REPLICATE® System | Overview

Until now, patients only had the following options when their dentist determined that a diseased or damaged tooth needed to be completely removed:

• A dental bridge
  In order to affix the dental bridge, healthy or previously intact dental crowns from adjacent teeth are ground down into the shape of a post in order to provide support for the dental bridge 

• A screw implant
  Three months post extraction, after the wound has healed, the implant dentist must cut a flap in the gum tissue to expose the bone, drill a hole into the patient's jaw, and screw in a conventional dental implant. Three months after that has healed, another flap is cut and the abutment, the portion that holds the final crown, is attached to the screw.

Patients want an easier, quicker, and gentler option for treatment. Dentists want to offer a qualitatively superior form of treatment, avoid unnecessary expenses and reduce the time and cost of additional procedures.

In order to meet this demand, NDI AG developed the REPLICATE System. For more than four years now, the technology has been successfully used in Europe and in the U.S. patient study.

With the REPLICATE System, the natural tooth's root is copied by means of a 3D X-ray. The anatomically shaped REPLICATE Tooth is then manufactured using titanium and ceramic. Unlike conventional treatment methods, the REPLICATE System allows the new tooth to be directly implanted upon the removal of the damaged tooth without drilling.

Worldwide, the REPLICATE System is the only one of its kind on the market. Through a variety of patents and patent applications in the United States and Europe, NDI AG has created high barriers of entry for imitators and competitors.

Over the last few years, the system has been proven in multiple patient care scenarios, meeting expected success rates and result outcomes as detailed in the goals of the clinical study. 

In Berlin, a comprehensive, certified production line has been set up. The certification authorized NDI AG to distribute the REPLICATE System in all EU member states.

Currently, NDI AG is focusing on getting FDA approval for the REPLICATE System and preparing a sales strategy for the United States, the world's most attractive market for dentistry. At the moment, the NDI AG is negotiating a contract, which could amount to more than €15,000,000 in revenue per year. The prospective customer is a chain of dental offices with more than 300 dentists in the United States.

The company’s success to date has motivated the lead investor, GUB, to invest another €1,000,000 in NDI AG in the current round of co-financing.

The Companists are investing together with an experienced, professional investor who's been active in this market for many years. The goal here is to push the total investment sum to €3,500,000.

NDI AG's goal is an exit either through a company sale or an IPO.

NDI AG’s REPLICATE Tooth is made using 3D X-ray images of the patient's jaw. This X-ray makes it possible to copy the shape of the root and create a customized REPLICATE Tooth that can be placed immediately after the extraction of the damaged tooth. 

The REPLICATE Tooth is designed to the dentist’s specification and the patient’s unique anatomy. It is manufactured and delivered to the dental office prior to the removal of the damaged tooth.

The REPLICATE System combines the natural tooth shape with proven materials, titanium and zirconia. This means that it offers a unique alternative to conventional screw-type implants and dental bridges.

The replacement of the anatomical shape of the natural tooth guides the design of each component of the REPLICATE Tooth. The titanium portion that connects to the bone and the dental ceramic portion that touches the gum tissue offer an anatomically advantageous fit, appearance, and proportion. After extraction, the entire cross-section of the tooth socket is filled with the REPLICATE Tooth A temporary crown, which acts as a protective cover during the healing process. This ensures that the REPLICATE Tooth is not overloaded while it heals.

A 3D X-ray and a dental impression are required for production. The dentist transfers the impression and digital data with a lab form containing patient-specific instructions to NDI AG. NDI AG creates an initial design and reviews it with the dentist, making changes if needed. After the design is approved, NDI AG produces the REPLICATE Tooth using clinically proven dental and implant materials. The entire process of manufacturing a REPLICATE Tooth, including design, takes approximately 8 to 10 working days.

NDI AG delivers the REPLICATE Systems components in sterilized packaging so they can be placed immediately following the extraction.

