Leonhardt Ventures LLC Celebrates 25th Anniversary of Launching First Aging Reversal Major Organ Regeneration Clinical Programs

Jun 23, 2026

Historic MyoCell™ Heart Regeneration Program Evolves Into BioLeonhardt™ and Lionheart Octopus™ Multi-Organ Regeneration Platform

HUNTINGTON BEACH, Calif. — Leonhardt Ventures LLC is proud to celebrate the 25th anniversary of the launch of one of the world’s earliest clinical programs focused on regenerating a failing major organ using a patient’s own cells.
“Twenty-five years ago, the landmark MyoCell™ program helped prove that repairing a failing human heart with a patient’s own living cells was not science fiction — it was clinically feasible. This breakthrough platform is now being applied in studies to nearly all organs of the human body in attempt to extend healthspan longevity dramatically by Lionheart Health, Inc.  Many breakthrough inventions take decades to reach broad commercial impact. The invention of the airplane took multiple decades to transform global travel, television took decades to become a household standard, the cell phone took over 30 years to evolve into today’s smartphone, and artificial intelligence spent more than 50 years in development before reaching the mass adoption it is achieving today. Regenerative medicine is following a similar arc with perhaps even more importance to life on earth.  Planes, phones, TVs and computers have no value without a healthy life. What began with the first clinical cell-based heart repair procedures in 2001 has now evolved into the BioLeonhardt™ and Lionheart Octopus™ multi-organ regeneration platform, combining bioelectric stimulation, precision pumps and bioreactors, regenerative biologics, cell therapy, gene therapy, and AI-guided protocols to target not only the heart, but also the kidneys and other aging organs. We believe the next 25 years will define the transition from treating organ failure to restoring organ function and extending healthspan longevity.  The company that truly solves real organ regeneration and meaningful healthspan longevity extension has a legitimate chance to surpass the valuation of SpaceX.  Reaching this journey goal took a major leap forward  25 years ago on May 24th, 2001 at Erasmus University with Dr. Patrick Serruys broadcast live to the EuroPCR Conference.  We celebrate this important historic anniversary now today.” 
— Howard J. Leonhardt, Founder & Executive Chairman, Leonhardt Ventures LLC and BioLeonhardt
The landmark May 24th, 2001 historic successful first-in-man percutaneous implantation of autologous skeletal myoblasts (muscle stem cells – satellite cells) into damaged heart muscle at the Thorax Center in Rotterdam, Netherlands. The pioneering procedure involved a team that included Howard J. Leonhardt, Prof. Patrick Serruys, Dr. Warren Sherman, Dr. Kumar Ravi, Dr. Doris Taylor, Dr. Pieter Smits, and colleagues.  This data was later published in 2023 in the Journal of American College of Cardiology (JACC) Journal > https://www.jacc.org/doi/10.1016/j.jacc.2003.06.017   This work followed publication in 1989 in The Physiologist of the first large animal heart repair with cells working with our team members Dr. Race Kao and Dr. George Magovern and our 1999 with Dr. Shinichi Kanno on bioelectric regeneration in Circulation.
This groundbreaking work became the foundation for Bioheart’s MyoCell™ program, one of the first large-scale efforts to regenerate damaged heart tissue using living cells.

The clinical experience was later reported in the landmark 2003 Journal of the American College of Cardiology publication led by Dr. Pieter Smits, documenting the first catheter-based intramyocardial delivery of autologous skeletal myoblasts for ischemic heart failure.

Over the following years, MyoCell advanced through Pilot, Phase I, Phase II (SEISMIC), and Phase II/III (MARVEL) clinical trials conducted at 52 clinical sites.

Clinical Results Demonstrated Reduced Disease Progression

Heart failure is normally a progressive disease in which many patients continue to worsen despite optimal medical therapy.

Across the MyoCell clinical program:

• Approximately 84% of treated patients improved in at least one major clinical parameter.

• Approximately 33% improved by two NYHA heart failure classes.

• Only approximately 16% experienced worsening of their condition.

In the randomized Phase IIa SEISMIC Trial:

• Up to 94% of MyoCell-treated patients improved or maintained their NYHA functional class.

• Control patients were significantly more likely to experience worsening heart failure.

• Treated patients improved six-minute walk distance by approximately 60 meters while controls showed virtually no improvement.

