Other News

FastWave Medical Announces Successful First-in-Human Procedures in Study of Sola™, Its Next-Generation Coronary Laser IVL System

Initial FIH procedures launch FastWave’s multi-center feasibility study evaluating the safety and performance of its laser-based coronary IVL platform. MINNEAPOLIS, June 3, 2025 /PRNewswire/ — FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, today announced the…

Conavi Medical Announces New Grant of Stock Options

TORONTO, June 03, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI; OTCQB: CNVIF) (“Conavi Medical” or the “Company”), announced that its board of directors (the “Board”) has approved grants of stock options (the “Stock Options”) Plan on June 2, 2025 pursuant to the terms of its Omnibus Equity Incentive Plan. A total of 5,849,098 Stock Options have been awarded to directors, officers, employees and consultants of the Company. The Stock Options are exercisable at a price of $0.39 CAD per share (being the closing price of the Company’s shares on the TSXV on June 2, 2025) for a period of 10 years from the date of the grant. 1,930,172 of such Stock Options were allocated as follows to the Company’s independent directors: 341,624 Stock Options to Anthony Giovinazzo, 341,624 Stock Options to Cathy Steiner, 330,807 Stock Options to Robert Mitchell, 358,242 Stock Options to Susan Allen and 557,875 Stock Options to Aaron Davidson. 3,581,216 of such Stock Options were allocated as follows to the Company’s officers: 298,413 Stock Options to Travis More, 266,863 Stock Options to Amandeep Thind, 393,924 Stock Options to Sumeet Dham, 425,000 Stock Options to Stefano Picone and 2,197,646 Stock Options to Thomas Looby. The remaining Stock Options were granted to other employees and consultants. The Company also announced minor changes to the composition of its Audit Committee, with Board Chair Aaron Davidson having stepped down from the Audit Committee and independent directors Susan Allen, Cathy Steiner and Robert Mitchell continuing to serve. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China’s National Medical Products Administration, and Japan’s Ministry of Health, Labor and Welfare. For more information, visit http://www.conavi.com/. Cautionary Statement Regarding Forward-Looking Information  This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ System. These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Contacts Stefano Picone Chief Financial Officer (416) 483-0100

FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System

San Clemente, CA – May 29, 2025 – Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company’s Spur Peripheral Retrievable Stent System a unique clinical solution for the treatment of […]

Bitterroot Bio Announces Dosing of First Patient in MATADOR Phase 2a Study of BRB-002, an Immunomodulating Therapy Targeting CD47 in Atherosclerotic Cardiovascular Disease

-Dosing initiated in proof-of-concept MATADOR Phase 2a study- -Initial results expected by year-end 2026- PALO ALTO, Calif. and NEEDHAM, Mass., June 02, 2025 (GLOBE NEWSWIRE) — Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, today announced the dosing of the first patient in its proof-of-concept MATADOR Phase 2a study in Australia, a randomized, double-blinded, and placebo-controlled trial evaluating BRB-002 in patients with established atherosclerosis. BRB-002 is a novel, investigational, immunomodulating protein therapy that targets CD47 as a potential treatment option for patients with atherosclerotic cardiovascular disease (ASCVD). By targeting CD47, BRB-002 directly acts on atherosclerotic plaque through the immunomodulation of macrophages, an approach distinct from current standards of care. This mechanism holds the potential to reduce vascular inflammation, a key driver of plaque rupture, as well as plaque burden, a significant risk factor for major adverse cardiovascular events (MACE). Dosing initiation follows favorable Phase 1 single ascending dose results, presented at the American College of Cardiology (ACC) Scientific Sessions earlier this year. BRB-002 was safe at all doses tested, with no serious adverse events (SAEs) observed. Notably, there was no clinically significant impact on hematologic parameters, including no observed anemia, thrombocytopenia, or febrile neutropenia. This encouraging safety data was accompanied by robust, dose-dependent target engagement, as measured by receptor occupancy (RO) on circulating blood cells, ranging up to 100% CD47 RO at the highest doses evaluated. The ongoing proof-of-concept MATADOR Phase 2a study will evaluate the safety and tolerability of multiple doses of BRB-002 in patients with ASCVD after 13 weeks of treatment. Additional clinical endpoints include pharmacokinetics and pharmacodynamics of BRB-002, as well as the change from baseline in carotid artery plaque inflammation as measured by 18F-FDG-PET/CT imaging. The study will enroll patients with imaging-documented carotid atherosclerosis in one or more dose exploration cohorts followed by a larger expansion cohort. The Company expects to report initial results from the MATADOR Phase 2a study by year-end 2026. “Today marks a significant milestone as we initiate dosing in our proof-of-concept MATADOR Phase 2a study. While current standards of care for ASCVD, particularly lipid-lowering therapies, have improved outcomes, many patients continue to face substantial residual risk, and there is considerable need for new approaches that address different pathological pathways,” said Craig Basson, MD, PhD, Chief Medical Officer of Bitterroot Bio. “This Phase 2a study will provide crucial insights into the safety, tolerability, and biological activity of our innovative approach with BRB-002. We are optimistic that targeting atherosclerotic plaque directly may lower vascular inflammation and residual risk, ultimately improving long-term cardiovascular health for ASCVD patients.” About BRB-002BRB-002 is a novel protein therapy that is being evaluated as an investigational agent in atherosclerotic cardiovascular disease (ASCVD). BRB-002 is an immunomodulatory agent that inhibits the CD47 cell surface receptor (“don’t eat me” signal) to ameliorate the underlying causes of atherosclerosis and reduce inflammatory plaque burden. A Phase 1 clinical study of BRB-002 was completed in Australia by Bitterroot Australia Pty Ltd, a wholly owned subsidiary of Bitterroot Bio, Inc. About Bitterroot BioBitterroot Bio, Inc. is a pioneer in the field of cardio-immunology, which investigates the interplay between the immune system and cardiovascular health. Bitterroot Bio’s research seeks to uncover critical roles that immune modulators play in the progression of cardiovascular disease. By targeting these diseases in this novel way, Bitterroot Bio’s mission is to transform the lives of patients suffering from cardiovascular diseases. For more information, please visit https://www.brbio.com or follow us on Facebook LinkedIn, or X. Media Contact: Pablo Fenton (Bitterroot Bio), media@brbio.com