United States, California, Los Angeles – 07-17-2019 (PRDistribution.com) —
Leonhardt’s Launchpads www.leonhardtventures.com an innovation and startup accelerator focused exclusively on organ and tissue regeneration and recovery technologies announced today Demo Days and Innovation Showcases to take place in San Francisco September 26th and Palo Alto September 27th, 2019. A data presentation will also take place September 28th at the TCT Cardiology Meeting in San Francisco for our startup Second Heart Assist, Inc.
- September 26th @ WeWork, 44 Montgomery Street, San Francisco, CA. 94104 Room 17A – 4pm to 6pm
- September 27th @ WeWork, 3101 Park Blvd., Palo Alto, CA 94104 – 4pm to 6pm
- September 28th @ Moscone Center, 747 Howard St, San Francisco, CA 94103 – 4pm
Second Heart Assist, Inc., one of Leonhardt’s Launchpads flagship startup companies, also plans to be presenting its First In Man Study Clinical Data for the first time at the Transcatheter Therapeutics TCT 2019 Annual Meeting INTERVENTIONAL HEART FAILURE AND HEMODYNAMIC SUPPORT: CHRONIC THERAPIES Session in San Francisco at the Moscone Center on September 28th at 4pm by Dr. Leslie Miller our Chief Medical Officer
The accelerator business model is to exit to a strategic partner each organ specific startup after first in man clinical study data is available for review. The company has announced it is opening password protected due diligence rooms for 5 of its 30 startups to pre-qualified CDA signed prospective buyers with intention to exit or develop a strategic partnership for each of these five by the end of 2019 – MyoStim ED (erectile dysfunction), OrthodontiCell (teeth straightening), Second Heart Assist (circulatory assist), HairCell (hair regeneration) and EyeCell (vision recovery). Leonhardt’s Launchpads startups have enrolled > 3500 patients (500 non-dental and 3000 dental) in organ regeneration and recovery clinical studies or evaluations to date and have more than 400 organ regeneration and recovery patent claims issued, pending, optioned or licensed.
Estimated Startup Exit Schedule
2019 Portfolio Class
Current as of May 15th, 2019 CEO Ranking
Expected Startup Ripe for Exits Schedule (Highly Subject to Change)
1. CancerCell www.cancercellinc.com
2. PressureStim www.pressurestim.com
3. BladderCell www.bladdercell.com
4. Stem Cell Bra www.stemcellbra.com
5. SkinStim www.skin-stim.com
6. TestiStim www.testistim.com
1. PancreaCell – https://leonhardtventures.com/pancreacell/
2. DentaCell www.dentacellaccelerator.com
3. OrthoStim www.ortho-stim.com
4. Instim www.instimcell.com
5. AortaCell https://leonhardtventures.com/aortacell/
1. EarCell www.ear-cell.com
2. Vascustim www.vascustim.com
3. Biopace https://leonhardtventures.com/bio-pace/
4. VibroCell https://leonhardtventures.com/vibrocell/
5. BioLeonhardt Whole Body and BodStim https://leonhardtventures.com/bioleonhardt-whole-body/
6. RegenaLung https://leonhardtventures.com/regenalung/
On deck circle working through the CalXelerartor www.calxelerator.com 108 day create to great program to be considered to be added to portfolio once an opening is available includes: PolypStim, AddictiStim, ImplantStim, MemoryStim, MigraineStim, NerveStim, CraveStop, PainStim, LymphStim, BoneStim, SnoreStim, AirwayStim, GingavaStim, InfectiStim, DetoxStim, OrthoStim Accelerator.
- MyoStim ED has published two clinical studies and has finished a third double blinded randomized placebo controlled clinical study soon to be published for its ErectStimTM product for bioelectric erectile dysfunction recovery. The MyoStim ED team is enrolling patients now in a 4th registry study as well..
- EyeCell has published data on 176 patients for bioelectric microcurrent eye vision recovery and will be enrolling patients through the balance of the year in two new controlled studies.
- HairCell has completed a 12 patient pilot study in South Africa and is opening up a registry study now OUS at additional clinics for bioelectric and in some cases bioelectric + biologics based hair regeneration.
- Second Heart Assist plans to be enrolling patients in a first in man study in Paraguay all this summer and fall and is working towards starting an FDA cleared Early Feasibility Study at Ohio State University later this year as well for a circulatory assist pump within an aortic stent on the tip of a 13,8FR catheter delivery system. In parallel the company is completing wireless power pre-clinical studies in Australia and Canada advancing safety and efficacy data towards plans to launch wireless power clinical studies next year.
