ErectiStim

ErectiStim is proprietary treatment protocol using non-invasive bioelectric signaling sequences intended to improve penile blood flow and rejuvenate penile tissue in men who have ED or who simply want to improve their sexual performance. It is intended to be painless, harmless and to not require medications or surgery (regulatory status is published in another section of this website). For very severe patients MyoStim ED is also developing Erectistim Plus which is a combination of non-invasive bioelectric signaling sequences and the ES-15 penile organ regeneration composition comprised of fifteen biological components including muscle stem cells, adipose derived cells and stromal fraction, selected growth factors and proteins such as SDF1, IGF1, Klotho and Follistatin, selected exosomes, micro RNA gel, oxygenated nanoparticles, selected alkaloids, low levels of progesterone hormone, human growth hormone, engineered nurtured hydrogel, extracellular matrix (pending regulatory clearance to begin clinical studies).

ErectiStim Plus Lite™ is a simpler, lower-cost version of ErectiStim Plus™, which is currently available in the U.S. market for use at qualified research centers.

ErectiStim Plus Lite™ includes the following three base components:

1. ErectiStim™ bioelectric stimulation of SDF1, PDGF, VEGF, klotho, follistatin, and sonic hedgehog.

2. Platelet Rich Fibrin (PRF), produced bedside within minutes using a specialized BIO PRF centrifuge from a small blood sample taken from the patient. This may include bioelectrically treated pre-injection PRF and bioelectrically stimulated post-injection PRF to enhance, extend, and amplify the release of regenerative proteins.

References:

Science Behind Bio-Prf

https://bio-prf.com/shop-page/
https://patents.justia.com/patent/20200000709
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388803/

3. Regenerative fluid derived from amniotic sources provided by Axolotl Biologix.

Reference:
https://azbigmedia.com/business/bioscience-industry/phoenix-based-axolotl-biologix-partners-with-leonhardt-ventures/

In qualified research centers, the following may also be included as special booster additives:

4. Selected exosomes.

References:
https://kimeralabs.com/products/
https://www.ncbi.nlm.nih.gov/pubmed/30257719

5. Immature myoblasts (muscle stem cells), based on research by Dr. Nestor Gonzalez-Cadavid.

Reference:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4886867/

6. Adipose tissue-derived stem cells, stromal vascular fraction, and endothelial progenitor cells.

References:
https://www.tissuegenesis.com/icellator-x/

Home

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6678927/
https://www.ncbi.nlm.nih.gov/pubmed/29958973

7. Wharton’s Jelly.

References:
https://stemcellstransplantinstitute.com/2019/10/03/properties-whartons-jelly-mesenchymal-stem-cells/
https://www.centerwatch.com/clinical-trials/listings/186921/erectile-dysfunction-use-wharton-jelly-erectile/

1. Bioelectric stimulation is administered 2 times per week for 35 minutes over a period of 4 weeks. If desired, maintenance treatments may be performed every 6 months, consisting of 2 sessions within one week.

2. 2 mL of PRF is mixed with either regenerative fluid derived from amniotic sources, and/or Wharton’s Jelly, and/or selected exosomes. This is administered once per month for 3 months, with maintenance consisting of one injection session every 2 years.

Additive booster protocol:

3. Autologous myoblasts (muscle stem cells), derived from the patient’s own thigh muscle, are administered once per month for 3 months, mixed with PRF and regenerative fluid. Maintenance consists of one injection session every 2 years.

4. Adipose tissue-derived stromal fraction, stem cells, and endothelial progenitor cells are mixed with PRF and regenerative fluid and administered once per month for 3 months. Maintenance consists of one injection session every 2 years.

PRF gel is essential to reduce migration of fluids away from the intended treatment location.

Biologics are delivered via a careful, slow infusion using a 5-minute hand injection into the penis corpora cavernosa, using a standard hypodermic 2 mL syringe or two 1 mL syringes, with a 26 or 27 gauge needle attached. The penis and patient should be immobilized during this slow infusion session to avoid injury.

Note: The total volume of biologics composition is a maximum of 2 mL per injection session, with no more than one session per month for 3 consecutive months. This applies whether using PRF and amniotic fluid alone or including booster additives such as selected exosomes, Wharton’s Jelly, adipose-derived stromal fraction and cells, and/or immature myoblasts (muscle stem cells).

