FIRST preventive, all advanced-ceramic (metal free) patient-centric, wordwide patented Medical Device solution to PERI-IMPLANTITIS &its general health pain beyond implant failure

About

Due to periodontal disease (bone loss around teeth), eventually, teeth are lost and replaced by implants, mainly Titanium alloys (86.2% of the market), which, though mechanically reliable, pose severe drawbacks: allergies, corrosion release of complex metal alloy particles, and accelerated PERIIMPLANTITIS requiring frequent, expensive, aggressive & painful mechanical treatments involving intense antibiotic use causing antibiotic resistance.

NACRE is a game changing solution for patients and dental clinics in the form of a revolutionary all-ceramic-composite dental implant system, made of patented materials, offering unique advantages: aesthetics, biocompatibility, versatility, periimplantitis prevention, personalized patient care and a biological seal using a patented Eco-bioglass thermal coating.

This Eco-Bioglass (G3) is a breakthrough substance which has obtained the SOLARIMPULSE Seal.

Tooth decay and periodontitis are the most prevalent bone-related and infectious pathologies, affecting half of the world’s population. The dental implants market size tops 4,500 M€, with an estimated CAGR of 5.5% for the next few years. Europe (40%) and America (34%) are the market leaders.

Traditional ceramic dental implants have failed to emerge for years, holding a market share of only 13.8%. Ceramics hold a clear aesthetic advantage over metals, but poor mechanical properties, complex clinical protocols, don't allow for inmediate load, use in aesthetic positions, aging performance, requiring multi-piece implants, cementation &veneering protesis.

Project IPR main features: A patented ceramic composite. Exclusive licence for (CSIC: ES2338740, US8546285, EP2460782, JP5543594) // A patented G3® bioglass material (EP 2510789) with antimicrobial properties that inhibit peri-implant failure – used for the coating.// Implant Design: World Intellectual Property Organization (WIPO) (application submitted on 16/07/2020, registry number: O-194-2020.

Key Benefits

Nanoker is a Spanish SME created in 2011 that specializes in advanced ceramic solutions for cutting-edge industrial and biomedical applications.

At present, the company has 22 employees, a turnover of 2.5 Million EUR, an EBITDA of 1 Million EUR, and is owned exclusively by individuals (founders and management) who share the belief of focusing the company’s growth strategy on bringing material-science based solutions to the wider market. In this endeavor, the dental implants market was identified back in 2016 as the one where we could make the deepest impact.

We’ve gathered an experienced, motivated and multidisciplinary team of people who have worked together for many years now, combining the necessary skills to make this project succeed.

It's worth highlighting the entrepreneurial character and track record of the shareholders as well as the whole team’s ample experience in project coordination and dental and medical device development, validation & launch.

The main threat for oral health is periodontal disease, the most common inflammatory and infectious disease in the world, which affects at least 50% of adults. It consists of the accumulation of harmful bacteria around teeth – which can eventually lead to tooth-loss and other serious health issues.

Periodontal disease does not only affect the mouth. It can interact with the host’s immune system, leading to terrible consequences with already proven crossed and two way severity correlation to Alzheimer, Diabetes, Chronic Kidney Condition, heart and respiratory diseases, fetus malformations and even COVID lethality rate.

In this regard, the restorative solution offered over the past 40 years, Titanium implants, has only worsened things. Titanium alloys, once sandblasted and acid etched offer acceptable osseointegration but are a real magnet for bacterial biofilm and have obvious aesthetical drawbacks due to its color. So now, in addition to tooth loss, we have aggressive periimplantitis and implant loss. Titanium Alloys (normally with Aluminium and Vanadium) have a very negative lifecycle environmental footprint, are included in the EU CRM (Critical Raw Material List) and cannot be recovered nor reused (not even most of the waste during implant production).

The available “Solution to the Titanium Solution” is Removing biofilm deposits from teeth- or implant-roots, which is an absolute nightmare for patients, gravely affecting their economy and QoL. It implies frequently visiting the dentist and undergoing expensive and painful surgical operations, in which the soft tissues need to be lifted – for mechanical-scraping techniques and antibiotic intensive treatments to be applied –, while the problem remains unsolved.

