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Portfolio Progress Updates
Video Update Posted May 9th, 2022 on Leonhardt’s Launchpads Progress > https://youtu.be/5aaUmo6wCmM
Heart & Cardiovascular
1. BioLeonhardt www.bioleonhardt.com – Large animal studies were launched in San Diego for TOTAL HEART REGENERATION with a combination bioelectric stimulator and re-fillable infusion pump. Data are forthcoming by the end of summer. Multiple patents were issued and are pending. BioLeonhardt is being featured in the next issue of Medtech Outlook Magazine this month.
2. Second Heart Assist, Inc. www.secondheartinc.com – Another round of long-duration animal studies was completed at Texas Heart Institute. Percutaneous placed circulatory assist pump. Surpassed $14 million in total capital raised. Multiple issued and pending patents. Preparing to enter 2nd round of clinical studies this summer.
3. Valvublator, Inc. www.valvublator.com – New round of test devices built – this time with a stronger radial force nitinol valve stimulation cage. We are preparing for large animal studies. Multiple issued and pending patents. The goal is to enter first-in-human studies OUS by year-end.
4. PressureStim www.pressurestim.com – We are enrolling in a clinical study for the reduction of blood pressure. Multiple issued patents. New portable stimulator developed with auto-sequencing of signals.
Patent – Bioelectric Blood Pressure Management
A patent # US1167141B2 for bioelectric blood pressure management was issued to Leonhardt Ventures LLC, inventor Howard J. Leonhardt. Abstract: Described are a system and method that utilize bioelectric signaling to balance electrical potentials in a subject’s body via neuro-hormonal circuit loops, to increase elasticity of the subject’s arteries to promote protein release to dampen arterial blood pressure, and to change arterial electrical charges to reduce narrowing of the arteries. The described system is designed to localize and stimulate the fibers inside the vagus nerve without inadvertent stimulation of non-baroreceptive fibers causing side effects like bradycardia and bradypnea. The system also controls release of specific proteins known to lower blood pressures including tropoelastin (known to increase elasticity in the aorta and other peripheral blood vessels).https://patents.google.com/patent/US11167141B2/en
1. DepressiStim www.depressistim.com – We received approval from the ethics committee to begin animal studies in San Diego. A pilot clinical study is about to launch in Brazil. We applied for IRB approval. Multiple patent claims have been filed for the bioelectrically-controlled release of Klotho, BDNF, GDF10, and serotonin. Dozens of successful lab brain studies were completed with encouraging results or controlled protein expressions. A new brain cap was developed from scratch.
Cosmetic and Personal Care
1. ErectiStim TM by MyoStim ED www.erectistim.com – Over 115 patients have been enrolled in clinical studies to date. More than 80% of treated patients have excellent results – up to 89% in certain studies. No adverse events were reported. A new portable stimulator was developed with auto sequencing from one signal to another. U.S. studies have been launched. A pre-Submission was made to the FDA for expanded labeling. FDA 510K clearance is already in place for improving circulation and muscle motion for the benchtop stimulator. We hold multiple issued patent claims and more are pending. We are currently enrolling more patients in clinical studies.
2. OrthodontiCell, Inc. www.orthodonticell.com – Clinical data was published in the Journal of Oral Research. 60% of treated patients achieved perfectly straight teeth at three months and 100% had finished at 6 months. OrthodontiCell will exhibit and hold a scientific advisory board meeting at the American Association of Orthodontists (AAO) Annual Session in Miami, Florida from May 21 -24. High volume production mold ordered. a new generation slimline design was developed and prototypes were built. A share offering will be placed on the StartEngine funding platform this month. www.startengine.com We hold multiple issued patents claims and more pending.
3. Stem Cell Bra www.stemcellbra.com – A 15-patient clinical safety and efficacy study was completed in Spain which followed a previous 16 large animal study and pilot clinical safety study. Results will be presented soon.
4. SkinStim www.skin-stim.com – SkinStim is enrolling in a bioelectric stimulation-only clinical safety and efficacy study in the US. This follows a previous bioelectric stimulation plus biologics clinical study in Utah and South Africa that achieved successful results for improving skin appearance. We hold multiple issued patents and more are pending.
5. HairCell www.haircellstim.com – HairCell is enrolling in a bioelectric stimulation-only safety and efficacy clinical study in the US which follows a previous bioelectric stimulation plus biologics clinical study in Utah and South Africa that achieved successful results for hair regeneration.
6. BreatheStim www.breathestim.com and ArchStim www.archstim.comworking via StimCore www.stimcoremd.com We have completed a number of successful clinical evaluation cases to improve breathing and are preparing to submit for IRB approval for a full-scale clinical study. We hold multiple patent claims issued and pending.
7. ImplantStim www.implantstim.com – A series of successful clinical evaluation cases were completed and we are preparing to submit for IRB approval for a full-scale clinical study for accelerated dental implant healing.
8. KlothoYears www.klothoyears.com – A beta program for Klotho level blood tests was launched. Approximately 20 klotho tests have been processed in studies to date and more are in process. We are working out the logistics for U.S. blood draws, specimen processing, and transportation to certified testing laboratories.
