Latest news with #PremarketApproval
Cision Canada
6 days ago
- Business
- Cision Canada
Perimeter Announces Preliminary Unaudited Revenues for the 2025 Second Quarter; Reduces Operating Costs by ~30% as Company Focuses on Commercial Sales Pipeline and Growth Opportunities
– Webcasted Q2-2025 conference call scheduled for August 26 th at 5:00 PM EDT – TORONTO and DALLAS, Aug. 11, 2025 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced preliminary unaudited revenues for the second quarter ended June 30, 2025, senior management changes, and the creation of a Perimeter Industry Advisory Board ("IAB"). Preliminary Unaudited Second Quarter 2025 Revenues Unless otherwise indicated, all amounts in this press release are expressed in U.S. dollars. Perimeter anticipates total revenue for the second quarter of 2025 to be approximately $500,000, representing year-over-year growth of approximately 100%. Sequentially, the Company expects that greater than 35% procedure growth will result in over 50% recurring revenue growth in Q2-2025 compared to Q1-2025. This was primarily driven by stronger current Perimeter S-Series system utilization, with significantly more interoperative OTC imaging procedures performed by existing surgeon users, and at a higher price per procedure. For the six-month period ended June 30, 2025, total revenue is expected to be approximately $1.0 million, compared to $345,000 in the 6-month period ended June 30, 2024 and $846,000 for the full year ended December 31, 2024. Gross margin is expected to be approximately 69% for the second quarter and 61% for the six-month period ended June 30, 2025, respectively. "We are excited that the growing adoption, both in terms of new system placements and increased current device utilization, we saw during the first three months of the year continued through the second quarter," commented Adrian Mendes, Perimeter's Chief Executive Officer. "To put that into perspective, six-month 2025 revenue alone is estimated to surpass revenues for all of 2024. Now, as our sales pipeline continues to build, and with the Premarket Approval application for our next-generation Perimeter B-Series under review with the FDA, we anticipate a continuation of strong growth moving forward." Further, Perimeter advised that it expects initial savings from its cost control efforts will result in an approximate 30% reduction in total operating costs, starting in Q3-2025. These figures are preliminary and unaudited, and actual revenues may differ. Perimeter is providing this information due to planned investment community meetings to be held ahead of its Q2-2025 financial results release and conference call later this month. Leadership Changes Perimeter announced today the appointments of Abbey Goodman as Vice President, Sales, and Paolo DiPasquale as Vice President, Corporate Development, in a move designed to further position the Company for continued sales success and growth: Ms. Goodman brings over 20 years of medical device sales experience, most recently serving as Profound Medical's Global Chief Commercial Officer. Prior to joining Profound, she progressed through a variety of senior sales leadership roles with Hologic, Novadaq Technologies, Covidien (now Medtronic), and DePuy Mitek. Ms. Goodman earned a BS in Biological Engineering from Louisiana State University. Mr. DiPasquale brings a unique perspective as someone who has over 17 years of experience in the U.S. and Canadian capital markets across Equity Research, Institutional Equity, and Investment Banking at Canaccord Genuity and Stephens. Most recently, he served as Chief Strategy Officer of a gaming and marketing company, where he managed its successful capital raising strategy and go-public process on NASDAQ. Mr. DiPasquale is a graduate of Duquesne University with two majors: a BSc in Finance and a BSc in Investment Management. In addition, Perimeter announced that Tom Boon has recently retired as Perimeter's Chief Operating Officer. Mr. Boon will continue to help guide the Company's commercial strategy through his membership on Perimeter's newly formed IAB (please see below). "We are excited to welcome Abbey and Paolo to the Perimeter team. They bring deep expertise and leadership that will be critical as we advance our business," said Mr. Mendes. "At the same time, we want to thank Tom for his outstanding leadership and contributions to Perimeter. We look forward to continuing to work with him in his new capacity on our IAB." Creation of Perimeter Industry Advisory Board Perimeter also announces the creation of an IAB to support the Company's growth strategies across all products, channels and geographies. Chairing the IAB will be Diana Chan, Managing Director of BridgeGap Solutions Group. With over 20 years of experience in the medical device industry, Ms. Chan is a seasoned marketing leader dedicated to driving growth and innovation. She played a key role in MOLLI Surgical's journey, from building