On March 21, 2023 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, and Quantum Leap Healthcare Collaborative reported that Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2 clinical trial (Press release, Atossa Therapeutics, MAR 21, 2023, View Source [SID1234629127]). The I-SPY 2 TRIAL evaluates neoadjuvant treatments for locally advanced breast cancer and is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery.

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The new study arm evaluating (Z)-endoxifen is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel agents that are more tolerable and effective than the current standard of care and address the risk of recurrence.

"Atossa is proud to partner with Quantum Leap Healthcare Collaborative and excited that (Z)-endoxifen has been added to their unprecedented I-SPY clinical trial, which is designed to quickly and efficiently bring new drug therapies to breast cancer patients who need them urgently," said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. "Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer. There remains a critical need for more effective and tolerable treatment options for this patient population."

"(Z)-endoxifen is one of the most active metabolites of tamoxifen. Tamoxifen is known to be effective in treating and preventing ER+ breast cancer, but may be most effective in those patients who can adequately metabolize it, " said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL. "(Z)-endoxifen may overcome some of the shortcomings of tamoxifen, as it is already the active metabolite. Perhaps most exciting is that it may be effective in premenopausal women without the need for ovarian suppression. Ovarian suppression in premenopausal women and aromatase inhibitors in postmenopausal women are associated with both short-term and potential long-term side effects that diminish adherence. (Z)-endoxifen holds promise of being a more effective and tolerable alternative to targeting the estrogen receptor in women with early-stage breast cancer."

Atossa is currently evaluating (Z)-endoxifen in two ongoing Phase 2 studies:

The EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) trial is a randomized non-inferiority study of (Z)-endoxifen compared to exemestane plus goserelin as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. Participants receive neoadjuvant treatment for up to six months, followed by surgery. The primary objective of the EVANGELINE study is to determine whether the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen is non-inferior to the ESD rate following treatment with current standard of care, exemestane plus goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, which in premenopausal women is associated with significant morbidity and inadequate compliance, which compromises efficacy and increases the risk of mortality.

The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)–endoxifen in premenopausal women with measurable breast density. Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in mammographic breast density (MBD). Participants also have a mammogram at 24 months to assess the durability of the MBD changes. MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer.

Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise. Currently, there are 41 open sites, all of which have the EOP program open.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 breast cancer.

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the anti-estrogenic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa has developed a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions converts a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. We are currently studying our (Z)-endoxifen in healthy women with measurable breast density and premenopausal women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by two issued U.S. patents and numerous pending patent applications.

On March 21, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that its SNAP-CAR technology was highlighted in a peer-reviewed article published in the Journal of Translational Medicine (Press release, Coeptis Therapeutics, MAR 21, 2023, View Source [SID1234629124]). SNAP-CAR is a multi-antigen chimeric antigen receptor T cell (CAR T) technology that can be adapted to different cancer indications, including hematologic and solid tumors.

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The article titled, "Tuning CARs: recent advances in modulating chimeric antigen receptor (CAR) T cell activity for improved safety, efficacy, and flexibility," discusses a variety of efforts and cross field collaborations striving to balance anti-tumor activity of next-generation cell therapies that also minimize harmful side effects associated with CAR-T. The article describes SNAP-CAR as an "up-and-coming" technology that covalently links therapeutic monoclonal antibodies (mAbs) to universal CAR receptors, with demonstrated function in vitro and in vivo, and represents a "powerful concept for overcoming suboptimal CAR functions due to the lower affinity of soluble adaptors to universal CAR receptors."

"We are pleased that SNAP CAR was featured in this peer-reviewed article, which highlights the latest developments in CAR T technologies designed to improve cell therapy outcomes and mitigate associated toxicities to enable improved safety, efficacy, and flexibility," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Research conducted at the University of Pittsburgh suggests that SNAP-CAR offers an opportunity to direct the power of CAR T to an array of cancers that have, until now, been inaccessible via current cell therapy technologies by providing a highly programmable antigen targeting platform. SNAP-CAR T cells can be engineered to address numerous cancers, including HER2-expressing ovarian cancer, which we are targeting as our potential first-in-human clinical development program."