ErectiStim employs precise bioelectric signaling sequences delivered non-invasively to the penis. These signaling sequences are designed to control the release of specific regenerative proteins on demand. Examples include SDF1 for stem cell homing; IGF1 and EGF for DNA repair and nerve regeneration; follistatin and klotho for muscle regeneration; and VEGF, PDGF, HIF1a, CXCL5, HGF, EGF, SDF1, and eNOS for improving blood circulation and promoting the formation of new, mature, large-diameter blood vessels with true endothelial lining.

Additionally, specific signaling sequences are designed to address the neuromodulation component of erectile dysfunction (ED).

In summary, ErectiStim is designed to: (1) improve blood flow long term, not just temporarily, (2) regenerate penile muscle tissue and help balance the myostatin-to-follistatin ratio, (3) regenerate nerve tissue, and (4) support recovery of healthy neurohormonal function related to ED.

At the core of the ErectiStim intellectual property platform are bioelectric signaling sequences involving SDF1 and PDGF, which support: (1) stem cell homing, (2) muscle regeneration via follistatin and klotho, (3) nerve tissue regeneration, (4) formation of new mature blood vessels via VEGF, PDGF, EGF, HGF, SDF1, HIF1a, CXCL5, and eNOS, and (5) neurohormonal balancing through bioelectric signaling that simulates normal physiological stimuli.

Note: In early studies, the full range of bioelectric signaling sequences has not yet been utilized. The first study used only a single VEGF signal focused on improving blood flow. The second study incorporates some signaling sequences for mature, long-lasting large-diameter blood vessel formation, muscle regeneration, and nerve regeneration, but does not include the complete set of sequences.

Warning cautionary statement – these listing POTENTIAL benefits are not clearly proven out yet in statistically significant placebo controlled Phase II/III studies under IRB and regulatory body supervision. Only one small pilot study has been completed to date which is inconclusive in these results.

• Harder erections
• More spontaneous erections
• More sustainable erections
• Enhanced sensation
• Better orgasms
• Increased length and girth
• Improved sexual performance

The effects of Erectistim have only been clinically tested in a limited small series of patients to date in a pilot study with follow-up limited to under 6 months. The product developers intend to prove out in new longer duration follow-up clinical studies to last at least two to three years after the initial treatment and possibly up to 10 years. A maintenance program of scheduled treatments may be needed to help maintain the effects over a longer period of time. Erectistim Plus by design is expected to provide even longer lasting effects than the original Erectistim product but their is not conclusive data to support this claim at this time.

No. The device used is classified as an FDA-cleared, class 1 medical device(i.e., it is safe for use with minimal potential for harm to the user). The Mettler Electronics stimulator used in the current Phase IIa studies has 510K market clearance as a Class II medical device for improving blood flow, mild pain relief, improving muscle motion and accelerating muscle recovery. It is not market cleared under its current 510K for treating erectile dysfunction directly. With sufficient data gathered we intend to file with the FDA to request to broaden the authorized labelling indication of use to include erectile dysfunction.

Electoral stimulation has been in wide spread use for wound healing and bone fracture healing for nearly 30 years. Mettler Electronics of Anaheim, California the OEM producer of our bioelectric stimulator with FDA 510K market clearance for improving blood flow and accelerated muscle healing has been treating patents for muscle injury recovery since the the 1950’s. What is new is controlling specific signals in a specific sequence for treating erectile dysfunction. There have been many studies documenting the use of lasers, vibrational energy, shock waves and sound waves for treating ED. This bioelectric stimulation technology is similar but provides what we believe to be much more precise control of the key components to full erectile dysfunction recovery.

The study highlighted below was conducted using only a single bioelectric signal applied for 15 minutes, twice per week, over a period of 4 weeks. A new study has begun enrollment at the same center, now utilizing five bioelectric signaling sequences and including longer-term follow-up.

https://www.ncbi.nlm.nih.gov/pubmed/29785045

Int J Impot Res. 2018 Jun;30(3):97-101. doi: 10.1038/s41443-018-0024-8. Epub 2018 May 22.

An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial.

Carboni C1, Fornari A2, Bragante KC2, Averbeck MA2, Vianna da Rosa P2, Mea Plentz RD2.

Abstract:

Erectile dysfunction (ED) affects approximately 150 million men worldwide. Functional electrical stimulation (FES) therapy has demonstrated regenerative potential for smooth muscle cells and is increasingly being adopted. FES may be a beneficial treatment option when ED is associated with degeneration of cavernous smooth muscle.

This randomized clinical trial evaluated the impact of FES on erectile function in men with ED. Twenty-two patients participated and were randomly assigned to either an intervention group (IG) or a control group (CG). The IG received FES therapy (50 Hz/500 µs) for 4 weeks, with two weekly sessions lasting 15 minutes each, at an intensity below the motor threshold. The CG received placebo FES following the same schedule.

