Executive Summary
& PPM Request

EXECUTIVE SUMMARY

Leonhardt’s Launchpads
by Cal-X Stars Business Accelerator

Elevator Pitch
Leonhardt’s Launchpads is a highly focused innovation accelerator focused on applying a core IP platform of bioelectrics and biologics for organ regeneration. The business model creates purpose specific Licensable Technology Platforms or startups for each specific organ application of our core IP and then seeks a strategic partnership or exit after first in human clinical study results are in for that specific organ purpose. The innovation accelerator has 17 products at clinical stage of development and 19 in pre-clinical development. The core stimulation and biologics technology is the same for all applications with slight modifications specific to individual organs. 800+ patients have been enrolled in clinical studies following our over 600 issued, pending, optioned or licensed patent claims. We are running 83% treatment success across all studies with no adverse events reported to date. Management team and board has brought numerous medtech and biotech products from concept to leadership positions in the past. The core research team has published over 1000 related papers in peer review journals and studies directly related to our current platform have been published in over a dozen peer reviewed journals including Nature Medicine, European Heart Journal, JACC, American Heart Journal and Circulation The Journal of the American Heart Association. Interested in Investing? Please e-mail: investor@leonhardtventures.com

Company Description
Problem: No other drug or device therapy today totally regenerates failing and aged organs back to their original healthy function. Our organs are built with bioelectric signaling instructions for controlled protein expressions and biologics led by stem cells and our innovation accelerator is dedicated to developing therapies that re-build and regenerate organs more like how they are made in the first place with living cell and natural type bioelectric instruction signals. All 7.8 billion alive today will eventually face the problem of failing organs some in younger years and all in later years of their life. There are over 25 million people worldwide with failing hearts. Over 697 million people having chronic kidney disease leading to kidney failure. In the USA alone over 661,000 people have failing kidneys. Over 4.5 million in the USA alone have some type of liver disease that may lead to liver failure. For all types of organ failure there are over 2 billion people worldwide suffering in one form or another with conditions that could be treatable with a true organ regeneration technology. Current cancer treatments with radiation and chemo therapies have very strong side effects and are often ineffective.

Solution: Our patented technology utilizes patented precise bioelectric signaling sequences for stem cell homing, proliferation and differentiation via controlled expression of SDF1 and PDGF as well as protein expression for tissue, muscle, nerve and blood vessel formation and regeneration. Patented bioelectric controlled protein expressions include tropoelastin for elasticity restoration, klotho, follistatin, COL17A1. IGF1, LIM and sonic hedgehog are expressed to regenerate damaged nerves as well as for other purposed. Klotho may be our most valuable controlled protein expression connected to healing multiple aging related disorders. When needed for the most serious organ failure cases a re-fillable implantable micro infusion pump that is re-filled daily with our proprietary fifteen component organ regeneration composition comprised of klotho expressing and hypoxia treated mesenchymal stem cells, selected exosomes, selected growth factors, secretome from amniotic membrane sourcing, amniotic fluid, bioelectricallly pre-treated platelet rich fibrin, Micro RNA gel, selected alkaloids such as tetraharmine, oxygenated nanoparticles, Wharton’s Jelly, nutrient hydrogel and organ specific matrix. The company in working to regenerate organs has also discovered and has over 9 issued U.S. patents and dozens of new claims pending for bioelectric cancer treatment. Our bioelectric cancer treatment platform is based on reading a cancer tumor and custom delivering bioelectric signals to jam their communication, illicit an immune response, starve them of blood supply and halt un-controlled cell division with eventual apoptosis of the cancer tumor cells followed by organ regeneration. Bioelectric treatment of cancer we believe can be more effective than current chemo or radiation therapies with less side effects.

