Patients Enrolled in Clinical Studies by Startup
as of April 1, 2020
- Second Heart = 4 pts Paraguay, 5 patients scheduled for June in Georgia
- OrthodontiCell = 47 pts Brazi enrolled, 1 pt USA more about to enroll in aligner and stabilization studies
- MyoStim ED = 105 pts Brazil + South Africa + Utah more enrolling
- HairCell = 12 pts South Africa
- EyeCell = 176 pts USA about to enroll 40 more
- PressureStim = 150 pts China/UC Irvine + 13 Brazil + enrolling in new study
- BladderCell = 56 pts Brazil = enrolling in new study now
- Stem Cell Bra = 6 pts South Africa & Brazil safety study, about to enroll in the efficacy study
- SkinStim = 10 pts South Africa, 5 pts Utah
- TestiStim = 1 pt USA
- KidneyCell = 21 pts Brazil + 242 pt review paper. Enrolling now a new study
- Valvublator = 1 pt Italy surgical
- DentaCell = 2000 pts USA by our collaborating advisors and researchers frequency specific microcurrent
- InStim = 1 pt Brazil inflammation
- OrthoStim/Tisugen = 10 pts USA Santa Rosa + 301 pt study completed in China by independent team following Liu patents
- Vascustim = 7 pts Mexico + 16 pts Czech Republic + 47 pts Wetling Switzerland, Denmark and Germany + new study in Mexico about to enroll
- BioLeonhardt = 61 pts previously competed by predecessor Bioheart with myoblasts alone one time delivery in USA and Europe now moving to myoblasts with host of support factors delivered daily with re-fillable micro infusion pump + 30+ bioelectric signals including inflammation management. Dr. Tomas Simniak in Poland and other investors in Brazil added about 40 more patients following our patents with improvements of their own.
- ImplantStim = 1 pt Hawaii
Total Authorized to Quote Conservatively = 800+
We are working to close partnership agreements with groups that have completed successful bioelectric or biologics based (or both) clinical studies for brain recovery, cancer, liver, lungs, knees (300+) which if all are concluded would increase patient count in clinic studies by > 1000 more.
Clinical Study Enrollment Numbers and Total Clinical Data Clarification
The number of clinical study patients enrolled in studies quoted in various communications not only include the number of patients enrolled in studies that we have designed, launched, funded and supported internally with our own devices, programming or compositions but also may likely include data or enrollment numbers acquired from collaborating investigators where they have completed and published the studies before joining forces with us in one form or another. The first MyoStim ED pilot studies for bioelectric treatment of erectile dysfunction by example, that we believe followed some of our early issued (VEGF signal) patent claims, were completed and published independently by Dr. Cristiane Carboni and her colleagues before she joined forces with us to complete a number of new follow-on studies with our supplied devices and programming. In this example the data from the new studies, with our devices and our patented or patent pending bioelectric stimulation programming, were superior to the original independent pilot study results. When we quote the total number of patients enrolled in all MyoStim ED studies we include the numbers enrolled in the earlier independent pilot studies. In some more rare cases data or clinical enrollment numbers quoted or cited from studies may include those done by independent investigators that we believe followed our issued patent claims that have not formally joined forces with us in any capacity. The related scientific articles sections or pages on our web sites include data from similar studies that may support directly or in-directly the research we are doing. These enrollment numbers are not counted in our total clinical study enrollment numbers quoted. In cases where we acquire intellectual property (IP) from an outside inventor, developer or investigator and previous pre-clinical and clinical data has been gathered supporting that IP we always strive to establish as part of the agreement that all ownership rights to that data is considered part of the acquisition.