Medical Technology is an up-and-coming field. Medical Technology is something that has brought about a tremendous revolution in the medical field. Not just one, but many companies and organizations are a part of this revolution.
This Interview with Cécile VIENNEY, President and CEO of Hyprevention, let us know more about the technological revolution in the field of medicine and how Hyprevention is propelling innovation in it.
Tell us about Hyprevention.
Hyprevention was founded in France in 2010, to develop innovative implantable medical devices for orthopedic surgery to address bone fragility. The idea of bone reinforcement came from Orthopaedic Surgeons. Seeing more and more elderly people coming to their hospitals for hip fracture treatments and any osteoporotic fractures due to the aging and growing population, they think about developing unique solutions. After studying the market opportunity and project feasibility, the surgeons and I have created Hyprevention together.
What were the initial challenges you faced?
As a newborn start-up company, the initial challenge for us was to raise more money than our investment to support our first product development up to commercialization. Therefore, we met business angels across Europe to convince them of our revolutionary and unique technology. Our financing partners are doctors and entrepreneurs. They understand our business in medical devices and the challenges linked to entrepreneurship. They are very supportive since the time they join the founders ‘team.
Our products are developed according to the clinical needs and market needs.
Which was that point that triggered the growth of Hyprevention?
Today, it’s the 510(k) clearance that we have received in March 2020 that gives us the best opportunity to grow Hyprevention and business.
After a few years of exploring the EU market, the new EU regulation limited drastically the introduction and even the maintenance for innovative products like ours, we put all our energy and resources to enter the US market and deliver quality products.
How have Hyprevention graphs changed since the foundation? Can you share a few statistics?
As explained above, our market is moving from CE products to FDA-510(k) products.
We will capitalize on our EU clinical experience, continue to develop our presence in Brazil where we get an ANVISA Licensing, and with our FDA-510(k) clearances, we will take the opportunity of any American market from the North to the South.
What is the reason behind Hyprevention’s long-standing success?
We have the support from our historical investors, we have the support from the surgeons who are always interested in innovation leading to clinical benefits to their patients. Also, we provide affordable solutions, that fit in the existing reimbursement coding.
What are the products/services Hyprevention focuses on? How are your services different from those in the market?
Our today focus is on the US launch of our device V-STRUT© Vertebral Implant. The V-STRUT© proposes a unique solution on the market, with a pedicle anchorage that is going to significantly improve the clinical performance for vertebral fracture treatment. Moreover, our device is very simple to use and reduces per-operative complications. Finally, as already said, we have a reasonable pricing positioning, and a very good margin, leading to a win-win-win situation. A win for the patient who will receive the best treatment for their pathology, a win for the payers with affordable pricing, and a win for Hyprevention with a good margin.
Our second focus is our historical product Y-STRUT® Hip Implant indicated to prevent hip fracture. We have initiated the US-FDA-510(k) process and are looking forward to putting it on the market.
How do you decide to take Hyprevention a step further in terms of your products/services?
Our products are developed according to clinical needs and market needs. The clinical need is identified by reviewing the scientific literature and by talking to surgeons who are expressing the gaps to be filled based on their daily activity at the hospital. Then, we make sure that these needs correspond to a large population, a sufficient market. That is why we have started by developing a Y-STRUT® Hip Implant to prevent hip fracture.
Hip fracture is a worldwide public health issue with the growing and aging population. Osteoporosis, leading to hip fracture, is a major burden for society. Then, we have developed V-STRUT© Vertebral Implant to address an unmet clinical need in the field of vertebral fracture, meaning treat with long term efficacy the fracture (avoid refracture) and prevent adjacent fractures at the upper or lower level of the vertebra, as observed with the products on the market.
Is there any new addition to the list of products/services? Anything exciting you would like to share?
Our technique is called STRUTPLASTY. It is the combination of a polymer implant with bone cement. The PEEK polymer we use presents mechanical characteristics close to the normal bone. The STRUTPLASTY aims to reinforce the bone with an anatomical solution, avoiding extra stress. After Y-STRUT® for hip and V-STRUT© for vertebras, there is another bone location that will benefit from the STRUTPLASTY technique.
What do you think are the responsibilities of an entrepreneur?
In the case of medical device companies like Hyprevention, the first responsibility of the entrepreneur is the patient, the customer. We develop quality products with a real clinical need to serve the patients. To do so, we need a strong team: shareholders, able to understand the need for investments prior, an operational team engaged in the product development, and a pool of supporting and skilled surgeons who contribute to the products development.
The responsibility of the entrepreneur is to find the right people and any stage, in order to build the best strategy and proceed with the best execution.
Can you please brief us about your professional experience?
I am a Mechanical Engineer. After several years in different industries, I joined STRYKER Spine where I developed innovative medical devices as Global Program Manager for 10 years. Then, I became Chief Operational Officer at VEXIM, a French start-up, for 2 years. VEXIM was acquired recently by STRYKER Spine for more than $180M. After this tremendous experience, I founded Hyprevention, 10 years ago, to develop the fracture prevention market in the hip.
What are the key achievements of your entrepreneurial journey?
As you say, it’s a journey. Almost, every day is an achievement. My role and my skills become stronger and stronger over time. That is my real achievement to serve Hyprevention I have founded.