Over 600,000 people suffer from slow and difficult to heal bone fractures within the U.S. every year. These ‘non-union’ fractures are common in people with low and imbalanced hormones, such as the elderly, but may also result from infection, inadequate blood supply to the bone, and incorrect splinting. Surgery, which has a low level of success, is the current standard of care. Full recovery from non-union fracture surgery is rare and repeat surgeries are often required.
MezoMax created a first of its kind, convenient, twice daily oral formulation called MMX that works by delivering calcium directly to the bone producing cells to accelerate healing and provide for more complete bone union in non-union fractures. We asked the founder and President of MezoMax, Dmitriy Rybin, PhD., about his discovery and subsequent founding of the company:
How did you become interested in science?
DR: Science is really a tool to better structure and simplify ideas; it is also a means to channel one’s innate curiosity. I’ve always been curious about the variety of the world. My curiosity about our world is diverse, ranging from not only physics and science, but also includes non-scientific exploration. However, it is my scientific training that has allowed me to simplify and connect common principles based upon these experiences.
When did you decide to start a company, and where did your team get together?
DR: My team and I decided to officially start our company a year ago, but this is actually the result of a five year collaboration between my colleagues here in the US and in Russia. I have often thought about starting a company during my 30-year journey in science with my co-founder Dr. Girgoriy Konygin. Our shared work at the Russian Academy of Sciences has been rewarding and is the basis for our company.
How does your technology work?
DR: Our technical approach is based upon fundamental principles of solid-state chemistry reactions that take place under external mechanical loads. Sometimes although the chemical composition of a drug remains unchanged, the molecular crystal is transformed into a new state with unique physical and chemical properties, including a significant increase in biochemical activity. Using this approach, it is possible to obtain new pharmaceutical forms that may not otherwise be possible using traditional methods of fine chemical synthesis or which might otherwise be too expensive to produce.
What lessons did you learn transitioning from science to entrepreneurship at IndieBio?
DR: Entrepreneurship is a very practical, applied endeavor. An entrepreneur needs to quickly figure out who needs our product, and this became much more important to me when I started thinking like an entrepreneur. It seems rather simple, but it’s not. It’s a pretty big mindset shift. More over, it’s necessary to talk about our product in simple and clear language, and not to use ‘science speak.’ Customers need to understand what our product is and why it’s important to them. Learning to make the extraordinary and complicated be understandable, while still keep it exciting, is no small feat! We could not have adapted to this new way of thinking and articulating our value proposition as quickly as we did without the steadfast support and constant counsel of the IndieBio team. We are and will continue to be grateful for their expert advice.
How do you think your success as a company will change the medical industry?
DR: On the surface, what we do appears to be so simple! In reality, what we’ve done is to create a new and important platform for drug creation, one which is based upon solid-state mechanochemical synthesis. This approach can be used to create new pharmaceutics that were not previously possible or that were too expensive to produce. As such, we believe our approach will continue to be an important basis for much of the future for creating new pharmaceutical treatments.
What milestones are you aiming to hit in the near future?
DR: MezoMax intends to introduce our first compound, MMX, to the US in 2022 for treatment of non-union fractures. Given the extensive clinical safety and efficacy data, we are pursuing an abbreviated approval process based upon the expert advice of four independent regulatory experts. Therefore, one of our first important milestones will be for us will be to meet with the FDA to confirm this viability of our regulatory strategy by March 2019 with the intent of filing our IND by July 2019. We expect to receive our NDA early in 2022, leading to our subsequent product launch.