Erectile function was assessed using the International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS), measured before and after treatment. Quality of life was evaluated using the WHOQOL questionnaire.

Statistically significant improvements were observed in the intervention group compared to the control group in both IIEF-5 and EHS scores after treatment (p < 0.05). Within-group improvements in the intervention group were also significant (p < 0.0001). Quality of life scores showed significant improvement in the intervention group compared to the control group (p < 0.05), with the exception of the Environment domain, which showed no significant change.

This study indicates that FES therapy may improve erectile function and overall quality of life in men with erectile dysfunction.

PMID: 29785045
DOI: 10.1038/s41443-018-0024-8

The initial study was with treatment with only one bioelectric signal for only 15 minutes twice a week for only 4 weeks. The MyoStim ED Erectistim new study will have treatment sessions of 35 minutes twice a week for 4 weeks and a single time a week for 8 weeks more. The Erectistim Plus clinical protocol is not finalized yet.

Warning caution – any performance or safety claims are yet to be fully proven out in statistically significant placebo controlled Phase II/II studies.

• Erectistim
• Is drug and surgery free
• Is completely non-invasive and has no known side-effects reported to date in small pilot studies (inconclusive more studies required)
• Is a simple in-office OR AT HOME procedure with each treatment taking only 15 to 35 minutes.
• Designed and intended to provide long lasting results up to 2 to 3 years and possibly even up to 10 years with no downtime (more studies needed to prove)
• Designed and intended to address multiple root causes of ED – poor blood flow, muscle degeneration, nerve damage and neuro hormonal dysfunction.
• Designed to bring back in balance the myostatin vs follistatin ratio to healthy normal levels. ED patients usually have elevated myostatin levels and depressed Follistatin levels.
• Designed and intended to offer potential long-term improvement rather than a reliance on medications.

Safety and efficacy data is not available to confirm this at this time. However, the MyoStim ED Erectistim scientific and clinical team believe future studies will prove out that using Erectistim with other therapies such as PRP platelet rich plasma, PRF platelet rich fibrin, amniotic fluid, hormone therapy, stromal fraction and stem cell therapies are more effective in combination than any of the therapies on a stand alone basis (more studies needed to prove). The development of Erectistim Plus our 2nd generation product intended for treating the most serve cases of ED is being designed with this in mind.

The ErectiStim™ therapy consists of a series of precise bioelectric signals delivered to the penile area or nerves feeding the penis that control various protein expressions for stem cell homing, stem cell proliferation, stem cell differentiation, blood vessel forming and blood circulation improving, muscle function repair and DNA repair. For very severe cases we combine this with a re-fillable micro infusion pump that micro feeds into penile tissue a cocktail of stem cells, growth factors, selected alkaloids, oxygenated nano particles, amniotic fluid, SVF, PRF, nutrient hydrogel and penile matrix in addition to bioelectric stimulation in attempt to stimulate ED recovery.

One of our collaborating researchers in Brazil, Dr. Cristiane Carboni, recently led a double-blinded, randomized, placebo-controlled study in 22 patients. This study demonstrated strong evidence that electrical stimulation for just 15 minutes, twice a week, using a single 50 Hz VEGF bioelectric signal can produce recovery from erectile dysfunction.

An initial study on the effect of functional electrical stimulation in erectile dysfunction can be found here: https://www.nature.com/articles/s41443-018-0024-8
May 22, 2018 – Erectile dysfunction (ED) affects approximately 150 million men worldwide. Functional electrical stimulation (FES) therapy has shown high regenerative capacity for smooth muscle cells and is increasingly being adopted to improve erectile function.

We are now working with Dr. Carboni on a new, more comprehensive study that will include not only the original VEGF-producing bioelectric signal but also a host of additional bioelectric signals designed to improve blood flow and muscle function, including a follistatin signal to balance myostatin.

Many studies over the years have explored electrical stimulation for improving blood flow, muscle recovery, and wound healing. In our “Related Articles” section on this website, we have posted several of these studies. Our own team published in Circulation the first paper working with Dr. Shinichi Kanno: A Simple Method for Angiogenesis using Bioelectric Stimulation of VEGF Release. Establishment of a simple and practical procedure applicable to therapeutic angiogenesis is described in:

https://www.ncbi.nlm.nih.gov/pubmed/10338463
S. Kanno – 1999 – Cited by 184
May 25, 1999 – Kanno S(1), Oda N, Abe M, Saito S, Hori K, Handa Y, Tabayashi K, Sato Y. … as a simple and practical method of therapeutic angiogenesis.

