Irvine, CA and Boulder, CO – SkinStim and HairCell, two startups in the Leonhardt's Launchpads innovation and startup accelerator(s), announced today a working partnership with NULASTIN®, an anti-aging skincare and haircare company. Leonhardt's SkinStim and HairCell will be launching clinical trials that will utilize the NULASTIN® patented elastin-based serums and creams for patients enrolling in the SkinStim and HairCell clinical studies for skin and hair regeneration.
Both the SkinStim and HairCell products are combinational therapies utilizing bioelectric stimulation-controlled release of regenerative proteins + PRF + regenerative fluid (secretome and/or exosomes from MSCs) and fractional micro-needling. The patented and patent-pending bioelectric signaling sequences can control the release of klotho, COL17A1, sonic hedgehog, SDF, PDGF, and tropoelastin. According to previous stand-alone therapy studies, these proteins are beneficial in both skin and hair regeneration. Tropoelastin is a precursor of elastin production and a promotor of cross-linking with collagen. COL17A1 received strong attention last year as independent researchers in Japan published powerful results demonstrating it as the stem cell competition protein that promotes healthy skin and hair regeneration. Leonhardt's Launchpads has developed proprietary bioelectric signaling sequences that unlocks and releases all of these regeneration promoting proteins.
“On the heels of our successful pilot clinical studies for hair and skin regeneration in South Africa utilizing our combination bioelectric and biologics therapy, we are now moving into larger scale Phase II studies in Europe with more comprehensive follow-up. Phase II will include the utilization of high-end analyzers to assess efficacy more precisely and more accurately. We like that all our patients in these new studies will have the same consistent serum/cream supply and dosing with the excellent product developed by the NULASTIN® team,” stated Dr. Leslie Miller, Chief Medical Officer, HairCell, SkinStim, and Leonhardt's Launchpads.
NULASTIN’s Keracyte® Elastin Complex is a patented molecular delivery system. The proprietary formula of 600 amino acids helps guide Elastatropin® (the precursor to human elastin) to the skin's extracellular matrix. The formulations are a direct result from work with DARPA (Defense Advanced Research Projects Agency) for emerging technology methods of promoting wound healing for the military. “We are delighted to join forces with the SkinStim and HairCell teams to work on further improvements in skin and hair regeneration and to conduct carefully designed clinical studies to prove both safety and efficacy of this combination therapy," stated Leah Garcia, Founder, and CEO of NULASTIN®.
"Our science team with over 30 years’ experience in regenerative medicine strongly believes that the combination of bioelectric stimulation controlled regenerative protein release with topical and injectable biologics is likely to provide superior results to any stand-alone therapy being tested today for skin and hair regeneration. We look forward to sharing the results of these well-designed upcoming studies later this year or early next year," stated Dr. Robert Kellar, co-inventor of the NULASTIN® core technology and scientific advisor to both Leonhardt's Launchpads (SkinStim and HairCell) and NULASTIN®.
"On average, the separate components of our combination therapies including PRF, klotho, MSCs secretome, exosomes, fractional micro-needling, sonic hedgehog, PDGF, SDF1, and tropoelastin all achieved about 10 to 20% increase in hair density and 49% improvement in skin smoothness and wrinkle reduction when studied previously on a stand-alone basis. This combination therapy's target goals are to reach 30-50% hair density improvement and > 80% improvement in skin smoothness and wrinkle reduction. We are implementing well-controlled studies with top-end analytic tools to attempt to prove this out to even the staunchest skeptics. We look forward to sharing these results with you soon," stated Howard J. Leonhardt Executive Chairman and CEO of HairCell, SkinStim, and Leonhardt's Launchpads and co-inventor of the combination product.
About SkinStim:
SkinStim, founded in 2015, is a startup in the Leonhardt's Launchpads innovation and startup launch accelerator(s) focused on applying a combination of bioelectrics and biologics in skin regeneration.
About HairCell:
HairCell, founded in 2014, is a startup in the Leonhardt's Launchpads innovation and startup launch accelerator(s) focused on applying bioelectrics and biologics in hair regeneration.
About Leonhardt's Launchpads:
Leonhardt's Launchpads, founded in 2008, is the organ regeneration and healing focused innovation and startup launch accelerator arm of Leonhardt Ventures LLC (formerly HJ Leonhardt & Co.) founded in 1982. This accelerator focuses on applying a core IP of bioelectrics and biologics for organ regeneration and healing.
About NULASTIN®:
Headquartered in Boulder, Colorado, NULASTIN® was founded in January 2016. The amazing science behind NULASTIN® is the work of Dr. Burt Ensley (Protein Genomics, Inc), who holds a Ph.D. in Microbiology and served as a former director of Amgen's Specialty Chemicals Group. After successfully synthesizing the first elastin Elastatropin® protein of its kind, Dr. Ensley produced Keracyte® Elastin Complex, a key component in the company’s innovative, restorative skincare and haircare collections.
For more information on SkinStim, visit www.skin-stim.com
For more information on HairCell, visit www.haircellstim.com
For more information on Leonhardt's Launchpads, visit www.leonhardtventures.com + www.calxstars.com
For more information on NULASTIN®, visit https://nulastin.com
Contact: Brian Hardy, Director of Marketing
SkinStim www.skin-stim.com and HairCell www.haircellstim.com
TEAM
LEAH GARCIA
Founder and CEO of NULASTIN, Inc., a biotech company offering restorative personal care products direct-to-consumer that replenish the elastin, collagen and luster of the skin; stimulates growth + thickening of the eyelashes, eyebrows and hair. The only company, worldwide that delivers cruelty-free, bioavailable elastin to the matrix of the skin.
