Nanomedicine, a convergence of nanotechnology and medical sciences, has unleashed transformative potential in healthcare. However, harnessing the benefits of nanomedicine requires a thorough understanding of its regulatory landscape. An in-depth discussion of regulatory considerations, including molecular safety assessment, harmonization of the regulatory landscape, and shaping the future of innovation, is presented in this discourse. The molecular safety assessment entails evaluating interactions between nanoparticles and biomolecules, ensuring compatibility at the molecular level. Harmonization involves developing international standards and guidelines for a consistent regulatory approach, while shaping innovations emphasizes integrating molecular safety assessments into early stages of development. Challenges encompass the need for standardized assessment methods, balancing innovation with safety, and addressing unique features of novel molecular designs. As the nanomedicine landscape evolves, effective regulatory strategies must navigate the intricate interplay of molecules and technologies, ensuring both patient access and product safety.

Neurodegenerative diseases (NDDs) gradually affect neurons impacting both their function and structure, and they afflict millions worldwide. Detecting these conditions before symptoms arise is crucial for better prognosis and duality of life, given that the disease processes often begin years earlier. Yet, reliable and affordable methods to diagnose NDDs in these stages are currently lacking. There’s a growing interest in using circulating extracellular vesicles (EVs), like small EVs (sEVs) also known as exosomes, as potential sources of markers for screening, diagnosing, and monitoring NDDs. This interest stems from evidence showing that these EVs can carry brain pathological proteins implicated in NDD pathology, and they can even traverse the blood-brain barrier. This review focuses on the creation of EVs, particularly sEVs with a size of less than 200 nanometers, methods for isolating sEVs, and recent advancements in biosensor development to detect NDD-related markers found in sEVs. Furthermore, it explores the potential of sEVs in diagnosing four major NDDs: Alzheimer’s disease (AD), Parkinson’s disease (PD), Huntington’s disease (HD), and multiple system atrophy (MSA).

The fusion of biomaterial science with clinical practice in oculoplastic and orbital surgery, particularly in the reconstruction of the posterior lamella of the eyelid, the lacrimal system, orbital floor fractures, and the development of implants for anophthalmic sockets, represents a frontier where materials meet surgical techniques. This review, which spans research from 2015 to 2023, delves into the application and integration of biopolymers and functional biomaterials in these complex areas. The discussion begins by reviewing the key anatomy of the external ocular surface, lacrimal system, and orbit. It then summarizes the various current surgical approaches for treating diseases affecting the external ocular surface and orbital involvement, with an emphasis on the associated challenges. The discussion continues with a comprehensive overview of the advantages and disadvantages of current and emerging biomaterials, including synthetic and natural polymers, used in reconstructive surgeries. These include applications for eyelid structure reconstruction, lacrimal system repair, orbital bone fracture repair, and orbital socket reconstruction. Throughout the review, the pathophysiology and challenges associated with these reconstructive procedures are explored, with an emphasis on surgical nuances and the ongoing pursuit of optimal reconstruction techniques. Finally, this review serves as a valuable resource for familiarizing clinicians with current knowledge and generating future hypotheses. It concludes that no evidence-based guidelines currently exist in oculoplastic surgery regarding the use of biopolymers in reconstructive procedures. Further research is needed to evaluate the efficacy and reproducibility of these biopolymers.

Nanoparticles (NPs) are at the forefront as they are providing unprecedented solutions to obstacles and issues in treating neurodegenerative diseases. Due to their size, surface characteristics, and ability to be functionalized, these carriers can directly deliver therapeutics across what is considered one of the main barriers to central nervous system (CNS) treatment, the blood-brain barrier (BBB). Through nano-technology, anti-disease agents such as Alzheimer’s, Parkinson’s, and Huntington’s therapies become more bioavailable, specific in action, and with fewer side effects. The NPs serve as molecular carriers that facilitate transport across the BBB by receptor-mediated transcytosis or by disruption of the barrier with a view to properly delivering drugs to the neural tissues. Some of the therapeutic applications of nanotechnology also present the concept of molecular medicine since the NPs are designed to deliver drugs in accordance with specific biomolecule signals. Besides the therapeutic applications, NPs replace the traditional contrast media for magnetic resonance imaging (MRI) and positron emission tomography (PET) scans for better diagnosis as well as disease tracking in the early stages. In addition, their effects on solubility increase the therapeutic potential of earlier useless compounds, and the preservation of bioactive molecules from degradation increases the therapeutic capacity of medications. Neurodegenerative disorders are marked by oxidative stress and inflammation that contribute to the disease severity; thus, liposomes, dendrimers, and polymeric NPs encapsulate antioxidants and anti-inflammatory compounds, so they target the areas most affected by the disease. Such sophisticated systems minimize the extension of neuronal deterioration and enhance the lot of such patients. The “theranostic” NPs allow for continuous diagnosis and treatment by containing both diagnostic and therapeutic features. These have created unprecedented opportunities to meet the unmet needs in CNS disorders and may revolutionize the evolution of managing neurodegenerative diseases and innovative neuroimaging procedures in the future.

