OrthodontiCell has developed an orthodontic auxiliary bioelectric device used in conjunction with braces or aligners to straighten teeth that considerably reduces the time needed to complete orthodontic treatment. This device uses bioelectric signaling sequences to precisely control selected protein expressions within the underlying bone and tissues surrounding the teeth’s roots. Specifically, these electric signals affect both RANKL (receptor activator of NF-κB ligand) and OPG (osteoprotegerin), the two principal proteins that regulate bone modeling and remodeling. This technology has extensive patent protection. Early results suggest that the time required to achieve desired straightening could be reduced by as much as 2/3rds.The team also has patented technology designed to freeze the position of teeth after straightening and keep them straight with minimal or no use of retainers. After completing and publishing successful animal study results with its first generation product and completing animal studies at the University of Utah for its 2nd generation product the team began enrolling in a first in human clinical study earlier this summer. The team was able to briefly review interim results from the investigators last week and has reported that they are on track so far to meet the clinical end point goals of the study. The full study results will be available this Fall.
In July the team received a Notice of Allowance from the U.S. Patent Office granting its claims for precise bioelectric stimulation control of the release of RANKL protein for accelerated tooth movement and OPG for teeth position stabilization. OrthodontiCell is one of the companies in Leonhardt’s Launchpads, an innovation and startup accelerator with a business model that involves selling its startup companies to strategic buyers soon after successful human experience. OrthodontiCell is in active discussions with a half dozen prospective strategic partners/buyers at this time. The team is in the process of selecting an advisory firm to manage a sale process scheduled for later this year or early 2020.
● RANKL based tooth movement acceleration is already proven in a number studies – Numerous studies have proven the ability of RANKL to reliably and consistently accelerate tooth movement. What is new here is instead of making dozens of needle injections of RANKL per week this technology releases the same volume of RANKL via bioelectric stimulation for a short 20 minute duration twice a week with much less pain and cost. RANKL injections were projected to cost $1000 per vial or $2000 per week for 6 months or over $56,000 per patient for the course of treatment. The needle injections cause inflammation and pain which interfere with results. The bioelectric treatment is expected to cost under $560 for 6 months, 100X less.
● OPG is proven to stabilize teeth positions – Numerous studies have documented the ability of OPG to stabilize tooth positions. What is new here is OPG release via bioelectric stimulation over the course of a few weekly sessions.
● FDA pathway clear on 510K – The OrthodontiCell team has made a pre-submission with the FDA and has an in-person meeting scheduled for October 8th, 2019. OthodontiCell believes it will have sufficient safety and efficacy data to support a full 510K market clearance by the end of this year.
Senior Management
Howard J. Leonhardt
Executive Chairman & CEO
30 years Medical Device experience, 23 issued patents, multiple exits
howard@leonhardtventures.com
Dr. John Marchetto
President and Chief Orthodontic Officer
30+ years experience as orthodontist and developer of the OrthodontiCell concept
Dr. Leslie Miller
Chief Medical Officer
40 years experience, author 241 publications, leader 80+ clinical trials
Peak Valuation Comparables
Align Technology = $31 billion
Smile Direct = $3.2 billion
Capital Raise Details
Total Authorized Shares: 5,000,000
Price Per Share: $12
Fully Diluted Valuation: $60 mil.
Raising: $250,000
Target Exit Valuation Milestone Deal: $900 million over time
Target ROI for this Round of Investors: 15X
Upcoming Milestones
● Launch of a second Human Clinical Trial using the bioelectric mouthpiece during aligner only treatment – August 2019
● Final data from first in Human Clinical Trial using the bioelectric mouthpiece during braces and wire only treatment – Late September 2019
● Launch of OPG teeth position stabilization study – September 2019
● Pre-Submission Meeting with FDA – October 8th 2019
● Meetings with orthodontic opinion leaders to gain endorsements – October 2019
● Advisory firm to lead a sell assignment to strategic buyers/partners – November 2019
● 2nd generation mouthpiece developed – February 2020
● Projected FDA 510K Market Clearance – March 2020