Executive Chairman’s Best guess estimate June 2023 on portfolio assets closest to exit
Note – ALL bioelectric products are based on same exact core stimulator with only slightly different signal sequence protocols. Nearly all use our stem cell homing and circulation improving signals common. So in sense we have only two highly focused startups in portfolio…
1. Second Heart Assist and
2. Bioelectric healing (supported by Klotho testing).
After Second Heart is sold we plan not to have any other product that is not core focused bioelectric based. We will be 100% ultra focused on developing applications for our patented core bioelectric stimulator technology only.
TOP TIER
1. Second Heart Assist, Inc. www.secondheartinc.com – Preparing to enroll in 2nd clinical study in USA.
2. BodStim www.bodstim.com by BioLeonhardt Whole Body – Enrolling in clinical studies in USA and Brazil. High interest product.
3. DepressiStim www.depressistim.com – Major protein expression results. Moving into clinical study. Industry sector booming. Early acquisition interest already. Could leap frog to first after first in human study results later this year.
4a. OrthodontiCell, Inc. www.orthodonticell.com – Filed for commercial approval 60 days ago. Clinical data just published.]
4b. MyoStim ED ErectiStim www.erectistim.com – Data on over 115 patients. Enrolling in USA. Filing 510K. Launching sales USA.
5. SkinStim www.skin-stim.com – Enrolling in 3rd clinical study in the USA. Sales in USA about to launch.
6. HairCell www.haircellstim.com – Enrolling in 3rd clinical study in the USA. Interim results BES alone look good.
7. PressureStim www.pressurestim.com – Could have data on over 250 pts by year end. Patents are solid.
8. BladderCell www.bladdercell.com and B-Alive www.b-alivestim.com – enrolling in 2nd clinical study. Some acquisition interest.
9. ArchStim www.archstim.com – excellent first pilot case completed high acquisition interest – could leap frog to first this month
10. ImplantStim www.implantstim.com – excellent first pilot cases completed. Could leap frog to first this quarter.
SECOND TIER
11. OrthoStim www.ortho-stim.com – could leap frog to first – launching clinical study
12. CancerCell www.cancercellinc.com – high likely to leap frog to first – launching clinical study
13. Stem Cell Bra/BreastStim www.stemcellbra.com – just completed 15 patient study in Spain
14. BioLeonhardt www.bioleonhardt.com – could leap frog to first. Long history of data including core data on 4 clinical studies published.
15. Valvublator, Inc. www.valvublator.com – could leap frog to first. Expect First in Human in Paraguay this year. Large animals first.
16. EyeCell www.eye-cell.com – Just got IRB approval for 3rd USA study following previous Chaikin and Kondrot studies.
17. BreatheStim www.breathestim.com – Pilot cases highly successful. Great interest in breathing improvement from acquirers.
18. InStim www.instimcell.com – successful pilot case fighting inflammation gusto-intestinal.
19. Second Brain www.secondbrainstim.com – Brazil Porto Alegre researcher with successful case result potential collaborator.
20. CerebraCell www.cerebracell.com – New protein expression discoveries BDNF, GDF10 lead path.
THIRD TIER
21. MemoryStim www.memory-stim.com – Very strong market demand for this product.
22. KidneyCell www.kidney-cell.com – enrolling in 2nd clinical study now
23. PancreaCell www.pancreacell.com – could leap frog to first. Major patents in process. Key relationship with Dr. Ricordi.
24. RegenaLung https://leonhardtventures.com/regenalung/ – Covid lung patent about to publish.
25. LiverCell www.livercellstim.com
25. TremorStim www.tremorstim.com – A leading close competitor thriving with millions raised.
26. Vascustim www.vascustim.com – Previous successful clinical results in Mexico and Czech Republic.
27. KlothoYears by KlothoBios www.klothoyears.com – In BETA commercial launch stage to early adopters in USA in Brazil. We have processed about 25 Klotho tests so far including those processed for SpineStim and KidneyCell studies. Building partnerships with LabCorp. Limited IP here to sell. Great support to BodStim www.bodstim.com which can be sold soon. ]
28. SpineStim www.spine-stim.com – Complete a pilot low dose safety clinical study in Costa Mesa, CA at NeuroMusclar Connections Institute with grant support. Preparing for higher dose 2nd clinical study.
Notes – BodStim, SkinStbrStim is very high with multiple discussion already ongoing with potential licensees or acquirers. At the highest levels there is very high interest in Valvublator. We have more data supporting our flagship BioLeonhardt heart regeneration platform than all our other technologies combined with 4 clinical studies and 7 animal studies already published on myoblast based heart regeneration. We are simply adding a trickle of bioelectricity and a few supporting proteins to the already proven technology. This could leap frog to number 1 by year end. Medtronic and BlueWind are waiting on results from the 2nd BladderCell study to meet again. We are working on meeting with Axonics Neuromodulation based in Irvine, CA that has shot up to over $2.5 billion in value with their implantable stimulator technology for bladder control. OrthoStim has high interest from CyMedica Ortho and they are waiting on data from new study. We are working on meeting with BioniCare VQ Orthocare based in Irvine, CA and Bioness based in Valencia, CA. DepressiStim has license interest already from multiple parties. OrthodontiCell, Inc. is about to launch a $1 million capital raise on StartEngine. We had the on boarding meeting yesterday. This capital will be used to support the USA commercial launch in the USA. Clinical data was published last month in the Journal of Oral Research and we just completed a successful exhibit at the Annual Meeting of Orthodontists in Miami. One group Young Innovations Inc. proposed providing $25 million for 50% of the company. Second Heart Assist, Inc. hopes to complete their U.S. Cardio-Renal Syndrome Heart Failure study at Ohio State University and Cleveland Clinic this summer and will then meet with up to a dozen potential acquirers again to discuss potential strategic acquisition/partnership. Second Heart Assist has engaged Truist Investment Bank and Wilson Sonsini for M&A representation and Vestech Securities for capitol raising. All our accelerator portfolio is represented by Wilson Sonsini for M&A negotiations. For all projects it is always hurry up and wait. And in most cases more cash, more focus or more personnel would not change timelines at all. By example OrthodontiCell has been waiting on its $100,000 mold to product good mouthpieces for 18 months now (in mean time we are now 3D printing smaller quantities for studies). They are also waiting on FDA response to their 510K filing. Second Heart is waiting on a Texas Heart hemolysis test fixture to be followed then by the FDA response our EFS study application.