In the MARVEL Phase II/III placebo-controlled trial:

• Cell-treated patients improved six-minute walk distance by more than 91 meters.

• Placebo-treated patients declined by nearly 4 meters.

Summary of Results
In Bioheart MyoCell studies, 84% of muscle cell-treated patients improved their exercise capacity, while the vast majority (69%) of the control and placebo cohorts either failed to improve or experienced measurable physical worsening. [1]

These studies helped establish regenerative cardiovascular medicine as a legitimate scientific and clinical field and demonstrated that cell-based therapies could potentially slow or reverse aspects of progressive heart failure.

From Heart Regeneration to Multi-Organ Regeneration

Today, the vision has expanded far beyond the heart.

BioLeonhardt and Lionheart Health are developing integrated regeneration systems that combine:

• Bioelectric stimulation

• Implantable and external stimulators

• Precision infusion pumps

• Regenerative biologics

• Protein expression therapies

• Cell therapies

• Gene therapies

• AI-guided personalized treatment protocols

The centerpiece of this effort is the BioLeonhardt platform and Lionheart Octopus™ architecture, a multi-organ regeneration system initially focused on the heart and kidneys and designed to expand to other aging organs throughout the body.

The platform combines:

• Organ-specific bioelectric signaling

• Regenerative protein expression enhancement

• Precision biologic delivery

• Continuous physiologic monitoring

• Closed-loop therapy optimization

The first target indications include heart failure, chronic kidney disease, vascular disease, and age-related organ decline.

Recognition for Innovation

The next-generation Lionheart Octopus™ system recently received a University of California Irvine Engineering Capstone Award, reflecting continued validation of the platform’s innovation and engineering excellence.

In addition, BioLeonhardt and Lionheart Health have been recognized for leadership in regenerative medicine, bioelectric medicine, and organ restoration technologies.  Lionheart Health was named spring 2024 a Top 40 semi-finalist in the $101 million Xprize Healthspan competition and applied this April 22nd to make it to the Final 10 (final round winners will be announced at the University of Utah in August).  Lionheart Health also won the Abbive Allergan ULP Innovation Award and was named a Finalist as Innovator of the Year and Life Sciences Technology Company of the Year.  Medtech Outlook Magazine recognized both Lionheart Health and BioLeonhardt as Micro Stimulator Developer of the Year in 2025.

Carrying the Torch Forward

What began in 2001 as a pioneering attempt to regenerate damaged heart muscle has evolved into a broader mission:

To restore function to aging organs, extend healthy lifespan, and ultimately make age-related organ failure a treatable condition rather than an inevitable consequence of aging.

Twenty-five years after the first MyoCell TM patient was treated in Rotterdam, the mission continues through BioLeonhardt and Lionheart Health, with the goal of regenerating not just one organ, but the entire interconnected organ system that supports human health and longevity.
    Original approach = 1 time injection of muscle or other stem cells alone in target organ
    Current approach = implanted under skin infusion pump and bioreactor filled daily with patented klotho expressing stem
    cells suspended in a nutrient hydrogel (Whartons Jelly, amniotic fluid, placental factors, tetraharmine, selected growth
    factors) + an implantable micro bioelectric stimulator that controls stem cell homing, klotho and other regeneration promoting protein expressions + BodStim TM bioelectric enhanced exercise + targeted multi-modality organ therapy (bioelectric + photo biomodulation + PEMF + biologics).
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Leonhardt Ventures LLC has over 800 patent claims covering healthspan longevity extension and organ regeneration technologies > https://patents.justia.com/inventor/howard-j-leonhardt.  Over 1 million patients have been treated with Leonhardt Ventures LLC and partnership inventions since 1982.
Lionheart News

Lionheart Octopus™ By Lionheart Health, Inc. Wins UCI Capstone Engineering Award

Selected References Supporting the MyoCell™ / Skeletal Myoblast Heart Regeneration Press Release

