New funding will accelerate clinical development of rapid-acting treatment
for psychiatric disorders
Boston, MA – April 21, 2015 -- Tal Medical, a clinical-stage medical device company developing a new treatment for depression and other psychiatric disorders, today announced a $14 million funding round from existing investor PureTech, a new institutional investor, and several prominent individual investors. Tal Medical will use the new funding to drive the company’s clinical research programs in major depressive and bipolar disorders, advance product development and scale up the organization.
“Our new and existing investors understand the game-changing potential for Tal Medical to help people living with depression, bipolar disorder and other psychiatric disorders,” said Jan Skvarka, the company’s President and CEO. “Their support is critical to advancing our efforts towards addressing a major unmet need in psychiatry by developing a safe, rapid-acting treatment for patients.”
Major depressive disorder (also called unipolar depression) and bipolar disorder (also called manic depression) are emotionally crippling diseases, affecting between 9% and 10% of the US adult population. Worldwide, they are the number one cause of disability and suicide. Current antidepressant medications can take 4 to 10 weeks to work, leaving many patients at a risk for suicide or functional impairment. Due to these limitations in current treatment options, Tal Medical hopes to provide a rapid-acting treatment for people with depression. The company is developing a neurostimulation-based treatment, called Low Field Magnetic Stimulation (LFMS), derived from echo-planar magnetic resonance spectroscopic imaging technology. In human clinical trials at McLean Hospital/Harvard University and the National Institutes of Health, LFMS has demonstrated a rapid onset of action without any major side effects in unipolar and bipolar depression patients. A multi-site study funded by the National Institute of Mental Health and led by Massachusetts General Hospital is currently testing the treatment durability. More studies are needed to confirm the early findings and establish optimal LFMS treatment regimen.
Tal Medical also announced the addition of two new team members, Mike Madden and Raju Kucherlapati, PhD. Mr. Madden was hired as the company’s EVP of Product Development. A medical device industry veteran, Mr. Madden brings 25 years of experience across multiple clinical areas. Prior to Tal Medical, he was the EVP of Engineering at NinePoint Medical, a venture-backed imaging company, and has held several senior R&D roles at Boston Scientific, Medtronic and Bard. Dr. Kucherlapati joined Tal Medical’s Board of Directors. He is currently the Paul C. Cabot Professor of Genetics and a Professor of Medicine at Harvard Medical School. Dr. Kucherlapati was the first Scientific Director of the Harvard-Partners Center for Genetics and Genomics, and a co-founder and a Board member of Abgenix (acquired by Amgen), and Millennium Pharmaceuticals (acquired by Takeda).
About Tal Medical, Inc.
Tal Medical, Inc. is a clinical-stage medical device company developing Low Field Magnetic Stimulation of the brain for the treatment of psychiatric disorders. LFMS is a first-in-class, non-invasive neuromodulation technology that has demonstrated a unique, rapid-acting effect in major depressive disorder and bipolar depression. Tal was founded by PureTech, in conjunction with leading scientists in the fields of depression and neuromodulation.
PureTech is a scientifically driven research and development company that conceptualizes, sources, and validates unexpected and potentially disruptive approaches to advance the needs of human health. Based in Boston, PureTech has an outstanding team of scientists, engineers and entrepreneurs, with connections to top tier academic institutions. PureTech has a thematic, problem-driven approach to developing its innovations, proposing non-obvious solutions rooted in academic research and developing them together with a creative group of cross-disciplinary experts. PureTech concentrates on a handful of major initiative areas at a time, generates and proactively identifies and reviews more than 650 technologies per year, and seeks to select only the most technologically and commercially promising concepts to advance. PureTech has active strategic partnerships with forward thinking health and technology companies.
Media & Communications Manager
BOSTON, MA – December 3, 2014 – Tal Medical, Inc., a clinical stage medical device company focused on developing an innovative, non-invasive neurostimulation treatment for psychiatric disorders, today announced the appointment of Atul Pande, M.D., as its Chief Medical Officer, Executive Vice President and a member of its Scientific Advisory Board. Dr. Pande is an industry veteran, who brings to Tal more than 25 years of experience in the fields of psychiatry and neurosciences.
“We are thrilled that Atul decided to join us and lead our clinical development efforts,” said Jan Skvarka, the company’s President and CEO. “This is an exciting time for us, as we are in the process of designing and launching several new clinical trials. Atul’s hands-on experience in trial design, his standing in the psychiatric clinical research community, and his dedication to our cause to find a safe acute treatment for depression and bipolar disorder, will be important in our accelerating scale-up efforts.”
Most recently, Dr. Pande was Senior Vice President and Senior Advisor, Pharmaceutical R&D at GlaxoSmithKline. For more than two decades, he has been active in the development of multiple important Central Nervous System drugs while holding various senior roles in Pfizer R&D, Parke-Davis/Warner-Lambert, and Lilly Research Laboratories. His experience includes drug development, registration, launch and lifecycle management in the areas of anxiety, depression, epilepsy, neuropathic pain, schizophrenia, traumatic brain injury, and Alzheimer’s and Parkinson’s diseases. Dr. Pande is a psychiatrist and fellow of several scientific societies, including the American Psychiatric Association. He began his career as a faculty member at the University of Michigan Medical School where his research focused on mood disorders. He has published over 50 peer-reviewed scientific papers and over 100 abstracts, book chapters, and book reviews.
