BioBehavioral Diagnostics Secures $8.5 Million Series A Financing.Funds Will Support Commercialization of Proprietary Diagnostic Products for the Objective Assessment of ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or and Measurement of Response to Medication CAMBRIDGE, Mass. -- BioBehavioral Diagnostics Company (BioBDx) announced today that it has secured an $8.5 million Series A financing co-lead by Sevin Rosen Funds Sevin Rosen Funds (SRF) is a venture capital firm that was established in 1981 by L.J. Sevin and Ben Rosen. SRF was involved in the financing of ArQule, CIENA, Citrix, Cypress Semiconductor, Electronic Arts, Lotus Development Corporation, Silicon Graphics, and Vitesse. and Tullis-Dickerson. BioBDx has created a proprietary diagnostic system for objectively measuring the core components of Attention Deficit Hyperactivity Disorder attention deficit hyperactivity disorder (ADHD), formerly called hyperkinesis or minimal brain dysfunction, a chronic, neurologically based syndrome characterized by any or all of three types of behavior: hyperactivity, distractibility, and impulsivity. (ADHD) to aid clinicians in accurate diagnosis. The BioBDx solution provides precise measures of symptom severity to systematically evaluate a patient's response to either a given dose and type of medication or to a non-pharmacological treatment, which can then be compared to a large database containing normal data to determine whether a given treatment is producing full or partial improvement. The product is expected to be commercially available in 2008. The company's lead product -- the McLean Motion and Attention Test for Attention Deficit Hyperactivity Disorder (MMAT/ADHD[TM] System) -- is a non-invasive, FDA-approved diagnostic system that provides objective and precise measures of the core symptoms of ADHD: inattention in·at·ten·tion n. Lack of attention, notice, or regard. Noun 1. inattention - lack of attention basic cognitive process - cognitive processes involved in obtaining and storing knowledge , hyperactivity, and impulsivity. While stimulant treatment can be remarkably effective in treating ADHD, individual patients can respond variably to different medications and improved diagnostic techniques could enhance outcomes for clinicians and patients alike. "While this fundraising validates the business opportunities for investors, providers, and payors, it is the children, adolescents, and adult patients, along with the parents, who we expect will be the biggest winners," said Eric Gordon, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and founder of BioBDx. "The MMAT/ADHD[TM] System may provide real hope for patients and families who struggle with ADHD and ineffective treatments for ADHD, including medication overuse overuse Health care The common use of a particular intervention even when the benefits of the intervention don't justify the potential harm or cost–eg, prescribing antibiotics for a probable viral URI. Cf Misuse, Underuse. and misuse. Families may save years of disappointment and doubt in attempting to correctly identify and treat this disorder." The funds raised in this financing will allow the company to commercialize its lead product, the MMAT/ADHD([TM])System, which BioBDx anticipates launching in the U.S. in 2008. BioBDx's product portfolio includes ADHD diagnostic systems for children, adolescents, and adults. The MMAT/ADHD([TM])System is currently FDA-approved for use by clinicians for the diagnostic assessment of ADHD and it is now finishing commercial development. In late 2006, the company filed a new Premarket Notification 510(k) with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. seeking marketing approval for the added use of enabling the clinician's systematic evaluation of a patient's response to either a given dose and type of medication or to a non-pharmacological treatment. "Providing clinicians with a non-invasive, office-based method to quantitatively measure the core symptoms of ADHD is winning half the challenge, said Dave McLean, General Partner, Sevin Rosen Funds. "Moreover, helping physicians determine the right drug and optimal dosage as part of an ongoing, personalized patient care will also help increase therapeutic success rates and this is what we believe makes this solution so special." Timothy Buono, a partner at Tullis-Dickerson, noted that, "BioBehavioral Diagnostics is establishing the clinical evidence that the MMAT/ADHD[TM] System could provide payors the means to promote quality care and optimal performance to their members through cooperating providers. The company's research demonstrates that the MMAT/ADHD[TM] System not only objectively measures the physiological changes related to ADHD, but also measures those alterations that affect health outcomes. Moreover, evidence is now accumulating that the positive therapeutic responses as reported by the MMAT/ADHD[TM] System in the clinician's office may be readily replicated outside the office, in the classroom, and in the workplace. These are especially meaningful results for the company and we