Proposed SpineStim™ research program will evaluate noninvasive targeted bioelectric stimulation and BodStim™ alone and in combination with an injectable regenerative composition containing Klotho-expressing stem cells, polylaminin and a nutrient-rich hydrogel
HUNTINGTON BEACH, Calif. — July 25, 2026 — Lionheart Health, Inc. and Leonhardt Ventures LLC today announced the filing of a new provisional patent application covering bioelectric stimulation systems intended to induce, enhance or regulate the expression and assembly of laminin and polylaminin-related extracellular matrix, together with additional regenerative protein-expression pathways for spinal cord injury recovery.
The provisional patent application includes methods and systems designed to combine bioelectric-controlled regenerative protein expression, noninvasive neuromuscular stimulation, stem-cell homing, extracellular-matrix support and, in advanced investigational embodiments, an injectable regenerative composition containing Klotho-expressing stem cells, polylaminin, peptides and nutrient hydrogel components.
The patent application is part of the broader SpineStim™ intellectual-property portfolio being developed for spinal cord injury recovery.
Leonhardt Ventures LLC has licensed its spinal cord recovery patents and related patent applications to SpineStim™. SpineStim has contracted with Lionheart Health, Inc. to support commercialization planning, clinical-site development, provider training, licensing, sales and distribution, subject to completion of the necessary research and receipt of applicable regulatory authorizations.
Bioelectric Expression of Polylaminin
Polylaminin, also referred to as polyLM, is a polymerized form of laminin, a major extracellular-matrix protein involved in cell adhesion, neurite extension, axonal growth and organization of neural tissue.
The newly filed provisional patent application includes claims directed to the use of precisely programmed bioelectric stimulation to influence the body’s production, organization, deposition or biological activity of laminin and polylaminin-related extracellular matrix at or near damaged spinal cord tissue.
The proposed approach is intended to investigate whether targeted stimulation can help create a more supportive biological environment for:
- Axonal extension across an injured area;
- Neuron and supporting-cell survival;
- Stem-cell recruitment and retention;
- Remyelination and neural-network reorganization;
- Formation of new blood vessels;
- Neuromuscular reconnection;
- Management of excessive or prolonged inflammation; and
- Recovery of motor, sensory and autonomic functions.
This work will also examine the potential for bioelectric stimulation to complement externally administered polylaminin. Polylaminin is not treated in the patent platform merely as a passive injectable material. The research strategy is designed to determine whether bioelectric signaling may influence both endogenous laminin-related pathways and the cellular response to an administered polylaminin matrix.
Published Brazilian preclinical research has reported that polymerized laminin supported axonal regeneration and functional improvement in animal models of spinal cord injury. Polylaminin has also been characterized as a three-dimensional extracellular-matrix structure capable of stimulating neurite formation beyond that observed with ordinary laminin.
Proposed Two-Arm SpineStim Research Program
Lionheart Health and SpineStim intend to develop a staged research program beginning with laboratory testing and appropriate preclinical safety studies. Subject to scientific, ethical and regulatory review, the program is expected to compare at least two principal investigational arms.
Arm One: Noninvasive Bioelectric Stimulation
The first arm is planned to use only noninvasive technologies, including:
- Targeted SpineStim bioelectric stimulation applied near the affected spinal cord region;
- Precisely programmed stimulation sequences intended to influence polylaminin- and laminin-related matrix activity;
- Bioelectric stimulation intended to influence Klotho, SDF-1, PDGF and other regenerative protein pathways;
- BodStim™ electrical muscle stimulation;
- Structured physical rehabilitation and neuromuscular re-education; and
- Standardized functional, neurological, imaging and biomarker assessments.
BodStim is intended to activate large muscle groups, help limit disuse-related muscle deterioration, support circulation and provide repetitive neuromuscular activity below or around the level of injury.
The noninvasive arm will be designed to determine whether targeted bioelectric stimulation and BodStim can provide measurable benefits without an injectable biologic intervention.
Arm Two: Bioelectric Stimulation Plus Injectable Regenerative Composition
The second arm is planned to receive the same targeted SpineStim stimulation, BodStim program and rehabilitation protocol, with the addition of an investigational injectable regenerative composition.
The proposed injectable formulation may include:
- Klotho-expressing mesenchymal or other regenerative stem cells;
- Polylaminin;
- Wharton’s Jelly-derived matrix or factors;
- Placental-derived regenerative factors;
- Amniotic-fluid-derived factors;
- Selected regenerative peptides;
- A nutrient-rich hydrogel;
- Supportive extracellular-matrix components; and
- Other components intended to support cell viability, retention, integration and controlled release.
The nutrient hydrogel is intended to help retain the composition near the treatment area while providing a supportive environment for the administered cells and biological factors.
The proposed combination arm will investigate whether the injectable composition provides an incremental benefit beyond stimulation and rehabilitation alone. The design will also evaluate whether bioelectric signaling can enhance stem-cell recruitment, survival, integration and regenerative activity after administration.
