Public Funding for Scubatx Limited

**Problem** Organ transplantation is the only affordable solution for many suffering end-stage organ-failure. Transplantation enables patients to live longer more fulfilled lives and reduces costs to the NHS over £300M/year. Organ demand far outstrips supply. Recent changes in law have tried to increase donor numbers by presuming consent, but organising operations and travel time between hospitals limits utilisation coupled with older/less-healthy donors means many organs cannot be used - over 11,000 patients die each year awaiting life-saving transplants. Solutions to address this are urgently needed saving lives, and making the most of the donor's life-saving gift. **Root of Problem** 99% of organs are still preserved on ice. This limits the time of preservation to 3-12 hours. Because of this many organs are wasted. New approaches capable of preserving some organs are capable of preserving organs for up to 24 hours. These systems are very costly and require specialist staff and facilities, which the NHS cannot afford. **Unmet Need** Need remains for improved preservation (healthier organs, more preservation time) that works within the current limitations of the NHS - people, money, logistics and physical space. Scientific research shows that optimising Oxygen delivery to organs during preservation is the critical factor to maintain health and extend preservation. **Innovative Solution** Supported by 20 years of scientific research - including previous work supported by InnovateUK - ScubaTx harnesses a proven but underused technique called Persufflation that delivers oxygen gas to the organ. ScubaTx device is simple to use, portable, fully-automated and affordable supporting widespread use across healthcare systems including the NHS. ScubaTx innovation isn't persufflation, but a patent-protected, fully automated device focused on minimising extra steps by doctors and nurses allowing them to focus on patient care whilst delivering improved preservation. ScubaTx will increase the availability of viable organs, lowering NHS costs and saving lives. **Outputs** With previous support from IUK, ScubaTx is close to completing the next-generation device. We have received significant interest from doctors and scientists to use our device. Grant funding will allow doctors to get hands-on experience with this device providing ScubaTx with important user feedback before increasing manufacturing to meet global needs. This grant will also allow ScubaTx to attract additional private investment and obtain its first commercial sales.

**Problem** Organ transplantation is the only available treatment for many patients suffering end-stage organ-failure. Transplantation enables longer life-expectancy, improved quality-of-life and reduced costs, versus standard-of-care. NHS transplant programme saves \>£300M/year. Transplant teams are overworked, and long unsociable hours limits staff recruitment. Unfortunately, donor-organ demand far outstrips supply. Recent 'opt-out' legislation targeted increasing donor numbers, but time and logistics are limiting factors, coupled with older/less-healthy donors means many organs cannot be used (not-retrieved, not-transplanted). Therefore, over 11,000 die each year awaiting life-saving transplant. Technologies maintaining donor organ quality are urgently needed to address this shortfall, saving lives, and making the most of the donor's gift. **Root of Problem** Many organs are not suitable for transplantation due to inability of standard-of-care organ preservation (Icebox) to maintain organs long enough to facilitate long-distance transport and logistics between donors and recipients. Icebox preservation times range from 3 to 12 hours depending on organ. Hypothermic and Normothermic Machine Perfusion devices capable of preserving some organ types (not pancreas) for up to 24 hours exist. However, cost of deploying them across healthcare systems is prohibitive; limiting their adoption. Furthermore, complexity means they require additional dedicated space, and additional staff from already overstretched transplant teams. **Unmet Need** The unmet need is for enhanced organ preservation (improved organ status, longer preservation time) that works within healthcare systems' real-world resource constraints; people, money, logistics and physical space. Research using Hypothermic and Normothermic Perfusion devices shows that optimizing Oxygen supply to organ vasculature is the critical factor for improved organ preservation over 24-hours. **Innovative Solution** ScubaTx harnesses Persufflation (gaseous oxygen perfusion), a proven but under-utilised organ preservation method. ScubaTx delivers Persufflation in a simple, portable, fully-automated, multi-organ, affordable format that will enable widespread deployment across healthcare systems world-wide. ScubaTx innovation isn't persufflation itself, but patent-protected practical embodiment of an automated base-unit delivering persufflation via organ-specific consumables, monitored by app. Persufflations key advantage is delivering Oxygen to the organ as a gas, at the optimal concentration/flow/pressure levels. Our device is a lot simpler to use, and no need for additional staff. We will significantly increase availability of viable organs; lowering costs and saving lives for financially stretched healthcare systems worldwide. **Outputs** Funding will accelerate health economics, and detailed-design and programming of base-unit, organ-specific consumables and monitoring-app; ready for industrialisation and clinical trials. Designs based on existing prototypes. This funding will move our technology one step closer to commercialisation and saving lives.