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).
"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:
MyoStim ED
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: howard@leonhardtventures.com
Cristiane Carboni
Department of Health Science and Rehabilitation,
Federal University of Health Sciences of Porto Alegre-UFCSPA,
Porto Alegre, Rio Grande do Sul, Brazil.
Emai: criscarboni@hotmail.com.
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.
About Leonhardt Ventures LLC: Leonhardt Ventures LLC (Leonhardt Vineyards LLC DBA Leonhardt Ventures) founded in 1982 and formed into and LLC ins 2005 is the commercialization arm of inventor Howard J. Leonhardt. Howard Leonhardt has over 21 issued U.S. patents and over 180 new patents claims pending with the USPTO at this time - https://patents.justia.com/inventor/howard-j-leonhardt. In the 1980's Leonhardt and team led the development of patented predictably compliant cardiovascular balloon catheters and the first bioelectric and vibrational energy treatments for leg ischemia and deep vein thrombosis. In the 1990's they developed the leading stent graft system for aortic aneurysm repair and the first percutaneous heart valves, intravascular lung catheters and biological pacemakers. In the 2000's the team accomplished the first ever non-surgical repair of a human heart with muscle stem cells and went on to developed a full portfolio of bioelectric, micro pump and mixed composition based organ regeneration technologies. Leonhardt Ventures LLC is the leading shareholder of all 30 startups in the Leonhardt's Launchpads organ regeneration and recovery accelerator. It also owns Leonhardt Vineyards www.leonhardtvineyards.com that has been producing grapes and wine in Sonoma Country, California since 2000 and leading share positions in a host of social good impact startups.
About Dr. Nestor Gonzalez-Cadavid: Dr. Gonzalez-Cadavid has made significant research contributions in several fields of cellular and molecular biology approaches to pathophysiology, and he has focused for the last 3 decades in translational sexual medicine research, mainly androgen dependence of penile growth and erectile function, and the effect of risk factors for erectile dysfunction, such as aging, diabetes, and smoking, on the nitric oxide/cGMP control of the erectile response. His group reported the first demonstration of the correction of erectile dysfunction in an animal model by gene therapy, and more recently showed that long-term continuous administration of nitric oxide donors and PDE5 inhibitors corrects in animal models the underlying corporal and arterial fibrosis associated with aging, diabetes and radical prostatectomy, as well as the fibrotic plaque of Peyronie’s disease. Lately, he has extended those studies to the modulation of multipotent and stem cell differentiation by nitric oxide, cGMP, and myostatin, and its application to the therapy of erectile dysfunction and other forms of urogenital disease and other conditions associated with tissue fibrosis. He is currently funded for some of these studies by NIH and other agencies and private companies. He serves as reviewer of many journals and member of several academic and research committees, and has three patents awarded.
Forward looking statements
This announcement may contain certain forward-looking statements. Whilst the Directors believe all such statements to have been fairly made on reasonable assumptions, there can be no guarantee that any of them are accurate or that all relevant considerations have been included in the directors' assumptions; accordingly, no reliance whatsoever should be placed upon the accuracy of such statements, all of which are for illustrative purposes only, are based solely upon historic financial and other trends and information, including third party estimates, and may be subject to further verification. These forward-looking statements are based on management's current expectations as of the date of this announcement and should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release. These statements involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any expectations expressed or implied by the forward-looking statements. These and other important factors, under the heading "Risk Factors" in the Company's recently issued circular to shareholders in relation to its proposed fundraising, available upon request, and under the heading "Principal risks and uncertainties" in the Company's last annual report, could cause actual results to differ materially from those indicated by the forward-looking statements made in this announcement. Neither the Company nor its Directors makes any representation or warranty in respect of the accuracy, completeness or verification of the contents of this announcement. Warning: Products mentioned have not yet been proven to be safe or effective by properly sized and powered Phase II/III clinical trials. Patents issued may not be maintained. Patents pending may not be issued. Company does not have sufficient resources on hand at this time to reach its stated goals. The company is understaffed and underfunded compared to similar competitors in the fields. A small staff maintains the updating of over 40 related web sites and all other materials and leaves the company prone that some information in some documents and web site pages may be significantly outdated. If you are considering an investment in any of these startups mentioned they must be regarded as no other than extremely high risk due to the early stage nature of the developments, the uncharted territory of paving new technologic pathways and the lack of funding and resources available to complete all essential tasks to being the products to commercial success in any form.
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 84111
Research 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.
