Study to support European clearance of Cordella™ Pulmonary Artery Sensor System for treatment of patients with chronic heart failure LISLE, IL – Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial,...Read the Full Article
QUEBEC CITY, July 11, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) today reported its results for the third quarter of 2019. HIGHLIGHTS Consolidated revenues of $7.9 M for the third quarter of 2019 compared with $6.4 M for the third quarter of 2018, an increase of $1.5 M or 23%;Fractional Flow Reserve ("FFR") sales of $5.2 M for the third quarter...Read the Full Article
– Staccato alprazolam is shown to rapidly suppress seizure activity at two minutes in five patients with epilepsy – – Staccato alprazolam generally well tolerated; no serious or severe adverse events reported – – Enrollment in Phase 2b, double-blind, placebo-controlled study ongoing – SUMMIT, N.J., July 09, 2019 (GLOBE NEWSWIRE) -- Engage...Read the Full Article
TORONTO, CANADA -- Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, is the proud recipient of Frost & Sullivan’s 2019 Global Prostate Cancer Diagnostic Imaging Technology Innovation Award. “Exact Imaging’s 29 MHz micro-ultrasound system, ExactVu™, offers a novel approach for targeted real-time...Read the Full Article
Dissident Withdraws the Consents of its Nominees from Consideration Prior to the AGM Aurinia Reaffirms its Commitment to Voclosporin and Creating Shareholder Value VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) is pleased to announce that shareholders of the Company (the “Shareholders”) elected all eight of...Read the Full Article
MONTREAL, June 25, 2019 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF), a leading specialty pharmaceutical company with a strong North American commercial platform, announces that Adele M. Gulfo has joined the Company's Board of Directors, further enhancing the Board’s commercial and business development expertise. Ken d’Entremont, Chief...Read the Full Article
TORONTO, June 20, 2019 /CNW/ -- Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis....Read the Full Article
BardyDx Carnation Ambulatory Monitor (CAM™) - P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection device (Above) SEATTLE, June 19, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Innovator, the premier nonprofit startup accelerator in the medical technology industry, has selected...Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (the “Company”), announced today the pricing of its previously announced underwritten public offering (the “Offering”) of 5,555,556 common shares and, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares. The common shares are being...Read the Full Article
- Detailed data from this trial will be presented at a medical meeting later this year - RESEARCH TRIANGLE PARK, N.C., June 18, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced preliminary overall survival (OS) results from a randomized Phase 2 trial which demonstrated that women with metastatic triple-negative...Read the Full Article
- Garry Nicholson to serve as new board chair -- Sir Andrew Witty, Fredric Eshelman, Pharm.D. and prior chair Seth Rudnick, M.D. re-elected - RESEARCH TRIANGLE PARK, N.C., June 13, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that current board member Garry Nicholson has...Read the Full Article
HistoSonics announced its non-invasive robotics platform and novel sonic beam cancer therapy successfully destroyed 11 tumors in eight patients during its first clinical trial. The results were presented this week at the 2019 Society of Interventional Oncology (SIO) Annual Meeting in Boston. The meeting also included preclinical presentations of what HistoSonics termed...Read the Full Article
SEATTLE, June 6, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Breakthrough, an independent organization that recognizes the top companies and solutions in the global health and medical technology market, has recognized the Carnation Ambulatory Monitor (CAM™) with...Read the Full Article
Dr. Vernon A. Orton, II & Dr. John M. Pettit with colleagues (above)SOURCE: Bellingham Urology Group, PLLC. TORONTO, CANADA -- (June 4, 2019) Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced that Bellingham Urology Group has acquired the ExactVu™ micro-ultrasound system...Read the Full Article
SOURCE: Zymeworks VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the appointment of two new independent members to its Board of Directors, further enhancing the Board’s commercial expertise. The new board members are Sue Mahony, Ph.D., MBA, a pharmaceutical executive with over 30...Read the Full Article
SOURCE: G1 Therapeutics G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today presented additional findings from a randomized Phase 2 clinical trial demonstrating the myelopreservation benefits of trilaciclib in patients undergoing chemotherapy treatment for 2nd/3rd-line small cell lung cancer (SCLC). Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has earned a milestone payment from Merck (known as MSD outside the US and Canada) achieved under the companies’ 2014 research and license agreement. Zymeworks will receive US$2.0 million in connection with Merck’s...Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW25, a novel Azymetric™bispecific antibody, for the first-line treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma in combination with standard of care...Read the Full Article
