TCD is a convenient, low-cost, and rapidly repeatable test compared to MR and CT in suspected ischemic stroke. However high sensitivity and specificity are demonstrated only in the proximal anterior circulation. In a cohort of 48 patients with angiographic proven occlusion TCD had an overall sensitivity of 83% and specificity of 94%, with sensitivity optimal in the proximal ICA (94%) and MCA (93%), and significantly less in the terminal VA (56%) and BA (60%).1
Abnormal ICA, MCA, or ACA Waveform Types
Dampened signal: Pulsatile flow with normal flow acceleration and decreased MFV ( 30% difference between hemispheres); any PI values.
Blunted signal: Delayed flow acceleration with stepwise maximum velocity arrival during mid to late systole compared with contralateral side and focal decreased MFV and positive end-diastolic flow Minimal signal: Presence of a flow signal with no end diastolic flow; PI 1.2.
Absent signal: No detectable flow at 40- to 65-mm depths (toward the probe) via transtemporal window (double-checked with insonation from contralateral window across midline at depths of 80 to 100 mm).2
TCD offers a noninvasive method to assess and classify the grade of shunting through a microembolic signals (MES) grading scheme, which can also help stratify patients according to risk of stroke.1
Contrast TCD is comparable to contrast TEE for detecting right to left shunts due to PFO (Type A, Class II evidence). TEE is superior to contrast TCD since it provides direct anatomic information regarding the site and nature of the shunt or presence of an ASA. While the number of microbubbles reaching the brain can be quantified by TCD, the therapeutic impact of this additional information is unknown (Type U).2
The test is positive for right-to-left shunt if a shower of high signal material (air) is detected in the MCA by TCD five to 10 seconds after the intravenous injection of 10 mL of agitated saline. If this shower of air emboli is detected after a minute of injection, it might indicate the presence of a pulmonary shunt; a diagnosis that cannot be obtained by TEE.2
INDICATION | SENSITIVITY (%) | SPECIFICITY (%) | REFERENCE STANDARD |
---|---|---|---|
Right to Left Cardiac Shunts | 70-100 | >95 | Transesophageal echocardiography |
TCD is probably useful to detect cerebral microembolic signals in a wide variety of cardiovascular/ cerebrovascular disorders/procedures including Coronary Artery Bypass Graft (CABG), Coronary intervention, Carotid Endarterectomy (CEA) and Trans Aortic Valve Repair (TAVR) procedures. (Type B, Class II-IV evidence). 1
INDICATION | SENSITIVITY (%) | SPECIFICITY (%) | REFERENCE STANDARD |
---|---|---|---|
Cerebral Microembolization | – | – | Experimental model, pathology, magnetic resonance imaging, neuropsychological tests |
However, data at present do not support the use of TCD for diagnosis or for monitoring response to antithrombotic therapy in ischemic cerebrovascular disease in these settings (Type U).1
Microemboli traveling along an insonated vessel will appear as high intensity transient signals (HITS) on the TCD spectrum.2
The delayed vasospasm of the cerebral vasculature is angiographically proven in up to 70% of cases of SAH and usually occurs 4 to 17 days after hemorrhage. It has significant implications on mortality and morbidity with approximately 25% of SAH patients developing delayed ischemic deficits due to vasospasm.1
Angiography is the gold standard for detecting vasospasm but is an invasive technique and unsuited to dynamic monitoring. TCD, however, is non-invasive, portable, and able to dynamically assess vasospasm and monitor the effectiveness of intervention. Conventionally, serial TCD measurements are performed daily after SAH.1
Vasospasm following subarachnoid hemorrhage is typically associated with increase flow velocity (FV) within intracranial vessels.2
TCD identifies MCA and BA vasospasm with a high sensitivity and specificity. A systematic review of 26 studies comparing TCD with angiography found that MCA MFV >120 cm/s was 99% specific and 67% sensitive to angiographic vasospasm of ≥ 25%. In a retrospective study of 101 patients, MCA MFV >120 cm/s was 72% specific and 88% sensitive for ≥33% angiographic vasospasm with a negative predictive value (NPV) of 94% for MFV <120 cm/s. In the same study, MFV >200 cm/s was 98% specific and 27% sensitive with a positive predictive value (PPV) of 87% for angiographic vasospasm of ≥33%. Therefore, MFV <120 cm/s and >200 cm/s may accurately predict absence and presence of angiographic MCA, vasospasm, respectively. 2
Mean FV obtained by TCD was found to correlate well with the residual lumen diameter of the MCA, and it has high specificity (100%) and good sensitivity (58.6%) in diagnosing vasospasm only due to the involvement of vessels that are not evaluated by TCD at times.1
INDICATION | SENSITIVITY (%) | SPECIFICITY (%) | REFERENCE STANDARD |
---|---|---|---|
Vasospasm after Spontaneous Subarachnoid Hemorrhage |
69 | 83 | Conventional angiography |
Intracranial ICA | 100 | 97 | – |
MCA | 100 | 93 | – |
ACA | 71 | 85 | – |
Includes the dual channel Lucid System, one 2-MHz Handheld Transducer, one remote control and one AC Power Adapter.
