May 17, 2018
and Axolotl Biologix announced today a strategic partnership to explore therapeutic and commercial opportunities of combining Leonhardt's bioelectric stimulator + micro pump + mixed stem cell-based compositions for organ regeneration with the lineup of amniotic-derived fluid products.
A major hurdle for regenerating damaged organs is having nutrients in place for recruited and infused stem cells to survive, thrive, differentiate and form new healthy organ tissues. Amniotic-derived fluid contains a variety of growth factors and cytokines that are optimized in the most regenerative environment known – the womb. This environment supports and encourages repair and regeneration.
Through this partnership, Axolotl Biologix will have access to Leonhardt's extensive expertise and technologies related to organ regeneration, including over 19 patented or patent pending bioelectric signaling sequences, re-fillable micro infusion pumps and stem cell based mixed compositions. Leonhardt Ventures and the 24 organ specific startups in its Leonhardt's Launchpads innovation accelerator(s) in California and Utah will have access to Axolotl Biologix’s full lineup of amniotic-derived fluid technologies.
Phillip Larson, President of Axolotl Biologix, commented, “We are very excited to explore whether the combination of bioelectric stimulation and our amniotic-derived fluid products can improve upon results found with either therapy on its own. We believe that there is strong potential that there are synergistic benefits to this combination that will improve patient outcomes."
Howard Leonhardt, Executive Chairman & CEO of Leonhardt Ventures, commented, “We are thrilled to work with Axolotl Biologix to develop, study and potentially commercialize new combination bioelectric and biologic candidates for patients suffering from degenerative diseases. Axolotl Biologix's expertise and experience in manufacturing amniotic-derived products is hugely helpful to our organ specific startups in developing their product pipelines.”
Leonhardt's Launchpads, the innovation and startup accelerator arm, has 24 organ regeneration startups in its 2018 portfolio class focused in these sectors:
Leonhardt's Launchpads startups are working steadily towards goals of entering well controlled clinical trials for diabetic ulcers, dental, orthodontist tooth movement, skin, hair, and joint regeneration in 2018, and heart, breast, kidney, liver, pancreas, inflammation, bone healing and cancer in 2019 or 2020. Erectile dysfunction, bladder, eye, ear hearing, lung, tendons, and mucosa regeneration should follow in 2020 or 2021, with Whole Body Regeneration in 2022 or 2023. It is the intent that many of these trials will be launched first OUS and later in the USA. Numerous pre-clinical studies are in process now.
The issued and pending bioelectric stimulation IP estate covers controlled release from stimulated cells and tissues key proteins known through pre-clinical and some clinical studies to potentially aid in organ regeneration and healing, including SDF1, IGF1, HGF, EGF, PDGF, VEGF, eNOS, HIF1a, CXCL5, tropoelastin, follistatin, Activin A+B. Patented or patent pending bioelectric signaling sequences include stem cell homing, proliferation and differentiation control signals, as well as signals to read and manage inflammation. Since 2016 the research team has begun bioelectric scanning organs to customize bioelectric therapies real time.
Both Leonhardt’s Launchpads and Axolotl Biologix are committed to proving these candidate combination therapies through properly designed and well controlled clinical trials with good science applied. The Leonhardt research team completed cell sodding and seeding studies with stent grafts in the early 1990s. Research team members Dr. Race Kao and Dr. George Magovern Sr. published the first stem cell based heart regeneration pre-clinical study with large animals in 1989 in The Physiologist. Working with Dr. Shinichi Kanno, the team published the first bioelectric regeneration paper in Circulation the Journal of the American Heart Association in 1999. The Leonhardt team led the historic first percutaneous aortic aneurysm repair in Australia in 1995, and the landmark first muscle stem cell non-surgical heart regeneration procedure in 2001 in The Netherlands. Axolotl Biologix’s experienced research team members have been working on biologic based therapies since the early 1990s. This mutual experience has led to the development of combination therapy candidates designed for organ regeneration and healing.
About Axolotl Biologix:
Axolotl Biologix, Inc., is a developer of innovative regenerative human cell and tissue medical technologies that is disrupting traditional painful and expensive treatment regimens. The company is rapidly building a portfolio of unique patented regenerative treatment products to improve patients’ outcomes with less pain and lower costs. Founded in 2016, Axolotl Biologix already has three products in production. AxoBioFluid® C, a cryopreserved liquid allograft, AxoBioFluid® A, a room temperature liquid allograft, and AxoBioMembraneTM, an amniotic allograft membrane patch, are targeted to advancing tissue regeneration. For more information, please visit the company’s website at . Axolotl Biologix is headquartered in Phoenix, 1637 Knudsen Drive, Phoenix, AZ 85027.
