Tiss'You Regenerative Company

Upcoming trade fair events

Tiss’You is happy to announce the upcoming events that will feature its expositions.

Between the 14th and the 17th of November, Tiss’You will exhibit at Medica 2022 in Düsseldorf. In this edition of the trade fair, the newest scientific findings from across the broad spectrum of diagnostic medicine will be presented. As part of the program by the specialist forum for laboratory medicine, renowned experts will be holding highly up-to-date lectures here on stage. You will find Tiss’You booth in Hall 10 Stand G67.

You will also find Tiss’You at the International Dental Show 2023 in Cologne. After a break due to the pandemic, IDS returns to full strength as the leading global trade fair for the dental community, which ensures sustainable success as a platform for innovation and market trends. Tiss’You booth can be found in Hall 4.1 Stand c078.

Clinical report of Arthrys double treatment on 20 patients

We are releasing a preliminary report of our Arthrys post-market clinical follow-up (PMCF) done in collaboration with Dr. Francesco Fiacchi, orthopaedic surgeon in Mantua (Suzzarra).

This PMCF activity enrolled patients with knee and hip osteoarthritis, treated with a first intra-articular injection of Arthrys 5mg/ml and a secondary shot of the same product at six months. We have assessed the safety and effectiveness of hydrolyzed collagen in ameliorating pain and functionality symptoms and its feasibility for re-treatment.

The report is available for direct download here or on Arthrys portfolio page.

New clinical report on Guided Bone Regeneration (SpherHA and Collygen)

In collaboration with Dental School in Turin, we are releasing a preliminary clinical report on the efficacy and safety of a guided bone regeneration strategy for the treatment of post-extraction sockets.

This post-market clinical follow-up shows successful bone and soft tissue regeneration after the use of SpherHA hydroxyapatite and Collygen protective membrane. The report is available here for direct download, or on SpherHA and Collygen portfolio pages.

New Arthrys clinical report

We are releasing a preliminary report of our Arthrys post-market clinical follow-up (PMCF). We are grateful to Dr. Federico Valli, orthopaedic surgeon in Milan, for his collaboration.

This PMCF activity was performed on osteoarthritis patients treated with one shot of Arthrys 5mg/ml, showing its safety and effectiveness in ameliorating pain and functionality symptoms.

The report is available for direct download here or on Arthrys portfolio page.

Medica 2021, World Forum for Medicine

Tiss’You will be present in Düsseldorf (Germany) for Medica 2021, World Forum for Medicine, from 15 to 18 October.

After an online edition due to the Covid-19 pandemic, the most important international trade fair for medicine is back with 2900 exhibitors from over 70 countries, with a rich program of presentations and conferences. There will be wide coverage on the most innovative healthcare topics: robotics and automation, the entry of artificial intelligence into medical routines and patient wearable devices, virtual reality in surgery, and the progressive digitalization of the medical world.

Tiss’You will welcome you at booth D48 in Hall 10 to present its products and biomaterials for regenerative medicine. In recent years, regenerative medicine has become a trend as a minimally-invasive approach to treat degenerative diseases. Some examples are osteoarthritis and musculoskeletal disorders for which we developed Arthrys, a medical device based on an injectable solution of hydrolyzed collagen peptides, which is indicated for the direct reinforcement of the extracellular matrix of connective tissues, naturally rich in collagen fibers. The innovative formulation of Arthrys can be exploited as a minimally invasive treatment for aging, degeneration, trauma, overload, and postural defects that cause pain and limited mobility in musculoskeletal structures, such as joints and surrounding connective structures (i.e., muscles, tendons, ligaments, menisci).

SpherHA – Antibiotic release test

Reconstructive bone surgery aims to regenerate the loss or resorption of bone through materials and techniques that allow to mimic and activate specific and fundamental reparative mechanisms such as osteogenesis, osteoinduction, and osteoconduction.

With general good health conditions, the bone displays an excellent healing capacity; therefore, in case of bone defects, it is sufficient to fill the void of the loss of substance with grafts or bone substitutes to provide the three-dimensional structure to sustain the regeneration process.

However, infection, e.g., osteomyelitis, is one of the major postoperative complications and evolves in complete bone disruption. Local delivery of antibiotics maximizes target tissue concentration and minimizes systemic toxicity risks. The use of bone substitutes exploited as antibiotic carriers is ideal to plan efficient and tailored bone regeneration strategies.

To help surgeons in this task, we tested SpherHA release capacity with the most common antibiotics; the results are available in the report below:

SpherHA –  Antibiotic Release Test Report – DOWNLOAD

3D PRINTING OF MEDICAL DEVICES AND ARTIFICIAL ORGANS: HYPE OR HOPE?

3D printing is a technology for the additive manufacturing of objects, i.e., adding material layer by layer starting from digital three-dimensional models. It promises to revolutionize many areas, including the medical field, because of the high flexibility for the production of medical devices and artificial organs. However, the high expectations of 3D printing collide with several limitations that need to be overcome, making 3D printing a declared yet unproven success.

3D printing already has applications in dentistry. A well-equipped dental lab can make custom crowns, bridges, and other prosthetic restorations for patients in a time-saving manner. Additive manufacturing can also be useful for reconstructing body parts following an accident: in 2013, the U.S. Food and Drugs Administration approved the use of a patient-specific cranial device from Oxford Performance Materials, Inc. that was designed based on computed tomography. The procedure allowed the reconstruction of 75% of the patient’s skull, and the company received subsequent approvals for 3-D printed facial reconstruction devices. 3D modeling is also useful for surgery planning, e.g., the prototype bone structures created by the Italian research group led by Nicola Bizzotto, or for forensic analysis for reconstructions of victims’ skulls and faces. In 2010, the use of 3D printing was proposed to predict, for educational purposes, the appearance of an unborn baby to simulate the presence or absence of deformities. The future will exploit 3D printing for tissue and organ printing, but in most cases, these are technologies and devices in the preclinical stage.

