Plasma Rich in Growth Factors is recognised as a medical product for human use by the Spanish Agency of Medicines and Medical Devices

Monday, July 15, 2013

• Endoret® technology, implemented and patented by BTI Biotechnology Institute, was the first technique for obtaining plasma rich in growth factors to receive international scientific endorsement.
• Endoret® technology complies with the Resolution published by the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) for obtaining plasma rich in growth factors and its use as medicinal product for human use.
• Its excellent therapeutic results in diverse fields of medicine, naturally accelerating the repair mechanisms of damaged tissues, are confirmed by multiple clinical trials and scientific publications since 1997.

Plasma Rich in Growth Factors is recognised as a medicinal product for human use by the Spanish Agency of Medicine Products and Medical Devices (AEMPS). The Resolution of the AEMPS published on 23 May 2013, represents pioneering regulations at the international level, and has had support from numerous scientific contributions by BTI Biotechnology Institute and its collaborators.

The Resolution establishes the therapeutic use (but not as a substitute) of plasma rich in platelets (PRP) and its fractions, components or derivatives as a medical product for human use. In this regard, Endoret® technology, developed by BTI, was the first technique for obtaining PRP for therapeutic use, Plasma Rich in Growth Factors (PRGF®), to receive international scientific endorsement.

The classification of plasma rich in growth factors as a medical product for human use means new requirements must be considered. From now on, its application must be by prescription only from doctors, dentists and podiatrists in their respective area of expertise, with the appropriate qualifications and experience in the treatment. Similarly, it must be performed with suitable equipment and instrumentation, and in healthcare facilities and centres that are duly authorised in accordance with the current regulations in the respective autonomous communities. In addition, various requirements have been established regarding quality, efficiency, traceability, drug surveillance and patient information, and the practitioner must guarantee compliance.

These include a requirement that the procedure for preparing and obtaining the plasma under a closed system uses approved materials and single-use disposable kits with the CE mark for each application. In this regard, Endoret® technology has the CE mark and complies with all the applicable requirements established by AEMPS for its use as a medical product for human use.

At BTI Biotechnology Institute we would like to highlight the significance of the categorisation of plasma rich in growth factors as a medical product for human use, something considered a milestones for Spanish science, achieved thanks to the scientific commitment to biological therapy developed by BTI since it began, along with more than 15 years of research, effort and perseverance.

Endoret® technology enables us to obtain a plasma rich in growth factors whose therapeutic applications imitate and accelerate the physiological repair mechanisms (by up to 40%) that start spontaneously in all tissues after an injury, stimulating their regeneration and repair and reducing the recovery time.

All of this is done using small concentrations of blood plasma obtained by centrifugation of the patient's own blood, which prevents any allergic reaction or rejection of the treatment occurring. Its excellent therapeutic results in diverse fields of medicine are backed by multiple clinical trials and scientific publications in the most highly regarded international journals.