Edison Histotripsy System Selected for Competitive Accelerated Market Access Program
Minneapolis, MN. February 14th , 2024 – HistoSonics ® , (www.histosonics.com), the manufacturer
of the Edison ® System and novel histotripsy therapy platforms, announced today that the
company’s Edison System has been selected to participate in the UK’s newly created Innovative
Devices Access Pathway (IDAP) Pilot Program designed to accelerate the development of cost-
effective medical devices and their integration into the UK market. Applications to compete for
one of the 8 available places in the highly 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 designed and developed by a partnership of 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 Scottish Health Technology Group to test the IDAP pathway and to
expedite the incorporation of novel medical technologies that have demonstrated the potential to
meaningful address the UK’s top healthcare concerns of today, as well as in the future. The
Edison Histotripsy System was measured against four distinct eligibility criteria that were
required of applicants for consideration in the IDAP program. Applicants must have met the
following in order to be considered for the IDAP Pilot Program; 1) the technology addresses a
life-threatening or seriously debilitating condition and there is a significant patient need, 2) the
technology is innovative and transformative, 3) the technology will provide system wide benefit,
and 4) the technology clearly helps to address one of the following Life Sciences Vision’s
Healthcare Missions. In addition to meeting the eligibility criterion set, the IDAP program
enlisted patient experts in the shortlisting and selection of the eight innovative and
transformative medical devices that were eventually chosen to participate.
“Selection to the IDAP program is validation of our team’s purpose of meaningfully changing
the lives of patients suffering from life-threatening conditions, starting in the liver, kidney and
soon in the pancreas. The criteria set forth for the IDAP Pilot Program align extremely well with
our company’s goals of providing access to innovative, non-invasive treatment to all those who
may benefit from histotripsy’s unique benefits across diverse health systems,” said Mike Blue,
HistoSonics CEO and President. “Our experience conducting clinical trials in the UK has
provided us with both the clinical outcomes and patient experiences that fulfill the rigorous
criteria set by the MHRA, and we look forward to continuing the progress we’ve made in
establishing the patient benefits of histotripsy across the UK,” added Blue.
The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation
that mechanically destroys and liquifies targeted tissue, including tumors, at sub-cellular levels.
HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver
personalized, non-invasive histotripsy treatments with precision and control. The company
believes that the novel mechanism of action of their proprietary technology may provide
significant advantages to patients, including the ability of the treatment site to recover and resorb
quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the
destruction of tissue under continuous real-time visualization and control, unlike any modality
that exists today.
The Edison System is indicated for the non-invasive destruction of liver tumors, including
unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
About HistoSonics
HistoSonics is a privately held medical device company developing a non-invasive platform and
proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action
that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The
company is currently focused on commercializing their Edison System in the US and select global
markets for liver treatment while expanding histotripsy applications into other organs like kidney,
pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.
For more information please visit: www.histosonics.com/
For Media Inquiries
Media contact:
Josh King
Vice President of Marketing
Email: Joshua.king@histosonics.com
Phone: 608.332.8124
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.