Commercial leader brings recent migraine space experience to Satsuma as it advances lead product candidate STS101 into Phase 3 development SOUTH SAN FRANCISCO, Calif., May 29, 2019 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc. ("Satsuma" or "the Company"), a Phase 3-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced...Read the Full Article
Austin, TX and Montreal, QC (May 28, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced today that it has obtained approval from Health Canada to conduct Phase 2 clinical trials evaluating AVID100, a novel anti-EGFR antibody-drug conjugate (ADC), in EGFR-overexpressing squamous cell...Read the Full Article
MONTRÉAL and BOSTON, May 29, 2019 -- enGene Inc., the high growth biotechnology company developing the Gene Pill™ - a robust, proprietary non-viral vector platform to deliver gene therapies via oral administration - today announced the appointment of José M. Lora, Ph.D., as Chief Scientific Officer. Dr. Lora will join the executive management team and will be...Read the Full Article
SOURCE: Zymeworks VANCOUVER, British Columbia--(BUSINESS WIRE)--Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has entered into a licensing agreement that grants Iconic Therapeutics, Inc. (Iconic) non-exclusive rights to Zymeworks’ proprietary ZymeLink™ antibody-drug conjugate (ADC) platform for the development of its ICON-2 Tissue Factor ADC for...Read the Full Article
SOURCE: Aurinia Pharmaceuticals Inc. VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today reported financial results for the first quarter ended March 31, 2019, and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars. First Quarter 2019 Highlights...Read the Full Article
SOURCE: Medexus Pharmaceuticals Inc. MONTREAL, May 14, 2019 -- Medexus Pharmaceuticals Inc. (the “Company”) (TSXV: MDP, OTCQB: PDDPF) announced today it has submitted to the TSX Venture Exchange (the “Exchange”) a notice of its intention to make a normal course issuer bid (the “Bid”). Provided the Company receives the approval of the Exchange,...Read the Full Article
Plans to submit U.S. and European marketing applications for trilaciclib following regulatory feedback First clinical data on oral SERD G1T48 expected in 3Q19 Management to host webcast and conference call today at 4:30 p.m. ET RESEARCH TRIANGLE PARK, N.C., May 09, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology...Read the Full Article
This work compares mpMRI with high-resolution 29MHz micro-ultrasound imaging, which maintains the workflow, simplicity and low cost of ultrasound and can be used to target biopsies without the need for MRI. Giovanni Lughezzani (1), Ander Astobieta (2), Frédéric Staerman (3), Eric Klein (4), Robert Abouassaly (4), Ahmed El-Shefai (4), Gregg Eure (5)...Read the Full Article
8 patients with predictable generalized or focal epileptic seizures treated with Staccato alprazolam 62.5% of patients respond with the cessation of seizure activity within two minutes of therapy administration and no recurrence of seizure activity within two hours Feasibility of both self-administration or caregiver-administration demonstrated Enrollment of additional 115 patients in double-blind,...Read the Full Article
VANCOUVER, Canada--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, is pleased to announce the detailed voting results on the items of business considered at its Annual General Meeting of Shareholders held on May 2, 2019 (the “Meeting”). Shareholder Voting Results The Shareholders voted on the following matters...Read the Full Article
SOURCE: Medexus Pharmaceuticals Inc. MONTREAL, May 7, 2019 -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF), today announced the launch of a new Metoject® Subcutaneous 15mg dose in Canada. Metoject Subcutaneous is a pre-filled syringe of methotrexate with a pre-attached subcutaneous needle that is approved in Canada for the...Read the Full Article
SEATTLE, May 7, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced it has been selected as the winner of the North American Remote Cardiac Monitoring Technology Innovation Award by Frost & Sullivan, a leader in global research and consulting solutions. BardyDx earned the distinction...Read the Full Article
SOURCE: Exact Imaging New EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities enable the ExactVu™ micro-ultrasound system to provide a complete men’s health urological imaging solution TORONTO, CANADA -- (May 7, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate,...Read the Full Article
Press Release: April 30, 2019 VICTORIA, British Columbia--(BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced it has appointed Dr. Daniel Billen to its Board of Directors. Dr. Billen’s appointment is effective April 29, 2019...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE) May 2, 2019-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the first quarter ended March 31, 2019. “We are pleased to have advanced both of our lead assets to the next stages of clinical development; recently commencing a Phase...Read the Full Article
Micro-Ultrasound and its Significant Clinical Benefits are Featured at the Largest Prostate Cancer Conference in 2 Clinical Talks, 5 Oral Presentations and Clinical Posters and a Skills Symposium CHICAGO, IL -- (May 3, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate,...Read the Full Article
