Top Achievements by Each Development Team Through 2021

Heart & Cardiovascular Group

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Second Heart Assist

  1. Pilot clinical study completed 4 patients.
  2. 17 large animal studies completed at Tufts, Q Test, APS and Texas Heart Institute.
  3. Long duration mock loop studies completed at University of Louisville and Vivitro Labs.
  4. Wireless device further developed and tested.
  5. Pioneering wireless power patent exclusively licensed for aorta.
  6. 5 patents exclusively licensed from CalTech.
  7. Dozens of new patent claims filed for product improvements.
  8. Selected for cover of Medtech Outlook Magazine. Chosen as one of Top Cardiovascular Innovations of 2021.
  9. Selected to present at TCT Heart Failure Shark Tank competition.

BioLeonhardt LTP (formerly MyoStim Pacers, Inc.)

  1. Ethics Committee approval received for large animal study at California Medical Innovations Institute.
  2. Acquired patent rights to klotho expressing MSCs.
  3. Patent issued for Stimulator, Pump and Composition.
  4. Bioelectric signaling sequence for Klotho expression discovered and patent filed.
  5. Bioelectric signaling sequences for Follistating expression discovered and patent filed.
  6. Bioelectric signaling sequence for S100a expression discovered and patent filed.
  7. Bioelectric signaling sequences for SDF1 and PDGF stem cell homing factors discovered and patent filed.
  8. Secured sourcing for exosomes, bio PRF, secretome from amniotic membranes, Klotho expressing MSCs, myoblasts.
  9. Secured souring for implantable stimulators.
  10. Secured sourcing from implantable pumps.
  11. Secured sourcing for delivery catheters and completed testing.

Valvublator LTP

  1. Secured OEM manufacturer Oscor Medical.
  2. Developed mitral valve product development plan.
  3. Filed dozens of new patent claims.
  4. Recruited all-star advisory board including Dr. Steven Ramee.

PressureStim LTP

  1. Launched clinical study Brazil with IRB approval. Enrolled first patients.
  2. Developed and tested wrist, ankle, back and ear lobe electrodes electrodes.
  3. Developed multiple potential research collaborations some with data already published or gathered supporting PressureStim.
  4. Developed high end slide deck by Steve Kovsky.
  5. Launched web site www.pressurestim.com
  6. Secured exclusive rights to pioneering bioelectric blood control patents from Schuler.
  7. Pioneering Leonhardt bioelectric blood pressure control patent issued.
  8. Patent filed for bioelectric tropoelastin expression for increasing elasticity.
  9. Patent filed for COL17A1, COL1, COL3 collagen production via bioelectric stimulation.
  10. Patent filed for klotho expression for controlling hypertension.

AortaCell LTP

  1. Patent issued for bioelectric stimulator, pump and composition.
  2. Sourced portable stimulator.
  3. Further developed klotho, SDF1, PDGF, tropoelastin and follistatin aorta smooth muscle regeneration signals.

BioPace LTP

  1. Developed BioPace www.bio-pace.com web site
  2. Developed portable one button operation stimulator.

VascuStim LTP (formerly MyoStim Peripheral)

  1. Developed new clinical protocol.
  2. Filed IP on bioelectric PRF with enhanced PDGF expression.
  3. Developed portable one button operation stimulator.
  4. Sourced sercretome from amniotic sourcing.
  5. Secured patent rights to klotho expressing MSCs.

VibroCell LTP

  1. Further prosecuted patent with USPTO.
  2. Built into Second Heart Assist Circulatory Assist Pump patent filing published by USPTO.
  3. Developed piezo electric crystal tear drop vibrational elements.

Brain

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CerebraCell LTP

  1. Further developed brain stimulation head piece.
  2. Filed patent on bioelectric BNDF controlled release.
  3. Filed patent on bioelectric GDF10 controlled release.
  4. Patent issued for bioelectric stimulator.
  5. Patent issued for bioelectric stimulator, pump and composition.
  6. Posted hundreds of supporting articles on web site.
  7. File patents on bioelectric klotho expression.
  8. Secured rights to klotho expressing MSCs patents.

MemoryStim LTP

  1. Developed 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.

Second Brain LTP

  1. Launched Beta web site www.seconbrainstim.com
  2. Gathered and reviewed all related articles https://secondbrainstim.com/scientific-articles/.
  3. Reached out to numerous potential research collaborators.
  4. Completed FAQs page – https://secondbrainstim.com/faq/
  5. Established connection with gut microbiota clinical site in Brazil.

TremorStim LTP

  1. Launched BETA web site – https://tremorstim.com
  2. Sourced wrist electrode band.
  3. Sourced portable stimulator.

SpineStim LTP

  1. Completed pilot safety clinical study at Neuro Muscular Connections Institute Costa Mesa, CA for spinal cord injury recovery.
  2. Secured grant funding for study from Luberski Family Foundation.
  3. Web site developed.

AddictiStim LTP

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

DepressiStim LTP

Web site www.depressistim.com launched.
Posted supporting articles on web site.
Reached out to potential research collaborators with data already in hand.
Developed bioelectric signaling for BDNF expression filed patent.
Developed bioelectric signaling for klotho expression filed patent.
Developed bioelectric signaling for GDF10 expression filed patent.

Cosmetic, Reproductive Health and Personal Care

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Stem Cell Bra LTP

  1. Completed 16 animal study with safety and efficacy.
  2. Completed low dose safety clinical study Brazil.
  3. Completed safety and efficacy 15 patient study Spain.

