LOS ANGELES, CA – 01-30-2019 (PRDistribution.com) —
|Team hopes to improve on 85% success of first study. First study to focus on precise controlled protein expressions via bioelectric signaling sequences intended for mature blood vessel, muscle and nerve regeneration.
FINAL DRAFT Ver 4.0 FOR REVIEW ONLY > Los Angeles, California, Salt Lake City, Utah, Pittsburgh, PA and Porto Alegre, Brazil – January 30th, 2019 – MyoStim ED www.erectistim.com is a clinical stage company within the Leonhardt’s Launchpads accelerator focused on bioelectric and biological treatment of erectile dysfunction. The bioelectric stimulator Erectistim is being tested first as a stand alone treatment of 15 minutes twice a week for 4 weeks.
Dr. Leslie Miller, Chief Medical Officer said: “We are pleased to announce the first patient enrolment in our second MyoStim ED Erectistim study examining bioelectric stimulation for erectile dysfunction recovery. This study will be double blinded, randomized and placebo controlled. This is an important milestone for MyoStim ED and its product Erectistim, building on the success of the previous published study where 85% of treated patients experienced significant improvement and no placebo patients recovered”.
“The first study utilized our previously patented bioelectric signaling sequence for VEGF expression which we know produces small new blood vessels that sometimes leak and sometimes retreat. The new study includes a full suite of angiogenic signals which may include controlled expressions of HGF, EGF, HIF1a, SDF1, PDGF, IGF1 and eNOS which we know from previous studies create more mature and larger diameter new blood vessels that do not leak and do not retreat with true mature endothelium linings. The new study will also include bioelectric signaling sequences intended to control release of SDF1 and PDGF for stem cell homing, for managing fibrosis, regenerating nerve tissues and neuro modulation. One of the most important adds in the new study is our patent pending bioelectric signaling sequences for controlled release of Follistatin intended for smooth muscle regeneration and myostatin/follistatin balancing, intended to reverse fibrosis.” stated Howard J. Leonhardt, Executive Chairman & CEO of MyoStim ED and co-inventor of many of bioelectric signaling sequences being used in the study.
“In our previous studies we demonstrated that erectile dysfunction, due to the decrease of blood flow or progressive vascular/penile corporal fibrosis leading to venous leak in the penile corpora cavernosa, resulting from the impairment of smooth muscle function may also be affected by the imbalance of the myostatin/ follistatin ratio, which in the penile corpora cavernosa may be essential for its healthy function. Therefore, reducing this ratio with signals increasing follistatin may help smooth muscle cells recovery and counteract fibrosis by inactivating myostatin expressed in the corporal smooth muscle. This new study, if successful, will lead a path to a product being available for the patients that do not respond to other therapies directed only towards improving blood flow and retention, or even to a novel early non pharmacological therapy.”, stated Dr. Nestor Gonzalez-Cadavid, Chief Scientific Advisor to MyoStim ED, and who holds academic positions not involved in this trial (Director of the Urology Research Laboratory, Los Angeles Biomedical Research Institute (LABioMed) at Harbor UCLA, Urology Research Laboratory Director, and Professor at the Department of Urology, UCLA School of Medicine)
Results of the previous single bioelectric signal study were published in a peer reviewed paper – An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial International Journal of Impotence Research ( IF 1.517 ) Pub Date : 2018-05-22 , DOI: 10.1038/s41443-018-0024-8
To evaluate the impact of FES on erectile function in men with erectile dysfunction. Twenty-two patients with ED participated in this randomized clinical trial. Participants were randomly assigned to two groups: intervention (IG) or control (CG). IG participants underwent FES therapy (50?Hz/500 µs) for a total of 4 weeks, divided into two weekly sessions lasting 15?min each, with intensity lower than the motor threshold. CG participants were treated with placebo FES and followed the same routine as the IG. 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 (p?0.0001) The WHOQOL revealed a significant difference between CG and IG after treatment (p?0.05), as well as a within-group difference in the IG after treatment (p?0.0001), except in the Environment domain, in which there was no difference between the pre- and post-treatment periods (50.9?±?2.8 pre vs. 52.3?±?3.1 post). This trial showed that FES therapy may improve erectile function and quality of life in men with ED.
