AI-powered Healthcare with therapeutic red blood cells

[1] Up to 90% adult PKU patients do not comply with low Phe dietary therapy. Untreated Phenylketonuria (PKU) lead to irreversible brain damage as severe as Psychotic disorders (anxiety and depression), autism spectrum disorders (ASDs) or attention-deficit/hyperactivity disorder (ADHD) / Mental Health impacting well-being. Patients with PKU had 7.7 times higher costs compared with non-PKU controls. PKU patients were hospitalized more often and stayed longer in the hospital compared with their matched controls. Also, in the outpatient sector, PKU patients utilized more healthcare resources regarding physician visits compared with their matched controls.

Rare disease of metabolism PKU: Because essential amino acid Phenylalanine (Phe) is found in dietary protein, this involves consuming a low protein diet. Foods that contain large amounts of Phe must be eliminated from a low Phe diet. High protein foods such as milk, dairy products, meat, fish, chicken, eggs, beans and nuts; cause high blood Phe levels for people with PKU - an inherited disorder of metabolism for lacking liver enzyme Phenylalanine hydroxylase (PAH) resulting in Phe build-up due to inability to breakdown dietary Phe.

Personalised Medicine for PKU patients implies diagnostic with real-time of blood Phe levels. That’s because differences between patients with the same disease is largely dietary intake (vegan, vegetarian and other diets or none). Rius Medical unlocks Digital Health with Diagnostic alongside Therapeutics!

[2] Access to innovative therapies and digital health solutions in this PRECISEU project implies collaboration and exchange between innovation ecosystems.

2.1 Baden-Württemberg based Rius Medical to lead PRECISEU sponsored clinical trial Phase 1 of new ATMP therapies solutions and new approaches to health data integration against Phenylketonuria (PKU) via contracting Lombardi Milan-based CDMO AGC Biologics (1x entity from non-PRECISEU regions) in supplying therapeutic red blood cells for clinical trial Phase 1 (i.e. TRL-6). Rius Medical supplies the Master Cell Bank, MCB-PKU asset / cell line cryovial to AGC Biologics.

2.2 Romania based Digital Innovation Zone, DIZ is a European-recognized digital innovation hub (eDIH) with a large team of specialists in technology, marketing, artificial intelligence, consulting, design and implementation. On this EoI, Rius Medical is a client to DIZ for health data integration on Phenylketonuria (PKU) patients and the new ATMP therapy by Rius Medical.

2.3 Regione Emilia Romagna (RER) based IRCCS AOU Policlinico “S.Orsola-Malpighi”. The IRCCS is a leading center for rare diseases in Emilia-Romagna, caring for over 10,300 patients with more than 200 different conditions—nearly a quarter of the region’s total rare disease patient population [Bologna, IT]. For PRECISEU sponsored clinical trial Phase 1 of new ATMP therapies by Rius Medical as PKU-therapeutic red blood cells against Inherited Metabolic Disorders Phenylketonuria (PKU), IRCCS AOU Policlinico has expertise with over 500 clinical studies and creative and experimental phase I-II-III-IV diagnosis and therapy programs that are active for treating oncological and hematological diseases in adult and pediatric patients.

2.4 Alternative to Italy clinical trials is the strong links to Spanish technology transfer institutions if Rius Medical EU clinical deployment is at biocat - building the Advanced Therapies community in Catalonia for advanced therapies. That is a CDMO in Spain Catalonia for supplying Spain Hospital Clínic and Hospital Sant Joan de Déu that aims to better understand phenylketonuria (PKU). Clinical trial in Catalonia provides the PKU patients for Rius Medical therapeutic red blood cells.