For use with the Lucid System
For use with the Lucid System
For use with the Lucid System
For the Lucid System
Provides the ability to mount the Lucid System on a Lucid System compatible medical cart.
Lucid System compatible
Lucid System compatible
Vice President of Finance
Mahmoud brings to Neural Analytics over 25 years of finance leadership in various industries, and over 15 years in the Medical Devices Industry. His areas of expertise include strategic planning, controllership, cost management, organizational growth, process improvements, systems implementation, and helping companies grow exponentially through both organic growth and M&A. Prior to joining Neural Analytics, Mahmoud was the head of finance for the Newborn Care strategic business unit of Natus Medical, Inc where he was a member of the leadership. Prior to Natus, Mahmoud held a Sr. Director of Financial Planning at Hansen Medical where he assisted in the commercialization of the first robotic system to treat Atrial Fibrillation, a Director of Finance at Medtronic Inc., and a Director of Financial Planning and Analysis at Kyphon Inc. where he assisted in the companies exponential growth until the company was acquired by Medtronic. Prior to medical devices, Mahmoud held various finance and controllership positions at Coherent Inc, Harris Corporation, Hewlett Packard, Ampex Corporation, and IBM WTC. He holds a Bachelor of Science in Accounting and Finance, and an MBA from Pepperdine University.
Chief Operating Officer
Henry Hewes is Chief Operating Officer for Neural Analytics. He comes to the team with over 15 years of commercial experience. Prior to Neural Analytics Henry held roles of increasing executive leadership responsibilities at Medtronic including Director of Global Marketing for the Acute Ischemic Stroke Neurovascular Business. Henry earned is Masters in Marketing and Corporate Strategy from The Carlson School of Management at the University of Minnesota.
Chief Product Officer
As a Senior Executive in the medical device industry, Art has a proven track record of delivering high quality, clinically impactful products. As Chief Product Officer for Neural Analytics, Art drives the development of new products from inception through post-delivery support. From targeted technology development through customer focused product development, Art’s responsibility is to ensure that Neural Analytics customers have best in class products to help them deliver better care to their patients. Art has over thirty years of high reliability, critical system development management experience including Class I, Class II, and Class III medical devices. Prior to joining Neural Analytics, Art was Vice President of R&D for Stryker / Physio-Control. Previous to Physio-Control, Art was Vice President of Engineering at FujiFilm SonoSite. In addition to driving innovation in new products and processes, Art has been instrumental in ensuring that M&A actions are smoothly integrated into the business while maintaining and expanding innovation and development capabilities. Art has also served in senior leadership roles in the Aerospace and Commercial Software industries. Art is a native of Washington State and has a Bachelor of Science in Electrical Engineering from the University of Washington.
Board Director
Yuri is the Managing Director of 37Ventures, a venture fund focusing on growing early-stage startups. He serves on the board of numerous companies, including Neural Analytics. Yuri has over 20 years of experience in the development, capitalization and growth of emerging technology companies. From 1993 to 2008, Yuri founded and held executive roles in Xylan, Access360, 5square, Folsom Lake Nissan. He was instrumental in driving the sale of Access360 to IBM in 2002.
