Leonhardt Ventures LLC Announces Preparation of New Provisional Patent Application for Bioelectric-Enhanced Oral Dissolving Strips to Accelerate Orthodontic Tooth Movement and Improve Long-Term Stability

Novel two-stage regenerative orthodontic technology combining RANKL, OPG, BMP9 and programmable bioelectric signaling is being developed by Leonhardt Ventures LLC for exclusive licensing to OrthodontiCell, Inc.

November 1, 2026 — Leonhardt Ventures LLC, a regenerative medicine and bioelectric technology innovation company founded in 1982, today announced preparation of a new U.S. provisional patent application covering bioelectric-enhanced dissolvable oral gel strips and mouthpieces designed to accelerate orthodontic tooth movement and improve long-term stabilization of teeth after straightening.

The technology is being developed by Leonhardt Ventures LLC for exclusive licensing to OrthodontiCell, Inc., a company focused on advancing bioelectric and regenerative orthodontic technologies.

The proposed innovation combines programmable bioelectric signaling with localized delivery of three key bone-remodeling proteins:

• RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand): Promotes osteoclast formation and bone resorption to potentially accelerate controlled tooth movement.
• OPG (Osteoprotegerin): Helps regulate RANKL activity and reduce excessive bone resorption after teeth have been repositioned.
• BMP9 (Bone Morphogenetic Protein 9): Supports osteogenic signaling and is being investigated for its potential to promote bone formation and stabilization.

Stage One: Accelerating Teeth Straightening

The proposed first stage uses bioelectric stimulation together with dissolvable oral gel strips containing RANKL or RANKL-pathway modulators.

The objective is to promote controlled alveolar bone remodeling around teeth undergoing orthodontic movement, potentially shortening treatment time when combined with braces or clear aligners.

Selected electrical waveforms will be investigated for their ability to enhance cellular signaling, tissue permeability and localized biologic delivery.

One research objective is to determine whether bioelectric-assisted transport can increase penetration of active compounds through gum tissues toward periodontal and alveolar bone structures.

Stage Two: Stabilizing Teeth After Straightening

After the desired tooth alignment is achieved, the proposed system transitions to a second biological program.

Bioelectric signals would be combined with dissolvable gel strips delivering OPG and BMP9, or other modulators of their pathways, to encourage bone stabilization.

The intended effects include:

• Reducing excessive osteoclast activity.
• Supporting osteoblast differentiation and new bone formation.
• Improving alveolar bone maturation around repositioned teeth.
• Supporting periodontal ligament recovery.
• Reducing orthodontic relapse.
• Potentially reducing the duration or frequency of retainer use.

The long-term goal is to develop a regenerative orthodontic approach in which newly straightened teeth achieve improved biological stability rather than relying exclusively on mechanical retention.

Bioelectric-Enhanced Delivery Without Repeated Needle Injections

A central feature of the proposed patent application is the combination of dissolvable oral gel strips with programmable bioelectric stimulation.

The research will investigate whether controlled electrical signaling can enhance the delivery and activity of selected therapeutic molecules in oral tissues.

Potential benefits include improved patient convenience, reduced dependence on injections, localized delivery and the ability to switch between tooth-movement and stabilization programs.

These benefits remain investigational and require experimental validation, particularly because large biologic proteins face significant barriers to penetration through oral tissues.

Intellectual Property and Exclusive Licensing

Leonhardt Ventures LLC is preparing patent claims covering:

1. Bioelectric-enhanced oral dissolving gel strips containing RANKL, OPG, BMP9 or their pathway modulators.
2. Intraoral mouthpieces integrating programmable bioelectric stimulation with controlled-release biologic materials.
3. A two-stage orthodontic treatment protocol transitioning from bone remodeling to bone stabilization.
4. Electrical stimulation methods intended to improve localized biologic transport and tissue response.
5. Coordinated delivery of osteoclastogenic and osteogenic signaling agents.
6. Personalized treatment programming based on tooth movement, bone remodeling and stabilization measurements.

The intellectual property is being developed for exclusive licensing to OrthodontiCell, Inc., which is expected to lead product development, clinical validation, regulatory strategy and commercialization.

The license arrangement provides OrthodontiCell, Inc. with exclusive commercialization rights to the covered technology, subject standard licensing terms used in all previous patent licenses.

Future Development

Leonhardt Ventures LLC and OrthodontiCell, Inc. envision a next-generation orthodontic platform combining bioelectric stimulation, biologic delivery and regenerative bone remodeling.

The research program will investigate whether this approach can accelerate tooth movement while improving the stability of final tooth positioning.

The technology remains investigational. Its ability to accelerate treatment, improve protein penetration or reduce retainer use has not yet been established in clinical trials.

