BioLeonhardt Files Provisional Patent Application for Electrical Stimulation Controlled Release of Follistatin
BioLeonhardt Files Provisional Patent Application for Electrical Stimulation Controlled Release of Follistatin
Santa Monica, CA and Salt Lake City, Utah , Feb. 16th, 2015 /PRBuzz- BioLeonhardt MyoStim www.bioleonhardt.com funded by Leonhardt Ventures a developer, manufacturer and marketer of advanced organ regeneration products focused on the heart and limbs has announced the expansion of its intellectual property portfolio. BioLeonhardt MyoStim is incubating within Cal-X Stars Business Accelerator, Inc. The Company has filed a provisional patent application in the U.S. Patent and Trademark Office for inventions relating to bioelectric stimulation controlled release of follistatin a powerful muscle repair and formation promoter. Follistatin-like 1 (FSTL1) is a protein that encourages the growth of healthy cells, contractile muscle tissue and even blood vessels, helping supply the newly created muscle tissue with oxygen and nutrients. This therapy invention was originally designed to reduce or eliminate scarring of the heart following a heart attack and reversing heart failure but may also be applicable to treating other organs suffering of muscle loss or degradation.
Howard J. Leonhardt the Founder and CEO of BioLeonhardt MyoStim and Dr. Jorge Genovese a collaborative researcher from Buenos Aires, Argentina are co-inventors of this product. Howard Leonhardt previously patented a series of electrical stimulation devices and signals for homing stem cells to targeted tissues and the controlled differentiation when required into contractile muscle, even within scar tissue starting back starting back in 2000. Dr. Genovese has been conducting electrical stimulation based regeneration research for over twenty years with numerous published peer reviewed papers.
"Folistatin is a key element in improving our ability to regenerate damaged hearts and limbs as well as other organs. Controlled on demand release from cells in a persons own body is ideal for optimizing and maximizing the powerful capabilities of follistatin to improve heart and limb function. Today's provisional patent filing is a great step towards helping millions of patients in great need without viable alternatives. The potential uses go well beyond heart and limb regeneration and may be useful for hundreds of applications." stated Howard J. Leonhardt, Co-Inventor
"Numerous published papers, including a number from our own labs, have documented the powerful ability of follistatin to promote repair and form new muscle when and where needed. Until now there was not a practical, safe and cost effective method of controlled delivery. This invention is designed to solve the missing puzzle piece to reproducibly produce safe results in regenerating not only hearts and limbs but other ailing organs including treating erectile dysfunction." Stated Dr. Jorge Genovese Co-Inventor
Last year a team led by scientists from Utrecht University in The Netherlands pubished postive heart regeneration results with a patch soaked in Follistatin (FSTL-1) placed on damaged heart tissue in small animals - REFERENCE: http://bit.ly/1MTLC7d. For human use it was determined by our team that longer repeat doses were needed and a natural release from a patients own electrically stimulated cells would lead successful human heart regeneration which led to this invention. Our patent pending signals for follistatin release match more closely with the natural low voltage signals in the human body.
A team from the University of Utah in part led by BioLeonhardt Scientitific Advisory Board Members and collaborative researchers Dr. Jorge Genovese and Dr. Amit Patel working with co-researchers in Rome, Italy published in Cell Transplantation, Vol. 21, pp. 493–503, 2013 - In Situ Electrostimulation Drives a Regenerative Shift in the Zone of Infarcted Myocardium - http://bioleonhardt.com/wp-content/uploads/2013/05/IN-SITU-ES-JG.pdf which included documenting increases in numerous beneficial proteins for heart regeneration with a 3V 10HZ signal. Dr. Jorge Genovese previously led a study - http://www.ncbi.nlm.nih.gov/pubmed/19530028 - Electrostimulated bone marrow human mesenchymal stem cells produce follistatin which utilized very high voltage 10 and 40V signals to cause bone marrow cells in the lab to increase release of follistatin. These high voltages proved impractical for use within the human heart due to their high risk propensity to potentially cause arrthymias. This created the need to discover a lower safer voltage signal that could be used in human hearts that led to this new provisional patent application.
