The field of medical technology is expanding. The field of medicine has undergone a massive upheaval because of modern technology. This revolution involves numerous businesses and groups rather than just one.
The technological revolution in medicine and how Hyprevention is fostering innovation were also topics covered in this interview with Cécile VIENNEY, President and CEO of Hyprevention.
Describe Hypprevention to us.
In order to provide cutting-edge implantable medical devices for orthopaedic surgery that treat bone fragility, Hyprevention was established in France in 2010. Orthopaedic surgeons were the ones who first proposed bone reinforcing. They consider coming up with novel solutions as they observe an increasing number of elderly patients seeking treatment at their hospitals for hip fractures and other osteoporotic fractures as a result of the ageing and expanding population. The surgeons and I developed Hyprevention after researching the market potential and project viability.
1. What difficulties did you initially encounter?
As a young start-up business, our first task was to obtain more money than our initial investment to finance the creation of our first product all the way through commercialization. As a result, we spoke with business angels all throughout Europe to persuade them of the revolutionary nature of our technology. Doctors and business owners are our financial partners. They are aware of the difficulties faced by entrepreneurs and our business in the field of medical equipment. Since they joined the founders’ team, they have been tremendously helpful.
Our goods are designed in accordance with market and clinical requirements.
2. What was the turning point that led to Hyprevention’s expansion?
The best chance for us right now to expand Hyprevention and our business is the 510(k) approval that we received in March 2020.
After a few years of market research in the EU, the new regulations severely restricted the launch and even the upkeep of cutting-edge items like ours. As a result, we focused all of our efforts and resources on entering the US market and supplying high-quality goods.
3. Since their creation, how have Hyprevention graphs changed? Could you provide some statistics?
As previously stated, our market is transitioning from CE to FDA-510(k) devices.
We will take advantage of the opportunity presented by any American market, from the North to the South, by using our clinical experience in the EU, expanding our footprint in Brazil where we have obtained an ANVISA Licensing, and obtaining FDA-510(k) approvals.
4. Why has Hyprevention been so successful for so long?
Our historical investors and the surgeons who are constantly interested in innovation that will assist their patients clinically support us. We also offer solutions that are reasonably priced and compatible with the current reimbursement coding.
The Goods and Services
5. What goods and services does Hyprevention concentrate on? How do your services differ from those offered by competitors?
Today, we are concentrating on the US release of our product, the V-STRUT Vertebral Implant. The V-STRUT offers a novel market solution with a pedicle anchorage that will greatly enhance clinical efficacy for the treatment of vertebral fractures. Our technology also lowers post-operative problems and is very easy to use. Finally, as was already mentioned, we have a very excellent margin and a reasonable pricing positioning, creating a win-win scenario. A win for the payers with reasonable pricing, a win for the patient who will receive the finest treatment for their pathology, and a win for Hyprevention with a healthy profit.
Our historical Y-STRUT® Hip Implant, which is intended to prevent hip fracture, is our second area of focus. We are eager to launch it on the market and have started the US-FDA-510(k) procedure.
6. How did you make the decision to expand on hypprevention in terms of your goods and services?
Clinical and market requirements are taken into account when developing our goods. Reviewing the scientific literature and speaking with surgeons who are expressing the gaps that need to be addressed based on their everyday activities at the hospital help identify the clinical need. Then, we ensure that there is a sizable population and market to meet these needs. To prevent hip fracture, we started by creating the Y-STRUT® Hip Implant.
With a growing and ageing population, hip fracture is a global public health concern. Hip fractures caused by osteoporosis are a significant cost on society. Then, to address an unmet clinical need in the field of vertebral fracture, we developed the V-STRUT Vertebral Implant to treat the fracture effectively over the long term (avoid refracture), as well as to prevent adjacent fractures at the upper or lower level of the vertebra, as observed with the products currently on the market.
7. Are there any new items or services on the list? Do you have anything exciting to share?
The name of our method is STRUTPLASTY. It consists of a polymer implant and bone cement combined. The PEEK polymer we utilise exhibits mechanical properties similar to those of healthy bone. The STRUTPLASTY attempts to avoid further stress by strengthening the bone with an anatomical solution. Another bone region will profit from the STRUTPLASTY procedure after the Y-STRUT® for the hip and the V-STRUT for the vertebrae.
8. What obligations do you believe an entrepreneur has?
The patient, or the consumer, is the first duty of the entrepreneur in the case of medical device businesses like Hyprevention. We create high-quality goods based on a genuine clinical need to benefit patients. To do this, we need a strong team composed of shareholders who can recognise the need for investments up front, an operational staff actively involved in the development of the product, and a pool of knowledgeable and supportive surgeons who contribute to the product’s development.
Finding the appropriate individuals at every level is the job of the entrepreneur in order to develop the best plan and move forward with the greatest execution.
9. Please provide us with a brief overview of your professional background.
After working for a while in various sectors, I joined STRYKER Spine, where for ten years I developed cutting-edge medical equipment as the Global Program Manager. I then spent two years as the Chief Operating Officer of the French start-up VEXIM. Recently, STRYKER Spine paid more than $180M to buy VEXIM. I started Hyprevention ten years ago to expand the fracture prevention market for the hip following this life-changing incident.
10. What are your entrepreneurial journey’s major accomplishments?
It’s a trip, like you said. Nearly every day is a success. Over time, my role and my abilities get progressively better. That is my greatest contribution to the Hyprevention organization I started.