SkinStim

SkinStim SS-15 mixed stem cell based composition is available under Investigational Device Exemption at this time in selected countries for regulatory clearance has been received. Not available for sale.

The SkinStim combination candidate skin regeneration therapy in part or full is not yet proven to be safe and effective in properly controlled clinical trials.

510K market clearance for the SkinStim Mettler bioelectric stimulator is limited to improved blood circulation, mild pain relief and accelerated muscle tone healing only. No other indications of use or performance claims are authorized. The product is not proven yet for skin regeneration.

Only patented bioelectric signal to control stem cell homing via SDF-1(stromal derived factor 1) release. Over a dozen studies have documented that SDF-1 is the key stem cell homing factor protein in nature. We had our first bioelectric stem cell homing patent issued in 2005 and published our first SDF-1 paper in 2012.
Only known patent pending bioelectric signal for turning switch back on for tropoelastin release. Tropelastin creates elasticity of tissues including skin. We lose tropoelastin production when we are about 9 years old. We figured out how to turn that switch back on.

Only known patent pending bioelectric signal for controlling IGF-1 (insulin growth factor) release for DNA repair. This protein is known to repair skin cells damaged from aging, sun and smoke damage.
Only known patent pending bioelectric signaling sequence for growing functionally new mature (true endothelium lining) blood vessels for improving circulation. Sequence includes VEGF, SDF-1, EGF, PDGF HGDF, eNOS, CXCL5, PDGF, tropoelastin, follistatin.

Only known patent pending bioelectric signal sequence for repairing damaged muscle tissue via controlled release of follistatin. Our bioelectric stimulator has FDA 510K market clearance for improving blood circulation, improving muscle tone and accelerated healing of injuries.

How does bioelectric signaling work? It communicates directly with the DNA and the membrane of cells to give them very specific instructions on what proteins to produce, what cell membrane pores to open and close and what ionic communication channels to activate or deactivate. The bioelectric signaling is just like the computer program that gives instructions to the micro processors, semi-conductors and diodes of a computer. We use natural signals that are the same ones used in nature to recruit stem cells, repair damaged skin, improve circulation and heal organs. We just amplify these natural signals and extend their duration under control. These natural bioelectric signals are at work every day to repair your body of small injuries such a knee or elbow scrape and work very well. When there is severe damage they are overwhelmed and the body needs some additional help. Some functions such as tropelasin release turn off in humans at an early age as part of our programmed pathway towards aging and death. We have learned to turn some of these switches back on.

Only skin regeneration therapy that in severe cases combines bioelectrics with biologics for best results. Our basic biologics package includes amniotic fluid, only available at room temperature storage and time release PRF (platelet rich fibrin). PRF time release skin repairing growth factors for over 21 days. Both amniotic fluid and PRF have been part of over a dozen pre-clinical and clinical studies for skin regeneration and other healing applications. We just filed a new patent on the combination of bioelectric signaling and PRF. Amniotic fluid has become widely used in the USA for diabetic foot and leg ulcer healing with between 140 and 240 growth factors within the solution and membranes.
Our patent pending SS-15 skin regeneration composition is for very advanced skin damage repair including burn recovery. It is comprised of fifteen components which include adipose derived stem cells, growth factors, amniotic fluid, PRF, selected exosomes, selected alkaloids, selected micro RNAs, nutrient engineered hydrogel, skin matrix and oxygenated nano-particles. All of these components have been studied separately with numerous supporting peer review published papers. We are planing now clinical trials for the full fifteen component mixed composition “skin regeneration cocktail” combined with bioelectric stimulation.

No team has more experience than our team in bioelectric and biologics based organ regeneration. We published our first stem cell regeneration paper in 1989 in The Physiologist with Dr. Race Kao and Dr. George Magovern and in 1999 our first bioelectric regeneration paper in CIRCULATION the Journal of the American Heart Association working with Dr. Shinich Kanno via VEGF expression.
Our Chief Medical Officer Dr. Leslie Miller has been a part of over 80 FDA authorized clinical trials and is author or co-author of over 240 publications including one of the leading textbooks on stem cell based regeneration.

SkinStim is supported by over 140 experienced advisors and mentors as part of the Leonhardt’s Launchpads innovation and startup accelerator which includes a number of the leading stem cell scientists in the world.

The SkinStim full treatment protocol includes in clinic bioelectric, infrared light, PRF, amniotic fluid, micro needling, electro acupuncture and electro massaging in combination and in very severe cases also the SS-15 skin regeneration composition with includes adipose derived stem cells. At home the patient continues mobile bioelectric and light treatments, nutrient hydrogel and stem cell extract Lumenaire skin cream/gel treatments and repeated electro massages. Clinicians and patients can choose any combination of the above.