its brand presence and implementing growth strategies to its successful exit after three years of commercialization through its acquisition by Stryker Corporation. Currently, she provides advisory and mentorship in the medtech space through BridgeGap Solutions Group, a consultancy she founded to support organizations with limited resources in business and market development. Prior to MOLLI Surgical, she held executive positions at Medtronic, Bard, and Fresenius Medical Care. Ms. Chan received a BA in Administrative and Commercial Studies from Western University, and an MBA from the University of Notre Dame. The full mandate and initial composition of the IAB will be announced at a later date. Conference Call Perimeter will report its second quarter 2025 financial and operating results after market close on August 26, 2025. Following the announcement, the Company will host a conference call and live audio webcast at 5:00 pm Eastern Time to discuss the results and provide a corporate update. To participate in the call, please dial 1-800-717-1738 or 1-646-307-1865. The conference call will also be broadcast live online through a listen-only webcast, which will be posted on the Investors section of the Company's website and archived for approximately 90 days. About Perimeter Medical Imaging AI, Inc. Based in Toronto, Canada and Dallas, Texas, Perimeter Medical Imaging AI (TSXV: PINK) (OTCQX: PYNKF) is a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the U.S., our FDA-cleared Perimeter S-Series OCT system provides real-time, cross-sectional visualization of excised tissues at the cellular level. The breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents our next-generation artificial intelligence technology that has recently been evaluated in a pivotal clinical trial, with support from a grant of up to US$7.4 million awarded by the Cancer Prevention and Research Institute of Texas. The company's ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month. Perimeter B-Series OCT is limited by U.S. law to investigational use and not available for sale in the United States. Perimeter S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by the U.S. FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established. For more information, please visit Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This news release contains statements that constitute "forward-looking information" within the meaning of applicable Canadian securities legislation. In this news release, words such as "may," "would," "could," "will," "likely," "believe," "expect," "anticipate," "intend," "plan," "estimate," and similar words and the negative form thereof are used to identify forward-looking statements. Forward-looking information may relate to management's future outlook and anticipated events or results and may include statements or information regarding the Company's results for the three and six months June 30, 2025, business strategy and strategic goals, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, taxes and plans and objectives of, or involving, Perimeter. Without limitation, information regarding management's views regarding the second quarter, the potential benefits of Perimeter S-Series OCT and Perimeter B-Series OCT and the expected benefits of Perimeter's updated version of its ImgAssist AI are forward-looking information. Forward-looking statements should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether, or the times at or by which, any particular result will be achieved. No assurance can be given that any events anticipated by the forward-looking information will transpire or occur. Forward-looking information is based on information available at the time and/or management's good-faith belief with respect to future events and are subject to known or unknown risks, uncertainties, assumptions, and other unpredictable factors, many of which are beyond Perimeter's control. Such forward-looking statements reflect Perimeter's current view with respect to future events, but are inherently subject to significant medical, scientific, business, economic, competitive, political, and social uncertainties and contingencies. In making forward-looking statements, Perimeter may make various material assumptions, including but not limited to (i) the accuracy of Perimeter's financial projections; (ii) obtaining positive results from trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market, and economic conditions. Further risks, uncertainties and assumptions include, but are not limited to, those applicable to Perimeter and described in Perimeter's Management Discussion and Analysis and Annual Information Form for the year ended December 31, 2024, which are available on Perimeter's SEDAR+ profile at and could cause actual events or results to differ materially from those projected in any forward-looking statements. Perimeter does not intend, nor does Perimeter undertake any obligation, to