“This new study will not only have additional bioelectric signaling sequences directed towards a more lasting affect but importantly addresses both muscle and nerve regeneration in addition to improving blood flow. For these reasons we entered the collaboration with the team at MyoStim ED that developed the Erectistim product.” stated M.S. Cristiane Carboni of Department of Health Science and Rehabilitation, Federal University of Health Sciences of Porto Alegre-UFCSPA, Porto Alegre, Rio Grande do Sul, Brazil, Manager Sociedade Brasileira de Estudos em Sexualidad Humana (Coordinator of the pelvic flood rehabilitation post graduation, University Inspirar of Port Alegre. Secretary of the Brazialian Society of Studies on Human Sexuality, and lead author of the original study published in the Internationa Journal of Impotence Research whom has now joined MyoStim ED also as Chief Scientific Officer.
For further information please contact:
Howard J. Leonhardt
Executive Chairman & CEO
Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc.
12655 W Jefferson Blvd
Los Angeles, CA 90066
Phone: (424) 291-2133
Fax: (866) 829-0929
Email: [email protected]
Department of Health Science and Rehabilitation,
Federal University of Health Sciences of Porto Alegre-UFCSPA,
Porto Alegre, Rio Grande do Sul, Brazil.
Emai: [email protected].
About MyoStim ED: MyoStim ED www.erectistim.com is a startup founded in 2016 incubating within Leonhardt’s Launchpads innovation and startups accelerators in California, Utah, Pittsburgh, Minneapolis and Australia. The focus is on development of bioelectric and biologics solutions for erectile dysfunction.
About Leonhardt’s Launchpads: Leonhardt’s Launchpads http://www.leonhardtventures.com founded in 2008 is the innovation and startup accelerator arm of Leonhardt Ventures LLC focused on organ regeneration and recovery technologies. The accelerator has labs and other research and startup launch related resources in both Northern and Southern California, Utah, Pittsburgh, Minneapolis and Australia. The accelerator is served by more than 140 experience advisors and mentors in all areas of expertise – https://leonhardtventures.com/team/+ https://calxstars.com/scientific-advisory-board/. The headquarters Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. located in Los Angeles with close collaborations with Mettler Electronics and DeviceLab and Hoag Hospital in Orange County, UCLA, USC , LABioMed, QIG Greatbatch, Pacific Neurosciences Institute, John Wayne Cancer Institute and Caltech in Los Angeles County. In Utah is Leonhardt’s Launchpads Utah, Inc, with two dedicated research labs a whole team of bioengineers, chemists, startup launch specialists and biologists and access to research collaborators at the University of Utah, BYU and Utah State University. Leonhardt’s Launchpads Pittsburgh launched in 2018 and works out of LifeXLabs. Leonhardt’s Launchpads Australia PTY also launched in 2018 and works in research collaboration with Queensland University of Technology and St. Vincents Hospital, Sydney. Leonhardt’s Launchpads has had an affiliated office in Minneapolis since its founded and works in close collaboration with Biomerics Advanced Catheter there as well as the University of Minnesota. Dr. Leslie Miller the Chief Medical Officer of Leonhardt’s Launchpads was formerly for more than a decade Chairman of Cardiovascular Medicine at the University of Minnesota. 30 startups are currently in the 2019 portfolio class in the areas of (1) Heart & Cardiovascular, (2) Brain, (3) Cosmetic & Personal Care, (4) Major Organ Regeneration and (5) Cancer – https://leonhardtventures.com/development-pipeline/ + https://leonhardtventures.com/our-companies/ + https://leonhardtventures.com/regenerative-medtech/. The innovation accelerator business model is to accelerate each organ specific innovation and corresponding startup through first-in-man studies and then find a strategic partner.
Leonhardt’s Launchpads by Cal-X Stars, 12655 W Jefferson Blvd, Los Angeles, CA 90066
Leonhardt’s Launchpads Utah, Inc. 370 S, 300 E, Salt Lake City, UT 84111Research Lab @ 2500 S State St. #224, Salt Lake City, UT 84115
See also PressureStim www.pressurestim.com for information on our bioelectric blood pressure treatment method and InStim www.instimcell.com for our bioelectric inflammation management products under development.
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