Smart Reactors is a Research and Development company based in Galway, Ireland established in 2019. The founding team have more than 40 years medical device experience across multiple disciplines including; Early Stage R&D to Full-Scale Commercialisation. The company is developing a Hemocompatible coating Heparin Free Technology which can be applied to multiple medical devices. The Company is at pre-seed and is actively exploring research and developing collaboration and funding opportunities.
The interaction of medical devices with blood leads to cellular as well as humoral reactions, which can result in an unwanted inflammation and activation of the coagulation.
The blood contacting devices involved in medical applications include a wide range of plastics, metals and alloys. These materials have excellent mechanical and physical properties, however they have variable hemocompatibility and when in contact with blood can lead to a pathophysiological reaction similar to traumatic shock. Therefore, minimization of the activation mechanisms induced by the foreign surfaces used in blood contacting medical devices is of top priority.
While heparin coatings have been the standard for more than 30 years, new surface treatments, mainly without heparin and not regarded as pharmacologically active surfaces are becoming the physician preference. It is important to recognise that hemocompatibility is not only characterized by the reduction of thrombus progression but also by reduced thrombin formation rate, less platelet loss and less activation of platelets, leukocytes, and lower inflammatory response reactions (e.g. complement system etc.). The unaltered long-term aim is to create an optimal biocompatible surface that is not recognized as “non-physiological” by the blood and thus does not provoke any pathological activation of the humoral and cellular defence mechanisms.
Smart Reactors have developed a proprietary passive surface coating technology that serves this unmet need.
The key features of the coating includes:
- Heparin Free Technology - Majority of competitors incorporate heparin which brings many challenges including;
- HIT (Heparin Induced Thrombocytopenia) -1% occurrence of Heparin users.
- Supply Chain - 80% of Heparin sourced from Asia, supply, contamination & recall issues.
- Regulatory Approvals - Heparin is a Drug and brings with it a designation as a “Medicinal product” or “combi-product” designations with longer approval time & cost associated.
- Manufacturing Cost - Heparin is a very expensive drug to source and subsequently expensive to apply to the device.
- Excellent In-Vitro Performance - Tested in a GLP laboratory and satisfies ISO 10993-4 requirements. On-Par or out performs key performance markers of leading market coatings.
- Biologically Inert - No bioactive substances
- Versatile Manufacturing Process -The manufacturing process is carefully defined with the technology compatible to a wide-range of surfaces
- Reduced Manufacturing Cost -The manufacturing cost is significantly less than that of Heparin coating technologies.
Smart Reactors surface coating may be developed for short and long term applications; e.g. intravascular vascular implants (stents, valves, prostheses, catheters, ports, etc.), extracorporeal circulation accessories (oxygenators, pumps, arterial and venous cannulae, tubing, etc.). The Smart Reactors coating mimics a physiological environment which can be very advantageous for the prevention of later rejection reactions of implants (host versus graft reaction).
Independent opinion statement, Prof Hans Peter Wendel, University of Tubingen - Report.
"Smart Reactors coating technology has been testing at Tubingen University in the GLP lab in accordance to ISO-10993-4. The advantages of the coating consists of a passivation & neutralization of the artificial device surface, leading to a fast formation of a blood friendly matrix, not recognised as artificial by the blood. The novel coating was evaluated in comparison to a number of commercially available coating, both heparin & non-heparin base systems. The hemocompatible markers tested during the studies demonstrate excellent hemocompatibility"
Prof. Hans Peter Wendel (Tubingen, Germany)
Prof & Dr. Wendel is a world renounced KOL & expert in the hemostaseology for Extracorporeal circulation and the interactions of blood to foreign surfaces. He worked for many years championing the Clinical Research Laboratory in the Department of Thoracic, Cardiac & Vascular Surgery at the University Klinikum in Tubingen, Germany.
"The development of a cost-efficient surface coating methodology imitating a natural occurring layer by utilising a natural occurring protein, such as albumin, would be a great opportunity to reduce certain side-effects and the potential of non-desirable body responses in case of undiagnosed HIT."
Dr Markus Fischer
Advanced Clinical Perfusion Scientist) Galway Clinic, Ireland
"There continues to be a significant demand for a cost effective, bioinert coating technology to improve the clinical performance of blood contacting medical devices. The Smart Reactors system is providing very encouraging data from in-vitro evaluations, indicating excellent blood compatibility"
Dr Mike Driver
Director, Biomaterials Consulting Limited and editor of Coatings for Biomedical Applications, Woodhead Press