BellaSeno has earned approval from the European regulator for its 3D printed Bone and Chest Wall Implants.

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Founded in 2015, German Medtech Company BellaSeno GmbH Gains EU Market Access for Customized 3D Printed Scaffolds.####

BellaSeno GmbH, a German medtech company, has been making strides in the medical device world since its establishment in 2015. Last summer, the ISO 13485-certified clinical stage medical device company announced two clinical trials for its 3D printed breast and chest implant products in Australia, where its subsidiary is located.

Now, the company has taken another step forward by being granted authorization in Europe under the EU medical device regulations for its customized 3D printed bone and pectus excavatum scaffolds. This market access allows the company to commercialize its 3D printed regenerative medicine products on the continent.

The company’s technology focuses on resorbable 3D printed soft tissue and bone reconstruction implants, which the company believes will bring about more effective and efficient patient care.

It’s an exciting time for medical innovation, and BellaSeno is at the forefront. With their 3D printed scaffolds now approved in the EU, the company is on track to become a major player in regenerative medicine. Pectus excavatum, the medical term for funnel chest, is a disorder most often seen in males and is the result of a malformation of the ribcage. The condition is characterized by an inward curvature of the ventral chest wall and depression of the sternum. Fortunately, a revolutionary procedure with 3D printed regenerative medicine products is able to treat this condition and restore normal looking torso.

Using scaffolds that are custom designed and 3D printed out of a completely resorbable PCL material, expert engineers and plastic surgeons work together to create a structure that works in harmony with the patient’s natural tissue to facilitate repairs. The scaffold slowly dissolves over time, allowing for the patient’s own tissue to take its place, and eventually any evidence of the deformity is gone.

This new procedure offers more than cosmetic benefits. It carries the potential to improve the patient’s overall health and quality of life. For those suffering from extreme cases of funnel chest, treatments may help restore normal posture and breathing and provide relief from chest pain and fatigue.

Pectus excavatum no longer has to mean a lifetime of living with the deformity. Thanks to the advanced techniques of 3D printing, patients now have the possibility of leading a normal, healthy life with the aid of regenerative medicine products. Regenerative Surgery Gets Major Upgrade with BellaSeno Resorbable Implants

Patients who need advanced regenerative surgery to restore complex three-dimensional structures now have a new option: BellaSeno resorbable implants. Early results from the first patients indicates that these implants are safe, well tolerated, and have the potential to change the field of regenerative surgery itself.

Dr. med. Tobias Grossner, Chief Medical Officer at BellaSeno, said, “We are confident that our approach will fundamentally shift the landscape for regenerative surgery.”

BellaSeno implants are crafted from natural tissue and designed to break down into the body over time as it heals itself while retaining maximum structural integrity. This breakthrough offers a highly effective therapy to restore complex anatomical structures without physical implant interference.

Surgeons are also welcoming this development in regenerative medicine. Professor Christian Schaefer, Head of the Orthopaedics Department at the Charité Berlin said, “The use of BellaSeno implants will enable us to treat a much higher number of patients. So far we had to depend on the availability of hard implants or autologous tissue grafts. Now we can perform prolonged and reliable patient treatments with natural implants.”

This achievement marks a great milestone in the advancement of regenerative surgery, providing patients with more options and greater success rates. BellaSeno is looking forward to continuing to develop and improve its implants and technologies in order to ensure not only the safety and efficacy, but also the affordability of such technology. News Article

A new type of automated manufacturing process is revolutionizing the way medical products and devices are produced. BellaSeno, a leader in the field, has developed an AI-driven, no-touch system that ensures patient safety and scalability. With this technology, medical implants can now be made with personalized characteristics and their proprietary AM technology platform meets the requirements of medical scaffolds for both soft tissue and bone.

Press Release

BellaSeno is proud to announce the launch of its AI-driven, no-touch manufacturing process enabling automated production of personalized medical devices and products with optimal patient safety and scalability. Their proprietary AM technology platform meets the necessary requirements of medical scaffolds for both soft tissue and bone and is used to produce a range of off-the-shelf and custom sterile medical implants and scaffolds.

