Top Achievements by Each Development Team 2020

BioLeonhardt LTP (former MyoStim Pacers, Inc.)

Valvublator LTP

PressureStim LTP

AortaCell LTP

1. Developed path to license Elastrin Therapeutics complimentary nano-particle technology.
2. Developed portable one button operation stimulator.
3. Further developed klotho, SDF1, PDGF, tropoelastin and follistatin aorta smooth muscle regeneration signals.

1. Prosecuted with USPTO new biological pacemaker patent claims.
2. Developed portable one button operation stimulator.
3. Sourced pacing infusion leads from Oscor Medical.

1. Further prosecuted patent with USPTO.
2. Built into Second Heart Assist Circulatory Assist Pump patent filing published by USPTO.

1.  Set up product development team with Dr. Robert Kellar, Michael Chabotov and Dr. Zvonmir Krajcer.
2.  Laid stage for $250,000 in sponsored research funding from WL Gore & Associates.
3.  Developed PulseGraft BETA web site www.pulsegraft.com
4.  Finalized patent licenses with Second Heart Assist and CalTech.
5.  Filed stand alone patent applications for pulsating stent graft.

CerebraCell LTP

1. Developed clinical protocol to launch in Brazil.
2. Developed collaboration with California Rehabilitation Institute Los Angeles Dr. Stephen Cramer.
3. Further developed bioelectric stimulation controlled klotho expression.
4. Developed portable one button stimulator.

1. Launched BETA web site – www.memory-stim.com
2. Further developed bioelectric klotho expression technology.
3. Sourced related research papers and made full review.
4. Developed portable one button stimulator.

TremorStim LTP

SpineStim LTP

AddictiStim LTP

1. Web site www.addicitstim.com about to launch.
2. Gathered related scientific articles and reviewed them.
3. Reached out to potential research collaborators with data already in hand.

1. Web site www.depressistim.com about to launch.
2. Gathered related articles and review them.
3. Reached out to potential research collaborators with data already in hand.

DentaCell Accelerator LTP

OrthodontiCell, Inc.

1. Submitted clinical study manuscript for publication.
2. Launched over aligner case study.
3. Developed portable one button stimulator.
4. Developed new mouthpiece.
5. Patent issued RANKL, OPG and more – https://patents.justia.com/patent/20200330753
6. New OPG pre-clinical study sent in for publication.
7. OrthodontiCell TM issued.
8. Tooth Movement Accelerator TM issued.

SkinStim LTP

1. Developed COL17A1 skin regeneration technology and filed patent.
2. Developed enhanced protocol for Europe.
3. Preparations made for USA study new sites launch.
4. Developed portable one button stimulator.
5. Complete pilot clinical study in South Africa and Utah.
6. Filed new patent published by USPTO https://patents.justia.com/patent/2019001566
7. Partnered with Nulastin for skin serum.

1. Sent manuscript in on 105 patient positive clinical study.
2. Developed portable one button stimulator.
3. Developed partnership with ProMens Laboratories in San Diego for U.S. studies launch.
4. Developed new nerve regeneration signals.
5. Add klotho to muscle regeneration program.
6. ErectiStim TM issued by USPTO.

1. Developed new protocol launching in Europe.
2. Signed aboard Dr. Sanjay Batra to advisory board.
3. Completed cases in Utah.
4. Developed a head helmet (to be ready soon).
5. Developed portable one button stimulator.
6. Partnered with Nulastin for hair serum.
7. Potential partnership in works with Vantis Institute Newport Beach, CA.

1. Launched BETA web site www.implantstim.com
2. Completed 3 successful pilot cases in Orange County, CA and Hawaii.
3. Filed new patent application.
4. Introduction to founders of 3i Innovations original dental implant company.

1. Launched BETA web site https://breathestim.com
2. Signed aboard Dr. Lee Surkin to advisory board.
3. Completed pilot clinical case with success.

ArchStim LTP

1. Launched BETA web site www.archstim.com
2. Completed successful pilot case.
3. Filed new patent application.

1. One patent issued.
2. One successful pilot case completed.
3. New patent claims filed.

EyeCell LTP

1. Developed new eye googles.
2. Filed IRB submission for new U.S. study.
3. Patents issued on bioelectric stimulator.
4. Patients issued on bioelectric stimulator, pump and composition.
5. Patent filed for sonic hedgehog expression.