After removing the damaged tooth, the REPLICATE Tooth is inserted during the same appointment and a temporary protective bridge is affixed to the adjacent teeth. After bone integration, approximately four to six months, the temporary bridge is removed and a final crown is placed.

NDI AG manufactures the REPLICATE System in Berlin, Germany.

The REPLICATE System offers patients and dentists the following advantages:

• Treatment is simpler, which means the training requirements for the dentist are reduced. Patients in need of dental implants will no longer have to be referred to a specialists or surgeon. In most cases, their regular dentist can perform the procedure.
• Dentists don't need to purchase any special tools, equipment, software or implant kits, leading to significant economic savings.
• Treatment is quicker. When the REPLICATE System is used, patients are able to leave the practice on the day of the extraction with a new, specially designed and fitted tooth. Additional appointments related to implant placement, gingival formers and placing abutments are unnecessary.
• The treatment is easier and gentler. There is no drilling. For this reason, it is frequently less painful.
• The procedure takes less time.
• The titanium root is joined with the ceramic portion through a soldering process, which leaves the unit free of any gaps that could collect bacteria, a common problem with traditional screw-type implants.
• The REPLICATE Tooth's natural shape distributes chewing forces more evenly.

The REPLICATE tooth's natural shape allows the patient's jaw to absorb wear from use more easily.

NDI AG positions the REPLICATE System as an alternative to conventional bridge restorations and single tooth implants.

Customizing industrial grade dental products on demand, and in a timely fashion, is challenging. NDI AG operates a modern production line in Berlin. Through industry automation and state-of-the-art software, it’s possible to produce a fully customized REPLICATE Tooth with a gross margin of more than 70%.

NDI AG can already deliver commercial products to the countries in the EU. In addition, many countries worldwide accept the quality management and approval tests that are standard across the EU.

Growing acceptance among dentists and implantologists is crucial for success. The dentist diagnoses and advises the patient about treatment options. NDI has focused its marketing efforts on collaborating with renowned experts and opinion leaders to speak at conferences, publishing study results in peer-reviewed journals, participating in dental congresses, and getting articles and case studies in trade journals.

The company distributes the REPLICATE System directly to dentists, specialists and dental centers in key markets, as well as through sales partners in the other markets, such as Asia.

Markets where dental health and dental aesthetics have a high priority are the main focus. Markets with predominantly self-paying patients in the high-end quality sector determine the demand and, of course, are also a top priority. For this reason, NDI AG is focusing first and foremost on gaining market approval for the REPLICATE System in the US.

The REPLICATE System enables the dentist to replace a damaged teeth in-office without referring the patient out to a specialist. This is especially attractive in the USA, where currently only 10% of general dentists place dental implants. Few dentists place traditional implants because of the inherent risk in drilling to place a screw-type implant.

Advantages compared to conventional treatment methods:

The patents that have already been granted and the pending patent applications will make it extremely difficult for competitors to imitate the REPLICATE System.

NDI has distribution or is currently negotiating distribution contracts in Poland, Hong Kong, Thailand, and Great Britain.

The company has coordinated the approval procedure with the American regulatory body, the FDA. In the fourth quarter of 2017, study data will be submitted with the company’s application for regulatory approval. The company plans to enter the American market during the first or second quarter of 2018.

NDI AG is negotiating its first large contact, which could amount to more than €15,000,000 in revenue per year. The customer is a chain of dental care offices with more than 300 dentists in the United States.

NDI AG’s goal is to sell the REPLICATE System to the over 196,000 practicing general dentists within the United States.

The United States is the world's largest single market for dentistry. Every year, 108 million teeth are removed in the world's industrialized countries. The United States alone sees 35 million extractions.  Of these 108 million, 16.7 million extractions are treated with bridges or screw-type implants each year; in the United States, this figure is 5.5 million (source: Technavio, IBIS, AAID). A 2% market share would result in revenue of over €300,000,000.

A recent marketing research study showed that patients in the United States are more interested in the REPLICATE System as a method of tooth replacement than the conventional options.

