Irvine, California, December 15th, 2020 – Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. is an innovation accelerator HIGHLY FOCUSED on organ regeneration and recovery based on a common IP platform of bioelectrics and biologics – https://leonhardtventures.com/development-pipeline/
Dear Fellow Stakeholders, Today I would like to provide a Year End 2020 update on the key milestones and corporate developments as well as goals for the balance of the year to come. This is forming up to be a breakthrough pivotal year. The updates below are by product groups not by priority – https://leonhardtventures.com/development-pipeline/
Perhaps our biggest development is that we are learning more and more that our breakthrough patent pending discovery of 2019 of increasing Klotho expression from cells by over 450% with bioelectric stimulation is proving out to be more valuable than we may have ever imagined at the time – Click Here
Researchers around the world are documenting many positive results from increasing or controlling klotho levels including treatment of Alzheimers, brain cognitive function recovery, memory, kidney failure, pancreas failure and diabetes, hypertension, chronic inflammation, alcoholism, cancer, lung damage, arthritis including osteoarthritis of joints, inflammatory bowel disease, depression, anxiety, heart disease, calcification of arteries and heart valves, aortic aneurysms and more including overall aging https://mybiohack.com/blog/longevity-intelligence-klotho-genetics-fat-vitamin. Klotho may also have a role in helping COVID 19 parents recover (we have begun a OUS study to examine this potential benefit) and possibly could even have a role in preventing COVID 19 infections (need much more data to support this use). More research needs to be done on all fronts but it certainly is exciting!
Latest news releases – Leonhardt’s Launchpads Completes Move to Irvine, California – Click Here
See our NEWS page for all our most recent press releases > Click Here
Major Highlights
- Approaching 1000 patients enrolled in clinical studies when including independent studies of collaborators following our patent or patent pending claims or similar technology.
- Approaching 400 patients enrolled in company sponsored clinical studies.
- 105 patients enrolled in MyoStim ED ErectiStim clinical studies.
- 46 patients enrolled in OrthodontiCell clinical studies.
- 30 patients enrolled in BladderCell clinical studies and 2 new studies launched.
- Over 20 patients enrolled in HairCell and SkinStim cosmetic studies.
- Scientific Advisory Board Members have published together over 2000 related pre-clinical and clinical studies.
- Over 800 patent claims issued, pending, licensed or optioned.
- Running 83% treatment success rate across all studies so far. No serious adverse events reported to date.
- Surpassed $10 million in capital raised for current portfolio of startups/LTPs. $2.5 million for innovation accelerator.
- Launched new capital campaign this week to raise $12.5 million more in capital and received $700,000 in investment commitments already from existing investors.
- 17 products at clinical stage of development. 18 products in pre-clinical development. All but 2 of them based on same core IP for bioelectrics, biologics and delivery systems just pointed to different organs.
- Pioneering patent issued for bioelectric stimulator, re-fillable pump and mixed organ regeneration composition.
- Pioneering patent issued for accelerated teeth straightening.
- Pioneering patent issued for bioelectric stimulator with signaling sequences for specific regenerative protein expressions.
- Pioneering patent claim issued for SDF1 and PDGF based stem cell homing, proliferation and differentiation control.
- Pioneering patent pending for bioelectric controlled Klotho expression – a powerful anti-aging protein found to be useful for many conditions including fighting inflammation, cancer, kidney failure, heart failure and hair loss.
- Pioneering patent pending for bioelectric controlled Sonic Hedgehog expression found to be useful for many applications especially nerve regeneration.
- Pioneering patent pending for COL17A1 expression found to be highly useful in skin and hair regeneration.
- CovidStim studies launched in Brazil. 9 patients in demonstrating about 20 to 25% reduction in ventilator time.
- Leased new R&D Lab and Office + Prototyping Lab Space at UCI Cove University Lab Partners in Irvine, California – https://www.youtube.com/watch?v=FIOUAkfpo1Q
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
- Approximately $900,000 total annual expenditures in 2020 about 24% lower than 2019 due to COVID delays and travel restrictions.
- Travel expense $16,372 about 67% lower than 2019 travel expenses of $50,000.
- Annual Rent for ALL Labs and Facilities Worldwide $28,000 about 40% below 2019 due to COVID austerity measures.
