Posted on: 18 Sep 18
TORONTO, Sept. 18, 2018 (GLOBE NEWSWIRE) — Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company”), the alone aggregation to accommodate a assay belvedere that provides the attention of real-time Alluring Resonance (“MR”) imaging accumulated with the assurance and ablation adeptness of directional and focused ultrasound technology for the incision-free ablation of afflicted tissue, appear that 3-year analytic outcomes and a subgroup assay of Benign Prostatic Hyperplasia (“BPH”) patients enrolled in the previously-reported -to-be Phase I Assurance & Achievability Abstraction of TULSA-PRO® (Chin et al, Eur Urol 2016) advised to appraise the assurance and attention of TULSA-PRO® to ablate prostate tissue in patients with localized prostate cancer, will be presented by Dr. Jurgen Futterer during a address affair at the German Society For Urology 70th Annual Congress 2018 (“DGU 2018”) in Dresden, Germany.
Dr. Futterer’s presentation, advantaged “MRI-Guided TULSA in Patients with Localized Prostate Cancer: Phase I 3-year Outcomes and Aboriginal Experience in TACT Cardinal Study,” is appointed for Thursday, September 27 at 8:39 AM CEST.
BPH is a non-cancerous amplification of the prostate gland due to an overgrowth of prostate cells. It is a accepted action as men age, about adverse the breeze of urine and creating cogent Lower Urinary Tract Symptoms (“LUTS”). Accepted surgical assay of BPH can aftereffect in abeyant complications such as astern , arrect dysfunction, cogent bleeding, and crave continued accretion times. Therefore, for several years abounding another minimally-invasive treatments accept been investigated.
As allotment of his presentation at DGU 2018, Dr. Futterer will address on an assay of LUTS in a subgroup (n=9) of the Phase I abstraction patients who had at atomic moderately appropriate BPH, based on International Prostate Symptoms Account (“IPSS”) ≥ 12, in accession to their blight at baseline. At 12 months afterwards TULSA, IPSS bigger by 9.8 ± 7.1 (58 ± 34%) from 16.1 ± 3.8 to 6.3 ± 5.0 (paired t-test p=0.0033), agnate to levels accomplished with avant-garde surgical therapies, and with at atomic a abstinent (> 5 point) abridgement accomplished by 8/9 patients (89%). IPSS affection of activity bigger by 2.0 ± 1.7 from 2.8 ± 1.1 to 0.8 ± 1.0 (p=0.0068), with 8/9 patients (89%) advertisement as “pleased” or “delighted.” Prostate aggregate abstinent on T2-weighted MRI decreased by 70 ± 19% from 54 ± 23 to 14 ± 5 cc (p=0.001), and uroflowmetry aiguille breeze amount (QMax) bigger by 7.4 ± 13 ml/s from 14.5 ± 4.1 to 21.9 ± 12.7 ml/s, but did not adeptness statistical acceptation due to the baby sample admeasurement (p=0.13). All patients (9/9) had abounding urinary abandonment (leak-free, pad-free) at 6 and 12 months. Arrect action (International Index of Arrect Function, “IIEF”) was abiding from 15 ± 9 at baseline to 16 ± 9 at 12 months (p=0.81), as was the admeasurement of patients with erections acceptable for assimilation (IIEF catechism 2), from 7/9 at baseline to 8/9 at 12 months.
“We are aflame to allotment this BPH subgroup assay from our Phase I analytic balloon at this celebrated urology meeting,” commented Arun Menawat, Profound’s CEO. “As with localized prostate cancer, TULSA-PRO® may present a able modality for assay of BPH, as it enables incision-free and targeted ablation of boundless prostate tissue by accouterment real-time MRI decision as able-bodied as millimeter precision. The added precision, the adeptness to personalize the assay to the patient’s anatomy, and the affiance of accouterment a one-time, minimally-invasive band-aid is now arch to broadcast analytic use of TULSA-PRO® in prostate affliction to accommodate BPH by clinicians in Europe that are accepting aboriginal adventures with this technology for the ablation of localized prostate cancer.”
“We are additionally admiring to be presenting antecedent abstracts from the TACT cardinal analytic balloon at DGU 2018 and abide to apprehend that, already the abounding after-effects from the abstraction are available, they will advice pave the aisle for the acknowledged commercialization of TULSA-PRO® in the United States and added drive analytic acceptance of the technology in Europe,” added Dr. Menawat.
About the Phase I Assurance & Achievability Abstraction of TULSA-PRO®
Thirty (30) patients with low/intermediate risk, agency bedfast prostate blight were enrolled in this multi-jurisdictional trial. Inclusion belief included ages 65 years or older, analytic date T1-T2a; PSA ≤ 10 ng/ml; Gleason Account 3 3 (USA/Europe) and ≤ 3 4 (Canada). Assay planning was performed beneath MRI decision with ameliorative absorbed of bourgeois whole-gland ablation, including 3 mm assurance margins about the ambit and at the apex. These assurance margins were included due to the attributes of this first-in-human Phase I assurance and achievability study, arch to about 10% balance applicative tissue accepted about the gland periphery. Ultrasound assay was delivered beneath real-time alive MRI thermometry acknowledgment control.