Various factors make the United States the most attractive market opportunity for NDI AG:

• Half the dental procedures in the world are performed in the USA.
• It is the world’s largest retail dental market.
• German technology is held in very high regard there.
• New technology and start-ups are not viewed critically or with hesitation. 
• Insurance companies do not dictate procedures or approve products.
• Dental health and dental aesthetics are a high priority.
• 196,000 general dentists compete for patients who want cosmetic care.

The field of dental care has not been known for major jumps in innovation over the last few decades. However, there is an excellent example of a technology-based start-up as a benchmark:

Align Technology (NASDAQ: ALGN)  with its patient-customized orthodontic product, Invisalign. Align Technology achieved a market share of more than 10% of orthodontic treatments in the US within 10 years. Align Technology is now listed on the NASDAQ stock exchange with a market capitalization more than 13 billion US dollars.

Current status

NDI AG was initially founded in 2006 as a limited liability holding company. This company was created by inventor Rüdger Rubbert's to hold several patent applications. NDI converted to an AG in January of 2009 and remains in this form today. The operating business launched in 2009 and received its first funding from outside investors at the end of 2010. The company now has 14 staff members.

The €14 million raised so far has allowed NDI AG to reach the following milestones:

• Commercializing the REPLICATE System.
• Completing several patient studies which were reviewed and approved by ethics committees in Germany and the USA.
• Validating the REPLICATE System in clinical practice for over four years
• Building a state-of-the-art, computer-aided design and manufacturing technologies in its plant in Berlin, Germany.
• Gaining patent protection for key features of the REPLICATE System, its design, and manufacturing methods.
• Building an outstanding reputation among international dental professionals for the REPLICATE System and NDI AG.
• Establishing the necessary sales systems in Europe and defining them for the United States market.

Upcoming Milestones

• Regulatory approval in the USA targeted for completion in the next 8-12 months.
• Completion of negotiations of the first major contract in the USA with a potential volume of more than €15 million per year.

Companisto investment level 1: €100,000

• Relocation and expansion of the Berlin plant to efficiently meet increased demand
• Registration of the REPLICATE System for approval in the USA with the competent authority, the FDA
• Preparation of follow-up financing

Companisto investment level 2: €500,000

• Hiring of additional production staff at the Berlin plant
• Renting new premises in the USA for sales and customer support, with the prerequisite of being able to expand for future production

Companisto investment level 3: €1,000,000

• Preparation of the launch in the USA
• Recruitment and training of employees for customer care in the USA

Companisto investment level 4: €1,750,000

• Hiring employees to support distribution in the USA
• Preparation of follow-up financing

Companisto investment level 5: €2.500.000

• Expanding infrastructure and purchasing original equipment to start production in the USA
• Foreseeable - preparations for going public on the Euronext stock exchange

The two founders, Rüdger Rubbert (German mechanical engineer, inventor and experienced CEO) and Lea A. Ellermeier (US marketing and sales executive and experienced CEO) have already established several successful technology companies and have more than 20 years of experience in introducing disruptive technologies in healthcare. The last US start-up they founded, Lingualcare Inc., was sold to 3M Company (NYSE:MMM) in 2007.

The founders and employees have invested more than €600,000 in NDI AG. German and US business angels and VC companies are involved with €12.5 million together. Institutional investors which include HTGF, BB Biotech Ventures, GUB and IBB Beteiligungsgesellschaft have invested €7.7 million. The Investitionsbank Berlin contributed to the financing of business development with a loan of €890,000 under the ProFIT program.

Founder and Management (f.l.t.r. Dr. Ernst-Ulrich Berndt, PD Dr. Ulrich Matern, Rüdger Rubbert, Lea Ellermeier, Ingo Fritz)

Natural Dental Implants AG
Edisonstraße 63
12459 Berlin, Germany

Phone: +49 30 40 369 55-0
Email: info@replicatetooth.com
Web: www.replicatetooth.com