San Francisco, Aug. 9, 2022 /PRNewswire/ -- Today Limbix Health, Inc. (Limbix), the leader in developing evidence-based, digital therapeutics for adolescent mental health, announced the launch of its Limbix Synapse platform. Through the platform, Limbix is able to efficiently build, distribute, and commercialize secure, compliant, and privacy-aware digital therapeutics. Developed on the Limbix Synapse platform, SparkRx™ is now available for licensed health care professionals to offer as adjunct treatment to adolescent patients with symptoms of depression in the US.
"We are excited to use the Limbix Synapse platform to expand our pipeline of digital therapeutics and enhance the therapeutics currently in our portfolio," said Benjamin Lewis, CEO of Limbix. "The platform gives us the opportunity to further our mission to improve mental health with accessible technology."
With the Limbix Synapse platform, Limbix is able to quickly build, test, and monitor clinical-grade therapeutics through the platform's mobile therapeutic development system, ensuring their security and compliance. The development system allows for highly flexible and customizable content across mobile and tablet devices, to meet requirements for integration with health system partners. The platform also integrates clinically validated protocols to build and validate therapeutics designed for clinical trials and the research operations necessary to run remote clinical trials, including a research portal for end-to-end study management.
The highly scalable Limbix Synapse platform enables the simultaneous development and deployment of multiple therapeutics, including Limbix's first digital therapeutic, SparkRx. The platform enables the development and commercialization of SparkRx worldwide, including in South Korea for Limbix's recently announced partnership with Bixink Therapeutics. The Limbix Synapse platform offers location-specific customization, including translation and localization, facilitating the global expansion of digital therapeutics.
Limbix is a digital therapeutic company passionate about building mental health treatments for adolescents. The Limbix team is uniquely suited to develop digital therapeutics, as its diverse team of clinicians, product designers, researchers, and engineers understand the value of pairing clinical expertise with technological innovation. Their first digital therapeutic, SparkRx™ by Limbix, is now available for licensed health care professionals to offer to patients in the US. The development and commercialization of SparkRx™ is conducted through the Limbix Synapse platform which enables the development and clinical research of secure, compliant, and privacy aware digital therapeutics. For more information about Limbix and SparkRx™ by Limbix, please visit limbix.com and sparkrx.com.
Indications for Use: SparkRx is a digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy - Behavioral Activation) in patients 13 to 22 years of age as adjunct treatment for symptoms of depression.
SparkRx has not been cleared or approved by the U.S. Food and Drug Administration. During the COVID-19 public health emergency, SparkRx is being made available without a prescription under the FDA's emergency guidance for digital health devices treating psychiatric disorders.
Warnings: SparkRx is not for emergency use. Please instruct patients to dial 911 or go to the nearest emergency room in the event of a medical emergency.
Patients should be clearly instructed not to use SparkRx to communicate severe, critical, or urgent information to their health care provider. Patients should also be informed that text they enter into SparkRx will not be monitored or reviewed by a health care provider.
SparkRx is not meant to be used as treatment without supervision of a health care provider. Please instruct your patients to contact you should they notice a worsening of symptoms or an increase in thoughts of suicide or self-harm.
SparkRx is not meant to be a substitution for any treatment or medication.
SparkRx is intended for patients whose primary language is English with a reading level of 5th grade or above, and who have access to an Android/iOS smartphone or tablet. SparkRx is intended only for patients who own a smartphone or tablet and are familiar with use of smartphone or tablet apps (applications).
SparkRx contains sensitive medical information. Please instruct patients to protect their information by password protecting their smartphone or tablet, and ensuring no one else may access their device.
SparkRx does not address concerns of active suicidal ideation with intent. SparkRx is not intended for the prevention of suicide attempts or self-harm behaviors. Patients with active suicidal ideation with intent or those who have had a past suicide attempt may still be given SparkRx to help treat depression but should not be given SparkRx to prevent, treat or mitigate active suicidal ideation with intent.
Patients with posttraumatic stress disorder (PTSD) who are currently experiencing marked alterations in arousal or reactivity associated with traumatic events may find that the level of exposure related to guided behavioral activation exacerbates symptoms.