Solutions for
Cerebrovascular
Disease

Lamiflo™ is the first non-pharmacologic for cerebrovascular disease.

Lamiflo™ is a new approach to an old problem

Lamiflo™ is a disruptive technology in current stroke protocol because it can be administered in the pre-hospital phase; will increase the number of patients qualifying for treatment by thrombolysis or intra-arterial thrombectomy; can be used in patients who do not qualify for either treatment; and could be used in patients, days to months after a stroke, who are still at risk for a second stroke.

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A global
emergency

Cerebrovascular disease is a global emergency as shown in the infographic on the right. Lamiflo™ is considered disruptive technology in its application to acute large vessel occlusion (LVO) stroke as in our current focus because it can be administered in the pre-hospital phase; will increase the number of patients qualifying for treatment by thrombolysis or intra-arterial thrombectomy; can be used in patients who do not qualify for either; and could be used in patients, days to months after a stroke, who are still at risk for a second stroke.

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Our goals

  • Apply for a proof of concept NIH Phase I SBIR grant for Lamiflo™.
  • Apply for NIH Phase II SBIR grant for IND enabling studies and Phase I clinical safety study on healthy volunteers and commercialization plan.
  • Obtain the IND and conduct Phase I clinical safety study in healthy volunteers.
  • With Partner support perform a Multicenter Phase II Clinical Safety and Efficacy Trial of Lamiflo™ in acute stroke patients with large vessel occlusion before or after Thrombolysis (TLY) or Intra-Arterial Thrombectomy (IAT).
  • Perform a Phase III Clinical Trial to compare the effectiveness of Lamiflo™ to other therapeutic procedures available again in LVO acute stroke patients; and
  • Obtain FDA approval for the medication.
  • Perform a Phase IV clinical trial in LVO acute stroke patients to obtain long term safety and other benefits of Lamiflo™ treatment.
  • Commercialization of Lamiflo™.

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