The precise cell source, manufacturing process, formulation, injection route, dose, timing and treatment location have not yet been finalized. These elements will require preclinical validation, safety testing, manufacturing controls and regulatory authorization before any human clinical use.
Coordinating Multiple Regenerative Protein Pathways
In addition to polylaminin-related expression, the provisional patent application covers the coordinated use of bioelectric signaling sequences intended to influence proteins and pathways associated with spinal cord protection and recovery.
These include:
- Klotho for neuroprotection, inflammation regulation, cellular resilience and healthy-aging biology;
- SDF-1/CXCL12 and PDGF for endogenous and administered stem-cell homing, recruitment and retention;
- BDNF and GDF10 for neuroplasticity, axonal sprouting and neurological recovery;
- Sonic Hedgehog for neural-development and nerve-regeneration pathways;
- IGF-1 and LIM-domain-related pathways for nerve, muscle and neuromuscular recovery;
- VEGF, eNOS, HIF-1α, HGF, EGF and CXCL5 for vascularization and circulation;
- Sestrins, sirtuins and SIRT6 for cellular stress response, mitochondrial function and longevity;
- Follistatin, S100A1 and related pathways for muscle preservation and regeneration;
- Tropoelastin and COL17A1 for extracellular-matrix and tissue-integrity support;
- Apelin, HMGB1, Wnt, GDF11, BMP9, OPG, Menin and OSER1; and
- Selected anti-inflammatory and tissue-remodeling signals.
Lionheart Health has previously announced research programs involving Klotho, SDF-1, PDGF, BDNF, GDF10, Sonic Hedgehog, Apelin, Sestrins, sirtuins, eNOS, VEGF and other regenerative pathways. Its published materials describe SDF-1 and PDGF signaling for stem-cell homing, angiogenic signaling for vascular support and Klotho-related signaling for cellular resilience and healthy-aging research.
“Spinal cord injury is unlikely to be solved by one protein, one cell type, one device or one injection,” said Howard J. Leonhardt, Executive Chairman and Co-CEO of Lionheart Health and founder of Leonhardt Ventures. “Our strategy is to coordinate the physical matrix, the regenerative cells and the biological instructions needed for repair. Polylaminin may help provide the structural environment, while Klotho, SDF-1, PDGF, BDNF and other bioelectrically controlled pathways may help recruit cells, protect neurons, restore circulation and encourage new neural connections.”
“The first proposed research arm is deliberately noninvasive,” Leonhardt continued. “That will allow us to assess targeted SpineStim and BodStim stimulation independently. A second arm is planned to add Klotho-expressing stem cells, polylaminin and a nutrient-rich hydrogel so that we can measure whether the combined biologic approach produces an incremental improvement.”
Lionheart Health Reaches Out to Brazilian Polylaminin Researchers
Lionheart Health and Leonhardt Ventures are reaching out to the Brazilian scientists, clinical investigators and development organizations responsible for advancing polylaminin research to propose a scientific and product-development collaboration.
The proposed collaboration may include:
- Exchange of nonconfidential scientific information;
- Joint laboratory and preclinical studies;
- Evaluation of bioelectric stimulation with polylaminin;
- Development of stimulation-plus-polylaminin study protocols;
- Biomarker and protein-expression analysis;
- Animal and veterinary research;
- Potential multicenter clinical-development planning;
- Regulatory-strategy coordination;
- Manufacturing and quality-system development; and
- Opportunities for research in both Brazil and the United States.
Lionheart Health believes that collaboration with the original Brazilian polylaminin researchers could help avoid duplication, strengthen experimental design and accelerate responsible evaluation of a potentially important spinal cord regeneration technology.
The company intends to respect all existing Brazilian intellectual property, institutional research agreements, regulatory requirements and commercial rights associated with polylaminin. Any collaboration would be subject to mutually acceptable agreements with the appropriate researchers, institutions, sponsors and rights holders.
A Collaboration History in Brazil Dating to 1986
The proposed outreach builds upon a nearly four-decade history of research, development and manufacturing relationships between the Leonhardt organizations and Brazil.
In 1986, Howard Leonhardt began working with Brazilian cardiovascular-device organizations, including Labcor Laboratories, which developed implantable heart valves, and DMG Brazil, which developed blood oxygenation technologies. Leonhardt Ventures’ published corporate history identifies its work with DMG and Labcor during the 1983–1988 period and records the launch of its Brazilian collaboration in 1986.
Subsequent Leonhardt-affiliated programs have included Brazilian device-manufacturing relationships, clinical-research collaborations and development work involving cardiovascular, bladder, orthopedic, neurological and bioelectric stimulation technologies. One published Leonhardt Ventures program, for example, described a bioelectric-plus-biologics bladder-function study developed with clinical investigators in Porto Alegre, Brazil.