Recent studies have also shown that both red and blue light can improve recovery of ED. ErectiStim™ plans to utilize a combination of red and blue light along with bioelectric signaling for stem cell homing, blood vessel circulation, muscle repair, and DNA repair. In the most severe cases, repeated delivery of a fifteen-component stem cell-based biologics composition is used as a comprehensive solution for ED recovery.

ErectiStim™ is designed to simulate tissues to control the release of key regenerative proteins:

• SDF1: Stem cell homing and blood vessel maturation
• IGF1: DNA repair
• Follistatin: Muscle repair
• HIF1a, EGF, HGF, PDGF, VEGF, SDF: Promotion of new blood vessel growth
• eNOS: Dialing blood vessels (same active agent as in Viagra)
• Tropoelastin: Improving tissue elasticity
• Activin A: Enhancing nerve connections

Erectile dysfunction (or ED), also called male impotence, is described as a consistent inability to achieve and maintain an erection sufficient for mutually satisfactory sexual intercourse with his partner. By itself, ED is not a disease but more of a signal that something else may be a problem. Erectile dysfunction is a common condition, affecting more than half of men ages 40 to 70.

Sexual dysfunction can sometimes be caused by disorders such as diabetes, high blood pressure, vascular disease, heart disease, nervous system disorders, and depression as well as an unwanted side effect from some medications. Male sexual dysfunction may be the symptom of such disorders that brings them to the doctor’s office in the first place.

Sexual health and function are important in determining a man’s quality of life. As Americans age, disorders such as erectile dysfunction (ED) are becoming increasingly apparent. Because this subject is discussed widely in the media, men and women of all ages are seeking guidance in an effort to improve their relationships and experience satisfying sex lives.

The successful treatment of ED has been shown to improve sexual intimacy and satisfaction, improve sexual aspects of quality of life as well as overall quality of life, and relieve symptoms of depression.

For a man to have an erection, a complex process takes place within his body.

Erection involves the central nervous system, peripheral nervous system, hormones, psychological and stress-related factors, local problems with the penis itself as well as blood flow or circulation. The penile portion of the process leading to erections represents only a single component of a very complex cascade of events.

Erections occur in response to touch, smell, and visual stimuli that trigger pathways in the brain. Information travels from the brain to the nerve centers at the base of the spine, where primary nerve fibers connect to the penis and regulate blood flow during erection and afterward.

Sexual stimulation causes the release of chemicals from the nerve endings in the penis that trigger a series of events that ultimately cause muscle relaxation in the erection bodies of the penis. The smooth muscle in the erection bodies controls the flow of blood into the penis. When the smooth muscle relaxes, the blood flow dramatically increases causing the erection bodies to become full and rigid, resulting in an erection. Venous channels normally draining blood are compressed and close off as the erection bodies enlarge.

Detumescence (when the penis is no longer in a state of erection) results when muscle-relaxing chemicals are no longer released. Ejaculation causes the smooth muscle tissue of the erection bodies in the penis to regain muscle tone, which allows the blood drainage channels to open. As the extra blood drains from the erection bodies, the erection loses rigidity and the penis returns to its original flaccid state.

ED occurs when this process does not progress normally. Arousal and erections are physical and mental activities, so it is important to remember that the sexual partner plays an integral role. Effective management of erection problems and erectile dysfunction is often more successful if the sexual partner is involved with the evaluation and treatment.

Yes, the terms mean the same.

Premature ejaculation is often confused with erectile dysfunction. Premature ejaculation is a condition in which the entire process of arousal, erection, ejaculation, and climax occur very rapidly, often in just a few minutes or even seconds, leaving both the sexual partner and the one experiencing premature ejaculation unsatisfied. Premature ejaculation may accompany an erection problem such as ED but is generally treated differently.

Erection problems will usually produce a significant psychological and emotional reaction in most men. This is often described as a pattern of anxiety and stress that can further interfere with normal sexual function. This “performance anxiety” needs to be recognized and addressed by your doctor.

Currently, virtually any man who wishes to have an erection can obtain it, regardless of the underlying cause of his problem. Many reasonable treatment options exist. Your first step is to find a well-trained, experienced, and compassionate doctor who is willing to take the time to understand you and fully examine you to discover the cause and discuss the treatments available to you.

Your doctor will want to rule out any other causes for your concern such as high blood pressure, prostate cancer, vascular disease, and diabetes.