  1. Smits PC, van Geuns RJ, Poldermans D, Bountioukos M, Onderwater EEM, Lee CH, Maat APWM, Serruys PWJC. Catheter-based intramyocardial injection of autologous skeletal myoblasts as a primary treatment of ischemic heart failure. Journal of the American College of Cardiology. 2003;42(12):2063-2069. DOI: 10.1016/j.jacc.2003.06.017.
  2. Duckers HJ, Houtgraaf J, Hehrlein C, et al. Final results of a Phase IIa, randomised, open-label trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: the SEISMIC Trial. EuroIntervention. 2011;6:805-812.
  3. Povsic TJ, O’Connor CM, Henry TD, et al. A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction. American Heart Journal. 2011;162:654-662.e1. DOI: 10.1016/j.ahj.2011.07.020.
  4. Bioheart, Inc. Bioheart, Inc. Announces Positive Results in the MARVEL Phase II/III Clinical Trial. Business Wire / BioSpace. September 17, 2009.
  5. Dib N, McCarthy P, Campbell A, et al. Feasibility and safety of autologous myoblast transplantation in patients with ischemic cardiomyopathy. Cell Transplantation. 2005;14(1):11-19.
  6. Dib N, Michler RE, Pagani FD, et al. Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy. Circulation. 2005;112:1748-1755.
  7. Menasché P, Hagège AA, Scorsin M, et al. Myoblast transplantation for heart failure. The Lancet.2001;357:279-280.
  8. Menasché P, Hagège AA, Vilquin JT, et al. Autologous skeletal myoblast transplantation for severe postinfarction left ventricular dysfunction. Journal of the American College of Cardiology. 2003;41:1078-1083.
  9. Menasché P, Alfieri O, Janssens S, et al. The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) Trial: first randomized placebo-controlled study of myoblast transplantation. Circulation.2008;117:1189-1200.
  10. Siminiak T, Kalawski R, Fiszer D, et al. Autologous skeletal myoblast transplantation for the treatment of postinfarction myocardial injury: Phase I clinical study with 12 months of follow-up. American Heart Journal.2004;148:531-537.
  11. Siminiak T, Fiszer D, Jerzykowska O, et al. Percutaneous trans-coronary-venous transplantation of autologous skeletal myoblasts in the treatment of post-infarction myocardial contractility impairment: the POZNAN trial. European Heart Journal. 2005;26:1188-1195.
  12. Herreros J, Prósper F, Pérez A, et al. Autologous intramyocardial injection of cultured skeletal muscle-derived stem cells in patients with non-acute myocardial infarction. European Heart Journal. 2003;24:2012-2020.
  13. Gavira JJ, Herreros J, Pérez A, et al. Autologous skeletal myoblast transplantation in patients with nonacute myocardial infarction: 1-year follow-up. Journal of Thoracic and Cardiovascular Surgery. 2006;131:799-804.
  14. Gavira JJ, Nasarre E, Abizanda G, et al. Repeated implantation of skeletal myoblast in a swine model of chronic myocardial infarction. European Heart Journal. 2010;31:1013-1021.
  15. He KL, Yi GH, Sherman W, Zhou H, Zhang GP, Gu A, Kao R, Haimes HB, Harvey J, Roos E, White D, Taylor DA, Wang J, Burkhoff D. Autologous skeletal myoblast transplantation improved hemodynamics and left ventricular function in chronic heart failure dogs. Journal of Heart and Lung Transplantation.2005;24(11):1940-1949. DOI: 10.1016/j.healun.2005.02.024.
  16. Taylor DA, Atkins BZ, Hungspreugs P, et al. Regenerating functional myocardium: improved performance after skeletal myoblast transplantation. Nature Medicine. 1998;4:929-933.
  17. Taylor DA, Silvestry SC, Bishop SP, et al. Delivery of primary autologous skeletal myoblasts into rabbit heart by coronary infusion: a potential approach to myocardial repair. Proceedings of the Association of American Physicians. 1997;109:245-253.
  18. Taylor DA. Cellular cardiomyoplasty with autologous skeletal myoblasts for ischemic heart disease and heart failure. Current Controlled Trials in Cardiovascular Medicine. 2001;2:208-210.
  19. Van den Bos EJ, Taylor DA. Cardiac transplantation of skeletal myoblasts for heart failure. Minerva Cardioangiologica. 2003;51(2):227-243.
  20. Van den Bos EJ, Davis BH, Taylor DA. Transplantation of skeletal myoblasts for cardiac repair. Journal of Heart and Lung Transplantation. 2004;23(11):1217-1227.
  21. Haider KH, Jiang S, Ye L, Law PK, Sim EKW. Myoblast transplantation for cardiac repair using transient immunosuppression. Basic and Applied Myology. 2003;13:45-50.
  22. Haider KH, Ye L, Jiang S, et al. Myoblast transplantation for cardiac repair: a clinical perspective. Molecular and Cellular Biochemistry. 2004;263:35-45.
  23. Guo C, Shim WSN, Wong P, Sim EKW. Myoblast transplantation for cardiac repair: from automyoblast to allomyoblast transplantation. Annals of Thoracic Surgery. 2008;86:1841-1848.
  24. Sim EKW, Wong P. Skeletal myoblast transplant in heart failure. Journal of Cardiac Surgery. 2003;18:529-533.
  25. Guarita-Souza LC, Carvalho KAT, Rebelatto C, et al. Cell transplantation: differential effects of myoblasts and mesenchymal stem cells. International Journal of Cardiology. 2006;111:423-429.
  26. Brofman PRS, Carvalho KAT, Guarita-Souza LC. Cell transplantation: a new option for treating cardiomyopathy. Progress in Biomedical Research. 2003;8:67-68.
  27. Sherman W. Skeletal myoblasts — myocyte replacement therapy. Cell Transplantation. 2007;16:971-979.
  28. Meliga E, Duckers HJ, Serruys PW, et al. Clinical experience with autologous myoblast transplantation.EuroIntervention.
  29. Duckers HJ, Houtgraaf JH, van der Giessen WJ, Serruys PW. Skeletal myoblasts for myocardial regeneration in patients with congestive heart failure: where have all the answers gone? EuroIntervention.
  30. Duckers HJ, Serruys PW, et al. Rationale and interim analysis data from the SEISMIC study. EuroIntervention.
  31. Pagani FD, DerSimonian H, Zawadzka A, et al. Autologous skeletal myoblasts transplanted to ischemia-damaged myocardium in humans: histological analysis of cell survival and differentiation. Journal of the American College of Cardiology. 2003;41:879-888.