“Brazil has been an important part of our research and manufacturing history since 1986,” Leonhardt said. “Brazilian scientists, physicians and engineers have repeatedly demonstrated creativity, technical excellence and a willingness to take on difficult medical challenges. We would be honored to explore a collaboration with the researchers who have dedicated decades to the development of polylaminin.”
Brazil’s Polylaminin Research
Polylaminin was developed through research associated with the Federal University of Rio de Janeiro. A peer-reviewed 2010 study reported axonal regeneration and functional recovery in an experimental spinal cord injury model. A subsequently published veterinary study evaluated a laminin-based approach in six dogs with severe chronic spinal cord injuries.
Brazil’s National Health Surveillance Agency, Anvisa, announced on January 5, 2026, that it had authorized a Phase 1 human clinical study of polylaminin for acute spinal cord injury. The authorized study focuses primarily on safety and tolerability and is designed to enroll five adults with recent, complete thoracic spinal cord injuries. Anvisa emphasized that the limited Phase 1 study is not designed to establish therapeutic efficacy and that additional controlled studies would be required.
Earlier human observations have generated interest, but the published registry describes an open-label, single-arm investigation without a concurrent control group. Such preliminary observations cannot establish that polylaminin caused any reported neurological improvement.
Polylaminin remains experimental. It has not completed the clinical-development process necessary to establish safety and effectiveness for routine spinal cord injury treatment.
Development and Regulatory Pathway
Lionheart Health and SpineStim anticipate a staged development pathway that may include:
- In-vitro confirmation of laminin- and polylaminin-related responses to selected bioelectric signals;
- Verification of Klotho, SDF-1, PDGF and other targeted protein-expression responses in relevant neural and supporting cell types;
- Characterization of the proposed injectable hydrogel and cell composition;
- Sterility, identity, potency, viability and release testing;
- Biocompatibility, biodistribution, tumorigenicity and toxicology studies;
- Small- and large-animal spinal cord injury studies;
- Comparison of the noninvasive and combination study arms;
- Independent scientific and data-safety review;
- Submission to applicable regulatory agencies and institutional review boards; and
- Carefully controlled human feasibility and later-stage clinical studies, if authorized.
Potential research endpoints may include standardized neurological classification, voluntary motor control, sensory function, bladder and bowel function, respiratory function, muscle mass, strength, mobility, electrophysiology, MRI and diffusion imaging, circulating biomarkers and quality-of-life measurements.
Intellectual Property and Commercialization
Leonhardt Ventures LLC has licensed its spinal cord recovery intellectual-property portfolio to SpineStim. SpineStim has selected Lionheart Health to support future commercialization, clinical-site development, training, licensing, sales and distribution.
Commercialization will not begin for any spinal cord regeneration indication unless the applicable product has completed the required development program and received all necessary regulatory authorizations.
The patent portfolio may encompass:
- Noninvasive targeted spinal stimulation;
- BodStim neuromuscular stimulation;
- Implantable microstimulators;
- Bioelectric protein-expression sequences;
- Laminin- and polylaminin-related expression;
- Injectable polylaminin compositions;
- Klotho-expressing stem cells;
- Nutrient hydrogels;
- Wharton’s Jelly and placental-derived factors;
- Amniotic-fluid-derived factors;
- Peptides and extracellular-matrix components;
- Controlled-release delivery systems;
- Imaging and biomarker-guided treatment planning; and
- Coordinated stimulation, biologics and rehabilitation protocols.
About SpineStim™
SpineStim™ is a regenerative-neurology development company focused on investigational technologies for spinal cord injury recovery. Its platform is designed to combine bioelectric stimulation, neuromodulation, regenerative protein-expression research, advanced extracellular-matrix materials, cell-based technologies and structured rehabilitation.
About Leonhardt Ventures LLC
Founded in 1982, Leonhardt Ventures LLC is an innovation and intellectual-property development organization focused on regenerative medicine, cardiovascular devices, bioelectric stimulation, longevity science and advanced therapeutic-delivery technologies.
Leonhardt Ventures and its affiliated companies have maintained research, clinical-development and medical-device manufacturing relationships in Brazil dating to 1986.
About Lionheart Health, Inc.
Lionheart Health, Inc. is a regenerative-medicine and healthspan-technology company developing bioelectric stimulation platforms, regenerative protein-expression technologies and multimodal health-optimization protocols.
Its portfolio includes BodStim™, Brain Band™, KidneyCell™, OrthoStim™, HairCell™, SkinStim™, EyeCell™, PainStim™, BioLeonhardt™ and other organ- and tissue-specific research and commercialization programs.
Media Contact
Lionheart Health, Inc. and Leonhardt Ventures LLC
Huntington Beach, California
Email: CS@LionheartHealthStim.com
Lionheart Health Stim website http://www.lionhearthealthstim.com + http://www.lionheartlongevity.com