DepressiStim TM Reports Progress on Treatment Resistant Depression Pilot Clinical Study
The DepressiStim TM Brain Band therapy system is intended to be indicated for adjunctive non-invasive treatment of chronic or recurrent depression in patients who are experiencing a recent depressive episode and whom do not have an adequate response to standard medications or therapies.
March 3rd, 2023 – Porto Alegre, Brazil and Mission Viejo, CA- DepressiStim TM (a Leonhardt Ventures LLC Co.) enrolled the first cohort of patients in a pilot study that will evaluate the Brain Band TM for DepressiStim TM to treat depression with non-invasive bioelectric stimulation technology. The pilot study received local institutional review board ethics committee approval. The device used has Anivisa clearance in Brazil and simultaneously the DepressiStim team is also working toward FDA clearance. The device uses low-intensity proprietary bioelectrical signaling sequencing programmed to control specific mood-related protein expressions on demand in brain tissue. These specific signaling sequences are patented or patent pending by Leonhardt Ventures LLC and are exclusively licensed to DepressiStim LTP for treating depression.
The objective of the pilot study is to determine whether the specific signaling sequence combined with the non-invasive bioelectric therapy treatment can safely and effectively reduce depressive symptom severity. The non-randomized prospective pilot study for manic depression will include 10 patients. Treatment sessions are 40 minutes five times per week for three weeks, equating to 15 treatments total. Followup will be 3 months. All patients will be tested for changes in serotonin, klotho, brain derived neurotrophic factor (BDNF) and down regulation of TNFa in blood serum levels. Changes in depression symptoms are measured using Montgomery Asberg Depression Rating Scale.
The first patient enrolled that completed the full 3 weeks of treatment achieved full relief of depressive symptoms. Additional data from the study will be forthcoming later this spring.
The purpose of the pilot study is to provide information necessary to help design a subsequent statistically significant randomized placebo controlled multi-center pivotal study.
DepressiStim is the first and only non-invasive bioelectric stimulation device for depression that is designed to control expressions of specific proteins known to help in depression recovery, such as serotonin, BDNF and klotho.
Reference #1: Lower klotho levels are associated with higher risk of depressionhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548667/
Reference #2; Klotho hold key to reducing negative stress effects on health https://www.drlamcoaching.com/blog/klotho-may-hold-the-key-to-reducing-negative-stress-effects-on-health/
Key facts
- Depression is a common mental disorder. Globally, it is estimated that 5% of adults suffer from depression.
- Depression is a leading cause of disability worldwide and is a major contributor to the overall global burden of disease.
- More women are affected by depression than men.
- Depression can lead to suicide.
- There is a need for another alternative treatment for people that do not respond to drugs or have a bad side effect from drugs.
This study is being supported by Leonhardt’s Launchpads Brazil located in Porto Alegre, Brazil with Dr. Cristiane Carboni as Research Coordinator. DepressiStim is also being supported in part by the University of California Irvine (UCI) Capstone Program in the Engineering School with students and faculty assigned to help develop and test the generation two Brain Band TM design.
Simultaneously to the ongoing clinical research and product’s development, new pre-clinical studies are being initiated at Leonhardt’s Launchpads R&D Lab in Irvine, California and the California Medical Innovations Institute/AcuLab in San Diego County. These studies are designed to look at the safety, help gauge duration and dosing of stimulations, and discover new potential bioelectric signaling sequences and their corresponding protein expressions.
About DepressiStim: Founded in November 2015 DepressiStim is a spin out of the startup CerebraCell LTP www.cerebracell.com that is the Leonhardt’s Launchpads incubator and Cal-X Stars Business Accelerator, Inc. www.calxstars.com and www.calxelerator.com accelerator programs which includes mentorship services. This program includes shared access to R&D wet lab and prototyping space at University Lab Partners and UCI Cove in Irvine, California just off the campus of the University of California Irvine. The team focuses on applying precise control of selected circulating protein expressions via proprietary bioelectric signaling sequences. See web site www.depressistim.com for more information.
About Leonhardt Ventures LLC: Founded in 1982 Leonhardt Ventures LLC has been a leader in developing breakthrough medical device innovation for over 4 decades. See www.lventuresnestg.wpenginepowered.com Leonhardt Ventures LLC has multiple hundreds of patent claims covering bioelectric, biologics and endovascular healing technologies – https://patents.justia.com/inventor/howard-j-leonhardt
Disclaimer: Forward looking statements may change. Please refer to risk factors in our private placement memorandum, annual report and on our web sites. Patents pending may not be issued. Patents issued may be invalidated. Early data may not translate to statistically significant data proving safety or efficacy. Additional studies are needed to prove safety and efficacy.