2018 Annual Progress Summary

Innovation and startup accelerator FOCUSED on organ regeneration with a convergence of bioelectrics and biologics.

2018 Portfolio of Startups 

Come to our Two Innovation Showcases near the JP Morgan Healthcare Conference 2pm to 8pm January 8th in San Francisco…

Second Heart Assist Wireless Powered Circulatory Assist Innovation Showcase 2pm to 5pm 
Book tickets here > https://www.eventbrite.com/e/second-heart-assist-innovation-showcase-wireless-powered-circulatory-assist-tickets-53840142315

Organ Regeneration Innovation Showcase – 29 Startups Featured
5pm tp 8pm
Book tickets here > https://www.eventbrite.com/e/organ-regeneration-innovation-showcase-leonhardts-launchpads-tickets-53838174429

Development Stage Pipeline Website Page
Click Here > https://leonhardtventures.com/development-pipeline/

2018 Elevator Pitches for Startup by Startup

Click Here >  https://leonhardtventures.com/2018-elevator-pitches/

2019 Organ Regenration Innovation Showcase Slidedeck with Introductions to all 30 Portfolio Startups – Click Here > https://app.slidebean.com/p/AaDUz4CxmQ/Leonhardts-Launchpads-Innovation-Showcase-Deck

HEART AND CARDIOVASCULAR

>  BioLeonhardt  – heart regeneration.
>  AortaCell – aorta regeneration.
>  BioPace – biological pacemaker regeneration.
>  Valvublator – heart valve regeneration.
>  VibroCell CoroStim– vibrational energy to prevent clots, plaque, calcification.
>  Vascustim (formerly MyoStim Peripheral)– limb blood flow improvement.
>  Second Heart Assist, Inc. – circulatory assist pumps 
> PressureStim – bioelectric blood pressure control. 

Brain

>  CerebraCell – brain regeneration.

Cosmetic & Personal Care

>  Stem Cell Bra – breast regeneration.
>  DentaCell Accelerator – dental gum regeneration + tooth pulp storage.
>  OrthodontiCell – bioelectric teeth straightening acceleration. 
>  SkinStim (formerly MyoStim Skin) – skin regeneration.
>  MyoStim ED ErectiStim – bioelectric erectile dysfunction treatment.
>  HairCell – hair regeneration 
>  Wave – bioelectric endometriosis treatment.
>  TestiStim – bioelectric testosterone management and infertility treatment. 

Major Organ Regeneration 

>  EyeCell – eye regeneration.
>  PancreaCell – pancreas regeneration.
>  RegenaLung – lung regeneration.
>  LiverCell – liver regeneration.
>  KidneyCell – kidney regeneration.
>  EarCell – ear hearing regeneration.
>  BladderCell – bladder regeneration.
>  InStim – bioelectric inflammation management. 
>  PolypStim – bioelectric polyp removal.
>. OrthoStim – bioelectric and biologics joint recovery. 
>  BioLeonhardt Whole Body Regeneration – Whole body regeneration.

Cancer Treatment 

>  CancerCell – bioelectric cancer tumor treatment + regeneration.

Links to websites of all startups in innovation accelerator found here – scroll to bottom of page click on startup name – https://leonhardtventures.com/our-companies/

Executive Chairman and CEO Letter to Stakeholders 

2018 has been an exciting year of progress.  We set a goal in January to get 5 products into clinical stage of development by year end and we are poised now to achieve as many as 13 products clinical ready.  We targeted to file, license or option more than 50 new patent claims and we filed over 180!  In addition we also in-licensed or optioned another 200 patent claims from universities or other outside institutions or inventors. We added two dedicated research labs in Utah. One at the Center for Medical Innovation in Research Park and the other at BioInnovations Gateway both in Salt Lake City. More than 20 team members have participated in our research projects in Utah since our opening there in late 2015.  In 2018 we were also honored to be accepted into LifeX Labs in Pittsburgh and and opened up a branch subsidiary in Australia. 

Our Heart & Cardiovascular team completed numerous pre-clinical studies and have put us in position to have Second Heart Assist in first-man-studies as early as December. The team completed 5 large animals, a mock loop study at the University of Louisville and two rounds of computational fluid dynamics studies. A wireless power demonstration is expected at Queensland University in Australia this month. BioLeonhardt is moving to large animal studies at Texas Heart Institute with Dr. Doris Taylor for heart regeneration after completing preliminary small animal studies at the University of Utah. Skeletal muscle regeneration studies are launching at McGowan Institute of Regenerative Medicine in Pittsburgh. AortaCell is set to start aorta regeneration pre-clincial studies at the University of Virginia.  BioPace is moving forward with Dr. Alonso Moreno in Utah with numerous grant applications filed and patent agreement with the University of Utah.  Valvublator has hired a President in Richard Henson and is moving towards building and testing prototypes for decalcifying and regenerating heart valves.  PressureStim is moving into clinical studies in Korea and China for bioelectric blood pressure control. 