We are signing up Skin Clinics right now to participate in the evaluation of our SkinStim Basic skin regeneration package = bioelectric + light + amniotic fluid + PRF + micro needling + electro acupuncture + electro massaging followed by at home use of Lumenaire cream/gel.
We are completing pre-clinical studies to apply to the FDA or OUS regulatory authorities to begin studies of our Skin Advanced skin regeneration package which includes the fifteen component SS-15 composition = adipose derived stem cells, + growth factors + amniotic fluid + PRF + selected exosomes + selected alkaloids + selected micro RNAs, nutrient engineered hydrogel, skin matrix and oxygenated nano-particles.

Our team has discovered 19 bioelectric signals so far for controlling specific protein expressions relating to healing organs including skin and we are working every day to discover more.
Our management team and board has brought a number of products from concept to market leadership and successful exit for investors over the years including the Poly-Cath cardiovascular balloon catheters in the 1980’s exited to Nippon Zeon, stent grafts and percutaneous heart valves exited to Medtronic AVE in the 1990s.

It is first and foremost controlled release of regenerative proteins via precise bioelectric signals. We have patented or patent pending of 19 bioelectric signals at this time and are adding more as our research continues. The primary signal is the one that releases SDF-1 which is a known stem cell homing factor. This protein recruits stem cells from your own fat, bone marrow and circulating blood to the stimulated regions of your face and neck. The second most important bioelectric signal sequence is the one for producing release of tropoelastin which is known to increase elasticity of tissues. We also have bioelectric signals for IGF-1 (DNA repair) and EGF, HGF, PDGF, eNOS and HIF1a all which are known to improve blood circulation and follistatin which is known to improve muscle tone.

We combine the bioelectric stimulation with our proprietary skin cream produced by our partnership company Luminaire and in severe skin regeneration cases such as burns, where permitted by regulatory authorities or in clinical trials, we also utilize our patent pending SS-15 fifteen component skin regeneration composition comprised of stem cells, growth factors, amniotic fluid, platelet rich fibrin, exosomes, selected Micro RNAs, engineered nutrient hydrogel, selected alkaloids such as harming and skin matrix.

We initiated a collaboration with Dr. Robert O. Becker the Author of The Body Electric in 1985. We completed our first stem cell based organ regeneration large animals studies in 1988 working with Dr. Race Kao and Dr. George Magovern which were published in The Physiologist in 1989. Dr. Doris Taylor one of our Scientific Advisory Board members published in Nature Medicine a paper on muscle stem cell regeneration of heart in 1999. In 1999 we published our first paper on bioelectric regeneration in CIRCULATION the Journal of the American Heart Association working with Dr. Shinichi Kanno. From 1999 to present we have raised and invested more than $145 million into organ regeneration research. In May 2001 we led a team in The Netherlands with visiting U.S. collaborators that completed the historic first-ever non-surgical stem cell based repair of a human heart. We went on to lead and sponsor Pilot, Phase I, Phase II and Phase II/III studies working with 33 centers in the USA and a half dozen in Europe. These studies were published in The Journal of the American College of Cardiology, American Heart Journal, EuroIntervention and European Heart Journal. The team filed their first stem cell delivery system patent application in 1995 for ProCell based on work that began in 1988 – https://www.google.com/patents/US5693029. Howard Leonhardt the company founder has 21 issued U.S. patent and about 100 new patent claims pending with the USPTO all related to organ regeneration and recovery. In 2000 the team began filing its first patents for bioelectric regeneration including in combinations with stem cells, growth factors, nutrient hydrogels and matrixes. In 2008 the team launched work that led to collaborations and resulting studies of applying both bioelectric stimulation, stem cells, amniotic fluid and growth factors to healing skin wounds. One of these collaborative studies resulted in a publications in the International Wound Journal utilizing non-invasive wireless bioelectric stimulation methods – http://calstockexchange.com/wp-content/uploads/2014/09/WMCS_International_Wound_Journal_Jan_2014.pdf. Separate related studies were completed with 16 patients in Czech Republic (stem cells alone) and 8 patients in Mexico (bioelectric stimulation alone). The SkinStim by MyoStim Skin team believes no other group has a much experience in bioelectric, stem cell, growth factor, nutrient hydrogel and matrix based organ regeneration. Via Leonhardt Ventures and Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. we have over 140 experienced team members and advisors – which includes over 35 scientific and clinical leaders in organ regeneration research – https://calxstars.com/scientific-advisory-board/

Short answer – Precise bioelectric signals give clear instructions to the stimulated cell DNA/RNA to produce specific regenerative proteins on demand. Bioelectric signals give clear instructions to cell membranes on what to let in and what to let out and serve as an equivalent or surrogate of environmental stimuli to cause a cell action in response.