Click to view the Announcement of Klotho based research program
To date, nearly 3,000 papers have been published on Klotho describing its relationship to aging-related disorders. A sampling of published papers can be found on our website https://klothoyears.com/scientific-articles/
Sales and Distribution
Leonhardt Ventures LLC is exploring various sales and distribution channels to launch SkinStim, HairCell, BodStim, ErectiStim by MyoStim ED, DepressiStim, and OrthoStim into the markets of North America, Europe, Australia, and New Zealand once a clear regulatory path is set. This includes a campaign being developed to reach MedSpas (skin, hair, body toning), Sports Medicine/Physical Therapy Clinics, and later Mental Health Clinics by Lionheart Health, Inc. a sales and distribution focused startup within the Leonhardt Ventures LLC family. Lionheart Health, Inc. is raising capital with intent for 75% of capital raised over the next 3 years to go to support sales launches activities for these products at no dilution to SkinStim, HairCell, BodStim, DepressiStim, OrthoStim and MyoStim ED current shareholders and 25% of proceeds will be used to purchase ownership stakes at market prices in these product suppliers. Lionheart Health, Inc. works with standard industry distributors margins. SkinStim, HairCell, BodStim, MyoStim ED and OrthoStim work with manufacturers larger gross profit margins in collaboration with their OEM manufacturing partners. Cal-X Stars Business Accelerator, Inc. has a 9% ownership position in SkinStim, HairCell, BodStim, MyoStim ED, DepressiStim, and OrthoStim with the opportunity to purchase an increased ownership stake in each forward. We are also preparing for the commercial launch of OrthodontiCell with a recent full FDA 510K filing made.
Major Organ Regeneration
1. EyeCell www.eye-cell.com – EyeCell just received IRB approval to begin a clinical study at multiple centers in the US which follows a previous successful pilot clinical study and multiple clinical evaluations. A new microcurrent-only portable stimulator with 100% auto-sequencing has been developed. In parallel, animal studies are being initiated to look at longer-duration dosing and additional new signaling sequences.
2. OrthoStim www.ortho-stim.com – We are about to begin enrollment in a clinical study in Brazil. A new portable stimulator was developed and an animation video was developed and is posted on the website.
3. BladderCell www.bladdercell.com and B-Alive www.b-alivestim.com – We are enrolling in 2nd and 3rd clinical studies in Brazil. A new portable stimulator was developed.
4. BodStim www.bodstim.com by BioLeonhardt Whole Body – BodStim is enrolling in clinical studies for muscle enhancement, focusing on increased Klotho and Follistatin expression. Lab studies demonstrated an ability to increase klotho expression in skin cells. Clinical evaluation of Klotho signaling demonstrated 150% increase in circulating Klotho.
FDA 510K clearance for muscle enhancement electrical stimulation body suit was obtained by our OEM partner.
5. KidneyCell www.kidney-cell.com – Is now enrolling in a second clinical study. The prior safety and feasibility study demonstrated the ability to increase circulating Klotho by 150% with only 1-hour of stimulation twice a week. The new study will measure the effects using increased stimulation strength and duration.
1. CancerCell www.cancercellinc.com – We hold 10 issued U.S. patents and more pending for bioelectric treatment of cancer. About to launch a pioneering pilot clinical study in Brazil focused only on increasing circulating klotho levels for suppressing tumor growth. In parallel, we are preparing to launch a second round of animal studies using a much longer duration of stimulation. The previous safety feasibility study protocol used only 30 minutes of stimulation twice a week. The new study will look at 24-hour stimulation every day for six weeks.
A patent, # US11185691 for Tumor Therapy was issued to Leonhardt Ventures, LLC, inventors Howard J. Leonhardt and Jorge Genovese in November 2021. Abstract: Described are a system and method that “reads” cancer tumors in real-time and custom delivers individualized bioelectric therapy to the patient https://patents.justia.com/patent/11185691
Cal-X Stars Business Accelerator, Inc. Business Model
Start-ups enter the innovation and start-up launch accelerator and receive mentorship and other forms of support through first-in-human studies in exchange for a 9% dilution floor equity position (unless anti-dilution waived) and pre-emptive right for the accelerator to purchase up to 20% equity in the start-up at market prices until graduation (completion of first-in-human studies) or exit which may be via convertible debt note. Start-ups receive access to shared start-up launch resources including laboratory space for early-stage experiments.
June 2022 Estimated Valuations for Portfolio Assets with Cal-X Stars Business Accelerator, Inc. shareholder positions in table > https://leonhardtventures.com/leonhardts-launchpads-valuations/
We have independent 3rd party 409a Valuation Reports on a number of our startups including Cal-X Stars Business Accelerator, Inc., Valvublator, Inc, OrthodontiCell, Inc. and Second Heart Assist, Inc. which may be sent upon request to firstname.lastname@example.org Note – So far all independent 3rd party valuation reports have matched exactly with our internal and advisory board established valuations validating our methodology.