This is the solution we propose: NACRE, a breakthrough enhancement to our already disruptive INPERIO all-ceramic dental implant system based on a globally-patented, ceramic-composite material of outstanding properties – which allow it to incorporate many disruptive design features. INPERIO is nearing its CE/MDR marking as a Class IIb Medical Device and shall hit the European market during 2022.

However, there is a specific feature that makes NACRE absolutely game-changing, and that is our bio glass coating, which is extremely stable (mechanically speaking), durable, metal free, ecofriendly, and after a controlled thermal treatment acquires bacteriostatic properties, representing the first and only real solution to prevent peri-implantitis (or harmful bacterial accumulation around implants).

However, this coating, according to the new European Medical Device Regulation, turns our solution into a Class III device, which implies many technical, time-related and economic burdens that exceed Nanoker’s organic financial capacity.

Indeed, we are set to disrupt the dental implants market, where traditional ceramics – due to their poor mechanical properties –have failed to deliver an alternative to Titanium, which translates into decades of no significant innovation and, thus, a huge concentration of the offer by the dominant players – while prices become more competitive and regulatory frameworks become more stringent.

This, of course, is bad news for the end-users: the patients, who are left with no alternative and continue to pay the long term toll in terms of both money and health.

We are going to initially focus our Project on Europe, since it is the biggest and fastest-growing geographic dental implants market. Besides, Europe is better set for disruption due to its higher ceramic-implant penetration and its important Premium Clinic Segment, whose practitioners are eager to differentiate themselves and truly satisfy their patients.

None of the 7 leading corporations - which represent over 80% of the world’s dental implant demand - is based in the EU.

The big players know what’s happening and have the tools and will to keep Tech disruption at bay. They don’t master technology and tend to believe in old solutions. Their strategy is based on aggressive marketing campaigns and diversification, instead of investing in improvement or in riskier and longer-term dental-technology endeavours.

Our goal is to give the power back to the patient, through our technology, which directly addresses their real problems. We intend to win their hearts and minds, as well as those of practitioners – who will thrive with change and alternative, providing market traction as main enablers for growth.

Our STRATEGY is based on three pillars:

1. SEGMENTATION: We will initially target the more sensitive and eager-for-differentiation PREMIUM CLINICS in the main EUROPEAN markets.

2. PATIENT PULL: We will address potential patients DIRECTLY, making them aware of the REAL COSTS of actual solutions and informing them of the ALTERNATIVE we offer.

3. PRODUCT PUSH: We will disseminate KNOWLEDGE by means of Key-Opinion-Leaders and other Indirect Actions, providing a tool to fight the VALUE/DISCOUNT trend.

Our PATIENT-CENTRIC market approach and ARCHITECTURE is built on the following:

• Setting up an automated and flexible SMART ceramic IMPLANTS FACTORY.
• Building a strong and prestigious BRAND.
• Deploying a NETWORK of “NACRE CENTERS”, to spread awareness, knowledge and attraction to patients and clinics.
• and, Establishing a community of NACRE-CERTIFIED CLINICS - EXCLUSIVE hubs to which the NACRE CENTERS will direct INFORMED PATIENTS.

We know that there is also a BLUE OCEAN waiting out there, populated by millions of patients suffering the pain of periimplantal disease and the burden of treatments that only delay its consequences. Through NACRE, we can ADDRESS and CURE this pain – even that of patients with implants already placed in their mouths.

In terms of MARKET TRACTION, we need to:

• Become a DIFFERENTIATION ENABLER for our customers, the Premium Segment Clinics, who will materialize the real VALUE of our solution, and
• DISRUPT THE MARKET, pivoting towards educated, DECISION-MAKING PATIENTS that want to MAKE THEIR OWN CHOICES.

By the end of 2027 we expect to hold a VERY SMALL, HOWEVER MEANINGFUL position in terms of Market Share, which implies that there will still be huge potential for additional growth.

Applications

-Dental Implants.
-Dental Prosthetic solutions.
-Dental Orthodontic devices.
-Other Medical Devices and biomaterials.
-Antimicrobial coatings.
-Antimicrobial substances and additives.

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