SOURCE: OPSENS Inc. QUEBEC CITY, April 30, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) is pleased to announce it has entered into a supply agreement as part of its long-term collaboration with Abiomed, Inc. ("Abiomed") for the Impella CP® heart pump. Abiomed has awarded Opsens a five-year...Read the Full Article
VANCOUVER, British Columbia / BUSINESSWIRE/ Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced it has expanded its leadership team with the hiring of three new vice presidents to support the Company’s expanded global clinical development: Mark Hollywood, Senior Vice President, Technical and Manufacturing Operations; Neil Josephson, M.D.,...Read the Full Article
Research Triangle Park, N.C., April 29, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a regulatory update on trilaciclib, a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. Based on written feedback from its end-of-Phase 2...Read the Full Article
SOURCE: Forbius Expansion of ongoing AVID200 Phase 1 solid tumor trial to include patients at clinical sites in CanadaAVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal oncogenic TGF-beta isoformsBest-in-class efficacy and safety potential by selectively targeting TGF-beta 1 & 3 while sparing TGF-beta 2, the...Read the Full Article
MANNHEIM, Germany – April 26, 2019 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments to address functional mitral regurgitation (FMR) in patients with heart failure (HF), presented new data confirming significant reduction in regurgitant volume directly after implantation of the Carillon® Mitral Contour System® at the German...Read the Full Article
Funding supports Phase 3 development of STS101 for the acute treatment of migraine, including pivotal Phase 3 efficacy trial with planned initiation in Q3 2019 SOUTH SAN FRANCISCO, Calif., April 24, 2019 /PRNewswire/ — Satsuma Pharmaceuticals, Inc. (“Satsuma” or “the Company”), a clinical-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of...Read the Full Article
LISLE, Ill., April 24, 2019 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that the company received ISO 13485:2016 certification from British Standards Institution (BSI) for its Quality Management System (QMS). Endotronix's adherence to internationally recognized standards for the medical device...Read the Full Article
SOURCE: Forbius Investigator-initiated trial to evaluate AVID200’s safety, anti-fibrotic activity, and ability to restore hematopoiesis in patients with myelofibrosisAVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal drivers of fibrosis in myelofibrosis and other fibrotic diseasesAVID200 spares TGF-beta 2, the isoform that promotes hematopoiesis and normal...Read the Full Article
A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits SAN CARLOS, Calif., April 23, 2019 /PRNewswire/ -- BAROnova, Inc., a medical device company focused on the development of first-in-class non-surgical solutions for the treatment of obesity, announced today that the U.S....Read the Full Article
This trial evaluates the efficacy of AVID100 in TNBC patients with EGFR-overexpression20% of TNBC patients highly overexpress EGFR; there is no approved targeted therapyAVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development, targeting both wild-type and mutant forms of EGFR Austin, TX, and Montreal, QC (Apr. 22, 2019) –...Read the Full Article
SEATTLE, April 16, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it has raised $35.5 million in Series B funding, led by River Cities Capital Funds with participation from new investors HealthQuest Capital, Aperture Venture Partners, Aphelion Capital, Lumira Ventures, and Rex Health Ventures. Existing equity investors, SV Health Investors, Health Enterprise Partners, and Ascension...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a late clinical-stage biopharmaceutical company focused on the global immunology market, today announced the appointment of Mr. Peter Greenleaf as Chief Executive Officer and as a Director on the Aurinia Board. The Company also announced...Read the Full Article
QUEBEC CITY, April 11, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) today reported its results for the second quarter of 2019. HIGHLIGHTS Consolidated revenues totaled $7.9M in the second quarter of 2019 compared with $5.4M in the corresponding period in 2018, an increase of $2.5M or 46%; Fractional Flow Reserve ("FFR") revenues of $4.9M for the second quarter 2019 compared...Read the Full Article
Breakthrough medical platform offers vision of personalized tumor treatments with its novel sonic beam therapy ANN ARBOR, MICHIGAN // Apr. 8, 2019 – HistoSonics, developer of a non-invasive robotics platform and novel beam therapy, announced today that it has closed a $54 million Series C financing. The round was led by Varian...Read the Full Article
https://www.youtube.com/watch?v=zJWcSkfBW4o Video Transcript: Related Article: MAKO Surgical acquired for $1.65 billion by Stryker Corp. “The MAKO Robot is an essential tool that helps us in surgery when we do a joint replacement like total hips and total knees and partial total knees. For us in this area, we're the first ones to...Read the Full Article
SOURCE: Forbius AVID100 is the only clinical-stage anti-EGFR ADC that targets both wild-type and mutant forms of EGFR with limited off-tumor toxicity due to novel mechanism of actionPhase 1 confirmed that AVID100 was well-tolerated and established a recommended phase 2 dose (RP2D) of 220 mg/m2 (~6 mg/kg) q3w, one of the highest amongst...Read the Full Article