Press Release – July 14th, 2016 – Santa Monica, Ca and Salt Lake City, UT – Leonhardt Ventures www.leonhardtventures.comannounced today that its startup Valvublator has filed with the U.S.PTO a provisional patent application covering devices and methods for heart valve regeneration designed to help a patient keep their own heart valve instead of getting an artificial implant. Howard J. Leonhardt the Founder of Leonhardt Ventures is the sole inventor.
Link to Valvublator Animation Video Here > www.leonhardtventures.com/valvublator
Components of the invention include:
- 9FR Deflecting tip guiding catheter – to reach heart valve – all other tools run up within this guiding catheter.
- Three catheter based de-calcification tools — (1) Abrasive burr on tip of deflecting tip catheter. (2) Ultrasonic cleaning, and (3) biologically safe solvent pressure cleaning. These de-calcification tools are used in sequence.
- Optical viewing catheter – to visualize all cleaning, regenerating and re-forming procedures.
- Suction vacuum – for holding heart valve leaflets during cleaning and for removing debris.
- Cerebral protection – both filter and deflector systems to ensure avoidance of stroke and other embolitic complications.
- 10 bioelectric regeneration signals – Delivered via an array on tip of catheter to heart valve. Signals include SDF-1 (stem cell homing), IGF-1 (DNA repair), HGF, EGF, Activin A+B, Follistatin, Tropoelastin, RANKL, eNOS and VEGF as well as stem cell proliferation and differentiation control signals.
- Nitinol valve orifice ring and placement device – to help restore original valve shape in severe loss cases.
- Micro infusion pump – designed to infuse 15 component VLV-15 proprietary regeneration composition to post de-calcified heart valve for regeneration purposes. Components include a number of cell types, growth factors, exosomes, Micro RNAs, Follistatin, Tropoelastin, SDF-1, IGF-1, HGF, heart valve matrix and HGH. Only used if steps 1 through 6 do not work to fully restore heart valve function.
- Autologous cell created heart valve leaflets – placed via catheter only if all the above steps to not work to restore full heart valve function. Grown in lab from patients own cells porous matrix materials as a heart valve shape mold. When the valve’s three leaflets come together to close the valve, there is some surface-to-surface contact between the leaflets, rather than an edge-to-edge seal. This safety margin helps prevent against blood leakage back into the left ventricle. No folds in the leaflets — natural aortic valve cusps flex without folding. Folds would crease the tissue and cause unwanted stress on the leaflets, negatively impacting durability. Minimum leaflet flex — the human aortic valve and this designed implant manages to open completely with the leaflets moving only 70 degrees, not the 90 degrees as other valves are designed to do. This improves the valve’s longevity.
“In 1988 working with Dr. Domingos Moreaus in Brazil the Leonhardt team built the first generation Valvublator deflecting tip abrasive vibrating burr catheter device for decalcifying heart valves. We have now added ultrasonic and biologically safe solvent pressure to the cleaning procedure. More importantly we also added followup heart valve stem cell based regeneration driven by specific proteins released by precise bioelectric stimulation. This signaling includes the SDF-1 stem cell homing signal.” states Howard J. Leonhardt, Inventor.
The team is finalizing pre-clinical studies preparing to enter clinical trials in 2017.
“If a patient can keep their own heart valve regenerated back to full function they are certainly better off than getting an artificial implant made of plastic, pig, cow tissue or steel. These artificial valves if they are steel require life long blood thinners which have dangerous side effects. If made of pig or cow tissue or artificial plastics they re-calcify much quicker than natural valves. If Valvublator works as designed it will be a revolution in heart valve treatment.” states Dr. Mark Cunningham, Chief Medical Advisor to Valvublator and Assistant Professor of Clinical Cardiothoracic Surgery, University of Southern California Keck School of Medicine “We clean our teeth professionally at the dentist before they get bad and diseased, why not enter early and de-calcify our heart valves BEFORE they are degenerated beyond recovery”? Cunningham further states.
This same Leonhardt team revolutionized heart valve treatment with the development of the first percutaneous heart valve in 1988 which resulted in the later filed and issued pioneering U.S. patent U.S. 5,957,949 http://www.google.com/patents/US5957949 This invention was sold to Medtronic in the fall of 1998 as part of the acquisition of Arterial Vascular Engineering, Inc.
It is projected that more than 1 million patients worldwide could benefit from a minimally invasive heart valve cleaning and regeneration procedure if safe and effective.
About Leonhardt Ventures: Founded in 1982 Leonhardt Ventures led the development of turn key cath labs, predictably compliant cardiovascular balloon catheters and electrical stimulation devices for blood flow improvement in the 1980s, intravascular lung, radiation and stem cell delivery catheters, vibrational energy for preventing clots and calcification and improving gas exchange, biological pacemakers, percutaneous heart valve and percutaneous stent grafts in the 1990s. Leonhardt’s patented stent graft is a market leading system today with Medtronic. In 1999 they formed the first stem cell repair of damage hearts company which led to the first-in-man non-surgical stem cell repair of a human heart in early 2001. Since 2000 the focus has been on heart and organ regeneration. Howard Leonhardt the founder of Leonhardt Ventures has 21 issued patents with over 100 issued patent claims and another 30 patent filings are pending or in process – http://www.google.com/patents/US5957949. Leonhardt filed patents in 2001 covering bioelectric signals for stem cell homing, heart regeneration and controlled cell differentiation into heart muscle – http://www.google.com/patents/US20050171578
Leonhardt has founded over 33 startups. See www.leonhardtventures.com
About Cal-X Stars Business Accelerator, Inc.: Founded in Santa Monica, CA in 2012 Cal-X Stars is a 5 year business accelerator. There are 30 startups in its 2016 portfolio class. 26 regenerative medtech and 4 regenerative economy startups. The Cal-X Stars business model is to take startups as far as the can for 5 years and then seek a strategic partner or an acquirer through a Dutch auction process. See www.calxstars.com
The Leonhardt Ventures’ Cal-X Stars Business Accelerator, Inc. 2016 Portfolio of 30 startups with their valuations may be viewed here – http://leonhardtventures.com/our-companies/
About Valvublator: Valvublator was originally founded in 1988, when the original prototypes for heart valve de-calcification with a vibrating dental burr were built and tested in Brazil, but went idle in order for the Leonhardt team to focus on other innovations and was re-launched again in 2013 as part of the Cal-X Stars Business Accelerator, Inc. See – http://leonhardtventures.com/valvublator/ + www.valvublator.com
Leonhardt’s Launchpads Utah: Formed in 2015 in Salt Lake City, Utah as a 5 year accelerator for regenerative medtech startups that are working in research collaboration with scientists and clinicians at the University of Utah, Utah State University, Westminster College, Brigham Young University and Utah Valley University. A member of BioUtah.