About Leonhardt’s Launchpads:
Operated by Cal-X Stars Business Accelerator, Inc., Leonhardt’s Launchpads is the innovation and startup accelerator arm of Leonhardt Ventures and inventor Howard J. Leonhardt. The five-year accelerator is incubating 27 regenerative medtech and 3 regenerative economy startups and licensable technology platforms (LTPs). The accelerator has affiliated offices and labs in Playa Vista and Salt Lake City, Utah. Life science incubator/accelerator operations began in 2008 at the University of Northern California Science & Technology Innovation Center (UNC STIC) in Santa Rosa, California under Leonhardt Ventures (Leonhardt Vineyards LLC DBA Leonhardt Ventures founded in 2005). In 2013 the organization was incorporated and moved its headquarters to Los Angeles, California where its primary headquarters are now.
About Leonhardt’s Launchpads Utah, Inc.:
Founded in November 2015 in Salt Lake City, Utah, just off the campus of the University of Utah, is an organ regeneration focused innovation and startup accelerator. The company has lab space at the USTAR BioInnovations Gateway Utah facility at and employs 6 biomedical engineers and biologists at this time, a local CPA and patent attorney and has recruited a half dozen local Utah based advisors.
About Leonhardt Ventures (Leonhardt Vineyards LLC DBA Leonhardt Ventures):
Founded in 1982 as a sole proprietorship (HJ Leonhardt & Co.) is the patent holding vehicle and venture capital arm of inventor Howard J. Leonhardt (formed into Califiornia LLC in 2005). In the 1980’s Leonhardt patented and developed a market leading cardiovascular balloon catheter, in the 1990’s the leading stent graft system for endovascular aortic aneurysm repair and one of the first percutaneous heart valves and biological pacemakers. Since 2000 the focus has been on organ regeneration technologies with a combination of bioelectric signaling and repeat delivery of mixed stem cell + growth factor based compositions. More recently Leonhardt has added a strong estate of IP related to bioelectric cancer tumor treatment, real time inflammation and blood pressure management as well as a “brain saving helmet” designed for cerebral stroke and TBI patients. Leonhardt has over 21 issued U.S. Patents with over 100 issued patent claims and dozens more pending. Leonhardt inventions have been used to treat more than 400,000 patients to date.
See to links to previous news stories. Leonhardt’s Launchpads startups filed over 75 new U.S. patent claims in 2017.
Cautionary Note Regarding Forward-Looking Statements:
Statements in this press release regarding the efficacy, safety, and intended utilization of Leonhardt’s Launchpads product candidates; the conduct, size, timing and results of discovery efforts and clinical trials; scope, duration, validity and enforceability of intellectual property rights; plans regarding regulatory filings, future research and clinical trials; plans regarding current and future collaborative activities and the ownership of commercial rights; future royalty streams, and any other statements about Cal-X Stars Business Accelerator, Inc. DBA Leonhardt’s Launchpads, Leonhardt Vineyards LLC DBA Leonhardt Ventures, Leonhardt Ventures LLC or Leonhardt’s Launchpads Utah, Inc. management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact our business are set forth in our 506D part C Cal-X Stars Business Accelerator, Inc. private placement memorandum originally filed in 2013 and updated via our Annual Reports. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we assume no obligation to update these forward-looking statements. Patents pending mentioned may not be issued. Existing patent licenses may not remain in effect or may expire. The startups are under-funded and understaffed compared to comparable firms in the industry and may not have sufficient resources to bring mentioned products through first-in-man studies.
CAUTION: Combination therapy technologies mentioned above are very early stage un-proven developments where safety or efficacy have NOT yet been proven in statistically significant randomized double blinded controlled clinical trials. Sufficient testing to prove safety and efficacy may require many years to be completed.
Leonhardt Ventures – this site includes links to all portfolio startup individual web sites.
For Leonhardt's Launchpads
Brian Hardy, Director of Marketing
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Leonhardt's Launchpads by Cal-X Stars Business Accelerator, Inc, 12655 W Jefferson Blvd, Los Angeles, CA 90066
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