About SNAP-CAR

SNAP-CAR, which Coeptis Therapeutics licensed from the University of Pittsburgh, is designed to be a "universal" CAR T cell therapy platform that can be adapted to different cancer indications. Instead of directly binding to a target on the tumor cell, CAR T cells are co-administered with one or more antibody adaptors that bind to the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent bond. Pre-clinical studies in mice have demonstrated that by targeting tumors via antibody adaptor molecules, the SNAP-CAR therapy provides a highly programmable therapeutic platform.

On March 21, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) and Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation therapies, reported that Gilead has exercised its option to exclusively license Nurix’s investigational targeted protein degrader molecule NX‑0479 (Press release, Gilead Sciences, MAR 21, 2023, View Source [SID1234629123]). This bivalent degrader, designated GS-6791, is the first development candidate resulting from the previously announced Nurix-Gilead collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation therapies.

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This press release features multimedia. View the full release here: View Source

GS-6791 is a potent, selective, oral IRAK4 degrader that targets both the scaffold and kinase functions of the IRAK4 protein kinase to block inflammatory responses downstream of toll-like receptors (TLR) and the pro-inflammatory IL1 cytokine family of receptors (IL1Rs). Degradation of IRAK4 by GS-6791 is hypothesized to have more sustained and deeper inhibition of TLR/IL1Rs signaling as compared to kinase inhibition due to its potential impact on additional signaling nodes. IRAK4 degradation has potential applications in the treatment of rheumatoid arthritis (RA) and other inflammatory diseases.

"The Nurix IRAK4 degrader program represents a quality modality targeting toll-like receptor and IL1 receptor-driven inflammation," said Flavius Martin, M.D., Executive Vice President, Research at Gilead. "We are pleased to advance our collaboration with Nurix and further expand our autoimmune pipeline with the goal of addressing the needs of people living with inflammatory diseases."

"Gilead’s exercise of the first license option under our agreement is an important milestone and evidence of the significant progress that we have made in our strategic collaboration," said Gwenn M. Hansen, Ph.D., Chief Scientific Officer at Nurix. "Our highly productive DELigase platform has enabled us to advance multiple degrader programs in our collaboration with Gilead and across our wholly owned pipeline. This progress demonstrates the value of our research enterprise and its capacity to create medicines to address an array of therapeutic areas in addition to oncology."

Terms of the Exercised Option

Under the terms of the parties’ Collaboration, Option and License Agreement, for the NX-0479 option that Gilead is exercising, Nurix will receive an option exercise payment of $20 million and potentially could receive up to an additional $425 million in clinical, regulatory, and commercial milestone payments, as well as up to low double-digit tiered royalties on product net sales.

About the Nurix-Gilead Collaboration

In June 2019, Gilead and Nurix entered into a global strategic collaboration to discover, develop and commercialize a pipeline of up to five innovative targeted protein degradation therapies for patients with cancer and other challenging diseases. Under the terms of the agreement, Nurix received an upfront payment of $45 million and is eligible to receive up to approximately $2.3 billion in total additional payments based on the successful completion of certain research, pre-clinical, clinical, regulatory and commercialization milestones as well as up to low double-digit tiered royalties on net sales. Nurix will retain the option to co-develop and co-detail up to two programs in the United States, subject to certain restrictions. For those programs that Nurix opts in to co-develop and co-detail, the parties will split development costs as well as profits and losses 50/50 for the United States, and Nurix will be eligible to receive royalties on ex-U.S. sales and reduced milestone payments. Gilead has the right to veto up to one co-development option, in which case the option will revert back to Nurix for use on potential future licensed products.

