Local dental innovation biotech business Stem Cell Implants Inc. has launched its seed round after completing a private round of pre-seed investment. The downtown startup hopes to revolutionize the way dental implants are made by using advancements in stem cell technology.
“I am excited to bring the new frontier of regenerative medicine to the dental industry,” said Dr. Allan Dovigi, DDS, MS, CEO and Cofounder of Stem Cell Implants.
Dr. Dovigi explained how his stem cell-based products can be custom-made from a single hair follicle, unlike most current products that often require donor sites or synthetic materials. The company shared that it already secured IP for what it calls a Pre-Osseointegrated Implant.
“[It’s] a multi-layer dental implant device comprised of a dental implant, a matrix coating on a surface of the implant, and a plurality of stem cells seeded on the matrix coating,” Dovigi said. “The stem cells are differentiated to form a bone matrix that osseointegrates (bone grows to the implant) with the implant surface in vitro (in a lab). This pre-osseointegration of the implant in vitro is a novel aspect of the method, allowing for a faster and more controlled process compared to traditional in vivo (in a living human) osseointegration…As a cell-based product, it requires clinical studies for full FDA approval, which can take from 3-5 years.”
Stem Cell Implants believes the tech will offer three key benefits. To start, the company says its method delivers unlimited amounts of bone and soft tissue that can be custom-made and formed in vitro for grafting. Secondly, there’s reportedly no risk of immune rejection or disease transmission. Thirdly, they say it offers quicker, more predictable stem cell-based healing.
Currently, the company’s minimally viable product is a stem cell-derived bone graft.
“We grow bone in vitro using stem cells and market it to the dental and orthopedic industries as a unique allograft (tissue from a donor),” Dovigi said. Stem Cell Implants hopes to fast-track production using 510(k) device approval from the FDA, which demonstrates that the tech is safe and effective and substantially equivalent to another device on the market. “It will reach the market faster as a 510(k) product, ideally within 12 months.”
The company’s current valuation remains undisclosed. “Right now, we can only share that we have $50,000 of funding and IP in place. We’re soliciting angel investors NuFund and Eli Lilly, among others, and our valuation is pending these negotiations. We plan to request a 409A valuation (the fair market value of the common stock of a private company as valued by a third-party appraiser) in mid-January, at which time we can share the fair market par value of our stock,” he added.
Dovigi graduated from the University of Toronto with his DDS and practiced general dentistry for nearly two decades in Canada. He completed his residency in Oral and Maxillofacial Pathology at the University of North Carolina before launching a biopsy service in Arizona, which grew to service California. He also taught as a full-time faculty member at Midwestern University’s College of Dental Medicine. Dr. Dovigi eventually merged his biopsy business with San Diego’s Oral Pathology Diagnostic Services, which was later sold.
He then joined Stemson Therapeutics as the Director of Histology and Pathology, before launching Stem Cell Implants in September of 2023 with his son, Marcus Dovigi, Cofounder and COO.
“The opportunity to harness my operations background to help bring stem cell therapy to the public is a dream come true. I’m excited to be part of the thriving and dynamic biotech industry,” said Marcus who managed a pathology lab for years.
“We’ve worked together before, having grown and sold a commercial pathology lab here in San Diego in the mid-2010s. We trust each other and work well together,” his father added. “Most importantly, our skillsets are complementary: [I’m] an experienced scientist while Marcus is innovative and business-focused, currently pursuing an MBA.”
Within five years, they hope to have established their stem cell-derived bone allograft product as a new standard in the market.
“We have friends and colleagues in Europe and [Key Opinion Leaders] across the globe to coordinate a worldwide market launch. We also plan to have ongoing phase 1 clinical trials for other autologous (from the same individual) stem cell-derived products (exact product pipeline to be determined). Our mission is to be a leader in the new frontier of stem cell regenerative medicine,” Dovigi said.
Stem Cell Implants
FOUNDED: September 2023
COFOUNDER & CEO: Dr. Allan Dovigi, DDS, MS
NOTABLE: CEO & Cofounder Dr. Dr. Allan Dovigi, DDS, MS has been at the forefront of the dental biotech industry ever since attending a groundbreaking osteointegration (connecting bone to implant) seminar in Canada more than 40 years ago.