VP of Engineering
Jay is VP of Engineering and is responsible for bringing products to market at Neural Analytics. He joined the company in 2015 and has over 25 years of medical device product development experience.
Board Member
Leo is the co-founder and CEO of Neural Analytics, Inc. Prior to starting Neural Analytics in 2013, Leo was the co-founder and CTO of Custom Nanotech Consulting and Director of Nanofabrication at Nabsys. Leo earned his MBA from the UCLA Anderson School of Management in 2014 and earned his PhD & MS in Biomolecular Nanotechnology & Solid-State Device Physics as an NSF IGERT fellow at Arizona State University in 2007. He also holds a double B.S. in Electrical Engineering & Biomedical Engineering from California State University, Long Beach.
Co-Founder & Chief Executive Officer
Leo is co-founder and CEO of Neural Analytics.
Prior to Neural Analytics, Leo obtained his MBA from UCLA Anderson and his PhD in biomolecular nanotechnology as an NSF IGERT fellow.
EVP Corporate Development
Mr. Anjan Chatterji is EVP of Corporate Development and Strategy at Neural Analytics and was a former board member from 2015-17. He is an educated lawyer and economist with over 10 years’ experience focusing on solely on the cycle of drug and device development and eventual monetization – he has several related portfolio companies as well as companies he self-founded. He has been a partner/director at major law and consulting firms working on valuations and deal transactions (non-dilutive licensing transactions or carve-outs) in the life sciences and medical device sector, as well as a general partner at a venture and fixed income fund, Horatio Washington Ventures, which was an initial investor in Neural Analytics. He has also worked several years in finance working to take several companies IPO and / or M&A. He has been able to raise over $300m in capital for his clients or portfolio companies and brought in over a billion in value through the transactions described above. Mr. Chatterji has a JD/MBA, as well as LLM from Northwestern University and was a graduate student for economic policy at University of Chicago.
EU Business Director
Aaron Green is the EU Business Director for Neural Analytics. Aaron joined the team in 2014 as Director of Business Development where he was in charge of kicking off initial clinical studies and military partnerships. He later served as head of finance and administration at Neural Analytics where he led investor relations and oversaw human resources. Prior to Neural Analytics, Aaron completed a Ph.D. and a Postdoc in computational chemistry at UCLA.
Chief of Quality Assurance and Regulatory Affairs
Javad brings to Neural Analytics 30 years of experience improving quality systems, process efficiency, regulatory compliance, product cost and organizational design, by establishing operational excellence through teamwork, lean six sigma and customer driven quality interaction. Javad served as Global Senior Vice President of Quality Assurance and Regulatory Affairs at Gambro AB. He has extensive knowledge and experience from the QA/RA arena, having operated globally for many years within the medical and diagnostic industry. Prior to joining Gambro, he was the Senior Vice President of Siemens Medical Solutions Diagnostics Division, where he was responsible for global Quality Assurance, Regulatory Affairs, Quality Systems, Health Environment and Safety, Reimbursement and Government Affairs, Medical and Clinical Affairs, and Biostatistics. He also served as a member of the Siemens Medical Solutions Diagnostics Management Group. Prior to joining Siemens, Mr. Seyedzadeh led the Quality and Regulatory functions at Bayer Diagnostics and Toshiba, where he helped create an innovative, worldwide quality management system-encompassing more than fifteen sites in forty-four countries-that made the division an industry leader. Mr. Seyedzadeh serves as a Director of JS Genetics, Inc. He is an advisor to the Food and Drug Administration’s Office of Diagnostics Devices Evaluation and sits on the ADVAMED advisory group.
Board Director
Nick built his first company, Firefly Network, focused on developing and commercializing collaborative filtering in 1995. After selling Firefly to Microsoft in 1999, Nick co-founded one of the first ISPs, PeoplePC, which he took public and merged with Earthlink. Most recently, Nick incubated and helped build several successful startups, including Loot Crate (named Inc. magazine’s “Fastest-Growing Private Company of 2016”) and Pluto TV, a streaming web platform. He holds an MBA from Harvard Business School, an undergraduate degree from Yale, and spent his early career at Goldman Sachs and McKinsey & Company.