- OrthodontiCell has completed enrollment in a 37 patient clinical study in Brazil and plans to file for publication of results later this year for bioelectric accelerated tooth movement and stabilization.
- BladderCell and KidneyCell have published first study results for non-invasive bioelectric bladder and kidney function recovery in Brazil and now are preparing to enroll in new randomized blinded placebo controlled studies.
- PressureStim has initiated contact with researchers in Asia that have completed three successful clinical studies for bioelectric blood pressure management. Pressurestim has one patent issued and number patent claims pending.
- CancerCell has launched an animal study at UCLA for customized bioelectric cancer treatment. CancerCell has 10 issued patents, including reading a tumor and custom designing bioelectric therapy delivery based on that read, and dozens of new patent claims pending including those for starving a tumor of blood supply and triggering an immune response.
- DentaCell affiliated investigators have treated more than 3000 patients with FDA frequency specific microcurrent signals for improving blood circulation, accelerating healing and pain reduction.
- SkinStim is enrolling patients in clinical studies in South Africa and other locations.
- Stem Cell Bra completed a 15 large animal study in Argentina and is filing regulatory applications to begin clinical studies soon. TestiStim completed a successful single patient pilot case and is gathering pre-clini data to support filing to begin a properly controlled clinical study.
- BioLeonhardt is completing multiple rounds of animal studies with intention to begin a new round of clinical studies for a 2nd generation product in late 2020.
- Vascutim has completed 23 patients in bioelectric and biologics leg wound healing studies OUS and is preparing to begin new studies.
Bioelectric stimulation controlled regenerative protein expressions are at the heart of 28 out of 30 startups within the Leonhardt’s Lauchpads 2019 startup portfolio class. These include these proteins expressions intended for these purposes…
1. SDF1 and PDGF for stem cell homing.
2. IGF1 for DNA repair.
3. Follistatin for muscle regeneration.
4. Tropoelastin for increasing tissue elasticity.
5. Klotho for multiple organ regeneration applications.
6. Sonic hedgehog for multiple organ regneration applications.
7. VEGF, SDF1, PDGF, EGF, HGF, eNOS, HIF1a, CXCL5, Klotho and Tropoelastin for growing larger diameter non-leaking new blood vessels.
8. RANKL and OPG for straightening teeth and other applications.
9. OPG for bone regeneration.
For attempting recovery of the most severely diseased organs the IP platform includes the use of a two chamber re-fillable micro infusion pump that is refilled daily with a fifteen component organ regeneration composition that is comprised of stem cells, PRF, selected exosomes, regenerative fluid from amniotic sourcing, selected alkaloids, micro RNA gel, nutrient hydrogel, oxygenated and other nanoparticles and organ specific matrix. The complete composition is only in animal studies at this time. A few of the components have entered controlled OUS feasibility studies such as autologous PRF and regenerative fluid from amniotic sourcing.
Despite published data from a number of studies the companies make no claims of proven safety or efficacy yet for any application of use. Our business model is to align with a strategic partner to carry each organ specific application through multiple larger scale double blinded, randomized, placebo controlled studs of statistical significance to prove out both the safety and efficacy.
