/C O R R E C T I O N -- HistoSonics, Inc./

In the news release, HistoSonics, Non-Invasive Robotics Pioneer, Releases Promising Data at Society of Interventional Oncology (SIO), issued 11-Jun-2019 by HistoSonics, Inc. over PR Newswire, we are advised by the company that some updates have been made post-distribution. The complete, corrected release follows:

HistoSonics, Non-Invasive Robotics Pioneer, Releases Promising Data at Society of Interventional Oncology (SIO)

Four abstracts presented including first-in-human results in liver tumors and preclinical evidence of histotripsy-induced immune response using novel sonic beam therapy

ANN ARBOR, Mich., June 11, 2019 /PRNewswire/ -- HistoSonics, Inc., developer of a non-invasive robotics platform and novel sonic beam therapy, announced today that promising new clinical and preclinical data were presented at the 2019 Society of Interventional Oncology (SIO) Annual Meeting in Boston, Massachusetts.

The four presentations included results from an ongoing first-in-human clinical trial in Barcelona, Spain, presented by Dr. Tim Ziemlewicz, University of Wisconsin, using Robotically Assisted Sonic Therapy (RASTSM), the company's proprietary platform which combines advanced robotics, imaging and the science of histotripsy to completely liquify and destroy targeted tissues, including tumors, at sub-cellular levels. Preclinical presentations included promising histotripsy induced immune responses in melanoma and liver cancer models, tumor volume reduction effects in liver cancer, and feasibility and safety in treating thyroid tissue. Below are highlights of each presentation.

Phase I Study of Safety and Efficacy of Hepatic Histotripsy: Preliminary Results of First in Man Experience with Robotically Assisted Sonic Therapy (RAST)

To date, 8 patients have been treated with a total of 11 tumors targeted, and all were treated in a single session. Patients had one (n=6), two (n=1) or three (n=1) tumors targeted in the procedure. All patients presented with multifocal liver malignancy, with primary disease of hepatocellular carcinoma (HCC) (n=1), cholangiocarcinoma (n=1) and metastasis from other organs including breast (n=1) and colorectal cancers (n=5). The primary endpoint of the first-in-man (FIM) study was acute technical success, defined as delivering the planned targeted volume. Secondary endpoints, among others, included safety of the procedure, local tumor progression (LTP), involution/healing of treatments, immunologic assessment, quality of life, and pain assessments post-procedure.

As reported, 100% of RAST treatments (11 of 11) achieved technical success in destroying the planned targeted volume of tissue, and no patients reported pain or requested analgesics post-procedure at any time point. Of additional note, all treated areas demonstrated rapid involution/healing at each time interval during follow-up. Treatment volumes contracted by an average of 81% upon 2-month follow-up imaging.

"The results of this study are encouraging, particularly that the ability to create a treatment zone and the rapid involution of the treatment zone noted in pre-clinical work was equivalent in patient treatments. In addition, the safety and tolerance of the procedure was excellent. I look forward to continued trials in the near future to confirm these promising early results," noted Dr. Tim Ziemlewicz, the presenting author.

One adverse event was reported (ablation syndrome in the patient with 3 treatments in a single session) and resolved 2 days post procedure, and 1 instance of LTP was identified at two months. Dr. Ziemlewicz commented that the observation of LTP in this study was consistent with other modalities and the rapid involution/healing of RAST treatments may help to identify these instances sooner.

This is the first use of RAST in humans. The principal investigators of the study were Dr. Joan Vidal Jove of Mutua de Terrassa University Hospital and Dr. Xavier Serres Créixams of Vall d'Hebron General Hospital.

Histotripsy Ablation Stimulates Potentially Therapeutic Tumor-directed Systemic Immunity

Dr. Amy Felsted, University of Michigan, reported promising data for the use of histotripsy to stimulate adaptive immune responses to tumor neoantigens in an immunocompetent murine model. The treatments included sham therapy, radiation, thermal ablation, or histotripsy with or without concurrent anti-CTLA-4 checkpoint inhibition immunotherapy.

Results showed that histotripsy stimulated potent local and systemic tumor-specific CD8+ T cell responses when used to treat melanoma and HCC in the mice models. The magnitude of histotripsy induced immunostimulation was significantly greater than that observed with sham, radiation or thermal ablation treatment groups, and was comparable to that seen with the checkpoint inhibition immunotherapy group. It was further noted that in the histotripsy arm, a complete response and necrosis of adjacent untreated tumors was observed, indicative of an abscopal effect. These and other immunostimulatory effects were associated with local and systemic release of the inflammatory damage-associated molecular pattern high mobility group box 1 (HMGB1). Furthermore, the addition of histotripsy markedly potentiated the therapeutic efficacy of anti-CTLA-4 checkpoint inhibition immunotherapy against both melanoma and HCC.

These preclinical observations demonstrate that non-invasive histotripsy stimulates potent local, regional, and systemic tumor-specific immune responses. Physicians leading the study reported that the potential for histotripsy combined with current immunotherapies may provide new therapeutic options to patients with otherwise resistant disease.

Non-Invasive Orthotopic Liver Tumor Ablation Using Histotripsy in an In Vivo Rodent Hepatocellular Carcinoma (HCC) Model

Dr. Mishal Mendiratta-Lala, University of Michigan, presented data on the feasibility and tumor volume reduction effects of histotripsy treatments in liver cancer, using an orthotopic, immune-competent in vivo rat HCC model. Results showed local tumor shrinkage was observed in 14/15 treatment rats (93.3%) with both complete and partial treatments. This study demonstrates the potential of histotripsy for non-invasive HCC tumor treatment with a high safety profile and low risk of local tumor progression in a small animal model.

Robotically Assisted Sonic Therapy (RAST) with Histotripsy for Noninvasive Thyroid Ablation in a Porcine Model

Dr. Johnny Swietlik, University of Wisconsin, reported on the feasibility of using RAST to deliver precise treatments in targeted regions of the porcine thyroid and thymus without causing damage to intervening tissues, including overlying fat or skin, a technique that represents another potentially therapeutic application for RAST in an area of large unmet clinical need in thyroid cancer.

About HistoSonics

HistoSonics is a venture-backed medical device company developing a non-invasive robotic platform and novel beam therapy, Robotically Assisted Sonic Therapy (RASTSM). RAST uses the science of histotripsy and the pressure created by focused sound energy to liquify and destroy targeted tissue, including diseased tissue and tumors, at sub-cellular levels. The company's new platform is designed to deliver personalized, tissue-specific treatments with unparalleled precision and control, and without the undesirable side effects of many of today's interventional and surgical modalities. Histotripsy was developed at the University of Michigan and is exclusively licensed to HistoSonics. The company is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, Michigan and Minneapolis, Minnesota.

The information and data described above has not been reviewed by the U.S. FDA. Statements related to evidence of safety and/or effectiveness will need to be reviewed by FDA prior to inclusion in official labeling. The HistoSonics RAST System has not yet been cleared by the U.S. FDA.

For more information please visit: www.histosonics.com/

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SOURCE HistoSonics, Inc.

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