Trimph is an Australian biomedical company that has developed an injectable class of scaffolds that is able to regenerate bone, cartilage and connective tissues. Trimph’s scaffolds are fully synthetic and resorbable to the body. Trimph has a robust Intellectual Property portfolio including a granted patent in the USA and Europe as well as multiple international patent applications.
The technology was co-invented by Dr Ali Fathi during his PhD at the University of Sydney. Ali and Terence founded Trimph in August 2015 and since then, established company’s ISO13485-2016 certified production facility, completed the first in human trial and secured private and public funds. Trimph has manufacturing, regulatory, clinical and technical expertise to launch minimally invasive therapeutic alternatives to improve patient outcomes.
Trimph’s device is an injectable scaffold that can be administered to different injured tissues without the need for invasive surgery.
At body temperature, Trimph’s device forms an adhesive gel to provide a physical scaffold that mimics the matrix formed during the early stages of healing.
Trimph’s physical scaffold compliments the natural healing process by providing an optimised environment for cellular regeneration and repair.
Over time, host cells repair the damaged tissue while Trimph’s scaffold resorbs to the body, leaving healthy tissue.
Trimph has established its own cleanroom production facility that is fully equipped to manufacture sterile medical devices. The infrastructure and the associated quality management system are ISO13485:2016 certified. Trimph’s in-house production facility is of a great importance for quality control, protection of technology know-hows, product development and production scalability. In addition, the company’s certified production capability facilitates efficient clinical development.
Trimph completed its first in human trial in Perth, Australia. The pilot trial involved the use of Trimph’s scaffold for socket preservation post tooth extraction in 10 patients. In all patients, Trimph’s device was successfully administered; there was no need for use of membrane or micro-suturing at the extraction site. This allows the principle investigator (A/Prof Calder) to save time in the theatre. In follow-up visits, wound closure was noted at seven days post-extraction and there was no sign of infection or inflammation in any patients. Three months post use of TrimphDent, tissues biopsies were collected from the site for histochemical analyses; the results showed that the product was fully resorbed and there was no sign pathological abnormality at the site. In addition, active bone remodelling was also noted at the site.
Easily injectable, instant gelation,
and no device malfunctions
No infection, inflammation
or pain reported
Wound closure noted
at 7 days post-extraction
Active bone remodelling
in all collected tissue samples
*Change in treatment plan due to personal circumstances.
In molecular level, Trimph is a water based solution of a propietry patent smart polymer and peptide that are covalently bonded. Upon the injection to the body, the product forms an elastic scaffold (hydrogel). To address different clinical needs, mechanical properties, adhesivity and the resorption rate of Trimph can be tuned.
The smart polymer is poly(N-isopropylacrylamide )-co-(polylactide/2-hydroxy methacrylate)- co -(oligo (ethylene glycol), denoted as PNPHO. Trimph’s smart polymer consists of four main building blocks, called monomers. The chemical composition of PNPHO and the role of each monomer is as follows;
Amine groups of peptides can bond covalently to succinimide ester arms of PNPHO smart polymer. The resorption rate of the final product can be tuned by the degree of crosslinking between PNPHO and peptide. This allows the formulation of Trimph hydrogels with varying physical properties for different clinical applications.
Amine groups of peptides can bond covalently to succinimide ester arms of PNPHO smart polymer. The resorption rate of the final product can be tuned by the degree of crosslinking between PNPHO and peptide. This allows the formulation of Trimph hydrogels with
TrimphGlue is an injectable elastic scaffold which is easily applied to bone defects. The scaffold is inherently angiogenic and promotes vascular ingrowth. Osteoinductive compounds can be incorporated at low doses, if required.
TrimphDent is a ready to use injectable scaffold that is applied immediately after tooth extraction to facilitate wound healing in both soft and hard tissue. Unlike other bone substitutes, TrimphDent is delivered to the socket as a liquid to stabilise the blood clot without the need for physical containment.
Trimph has a robust Intellectual Property portfolio including a granted patent in the USA and Europe as well as multiple international patent applications. The granted patent covers the proprietary smart polymer. Further patent fillings protect specific formulations of the polymer and relevant clinical applications.
Trimph’s production facility in Alexandria, Sydney is capable of producing 500 sterile devices per week. Quality control and quality assurance of the manufacturing process as well as tractability and distribution of products are governed certified quality management.
Trimph has completed cytotoxicity and biocompatibility study in accordance with ISO10993 requirements. Trimph’s devices are well tolerated in the body and biocompatible. In addition, numerous animal studies confirmed the ability of the product for the regeneration of different tissues.
Trimph products are produced locally under the close supervision of Trimph’s technical team at its own production facility. The associated Quality Management System is ISO13485:2016 certified by BSI. The ISO certification covers the production of all Trimph based, sterile and injectable medical devices.
With the aid of NSW Health and Accelerating Commercialisation funding, Trimph completed its First-in-Human Trial. Trimph’s pilot trial was conducted in Perth under ICH/GCP and ISO 14155 requirements. The product was well-tolerated in all patients as there was no report of discomfort, pain, infection or inflammation at the site. Wound closure was also noted within 7 days post tooth extraction. Preliminary results also showed active bone remodelling at the socket site.
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