MedTech Chats: MEGA BIOPHARMA Partners with NAMSA to De-Risk Disruptive Dental Technology

In NAMSA’s first edition of “MedTech Chats,” we sit down with MEGA BIOPHARMA’s Bone Division Director and Dental Surgeon, Dr. Laurent Helewa.

What follows is a discussion regarding the French company’s disruptive product, Bionacre®, a natural biomaterial extracted from nacre that has yielded scientifically proven results in the domains of bone and skin repair. We discover how a long-forgotten technology, Mother-of-Pearl, is now providing significant advantages for bone/tissue regeneration and positive impacts to the industries of Dental Surgery, Orthopedics, Dermo-Cosmetics, Dermatology and Veterinary Care.

Additionally, Dr. Laurent highlights how NAMSA’s APEX PROGRAM is serving a key role in helping MEGA BIOPHARMA effectively communicate with stakeholders, de-risk the program and set the stage for successful U.S. Food and Drug Administration (FDA) 510(k) regulatory submission and approval.

Focus On

NAMSA APEX Program: A program designed to accelerate great ideas into great medical products that advance healthcare today and into the future. The NAMSA APEX ProgramTM provides MedTech manufacturers of complex development programs with predictable, proven support and guidance across all phases of product development to deliver significant time and cost savings.

About MEGA BIOPHARMA

MEGA BIOPHARMA is a French player in marine biomaterials, a pioneer in the development of BIONacreR. This natural biomaterial extracted from nacre has yielded scientifically proven results in terms of the domains of bone and skin repair. The company aims to offer innovative therapy solutions in several fields: Dental Surgery, Orthopedics, Dermo-Cosmetics, Dermatology and Veterinary Care.

Can you tell us about yourself and your role at MEGA BIOPHARMA?

My name is Dr. Laurent Helewa and I am Dental Surgeon who elected to shift focus to the MedTech industry after practicing surgery for 10 years. I joined MEGA BIOPHARMA in 2020 to lead the organization’s Medical Device and Dental Business Units. Combining my expertise with founding various innovative medical device companies, familiarity with MEGA BIOPHARMA’s leadership and understanding of the immense market opportunity for the company’s technology, it was a perfect partnership.

In the Medical Device Industry, innovation tends to happen in one of two ways: 1) identifying an unmet clinical need and developing a technology to solve that problem; or 2) the ‘Technology Push’–a discovery or invention of a useful technology and then seeking a clinical application. Which of those two scenarios best describes MEGA BIOPHARMA?

MEGA BIOPHARMA is squarely in the ‘Technology Push’ category. Our medical device technology comes from Mother-of-Pearl (Nacre), the iridescent inside lining of mollusk shells. The medical potential of this material was discovered over 30 years ago by two Dental Surgeons, Dr. Serge and Dr. Georges Camprasse. They discovered that Mother-of-Pearl was better for bone and tissue regeneration than any other material available, could be implanted effectively, improve cicatrization and more. The doctors became enamored with this technology at a time when experimentation was freer and less regulated and worked on it for quite some time. They extracted the material by scraping the internal layer of shells of large pearl oysters. However, they were Dentists and had no experience as business entrepreneurs. Then, about 15 years ago, Joël Drai (Founder and Chairman of MEGA Dental —the leading distributor of dental equipment in France) identified the opportunity with Mother-of-Pearl technology and founded MEGA BIOPHARMA to bring this innovation to the global MedTech marketplace.

30 years is a long development period!

Three decades seems like a pretty long time, but time has been more than useful to show evidence of the remarkable properties of Mother-of- Pearl. Over the years, we’ve conducted much proof-of concept testing, countless experiments and in-vivo studies on animal and human models, resulting in many lessons learned.

Our team realized that the Incas and the ancient Chinese were already using Mother-of-Pearl for its tissue regeneration properties and health benefits. It was only through deep and extensive research that we understood that this technology had been well known throughout human history and was only rediscovered recently through science. It took our founders’ unique combination of dentistry knowledge and diving skills to see this. It took curious minds to recognize that a byproduct of the pearl industry, the interior of the Mother-of-Pearl shell, could serve many useful purposes and unmet MedTech needs.

Many innovations happen in this way. For example, Alexander Fleming who accidentally left culture plates to ferment discovered penicillin with his researcher’s eye, while others may have just thrown out the mold. You must be curious enough to see opportunities where others miss them. Nature’s biomimetic features give us many opportunities in the medical field—we just need to figure out how to exploit them.

Do you think we are now rediscovering the potential of nature for medical technology?

There’s a French expression, “Embrace too much, embrace badly,” meaning, we knew we had to prioritize where proof-of-concepts were the most promising—and, that was in bone regeneration. Throughout testing, our teams were able to reconstruct long bones, specifically 15cm of the femur. We also confirmed positive Osteoconductive and Osteomimetic performance, which is truly an incredible medical feat. Since our team works within the Dental Industry, we were very familiar with the market and had access to an established dental distribution network and dental KOLs. Thus, it was a natural fit to prioritize the Dental Market before pursuing other Orthopedic indications.

After you moved from the research phase to the commercialization phase, what were some of the decisions you made?

We have not yet reached the commercialization phase, but we have made important strategic decisions, including the choice to follow a vertical approach of ‘farm to the patient.’ MEGA BIOPHARMA has approved aquaculture sites in the Indian Ocean to operate farms where the oyster species we are interested in can be bred.

That’s unusual for a medical company to make their own raw materials.

Yes, but it allows us to manage the entire supply chain and production. Our teams have determined that we can be most efficient by controlling the development process in its entirety, which is particularly important considering our Class 3 Implantable Medical Devices have to comply with specific regulatory rules defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and/or CE-marks.

