Pasithea

Pasithea addresses the gaps in existing treatments for sleep apnea syndrome with an innovative non-invasive neuromodulation device that is clinically validated and secured by 9 family patents. Simplified pathway, longitudinal treatment monitoring, and a solid market entry strategy, the company aims to significantly improve the quality of life of SAS patients and contribute to better long-term treatment adherence. The experienced team and government support for DTx position Pasithea as a promising player in the treatments for sleep apnea syndrome.

The Innovative Solution from Pasithea 

• New Therapeutic Device: Pasithea proposes a non-invasive kinesthetic neuromodulation device using the “startle reflex” to activate the subcortical centers controlling the muscles of the upper airways. This innovation aims to provide a quick, easy-to-use, and effective solution for a large proportion of patients.
• Innovation: At the current stage of our knowledge, Pasithea is the only proposal capable of both
  • Detecting the respiratory event (Apnea - Hypopnea) in its early phase
  • Applying non-invasive neuromodulation of the autonomic nervous system to stop the event
  • Adapting the neuromodulation according to the patient and his sleep stage.
• Longitudinal follow-up: A dedicated therapeutic smartphone application (DTx) allows remote patient monitoring, facilitating longitudinal follow-up by health professionals covering titration, efficacy, and adherence.
• Competitive Advantages of the new device:
  • Targets patients who have failed CPAP treatment and patients with moderate syndrome.
  • Easy to use, not bulky, suitable for the majority of patients.
  • Reduced care pathway to a minimum
  • Cloud-based therapeutic monitoring, accessible by health professionals.
• Validation / Protection: Clinically validated in two multicenter studies on more than 100 patients and protected by 9 patent families, the treatment has demonstrated a reduction in frequency (-40%), duration (-30%) and severity of apneas, resulting in a significant decrease in syndrome severity (-40%). The technology has benefited from four years of research and nine patents securing it.
• Experienced Team: The Pasithea team, led by CEO Pierre Ansay with 20 years of experience in the development of bio-electronics and sleep medicine startups, from scratch to the CE and/or FDA clearances. He is accompanied by the two inventors Alfredo Hernandez (CSO, research director at INSERM Rennes and he has authored/co-authored more than 200 peer-reviewed publications and he is inventor of more than 50 individual patents, most of which have been transferred to or co-registered with MedTech companies.) and Jean-Louis Pepin (international KOL in sleep medicine with more than 600 published articles and he is ranked as having the 3rd highest expertise worldwide in the field of sleep apnea by the “Expertscape” website). A CTO candidate has also been hired, a former PhD of Alfredo,  with more than 10 years of experience in biomedical engineering.
• Roadmap for Market Entry: The company has developed a solid 4-year plan for device reimbursement, integrating internal strategic development, subcontracting, and high-impact clinical studies. Market access is facilitated by the reimbursement regime for digital therapy (DTx) applications.