Our Brain group with CerebraCell presented at a number of major conferences including the Neuro Tech Leaders Forum and is launching animal studies for TBI and stroke at McGowan Regenerative Medicine Institute in Pittsburgh. 

This year our Cosmetic & Personal Care group made the most progress of any our portfolios in launching clinical studies.  MyoStim ED with the ErectiStim product published in late May a first-in-man clinical study led by our Chief Scientific Officer Cristiane Carboni. The results were highly encouraging with 85% of treats patients having recovery while all patients in the placebo group had no recovery.  The treatment time was only 15 minutes 2X a week for only 4 weeks. We have now launched a second clinical study for MyoStim ED ErectiStimTM with goal of achieving 100% success in ED recovery. This time we are including muscle regeneration bioelectric signals in addition to the previous blood circulation signal sequence used in the previous study. SkinStim launched a clinical study at The SkinMedix Clinic in Los Angeles and is preparing to launch studies in South Africa, Pittsburgh, Austin, Texas, Utah and other locations. HairCell launched a clinical study in South Africa working with Dr. Catherine Davies.  Stem Cell Bra completed animal studies in Argentina and is preparing for a first-in-man study. The animal studies demonstrated 20 to 30% breast tissue growth while only wearing the Stem Cell Bra 1 hour every other day for a month. OrthodontiCell teamed with research collaborators in Brazil completed a positive animal study and now are working to launch a first-in-man study.  IRB approval for the study was received this month.  The team hopes to prove it can cut time to wear braces or aligners by 2/3rds from 18 months down to 6 months and keep teeth straight after straightening. DentaCell Accelerator has developed a full portfolio of products with an all-star team assembled.  TestiStim secured an issued U.S. patent and completed a pilot clinical evaluation in Los Angeles for bioelectric testosterone management. 

Our Major Organ Regeneration team moved a number of products from lab testing into animal studies includingEyeCell which also completed human cadaver eye studies.  PancreaCell made it to the finals of the American Diabetes Association Innovation Award and is initiating research collaboration with the University of Miami. LiverCell and KidneyCell are moving into animal studies with McGowan Regenerative Medicine Institute in Pittsburgh.  RegenaLung, EarCell, BladderCell, Instim, PolypStim and Wave all filed major new patent applications and moved closer to animal studies. BioLeonhardt Whole Body with BodStim filed to participate in the USC SLAM Innovation competition and is preparing and NSF SBIR grant application.

Our Cancer group with CancerCell has filed with the ethics committee at UCLA to begin a bioelectric treatment protocol in small animals. CancerCell has numerous issued patents and patents pending. 

In 2018 we filed over 180 new patent claims with the United State Patent and Trademark office and licensed in  over 200 additional patent claims as well.  The new filings included a full series of claims for reading inflammation and custom designing bioelectric treatments based on that real time read. In licensed patents included issued patents for testosterone management, infertility and bioelectric blood pressure management.

Our overriding goal for 2019 is to position at least 5 of our startups for a strategic partnership after first-in-man study results by year end. We have assembled an amazing team focused on achieving this goal. 

Progress Summary 

Heart & Cardiovascular 

• Second Heart Assist, Inc. – Expect to move clinical studies in Paraguay, Australia and at Ohio State University over the next 90 days.
• Vascustim – moving into clinical studies now. 
• BioLeonhardt – completing small animal studies U Utah and moving into large animal studies at Texas Heart Institute. 
• AortaCell – moving into large animal studies at the University of Virginia now. 
• VibroCell – moving into large animal studies at Queensland University. 
• Valvublator – recruited a President and preparing prototypes for testing. 
• BioPace – filed a number of grant applications.  In licensed patent U of Utah. 
• PressureStim – collaborating with researchers in China. Filed patents. 

Brain

• CerebraCell – preparing for animal studies. Presented at Neuro Tech Leaders Forum. 

Cosmetic and Personal Care 

• HairCell – launched clinical study in South Africa. 
• SkinStim – launched clinical study in Los Angeles working to open other sites. 
• MyoStim ED ErectiStim – completed clinical study Brazil.  Published results.  Enrolling new study. 
• OrthodontiCell – completed numerous animal studies.  Launched clinical study in Brazil and preparing for other locations. 
• DentaCell Accelerator – developed numerous new products.  Collaborators have gathered clinical data on frequency specific micro current therapies and PRF in dentistry. 
• Stem Cell Bra – completed additional animal studies in sheep and cows 15 large animals safety study. Launching clinical study South Africa. 
• TestiStim – secured issued U.S. patent.  Completed pilot clinical evaluation in Los Angeles. 

Major Organ Regeneration.

