KYME NanoImaging srl was founded on April 2018 in Naples.
The company is managed by a team of three biomedical engineers, a researcher in Bioengineering and a Professor of the University of Naples “Federico II”.
KYME is also a spin-off project of the “Center for Advanced Biomaterials for Healthcare” of Istituto Italiano di Tecnologia (IIT@CRIB) of Naples.
Need. Magnetic Resonance Imaging (MRI) is the most used diagnostic modality and about 40% of MRI scans are performed with Contrast Agents (CAs), which improve the quality of the MR images. More than 8 million of MRI scans use CAs in Europe, and more than 10 million in USA. Despite the use of CAs, the medical images still have poor contrast and clinicians are forcedinject high dosage, causing accumulation of the CAs in brain and kidneys and acute side effects, like allergies or nephrotoxicity. Between 2010 and 2017, FDA and EMA suspended the marketing authorization for 4 out of 9 CAs available at the time.
Solution. KYME proposes the solution to overcome some limitations of commercial CAs combining biocompatible materials with clinically approved CAs through a nanotechnology platform. The proposed formulation improves efficacy of current CAs up to 10 times without modifying their chemical structures, as approved in clinical use by FDA, potentially reducing administration dosage and toxic effects.
Market and business perspective. KYME intends to penetrate the global market of CAs, which is expected to grow by about 43% by 2022, reaching an estimated value of $6 Billion. Current CA business is led by multinational players (Bayer, Bracco, Guerbet). Since most of CAs’ patents owned by these companies are now expiring, the market will tend to be more competitive and dynamic, moving towards a new equilibrium leaving space to innovative solutions. KYME aims to catch this opportunity offering to big companies the chance to improve their existing products and renew the expiring patents.
Stage of development and financial needs. The proof of concept is published in peer-reviewed journals. KYME products are made through a patented process, PCT application deposited on December 2015. The products are manufactured prototypes and are currently studied in IIT@CRIB laboratories in compliance with Good Manufacturing Practice (GMP) rules. Preclinical studies on mice are performed in collaboration with hospitals and diagnostic centers in Naples, while further preclinical studies on big animals will be outsourced to Contract Research Organizations (CRO). Larger scale clinical tests are the main reason for fund searching.