An expert focused on bio-compatible biomaterials, pioneering advancements in bone regeneration and implant technology: Medical Inventi S.A.

Medical Inventi S.A., a trailblazer in the field of biotechnology and biomaterials, was founded in 2011 as a groundbreaking initiative born out of the collaboration between the academic experts from the Medical University of Lublin and private investors. This innovative venture was driven by the vision of commercializing scientific research to address the critical need for the prevention and protection of human health. Led by two distinguished scientists, Prof. Grażyna Ginalska and Prof. Anna Belcarz, Medical Inventi embarked on a mission to transform years of rigorous research into practical solutions for the medical community. The creation of Medical Inventi’s flagship product, FlexiOss^®, was rooted in a pressing challenge faced by orthopedic surgeons: the need for a bone-replacement biocomposite that could mimic natural bone while being surgically convenient. Through close collaboration with orthopedic specialists from the teaching hospitals of the Medical University of Lublin, Prof. Ginalska and Prof. Belcarz spearheaded extensive research and laboratory work. After several years of development, they successfully created an innovative biocomposite prototype, leading to the establishment of Medical Inventi to bring this breakthrough to the market.

FlexiOss^® is a versatile and revolutionary product designed for use in orthopedics and traumatology. It serves as a single material for bone filling and regeneration, and can be combined with other materials, such as the patient’s bone or allogeneic bone grafts, for comprehensive bone reconstruction. FlexiOss^® is particularly effective in procedures addressing defects in the compact cortical layer of long bones, trauma-induced bone defects, and tumor resections.

Building on the success of FlexiOss^®, Medical Inventi has expanded its product line to include two additional brands: FlexiOss^®Dent, tailored for dentistry, and FlexiOss^®Vet, designed for veterinary applications. FlexiOss®Dent is utilized in oral surgeries, periodontal procedures, and implantology, while FlexiOss^®Vet offers similar benefits in veterinary medicine, providing advanced solutions for bone repair and regeneration. With a foundation in cutting-edge research and a commitment to improving patient outcomes, Medical Inventi continues to innovate and lead in the field of biocomposite solutions.

In conversation with Maciej Maniecki, President of Medical Inventi S.A.

Q. FlexiOss^® is described as a third-generation implantable biomaterial. Can you elaborate on the unique properties that differentiate it from other bone-replacement materials on the market?

FlexiOss^® is a patented, innovative third-generation biomaterial designed to support bone tissue regeneration. It’s a biphasic composite of hydroxyapatite and polymer, which forms a stable, collagen-like triple helix structure. This unique composition minimizes inflammation and allows the material to absorb liquids like blood or drug solutions, making it highly adaptable to bone defects. FlexiOss^® is also highly porous, promoting rapid integration with the patient’s natural bone. Additionally, it can carry antibacterial drugs, reducing the need for systemic antibiotics, and its haemostatic properties help control bleeding during surgery.

Q. What have been the main regulatory hurdles in bringing FlexiOss^® to market, and how have you navigated them successfully?

Initially, our company had the expertise, patent protection, and confidence in FlexiOss^® as an excellent bone replacement biocomposite, validated by lab results, animal studies, and early human trials. However, to commercialize it, we needed certifications proving its safety and effectiveness. This marked the beginning of a challenging journey: preparing for clinical trials, securing funding, and conducting a multi-centre clinical study. Afterward, we developed the necessary documentation and submitted applications to regulators. Following a successful audit, we received the CE mark in 2021, allowing us to sell in the EU. Additionally, transitioning from small-scale lab production to full-scale manufacturing was a significant hurdle. It took five years to develop an innovative production line for FlexiOss^®, now protected by a U.S. patent. Today, we have a cutting-edge production facility and are actively educating the medical community while introducing FlexiOss^®, a Class IIB medical device, to the market.

Q. How does Medical Inventi approach partnerships with other organizations or academic institutions to drive innovation and commercialization?

Medical Inventi was founded by scientists from the Medical University of Lublin, and the inventors and the University are still shareholders in the Company. This fact and the publicity surrounding our project have resulted in many universities from both Poland and other European countries cooperating and wanting to cooperate with us. In this respect, it is worth mentioning the planned project with the Universities of Milan and Bologna. In pursuing its development strategy, the company will expand its product portfolio beyond the FlexiOss^® family. This year, we acquired the rights and know-how to two other innovative solutions resulting from the work of scientists. We plan to be an entity that exemplarily commercializes Polish inventions in healthcare.

Q. How does Medical Inventi ensure that its products minimize stress and pain for both human and animal patients?

Medical Inventi is a manufacturer of a medical device. What we ensure is that the device is safe and accelerates the process of natural bone reconstruction, which benefits the patient by reducing the period of recovery and rehabilitation. It is up to the practitioner performing the FlexiOss^® procedure to decide on its use. Whether they use it dry or soaked, as a whole or cut into slices, how they use it is each doctor’s decision. Our FlexiOss can be soaked in various liquids including antibiotics. Our research results confirm that the antibiotic release process from our biocomposite is optimal, i.e. 10-14 days.

Q. What does the future hold for your company and its customers? Are exciting things on the way?

I am hopeful and convinced that the next few years will see the dynamic development of our Company. In accordance with the strategy developed two years ago, called 4^*expansion, we are implementing certain activities. By 4^*expansion we mean geographic expansion, branding, applications and new products. We consistently carry out tasks in each of these 4 areas. The separate brands i.e. FlexiOss^® for orthopedics, FlexiOss^®Dent for dentistry and FlexiOss^®Vet for veterinary medicine are activities in 3 completely separate markets. Geographical expansion includes activities on 4 continents and in more than 20 countries. New applications include orthopedic oncology, neurosurgery and spinal surgery or war wounds. New products include Polysaccharide-protein-ceramic biomaterial and Membrane made of biodegradable fibers.

The challenges facing the Company are great, but their implementation will bring tangible benefits to all. Both for patients and doctors, but also for Medical Inventi’s shareholders.

Meet the leader behind the success of Medical Inventi S.A.

Maciej Maniecki is the President of Medical Inventi S.A., with a strong background in business and innovation. As a co-founder and long-serving President of Safo, and later a board member of Asseco Business Solutions, he brings extensive experience in leading and supporting innovative projects. Maciej excels in research and development, particularly in the commercialization of new ideas and facilitating knowledge transfer between academia and industry. He is a seasoned leader, recognized for initiating and driving numerous projects that promote regional entrepreneurship and the development of innovation. His expertise positions him as a key figure in advancing medical technology. 

“Medical Inventi is a manufacturer of a medical device. What we ensure is that the device is safe and accelerates the process of natural bone reconstruction”