Executive Summary Overview
An FDA 510K bioelectric stimulator programed with precise signals for improving blood circulation, inflammation management, mild pain relief, improvement of muscle motion and accelerated healing.
Over 400 patent claims issued, pending, licensed or optioned for organ regeneration and recovery. Patent claims cover over 20 regenerative proteins expressions including SDF-1 + PDGF for stem cell homing, a full suite of angiogenesis (blood vessel forming) protein expressions and bioelectric signaling sequences for managing inflammation, blood pressure, muscle formation and nerve regeneration. Important regeneration promoting controlled proteins expressions include klotho, tropoelastin (for increasing elasticity), follistatin and sonic hedgehog.
Related Supporting Studies (studies from our own research collaborators have a star * in front of their title).
• EFFECTS OF FUNCTIONAL ELECTROSTIMULATION ON ERECTILE FUNCTION RECOVERY FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY: A RANDOMIZED SHAM-CONTROLLED STUDY. (1)
• Functional electrostimulation was efficacious and safe as a penile rehabilitation procedure in improving recovery of unassisted EF in patients undergoing NSRP. The effect of FES was maintained after cessation of active therapy
• Regenerative technology for future therapy of erectile dysfunction. (2)
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• We recently reported in mouse models of type I and type II diabetic ED that two successive intracavernous injections of synthetic Ang1 protein, a soluble and potent Ang1 variant, significantly increased cavernous endothelial cell proliferation, eNOS phosphorylation, and cGMP expression and decreased the production of reactive oxygen species, such as superoxide anion and peroxynitrite . These changes restored erectile function up to 4 weeks in the diabetic mice.
• Local delivery of synthetic Ang1 protein also induced complete recovery of endothelial cell-cell junction proteins and decreased cavernous endothelial permeability in the diabetic mice
• *An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial. (3)
• Twenty-two patients with ED participated in this randomized clinical trial. Participants were randomly assigned to two groups: intervention (IG) or control (CG).
• Erectile function was assessed by the validated International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS), applied before and after treatment, and quality of life, by the WHOQOL questionnaire. Statistically significant differences in IIEF-5 and EHS were found between the IG and CG after treatment (p < 0.05), as well as a within-group difference in the IG when comparing the post-treatment periods
• This trial showed that FES therapy may improve erectile function and quality of life in men with ED.
Upcoming Milestones for MyoStim ED with ErectiStimT™
• Enrollment in international registry study summer 2019
• Start of auction for exit fall 2019
2. Ji-Kan Ryu, Jun-Kyu Suh. Regenerative technology for future therapy of erectile dysfunction. Translational Andrology and Urology (TAU). 2012 June 4: 1(3).
3. Cristiane Carboni, Alexandre Fornari, Karoline C. Bragante, et al. An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial. International Journal of Impotence Research. 2018 May 22: 30; 97-101.
Howard Leonhardt, Executive Chairman and CEO, is an inventor and serial entrepreneur with over 21 issued U.S. patents and dozens more pending. He developed the leading endovascular stent graft system and the first percutaneous heart valve, both now a part of Medtronic. He has founded over 30 startups and has numerous successful exit.
Dr. Cristiane Carboni, Chief Scientific Officer, received his Doctorate of Dental medicine and his orthodontics certificate at Tufts University School of Dental medicine. Dr. Marchetto is a member of the American Association of Orthodontists and the American Dental Association, among many others. Dr. Marchetto is on staff at Memorial Hospital for Joe DiMaggio Children’s Hospital Craniofacial Team. They care for children with cleft lips and palates, as well as other facial anomalies.
Dr. Nester Gonzalez-Cadavid, Chief Scientific Advisor, is Professor of Urology, at David Geffen School of Medicine at UCLA. He is Professor of medicine, Division of Endocrinology, Metabolism and Molecular Medicine at Charles R. Drew University of Medicine and Science. Dr. Gonzalea-Cadavid is also Director, Urology Research Laboratory, LA Biomed at Harbor-UCLA Medical Center.
Dr. Robert Gelfand
Research Lab Manager
Dr. Leslie Miller
Vice President Clinical Affairs
Vice President Engineering & Product Development
Dr. Jorge Genovese
Vice President Bioelectric Research
Dr. Stuart Williams
Vice President Biologics Research
Dr. Alonzo Moreno
Senior Advisor, Research Lab Utah Co-Manager
Research Lab Utah Co-Manager,
Director of Marketing