The use of autologous cartilage and bone grafts remains the gold standard in augmentation rhinoplasty performed to reconstruct of the nasal dorsum. Meanwhile, limited number of available sources, donor site morbidity, and unpredictable graft resorption represent significant disadvantages of autografting. The aim of this study is to test combination of autologous stromal vascular fraction (SVF) and commercially available bone substitutes (BSs) as new tissue-engineered grafting material (GM) for rhinoplasty. A series of consecutive cases includes four adult patients who underwent rhinoplasty to correct saddle nose deformity (SND) using the new graft technique. SVF was isolated from liposuction aspirate using standard methodology of enzymatic digestion. Two types of BSs were combined with SVF: Bio-Oss granules to create a moldable graft (M-graft), and block-shaped BoneMedik-S to create rigid grafts (R-grafts). The moderate SND was treated using an M-graft. In case of major or complex SND, the nasal dorsum was reconstructed with dorso-columellar L-shaped framework made of R-grafts. The results were evaluated over a period of 6 months to 3 years postoperatively using photogrammetry and FACE-Q appearance appraisal scales. Computerised tomography (CT) scanning of the reconstructed nose and histological analysis of grafted material were also carried out. No complications were observed. The photograms show the restoration of the correct contour of the nose. FACE-Q appraisal scale scores increased significantly, including satisfaction with nose appearance, psychological well-being, and social function. In CT evaluation, there was no substantial resorption or warping of the grafts. Histological findings show osteogenic remodeling of the grafted material. Thus, combining autologous SVF with BSs is a promising strategy for developing rhinoplasty GM.

Translating biomaterials research into clinical products is a multidisciplinary yet rewarding journey. It should primarily aim to improve patient treatment and clinical outcomes by addressing unmet clinical needs. Four examples of commercial development of biomaterial implants illustrate the diversity of paths, starting from academic research work (AlchiMedics, TISSIUM, Cousin Surgery) or corporate initiatives to develop new products (Medtronic-Sofradim Production). They have been selected from the Translational Research session of the 2022 Conference of the European Society for Biomaterials (ESB) in Bordeaux (France). Commitment, agility, and perseverance were among the key common skills to successfully meet challenges, especially the most unexpected ones. All dimensions of translation projects must be integrated from the start, including the regulatory strategy.

The design of effective treatments for critical size bone defects, which result from various conditions such as trauma, infection, injury, or tumor resection, presents a significant challenge in clinical practice. While autologous grafts are commonly regarded as gold standard treatments in these complex healing scenarios, they are often associated with notable limitations, including donor site morbidity and limited graft volume. As a result, recent research trends have shifted towards developing biomaterials that better emulate the inherent complexity of the native bone structure and function through implementation of a “Diamond Concept” polytherapy strategy. Central to this approach is the utilization of biomaterials, increasingly composed of composite materials that integrate bioactive osteoinductive factors and cell sources to enhance healing outcomes. The usage of Wnt signaling specific agonists as osteoinductive mediators has been recently shown to be a promising strategy for promoting healing, as this pathway is well established to have an important role in both osteogenic differentiation and bone formation processes. Implementation of a localized delivery system through scaffold incorporation is necessary in this scenario, however, to minimize any potential off-target effects caused by the Wnt signaling cascade’s non-specificity to bone. Findings in the literature clearly show that this approach holds promise to improve clinical healing outcomes, paving the way for more effective treatment options. In this review, we will generally discuss the design of biomaterials, specifically bulk materials and composites, for the treatment of critical size bone defects. Additionally, we will highlight recent work on the design of chitosan-based scaffolds modified with purine crosslinking, to overcome cytotoxicity issues associated with other chemical crosslinkers. In this context, we focus on optimizing material design for this bone healing application and discuss the benefits of localized Wnt agonist as mediators to improve the scaffold’s osteoinductive behavior.