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Valvublator

Valvublator is designed to help patients keep their own heart valve instead of getting a pig, cow, plastic or steel artificial implant! Catheter based and non-invasive systems to decalcify and regenerate heart valves with precise bioelectric signaling sequences and precision focused ultrasonic energy.

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(424) 291-2133

5270 California Avenue, Irvine, California, United States of America 92617

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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 Us & History

Valvublator is focused on non-surgical regeneration of heart valves so that patients may keep their own heart valve instead of getting an implant. MyoValve a Valvublator subsidiary is focused on developing tissue engineered heart valves delivered via a percutaneous method.

  • 1985: The book Body Electric was published by Dr. Robert O. Becker and we engaged him as an advisor to Leonhardt Ventures in the use of microcurrents to improve blood flow where needed and to regenerate tissues including heart valve leaflets.
  • 1987: Howard J. Leonhardt Valvublator founder visited Dr. Domingos Moraes in Rio De Janeiro, Brazil in 1987 with Dr. Ivan Casagande and Dr. Richard Bianco (from the University of Minnesota) to view the implantation of the LABCOR or BIOCOR porcine heart valve via open chest surgery.
  • Design Inspiration: After witnessing a procedure where a surgeon explained that often he can clean calcification from leaflets with simple scrapes, Howard Leonhardt drew up the design of a vibrating dental burr on the end of a deflecting tip catheter, Valvublator I, to reduce the need for open chest surgery.
  • 1987-1991: Launched the DeltaVein electrical stimulator project and in 1991 introduced the first conformance sealing stent graft for aortic aneurysm repair – the TALENT Stent Graft.
  • 1994-2001: Began work with Dr. Stuart Williams at the University of Arizona to cell sod vascular grafts and heart valve leaflets and in 2001 led the completion of the first-in-man non-surgical percutaneous catheter based muscle stem cell repair of a damaged human heart.
  • 2008-2013: Moved the Leonhardt Ventures research lab to California to renew work on inventions like the Valvublator; in 2013, a full expert team joined to advance the technology platforms.

Our Vision: A New Paradigm

New Paradigm = Decalcify and Regenerate Heart Valves BEFORE a cow, pig, plastic, steel or cadaver implant is needed! We believe our minimally invasive or non-invasive decalcification and regeneration product will be used in the future to decalcify and regenerate heart valves BEFORE they get so diseased that a pig, cow, cadaver, steel or plastic implant is needed. Just like we go to the dentist early now to clean our teeth BEFORE plaque and disease gets too advanced requiring a dental tooth implant.

Innovation Methodology & Strategic Development

Note – To reduce development time, cost and speed to clinic the Valvublator team utilizes where-ever and when-ever possible readily available components and devices. We believe this is just plain smart.

  • Adaptations: Our surgical decalcification device is adapted from a dental plaque scaler; our vibrational energy device for bulk calcification removal is adapted from a vibrational energy engraving device; and our citric acid pulse jet sprayer is adapted from a Water Pik TM device.
  • Smart Innovation: Our bioelectric stimulator has FDA 510K market clearance for various applications; we re-programmed this existing stimulator with our bioelectric signals for stem cell homing, myogenesis and arteriogenesis that all fell within the range of frequencies, wave forms, voltages and amperages (micro current) already cleared by the FDA.

/ – THE TECHNOLOGY

The Technology behind it

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

Heart Valve Regeneration

Causes Stimulated Tissues to Release SDF-1 and Follistatin which Causes Stem Cells to Home to Site and Forms New Smooth Muscle. Decalcifies + Cell Sods + Regenerates + Surface Modifies + Strengthens = Rebuilds heart valve leaflets and orifice utilizing a patient’s own cells.

  • Full real time optical and echo viewing to guide valve repair.
  • Embolitic fragment protection throughout procedure.

Combination of:

  1. Mechanical burr cleaning with controllable deflecting tip.
  2. Ultrasonic cleaning.
  3. Biochemical safe solvent cleaning.
  4. Vacuum removal of debris.
  5. Cell sodding micro needles.
  6. Microcurrent regeneration signal = recruits stem cells with homing signal and differentiates them to valve tissue.
  7. Spay-on scaffolding for rebuilding highly damaged leaflets.
  8. Full optical, ultrasound or echo viewing of valve repair field of view real time.

Valvublator’s 4 Step Process to Total Heart Valve Regeneration

The future is non-invasive heart valve decalcification and regeneration and Valvublator plans to lead the way!

  1. 3 stage decalcification cleaning: (1) vibrating burr + (2) ultrasonic + (20 biologically safe solvent (citric acid) all via same guiding catheter.
  2. Reduce risk of re-calcification: Treat valve with special spray (confidential composition at this time) on composition following decalcification to reduce risk of re-calcification.
  3. Regenerate valve by recruiting stem cells: and releasing other regenerative proteins with bioelectric signaling that starts as invasive catheter electrode placements for first treatments and then transitions to non-invasive treatments over a course of about 12 to 20 weeks.
  4. Prevent re-calcification: by monthly @ home stimulation 30 minutes of thigh muscle with non-invasive gel electrodes to release beneficial proteins such as klotho. Our patent pending bioelectric signaling sequences developed at our lab in Utah increase Klotho expression by up to 480%.