OrthoStim LTP and OrthoStim Accelerator LTP

1. New portable stimulator developed.
2. Knee wrap electrodes sourced.
3. Clinical study launching in Brazil.
4. OPG signaling developed.
5. BMP 9 signaling developed.
6. Bioelectric PRF with enhanced PDGF expression developed.

LiverCell LTP

1. Patent issued for bioelectric stimulator.
2. Patent issued for stimulator, pump and composition.
3. Portable bioelectric stimulator one button operation developed.

KidneyCell LTP

1. Pilot clinical study nearly complete in Brazil.
2. 150%+ increase in circulating Klotho recorded.
3. Patent issued for stimulator, pump and composition.
4. Patent issued for bioelectric stimulator.
5. Kidney treatment patent filed – https://patents.justia.com/patent/20200289820

1. Ear electrodes sourced.
2. Portable stimulator one button operation developed.
3. Clinical protocol developed.
4. Clinical pilot study launching in Brazil.

1. Completed succesful pilot clinical study.
2. Launched new study adding pelvic stimulation.
3. Lauching new study adding biologics.
4. Patent issued for stimulator, pump and composition.
5. Patent issued for bioelectric stimulator.
6. Discussions held with multiple potential acquirers.
7. Web site upgraded see www.bladdercell.com
8. B-Alive www.b-alivestim.com launched to address women patents.

1. Electrode body suits sourced.
2. Patent issued for stimulator, pump and composition.
3. Patent issued for bioelectric stimulator.
4. Wrist and ankle electrodes sourced.
5. Portable one button stimulator developed.
6. Bioelectric klotho expression further developed and tested.

InStim LTP

1. Pilot clinical case completed in Brazil with success.
2. Inflammation patent filed – https://patents.justia.com/patent/20190022389
3. BETA web site launched www.instimcell.com

1. Tested bioelectric sonic hedgehog expression for nerve regeneration.
2. Tested PDGF expression from PRF.
3. Tested COL17A1 expression for hair and skin regeneration.
4. Developed eye googles for EyeCell studies.
5. Assisted in development of HairCell helmet.
6. Supported OrthodontiCell FDA 510K submission preparation.
7. Supported Second Heart Assist pre-clinical and clinical studies.
8. Wrote paper on OPG expression submitted for publication.
9. Completed BladderCell lab studies.
10. Supported development of OrthodontiCell mouthpiece design.
11. AortaCell Elastrin Therapeutics nanoparticles license opportunity lined up.

Major Highlights

OUR TEAM > Click Here

OUR SCIENTIFIC ADVISORY BOARD > Click Here

PATENTS > Click Here

News Releases > Click Here

Our 2019/20 Annual Report > Click Here

Our 2020/21 Annual Report is already under construction by our amazing marketing team and will be released just before Annual Shareholders Meeting which is schedule for April 8th, 2021 at 2pm PT, 5pm ET

Heart & Cardiovascular Group

1. Second Heart Assist – is preparing for completion of a cardio renal syndrome heart failure clinical study in February 2021 on the heels of our previous successful short duration pilot clinical study and years of pre-clinical studies. Second Heart Assist has multiple issued and pending patent claims for its unique true aortic stent based technology platform including pioneering claims for wireless power. Most recent filed IP relates to electro active polymer shape and length changing impeller design.

2. BioLeonhardt – had a pioneering patent issued June 30th, 2020 for a combination stimulator, pump and composition and is preparing for a large animal study at the California Medical Innovations Institute under the leadership of Dr. Doris Taylor in early 2021. A previous small animal feasibility study for heart regeneration was completed at the University of Utah with full grant support.

3. Valvublator – has engaged an OEM manufacturing partner and is planning to launch large animal studies in early 2021 for percutaneous heart valve decalcification and regeneration. A number of lab tests have already been completed.

4. Vascustim – after completing previous bioelectric alone and biologics alone pilot clinical studies the Vascutim team is preparing to launch the first combination bioelectric and biologics treatment clinical study for critical limb ischemia and leg and foot ulcer treatment.