Artificial organ printing must overcome some limitations before becoming the new frontier of medical devices. First, the supporting scaffold must possess sufficient mechanical strength to be implanted in the body, be successfully vascularized, and have the necessary spatial resolution and internal structure to function as a tissue. Obstacles also exist from a regulatory standpoint: in both America and Europe, medical device regulation has strict rules to ensure the safety and performance of medical products. All of this collides with the biggest advantage of 3D printing: flexibility. Devices made by 3D printing can be highly customized, but this fits poorly with a system where it is generally impossible to change the basic design of a certified product. New rules are needed to ensure the reproducibility, sterility, and, last but not least, safety and performance of medical devices derived from 3D printing. In the future, authorization for the use of an artificial organ (or a medical device 3D-printed in an operating theatre) may be put upon an ethics committee rather than national regulatory bodies. In this case, however, it will be important to distinguish between research and medical treatment. Designing a custom device for a patient with a serious condition and stepping outside the boundaries of the state of the art may be considered medical practice rather than experimentation. However, even if the use of 3D printed dental prostheses would uprise fewer regulatory implications, more aggressive 3D printing-based procedures would subject patients to procedures under uncontrolled circumstances with uncertain outcomes. Finally, new unpredictable ethical dilemmas may arise: for instance, what if modeling healthy unborn fetuses’ prediction was leveraged to persuade a mother against abortion?

The Nobel Prize winner for literature Kazuo Ishiguro hypothesized in his famous novel Never Let Me Go a way for mankind to meet the need for organs for donation: the use of biological clones, created for exclusive and selfish use to ensure the life of human beings “born from parents”. The story is precise in observing two phenomena; the first is the need to find a solution to the transplant lists: every year, in the United States alone, there are more than one hundred thousand patients on the waiting list to receive an organ and, every day, there are about twenty deaths due to the lack of a donor. Overpopulation and the habits of the Western world steadily increase these numbers. The other phenomenon is the fundamental individualism that leads men to worry only about their own well-being, diverting science with positivistic drives and no ethical brakes.

Indeed, science fiction is a distortion and fails to predict the future, but it lucidly analyzes the present. Artificial organ printing may become the new frontier in the medical use of additive printing in the future, but we are still far from those days. In 2011, surgeon Anthony Atala of Wake Forest University described a preliminary study of organ regeneration in a TED talk, showing a bio-ink printed matrix in the shape of a kidney. Some journalists reported the scientifically incorrect news of the first artificial kidney that could be implanted and function. The enthusiasm and inaccuracy of the media, over the years, have generated inordinate hype towards the technology of 3D printing, which today finds itself in a peak of inflated expectations that cannot be realistically satisfied and risk disappointing – consequently invalidating the research and development of a promising technology.

Today, the consolation is that the use of scaffolds for regenerative medicine and tissue engineering exploits successful technologies, such as subtractive manufacturing: a bit the opposite of 3D printing, that exploit subtraction from blocks of raw material to obtain matrices, for example with the decellularization of animal tissues. At Tiss’You, this process is carried out with EstRem, a trans-esterification reaction capable of providing heterologous bone matrices that are perfectly compatible with humans.

Arthrys and the treatment of pain

Pain is a multifactorial pathology with social, psychological, and emotional components. In medicine, it is commonly considered as the consequence of a pathology or a trauma, but recently pain is acquiring relevance on its right and no longer only as a symptom. For instance, the pain that sometimes affects muscles, tendons, and joints depends on many factors, such as trauma, injuries, postural defects, and overload conditions. However, if appropriate, a doctor can specifically diagnose low back pain or knee pain. It is possible to diagnose osteoarthritis by observing articular cartilage degeneration on an x-ray, or tendon rupture on ultrasounds/MRI, but there is no absolute correlation between clinical signs and pain.

Pain leads patients to lose functions in daily, work, and sports activities, resulting in a challenge to clinicians. Except for orthopedic issues requiring surgery, musculoskeletal pain is often addressed with oral drugs or local cortisone infiltration, which are only temporary relief. However, to offer better benefits, pain therapy can take advantage of molecules and formulations with targeted action.

For joint pathologies, such as arthrosis, the use of hyaluronic acid (of different molecular weights) can provide relief to patients with joint pain through viscosupplementation, which improves the viscosity and elasticity of the synovial fluid.  Alternatively, regenerative medicine allows the use of the patient’s cells and elements to trigger the self-healing processes of injured tissues. One example is the use of Platelet-Rich Plasma (commonly known PRP, its acronym, or growth factors) that is obtained from blood withdraw from the patient himself and used immediately, after appropriate centrifugation.

Arthrys low molecular weight collagen peptides have a specific reinforcing action for connective tissue structures. Once injected into the site of interest, their concentration gradient can counteract the degradation phenomena affecting the extracellular matrix. Moreover, their weight of about 3kDa allows them to interact in the processes of inflammation and pain. The presence of Vitamin C and Magnesium protects the peptides from oxidation and allows a further antalgic action and the improvement of the cellular adhesion of the progenitor cells involved in the reparative processes.

Arthrys is a ready and easy-to-use solution that can quickly and naturally counteract pain and other symptoms of limited functionality.

The subjectivity of pain can have consequences on the response to therapy: awareness of the diagnosis and expectations of recovery are psychological features that may influence the clinical outcome. To find a solution to the high variability in response to treatments, research and development of new products are working to provide new and more effective solutions to combat pain.