Neuraltide

Neuraltide develops the “Smart Swell-Suit®” or “3S”, a class IIb non-invasive and physiologically effective medical device intended to treat patients suffering from an Ischemic stroke who are non-eligible or contraindicated to standard of care treatments. 

Today, a vast majority of the patients couldn’t get causal treatments (Thrombolysis, Thrombectomy) that consist of re-perfusing the brain mainly because of a narrowed therapeutic window and potential side-effects.

The “3S” is composed of a Lower Body Suit (LBS , consumable) and a Central Unit (CU, equipment).

The LBS is adjusted on the body of the patients; it is activated and monitored by the CU; and then it generates a repeatable therapeutic gradient of pressure based on the Lower Body Positive Pressure (LBPP) Principle that speeds the blood stream up to the brain toward the heart and re-perfuses the brain damaged and at risk to necrosis.

Neuraltide is developing the “3S” with external R&D partners, BioSerenity & Ciele Innovelec that master required technical bricks.

The technology of the Smart Swell-Suit is protected by 2 patents filed in the key continents (Europe, USA, Japan and China). The core patent has been granted in Europe and China early 2023. We plan to file additional patents to strengthen our portfolio and prolong current IP protection.

Neuraltide is up to start to enrolling the first patients in June 2024 in the Tide-In study; a first-in-human, European multicentric, prospective, randomized clinical trial (equivalent to a phase II trial) with the objective to validate the “3S” technology in ischemic stroke patients with cerebral perfusion impairment. The Principal Investigator is Pr. Pierre Amarenco (Bichat’ Hospital-France / Brain Health Research Institute – Ontario, Canada) who is also an internationally recognized expert in cerebrovascular diseases with solid medical network across Europe and North of America.

Neuraltide works closely with an International Advisory Board composed by Pr. P Amarenco (AP-HP Paris); Pr. JC Baron (INSERM); Pr. G Albers (Stanford - USA); Pr. J Saver (UCLA - USA); Pr. D Liebeskind (UCLA - USA); Pr. S Yusuf (PHRI Halmilton CANADA); Pr. M Sharma (PHRI Hamilton CANADA).

In the next 2 years Neuraltide aims to work on the industrialization of the “3S” to get ready to apply for CE Mark end of 2026 , beginning 2027 and prepare US market access (Medical Device classification under FDA rules: eligibility Breakthrough Device Designation, with the support of our North American Advisory Board).