Updated on 27 October 2025
AI-powered Healthcare with therapeutic red blood cells
Founder and CEO at Rius Medical
Waldachtal, Germany
About
[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 ERDERA project implies collaboration and exchange between innovation ecosystems.
2.1 Baden-Württemberg based Rius Medical to lead ERDERA sponsored clinical trial Phase 1/2 of new ATMP therapies solutions and new approaches to health data integration against Phenylketonuria (PKU) via Cell Factory – Pharmaceutical Facility “University of Turin” in supplying therapeutic red blood cells for clinical trial Phase 1/2 (i.e. TRL-6). Rius Medical supplies the Master Cell Bank, MCB-PKU asset / cell line cryovial to IT-FR-AT CDMOs.
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 Emilia-Romagna entity University of Parma for clinical studies services is focusing on secondary use of Health data only – (meaning cohort B and C).
2.4 IT-FR-AT-DE clinical trials in providing PKU patients cohort A with Rius Medical therapeutic red blood cells. Clinic opportunities are still open.
Stage
- TRL 6
Topic
- Endocrine/nutritional/metabolic diseases
- Mental and behavioural disorders / psychiatry /psychology
- Diseases of the nervous system / neurology
- Rare diseases
- Regenerative medicine
Sector
- Health data
- ATMPs
- AI
- Diagnostics
- Rare diseases
Type
- Co-development
- Clinical validation
Organisation
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Business Opportunity
- TRL 6
- ATMPs
- Oncology
- Pediatrics
- Health data
- Diagnostics
- Rare diseases
- Rare diseases
- Clinical validation
- Research collaboration
- Congenital or chromosomal abnormalities
- Pregnancy, childbirth and the puerperium
- Diseases of the blood and immune disorders
- Diseases of the nervous system / neurology
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- Health data
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- Research collaboration
Simone Melchionna
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- Musculoskeletal system, connective tissue
- Other symptoms, deviant clinical findings
Xin Xiong
Principal Investigator at NMI Natural and Medical Sciences Institute
Reutlingen, Germany