Board Director
Dr. Koutouzis joined Magnetar Capital in the spring of 2016. He worked on the equity desk for the first 10 years focused on risk arbitrage investments. Currently, he is a member of the fixed income team, responsible for the underwriting process for structured finance solutions across the life sciences. Prior to Joining Magnetar and to this day, Dr. Koutouzis continues to practice Emergency Medicine at Northwestern Memorial Hospital. In addition to his responsibilities at Magnetar Capital, Dr. Koutouzis co-manages the health care investments at Reimagined Ventures Capital. Dr. Koutouzis graduated from Florida State University with a BS degree in Nutrition/Exercise Science and an MD degree from the University of Miami School of Medicine. Dr. Koutouzis performed his residency and received his graduate degree in Emergency Medicine from Northwestern University.
Board Director
Jeremy is currently the VP, Head of Business Development and Licensing at Novartis. Prior to Novartis, Jeremy was a Managing Director at MPM Capital where he was responsible for leading MPM’s life sciences-focused digital innovation investment strategy. As a serial technology entrepreneur and venture capitalist, Jeremy is a frequent speaker on digital innovation within healthcare and life sciences and is a member of the Advisory Committee for SMART Platforms.org. Jeremy graduated cum laude from Princeton University’s Woodrow Wilson School of Public and International Affairs, with a focus on biotechnology and medical policy.
Board Director
Dongmei is the CEO & IC Chairman of GP Healthcare Capital Co., Ltd. and is responsible for general management. Ms. Ji has 16 years of experience working in financial institutions and over 10 years of experience in equity investment. As a part of her work at GP Capital, Dongmei invested in companies including Sinobioway Medicine and Huayu Landscape. Ms. Ji is also the board director of V-Grass. She holds a master’s degree in biology from Fudan University.
Board Director
Stanton has been Chief Scientific Officer at Edwards Lifesciences since 2008 and also serves as Corporate Vice President, Advanced Technology. Stanton joined the company in 2004, when Edwards acquired Percutaneous Valve Technologies, a company that Stanton helped to found in 1999 and at which he served as President and CEO. Previously, Mr. Rowe was Corporate Vice President of Business Development and Strategic Planning for Datascope and Vice President of Business Development for Johnson & Johnson’s Interventional Systems Division. Stanton is a member of board of directors of InSeal Medical, Ltd., as well as a board member for the Discovery Science Center in Orange County. Mr. Rowe earned his bachelor’s degree from the University of Alabama.
Board Member
Roy is the Executive Director of the UCLA Business of Science Center and a professor at the David Geffen School of Medicine at UCLA. Roy has a background in international finance, banking and real estate, and serves as director of several banks domestically and abroad. In addition, Mr. Doumani has been involved in multiple life sciences startups, including Agensys as a founder, investor and director and Kite Pharma as a founder and current director. Roy graduated from UCLA with a degree in Business and Finance and also earned a law degree from USC.
Chief Medical Officer
Neil Martin, M.D. FAANS, is a neurosurgeon in Pennsylvania at Geisinger Health. He specializes in the research and treatment of brain injury and neurovascular disorders, including arteriovenous malformation, aneurysm and stroke. Over the past twenty years, Dr. Martin and his team have collaborated with colleagues in interventional neuroradiology and stereotactic radiosurgery to treat more than 5,000 patients with central nervous system vascular disorders including aneurysms, arteriovenous malformations, and carotid and intracranial atherosclerosis.
Co-founder, VP Software Engineering
Dan completed his MBA at UCLA Anderson in 2013, Dan cofounded Neural Analytics and now heads product development. Prior to Neural Analytics, Dan was Senior Software Architect for a leading CAD/CAM application.
Co-Founder & Chief Science Officer
Robert is co-founder and CSO. He completed his Ph.D. in Biomedical Engineering at UCLA focused on the analysis of cerebral dynamics. At Neural Analytics, he leads scientific development and strategic direction for the core technology.