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).

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.

Improving the performance of blood-contacting medical implants is a global health necessity aimed at reducing mortality and morbidity in patients with cardiovascular diseases. Surface modification of the biomaterials from which the vascular grafts are constructed has been used to reduce the risk of complications such as thrombosis and infection. Herein with a focus on vascular tissue engineering, we provided an overview of (a) fundamental hemodynamic considerations for blood-contacting biomaterials, (b) surface modification strategies to attenuate nonspecific adhesion of proteins, improve hemocompatibility, and induce the formation of a confluent endothelial lining, and (c) the guidelines for the clinical development of surface modified biomaterials.

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.

A potential solution for prosthetic heart valves is tissue-engineered heart valves. Tissue-engineered heart valves (TEHVs) are designed to replicate the complex properties found in natural tissues, such as stiffness, anisotropy, and composition and organization of cells and extracellular matrix (ECM). Electrospinning is regarded as a highly versatile and innovative approach for fabricating numerous fibrous designs. In this review, we discuss recent developments in electrospun heart valve scaffolds, including scaffold materials, cell types, and electrospinning setups used to prepare aligned nanofibers. Despite the fact that natural biomaterials provided excellent biocompatibility, nanofibers from synthetic materials provided the required mechanical compatibility. Accordingly, most studies highlighted the benefits of designing composite heart valves using biological and synthetic polymers. Various strategies, such as the application of motorized mandrel and micropatterned collector in electrospinning were effective in controlling nanofiber alignment. Studies also showed that aligned nanofiber’s mechanical strength and anisotropic structure promote cell proliferation, and differentiation, and promote attachment. Numerous studies have reported that multiple cell sources are suitable for producing heart valves. Successful results were obtained with human umbilical vein endothelial cells (HUVECs), since they provide a convenient cell source for cellularization of valve leaflets. A higher conductivity of scaffolds was achieved by using biomaterials that conduct electricity, such as polyaniline, polypyrrole, and carbon nanotubes, which resulted in better differentiation of precursor cells to cardiomyocytes and higher cell beating rates. In light of these attributes, nanofibrous scaffolds produced through electrospinning are expected to offer numerous advantages for tissue engineering and medical applications in the near future. However, multiple challenges were identified as cell infiltration and 2D nature of nanofiber mats necessitate further engineering approaches in electrospinning procedure leaflet production.

Mineral nanoparticles and osteoinductive biomaterials are essential in advancing bone regeneration by addressing skeletal conditions and injuries that compromise structural integrity and functionality. These biomaterials stimulate the differentiation of precursor cells into osteoblasts, creating biocompatible environments conducive to bone tissue regeneration. Among the most promising innovations, mineral-based nanoparticles and nanocomposite hydrogels have emerged as effective strategies for enhancing osteoinductive potential. This review explores the diverse types of osteoinductive biomaterials, including natural sources, synthetic compounds, and hybrid designs that incorporate mineralized nanoparticles. Emphasis is placed on polymeric hydrogels as delivery platforms for these materials, highlighting their dual role as structural supports and bioactive agents that promote osteogenesis. Challenges such as immune rejection, biodegradability, mechanical stability, and short in vivo residence time are critically discussed, alongside their impact on clinical translation. By presenting a comprehensive analysis of mechanisms, applications, and limitations, this review identifies opportunities for integrating osteoinductive biomaterials with emerging fields like immunology and biomechanics. Ultimately, this work aims to provide actionable insights and advance the development of novel, clinically relevant solutions that improve patient outcomes and address the growing global need for effective bone repair and regeneration.

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.

Hydrogel-based drug delivery systems (DDS) offer promising alternatives for treating ocular diseases by overcoming the limitations of traditional therapies, such as low bioavailability, frequent administration, and invasiveness. Hydrogels, with their high biocompatibility and ability to respond to external stimuli, can provide sustained and targeted drug delivery. This review highlights the unique properties of hydrogels, including their swelling behavior, porosity, and mechanical strength, making them suitable for various ocular applications. The classification of hydrogels based on cross-linking methods, origins, and stimuli responsiveness is discussed, emphasizing their potential in drug delivery for dry eye disease (DED), glaucoma, corneal alkali burns, and neovascularization. Notable advances include thermosensitive and pH-responsive hydrogels, which have shown promising results in preclinical studies. Despite these advances, most studies are still in preclinical stages, highlighting the need for rigorous human trials to validate the safety and efficacy of hydrogel DDS. Collaborative efforts among researchers, pharmacologists, and ophthalmologists are essential to translating these innovations into clinical practice, ultimately improving patient outcomes in ocular disease management.

Silver iodide (AgI) nanostructures have been considered as promising candidates for optical biosensors owing to their optical characteristics of optical properties, including tunable surface plasmon resonance (SPR) and fluorescence enhancement. Such properties let one analyze biomolecules with high sensitivity, which makes them ultra-useful in diagnostics. The formed AgI nanostructures can be synthesized using chemical precipitation and template methods that enable fine-tuning of the morphology and crystallinity of the final nanostructure. The presence of SPR enhances optical signals potentially, and fluorescence enhancement helps visualize biomolecule interactions easier as the analyte concentration is usually low. Such uses of biosensors include applications in proteins, nucleic acids, and other biomolecules for progress in disease diagnosis and pharmacogenomics. Moreover, the good biocompatibility level of the created AgI nanostructures makes it possible to integrate them into biological systems safely, increasing their usage in medicine. This integration of their appealing optics, biosensing operating principles, and biocompatibility establishes their centrality in the creation of future photonic biosensors for faster, intuitive, and painless detection.

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.