Howard Leonhardt co-inventor of this device previously patented an electrical stimulation device for recruiting stem cells to damaged organs including the heart by causing the release of SDF-1 stromal derived factor-1 on demand working in collaboration with Dr. Juan Chachques of Paris - http://www.google.com/patents/US20050171578. This issued U.S. patent has a separate claim for controlling the differentiation of pluripotent stem cells , recruited or injected from sources of bone marrow, fat and circulating blood, to contractile muscle in the depth of myocardial scar tissue. The stimulation voltages of this Leonhardt Chachques patented device range from 1 mV to about 40 mV in line with natural voltages sent by the brain to tissues to stimulate protein releases for repair and regeneration naturally. In line with the natural signals utilized to form heart tissue during fetal development. In total Howard Leonhardt co-inventor of this provisional patent has over 21 issued U.S. patents related to treating heart and cardiovascular disease with over 100 individual patent claims with dozens more pending or in process - http://patents.justia.com/inventor/howard-j-leonhardt
Howard Leonhardt presented earlier this month their team's 27 Year Experience with Stem Cell Therapies for Organ Regeneration and highlighted some of the spin out startup techonlogy platforms that have emerged from the original work on heart regeneration which are now also incubating in the Cal-X Stars Business Accelerator and Leonhardt's Launchpads - http://mysocialgoodnews.com/howard-leonhardt-to-present-27-years-of-experience-with-stem-cell-therapies-at-academy-of-regenerative-practices-winter-conference-and-scientific-seminar/
About BioLeonhardt MyoStim:
BioLeonhardt MyoStim is a developer of products for heart and limb regeneration. Its flagship product for heart regeneration utilizes a micro voltage signal generator the size of a quarter implanted in the abdomen of a patient coupled with a re-fillable micro pump. The regeneration stimulator is programmed to cause stimulated tissues to release on demand control SDF-1 (a stem cell homing signal), VEGF (a blood vessel growth protein), HGF (an arrhythmia inhibitor), Follistatin (a muscle repair and formation promotor), VEGF microRNA PI3K/Ak activity enhancer for cardiac stem cell migration, Tropinelastin (improves elasticity of tissues). The micropump is re-filled at least once a week with MicroRNAs, nutrient hydrogel, adipose derived cells including endothelial progenitor cells, muscle stem cells, follistatin, pyruvate, tropinelastin, cardiac matrix and a cardiomyogenic and angiogenic cocktail of additional growth factors. The pump+stimulator combination is designed to totally regenerate a failing heart over a 36 month course of treatment. A similar combination product is used for limb salvage. BioLeonhardt MyoStim legally operates now during its formative development stage as a technology platform license unit (startup) of Leonhardt Vineyards LLC DBA Leonhardt Ventures operating within the Cal-X Stars Business Accelerator, Inc. and will soon be spun out as a stand alone C corporation when its own financial standing is secure enough. All capital for BioLeonhardt MyoStim (a high risk early stage startup) is raised only through Cal-X Stars Business Accelerator, Inc via 506D Part C - SEE RISK FACTORS HERE > http://calxstars.com/investor-relations/ limited to accredited and sophisticated investors only or Leonhardt Ventures's own internal funds at this time. Leonhardt Ventures' Cal-X Stars Business Accelerator is led by over 70 business mentors and team members with substantial industry experience - http://calxstars.com/team-cal-x/ and over 35 scientists and clinicians on our Scientific Advisory Board - http://calxstars.com/scientific-advisory-board/
Contact: BioLeonhardt MyoStim a Cal-X Stars Business Accelerator, Inc. Startup Technology Platform - Media Relations Brian Hardy @ firstname.lastname@example.org or Howard Leonhardt @ email@example.com. Web Sites: www.bioleonhardt.com, www.myostimpacers.com, www.calxstars.com, www.leonhardtventures.com