In the Phase I study, TULSA-PRO® accustomed authentic and absolute ablation of targeted prostate tissue, while accouterment a well-tolerated favorable assurance contour with accessory appulse on urinary, arrect and bowel action at 12 months. There were no intraoperative complications, no belly abrasion or fistula, no Grade 4 or college adverse events, alone one attributable Grade 3 adverse accident (GU infection, bound aural 2 weeks), and an arrect dysfunction amount of 8% (IIEF account 2 ≥ 2). At 12 months, 1/30 (3.3%) patients had Grade 1 urinary appetite incontinence, acceptation that it was casual (with coughing, sneezing) and does not crave pads. Functional quality-of-life outcomes showed a favorable, advancing trend of antecedent abasement with consecutive advance in achievement aback to baseline levels, aural 3 months (IPSS, UCLA-PCI-SF Bowel Habits) and 12 months (IIEF). Exploratory endpoints of assay ability (including PSA and biopsy) showed average PSA abbreviating 90% to base 0.60 ng/ml, and all-embracing absence of clinically cogent ache in 69% of patients, in animosity of the advisedly bourgeois assurance margin.
TACT, a prospective, open-label, single-arm cardinal analytic study, enrolled 115 patients with biopsy-proven, organ-confined prostate blight beyond 13 analysis sites in the United States, Canada and Europe. The pre-treatment average age of the patients enrolled in TACT was 64 years and their average PSA was 6.5 ng/ml. About 61% of patients had a Gleason account of 7 and 39% had a Gleason account of 6, pre-treatment. The primary ability endpoint of TACT is the admeasurement of patients accomplishing a post-treatment prostate-specific antigen (“PSA”) abridgement ≥ 75% of their pre-treatment baseline value. The Company’s pre-established achievement ambition for the success admeasurement is 50% of patients.
As ahead appear at the 2018 American Urological Association Annual Meeting, the average PSA abridgement to-date is 95% (nadir 0.36 ng/ml), and 95% (109 out of 115) patients accept met the PSA endpoint.
The primary assurance endpoint of TACT is the abundance and severity of adverse events. The amount and attributes of attributable austere adverse contest were agnate to those appear in the Phase I Assurance & Achievability Abstraction of TULSA-PRO®. Added accessory endpoints of TACT are focused on quality-of-life ancillary furnishings frequently associated with accepted prostate blight therapies, such as arrect dysfunction and urinary incontinence. As the accepted appraisal aeon for these ancillary furnishings is 12 months post-treatment, the sample admeasurement of evaluable patients is not yet ample abundant to assess.
About Profound Medical Corp.
The Profound Medical Corp. aggregation is committed to creating the able aggregate of real-time alluring resonance advice as the imaging belvedere and ultrasound as the activity antecedent for carrying non-invasive ablative accoutrement to clinicians. These key technology pillars, affiliated with able software and robotics, accept the abeyant to accomplish unmet needs of patients and clinicians in abounding anatomies and ache states, including prostate cancer, uterine fibroids, and cartilage metastases. Our mission is to “profoundly” change the accepted of affliction by creating a tomorrow area clinicians can confidently ablate tissue with precision; a tomorrow area patients accept admission to safe and able assay options, so they can bound acknowledgment to their circadian lives.
Profound is commercializing a atypical technology, TULSA-PRO®, which combines real-time Alluring Resonance Imaging with transurethral, robotically-driven ameliorative ultrasound and closed-loop thermal acknowledgment ascendancy that is advised to accommodate absolute ablation of the prostate while accompanying attention analytical surrounding analysis from abeyant ancillary effects. TULSA-PRO® is CE apparent and Profound is currently administering a pilot bartering barrage of the technology in key European and added CE mark jurisdictions. The Aggregation is additionally allotment a multicenter, -to-be FDA-registered analytic trial, TACT, which, if successful, is accepted to abutment its appliance to the U.S. Food and Drug Administration for approval to bazaar TULSA-PRO® in the United States.
Profound is additionally commercializing Sonalleve®, an avant-garde ameliorative belvedere that combines real-time MR imaging and thermometry with thermal ultrasound to accredit absolute and incision-free ablation of afflicted tissue. Sonalleve® is CE apparent for the assay of uterine fibroids and booze affliction assay of cartilage metastases. The technology was additionally afresh accustomed by the Chinese Food and Drug Administration for the non-invasive assay of uterine fibroids. The Aggregation is additionally in the aboriginal stages of exploring added abeyant assay markets for Sonalleve®, such as non-invasive ablation of belly cancers and hyperthermia for blight therapy, area the technology has been apparent to accept analytic application.
This absolution includes advanced statements apropos Profound and its business which may include, but is not bound to, the expectations apropos the ability of Profound’s technology in the assay of prostate cancer, uterine fibroids and booze affliction treatment. Often, but not always, advanced statements can be articular by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including abrogating variations) of such words and phrases, or accompaniment that assertive actions, contest or after-effects “may”, “could”, “would”, “might” or “will” be taken, action or be achieved. Such statements are based on the accepted expectations of the administration of Profound. The advanced contest and affairs discussed in this release, may not action by assertive defined dates or at all and could alter materially as a aftereffect of accepted and alien accident factors and uncertainties affecting the company, including risks apropos the biologic industry, bread-and-er factors, the disinterestedness markets about and risks associated with advance and competition. Although Profound has attempted to analyze important factors that could account absolute actions, contest or after-effects to alter materially from those declared in advanced statements, there may be added factors that account actions, contest or after-effects to alter from those anticipated, estimated or intended. No advanced account can be guaranteed. Except as appropriate by applicative balance laws, advanced statements allege alone as of the date on which they are fabricated and Profound undertakes no obligation to about amend or alter any advanced statement, whether as a aftereffect of new information, approaching events, or otherwise, added than as appropriate by law.
For added information, amuse contact:
Stephen Kilmer Investor [email protected] T: 647.872.4849
Last adapted on: 19/09/2018
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