By seeing your doctor, you may very well be saving your life if the doctor detects – and treats – a life-threatening illness. Often, you can restore your sexual health by treating a condition such as high blood pressure with diet and exercise or controlling your diabetes.

For some men, erectile dysfunction develops with age or may be related to depression or another psychological cause. In these cases, psychological counseling with you and your sexual partner may be successful.

Medications can cause ED, especially drugs you might take to control blood pressure or depression (antidepressants) (see Impotence/Erectile Dysfunction for a list of medications that may cause ED). Anti-ulcer drugs can be a cause, as can alcohol or drug abuse. ED is a side effect. Talk with your doctor about medications that might not cause this side effect. Do not just stop taking your prescribed medication.

Other causes include damage to the erection bodies in the penis; diabetes; various hormonal disorders; blood flow problems; psychological factors, such as depression; and surgical complications from abdominal, pelvic, or back surgery.

Treatment options include sexual counseling, medications, external vacuum devices, hormonal therapy, penile injections, or intraurethral suppositories (see Impotence/Erectile Dysfunction for treatment options). In highly selected cases under the supervision of a urology specialist in ED, combination therapy using several of these methods together can be used. If none of these therapies is satisfactory, penile implants through surgery can be considered.

Most patients start with Viagra and other similar drugs. No one could miss all of the consumer advertising for drugs to aid in ED. You see advertising for these drugs in magazines and on TV. Certainly there are plenty of jokes about Viagra and similar drugs, but ED is not funny if you are experiencing it.

Viagra (sildenafil citrate), a prescription medication for the treatment of erectile dysfunction, is the first pill available that’s been proven to improve erections in most men with impotence.

Since its introduction in March 1998, no other therapy for ED has achieved such wide public recognition. Viagra doesn’t improve erections in normal men, only in those with difficulty in achieving or maintaining erections sufficient for sexual intercourse due to a true medical problem. It is not an aphrodisiac (sexual stimulant) and will not increase sexual desire. Unlike other treatments for erectile dysfunction, Viagra requires sexual stimulation to function. Without this stimulation, Viagra won’t have any effect.

Viagra works by blocking an enzyme found mainly in the penis that breaks down chemicals produced during sexual stimulation that normally produce erections. Viagra allows these chemicals of arousal to survive longer and improves erectile function. That is also why sexual stimulation is necessary for Viagra to work.

In general, Viagra works successfully in about 65-70% of all impotent men.

Viagra works best if taken about 30 to 60 minutes before sexual activity. Only 1 tablet should be taken per day. It should be taken on an empty stomach. Increasing the dosage of Viagra beyond the recommended amounts will not improve the response and will only result in greater side effects.

Several drugs very similar to Viagra have recently been approved by the FDA. These drugs, called vardenafil (Levitra), Stendra (avanafil) and tadalafil (Cialis), have essentially the same activity and general precautions as Viagra. Levitra may be taken with food where Viagra needs to be taken on an empty stomach. Cialis has a much longer duration of improved erection function (up to 24-36 hours) compared with Viagra and Levitra (up to 4 to 6 hours). Cialis in daily dosage now has FDA approval for treatment of patients with benign prostatic hyperplasia and erectile dysfunction for clinical situations where treatment of both conditions has been shown to be of medical necessity. Stendra is effective when taken with or without food, and it works within 15 minures. Moderate consumption of alcoholic beverages is possible with Stendra.

The most common side effect of Viagra and similar drug use is headache, affecting about 16% of users. A drop in blood pressure, transient dizziness, and facial flushing (red face) are reported in 10%. Indigestion occurs in 7% and nasal congestion in 4%. Between 3% and 11% of users report some visual problems while on Viagra. This visual disturbance is described as either blurred vision, increased light sensitivity, persistence of a bluish tinge, or temporary loss of the ability to distinguish between blue and green.

Cautions: Viagra, Levitra, and Cialis are absolutely not to be taken by men with heart conditions who are taking nitrates such as nitroglycerine or isosorbide (Isordil, Ismo, Imdur). Certain street drugs such as “poppers” also can cause serious problems if taken with Viagra, Levitra, or Cialis. Ecstasy is a street drug that may increase sexual desire but interferes with performance. This has prompted some men to combine ecstasy with Viagra, Levitra, or Cialis. This mixture (a combination sometimes called “sextasy”) can improve erection ability but also causes severe headache and priapism. (Priapism is an abnormally prolonged erection that becomes extremely painful and may result in permanent damage to the erection mechanism.) There are also potentially dangerous effects to your heart from mixing Viagra and similar medications with various other street drugs.