Market Opportunity: $500 Billion addressable worldwide market with projected growth at 8% including treatment of failing hearts, heart valves, biological pacemaker, aortas, blood vessels, hypertension, leg and foot wound healing, lower limb ischemia, gut microbiota failure, breathing disorders, dental arch reformation, immune system failure, inflammation disorders, kidneys, livers, pancreas, lungs, bladder, brain, memory-dementia, anxiety-depression, skin, hair, erectile dysfunction, teeth including teeth straightening and dental implant accelerated healing, gums, eye vision and ear hearing. The cancer treatment market is expected to each $176 billion by 2022 worldwide.

Competition: SetPoint Medical of Los Angeles is a competitor focused on applying vagus nerve stimulation for inflammatory disorders including arthritis. Novocore is a leading competitor for bioelectric cancer treatment.

Market Traction: Over 800 patients enrolled in clinical studies. Running 83% treatment success rate across all studies with no adverse events reported to date. Over 600 patent claims issued, pending, optioned or licensed.

Sampling of published clinical data….

• MyoStim ED ErectiStimTM = 90% of 105 patients treated with non-invasive bioelectric treatment only for erectile dysfunction report recovery.
• OrthodontiCell = 2/3rds reduction in teeth straightening time. Improved tipping teeth angle results. 70% reduction in pain and discomfort.
• BladderCell = Majority of patents treated with non-invasive stimulation report recovery.
• EyeCell = Majority of patients treated report improvement of vision.
• VascuStim = All 7 bioelectric and 12 of 16 biologics treated patients on limb amputation list saved from limb amputation.
• HairCell = Up to 30% improvement in hair density.
• SkinStim = Majority of patients report satisfactory improvement in reduction of facial wrinkles.
• ImplantStim = Majority of patients showing > 70% acceleration in healing time compared to historical controls.
• TestiStim = Stable testosterone management in single treated pilot study patient.
• InStim = Elimination of inflammation related pain events in bowl inflammation in pilot study patient.
• KidneyCell = Improvement in kidney function observed in all 7 patients treated so far.
• CovidStim = 20% reduction in ventilator time observed in all 7 patients treated so far compared to non-treated patients in same ICU.

Target results for new clinical studies enrolling or about to enroll with funding in place…

• PressureStim = 10mm HG reduction in high blood pressure with wrist and ankle stimulation.
• Stem Cell Bra = 20 to 30% increase in breast tissue volume with non-invasive bioelectric stimulation of breasts.
• BladderCell II and III studies = 90%+ of treated patients reporting recovery of incontinence disorders.
• EarCell = 20% plus improvement in hearing.
• CerebraCell = 20% improvement in cognitive function and motor function in stroke recovery patients with 20% time acceleration of recovery results compared to historical controls.
• SpineStim a unit of CerebraCell = 20% improvement of motor function in spinal cord injury patients.
• KidneyCell II = 50%+ of patients on dialysis removed from dialysis.
• OrthoStim = 70% reduction in knee pain and 70% improvement in up and go time.

Target results for upcoming pre-clinicial animal studies about to launch with funding in place..

• BioLeonhardt = 20%+ improvement in post infarction cardiac improvement (heart regeneration) compared to control animals.
• Valvublator = Significant reduction of mitral valve regurgitation and aortic valve insufficiency in bioelectric and biologics treated animals.
• CancerCell = 80%+ eradication of cancers tumors with multi-modality 24 hour bioelectric treatment for 12 weeks.
• PancreaCell = Insulin production levels restored to normal after bioelectric and biologics treatment.
• BioPace = 80% of animals restored to normal biological pacemaker function.
• InStim II = 50% reduction in inflammatory episodes in inflammation disorder patients.

Business Model: The innovation accelerator seeks to exit each organ specific Licensable Technology Platform (LTP) via a milestone and royalty agreement via an Asset Sale/Purchase Agreement with a strategic partner/acquirer. The accelerator will begin outreach efforts to secure a strategic partner/acquirer immediately following positive results from a first-in-human clinical study for that specific organ application of our core IP.

