HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, announced the selection of the Innovative Devices Access Pathway (IDAP) pilot program, which will develop cost-effective medical devices and their integration into the British market. The application phase for one of the 8 available places in the sought-after UK program began in 2023 and was open to UK and international commercial and non-commercial developers with new health technology solutions.
The IDAP pilot program was launched as part of a partnership between the Department of Health and Social Care, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), NHS England, Health Technology Wales and the Scottish Health Technology Group designed and developed to test the IDAP pathway and accelerate the deployment of novel medical technologies that have proven potential to meaningfully solve the UK’s key health challenges today and in the future. The Edison Histotripsy System was evaluated against four different eligibility criteria that were critical for inclusion in the IDAP program. To be considered for the IDAP pilot program, applicants had to meet the following criteria: 1) the technology addresses a life-threatening or debilitating condition and there is significant patient need, 2) the technology is innovative and transformative, 3) the technology provides a system-wide benefit and 4) the technology demonstrably contributes to achieving one of the following Life Sciences Vision’s Healthcare Missions. The IDAP program not only met the eligibility criteria, but also involved patient experts in the pre-selection and selection of the eight innovative and innovative medical devices that were ultimately selected for participation.
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“Acceptance into the IDAP program is an important recognition of our team’s goal to make a lasting difference in the lives of patients suffering from life-threatening diseases, starting with patients with liver and kidney diseases and soon with pancreatic diseases.
“The criteria defined for the IDAP pilot program align well with our company’s goals of providing access to innovative, non-invasive treatment across a wide range of healthcare systems to all people who can benefit from the unique benefits of histotripsy,” said Mike Blue , CEO and President of HistoSonics. “Our experience in conducting clinical trials in the UK means we have both the clinical outcomes and patient experience to meet the MHRA’s rigorous criteria and we look forward to continuing our progress in establishing the patient benefit of histotripsy in the UK United Kingdom,” continued Blue.
Scientific histotripsy uses focused acoustic energy to produce controlled acoustic cavitation that mechanically destroys and liquefies target tissue, including tumors, at the subcellular level. The HistoSonics Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control. The company believes the proprietary technology’s novel mechanism of action offers significant benefits to patients, including allowing the treated area to regenerate and reabsorb more quickly. What is also unique to date is that HistoSonics’ platform offers doctors the ability to monitor tissue destruction with continuous real-time visualization and control, unlike any other modality.
SOURCE : BusinessWire