On March 21, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas")reported that it will present detailed results from the Phase 3 GLOW trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) versus placebo plus CAPOX in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (Press release, Astellas Pharma, MAR 21, 2023, View Source [SID1234629122]).

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In the study, investigational treatment zolbetuximab plus CAPOX demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo plus CAPOX. Specifically, zolbetuximab plus CAPOX reduced the risk of progression or death by 31.3% (n=507; hazard ratio [HR]=0.687; [95% confidence interval [CI]: (0.544-0.866)]; p=0.0007) compared to placebo plus CAPOX, meeting GLOW’s primary endpoint. Median PFS was 8.21 months (95% CI: 7.46–8.84) in the treatment arm and 6.80 months (95% CI: 6.14–8.08) in the placebo arm.

The study also showed that zolbetuximab plus CAPOX significantly prolonged overall survival (OS), a key secondary endpoint, reducing the risk of death by 22.9% (HR=0.771; 95% CI: 0.615-0.965; p=0.0118). Median OS was 14.39 months (95% CI: 12.29-16.49) and 12.16 months (95% CI: 10.28-13.67) for the treatment arm and placebo arm, respectively.

The incidence of serious treatment-emergent adverse events (TEAEs) was similar between both arms (47.2% versus 49.8% in the zolbetuximab versus placebo arms, respectively) and consistent with previous studies.1 The most frequent TEAEs in the GLOW study were nausea (68.5% versus 50.2%), vomiting (66.1% versus 30.9%) and decreased appetite (41.3% versus 33.7%) in the zolbetuximab versus placebo arms.

"The progression-free and overall survival data from GLOW demonstrate the potential of zolbetuximab in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric and gastroesophageal junction cancer," said Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and the primary investigator of GLOW. "While the treatment landscape is continuing to evolve, patients at this stage of the disease are in need of options and the GLOW data are encouraging for this patient population."

These detailed results from the GLOW trial will be presented at the March American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series (Wednesday, March 22, 2023, at 4:00 p.m. ET) by Manish A. Shah, M.D., Medical Oncologist and Director of the Gastrointestinal Oncology Program, Weill Cornell Medicine, New York.

"We are committed to the ongoing clinical development of zolbetuximab and to bringing new therapeutic options for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "These two statistically significant Phase 3 trials, GLOW and SPOTLIGHT, will serve as the basis for global regulatory submissions, marking remarkable progress in our gastric cancer development program."

The GLOW and SPOTLIGHT studies are a part of Astellas’ gastric cancer development program to investigate targeted treatment options such as zolbetuximab and address patient needs in locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. In both trials, approximately 38% of these patients had CLDN18.2-positive tumors (≥75% of tumor cells with strong-to-moderate membranous CLDN18.2 staining intensity), as determined by a validated immunohistochemistry assay.2

About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer
Gastric cancer, also commonly known as stomach cancer, is the fifth most commonly diagnosed cancer worldwide.3 Signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, diarrhea or constipation, bloating of the stomach after meals and loss of appetite and sensation of food getting stuck in the throat while eating.4 Signs of more advanced gastric cancer can include unexplained weight loss, weakness and fatigue and vomiting blood or having blood in the stool.5 Risk factors associated with gastric cancer can include older age, male gender, family history, H. pylori infection, smoking and gastroesophageal reflux disease (GERD).4,6 Because early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, gastric cancer is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs.4 The five-year relative survival rate for patients at the metastatic stage is approximately six percent.7 Gastroesophageal junction (GEJ) adenocarcinoma is a cancer that starts at the area where the esophagus joins the stomach.8

About Zolbetuximab
Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody (mAb) that targets and binds to CLDN18.2, a transmembrane protein. Zolbetuximab acts by binding to CLDN18.2 on the cancer cell surface of gastric epithelial cells. In pre-clinical studies, this binding interaction then induces cancer cell death by activating two distinct immune system pathways — antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).9 The safety and efficacy of zolbetuximab are under investigation in gastric, gastroesophageal junction and pancreatic cancers and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.