Financial Information: Leonhardt’s Launchpads is seeking $15 M in investment expected to be the final investment round available to outsiders before exit events permit 100% inside financing forward. We have raised $2.5 million of this already and have received an additional $2 million convertible debt loan. All investments into the innovation accelerator are 2:1 meaning if you invert $35,000 you get $35,000 in Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. shares @ $0.36585 a share AND at no additional charge $35,000 in warrants to acquire a no additional charge unit shares in any of our organ specific Licensable Technology Platforms (LTPs) ie; LiverCell LTP for liver regeneration, RegenaLung LTP for lung regeneration, Bioleonhardt LTP for heart regeneration, Valvublator LTP for heart valve regeneration, HairCell for hair regeneration, SkinStim for skin regeneration. Investor has until Dec. 31 of the year they invested, following year if last quarter investment, to decide the allocation of their free of additional charge warrant value ie; $35,000 into LTP unit share ownership.

See legal and risk disclaimers in our PPM (password to link upon request) and on the company website at www.lventuresnestg.wpenginepowered.com

For more details, see www.lventuresnestg.wpenginepowered.com
See introductory video at
Interested in Investing? Please e-mail: investor@leonhartventures.com
See 2020 Annual Report > Click Here
Our Investors FAQs page is here > Click Here

Development Pipeline page > Click Here

Team > Click Here

Scientific Advisory Board > Click Here

Patents > Click Here

News > Click Here

Valuations Portfolio LTPs and Startups are here > Click Here >  Password available upon request

Form D 506 (c) Private Placement Memorandum – Password available upon request 

PPM $15 million Use of Proceeds
Cal-X Stars Business Accelerator, Inc. DBA Leonhardt’s Launchpads 2020 Private Placement under Form D 506 (c)
Permits public advertising – limited to verified sophisticated accredited investors with experience in biotech or medtech investments
Read all risk warnings – early stage developments in highest risk category for total loss
($2,500,000 already raised as of November 15th, 2020)

Basic Breakdown
About $3,000,000 PRE-CLINICAL to get all 30 products patented, developed and through animal studies
About $11,750,000 CLINICAL to get all 30 product innovations through first-in-human studies of about 10 to 30 patients each which leaves prime ripe for potential strategic partnership opportunity
By product groups:
Heart & Cardiovascular (8) = $4,000,000
Brain (4) = $1,000,000
Cosmetic & Personal Care (7) = $2,000,000
Major Organ Regeneration (10) = $2,000,000
Cancer (1) = $1,000,000
Regenerative Economy Maintenance or Other (3) = $250,000
Loan and interest payments debt = $2,000,000+ interest
Offering Cost and General Overhead Expenses = $1,500,000+ (may cost more)
Reserve for Additional Potential General Overhead Increases and Other Purposes = $1,250,000
2020 Published Goals in Annual Report and on Web Site – Click Here

Estimated Startups Ripe TO BEGIN Strategic Acquisition Outreach Schedule
Leonhardt’s Launchpads 2020 Portfolio Class Current as of April 1, 2020 CEO Ranking
(very highly subject to change)

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
1. Second Heart Assist, Inc. www.secondheartinc.com – finished 1 pilot clinical study about to start a 2nd soon.
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
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
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
1. PancreaCell https://leonhardtventures.com/pancreacell/ – preparing for large animal study.
2. DentaCell 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
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/ – www.bio-pace.com – 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
1. MemoryStim (New) www.memorystim.com – preparing for pilot clinical study.
2. Second Brain (New) www.secondbrainstim.com = preparing for pilot clinical study.
3. PulseGraft (New) www.pulsegraft.com = preparing for mock loop study.
4. ArchStim (New) = building web site.
5. BreatheStim (New) www.breathestim.com = preparing for clinical study.
6. DepressiStim (New) = preparing for clinical study for depression treatment.
7. CovidStim (New) = enrolled 7 patients in Brazil clinical study basic product. Preparing animals safety studies for full product.
8. SpineStim (New) = Enrolling in clinical study for spinal cord injury recovery.

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, Airway Arch Expander, GingavaStim, InfectiStim, DetoxStim.