Certainly, that gives you the advantage of greater control, but can you tell us about the disadvantages?

We’re a relatively small company and since we have made the decision to keep control of most of our engineering and manufacturing endeavors, we bear most of the costs. We operate within a rather restrictive medical device regulatory environment, and considering we are planning to go to market with Class 3 Implantable Medical Devices of animal origin, we have checked all the boxes of difficulty!

But for us, it’s an investment. Credit goes to the management and the investors who trust that tomorrow there will be a better reward. By building our own production with all the complexity and costs incurred, we will have unique expertise of our patented technology—no equals, no copies. If you license a formula, you lose control of the design, development, conception, marketing and so on. In my experience, it’s not a linear curve in business. The further you go, the more value is created—it’s exponential.

Often, a challenge for start-up companies is balancing time, effort and costs throughout development. How do you manage this?

It’s important to understand when to turn to an experienced, knowledgeable development partner for guidance. For us, that trusted partner is NAMSA.

Before this project started, we had previously collaborated with NAMSA for projects related to support of the EU Medical Device Regulation (MDR). Based on our positive experience, we elected to engage with NAMSA in a more intentional way to help build and support our U.S. FDA and CE-Mark Submissions and to de-risk our program.

We had three important requirements when selecting a development partner:

1. Demonstrated therapeutic expertise with bone substitutes;
2. Proven U.S. and EU regulatory experience, including previous Notified Body expertise; and
3. Fluency in French, as we required a dedicated team to communicate with us and our stakeholders flawlessly.

NAMSA perfectly fulfilled these criteria and more, so I felt confident to partner with them deeply. I recognized that the MDR may be complicated and unpredictable for us, and we had many potential risks. It may cost more, but by working with NAMSA, it’s a guarantee of positive outcomes and results, including de-risking the program.

Can you speak more to why a partner with regulatory expertise is so critical for a MedTech start-up such as yours?

When I started in the medical device field 20 years ago, my perception was that regulatory matters were a necessary evil, an annoyance. Today, it’s the key to market entry. Any business plan begins with a regulatory focus, well before execution capacity, as it determines a “go or no go” decision. I am very familiar with several French companies that will stop regulatory activities because the MDR is ‘too complicated,’ and it often forces a “no- go” decision. So, you must address regulatory issues perfectly, as these are intimately linked to quality requirements and eventually, company-level best practices.

NAMSA often helps manufacturers tell their stories to regulators— stories of efficacy and safety that they must hear. But as a manufacturer, it’s important to also understand how to tell your story to other stakeholders. Can you say more about these considerations?

Yes, while regulatory stakeholders are one of the most important audiences, we must understand how to powerfully convey our story to business partners, opinion leaders, marketing groups and others. It is imperative to tell as accurate and truthful a story as possible—it’s in our ethics and secondly, it’s better for long-term business. But, there are different perspectives for each stakeholder. For example, when I was a practicing Dental Surgeon, I purchased dentistry products from distributors and I wasn’t really interested in learning the content of 2,000-page regulatory files. Just knowing that a product was CE-marked was enough of a guarantee of conformity. In other words, my choice was guided by other factors besides the regulatory perspective. Today, in the Dental Industry, products offered have grown substantially so it’s now a must to convince Dentists of technology benefits with an articulate pitch.

And investors?

For investors, it’s about costs with risks. There is risk and uncertainty which is linked to regulatory constraints, R&D, commercialization, etc. My job is to push the wagons forward at the right time and at the right speed. There’s no point in having great marketing if you don’t have certification. There is also an impact on production since we are producers ourselves.

What role can a CRO play in supporting not just regulatory questions, but also in addressing all stakeholders?

That’s why I called NAMSA! I know the regulatory question is just one element in the success chain. If one of the major links is broken, the whole process will fail. NAMSA has started to help us on the regulatory questions and is now playing a key role in developing our overall business plan. I must give your team credit because the business plan was not in our initial plan with NAMSA, to manage non- regulatory questions. But, both regulatory and other challenges have been executed and managed wonderfully by NAMSA.

You engaged with us under the NAMSA APEX Program, our full suite of development solutions with one vendor. Can you say more about this experience?

Working with a single APEX Program Director that guides a cross- functional team of experts and is supported by a Project Manager has been invaluable to our success. From 24/7 on-demand dashboards to monthly Steering Committee meetings, all aspects of our program have been monitored in detail. At any given time, we understand where we are with costs, timelines and overall development goals. There is great benefit to having all aspects of development under one roof as it brings close collaboration and regular communication.

Do you have any closing thoughts you’d like to share? What’s next?

The path we took was complicated at first, especially since we were working with an innovative and disruptive technology. But I think that there’s incredible merit to have persisted and continued to invest in this technology. And, much of it is due to NAMSA and their services and solutions. That in and of itself is a success!

We are currently taking giant steps towards commercialization, moving forward faster than expected, but also in a much more secure manner than before. We continue to be focused on FDA 510(k) approval and U.S. commercialization and look forward to continuing our partnership with NAMSA to make commercialization a success.

About MEGA BIOPHARMA

MEGA BIOPHARMA is a French player in marine biomaterials, a pioneer in the development of Bionacre®. This natural biomaterial extracted from nacre has yielded scientifically proven results in terms in the domains of bone and skin repair. The company aims to offer innovative therapy solutions in several fields: dental surgery, orthopedics, dermo-cosmetics, dermatology and veterinary care. Web: megabiopharma.com

About NAMSA

Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move Clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Web: namsa.com