Leah is an award-winning infomercial host and television professional. In 1998, she founded NaturallyCaffeinated®, Inc., that manages on-air talent, entertainment and video production. She is the producer of LeahGarciaFitness®, on-demand workout videos, and has published two fitness books for Globe Pequot Press. She recently retired from CBS Sports as the sideline reporter for the Professional Bull Rider’s tour (PBR).
From 2003 to 2012, Leah was the product spokesperson for Slendertone®, Contour Core Sculpting System and Prizm Medical EMS Class II medical consumer devices. Leah was instrumental in achieving revenues of $220 million through assistance with product design, development, media, production, marketing and operations.
From 1992 to 1997, Leah raced mountain bikes professionally. She is the 1994 UCI Mountain Bike Hill-Climb World Champion; and a member of the United States National Team. Her titles include Basque National Champion (Spain) and North American Mountain Bike Champion.
Leah graduated on the Dean’s Honor List in the School of Communication Arts and Humanities from California State University, San Luis Obispo, California with a degree in Speech Communication, majoring in Public Relations and Marketing.
BURT D. ENSLEY, Ph.D.
Founder of NULASTIN®, Inc., serves as an advisor and formulator for the company. He is the Founder of Protein Genomics, Inc. and DermaPlus, Inc., Arizona-based biotechnology companies involved in wound healing, tissue regeneration, and skin care. His professional career began in 1981 when he was hired by Amgen, Inc., a start-up biotech firm in Thousand Oaks, Calif., that he helped become the largest such company in the world within 10 years. Amgen now has 40,000 employees and $12 billion in annual revenue.
In 1989, Dr. Ensley left Amgen to serve as director of advanced technologies for Envirogen, Inc. There, he led research and field demonstrations of biological and physical/chemical technologies for the treatment of hazardous wastes from the Company's inception until its Public offering in 1992. He then became a founder and the President, CEO, and Director of Phytotech, Inc., a biotechnology company using plants for the treatment of contaminated soil and water.
In 1999, Dr. Ensley founded Nucycle Therapy, Inc., a biotechnology company involved in discovering, developing, and commercializing unique nutritional supplements and high-value nutraceutical and therapeutic products from plants. He served as the Company's CEO from 1999 to 2001. The Company was able to scale-up the manufacture of 50 million doses of plant-based nutritional mineral supplements and was sold to Integrated Biopharma, a publicly-traded entity, in 2001.
Dr. Ensley was elected to Fellowship in the American Academy of Microbiology in recognition of his research accomplishments. His professional affiliations have included membership in the Board of Directors and Co-Chair of The BIO5 Institute at the University of Arizona; Board of Trustees at the Biotechnology Council of New Jersey; Board of Directors of the Natural History Museum at the University of Kansas; the American Association for the Advancement of Science; the American Society for Microbiology; service on the National Research Council Committee on Catalysis; and on the Biology Directorate Advisory Committee of the National Science Foundation. He is an Adjunct Professor at Northern Arizona University.
He holds his Ph.D. degree in microbiology from the University of Georgia (1979), his master's degree in biology from the University of New Mexico (1976), and bachelor's degree in biology from the University of New Mexico (1974).
Dr. Ensley has 30 publications in the peer-reviewed scientific literature and holds 20 issued and 2 pending US patents.
ROBERT S. KELLAR, Ph.D.
Chief Technology Officer for NULASTIN® and Chief Science Officer for Axolotl Biologix. He has over 19 years of experience in the development and regulatory approval of medical devices, cell-based products, and regenerative medicine and tissue-engineered technology. He has 35 peer-reviewed publications and 6 issued US patents. He received his PhD from the University of Arizona in 2001.
Dr. Kellar currently serves on the Scientific Advisory Board for Leonhardt's Launchpads innovation accelerator, and is on the Faculty in the Center for Bioengineering Innovation (CBI), Biological Sciences and Mechanical Engineering at Northern Arizona University. Dr. Kellar has helped to co-found a number of companies including Development Engineering Sciences, a biomedical consulting firm, Flagship Biosciences, a digital pathology company, and Autogenesis Corporation, a wound healing company. He serves as an Advisory Board Member for Protein Genomics, a protein polymer medical device company, BioLeonhardt, VascuStim, SkinSim, MyoStim ED and HairCell.
Dr. Kellar's previous roles include: VP of Research and Development at Histogen, Inc. in San Diego, CA, Product Specialist at W.L. Gore and Associates in Flagstaff, AZ, and Lead Scientist and Project Manager at Advanced Tissue Sciences, Inc. in La Jolla, CA..
HOWARD J. LEONHARDT
Founder, Executive Chairman, and CEO of Leonhardt's Launchpads, HairCell, and SkinStim. He is an inventor with over 25 issued patents for organ regeneration and recovery with hundreds of new claims pending with the USPTO https://patents.justia.com/inventor/howard-j-leonhardt. He is most well known for developing a leading cardiovascular balloon catheter, the PolyCath in the 1980s, the market-leading stent graft for aortic aneurysm repair without open surgery, The TALENT stent graft ($1 billion in annual sales), and one of the first biological pacemakers and percutaneous heart valves (TAVR) in the 1990s as well as leading the team that completed the first-ever stem cell repair of a human heart without surgery in 2001. He has founded over 40 startups with numerous exits and is the owner of Leonhardt Vineyards, a California producer of fine wines since 2000.
DR. LESLIE MILLER
Chief Medical Officer for Leonhardt's Launchpads, HairCell, and SkinStim. Dr. Miller is a board-certified cardiologist and one of the world's leading experts in developing and evaluating regenerative medicine therapies, especially for cardiovascular disease. He has been involved in over 100 clinical trials and has published more than 250 manuscripts. He was formerly Chairman of Cardiovascular Medicine at the University of Minnesota for over a decade. He is also a co-editor of one of the leading textbooks on Regenerative Medicine.