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If you want reliable and personalised medical devices and products, you can look at BellaSeno’s AI-driven, no-touch manufacturing process. This ensures patient safety and scalability, as well as meets the requirements of medical scaffolds for both soft tissue and bone. Plus, you can get off-the-shelf and custom sterile medical implants and scaffolds! Check out this revolutionary new technology today! #BellaSeno #AIMedicalManufacturing #SaferMedicalDevices BellaSeno offers advanced custom design software with a twist – 3D unit-cell based architectures. This means that the designs are optimized to provide maximum strength and flexibility, which, when combined with a unique fully open porous design, allows for full integration of the implant into the body with no need for encapsulation. A further benefit of this type of design is that it encourages vascularization within the regenerative site. Truly the perfect solution for demanding medical applications. Polycaprolactone (PCL) scaffolds for difficult large bone defects are a groundbreaking biocompatible option for bone regenerative therapy that 3D printing is making possible. They are resorbable, customizable, and are manufactured with a unique quality that is helping to revolutionize bone repair.

Unlike traditional autografts, the PCL scaffolds are mechanically compressable, with “dynamic mechanical compressability” that allows them to be packed into segmental defects and voids with precision and stability and helps secure autologous or allogenic bone grafts within those sites.

The advantage of these scaffolds compared to traditional autografts is their higher success rate in regenerating tissue, since the scaffolds help to keep the grafts firmly in place and guide the growth of new tissue from the graft. It is also less traumatic, since no additional surgical sites are needed for graft harvesting.

3D printed PCL scaffolds are becoming a reliable alternative for supporting bone regeneration and helping to make the surgery and recovery process more successful and less painful. And by using PCL materials and 3D printing technology, surgeons can customize the scaffold’s structure, design, and mechanical properties to fit their patient’s needs. BellaSeno Shows Off Impressive Mechanical Properties with 3D Printed Medical Scaffolds

At the recent EFORT Congress, medical technology firm BellaSeno showcased advanced 3D printing technology that yields medical scaffolds with superior mechanical properties. The scaffolds are able to withstand increased stress loads and long-term cycles compared to competitor products.

In this particular demonstration, BellaSeno collaborated with Evonik to produce 3D printed medical scaffolds with resorbable polymers from their Resomer range. As a result, the scaffolds are now approved for use in the medical market, giving BellaSeno customers access to cost-effective and efficient ways to help patients heal faster.

The strength, flexibility, and resiliency of the medical scaffolds from BellaSeno provide an exciting opportunity to revolutionize medical care. Shortening and improving recovery time for patients, and giving surgeons greater precision and control, 3D printed medical scaffolds could soon become the norm in orthopedic surgery.

BellaSeno is filled with ambitious innovators striving to make a real difference in medical care. Their commitment has been rewarded with a breakthrough in 3D printing, and the potential to help save lives. Mohit Chhaya, CEO of BellaSeno, has shared the excitement of the company’s recent acquisition of European market access authorization for custom-made bone and pectus excavatum scaffolds. Clinical data collected from patients who have benefited from the product have been extremely positive, further encouraging the company’s efforts.

Now, BellaSeno is pursuing and anticipating to receive authorization approval for additional products in multiple geographic areas. One such product under consideration are off-the-shelf breast implants that could potentially benefit both reconstructive and plastic surgery patients.

The company’s focus remains and is devoted to creating a diversified portfolio capable of encompassing ongoing medical advances and catering to a variety of markets. Additionally, its sophisticated manufacturing infrastructure has put BellaSeno in a prime position to achieve its aim of becoming a multifaceted provider of durable and desirable medical supplies. Keep up with the 3D printing revolution by subscribing to a newsfeed on the latest industry developments. Get insights on emerging trends, innovations, and opportunities to maximize your profits and drive your business forward. Plus, receive timely offers from third party vendors. Don’t miss out – stay in the know on the latest 3D printing industry news!

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