Technology Specifications

  • Date of Invention: Original Design 1987, Enhanced Design 2012.
  • Device Structure: The Valvublator is an 8FR deflecting tip catheter with a special tip for decalcifying and cell sodding heart valve leaflets so a patient may keep their own heart valve instead of getting an implant.
  • Components:
    • Dental Burr at Tip – For cleaning plaque from leaflets and valve ring orifice.
    • Ultrasound Transmitter – For cleaning calcification plaque from leaflets and viewing.
    • Electrical Energy Transmitter – For causing heart valve leaflets to release SDF-1 to increase leaflet strength.
    • Infusion Lumen – For cleaning plaque with biologically compatible solvent and clearing area for viewing.
    • Optical Lens Viewing Port – For viewing the cleaning and healing procedures.
    • Micro needle Tip – For injecting cells into leaflets to reinforce strength.
    • Spaying apparatus tip – For spraying heart valve leaflets with healing gel.

Valvublator Product Image
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Valvublator Product

Product Pipeline

Valvulblator is developing its product in three delivery platforms:

  • Surgical Valvublator: for cardio thoracic surgeons.
  • Minimally Invasive Catheter Valvublator: for interventional cardiologists.
  • Non-Invasive External Valvublator: for cardiologists and doctors offices and perhaps home use for some re-calcificaiton prevention signals ie; klotho.

Valvublator image
/ – KNOWLEDGE BASE

Related resources

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

Valvublator Core Investment & Strategic Documents

This section contains high-level business documents, investment decks, and regulatory filings that define Valvublator’s market position and legal compliance.

Executive Summary

A concise overview of Valvublator’s mission, market potential, and the core technology designed for total heart valve regeneration.

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Valvublator Pitch Deck

A comprehensive visual guide for investors detailing the problem, the bioelectric solution, and the company’s growth roadmap.

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Valvublator Presentation Slides

Detailed slides illustrating the innovation methodology and the transition from invasive to non-invasive treatments.

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SEC Rule 506 and Rule 144A (General Solicitation)

Official SEC final rules regarding the lifting of prohibitions against general solicitation in private offerings.

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Patents & Proprietary Inventions

These resources highlight the intellectual property and historical patent filings that form the foundation of Valvublator’s technology.

Percutaneous Placement Valve Stent Patent

The landmark patent (US5957949) for a valve stent delivered via catheter, a foundational element of percutaneous valve intervention.

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Method of Enhancing Myogenesis by Electrical Stimulation

A proprietary method for using electrical signals to stimulate muscle formation and tissue repair.

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Scientific Research – Heart Valve Regeneration & Stem Cells

This group includes peer-reviewed scientific articles and clinical studies supporting the efficacy of regenerative medicine and stem cell homing for valve repair.

Heart Valve Regeneration

A core scientific study exploring the potential to regenerate heart valve tissue rather than replacing it with artificial implants.

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Stem Cells for Heart Valve Regeneration

Research focusing on the utilization of stem cells as the primary building blocks for rebuilding damaged valve leaflets.

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Regenerative Medicine Approach to Valve Replacement

An AHA Journal publication detailing the shift toward regenerative therapies in modern cardiology.

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Mechanistic Roles of Matrilin-2 and Klotho

Study on how specific proteins modulate inflammatory activity in human aortic valve cells to prevent disease progression.

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Twelve-Month Results of Cell Repopulation

Long-term results of allogeneic transplantation and cell repopulation in valved aortic conduits.

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Aortic Valve Preservation in Acute Dissection

Research into surgical techniques and logic behind preserving the natural aortic valve during critical dissections.

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Cutting-Edge Technologies for Valve Calcification

An in-depth look at emerging technologies aimed at treating heart valve calcification via regenerative methods.

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The Stem Cell Movement

A Circulation Research piece on the history and future trajectory of stem cell therapies in cardiac repair.

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Degenerative Mitral Stenosis: Unmet Need

Analysis of the current gaps in treating mitral stenosis and the urgent need for percutaneous (catheter-based) solutions.

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Bioelectric Signaling & Ultrasonic Decalcification

Scientific evidence supporting Valvublator’s specific use of microcurrents to recruit stem cells and ultrasonic energy to remove calcification.

SDF-1α as a Therapeutic Stem Cell Homing Factor

Scientific proof that SDF-1α acts as a signal to “call” stem cells to the site of injury for natural tissue repair.

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SDF-1 in Myocardial Repair

A nature journal article validating the role of SDF-1 in repairing myocardial tissues.

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Low Current Electrical Stimulation & Cytokine Expression

Research showing that low-level microcurrents can trigger the release of beneficial regenerative proteins.

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Intercellular Signaling Peptides & Proteins

Advances in understanding how electrical stimulation coordinates cellular signaling for healing.

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Ultrasonic Decalcification of Calcified Valve and Annulus

Evidence for using ultrasonic energy to break down and remove calcium deposits from heart valves.

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A New Ultrasonic Process for Aortic Valve Decalcification

Detailed study on a specific ultrasonic process designed for renewing aortic valve health through decalcification.

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Citric Acid as a Decalcifying Agent

Validation for using citric acid as a safe biochemical solvent to dissolve calcified human heart valve deposits.

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/ – INSIGHTS & PERSPECTIVES

Related posts

Want to learn more? Browse our clinical resources and scientific publications on our latest updates and insights.

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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Valvublator is focused on non-surgical regeneration so that patients may avoid the risks associated with cow, pig, or mechanical implants. Our system combines mechanical cleaning, ultrasonic energy, and microcurrent signals to recruit stem cells for total valve repair.

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