About GLOW Phase 3 Clinical Trial
GLOW is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab (IMAB362) plus CAPOX (a combination chemotherapy regimen which includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment of patients with CLDN18.2 positive, HER2- negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America and Asia. The primary endpoint is progression-free survival of participants treated with combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability and quality-of-life parameters.

For more information, please visit clinicaltrials.gov under Identifier NCT03653507.

About SPOTLIGHT Phase 3 Clinical Trial
SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab (IMAB362) plus mFOLFOX6 (combination regimen of oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment of patients with CLDN18.2-positive, HER2- negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America and Asia. The primary endpoint is progression-free survival of participants treated with combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability and quality-of-life parameters.

For more information, please visit clinicaltrials.gov under Identifier NCT03504397.

Pipeline in Claudin 18.2
In addition to zolbetuximab, ASP2138 is under development in our Primary Focus Immuno-Oncology.
ASP2138 is currently in a Phase 1 trial for people with gastric, gastroesophageal junction or pancreatic cancer.

For more information about ASP2138, please visit clinicaltrials.gov under Identifier NCT05365581.

An expanded Phase 2 trial (NCT03816163) in metastatic pancreatic cancer is in progress. The trial is a randomized, multi-center, open-label study, evaluating the safety and efficacy of investigational zolbetuximab in combination with gemcitabine plus nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer with CLDN18.2-positive tumors (defined as ≥75% of tumor cells demonstrating strong-to-moderate membranous CLDN18.2 staining based on a validated immunohistochemistry assay).

On March 21, 2023 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), a global leader in robotic energy-based therapies, reported a recent presentation of positive results from a large, multicenter, non-inferiority study comparing Focal One high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 38th Annual Congress of the European Association of Urology (EAU), which was held March 10-13, in Milan, Italy (Press release, EDAP TMS, MAR 21, 2023, View Source [SID1234629121]).

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The study, which ran from April 2015 through September 2019, compared Focal One HIFU versus RP as a first line treatment for patients with localized prostate cancer (grade groups <3). A total of 3,328 patients from 42 treatment centers were included: 1,967 were treated with Focal One HIFU and 1,361 underwent radical prostatectomy surgery. Patients were followed for 30 months.

Select data highlights:

At 30 months, the STFS was higher in the HIFU arm (90.1%) compared with RP arm (86.8%);
Risk of salvage treatment was greater than 1.2-fold higher after RP (HR: 0.75, 95% CI [0.64-0.96], p = 0.02);
ICS score, a measure of urinary incontinence, was significantly lower after HIFU (0 vs 1, p < 0.001);
IIEF-5, a measure of erectile function, decreased significantly less after HIFU than after RP despite (median Δ = -4 vs -9 p < 0.001);
Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p>0.0001);
After HIFU, median PSA nadir was 0.34 ng/ml and positive biopsy rate was 12.5%; after RP, median PSA was 0.01 ng/ml and positive margins (PM) were reported in 26% of RP-treated patients.
Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the study, commented, "I was very pleased to present, for the first time, the final consolidated results from this major academic study which was sponsored by the French Association of Urology. This is the largest study ever done to prospectively evaluate HIFU against radical prostatectomy. The aim of this post-approval, non-inferiority study was to compare the survival rates without salvage treatment in both arms, as well as to confirm reimbursement of HIFU in France. These results confirm the growing importance of HIFU in the management of localized prostate cancer."

Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS, added, "The positive results from this very large study add to the significant and growing body of evidence demonstrating not only the efficacy of HIFU, but also the superior side effect profile which can meaningfully impact patients’ quality of life. With a growing recognition of the clinical benefits of HIFU treatment, EDAP continues to expand global access to Focal One HIFU so that more prostate cancer patients have the opportunity to realize the treatment benefits of our therapeutic HIFU technology."

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market. EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit View Source, us.hifu-prostate.com and www.focalone.com.