“These are paradigm shifting times in neurosciences,” added Dr. Pande. “While pharmaceutical companies are hitting a brick wall in their drug development efforts in psychiatry, new emerging neurostimulation-based techniques pursued by medical device companies show great promise in areas such as depression or bipolar disorder. Tal, with its innovative LFMS technology, its promising early clinical data, and a leading team of executives and advisors, clearly stands out in the field.”
Dr. Pande is joining effective as of December 1.
About Tal Medical
Tal Medical, Inc. is a privately-held, clinical-stage medical device company focused on developing low-field magnetic stimulation (“LFMS”) of the brain for the treatment of psychiatric disorders. LFMS is a first-in-class, non-invasive neuromodulation technology that showed a rapidly-acting effect in early human clinical trials in major depressive disorder and bipolar depression. The technology, invented at the McLean Hospital (affiliate of Harvard Medical School), has the potential to redefine the clinical practice of psychiatry, in a similar way as medical devices have done in cardiology, oncology and other clinical areas. Tal was founded in 2010 by PureTech, a science and technology research and development company, in conjunction with leading scientists in the fields of depression and neuromodulation.
BOSTON, April 10, 2014 – Tal Medical, Inc., a clinical-stage company developing breakthrough treatments for psychiatric diseases, has added two industry veterans to its leadership team. Jan Skvarka has joined as the company’s President, CEO and member of the Board of Directors, and Ben Shapiro, MD as a member of the Board of Directors.
Jan Skvarka is joining Tal after spending 14 years with Bain and Company, a leading global management consultancy. As one of Bain’s leading partners in the company’s Healthcare Practice, he advised senior executives of medical device and pharmaceutical companies on issues of strategy and operations, as well as entering and building new businesses. Prior to Bain, he worked with Price Waterhouse Corporate Finance in M&A and capital raising. He holds an MBA from Harvard Business School.
Ben Shapiro, MD is a Senior Partner and Chairman of the Board at PureTech Ventures, a leading healthcare venture creation company. Prior to PureTech, Dr. Shapiro spent 13 years with Merck, most recently as EVP, Worldwide Licensing and External Research, and prior to that as EVP, Basic Research. In his role at Merck, he led research programs resulting in FDA registration of about 25 drugs and vaccines. Previously, he was Professor and Chairman of the Department of Biochemistry at the University of Washington. He received his MD from Jefferson Medical College.
Steve Paul, MD, Tal’s Chairman of the Board and previous acting CEO, is moving into an Executive Chairman role, to further play a hands-on role in the company’s management and capital raising efforts. Dr. Paul is former head of R&D at Eli Lilly, which under his direction developed some of the most successful CNS drugs/medications, incl. Zyprexa® and Cymbalta®. Previously, he served as Scientific Director of the National Institutes of Mental Health. Andrew Miller, PhD, will continue in his role as Tal’s COO. Dr. Miller is also a Principal at PureTech, where he has helped launch several innovative healthcare companies.
“We are very excited to have Mr. Skvarka and Dr. Shapiro join us at Tal” said Dr. Paul. “After recently publishing encouraging human proof-of-concept data, our low-field magnetic stimulation (LFMS) technology has also been selected by the NIMH for their RAPID treatment program evaluating novel rapidly-acting anti-depressant treatments. We are now at a point that we are ready to accelerate our path towards pivotal clinical trials and commercialization. Mr. Skvarka and Dr. Shapiro are industry visionaries, who are bringing to Tal a wealth of expertise in medical devices, neuroscience and in building new, innovative businesses with revolutionary clinical and commercial potential”, added Dr. Paul.
Last year, Tal received proof-of-concept data from a randomized, double-blind, sham-controlled trial in patients with major depressive and bipolar disorders at the McLean hospital, a leading psychiatric research hospital. The data indicate an anti-depressant response within minutes of patients receiving a single 20-minute LFMS treatment. Given this unique, rapid effect of LFMS treatment, the NIMH has selected LFMS for a multi-site clinical trial led by Maurizio Fava, MD, Director of the Clinical Research Program at Massachusetts General Hospital and a world-renowned researcher in psychiatric disorders. The trial will examine the efficacy and durability of LFMS treatment over an extended period of time in patients with major depressive disorder. The need for rapidly acting treatments in depression patients is one of the key unmet clinical needs in the disorder, where anti-depressant drugs typically take 4-6 weeks until the onset of action.
About Tal Medical
Tal Medical, Inc. (www.talmedical.com) is a privately-held, Boston-based medical device company pursuing the development of low-field magnetic stimulation (LFMS) for the treatment of depression and other neuropsychiatric disorders. LFMS is a first-in-class, non-invasive, neuromodulation technology. Tal's table-top LFMS device works through a completely novel mechanism of action compared to any existing depression treatment. LFMS uses an external electromagnetic coil to apply a time-varying magnetic field to the brain, which induces a time-varying electrical field. LFMS uses electric fields that are orders of magnitude lower than those in existing neuromodulation technologies electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). Tal was founded in 2010 by PureTech (www.puretechhealth.com), in conjunction with leading scientists in the fields of depression and neuromodulation. The LFMS technology was licensed from McLean Hospital.
