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VascuStim

VascuStim is a biotechnology leader dedicated to redefining regeneration and recovery through innovative bioelectric stimulation. We utilize precise signaling for controlled protein expression and stem cell homing to develop treatments that restore healthy tissue and organ function.

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(424) 291-2133

12130 Millennium Dr, Los Angeles, California, United States of America 90094

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/ – THE COMPANY

About this Venture

Discover our background, mission, and the world-class research driving our next-generation medical technology.

About VascuStim

VascuStim is in the business of developing treatments utilizing the innovative advancements in bioelectric stimulation controlled protein expression, stem cell homing, proliferation and differentiation combined with stem cel based mixed compositions such as amniotic fluid which has over 240 known growth factors critical and important to healthy tissue and organ development and repair. We committed to gathering data in well controlled studies with patient safety always established first and foremost. Our stem cell based compositions are procured and handled by an FDA HCT/P certified lab. The company prides itself on its state-of-the-art technology and its ability to provide products of the highest standards in the industry. Our amniotic fluid and membranes are processed from donated human tissue from full term deliveries and are regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

Our Mission

VascuStim’s mission is to harness the power of precise bioelectric signaling for controlled protein expressions, including stem cell homing, to promote improved peripheral vascular circulation, healing, recovery and performance. When needed for the most severe cases we combine this with repeat deliveries of amniotic fluid membranes and our VS-15 multi-component stem cell + growth factor based organ regeneration and healing composition.

Our Story

VascuStim specializes in bioelectric signaling technologies that are redefining regeneration, healing, and recovery. The core of this technology platform are bioelectric signals for stem cell homing, proliferation and differentiation control as well as specific signals For severe cases we combine this with repeat applications of amniotic fluid membranes and repeat delivery of our VS-15 multi-component proprietary regeneration and healing composition comprised of stem cells, growth factors, selected exosomes, selected micro RNAs, selected alkaloids, nutrient hydrogel and matrix.

No organization has more experience in stem cell and bioelectric signaling based organ regenerative and recovery. Our electrical stimulator manufacturing partners in Southern California began building their first therapeutic electrical stimulation and ultrasonic therapy devices in 1955. In 1985 after consultations with Dr. Robert O. Becker the Author of The Body Electric we began our research program on improving blood circulation and organ regeneration. We published our first heart regeneration study in The Physiologist working with Dr. Race Kao in 1989 and our first bioelectric limb regeneration and ischemia treatment paper in CIRCULATION with Dr. Shinichi Kanno in 1999. We began filing a series of over 100 U.S.P.T.O. patent claims that year on bioelectric, stem cell and growth factor based organ regeneration and recovery. In the 1990’s we developed and patented the first endovascular percutaneous delivered aortic aneurysm and heart valve repair systems. In 2001 our Leonhardt team lead the completion of the historic landmark first ever non-surgical stem cell repair of a human heart. This led to publication of Pilot, Phase I, Phase II and Phase II/III study results. In 2016 we team with The Reems Lab at The University of Utah that had over a decade of experience in processing amniotic fluid membranes for healing applications. Over 400,000 patients have been treated to date with Leonhardt inventions for organ regeneration, treatment and recovery.