5. PressureStim – is preparing to enroll in clinical study in Brazil for bioelectric blood pressure treatment and is contact with numerous centers worldwide that have already completed successful independent filings following our original patented concept. In discussion about acquiring data and patent rights with other research teams that have already gathered data following our original patent claims on over 100 patients with positive results. AortaCell and VibroCell are still in pre-clinical lab studies and are building their patent protection filings. BioPace www.bio-pace.com has filed a number of research grant applications for its biological pacing product and has filed a number of new patent claims.

Brain

1. CerebraCell – is preparing to enroll patients in a stroke recovery study in Brazil working with a team that previously completed successful electrical stimulation stroke recovery studies. CerebraCell has launched a spinal cord injury clinical study at Neuro Muscular Connection Institute in Costa Mesa, CA with full grant support. This may be spun out to become SpineStim soon Second Brain, MemoryStim and TremorStim are at early stage of development and are seeking out research collaborators while multiple new patent claims are being filed.

Cosmetic, Personal Care & Reproductive Health

1. MyoStim ED with its ErectiStim TM product has completed more than 105 patients in 5 clinical studies with great success for erectile dysfunction recovery and has submitted its manuscript for publication. Our stimulator and electrodes have full FDA 510K and CE Mark clearance to move to commercialization. We are in discussions with numerous potential commercialization strategic partners. A new portable at home stimulator is in development and is expected to be available for testing in early 2021.

2. HairCell has completed a successful pilot clinical studies for hair regeneration at 3 clinics in South Africa and Utah. The HairCell team has mutlple patent claims issued and pending including for COL17A1. HairCell is seeking a commercialization partner at this time. HairCell is preparing to launch a new study in Europe in early 2021 and has signed up Dr. Sanjay Bantra a scientist with substantial experience in this space as an advisor. HairCell added the Nulastin hair regeneration serum to its product lineup in 2020 via agreement.

3. SkinStim has completed a successful pilot clinical study for skin regeneration and has filed dozens of skin specific patent claims including for bioelectric controlled release of COL17A1, klotho and tropoelastin. SkinStim is seeking a commercialization partner at this time. SkinStim is launching an new clinical study in Europe in early 2021. SkinStim added the Nulastin skin regeneration serum to its product lineup in 2020 via agreement. This serum penetrates deep to restore elasticity. Separately SkinStim has a pioneering patent pending for bioelectric tropoelastin expression that also improves elasticity. The original SkinStim patent issued is for stem cell homing via bioelectric controlled expression of SDF1 and PDGF

4. OrthodontiCell has completed a successful pilot clinical study for accelerated teeth straightening and just had issued a pioneering patent for bioelectric controlled RANKL, SDF1 and OPG expression. OrthodontiCell is in discussions with numerous potential commercialization partners. OrthodontiCell plans to file a new 510K with the FDA in early 2021 and to launch a larger scale over aligner study and a stabilization study.

5. Stem Cell Bra completed a successful 15 large animal study and a pilot clinical low dose safety study with non-invasive stimulation using our 510K market cleared bench top stimulator (signals in cleared range for improving blood circulation) and is now preparing to enroll in an efficacy study OUS in 1H 2021. Stem Cell Bra continues pre-clincal studies to prepare for future animal and clinical studies combining bioelectric stimulation, biologics/stem cells repeat deliveries and fat grafts. We are in contact with research teams that have already completed positive adipose derived cells + fat graft clinical studies about collaboration with meeting scheduled for this month. The team seeks to secure a strategic partner now to take these above products through to full commercialization while it continues to enroll more patients in studies.

6. DentaCell Accelerator has multiple products under development including ImplantStim which completed a successful first pilot cases for accelerated dental implant healing. DentaCell has dozens of patent claims issued and pending including bioelectric PRF. DentaCell Accelerator this past quarter spun out BreatheStim www.breathestim.com and ArchStim. BreatheStim is focused on a holistic complete solution for breathing disorders and sleep apnea. ArchStim is developing a mouth insert for mouth/jaw arch expansion.

7. TestiStim has a U.S. issued patent and a successful pilot clinical case and now is preparing to enroll more patients in studies for bioelectric testosterone management and infertility treatment.

Major Organ Regeneration

1. BladderCell has completed a successful pilot clinical study for bladder recovery and regeneration and is preparing to enroll more patients in two new studies – one that adds pelvic stimulation and another that adds biologics injections and infusions. BladderCell has multiple issued and pending patents and is in the process of filing more patent claims. BladderCell is seeking a strategic commercialization partner at this time and has had discussions with numerous interested parties already.