About Leonhardt Ventures LLC

Founded in 1982, Leonhardt Ventures LLC is an innovation and intellectual property development company focused on bioelectric medicine, regenerative technologies, organ regeneration and healthspan improvement. The company develops and licenses technologies to specialized operating companies.

Website: https://leonhardtventures.com

About OrthodontiCell, Inc.

OrthodontiCell, Inc. www.orthodonticell.com is a regenerative orthodontic technology company focused on developing bioelectric and biologic approaches to accelerate orthodontic tooth movement, support periodontal and alveolar bone remodeling, and improve long-term treatment stability.

Patent status: U.S. provisional patent application in preparation.

Licensing status: Technology being developed for exclusive licensing to OrthodontiCell, Inc.; definitive licensing terms subject to confirmation.

OrthodontiCell™ — Patent and Scientific Reference List

Prepared for Leonhardt Ventures LLC | Exclusive license program: OrthodontiCell, Inc. | November 2026

This reference list is organized to support the proposed provisional patent application covering bioelectric-enhanced dissolvable oral gel strips and intraoral mouthpieces for accelerated orthodontic tooth movement and post-treatment stabilization.

The scientific rationale involves two distinct biological stages:

• Stage 1 — Accelerated tooth movement: RANKL-mediated osteoclast activity, periodontal ligament remodeling, SDF-1/CXCL12, PDGF, VEGF and bioelectric signaling.
• Stage 2 — Stabilization and relapse prevention: OPG-mediated regulation of bone resorption, BMP9 and other osteogenic signals supporting alveolar bone formation and remodeling.

An important distinction for patent drafting is that evidence supporting a protein’s role in bone remodeling does not automatically establish that an oral gel strip can deliver it to the target tissue, or that electrical stimulation will enhance its penetration.

The proposed goals of achieving complete alignment in three months for every patient and reducing relapse below 2% should be presented as aspirational development targets, not scientifically validated results.

1. Leonhardt-related patents and patent applications

These are the most relevant identified patent documents. Legal ownership, maintenance status, claim scope and exclusive licensing rights should be checked against the USPTO assignment and patent records before inclusion in an executed licensing schedule.

Patent / publication	Title and relevance	Priority
US 10,695,563 B2	Orthodontic Treatment. Core Leonhardt patent covering bioelectric RANKL activation for movement and OPG-mediated stabilization.	Critical
US 2020/0330753 A1	Orthodontic Treatment. Related application describing RANKL, OPG, SDF-1, VEGF and eNOS signaling.	Critical
US 10,960,206 B2	Bioelectric Stimulator. Relevant to programmable stimulation hardware and signal delivery.	High
US 11,691,007 B2	Bioelectric OPG Treatment of Cancer. Relevant OPG signaling technology, although its therapeutic indication differs.	High
US 2022/0409894 A1	Modulation of VEGF and Pulse Width Utilization. Relevant to angiogenic signaling and waveform design.	Medium
USD 957,646 S1	Dental Mouthpiece. OrthodontiCell-related device design protection.	High
USD 1,025,361 S1	Dental Mouthpiece. Additional OrthodontiCell-related design protection.	High

The 2020 issued orthodontic patent is particularly important because it already describes the sequential biological approach involving RANKL and OPG.

Existing OrthodontiCell technical materials

The OrthodontiCell March 2020 technical presentation specifically discusses bioelectric-controlled RANKL release for accelerated movement and OPG release for stabilization. It is useful as a historical reference for the proposed new application.

OrthodontiCell+1

2. Scientific references — accelerating tooth movement

Reference	Main finding	Relevance
Kanzaki et al. (2006) — Local RANKL gene transfer to periodontal tissue	Local RANKL gene transfer increased osteoclastogenesis and accelerated experimental tooth movement in rats.	Direct RANKL support
Yamaguchi (2009) — RANK/RANKL/OPG during orthodontic tooth movement	Describes how the RANKL/OPG balance regulates bone remodeling during orthodontic movement.	Mechanistic foundation
Alves et al. (2009) — EGF-liposome mediated bone modeling	Local EGF delivery increased RANKL expression in experimental orthodontic remodeling.	Localized biologic delivery
Peng et al. (2021) — IGF-1 accelerates tooth movement in rats	Recombinant IGF-1 promoted osteoclast formation and tooth movement in a rat model.	Additional growth factor
Parcianello et al. (2022) — Growth factors and orthodontic movement: systematic review	Reviewed 24 animal studies; identified promising effects for EGF, FGF and prostaglandin E2.	Broad preclinical support
Pharmaceutics (2024) — Local administration of biofunctional molecules: systematic review	Reviewed 36 studies of local biologic interventions, including RANKL, growth factors and topical-delivery approaches.	Strong starting review

PubMed+3

These studies provide meaningful support for investigating biochemical acceleration of orthodontic movement. Most evidence remains preclinical, however, and does not establish predictable three-month completion across all orthodontic cases.