Unmatched Experience

VascuStim is a unit of Leonhardt Ventures, led by Howard J. Leonhardt, which began organ regeneration research in the 1980’s. We completed with Dr. Race Kao and Dr. George Magovern our first stem cell repair of heart in a large animal in 1988 which was published in The Physiologist in 1989 Kao RL, Rizzo C, Magovern GJ: Satellite cells for myocardial regeneration. Physiologist 1989; 32: 220. In the 1990’s we gained world leadership positions in the development of cardiovascular balloon catheters, intravascular lungs, electro magnetic radiation and stem cell delivery catheters, aortic stent grafts and percutaneous heart valves. Our patented stent graft still holds the world’s leading share of endovascular aortic aneurysm repairs. In 1999 we published our first paper on bioelectric stimulation controlled limb ischemia treatment in the American Heart Association Journal CIRCULATION Circulation. 1999 May 25;99(20):2682-7. working with Dr. Shinichi Kanno. Our team went on that year to file the first in our series of over 100 U.S. patent claims for bioelectric stimulation controlled protein expressions. In 2001 we made history by completing the first-in-man non-surgical stem cell repair of a human heart in The Netherlands working with Dr. Patrick Serruys, Dr. Pieter Smits, Dr. Doris Taylor and Dr. Warren Sherman. In the 2000’s our team was the first to receive FDA permission to enter first stem cell therapy clinical trials for heart repair and later combination heart and gene therapy. Over 400,000 patients have been treated to date with Leonhardt inventions. Our vascular related inventions have been used by more than 2000 centers worldwide in over 40 countries. Recently we helped lead with collaborating associates limb salvage trials in Mexico and Czech Republic in 7 and 16 patients respectively with bioelectric stimulation and adipose derived cell compositions. We worked with a team in Denmark that completed a 47 patient clinical trial in Germany and Switzerland for wireless microcurrent treatment of non-healing ulcers. This data was published in the International Wound Journal in 2013. The Leonhardt team has helped lead clinical trials for stem cell therapies at over 38 leading research centers worldwide which includes 33 leading U.S. centers.

Our Leadership & Expertise

Our Chief Medical Officer

Dr. Leslie Miller, former Chief of Cardiovascular Medicine at the University of Minnesota, has been involved in over a dozen stem cell therapy cardiovascular related clinical trials. He is co-editor of the textbook Stem Cell and Gene Therapies for Cardiovascular Disease. Our Scientific Advisory Board is comprised of over 30 leading clinicians and scientists with unprecedented experience in the field.

Jo-Anna Reems, Ph.D.

Jo-Anna Reems, Ph.D. is Research Professor in the Division of Hematology and Hematologic Malignancies, Department of Internal Medicine at the University of Utah School of Medicine. She is also the Scientific Director of the University of Utah Health Care Cell Therapy & Regenerative Medicine Facility, which is FACT accredited. Dr. Reems is certified by the American Society of Clinical Pathologists as a Medical Technologist, and a Specialist in Blood Banking.The Reems Laboratory focuses on delivering novel cellular products that have the potential to improve the quality of life for patients. In her role as the Scientific Director for the Stem Cell Facility, Dr. Reems’ vision is to create a premier Cell Therapy and Regenerative Medicine Center of Excellence for the state of Utah that facilitates the translation of cutting-edge cell therapy and tissue engineered research into clinical products that extend and improve the quality of life of individuals suffering from debilitating diseases and injuries.

Dr. Reems obtained her B.S. in Medical Technology at the University of Colorado at Boulder. She then earned her Ph.D. in Biochemistry at the University of Colorado Health Sciences Center in Denver, Colorado. After her doctoral studies, Dr. Reems completed a Research Fellowship at Fred Hutchinson Cancer Research Center, with a focus on Regulators of Hematopoiesis. Prior to joining the University of Utah as faculty, Dr. Reems functioned as the Scientific Director of the Cell Therapy Facility at Puget Sound Blood Center in Seattle, Washington.

Collaboration & Innovation

VascuStim a Leonhardt Ventures company incubating in the Leonhardt’s Launchpads by Cal-X Star Business Accelerator, Inc. startup innovation accelerator(s) is seeking investigators input at this time for the final product design and the design of pre-clinical and clinical studies to prove our this combination therapy for the above mentioned indications of use.

