosis and management of Traumatic Brain Injury (TBI), today announced that it has formed a partnership with the Home Base Program to increase the awareness of the long-term issues associated with TBI in both active and retired military personnel. “Early detection of TBI is critical in minimizing the long-term effects of injuries sustained in training or deployment,” stated James Wylie, Executive Chairman of NanoDx. “Our handheld NanoDx™ System was designed for rapid, point-of-injury diagnosis and is capable of delivering a direct test result in less than 2 minutes from a drop of whole blood.” Home Base, a Red Sox Foundation and Massachusetts General Hospital Program, is dedicated to healing the invisible wounds of war through world-class clinical care, wellness, education, and research.  As a National Center of Excellence, Home Base operates the first and largest private-sector clinic in the nation devoted to providing life-saving clinical care and support for the treatment of post-traumatic stress, traumatic brain injury, anxiety, depression, and other issues associated with military service. Michael Allard, Chief Operating Officer of Home Base commented, “Home...

NanoDx gets $18M to pursue fast, easy COVID-19, TBI tests; aims for market shortly

Widespread point-of-care (POC) and at-home diagnostics have long been widely held goals. However, that hasn’t been widely translated into reality. Startup Nanodiagnostics Inc. has been working for years toward a panel of POC tests, helmed by one for traumatic brain injury (TBI) that was quick, simple and accurate enough to use at the sports stadium or on the sidelines of a soccer field.

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

BioDirection®, Inc. Closes $18 Million Series C Financing Led by Shepherd Kaplan Krochuk, LLC

Boston, MA – BioDirection®, Inc. d/b/a NanoDiagnosticsTM, Inc. (NanoDxTM), a privately held medical device company developing cutting-edge and rapid point-of-care in-vitro diagnostic products for the objective detection, diagnosis and management of Traumatic Brain Injury (TBI), virus detection and inflammatory disease today announced that it has closed an $18 million Series C Convertible Preferred Stock Financing. The financing was led by the Alternative Investment division of Shepherd Kaplan Krochuk, LLC (SKK), a diversified Wealth and Asset Management firm located in Boston, Massachusetts. Mr. Steve Brackett, President and Managing Member of SKK, commented "The global need for rapid, definitive and efficient diagnostic technologies has never been greater than it is currently. NanoDxTM fits SKK's investment strategy, which focuses on cutting-edge, proprietary technology platforms addressing large endemic issues and conditions in the global markets. We are impressed by the depth and breadth of NanoDx' s current products and development plans, and we are excited to be working with such an experienced and visionary team." "Based on the high level of interest and SKK's leadership in the financing, our shareholders approved an increase in the oversubscribed initial financing, originally targeted to be $15 million USD, to $18 million USD in May 2020. SKK now...

Brain Injuries Are Common in Battle. The Military Has No Reliable Test for Them.

Traumatic brain injury is a signature wound of the wars in Iraq and Afghanistan. But the military still has no objective way of diagnosing it in the field.

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

Still Misunderstood: How Traumatic Brain Injuries Affect America’s Veterans

DoD guidance and the latest traumatic brain injury research, led to an overhauling of how TBIs are assessed and managed in the military.

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

Top 10 NanoTech Solution Companies – 2020

Enterprise Technology Review

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

BioDirection, Inc. Appoints Dr. Jean-Luc Boulnois to its Board of Directors

Facility to manufacture key nanosensor component of the Tbit™ System

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...

BioDirection, Inc. Announces Manufacturing Facility in Albuquerque, NM

Facility to manufacture key nanosensor component of the Tbit™ System

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...

BioDirection, Inc. Announces Move of Corporate Headquarters to Southborough, Massachusetts

Concussion diagnosis and management company has established its commercial base of operations in Massachusetts

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...