3. Scientific references — OPG and relapse prevention

These are among the most directly relevant papers for the second-stage stabilization concept.

Zhao et al. (2012)

Local osteoprotegerin gene transfer inhibits relapse of orthodontic tooth movement

American Journal of Orthodontics and Dentofacial Orthopedics, 141(1), 30–40.

Local OPG gene transfer significantly inhibited orthodontic relapse and reduced osteoclast numbers in rats. This is direct support for studying OPG during the retention phase.

PubMed

Hudson and colleagues (2012)

Local delivery of recombinant osteoprotegerin enhances postorthodontic tooth stability

Calcified Tissue International. DOI: 10.1007/s00223-012-9579-4.

This animal study reported relapse equivalent to 63% of the original movement in controls, compared with 31% and 24% in low- and high-dose OPG-Fc groups.

It also documented systemic exposure following local administration, an important safety consideration.

PubMed

Orthodontic relapse in an OPG-Fc animal study

Relapse as a percentage of the original tooth movement, measured 24 days after appliance removal. Not human clinical results.

The data show a substantial experimental reduction in relapse, but not elimination. They also do not establish a universal 30% standard-care relapse rate or support a projected under-2% rate for OrthodontiCell.

4. Bioelectric stimulation references

Reference	Finding	Patent relevance
Spadari et al. (2017)	Electrical stimulation enhanced tissue reorganization during experimental orthodontic tooth movement in rats.	Bioelectric remodeling
Chaudhari et al. (2021)	Investigated modulation of OPG and TGF-β1 mRNA expression using bioelectrical stimulation.	Bioelectric OPG regulation
Dutta et al. (2024)	Human-study systematic review found a potentially positive relationship between electrical stimulation and tooth movement, but limited evidence.	Human clinical rationale
Sirri et al. (2026)	Umbrella review reported a pooled 1.78 mm increase at three months for bioelectric stimulation-related interventions, with low-certainty evidence.	Recent evidence
Cochrane Review (2023)	Found low-to-very-low-certainty evidence for nonsurgical acceleration methods overall.	Evidence limitations

ClinicalTrials.gov+3

The 2021 Chaudhari paper is particularly relevant because it connects bioelectrical stimulation and OPG expression. The 2026 review offers more recent clinical context, although the reported movement improvement should not be interpreted as a reduction in total orthodontic treatment duration.

5. BMP9, periodontal bone formation and stabilization

BMP9 + NELL1 (2021) — NELL1 augments osteogenesis and inhibits inflammation of human periodontal ligament stem cells induced by BMP9.

This study investigated BMP9-driven osteogenic differentiation in human periodontal ligament stem cells. NELL1 enhanced the osteogenic response and reduced inflammatory gene expression in the experimental system. The findings support investigation of BMP9/NELL1 combinations for alveolar bone regeneration, but they do not establish prevention of orthodontic relapse in humans.

PubMed

For the proposed stabilization phase, the following proteins merit consideration:

Protein / pathway	Potential contribution	Evidence interpretation
OPG	Suppresses RANKL-mediated osteoclast formation	Direct animal relapse evidence
BMP9 / GDF2	Osteogenic differentiation and bone formation	Periodontal regeneration evidence
NELL1	Enhances osteogenesis and may regulate inflammation	Preclinical BMP9 combination
BMP2 / BMP7	Osteogenic differentiation and mineralization	Established bone biology; application-specific testing needed
PDGF-BB	Periodontal tissue repair and cellular recruitment	Supportive regeneration biology
VEGF-A	Angiogenesis supporting tissue repair	Supportive, not independently stabilizing
SDF-1 / CXCL12	Progenitor-cell recruitment	Supportive regeneration biology
TGF-β1	Extracellular matrix and periodontal tissue remodeling	Requires careful timing and regulation

6. SDF-1, PDGF, VEGF and additional proteins

The literature supports including these pathways as secondary or combination targets, but the evidence varies considerably.

Target	Rationale for investigation	Proposed phase
RANKL	Osteoclast differentiation and bone resorption	Movement
M-CSF	Supports osteoclast precursor survival and differentiation	Movement
IL-1β / PGE2	Inflammatory mediators involved in remodeling	Movement, tightly controlled
SDF-1 / CXCL12	Recruitment and trafficking of progenitor cells	Both
PDGF-BB	Periodontal cell proliferation and tissue repair	Both
VEGF-A	Vascular remodeling and angiogenesis	Both
IGF-1	Growth factor affecting bone-cell activity	Movement / repair
FGF2	Periodontal and bone-cell signaling	Movement / repair
OPG	RANKL inhibition	Stabilization
BMP9 + NELL1	Osteogenic differentiation	Stabilization
Osteocalcin / RUNX2	Bone formation and osteoblast maturation markers	Stabilization biomarkers

The comprehensive 2024 systematic review is a useful source for the RANKL, IGF-1, FGF, M-CSF and other tooth-movement evidence, while the biological-mediator review covers RANKL, OPG, osteocalcin and RUNX2.