Boston, MA – The National Institute of Mental Health has prioritized the development of a rapidly acting treatment for depression as a key research goal. As a result, NIMH created the Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) program to identify and test promising antidepressant interventions. Tal Medical’s LFMS technology was selected to be tested in the first trial as part of the RAPID program. Historically, depression treatments have focused on molecular-based approaches targeted at a family of neurotransmitters and require weeks of therapy before for a clinical benefit is achieved. Modern science is increasingly associating the pathophysiology of depression, and other neuropsychiatry conditions, with dysfunction in specific brain areas and circuits. Tal Medical Inc. (Tal) is developing an innovative, non-invasive, neuromodulation technology that seeks to normalize this neurocircuitry dysfunction. Tal’s first-in-class Low Field Magnetic Stimulation (LFMS) device is based on a discovery from McLean Hospital, a leading psychiatric research hospital.
“There is a well-documented lack of innovation in the field of antidepressant drug development and LFMS has the potential to break this paradigm and offer patients a clinical profile completely different from that of current therapies” said Steve Paul, M.D., “The sham-controlled data with LFMS indicate an antidepressant response within minutes of patients receiving a single 20 minute LFMS treatment.” Dr. Paul was President of Lilly Research Laboratories at Eli Lilly and Company, where his teams led the development and launch of the current market leading antidepressant, Cymbalta, along with other important psychiatric medicines such as Zyprexa and Strattera. Dr. Paul is the Chairman and a Co-founder of Tal. “We look forward to building on our exciting clinical data on LFMS via the RAPID program. The selection of LFMS as the first treatment to be tested brings significant validation to the technology,” added Dr. Paul.
Depression is one of the most common and serious mental health disorders, affecting 6-7% of the US adult population annually. Over 270M antidepressant prescriptions are filled annually and generated over $9B in sales in the US in 2012. While there are many treatment options available to clinicians, all currently available antidepressants require several weeks to work and unfortunately, many patients respond only partially or not at all. The time delay of response and the refractory nature of depression can lead to tragic outcomes like severe disability and suicide.
“A therapy that acts quickly would be a major step forward for the field given the significant time lag to onset of current therapies” said Maurizio Fava, MD, Executive Vice Chair of the Department of Psychiatry at the Massachusetts General Hospital (MGH) and Executive Director of the MGH Clinical Trials Network and Institute (CTNI). “We are delighted to be part of the RAPID program to help develop the next generation of antidepressant therapies, and particularly excited to be testing this intriguing technology which has the potential to help so many patients.”
The National Institute of Mental Health (NIMH) Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) program put together a steering committee of independent key opinion leaders and staff from both NIMH and MGH to evaluate the top industrial and academic proposals for novel drug and device treatments. Of all the treatments reviewed, Tal’s LFMS technology was selected as the most promising, innovative treatment option, and NIMH is funding a 90-subject proof-of-concept study comparing LFMS to sham treatment to assess its rapid antidepressant efficacy in patients with treatment resistant Major Depressive Disorder. The MGH was awarded National Institute of Mental Health contract #HHS-NIH-2011-00006I to conduct the multi-site clinical trials as part of the RAPID program. The LFMS RAPID trial has launched and is currently recruiting patients (www.clinicaltrials.gov) at six leading academic medical centers: The Massachusetts General Hospital, Yale University, Mount Sinai School of Medicine, The University of Texas-Southwestern Medical Center, Emory University and the University of Alabama-Birmingham.
Depression is a disabling mental illness characterized by persistent feelings of sadness, hopelessness, irritability, loss of interest, fatigue, sleep disruption, pain and suicidal thoughts, among other symptoms. These symptoms interfere significantly with normal social, family, and work functioning and the World Health Organization reports that depression is the leading disease-related cause of disability in the US and Canada. In addition to limitations in the efficacy offered by current antidepressant medications, patients often experience significant adverse events including sleep disruption and sexual dysfunction and all antidepressant medications have a black box warning from the FDA about the potential increase of suicidal thinking and behavior in patients under the age of 24.
About Tal and LFMS:
Tal Medical, Inc. (www.talmedical.com) is a privately-held, Boston-based medical device company pursuing the development of low field magnetic stimulation (LFMS) for the treatment of depression and other neuropsychiatric disorders. LFMS is a first-in-class, non-invasive, neuromodulation technology. Tal’s table-top LFMS device works through a completely novel mechanism of action compared to any existing depression treatment. LFMS uses an external electromagnetic coil to apply a time-varying magnetic field to the brain, which induces a time-varying electrical field. LFMS uses electric fields that are orders of magnitude different from the existing neuromodulation technologies electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). Tal was founded in 2010 by PureTech (www.puretechhealth.com), in conjunction with leading scientists in the fields of depression and neuromodulation. The LFMS technology was licensed from McLean Hospital.