• EyeCell – completed small animal and human cadaver eye studies at U of Utah.  Collaborators completed frequency specific microcurrent clinical evaluations. 
• PancreaCell – made it to finals of American Diabetes Association Innovation Awards California.   Initiated research collaboration with University of Miami. 
• LiverCell – launching animal studies. 
• KidneyCell – launching animal studies. Initiating collaboration with Brazil researchers with clinical data.
• RegenaLung – seeking out research collaborators. 
• BladderCell – preparing to launch clinical studies in Brazil.
• EarCell – filed numerous new patent claims.  Search for research collaborators. 
• Instim – filed numerous new patent claims.
• BioLeonhardt Whole Body and BodStim – secured research partners for components.  Preparing NSF SBIR grant application. Developed BodStim wearable regeneration suit. 

Cancer 

• CancerCell – Launching animal study at UCLA.  Filed and in-licensed in numerous patent claims. 

Board of Directors 2018

Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. 
Howard J. Leonhardt – Executive Chairman & CEO
Jeremy Koff – Chair Compensation Committee
Dr. Mark Cunningham 
Jeff Donofrio 
Ken Evans 
Dr. Leslie Miller – Chief Medical Officer 
Brittany Brown – CPA, Secretary & Treasurer 
Alex Richardson – Vice President Engineering & Product Development  

Second Heart Assist, Inc.
Howard J. Leonhardt – Executive Chairman & CEO
Dr. Dinesh Patel 
Jeff Donofrio – President 
Ken Evans 
Dr. Mark Cunningham
Dr. Leslie Miller – Chief Medical Officer 
Alex Richardson – VP Engineering & Product Development 
Brittany Brown – CPA, Secretary & Treasurer  

Leonhardt’s Launchpads Utah, Inc.
Howard J. Leonhardt – Executive Chairman & CEO
Jeremy Koff – Vice President Strategic Development 
Dr. Dinesh Patel 
Dr. Leslie Miller – Chief Medical Officer 
Dr. Brett Burton – Director R&D & Startup Launches 

Leonhardt’s Launchpads Pittsburgh, Inc.
Howard J. Leonhardt – Executive Chairman & CEO
Phil Patton – EVP Business Development & President KidneyCell 
Dr. Leslie Miller – Chief Medical Officer. 

Leonhardt’s Launchpads Australia PTY
Howard J. Leonhardt – Executive Chairman & CEO
Paul Niederer – Managing Director 
Dr. Leslie Miller – Chief Medical Officer 

Management 
Howard J. Leonhardt – Executive Chairman & CEO
Dr. Leslie Miller – Chief Medical Officer 
Dr. Stuart Williams – VP Biologics Research 
Dr. Jorge Genovese – VP Bioelectric Research 
Alex Richardson – VP Engineering and Product Development 
Jeremy Koff – EVP Strategic Development 
Jeff Donofrio – President Second Heart Assist, Inc. 
Ken Evans – VP Corporate Development, President EarCell
Tom Newman – VP Physician Relations, President DentaCell Accelerator 
Paul Norman – Managing Partner Accelerator(s)
Derek Kahn – President HairCell 
Dr. John Marchetto – President and CMO OrthodontiCell 
John Grosso – President Stem Cell Bra
Dr. Harish Kapoor – President PancreaCell
Dr. Nic Chronos – Chief Scientific Officer PancreaCell, VP Clinical Research BioLeonhardt 
Paul Niederer – President Leonhardt’s Launchpads Australia PTY
Dr. Richard Miron – Chief Advisor PRF Research, Managing Partner DentaCell Accelerator  
Dr. Robert Kellar – Chief Advisor Amniotic Fluid Research  
Dr. Mark Cunningham – VP Research Valvublator 
Dr. Alonso Moreno – Chief Scientific Officer BioPace, VP Research Leonhardt’s Lauchpads Utah 
Phil Patton – President KidneyCell, EVP Corporate Development Pittsburgh 
Dr. Val Kanter – Chief Medical & Scientific Officer DentaCell Accelerator 
Dr. Brett Burton – Director of R&D and Startup Launches 
Dr. Santosh Kesari – Chief Scientific Advisor CancerCell and CerebraCell 
Brian Hardy – Director of Marketing 
Kapil Sharma – Bioengineer and Startup Development & Chief Technology Officer AortaCell 
Cristiane Carboni – Chief Scientific Officer MyoStim ED, Wave and BladderCell 
Sejal Choudhuri – Chief Biologics Researcher 
Allen Turner – Chief Patent Counsel
Bruce Methven – Chief Securities Counsel
Brittany Brown – CPA, Secretary and Treasurer
Kim Medina – Accounts Payable
Dr. John Langell – Chief Innovation Advisor Utah
David Robinson – Chief Startup Launch Advisor Utah
Dr. Dinesh Patel – Chief Strategic Advisor Utah 
Larry Stevens – Chief FDA & Regulatory Consultant
Michael Williams – Chief Engineering Consultant
Ryan Stanfield – Engineering Consultant
Scott Marland – Engineering and Startup Launch Consultant Utah
Jon Teal – Engineering and Design Controls Consultant
Doc Vu – Prototyping and Quality System Consultant 

Link to team page – https://leonhardtventures.com/team/

Link to Scientific Advisory Board page – https://calxstars.com/scientific-advisory-board/