Stem Cell Implants Inc.

Executive Summary: Stem Cell Implants Inc. aims to introduce the power of stem cell biotechnology to the dental and orthopedic markets.

Summary and Purpose: The bone grafts and substitutes industry rests on mature technologies that have experienced incremental improvements over the past few decades. The recent advent of induced pluripotent stem cells presents a singular opportunity to advance the industry through an autologous approach to bone regeneration. Our unique products are poised to transform dentistry and orthopedics.

Problem: Bone grafts are used for many applications. For example, dental implants require sufficient bone for support and proper integration into the patient’s jaw. Bone loss limits the ability to place an implant and its subsequent functionality, and 50-70% of dental implant procedures require bone grafts. Unfortunately, the jawbone has a natural tendency to rapidly lose shape and volume after tooth loss. Despite advances in surgical materials and techniques, complete and predictable regeneration of bone remains a challenge. Current approaches—primarily autografts and allografts—have considerable drawbacks. The drawbacks of autografts include the need for two surgical procedures, limited amounts of tissue, and donor site morbidities; drawbacks of allografts include the risk of disease transmission, poor quality and consistency from lot to lot, and supply shortages. A single ideal synthetic bone graft substitute has not been developed.

Solution: The recent advent of induced pluripotent stems cells in the field of regenerative medicine offers a singular opportunity to solve the problem of inadequate bone graft materials. The literature demonstrates that bone can be grown in vitro and successfully transplanted into a human recipient. Our minimally viable product is artificial bone engineered in a lab using allogenic (donor) stem cell lines. Stem cells offer a potentially unlimited supply of bone. The biotechnology has matured enough for large-scale manufacturing at competitive prices.

Minimally Viable Product: Our minimally viable product is a highly differentiated allogenic stem cell-derived bone graft. It is considered a Class II medical device requiring 510(k) FDA clearance. The unique selling proposition is superiority to autografts and allografts due to the power of stem cells. Human stem cells can be combined with synthetic materials to grow bone in vitro. The artificial bone will be decellularized, sterilized, and packaged for sale direct to the provider. It will be mass produced at a GMP manufacturing facility for off-the-shelf distribution.

Customers:
1) Targeting by practitioner: In the USA, cadaver-derived allografts are currently used by over 10,000 dental specialists (OMFS, periodontists, and prosthodontists) and over 60,000 general dentists who place dental implants. All of these practitioners are part of the target market, with the following priorities: 
      a) Periodontists and prosthodontists. Active in implant surgical placement, while also functioning as KOLs for general dentists placing implants.
      b) General practitioners who make dental implants a significant portion of their practices. These would be identified by ABOI and ICOI Diplomate status.

2) Targeting by procedure:
     (a) Socket grafting;
     (b) Immediate placement after extraction;
     (c) Esthetically demanding procedures.

Team:
Allan Dovigi DDS MS, Co-Founder/CEO: 
     Clinician scientist with expertise in general dentistry, implant dentistry, and oral and maxillofacial pathology. Most recently served as director of pathology and histology at a biotech           startup developing stem cell therapies. Experienced entrepreneur with multiple successful exits.

Marcus Dovigi, Co-Founder/COO:
      Healthcare operations expert and experienced entrepreneur with multiple successful exits. MBA and PMP in progress.

Brent Vernon PhD, CSO:
      Member of the Biomedical Engineering Faculty at the School of Biological and Health Systems Engineering at Arizona State University. Pioneer researcher on the development of                  injectable, in-situ gelling biomaterials tailored for applications in drug delivery and endovascular embolization. 

Neil Park DMD MD, Board of Directors:
     VP of Clinical Affairs at Glidewell and key opinion leader in the dental implant industry. Senior corporate executive with broad based skills and experience sales and marketing.                         Has reviously developed and executed successful go-to-market strategies in dental implants. 

Kevin Buckley JD, Legal Counsel: 
     Founder of Torrey Pines Law Group, accomplished international patent attorney with over 25 years of experience in biopharma. Has advised numerous startups with respect to                       regulatory approval, direct-to-consumer sales, and commercial-stage marketing.