Bioelectric Signals in Regeneration

Alongside the biochemical signals that underlie regenerative ability functions an important and powerful system of biophysical controls that orchestrates cell behavior into the patterning needs of the host organism. Bioelectricity refers to the slow changes in ion content and resting membrane voltage (Vmem) that are present in all cells. Distinct from the rapid action potentials of excitable nerve and muscle, and from the effects of external electromagnetic field exposure, it is now known that endogenous gradients of voltage serve as instructive signals regulating cell proliferation, differentiation, and migration (reviewed in (Nuccitelli, 2003; McCaig et al., 2005; Blackiston et al., 2009; McCaig et al., 2009; Sundelacruz et al., 2009)). Even more exciting than the control of position, type, and number at the level of individual cells, is the role of bioelectric signals in large-scale pattern formation during cancer suppression, embryogenesis, and regeneration (Lund, 1947; Nuccitelli et al., 1986; Levin, 2007, 2009). Standing gradients of voltage and ion fluxes among cells serve to regionalize tissues as pre-patterns for gene expression domains (Burr and Hovland, 1937; Burr and Sinnott, 1944; Vandenberg et al., 2011), provide coordinates to guide morphogenetic rearrangements (Shi and Borgens, 1995), dictate anatomical identity and polarity of actively patterning tissues (Marsh and Beams, 1949; Kurtz and Schrank, 1955; Marsh and Beams, 1957; Levin et al., 2002; Adams et al., 2006; Beane et al., 2011), and serve as master-regulators for initiating the development of specific organs and the regeneration of whole appendages (Borgens et al., 1979; Jenkins et al., 1996; Pai et al., 2012). (see full reference link below).

TRANSDUCING BIOELECTRIC SIGNALS INTO EPIGENETIC PATHWAYS DURING TADPOLE TAIL REGENERATION

Short answer – Traditional microcurrent devices were designed to accelerate healing via “current of injury” signaling, to improve mildly blood circulation and muscle tone and provide mild pain relief. Traditional TENS devices were designed to lower pain. Nearly all of these devices have very fuzzy noisy signals compared to new modern precise bioelectric signaling stimulators, such as those used and programmed by SkinStim. Traditional microcurrent facial devices do not have specific precise signals or sequences for controlling the release of specific regeneration promoting proteins on demand and even if programmed with these signals do not have the clarity of signal for the body to understand the instruction. When they send their signals the body says back “what I cannot understand you, speak more clearly, what do you want me to do?”. Bioelectric stimulators, such as SkinStim’s, have precise programming to deliver precise clear signals to control protein expressions on demand. These controlled protein expressions are for very specific purposes. See below.

Examples of controlled protein expressions only possible with precise bioelecdtric signaling with a high precision stimulator with clarity of signals.

1. SDF-1 and PDGF protein expression – controls stem cell homing to bioelectric stimulated location.
2. Tropoelastin protein expression – controls release of elastin which increase elasticity of treated area and surrounding tissues.
3. VEGF, HIF1a, eNOS, CXCL5, EGF, HGF, PDGF, SDF1 protein expression sequence – promotes growth of new mature (true endothelium lining) blood vessels to improve blood circulation. VEGF alone creates leaky blood vessels that retreat shortly after treatment. eNOS dilates blood vessels.
4. IGF1 protein expression – helps promote DNA damage repair such as from sun and aging in skin.
5. Interleukins protein expressions – helps modulate inflammation when delivered in proper sequence at proper time.
6. Stem cell differentiation signal – switches from stem cell recruitment and proliferation mode to differentiation mode. Local microenvironment helps determine stem cell pathway of differentiation. In skin the differentiation bioelectric trigger signal helps recruited and multiplied stem cells to form new fresh skin in the place of damaged aged skin.

Traditional microcurent or TENS facials do not control with preciseness any of the above. At best they provide a temporary slight improvement of blood circulation if there is a surface wound these general “current of injury” signal have demonstrated accelerated healing.

One of the first studies documenting the positive effects of microcurrent stimulation on this problem was by the team of Wolcott et all in 1969. These researchers applied stimulation in the range of 200-800 uA to a wide variety of wounds using alternating current polarities. A control group was treated with ordinary wound care methods The treated group showed 200-35O% faster healing rates than controls, with stronger tensile strength of scar tissue and antibac- terial effects in infected wounds.