/ A - Our Team

Our Team

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    Dr., 

    Barry Katzen

    Chief Vascular Institute Advisor

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    Dr., 

    Richard Neville

    Chief Limb Ischemia Advisor

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    Dr., 

    Jacob Cynamon

    Chief Interventional Radiology Advisor

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    Dr., 

    Harrison Lazarus

    Chief Vascular Surgery Advisor

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    Dr., 

    Juan Parodi

    Chief Endovascular Advisor

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    Dr., 

    Leslie Miller

    Chief Medical Officer

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    Howard Leonhardt

    Executive Chairman & CEO

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    Matt Fendrich

    Vice President Physician Relations

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    Dr., 

    Joanna Reems

    Chief Advisor Amniotic Fluid Membranes

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    Dr., 

    Jorge Genovese

    Chief Bioelectric Regeneration Advisor

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    Dr., 

    Nicolas Chronos

    Chief Cardiology Advisor

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    Dr., 

    Robert Kellar

    Chief Wound Healing Advisor

/ – THE TECHNOLOGY

The Technology behind it

Discover the science and innovation driving our advanced solutions, designed to deliver safe, effective, and transformative results.

Amniotic Membrane Technology

Amniotic membrane is placental tissue that comes from donated placenta after childbirth. It consists of the innermost layer of tissue that is comprised of a thin epithelial layer, a thick basement membrane and an avascular stroma. There are several unique properties of amniotic membrane that make it ideal for wound healing.

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Properties and Therapeutic Potential of Amniotic Membrane

Amniotic membrane has abundant stem cells that one can harvest without moral and ethical concerns.

Amniotic membrane lacks immunogenicity via a low expression or lack of expression of histocompatibility antigens.

Amniotic membrane has the ability to produce healing with little to no scarring. Along with the indirect contribution of amniotic membrane’s anti-inflammatory effects, there has been evidence of direct reduction of scarring. Tseng and colleagues demonstrated in a laboratory study that there was a direct anti-scarring action on ocular surface fibroblasts by suppressing transforming growth factor beta (TGF-b). The TGF-b is responsible for activation of fibroblasts and by down-regulating this process, there is a reduction and prevention of adhesion and fibrosis.

Amniotic membrane has the ability to impart anti-inflammatory effects by mediating pro-inflammatory cytokines such as interleukin (IL-6) and TNF-alpha. Tseng and colleagues noted that enzyme-linked immunosorbent assay (ELISA) extracts have high levels of IL-10, which counteracts inflammatory effects. In addition, they have found amniotic membrane down-regulates the expression and production of IL-1, and up-regulates interleukin-1 receptor antagonist (IL-1RA).

Given all these properties of amniotic membrane, this team seeks to initiate well designed studies to prove out the potential safety and efficacy of this product to heal these challenging diabetic wounds as well as treating critical limb ischemia, limb salvage and diabetic neuropathy.

Clinical Feasibility and Bioactive Composition of Full-Term Amniotic Fluid

Amniotic fluid (AF) possesses anti-inflammatory, anti-microbial and regenerative properties that make it attractive for use in clinical applications. The goals of this study were to assess the feasibility of collecting AF from full-term pregnancies and to evaluate non-cellular and cellular properties of AF for clinical applications. Donor informed consent and medical histories were obtained from pregnant women scheduled for C-sections and infectious disease testing was performed the day of collection. AFs were evaluated for total volume, fluid chemistries, total protein, and hyaluronic acid (HA) levels. AF was also assessed with quantitative antibody arrays, cellular content and for an ability to support angiogenesis.

Findings and Therapeutic Potential of Amniotic Fluid

Thirty-six pregnant women consented and passed donor screening to give birth tissue. AF was successfully collected from 17 individuals. Median AF volumes were 70 mL (range 10–815 mL; n = 17). Fluid chemistries were similar, but some differences were noted in HA levels and cytokine profiles. Cytokine arrays revealed that an average of 304 ± 20 of 400 proteins tested were present in AF with a majority of cytokines associated with host defense. AF supported angiogenesis. Epithelioid cells were the major cell type in AF with only a minor population of lymphoid cells. Cultures revealed a highly proliferative population of adherent cells capable of producing therapeutic doses of mesenchymal stromal cells (MSCs). These findings showed that significant volumes of AF were routinely collected from full-term births. AF contained a number of bioactive proteins and only a rare population of MSCs. Variations noted in components present in different AFs, warrant further investigations to determine their relevance for specific clinical applications.