“We are committed to designing and implementing well controlled pre-clinical and clinical studies to prove out the safety and efficacy of our organ specific applications in incremental steps over time always putting patient safety first. Early pre-clinical and limited pilot clinical study data is encouraging us that there may be a place for bioelectric signaling controlled protein expressions in helping patients recover in the future and for the more severely diseased patients there seems to be a place for repeat deliveries of not only stem cells but a well designed cocktail of support factors.” Dr. Leslie Miller, Chief Medical Officer
“Our building patent portfolio we believe is the most comprehensive in the industry related to the optimal bioelectric signaling for controlled protein expressions with the potential to aide in organ recovery. For the most severely diseased patients our patent portfolio includes a re-filable two chamber micro infusion pump an a multiple component stem cells and support factors mixed composition that we believe will be proven out over time through properly controlled studies to be more effective than previous studies of one time delivery of stem cells alone.” states Howard J. Leonhardt, Executive Chairman and CEO
“Every day we are working on the discovery on new bioelectric signaling sequences of new protein expressions that may be useful in supporting organ regeneration and recovery at our two dedicated research labs in Utah and our lab at LABioMed in Los Angeles with a great team of people supported by experienced mentors. We have a goal to double the number of patent pending protein expressions in our IP estate within the next 12 to 24 months”. stated Dr. Brett Burton, Vice President of Research and Development, Leonhardt’s Launchpads Utah
“Recent advancements in electronics now permits precise clear bioelectric signaling that can give cells precision instructions to produce specific regenerative protein expressions for specific purposes on demand. This has opened up a whole new world of potential therapeutic solutions. No other group is working as hard as our team to apply these breakthroughs into patient benefit in the near future”. states Alex Richardson Vice President of Engineering and Product Development @ Leonhardt’s Launchpads
About Leonhardt’s Launchpads: Founded in 2008 in California an innovation and startup accelerator focused on applying bioelectrics and biologics to organ regeneration and recovery. 30 startups in current 2019 portfolio class in these groups (1) Heart & Cardiovascular, (2) Brain, (3) Cosmetic & Personal Care, (4) Major Organ Regeneration and (5) Cancer. 500 patients have been enrolled in clinical studies so far and over 400 patent claims issued, pending, optioned or licensed. Nearly all startups in the accelerator emanate from Howard Leonhardt and Leonhardt Ventures patented or patent pending inventions most specifically in the area of bioelectrics, biologics, re-fillable micro pumps plus endovascular catheter and stent systems. Headquartered today in Los Angeles with branch locations in Utah, Pittsburgh, Petaluma, Australia and Minneapolis. Strong product development collaborations are maintained with Mettler Electronics in Anaheim, DeviceLab in Tustin, Rev1 Engineering in Murietta, CA and Biomerics in Utah and Minnesota, The MironLab Los Angeles, Axolotl Biologix Phoenix, BioInnovations Gateway Utah, LABioMed and Pacific Neurosciences Institute in Los Angeles, UNC Foundation and King Technology Ventures in Petaluma, CA, ViVitro Labs Victoria, Canada, CalTech Pasadena as well as Queensland University of Technology (QUT) in Brisbane, Australia.
About Leonhardt Ventures: Founded in 1982 as HL Leonhardt & Co. (Since 2005 Leonhardt Vineyards LLC DBA Leonhardt Ventures) is the commercialization and venture capital arm of inventor Howard J. Leonhardt an inventor with over 22 issued patents for organ regeneration and recovery and hundreds of new patent claims pending. The team patented and developed PolyCath balloon catheters in the 1980’s, stent grafts and percutaneous heart valves in the 1990’s and since 2000 has focused on bioelectric and biologics based organ regeneration starting with heart regeneration www.bioleonhardt.com Over 400,000 patients have been treated with Leonhardt inventions to date including the leading stent graft system for repairing aortic aneurysms.
About Second Heart Assist: Founded in 2016 in Utah is focused on developing a circulatory assist pump within an aortic stent. The team has developed a temporary percutaneous catheter based model and a wireless powered chronic implant both of which are currently under testing. See www.secondheartinc.com for more information.
Warnings and Disclaimers: Patents pending may not be issued. Patents issued, licensed or optioned may not be maintained. Products may be found to infringing on other patents. Products are early stage in development and are not yet proven safe or effective. Company lacks sufficient resources to bring these products fully to commercialization. As an investment these early stage startups have to be regarded in the highest risk category for total loss. Forward looking statements are subject to change without notice. Any timelines, implied or quoted, are highly subject to change even by years. Company is understaffed and underfunded by typical standards to complete any of its product developments. The company is highly dependent on a few key individuals and suppliers to move forward its developments at this time. With a small staff information across over 50 plus maintained web sites maybe out of date at any time.
Additional Regulatory Warning Note – Our primary bioelectric stimulator sourced from Mettler Electronics of Anaheim, California founded in 1957 https://www.mettlerelectronics.com/history/ has FDA 510K – K113017 – market clearance ONLY for improving blood circulation, mild pain relief, relief of arthritis related stiffness and accelerated muscle injury recovery. Any other indications of use require clinical data to be gathered to support additional new regulatory filings to gain proper regulatory clearances for additional labelling indications of use. None of our startup’s products are for sale anywhere worldwide especially in the USA. Products are only available for investigational use where proper regulatory permissions have been granted including government and institutional review board (IRB) approvals where necessary and in all cases appropriate patient consent process has been followed properly communicating all associated risks clearly. We make no claims that our products are safe or effective for any indications of use outside of the 510K cleared indications mentioned above.
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