About Leonhardt Ventures: Since 1982 Howard Leonhardt (later registered as Leonhardt Vineyards LLC DBA Leonhardt Ventures 2005) www.leonhardtventures.com has led the development and marketing of devices and biologics for treating cardiovascular and heart disease. In the 1980s they developed leadership in patented cardiovascular compliant balloon catheters, in the 1990's stent grafts and percutaneous heart valves, in the 2000's stem cell compositions for heart muscle repair and 2010's electrical stimulation regenerative devices - http://www.leonhardtventures.com/about-us.php Leonhardt Ventures owns 50.1% of Cal-X Stars Business Accelerator, Inc. formed in 2012 and incorporated in California in 2013 a 5 year business and innovation accelerator for regenerative medtech and regenerative ecnonomy startups www.calxstars.com The above mentioned startups are all startup technology platforms at this time within the accelerator transitioning over 5 years from early stage concepts into full fledged stand alone companies. Cal-X Stars also helps operate Leonhardt's Launchpads www.leonhardtslaunchpads.com, LABioHub www.labiohub.org, Startup California http://startupcalifornia.org, Cal-X Crowdfund Connect www.calxcrowdfund.com and Cal-Xelerator www.calxelerator.com all focused on launching early stage startups.
This provisional patent application was filed electronically utilizing www.legalzoom.com software.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These statements may be identified by words such as "estimates," "anticipates," "projects," "plans," "proposes" or "planned," "seeks," "may," "will," "expects," "intends," "believes," "should," "would," "could" and similar expressions or the negative versions thereof and which also may be identified by their context, such as references to "products under development". All statements that address operating performance or events or developments that Cal-X Stars Business Accelerator, Inc. or any of its incubating startups such as BioLeonhardt MyoStim expects or anticipates will occur in the future are forward-looking statements. While management has based any forward looking statements included in this release on its current expectations, we operate in a complex and changing domestic and international competitive environment where new and unanticipated risks may arise, and consequently the information on which such expectations were based, such as expectations of distributor product placements and sales, timing of planned and anticipated product deliveries or product introductions, may change. Forward-looking statements involve inherent very high risks and multiple uncertainties which could cause actual results to differ materially from those in the forward-looking statements as a result of various factors, including those risks and uncertainties described in the Risk Factors and in Management's Discussion of the Company's filed Private Placement Memorandum. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. The information shared communicates our intent of direction but does not imply in any form that any required agreements, patents are locked secure in place. All our incubating startups are under funded and under staffed and we are bootstrapping to make progress with limited resources. We are at even greater risk due to our business plan of bringing multiple statups forward simulateneously with a small core staff spread thin. Cal-X Stars Business Accelerator, Inc. incubates early stage startups and technology platforms focused on regenerative medtech and regenerative economy innovations. By nature these early stage startups are high risk investments compounded in risk by requiring many years to get to market through clinical trials and multiple collaborative agreements which are not yet secured. This investment is only suitable to sophisticated and accredited investors prepared to lose all of their investment understanding clearly the very high risk.
• The securities may be sold only to accredited investors, which for natural
persons, are investors who meet certain minimum annual income or net worth
thresholds; > $200K individual income or $300K joint. > $1 million in assets excluding primary residence.
• The securities are being offered in reliance on an exemption from the
registration requirements of the Securities Act and are not required to comply
with specific disclosure requirements that apply to registration under the
• The Commission has not passed upon the merits of or given its approval to the
securities, the terms of the offering, or the accuracy or completeness of any
• The securities are subject to legal restrictions on transfer and resale and
investors should not assume they will be able to resell their securities; and
• Investing in securities involves substantial high risk, and investors should be able to bear the
loss of their investment