Additional Supporting References: Race Kao, Shinichi Kanno, Electrical Stimulation, and Klotho Heart Regeneration

The BioLeonhardt and Lionheart Octopus™ platform is also supported by a broader body of work linking muscle-derived cells, bioelectric stimulation, myocardial repair, and Klotho-mediated cardioprotection.

Selected additional references include:

• Kao RL, et al. Studies on autologous satellite cells, skeletal muscle conditioning, chronic electrical stimulation, and fatigue-resistant muscle development for circulatory support applications.

• He KL, Yi GH, Sherman W, Zhou H, Zhang GP, Gu A, Kao R, Haimes HB, Harvey J, Roos E, White D, Taylor DA, Wang J, Burkhoff D. Autologous skeletal myoblast transplantation improved hemodynamics and left ventricular function in chronic heart failure dogs. Journal of Heart and Lung Transplantation. 2005;24(11):1940-1949.

• Kanno S, et al. Nitric oxide facilitates cardiomyogenesis in mouse embryonic stem cells and supports the broader concept of biologically guided cardiac regeneration.

• Studies on electrical stimulation of skeletal muscle and engineered muscle constructs demonstrate that bioelectric stimulation can influence muscle maturation, myosin synthesis, angiogenic signaling, functional assembly, fatigue resistance, and regenerative remodeling.

• Klotho-related cardiovascular studies report that Klotho may improve cardiac function and remodeling, reduce fibrosis, suppress inflammatory signaling, reduce apoptosis, and provide cardioprotective effects after myocardial infarction and ischemia/reperfusion injury.

• Recent reviews further support Klotho as an important anti-aging protein linked to cardiovascular risk, cardiac aging, coronary disease, heart failure biology, and kidney-heart axis regulation.

Together, these references support the transition from first-generation MyoCell™ heart regeneration toward BioLeonhardt’s next-generation integrated platform combining cells, bioelectric stimulation, precision pumps, regenerative compositions, Klotho biology, and multi-organ regeneration beginning with the heart and kidney.
Howard J. Leonhardt
Executive Chairman & CEO
Lionheart Health, Inc.
Leonhardt Ventures LLC
21060 Pacific City Cir Unit 6115
Huntington Beach, CA 92648

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