are excited to be contributing to the product launch in 2008." About ADHD ADHD is a neurobiological neu·ro·bi·ol·o·gy n. The biological study of the nervous system or any part of it. neu ro·bi disorder characterized by developmentally inappropriate impulsivity, attention, and hyperactivity. ADHD is estimated to affect 5-12% of U.S. children and adolescents and another 4-8% of U.S. adults. The medication market for ADHD-related pharmaceuticals in the U.S. has grown from $750 million in 2000 to currently approximately $3 billion. Current behavioral diagnostic methods are subjective and could vary amongst practitioners. Similarly, there currently are no quantitative diagnostic tools to help physicians determine the right medication or evaluate a drug's efficacy for an individual patient. Clinical experience in psychiatry acknowledges the need to increase positive rates of accurate ADHD diagnostic assessments while using the American Psychiatric Association The American Psychiatric Association (APA) is the main professional organization of psychiatrists and trainee psychiatrists in the United States, and the most influential world-wide. Its some 148,000 members are mainly American but some are international. (APA (All Points Addressable) Refers to an array (bitmapped screen, matrix, etc.) in which all bits or cells can be individually manipulated. APA - Application Portability Architecture ) and the American Academy of Pediatrics The American Academy of Pediatrics ("AAP") is an organization of pediatricians, physicians trained to deal with the medical care of infants, children, and adolescents. Its motto is: "Dedicated to the Health of All Children. (AAP AAP - Association of American Publishers ) guidelines. The majority of clinicians who perform the behavioral diagnoses and prescribe medication are pediatricians and general practitioners, rather than psychiatrists or neurologists who specialize in evaluating psychiatric and behavioral disorders. Clinicians require increasingly sophisticated and quantitative measures to improve diagnostic ADHD assessment and therapeutic outcomes. With the advancement of systems that provide rapid, quantitative and objective measures of the symptoms of ADHD, substantial increases in rates and speed of ADHD patient normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record. above the customary community care levels could be expected. About the MMAT/ADHD[TM] System The MMAT/ADHD[TM] System objectively measures a patient's ability to sit still and pay attention, while generating quantitative data that have been directly correlated to brain function and blood flow through functional magnetic resonance imaging functional magnetic resonance imaging n. Abbr. fMRI Magnetic resonance imaging that provides three-dimensional images of the brain based on changes in blood flow and that can be correlated with brain functions. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ) techniques. The MMAT/ADHD[TM] System provides precise, reliable, and reproducible information on symptom severity under controlled conditions that replicate a classroom or employment environment. Through BioBDx's proprietary Behavior Capture[R] System, the MMAT/ADHD[TM] System has been engineered to precisely provide clinically relevant measurements of behavior that manifest from the three core symptoms of ADHD (hyperactivity, impulsivity, and inattention). The MMAT/ADHD[TM] System provides exceptional performance and reproducibility, and promotes vastly improved patient outcomes. The BioBDx product portfolio includes ADHD diagnostic systems for children, adolescents and adults. The MMAT/ADHD[TM] System was invented by Martin H. Teicher, M.D., Ph.D., the director of the Developmental Biopsychiatry Research Program at McLean Hospital since 1988. McLean Hospital is the largest psychiatric facility of Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. , an affiliate of Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world and a member of Partners HealthCare. About BioBDx BioBehavioral Diagnostics Company (BioBDx) is a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. whose mission is to develop, manufacture, and market proprietary diagnostic systems for the quantitative assessment of behavioral disorders, including the measurement of medication response and the prediction of therapeutic efficacy for a patient. The company's lead product, the McLean Motion and Attention Test for Attention Deficit Hyperactivity Disorder (MMAT/ADHD([TM]) System), is designed to enable clinicians to accurately make office based diagnoses for ADHD, select the right class of medication, and measure therapeutic efficacy of a given drug while determining an optimal dosage. The BioBDx product portfolio includes ADHD diagnostic aid systems for children, adolescents, and adults. The MMAT/ADHD[TM] System is currently FDA approved as an aid for the diagnosis of ADHD. The company anticipates a product launch early in 2008. For more information on BioBDx, please visit http://www.biobdx.com/ |
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