MyoStim ED Erectistim
Update on Progress
Designed as a non-invasive method to recover from erectile dysfunction without the need for drugs or surgery. Two positive clinical studies completed and a third has finished enrollment. The latter with four additional bioelectric signaling sequences added intended to not only address blood flow improvement but also muscle and nerve generation as well as restoring neuro hormonal balance.
MyoStim ED Erectistim has published results from two clinical studies with its 1st generation product and just completed enrollment in a third clinical study with its 2nd generation product with additional bioelectric signaling sequences.
- Over 200 issued and pending U.S.P.T.O. patent claims covering bioelectric signaling sequences for organ regeneration and recovery.
- 85% success in significant ED recovery in first clinical study.
- 2nd clinical study in post prostate surgery patients demonstrated >50% ED recovery.
Expected Advantages Over Other Devices – Designed To Intended To (confirmation pending full scale controlled studies)
- Long lasting new blood vessel formation. Mature arteries with true endothelium linings that do not leak. Larger diameter blood vessels.
- True muscle regeneration via follistati and klotho controlled bioelectric protein expressions.
- Nerve regeneration via IGF1 and other protein expressions.
- Neuro hormonal balancing via bioelectric signaling.
- For severe cases combined with re-fillable micro infusion pump and the ME15 fifteen component ED treatment composition. Slowly infused and re-filled.
- Only system with stem cell homing signals to recruits a patient’s own stem cells to their damaged tissue.
Recent Milestones
- Paper published by Chief Scientific Advisor Dr. Nestor Gonzalez-Cadavid on role of myostatin antagonist (follistatin) in ED recovery.
- Patent filed for controlled follistatin expression (myostatin antagonist)
- Randomized placebo controlled study completed and published. 85% success rate.
- Post prostrate surgery study randomized placebo controlled study completed and published. >50% success rate.
- Completed enrollment in new randomized placebo controlled study with additional bioelectric signaling sequences.Bench top bioelectric stimulator partner received 510K market clearance for improving blood circulation, mild pain relief and accelerated muscle related healing. Wearable bioelectric stimulator partner received 510K and OTC market clearance for mild pain relief and improving blood circulation.
- Patent filed for Klotho controlled expression.
- Patent filed for Sonic hedgehog controlled expression.
Expected Upcoming Milestones (Subject to Change)
- Publication of 3rd clinical study results this time with additional bioelectric signaling sequences.
- Additional sites added to clinical registry.
- Process to secure strategic partnership.
Executive Management
Howard J. Leonhardt
Executive Chairman & CEO
[email protected]
“Inventor and experienced entrepreneur. Over 200 patent claims for organ regeneration.
Led team that completed first non-surgical stem cell heart regeneration in 2001.”
Dr. Leslie Miller
Chief Medical Officer
[email protected]
*241 peer reviewed publications, 80+ clinical trials, former Chairman Cardiovascular Medicine
U of Minnesota for over a decade.
Cristiane Carboni MSc, PT
Chief Scientific Officer
[email protected]
Cristiane
Masters Degree Pelvic Floor Rehabilitation. University of Barcelona/Spain and in Science of Rehabilitation.
UFCSPA(Federal University of Health Sciences of Porto Alegre)/Brazil
Alex Richardson
Vice President Engineering & Product Development
[email protected]
*Over 30 years experience developing medical devices many serving Alfred Mann Cos.
Dr. Brett Burton
Vice President R&D
[email protected]
PhD. Bioengineering, 7 years experience.
Jon Dillon
Vice President Mergers & Acquisitions
[email protected]
30 years medical device and pharmaceuticals industry experience.
Dr. Nestor Gonzalez-Cadavid
Chief Scientific Advisor
[email protected]
MSc, 1961, University of Buenos Aires, Argentina, PhD, 1964, University of Buenos Aires, Argentina,
PhD, 1967, University of London, England
Investigator, LA BioMed Professor of Urology, David Geffen School of Medicine at UCLA
Professor of Medicine, Division of Endocrinology, Metabolism and Molecular Medicine,
Director Urology Research Laboratory, LABioMed @ Harbor-UCLA Medical Center
Market Size
$4 billion +
https://www.marketwatch.com/press-release/global-erectile-dysfunction-market-to-surpass-us-43-billion-by-2026-2019-01-11
Markets
Erectile dysfunction.
Male fertility.
Valuation Analysis
Current valuation $45 million.
3,000,000 total shares authorized.
Current price per share $15
Valuation Comparables
HIMS = $1 billion
RO Roman = $500 million
Boston Med Group = Private
Gainswave = Private
Risk to Investment
An investment in MyoStim ED and Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. must be considered to be a high-risk investment. MyoStim ED is a development stage company and currently has no FDA market cleared products in its portfolio. Early indications of efficacy in pre-clinical studies may not necessarily translate into positive clinical results. As with any company, they may be unable to obtain sufficient capital to fund planned development programs. There are regulatory risks associated with the development of any device and MyoStim ED may not receive FDA market clearance for its product candidates despite significant time and financial investments. Regulatory approval to market and sell a medical device does not guarantee that the device will penetrate the market, and sales may not meet expectations. Patents issued, licensed, optioned or pending may not be maintained or may be found to be invalid due to prior art. The company may be found to be infringing patent of others.The company is highly dependent on outside suppliers, which are not under control of the company, which may not meet timelines or other needed requirements for product development or regulatory compliance.