HistoSonics Inc. Archives - Medical Design Sourcing

HistoSonics scores reimbursement win for sonic beam therapy

The Edison histotripsy system. [Image courtesy of HistoSonics]HistoSonics announced today that the Centers of Medicare & Medicaid Services (CMS) set a new payment rate for its tumor treatment.

Minneapolis-based HistoSonics develops a histotripsy treatment for liver tumor procedures. Last month, the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms.

Edison, an image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. The system received FDA investigational device exemption in February. In March, HistoSonics announced the first kidney tumor treatment with its novel therapy system.

CMS set a new payment rate for this therapy, increasing the payment to $17,500. In its rule-making process, CMS utilized claims data from the HistoSonics #HOPE4LIVER trial in the U.S. to increase the outpatient payment…

FDA grants de novo nod to HistoSonics histotripsy system

The Edison histotripsy system. [Image courtesy of HistoSonics]HistoSonics announced today that the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms.

Edison, an image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. The system received FDA investigational device exemption in February. In March, HistoSonics announced the first kidney tumor treatment with its novel therapy system.

The company believes Edison’s mechanism of action could provide significant advantages to patients. Those include the ability of the treatment site to recover and resorb quickly. Additionally, the platform enables physicians to monitor the destruction of tissue under continuous, real-time visualization and control.

Minneapolis-based HistoSonics says the de novo nod makes Edison the first and only histotripsy platf…

FDA approves HistoSonics IDE trial for sonic beam therapy that treats renal tumors

An example of the company’s Edison technology targeting kidney tissue to be destroyed in a non-invasive histotripsy procedure. [Image courtesy of HistoSonics]HistoSonics announced today that it received FDA approval for an investigational device exemption (IDE) trial of its Edison system.

Minneapolis-based HistoSonics designed its Edison system to target and destroy targeted primary renal tumors. It achieves this in a non-invasive manner without the need for incisions or needles. Edison uses a novel sonic bean therapy called histotripsy.

HistoSonics has backing from some major players in the medtech space. In May 2022, it entered into an agreement with GE HealthCare to use its ultrasound imaging to power the novel sonic beam therapy. In December 2022, HistoSonics raised $85 million in a financing round led by Johnson & Johnson Innovation.

The company said FDA approval for the Hope4Kidney trial follows recent results from its Hope4Liver trials. Bot…

J&J leads $85M raise for HistoSonics

The Edison system. [Image from the HistoSonics website]HistoSonics announced today that it raised $85 million in a financing round led by Johnson & Johnson Innovation.

Minneapolis-based HistoSonics develops a novel sonic beam therapy. This uses histotripsy, which mechanically destroys and liquified unwanted tissue and tumors at sub-cellular levels. It develops the non-invasive Edison platform that combines imaging with proprietary sensing technology to deliver beam treatments.

Edison, currently not for sale, is intended for use in the destruction of liver tissue. The company expects marketing authorization from the FDA in 2023.

HistoSonics said in a news release that it plans to use proceeds from the financing to support Edison. That includes its anticipated commercial launch, additional clinical trials and expanded application development.

With Johnson & Johnson Innovation leading the round, HistoSonics also saw participation from existing i…

HistoSonics, GE Healthcare agree to integrate ultrasound into sonic beam liver therapy

[Image from HistoSonics]HistoSonics announced today that it agreed with GE Healthcare to use its ultrasound imaging to power novel sonic beam therapy.

Minneapolis-based HistoSonics’ agreement formalizes ongoing efforts to use GE Healthcare’s Logiq E10 Series ultrasound imaging platform to power the real-time visualization features of HistoSonics’ sonic beam liver therapy platform.

Under the agreement — and upon market authorization — HistoSonics will distribute GE Healthcare’s Logiq E10 Series in a one-to-one basis with its breakthrough liver therapy system, according to a news release.

HistoSonics designed its Edison system to use histotripsy to non-invasively destroy targeted liver tissue. Edison mechanically destroys and liquified targeted tissues at a sub-cellular level. The company said it plans to use GE Healthcare’s imaging platform to offer continuous visualization for key and unique elements of the histotripsy therapy …

HistoSonics announces $40m Series C

Non-invasive robotics platform and sonic beam therapy developer HistoSonics announced today that it closed a Series C-1 financing worth $40 million.

Yonjin Venture led the oversubscribed funding round, while Varian Medical Systems, Johnson & Johnson Innovation, Venture Investors, Lumira Ventures, State of Wisconsin Investment Board and more participated as well, according to a news release.

Minneapolis-based HistoSonics intends to use the proceeds to accelerate activities centered around its Edison platform for non-invasive, personalized treatments with histotripsy for destroying targeted tissues at sub-cellular levels. Other funds may be used to launch new strategic projects as well.

Through histotripsy and focused sound energy, the Edison platform generates pressures strong enough to liquify and destroy those targeted tissues, offering the ability of the treatment site to recover and heal quickly while giving physicians a chance to monitor the dest…