2. KidneyCell is enrolling patients in 2nd clinical study in Brazil for bioelectric kidney recovery. The team filed last year a pioneering patent for bioelectric controlled release of klotho known in previous studies to aide in kidney recovery. These studies focus on increasing circulation Klotho to improve kidney function. KidneyCell has begun efforts to secure a strategic commercialization partner with its first in human study results soon to be published.

3. EyeCell is collaborating with investigators that previously enrolled over 176 patients in microcurrent therapy vision improvement studies. The EyeCell team is working with these investigators to now launch two new studies with our stimulators, eye googles and bioelectric programming. An IRB submission has been made with hope to launch these new studies within the next 30 to 60 days.

4. EarCell is preparing to begin enrollment in a hearing recovery clinical study in Brazil.

5. OrthoStim is preparing to begin enrollment in a knee joint recovery clinical study in Brazil. The team just filed a new patent application for bioelectric stimulation control of OPG release for treating osteoporosis.

6. InStim is preparing to begin soon bioelectric inflammation control studies for IBD. 1 successful pilot feasibility case was completed in Brazil.

7. RegenaLung is exploring COVID related research grants to advance its lung regeneration and inflammation control product platform. RegenaLung is seeking a strategic partner to develop its patented technologies further for lung regeneration.

8. BioLeonhardt Whole Body with BodStim is evaluating available bioelectric stimulation body suits developed by others at this time for potential collaboration. PancreaCell and LiverCell are reaching out to develop collaborations for research with experienced investigators.

Cancer

1. CancerCell is preparing to enroll in a 2nd animal study in Brazil following a previous feasibly small animal study at UCLA. CancerCell has 9 issued U.S. patents https://cancercellinc.com/list-of-the-issued-cancer-patents/ for bioelectric cancer treatment and many dozens of new claims pending. The team just filed a patent application for bioelectric OPG expression control for treating bone related cancers. Previous patent filings cover reading a tumor and customized delivery of bioelectric signals to jam communication, illicit an immune response, starve a tumor of blood supply, reduce inflammation and eventually promote healing of the organ.

Financial Update We have raised about $10 million in capital to date for our portfolio of startups and innovations with the lions share being for our Heart & Cardiovascular Portfolio especially Second Heart Assist, Inc. Approximately $2.5 million has been raised for our current bioelectric innovations platform portfolio of technologies and organ specific applications. We received just this week as of this writing $700,000 more in investment commitments into our innovation accelerator (expected to come in early 2021) and we are launching a campaign now to raise another $11.8 million in capital. We are asking each advisor, employee, supplier and existing shareholder to arrange a Zoom call introducing us to at least 3 potential pre-qualified accredited experienced biotech medtech investors.

Financial Highlights 2020

Estimated Startups Ripe for Strategic Acquisition Outreach Schedule Leonhardt’s Launchpads 2020 Portfolio Class Current as of April 1, 2020 CEO Ranking (very highly subject to change) See our Innovation Startups Here Note – Ripe for beginning strategic partnership/acquisition outreach efforts is defined as having completed at least a pilot first in human feasibility study in at least 5 patients, preferably more, demonstrating reasonable trends towards efficacy and safety. The startup or Licensable Technology Platform should have also filed a number of patent claims, or licensed or optioned them, as well by this stage preferably with some U.S. issued patent claims.

2020/21

1. Second Heart Assist, Inc. www.secondheartinc.com – finished 1 pilot short duration use clinical study about to finish new longer duration use cardio-renal syndrome heart failure clinical study in February 2021.

2. OrthodontiCell www.orthodonticell.com. – finished 1 clinical study and about to start a 2nd and 3rd soon.

3. MyoStim ED www.erectistim.com – finished 5 clinical studies so far 105 patients and counting.

4. HairCell www.haircellstim.com – finished 1 pilot clinical study and about to enroll more patients.

5. EyeCell www.eye-cell.com – published on 176 microcurrent treatment patients about to start a new study.

2021/22

1. CancerCell www.cancercellinc.com – completed feasibility small animal study at UCLA preparing for large animal study that will lead to pilot clinical study.