- Total net wages $150,000 in cash and balance in share options. ‘
- Accounting expenses about $26,000 a 74% reduction from 2019 accounting expenses of about $110,000
- Contract independent contact labor $33,209 a 78% reduction from 2019 which was $152,438
- Patent filing and prosecution expenses $130,000 a 60% increase over 2019.
- 2021 base budget is $1.4 million with provision to increase up to $12.5 million if current PPM capital raise is completed in full.
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. 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.
Investors FAQ page > https://leonhardtventures.com/frequently-asked-questions/
Investment Term Sheet Page – https://leonhardtventures.com/term-sheet/ PW Leonhardt
General Information:
To visit any of the innovation platforms individual web sites click here and follow prompts > Click Here
See our NEWS page for all our most recent press releases > Click Here
Here is a link to our 2020 Goals published in January > Click Here
Link to our 2019/20 Annual Report is here > Click Here
Here is a link to our Team Page with bios > Click Here
Scientific Advisory Board > Click Here
Here is a link to most of our internal published patents and patents pending > Click Here
LinkedIn Page > Click Here
Twitter Page > Click Here
Facebook Page > Click Here
Investor FAQs Page > Click Here
Sincerely, Howard J. Leonhardt
Executive Chairman & Chief Executive Officer
About Leonhardt’s Launchpads: Leonhardt’s Launchpads is the innovation accelerator arm of Leonhardt Ventures LLC focused on organ regeneration and recovery based on a common IP platform of bioelectrics and biologics. The accelerator has over 600 patent claims issued, pending, optioned or licensed for organ regeneration and recovery. These include pioneering patents for stem cell homing via SDF1 and PDGF and key regeneration promoting protein expressions such as klotho, follistatin, IGF1, COL17A1, HGF, EGF, VEGF and others. The company recently had a pioneering U.S. patent issued for a combination bioelectric stimulator, re-filllable infusion pump and multi-component biologics composition for organ regeneration.
Safe Harbor and Risk Warnings Statement This press release contains express or implied forward-looking statements within the Private/ Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Leonhardt’s Launchpads is using forward-looking statements when it discusses its hope and belief that its products will play an instrumental role in overcoming the impact of failing, degenerating, diseased or aged organs. The expected timing of the of enrollment and completion of various clinical studies mentioned are all forward looking and subject to change without notice. Patents mentioned may not be maintained or may be invalidated. Patents pending may not be issued. Company lacks sufficient resources to bring its products through first in human studies and may not be able to obtain those resources. Products are not yet proven safe or effective and are all early stage in development. Due to the early state of these developments any investment has to be deemed at the highest risk category for total loss. Due to a small staff maintaining information on over 40 related web sites information is prone to be out of date at times. If you have any questions please email us to get a reply. Brian Hardy Director of Marketing brian@leonhardtventures.com
Contact Info
Headquarters
Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc., 613 Iris Avenue Corona Del Mar, CA 92625
Other locations
Leonhardt’s Launchpads @ UCI Cove 5270 California Avenue, Irvine, CA 92617
Leonhardt Ventures LLC 613 Iris Avenue Corona Del Mar, CA 92625
Leonhardt’s Launchpads Utah, Inc. Research Lab 2500 S State St. #D249, Salt Lake City, UT 84115
Leonhardt’s Launchpads Utah Lab #2 2nd Research Lab Research Park 417 Wakara Way Rm 3321 Salt Lake City, 84108
Second Heart Assist, Inc. 2500 S State St. #D249 Salt Lake City, UT 84115
Leonhardt’s Launchpads @ ScaleLA 3415 S Sepulveda Blvd 10th Floor Los Angeles, CA
Leonhardt’s Launchpads @ Pacific Neuroscience Institute + John Wayne Cancer Institute 2125 Arizona Ave Santa Monica, CA 90404
Leonhardt’s Launchpads Los Angeles R&D Lab 1124 W Carson St. Torrance, CA 90502
Leonhardt’s Launchpads Pittsburgh 132 Tiffany Ridge Dr Coraopolis, PA 15108
LEONHARDT’S LAUNCHPADS AUSTRALIA PTY LTD 5 Martin Place Sydney, NSW, 2000
LEONHARDT’S LAUNCHPADS BRAZIL Street Marcelo Gama, 259 90540050 -Porto Alegre, Brazil Leonhardt’s
Launchpads Europe (representative office for research collaborations) Herengracht 449A, 1017 BR Amsterdam Netherlands
Phone: (424) 291-2133
Fax: (866) 829-0929