BOSTON, Sept. 9, 2015 /PRNewswire/ -- Tal Medical, a clinical-stage medical technology company developing an innovative, rapidly-acting treatment for depression and other neuropsychiatric disorders, announced today that the first subject has been enrolled in the dose optimization study.
"Initiating the dose optimization study represents a significant milestone in our strategy to bring a safe, rapidly-acting treatment to patients suffering from major depressive disorder," said Jan Skvarka, Tal Chief Executive Officer. "We look forward to advancing this study and assessing various dosing regimens with the potential to provide significant medical benefits to depression patients."
The randomized, placebo-controlled dosing study will be conducted in 120 patients across multiple sites in the U.S. Topline data are expected in early 2017.
The Company also announced that it has received positive confirmation from the U.S. Food and Drug Administration (FDA) that Tal's dosing study is a nonsignificant risk (NSR) device study. The FDA's NSR designation allows Tal to proceed with the dose optimization study in the U.S. without submitting and obtaining approval of an investigational device exemption (IDE) application because the study, as assessed by the FDA, is not considered to present a potential for serious risk to the health, safety, or welfare of a subject. NSR devices are those that are generally considered to be low risk based on their intended use in the study. Examples of NSR devices include daily wear contact lenses, dental filling materials, and jaundice monitors for infants.
In 2013, Tal received initial proof-of-concept data from a randomized, double-blind, sham-controlled trial in patients with major depressive and bipolar disorders conducted by McLean Hospital, a leading psychiatric research hospital affiliated with Harvard Medical School. In the study, a single 20-minute treatment demonstrated rapid onset of action, substantial effect size, and a strong safety profile. Given this unique, rapid effect of LFMS treatment, the National Institute of Mental Health has selected LFMS for a multi-site clinical trial. The trial is examining the efficacy and durability of the treatment over an extended period of time in patients with major depressive disorder.
Depression is one of the most common and serious mental health disorders, affecting more than 350 million people globally. In the U.S. alone, over 270 million antidepressant prescriptions are filled annually and generated over $9 billion in sales in 2012. While there are several treatment options available to clinicians, substantial unmet need remains in depression. Currently approved antidepressant therapies take several weeks to produce response, many patients respond only partially or not at all and often experience significant adverse events. As a result, depression is the leading cause of disability and suicide worldwide.
Tal Medical is a clinical-stage medical technology company developing Low Field Magnetic Stimulation (LFMS) of the brain for the treatment of depression and other neuropsychiatric disorders. LFMS is a first-in-class, non-invasive neuromodulation technology that has demonstrated a rapid-acting effect in major depressive disorder and bipolar depression. Tal was founded by PureTech Health (PureTech Health plc, PRTC.L), in conjunction with leading scientists in the fields of depression and neuromodulation.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a science-driven healthcare company, seeking to solve some of today's toughest health challenges through disruptive approaches. Based in Boston, Massachusetts, PureTech has a pipeline of 12 operating companies, seven of which are "growth stage" with external validation including strategic partnerships, outside funding, proof-of-concept or peer review in prestigious scientific journals. PureTech is problem-focused and solution-agnostic, looking beyond traditional disciplines and approaching healthcare problems from different perspectives. Focusing on areas of significant unmet medical need, PureTech evaluates more than 650 ideas per year, prioritizing, selecting and testing what it believes to be the most scientifically and commercially promising concepts to advance. PureTech's leading team and board, along with an advisory network of more than 50 experts across multiple disciplines, gives PureTech access to potentially groundbreaking science and technological innovations. For more information, visit www.puretechhealth.com and connect with us on Twitter.
PureTech has holdings of 54.3% in Tal on a diluted basis. This calculation of PureTech's holding includes issued and outstanding shares as well as options to purchase shares, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans.
Forward Looking Statement
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SOURCE Tal Medical