Who we are?
- German Start-up, EMA SME Qualification EMA/SME/357/15/R1
- To develop autologous (own) cord blood stem cell therapies in Europe/USA for the treatment of Pediatric brain injury
- Our product was granted ATMP-TEP Classification by EMA
What do we do?
- Develop and market (own) cord blood stem cell treatments for
- The treatment of Pediatric brain injury
- Periventricular leukomalacia
- Neonatal encephalopathy
- Perinatal intracranial hemorrhage
- Pediatric stroke
- Cerebral palsy
- Spinal cord injury
- Traumatic brain injury
What makes us unique?
- Worldwide first Orphan Drug Designation granted by the European Commission/EMA on October 14, 2016 for
- ‘Autologous mononuclear cells derived from human cord blood’ for the treatment of newborns suffering from:
- First successful autologous cell therapy of Cerebral palsy and coma in 2009 (Jensen et al., 2009; 2011; 2013)
- First successful autologous cell therapy of Perinatal ischemic stroke during birth (Jensen and Hamelmann, 2016)
- First pre-clinical prevention of ‘spastic paresis’ in newborn rats after cerebral hypoxic-ischemia (Meier et al., 2006)
What do we want?
- We seek early access to the market and ‘market exclusivity’ granted by EMA based on our autologous ATMP-TEP product and Orphan drug designations.
- Our ultimate goal is to provide for those in need early access to an autologous cord blood treatment for ailments for which there is no cure at present.
- We invite investors to participate in an unprecidented therapeutic innovation – The future of brain repair is now!
- New investors:
- Family Office A&C, Germany
- Professor M.R. Franz, M.D., PhD
Georgetown University, Washington D.C., USA
Entrepreneur, scientist, and founder
Is there a market in Europe?
What is the incidence of the disease each year?
- 15,000 children suffer from Periventricular leukomalacia
- 15,000 children suffer from Neonatal encephalopathy
- 27,000 children suffer from Perinatal intracranial hemorrhage
- 1,200 children suffer from Stroke
- 10,000 children suffer from Cerebral palsy
- 1,700 children suffer from Spinal cord injury (SCI)
- 3,000 children suffer from Traumatic brain injury (TBI)
Is the treatment safe?
- Worldwide approx. 387 children have been treated for brain disorders with autologous cord blood stem cells employing >500 infusions.
- Due to the autologous nature of the cord blood treatment, no serious infusion related adverse events have been observed. Rarely, mild transient adverse events were noted (1.5%) (Sun et al., 2010).
- Jensen A, (2014) “Autologous Cord Blood Therapy for Infantile Cerebral Palsy: From Bench to Bedside,“ Obstet Gynecol Int
- Sun J et al., (2010) “Differences in quality between privately and publicly banked umbilical cord blood units: a pilot study of autologous cord blood infusion in children with acquired neurologic disorders,” Transfusion, vol. 50, no. 9, pp. 1980–1987.