Hyaluronan, Hyaluronic Acid, Sodium Hyaluronate, HA
Hyamedix is a Hyaluronan technology company specialized in the development and use of various forms of Hyaluronan for research, diagnostics, medical device and therapeutic (drug delivery/release) applications. In addition, we offer extensive product development expertise from formulation through product registration (CE mark).
Hyamedix personnel represent over 30 years experience in Hyaluronan and Hyaluronan related technologies and can help bring your product to market utilising our substantial expertise in:
Hyaluronan formulation in our dedicated development labs.
Production, regulatory and product launch for Hyaluronan based products.
Our technology portfolio offers unique IP benefits to your products, supplying additional differentiation for your product in your market.
The Hyamedix IP forms the basis of two technologies that utilise the natural benefits of hyaluronan (HA) for devices, diagnostics and drugs:
Hyaluronan Formulation, Product Development, Production and Regulatory Support
Hyamedix can help in all your
Hyaluronan based formulations, product development, production set up and regulatory demands with 30 years experience in developing Hyaluronan based products for the medical device and pharmacutical industries.
Hyalink™ X is a patented technology for preparing cross-linked Hyaluronan hydrogels. The process results in safe and efficacious products with characteristics specified by the client. The Hyalink™X hydrogels are appropriate for all types of clinical, pre-clinical and research/diagnostic applications. Hydrogel properties are specified by the client after consulting with our formulation scientists.
Hyalink™ X is versatile and adaptable to customers’ specific requirements to produce ready to use devices for many applications and sustained release/depots for drug formulations.
Benefits of Hyalink™ X
Versatile and proven technology producing hydrogels with customized viscoelastic properties,
Proven scalability for clinical products,
Well tolerated, safe, biocompatible - 2 decades of use with millions of patient injections
Demal fillers and viscous supplements-Highly tunable process to develop new proprietary formulations or to mimic existing commercial products
Topical formulations-Formulations for topical skincare or wound care applications
Ophthalmic surgery-OVD (ophthalmic visco-elastic devices) formulations to compliment high molecular weight HA products
Anti-adhesion-Products for surgical applications to prevent adhesion or to stop post surgery bleedings
Drug delivery / controlled release-Injectable drug loaded depots to extend release of almost any API, including small molecules, peptides and proteins,
Simple biodegradable vehicle and not a New Chemical Entity (NCE) as defined by regulatory authorities
Streamlined business model for faster time to market
Access to the Hyalink™ X technology (tech transfer + final hydrogel formulation support) is by license or as bulk (non-sterile or sterile) raw material. In either case, Hyamedix can support you in your product development with our extensive knowledge of Hyluronan in order to enable fast product development.
Our R&D capabilities include, but are not limited to, the investigation of hydrogel swelling, rheology, biodegradation, subsequent processing to suit given applications, compatibility with excipients, active pharmaceutical ingredients (APIs), and preservatives. With an established expertise in Hyaluronan and cross linked Hyaluronan, Hyamedix is here to support in the development of your innovative solutions.
With dedicated formulation labs, Hyamedix can develop proprietary custom formulations based on hyaluronan for many application areas including cosmetics, medical devices and pharmaceuticals.
We have extensive experience working with medical device and pharmaceutical clients developing viscous formulations in the areas of dermo-cosmetics (topical and injectable), dermal fillers, mesotherapy, wound care, ophthalmology, orthopaedics and oncology.
We can also support in the area of drug delivery and controlled release.
Hyamedix can support and help with existing client formulations by optimising those formulations for better processability, sterilisation and/or efficacy in the determined application area.
Hyaluronan Product Development & Regulatory Support
With years of experience in Hyaluronan product development, our team can support in getting from the very initial stages of product concept through to product launch.
We have extensive experience working with medical device and pharmaceutical clients developing new products and/or the optimisation of existing products in the areas of dermo cosmetics (topical and injectable), dermal fillers, mesotherapy, wound care, ophthalmology, orthopaedics and oncological applications.
We can also support in the area of drug delivery and controlled release.
With an ever changing regulatory environment, we can help in developing a regulatory plan to meet the needs of any Hyaluronan based medical device or drug product.
We can support in the following areas:
Development of a Regulatory Plan
Development of a Quality Management System (QMS)
Choice and dialogue with an appropriate authority/notified body
Understanding and compliance with the Medical Device Regulation (MDR) and/or the Medical Device Directive (MDD)
Preparation and submission of relevant documents
CE marking and registration
Hyamedix can also assist in any other aspect of developing new products in regards to production and lab set up, scale up and any other production related demands.
Hyalink™ 3D - Patent Pending HA hydrogel printing technology
Our patent pending Hyaluronan (HA) 3D hydrogel printing technology for cell culture, regenerative medicine, tissue engineering and drug delivery and drug release
A highly tunable and reproducible 3D hyaluronan based hydrogel bioprinting technology using Computer Aided Design (CAD) software enabling the creation of tissue constructs with heterogeneous compositions and complex microarchitectures
Can be used for preparing scaffolds/matrices for cell culture analyses, tissue engineering (bone, cartilage, skin, heart valves, etc.) and as a drug delivery/release vehicle
Well-described constituents already used in many medical applications; hyaluronan based cross linking, 100% biocompatible
1 Department of Anesthesiology, Rush University Medical Center, Chicago, IL, United States. Electronic address: Jeffrey_kroin@rush.edu.
2 Department of Biochemistry, Rush University Medical Center, Chicago, IL, United States.
3 Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, United States.
4 TAK Biopharma (as of 2017 known as Hyamedix), Copenhagen, Denmark.
5 Albumedix (Novozymes), Cincinnati, OH, United States.
6 Department of Biochemistry, Rush University Medical Center, Chicago, IL, United States; Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL, United States; Department of Internal Medicine (Section of Rheumatology), Rush University Medical Center, Chicago, IL, United States; Department of Bioengineering, University of Illinois at Chicago, IL, United States; Jesse Brown Veterans Affairs Medical Center, Chicago, IL, United States.
Intraarticular steroid injection has been the mainstay of short-term treatment of knee osteoarthritis (OA) pain. However, the duration of therapeutic effect from a single injection is not as long as desired. In this study we use a viscous formulation of triamcinolone acetate (TCA) in hyaluronic acid to prolong the anti-allodynia effect of that steroid. OA was induced in mice by a partial medial meniscectomy. Over time the animals' developed a mechanical allodynia in the injected leg. Mice were then given a single intraarticular injection of TCA in a short-acting DMSO formulation, or a standard commercial suspension, or the drug formulated in 5% hyaluronic acid for slow-release. Control injections in OA mice were PBS or 5% hyaluronic acid vehicle. Mechanical allodynia was then monitored over the therapeutic period. Organotypic spinal cord slices and DRG culture were performed to assess whether TCA attenuates expressions of pain mediators induced by interleukin 1β. TCA 40μg in a fast-releasing DMSO formulation produced relief from mechanical allodynia for a few days compared to PBS control injections (P=0.007). Similarly, the commercial suspension of TCA 40μg also produced relief from mechanical allodynia for a few days compared to PBS control injections (P=0.001). However, TCA 100μg in 5% hyaluronic acid produced relief from mechanical allodynia for at least 28days compared to PBS control or 5% hyaluronic acid vehicle injections (P=0.0005). Furthermore, TCA significantly suppressed expression of pain mediators induced by interleukin 1β in spinal cord and DRG organotypic culture. Intraarticular TCA in a sustained release formulation of viscous 5% hyaluronic acid will produce a long-term attenuation of mechanical allodynia in the OA knees of mice.