R&D patented bi-flow arterial cannula, called ;RHP2022, medical device for the re-infusion of oxygenated and decapneized blood through a peripheral artery in the ECLS, ECMO, solving distal ischemia.
Current Status
In July 2022 the patent PCT / IT2022 / 000038, previously 18/7/2022, was filed.
• In November 2022 the fluid dynamics tests in the tank are scheduled with certification of the final prototype.
• In December 2022, preclinical tests will begin, with a dedicated Phase 1 trial, under the protection of the authorization of an RUO from the Ministry of Health and I with the participation of a team of cardiac surgeons already identified.
• In February 2023, due diligence procedures began with various companies in the sector.
Problem or Opportunity
In the peripheral ECMO-VA modality (VA = veno-arterial), the channeling of the common femoral artery (infusion cannula) exposes the patient to the risk of reduced distal perfusion of the dependent zone, predisposing to probable ischemia of the lower limb.
Solution (product or service)
"RHP2022", changes the paradigm of acute ischemia of the channeled lower limb during the execution of the ECMO, reducing the incidence of the same, almost equal to 0. Reassures towards an innovative adjustable double flow system, with external sliding door and door of fixed dimensions, according to the patient's oxygen demand, it guarantees the effective and efficient perfusion of the lower limb without compromising the ECMO main flow towards the heart.
Business model
Will constitute a fundamental asset for the clinical positioning of the purchaser, and potentially could represent a gold standard for the practice of ECMO. RHP2022 an element of strength in the negotiation of an "exit strategy with big players in the market."
The agreed strategy is to arrive at a pre-certification with data obtained in preclinical and with fluid dynamics, the creation of a final validated prototype, accompanied by quality, operational and safety manuals.In addition, to the potential buyer, it is also intended to offer the Regulatory Path Design (MDR)
