OrthodontiCell Announces Notification of Patent Allowance USPTO Application 15/471,954 Related to Orthodontic Treatment
June 25th, 2019
Salt Lake City, Utah and Los Angeles, CA - June 25th, 2019 (PRDistribution) - OrthodontiCell, a biomed company focused on the development of therapeutics to accelerate tooth movement and improve stabilization, announced today that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for OrthodontiCell's U.S. Patent Application Serial Number15/471,954 "Orthodontic Treatment". This application includes claims intended to accelerate teeth straightening by up to 2/3rds compared to standard brace or aligner therapies alone and after teeth straightening to rapidly achieve stabilization of the teeth in their final positions with minimal use of retainers.
The claims in this allowed application cover a method to control the release of RANKL, SDF1, KLOTHO and VEGF proteins to accelerate tooth movement and the release of OPG to stabilize teeth positions after straightening. Claims also cover customized inflammation management.
"A number of studies have documented that injected RANKL can stimulate acceleration of teeth straightening by up to 2/3rds faster compared to standard braces or aligners alone. This patented technology is the first to control the same volume of RANKL delivery as used in these previous successful studies via bioelectric signaling sequences instead of costly, painful and inconvenient needle injections." stated Dr. John Marchetto, co-inventor, co-founder and President of OrthodontiCell, also a practicing Orthondontist with over 30 years experience.
"Delivery of this therapy conveniently by only wearing a comfortable bioelectric mouthpiece 7 to 20 minutes twice a week for only about 6 months makes it a far more desirable choice for patients than bi-weekly multiple needle injections at a clinic. The injections can cost more than $1000 a dose while the cost for this therapy is minimal." stated Dr. Leslie Miller, Chief Medical Officer.
OrthodontiCell has 37 patients enrolled in their new multiple bioelectric signaling sequence clinical study that began last spring in Brazil and expects to report followup data later this year. This new study includes bioelectric signaling sequences for controlling RANKL protein expression for the first time. This clinical study follows a previously published successful animal single signal (VEGF) study - https://www.ncbi.nlm.nih.gov/pubmed/26917494- published by the same investigational team lead by Dr. Mauro Santamaria Jr. and Dr. Milton Santamaria, Heminio Ometto University Center, Araras, Brazil and Division of Periodontics, College of Dentistry, State University of São Paulo, Brazil.
The bioelectric stimulator used in these studies already has FDA market clearance in the USA for improving blood circulation, mild pain relief and accelerated muscle healing. The team is gathering data in carefully controlled IRB approved studies with intent to file an application with the FDA in the near future requesting an expansion of the labelling indications of use. Warning - The device is not yet market cleared for accelerated tooth movement or stabilization.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2037.
This application is part of an expanding patent estate for Leonhardt's Launchpads organ regeneration and recovery portfolio with over 400 patent claims issued, pending, licensed or optioned to date.
"The industry leader in aligner treatment reached a valuation of greater than $31.5 billion last September. This made them the No. 1 performing stock on the S&P 500 last year with the market growing at almost 20% annually and is expected to soon surpass $4 billion annually. Utilizing our technology with their aligners will allow the treatment to be completed in at least half to one third the time. Up to 1/3rd of patients getting their teeth straightened end up reverting back to some crookedness after stopping treatment. Peer pressure to have straight teeth is growing. Studies show that people are viewed more successful when they have straight teeth. One study (Ref 1 below) showed that 2 of 5 single people would not date again someone they had a first date with that had crooked teeth. These trends of the "appearance generation" all point towards a large growing market opportunity for the OrthodontiCell product." stated Howard J. Leonhardt, co-inventor, co-founder, Executive Chairman & CEO.
"We believe our technology that is designed (pending confirmation in statistically significant studies) to reduce by 2/3ds the time to straighten teeth and to stabilize teeth positions after straightening, all potentially with less pain and inflammation, has a chance to lead the industry. In our laboratories we have documented in numerous studies our ability to increase the expression of the key proteins responsible for accelerated tooth movement, such as RANKL, and OPG for stabilization with precise bioelectric signaling sequences." stated Dr. Jorge Genovese, Vice President of Bioelectric Regeneration Research and co-inventor.
"Our team is committed to conducting double blinded, randomized, placebo controlled studies with statistical significance before making any marketing claims of safety of efficacy. The current study enrolling Brazil is just one first step in that direction with more studies planned. Before introducing into clinical studies new bioelectric signals we undertake significant pre-clinical lab and animal studies. To support the OrthodontiCell development we have conducted over 500 stimulation experiments in our Utah lab." stated Dr. Brett Burton Vice President of Research and Development
Reference (1) :
First Impressions Are Everything: New Study Confirms People with Straight Teeth are Perceived as More Successful, Smarter and Having More Dates
OrthodontiCell www.orthodonticell.com is a startup operating within the Leonhardt's Launchpads www.leonhardtventures.com innovation and startup accelerator labs and facilities in both Utah and California focused on applying bioelectrics and biologics to orthodontics. OrthondontiCell is a spin out of the DentaCell Accelerator www.dentacellaccelerator.com an innovation accelerator focused on applying bioelectrics and biologics in dentistry within the Leonhardt's Launchpads by Cal-x Stars Business Accelerator, Inc. parent accelerator.
About Leonhardt's Launchpads:
Leonhardt's Launchpads is the innovation and startup accelerator arm of Leonhardt Ventures (Leonhardt Vineyards LLC DBA Leonhardt Ventures) with research labs and offices in California and Utah. The Leonhardt team led the development of patented cardiovascular balloon catheters in the 1980's, stent grafts and percutaneous heart valves in the 1990s, and stem cell and bioelectric based organ regeneration technologies from 1999 forward. In 2001 the Leonhardt team led the first in man case of non-surgical stem cell based heart regeneration. Leonhardt's Launchpads has 30 startups in in 2019 portfolio class - https://leonhardtventures.com/development-pipeline/all focused on organ regeneration and recovery with these groups (1) Heart & Cardiovascular, (2) Brain, (3) Cosmetic & Personal Care, (4) Major Organ Regeneration and (5) Cancer. The team has over 400 patent claims issued, pending, optioned or licensed covering organ regeneration and recovery including customized inflammation management.
Warnings and Disclaimers: Patents pending may not be issued. Patents issued, licensed or optioned may not be maintained. Products are early stage in development and are not yet proven safe or effective. Company lacks sufficient resources to bring these products fully to commercialization. As an investment these early stage startups have to be regarded in the highest risk category for total loss. Forward looking statements are subject to change without notice. Any timelines, implied or quoted, are highly subject to change even by years.
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s 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, Leonhardt Vineyards LLC DBA Leonhardt Ventures, 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 Businesss 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.
CONTACT: Brian Hardy
Director of Marketing
OrothodontiCell a Leonhardt's Launchpads co.
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