PMC+1

For SDF-1, PDGF and VEGF specifically, the Leonhardt orthodontic patent already identifies them as proposed signaling targets. That establishes a documented patent rationale, but not independent clinical proof that increasing each protein accelerates tooth movement.

7. Patent-references

For the new Leonhardt Ventures LLC provisional application intended for exclusive licensing to OrthodontiCell, Inc., I would prioritize these references in the technical disclosure.

Priority	Patent or paper	Main purpose
1	US 10,695,563 B2 — Leonhardt	Foundational RANKL/OPG orthodontic bioelectric system
2	Kanzaki et al., 2006	RANKL-mediated acceleration
3	Hudson et al., 2012	OPG protein delivery and relapse reduction
4	Zhao et al., 2012	OPG-mediated stabilization
5	Chaudhari et al., 2021	Bioelectric modulation of OPG
6	BMP9/NELL1 study, 2021	Periodontal bone regeneration
7	Dutta et al., 2024	Human electrical-stimulation evidence
8	Sirri et al., 2026	Updated clinical evidence
9	Pharmaceutics systematic review, 2024	Local biologic delivery and alternative agents
10	OrthodontiCell mouthpiece design patents	Existing intraoral device intellectual property

Patentable improvements under investigation at Leonhardt Ventures LLC R&D Lab in Irvine, CA.

The combination of existing bioelectric-controlled orthodontic signaling with a staged, localized biologic-delivery platform, rather than the already-described RANKL/OPG switching concept alone.

Particularly important areas to develop and document are the dissolving-strip formulation, protected protein release, electrical transport through oral mucosa, targeted electrode placement, separate movement and retention programs, and measurable control of the RANKL-to-OPG balance.

The scientific gap most worth addressing first is whether bioelectric assistance can actually deliver intact, biologically active RANKL, OPG or BMP9 from a strip to the periodontal ligament and alveolar bone at therapeutically meaningful concentrations. Demonstrating that would substantially strengthen the technical foundation of the proposed patent.

Under development = Bioelectric-Enhanced Intraoral Dissolvable Biologic Delivery Systems for Accelerated Orthodontic Tooth Movement, Periodontal Regeneration and Post-Treatment Bone Stabilization.

Leonhardt Ventures LLC is developing a next-generation bioelectric-enhanced oral biologic delivery platform for exclusive licensing to OrthodontiCell, Inc.

Published laboratory research involving OrthodontiCell-affiliated investigators has demonstrated increases exceeding 300% in selected bone-remodeling gene-expression measurements, including OPG and TGF-β1, together with a 28% increase in osteoblast-culture mineralization under tested conditions.

Building upon these findings, the proposed technology seeks to combine programmable bioelectric signaling with dissolvable oral gel strips to enhance localized delivery and biological activity of RANKL, SDF-1, PDGF, VEGF, OPG, BMP9 and other regenerative proteins.

If future studies demonstrate a 300% increase in delivery of biologically active proteins to their intended periodontal and alveolar bone targets, this could create opportunities to improve the efficiency of orthodontic tooth movement, support periodontal tissue regeneration and strengthen post-treatment stabilization.

The ultimate goal is to shorten orthodontic treatment times and reduce relapse and retainer dependence, subject to successful preclinical and clinical validation.

The potential advantage of combining two bioelectric mechanisms

The proposed OrthodontiCell technology could investigate two complementary effects:

1. Stimulating the patient’s own protein expression. Laboratory evidence indicates that electrical signals can modulate endogenous OPG, TGF-β1 and other remodeling-related pathways. In an experimental animal study, microcurrent also altered osteoclast activity and periodontal growth-factor expression.

2. Enhancing delivery of proteins from dissolving gel strips. The mouthpiece could be investigated for electrically assisted transport of externally supplied RANKL, OPG, BMP9 and other biologics. Whether intact proteins can penetrate deeply enough into the intended tissues remains to be established.

Combining these mechanisms could theoretically improve the concentration, timing and location of biological activity while reducing unnecessary exposure elsewhere.

Proposed development goals

The program could target faster orthodontic alignment, improved periodontal recovery, stronger post-treatment bone support and less relapse. However, the desired three-month treatment completion and under-2% relapse rate require prospective clinical evidence before they can be presented as expected patient outcomes.

Forward-Looking Statements: This announcement contains descriptions of proposed research, patent filings, licensing arrangements and investigational medical technologies. No clinical efficacy or safety claims have been established for the proposed combination. Development and commercialization are subject to successful testing, regulatory review and applicable approvals.