The Reems Lab Processing

The way the amniotic tissue is processed also makes a difference in maintaining the integrity of the amniotic membrane. The VascuStim team sources amniotic fluid and membranes from the patent pending processes developed at the Reems Lab at University of Utah. Dr. Joanna Reems has over 20 years experience processing and studying amniotic fluid for therapeutic purposes.

Reems Lab Cell Processing
/ ? — FAQ

Common questions

Don’t see your question? Reach out and our clinical team will respond personally.

It depends on the country you are in due to regulatory constraints and compliance requirements. In the USA the Vascustim treatment protocol is restricted to delivery of bioelectric stimulation signals that fall within the range authorized under the current 510K market clearance and the use of amniotic fluid filled membranes available under the FDA homologous exemption rules. In other countries where permitted we utilize a broader range of bioelectric signals and add repeat delivery of adipose tissued or bone marrow derived stem cells and selected growth factors, exosomes, Micro RNAs, platelet rich plasma, nutrient hydrogel and alkaloids.

Our patented and patent pending precise bioelectric signals with precise sequence control the release of VEGF, PDGF, SDF-1, eNOS, HGF and HIF 1 alpha all known from previous stand alone studies to promote new blood vessel formation thus improving circulation. eNOS serves to dilate existing blood vessels to a larger inner diameter promoting better blood flow. SDF-1 is stem cell homing signal the contributes to injury and wound repair. By placing the + positive anode of the stimulation leads on one side of a wound and the – negative on the other side the device can create current flow across the wound which has been demonstrated to accelerated healing and reduce risk of infection in previous studies. In countries where it is permitted the addition of repeat injections of stem cells and growth factors has been found to contribute to improving blood flow and healing in previous studies. Sequence control is important as it has been demonstrated VEGF alone creates leaky (due to porous immature walls) new blood vessels but when followed by SDF-1 stimulation these blood vessels become more mature with true endothelium linings, a larger inner diameter with greater flow without leaking.

In the USA our electrical stimulation device has 510K market clearance for improving blood circulation, improving muscle function and recovery and mild pain relief. Amniotic fluid filled membranes as wound dressings are available in the USA and FDA’s homologous exemption. Outside of the USA autologous stem cells and growth factors may be added to the treatment protocol where permitted by law. Vascustim provides point of care lab kits to harvest these stem cells and growth factors from a person’s own fat (adipose) tissue or bone marrow.

We are preparing a complete reimbursement manual which will soon be published on our web site. Reimbursement cods are available for wound healing, pain relief, improving blood circulation, muscle function recovery and when sufficiently proven for by-pass (in this case biological bypass as a substitute to standard surgical vein bypass from the thigh to the foot).

/ – KNOWLEDGE BASE

Related resources

Want to learn more? Browse our clinical resources and scientific publications on our comprehensive suite of targeted treatments.

Clinical Studies & Systematic Reviews

This group contains comprehensive research papers and systematic reviews that provide high-level evidence for the efficacy of bioelectric stimulation in wound management.

Impact of Continuous Electrical Microcurrent on Wounds

A systematic review analyzing the positive effects of microcurrent on acute and hard-to-heal wounds.

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A Current Affair: Electrotherapy in Wound Healing

A scientific analysis of the biological mechanisms by which electricity heals tissue.

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Electrical Stimulation and Cutaneous Wound Healing

A detailed clinical evidence review showing how electrotherapy accelerates skin repair.

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Effect of Electrical Stimulation on Chronic Leg Ulcers

Research focused on the reduction of ulcer size and improvement in appearance through stimulation.

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Microcurrent as an Adjunct Therapy

A study on accelerating chronic wound healing and significantly reducing patient pain levels.