OrthodontiCell, Inc.

  1. Completed pilot clinical study with successful results.
  2. Launched over aligner case study.
  3. Sourced portable stimulator.
  4. Developed two generations of mouthpieces.
  5. Patent issued RANKL, OPG and more – https://patents.justia.com/patent/20200330753
  6. OPG pre-clinical study published.
  7. OrthodontiCell TM trademark issued.
  8. Tooth Movement Accelerator TM issued.
  9. U.S. multi-center protocol developed and discussions with funding partners initiated.
  10. Main Stage posting developed.

SkinStim LTP

  1. Developed COL17A1 skin regeneration technology and filed patent..
  2. Launched U.S. bioelectric stimulation study at numerous sites.
  3. Sourced portable stimulator.
  4. Completed pilot clinical study in South Africa and Utah.
  5. Patent issued by USPTO https://patents.justia.com/patent/2019001566

MyoStim ED ErectiStimTM LTP

  1. Completed 105 patient positive clinical study.
  2. Sourced portable stimulator.
  3. Launced U.S. study at multiple sites.
  4. Developed new nerve regeneration signals.
  5. Added klotho to muscle regeneration program.
  6. ErectiStim TM issued by USPTO.
  7. Filed patent for sonic hedgehog gel electrodes.
  8. Filed patent for bioelectric sonic hedgehog expression.

HairCell LTP

  1. Signed aboard Dr. Sanjay Batra to advisory board.
  2. Completed OUS HairCell Plus Biologics study with positive results in South Africa.
  3. Launched U.S. study at multiple locations.
  4. Sourced portable stimulator.
  5. Got press coverage in Follicle for Thought.

ImplantStim LTP

  1. Launched web site www.implantstim.com
  2. Completed 3 successful pilot cases in USA.
  3. Filed new patent application.
  4. Introduction to founders of 3i Innovations original dental implant company.

BreatheStim LTP

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

ArchStim LTP

  1. Launched web site www.archstim.com
  2. Completed successful pilot cases.
  3. About to file new patent application.

TestStim LTP

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

Major Organ Regeneration

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EyeCell LTP

  1. Developed new eye googles.
  2. Developed collaboration with Dr. Chaikin that published 20 patient study.
  3. Developed collaboration with Dr. Kondrot and colleagues that have completed over 100 cases.
  4. Filing IRB submission for new U.S. study.
  5. Patents issued on bioelectric stimulator.
  6. Patients issued on bioelectric stimulator, pump and composition.
  7. Patent filed for sonic hedgehog expression.
  8. Additional lab and animal studies in progress.

PancreaCell LTP

  1. Patent issued for bioelectric stimulator.
  2. Patent issued for stimulator, pump and composition.
  3. Portable bioelectric stimulator sourced.
  4. Filed patent application for diabetes treatment via FABp4 and Klotho expression control up and down.

OrthoStim LTP and OrthoStim Accelerator LTP

  1. New portable stimulator sourced.
  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.
  7. Patent filed for bioelectric klotho expression.
  8. Patent rights to klotho expressing MSCs secured.
  9. Clinical study launching in USA.

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

EarCell LTP

  1. Ear electrodes sourced.
  2. Portable stimulator one button operation developed.
  3. Clinical protocol developed.
  4. Clinical pilot study lined up to launch in Brazil when funding available.

BladderCell LTP

  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 www.bladdercell.com
  8. B-Alive www.b-alivestim.com launched to address women patents.
  9. Sourced bioelectric body suits from multiple vendors including one with FDA 510K clearance for muscle enhancement.

BioLeonhardt Whole Body and BodStim

  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.
  7. BodStim www.bodstim.com web site developed.

InStim LTP

  1. Pilot clinical case completed in Brazil with success.
  2. Inflammation patent issued.
  3. Web site launched www.instimcell.com
  4. Patent filed for Klotho bioelectric inflammation management.

RegenaLung with CovidStim

Patent issued for stimulator, pump and composition.
Patent issued for bioelectric stimulator.
Bioelectric klotho expression tested in Covid patients in Brazil to improve breathing.
Completed pilot clinical study for CovidStim Brazil.
Further developed klotho expression technologies.
Patent issued for bioelectric inflammation management.
Filed patent application for COVID treatment.

Cancer

www.cancercell.com

  1. Prepared for pre-clinical study launch Brazil.
  2. Completed feasibility study at UCLA in animals.
  3. File new patent on OPG cancer treatment – https://patents.justia.com/patent/20200330759
  4. Prosecuted further bioelectric tumor therapy patent – https://patents.justia.com/patent/20190030330
  5. Prosecuted further Klotho cancer treatment claims – https://patents.justia.com/patent/20200289826
  6. 12 issued related patents. Major new Tumor Therapy patent issued November 2021.

Leonhardt’s Launchpads Irvine Lab

  1. Developed bioelectric signaling for COL1.
  2. Developed bioelectric signaling for COL2.
  3. Proved klotho expression from fibroblasts.
  4. Developed myoblast culturing methods for upcoming studies.
  5. Developed klotho expression from MSCs.

Major Highlights

  1. Over 700 patent claims issued, pending, in process, licensed, optioned or option pathway developed.
  2. Thousands of pre-clinical lab experiments completed.
  3. Positive clinical data on multiple hundreds of patients.
  4. Over 20 products at clinical stage of development all based on same focused core IP.
  5. Through partnerships multiple FDA market clearances.
  6. Over 100 meetings so far with potential strategic partners/acquirers for portfolio technologies.