2. PressureStim www.pressurestim.com – launching clinical study in Brazil. In contact with independent teams that have completed already over 150 patients.

3. BladderCell www.bladdercell.com – enrolling in a new study in Brazil collaborating with teams that completed previous similar studies.=

4. Stem Cell Bra www.stemcellbra.com – completed 15 large animals and a pilot safety only low dose clinical study. Preparing for full dose clinical efficacy study.

5. SkinStim www.skin-stim.com – completed pilot clinical study. Preparing to enroll more patients.

6. TestiStim www.testistim.com – completed a single pilot case. Preparing to enroll more patients.

7. ImplantStim www.implantstim.com – completed a single pilot case. Preparing to enroll more patients.

2022/23

1. BioLeonhardt www.bioleonhardt.com – preparing for large animal study.

2. LiverCell www.livercellstim.com – preparing for large animal study.

3. KidneyCell www.kidney-cell.com – enrolling in 2nd clinical study.

4. Valvublator www.valvublator.com – preparing for large animal study. Collaborating with team in Italy that completed 1 surgical case similar method.

5. CerebraCell www.cerebracell.com – preparing to enroll in non-invasive stroke recovery study working with team that has already completed similar previous study.

2023/24

1. PancreaCell https://leonhardtventures.com/pancreacell/ – preparing for large animal study.

2. DentaCell Accelerator www.dentacellaccelerator.com – multiple innovations in development.

3. OrthoStim www.ortho-stim.com – preparing to enroll in pilot clinical study.

4. Instim www.instimcell.com – completed a single pilot case. Preparing to enroll more patients.

5. AortaCell https://leonhardtventures.com/aortacell/ – preparing for large animal study.

6. TremorStim www.tremorstim.com – preparing for pilot clinical study. May acquire rights from group that has already competed a clinical study.

2024/25

1. EarCell www.ear-cell.com – preparing for pilot clinical study for non-invasive product and animal study for bioelectric + biologics invasive therapy.

2. Vascustim www.vascustim.com – preparing to enroll in 3rd clinical study this one first to combine bioelectric and biologics.

3. Biopace – https://leonhardtventures.com/bio-pace/ – preparing for small animal study.

4. VibroCell https://leonhardtventures.com/vibrocell/ – preparing for large animal study.

5. BioLeonhardt Whole Body and BodStim https://leonhardtventures.com/bioleonhardt-whole-body/. – focused on filing patents and grant application.

6. RegenaLung https://leonhardtventures.com/regenalung/ – preparing for large animal study.

7. MilkStim www.milkstim.com (not fully in accelerator yet) – pilot animal studies completed. Preparing to enroll more animals.

2025/26

1. MemoryStim (New) www.memorystim.com – preparing for pilot clinical study.

2. Second Brain (New) www.secondbrainstim.com– preparing for pilot clinical study.

3. BreatheStim (New) www.breathestim.com – early launch stage.

4. ArchStim (New – building out web site. Testing first prototypes.

5. PulseGraft (New) www.pulsegraft.com – developing active pulsation hemodialysis graft and exploring other applications.

6. CovidStim (New) – web site under development – launched non-invasive bioelectric stimulation study Brazil. Preparing to launch safety animal study biologics + bioelectrics. Seeking research partner now.

7. DepressiStim (New) – web site under development – reaching out to research collaborators.

8.  AddictiStim (New) – web site under development – reaching out to research collaborators.

When one of our top 30 startups exits the portfolio it will be replaced by one the startups from the “On Deck” circle or an outside applicant. The accelerator accepts approximately 1 startup/LTP for every 1000 ideas evaluated. Normally outside of the accelerator founded startups or IP platforms are only brought into our accelerator if they merge into one of our existing organ specific startups. In the “On Deck” circle working through the CalXelerartor www.calxelerator.com 108 day create to great program to be considered to be added to long duration parent accelerator portfolio once an opening is available includes: AddictiStim, MigraineStim, ObesityStim, DiabetesStim, NerveStim, CraveStop for obesity, PainStim, DepressiStim, BoneStim, SnoreStim, VirusStop, LymphStim, PolypStim, AirwayStim, GingavaStim, InfectiStim, CellBeat/AortaBeat, DetoxStim.