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Immune Response Modification

Research into how combined therapy (ultrasound and microcurrent) modifies the immune response for better healing.

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Vascular Health & Angiogenesis

These resources focus on restoring blood flow (circulation) and the growth of new blood vessels (angiogenesis) to save limbs.

Therapeutic Angiogenesis Procedure:

Establishment of a practical procedure for stimulating the growth of new blood vessels.

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Blood Flow in Chronic Critical Limb Ischemia

A study on the effects of electrical stimulation on patients following regenerative therapy for CLI.

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SDF-1/CXCL12 as a Target for Angiogenesis

Identifying key protein targets for treating critical leg ischemia through vascular growth.

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VEGF Release Following Electrical Stimulation

Research confirming that electrical stimulation triggers the release of Vascular Endothelial Growth Factor.

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Angiogenic Potential of Stem Cells

How electrical stimulation promotes the ability of adipose-derived stem cells to form new blood vessels.

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Diabetes & Neuropathy Solutions

Specific scientific literature addressing the unique challenges of diabetic foot ulcers and nerve damage.

Electrical Stimulation for Perfusion in Diabetes

The PRIZM study on enhancing circulation and blood flow in diabetic patients.

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Sonic Hedgehog Protein in Diabetic Neuropathy

Investigating the efficacy of specific proteins in treating experimental diabetic nerve damage.

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Bioelectric Stimulation + Amniotic Fluid in Diabetic Ulcers

A specialized article on the combination therapy for foot and leg ulceration.

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Regenerative Medicine & Amniotic Technology

Resources regarding the use of amniotic tissue, gene activation, and multi-component regenerative therapies.

Amniotic Fluid Stem Cells on Wound Healing

A rat model study evaluating the regenerative properties of amniotic fluid cells.

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Human Amniotic Membrane Grafts

Medical review of the use of amniotic grafts in treating non-healing chronic wounds.

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Stem Cell and Gene Therapy for Cardiovascular Disease

A comprehensive textbook regarding the future of regenerative cardiovascular medicine.

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Anti-Aging β-Klotho Gene-Activated Scaffold

Research on human adipose stem cells and rejuvenative wound healing responses.

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Tisugen Knee Data

A collection of research papers and data regarding knee regeneration and tissue repair.

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Patents, Protocols & Product Information

Official documentation including the clinical trials, patents, and product models specific to VascuStim.

Method of Enhancing Myogenesis (Patent)

The official patent for using electrical stimulation to enhance muscle tissue creation.

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MARVEL Clinical Trial

Data on the safety and efficacy of myoblast implantation following a heart attack.

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VascuStim Model #240

Official product page for the flagship VascuStim bioelectric stimulator.

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VascuStim Clinical Protocol

The step-by-step medical protocol for administering VascuStim treatments.

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VascuStim Patient Consent Form

Standardized documentation for patients undergoing clinical procedures.

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Wearable Nanogenerators for Healing

Cutting-edge research on wearable electric field generators for wound repair.

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Aetna Medical Policy Bulletin

Insurance and medical policy details regarding electrical stimulation for chronic ulcers.

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CAUTION Disclaimer and Warning:

Products described on this web site are in early stage development and are not yet proven safe or effective in statistically significant controlled clinical studies. Any statement or phrases implying efficacy or safety in any form are considered modified by “intended to” or “designed to”. Investigational use only in countries where investigation is permitted by law and proper filings have been made and appropriate regulatory clearances have been granted. Any use of the product(s) must be in an authorized clinical study with institutional review board (ethics committee) approval and proper patient consent procedures followed. For other countries product is only available for laboratory investigation by credentialed institutions and investigators with proper clearances with a research agreement in place with a study sponsor. NOT AVAILABLE FOR SALE.

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We are seeking investigators and strategic partners to help finalize our product design and move into pre-clinical and clinical studies. Help us bring these life-saving combination therapies to patients suffering from critical limb ischemia and diabetic neuropathy.

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