update or revise any forward-looking information contained in this news release to reflect subsequent information, events, or circumstances or otherwise, except if required by applicable laws. Financial Outlook This press release contains a financial outlook within the meaning of applicable Canadian securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company's forecasted revenue for the three and six months ended June 30, 2025 and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions including the assumptions discussed under the heading "Forward-Looking Statements" herein. The actual results of the Company's operations for any period will likely vary from the amounts set forth in these projections and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading "Forward-Looking Statements" herein, it should not be relied on as necessarily indicative of future results. Stephen Kilmer Investor Relations Direct: 647-872-4849 Email: [email protected] Adrian Mendes Chief Executive Officer Toll-free: 888-988-7465 (PINK) Email: [email protected]
Business Wire
23-06-2025
- Business
- Business Wire
Ancora Heart Inc. Reaches First Enrollment Milestone in CORCINCH-HF Heart Failure Pivotal Trial
SANTA CLARA, Calif.--(BUSINESS WIRE)-- Ancora Heart, Inc., a medical device company developing a transcatheter device-based therapy to address heart failure (HF), today announced that it has reached the first enrollment milestone in the CORCINCH-HF pivotal trial evaluating the AccuCinch ® Transcatheter Left Ventricular Restoration System in patients with heart failure with reduced ejection fraction (HFrEF). Six-month follow-up data on these 250 patients will support the company's Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA). 'The AccuCinch System is the only completely transcatheter procedure to treat the enlarged left ventricle. Reaching this milestone is an incredible accomplishment in heart failure research." - Jeff Closs, president and CEO, Ancora Heart Share The AccuCinch System is an investigational device designed to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall. Results from early clinical studies were presented at the 2023 Technology and Heart Failure Therapeutics conference and simultaneously published in the Journal of Cardiac Failure. The AccuCinch System was granted Breakthrough Device Designation from the FDA in 2022. 'The AccuCinch System is the only completely transcatheter procedure to treat the enlarged left ventricle,' said Jeff Closs, president and CEO of Ancora Heart. 'Reaching this milestone is an incredible accomplishment in heart failure research and a model example of collaboration across heart failure and structural heart care teams at participating CORCINCH-HF clinical trial sites. We'd like to thank study investigators for their commitment to innovation and partnership, and we look forward to building on this momentum as we work toward reaching our full enrollment target of 400 patients.' The CORCINCH-HF study is evaluating the safety and effectiveness of the AccuCinch System in patients who have symptomatic HF with reduced ejection fraction. An estimated 6.7 million adults in the U.S. live with heart failure, and about half have HFrEF. 1,2 'Despite advances in guideline-directed medical therapy, many patients with heart failure continue to experience debilitating symptoms,' said Ulrich Jorde, MD, global co-principal investigator of the CORCINCH-HF Study, professor of medicine, Albert Einstein College of Medicine, and section head of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Montefiore Health System in New York. 'Reaching this milestone in the CORCINCH-HF study is a significant step toward determining whether this treatment option may improve the length and quality of their lives.' 'AccuCinch is a device-based therapy aimed at reverse remodeling of the enlarged left ventricle,' said Mark Reisman, MD*, global co-principal investigator of the CORCINCH-HF Study, director of structural heart disease at NewYork-Presbyterian/Weill Cornell Medical Center and co-director of structural heart disease for NewYork-Presbyterian Queens and NewYork-Presbyterian Brooklyn Methodist Hospital, who was recruited to Weill Cornell Medicine as a professor of medicine. 'This trial is designed to evaluate the safety of the device and procedure and whether we can improve heart structure and function and thereby help patients feel better, avoid hospitalizations and live longer.' About Heart Failure An estimated 6.7 million adults in the U.S. live with heart failure, a condition in which the heart's muscles weaken and lose their ability to pump enough oxygen-rich blood to the body. 1,2 Heart failure patients suffer from debilitating symptoms, including persistent exhaustion, trouble breathing and confusion, as well as frequent hospitalizations. About half of HF patients have heart failure with a reduced ejection fraction (HFrEF) and an enlarged left ventricle, the main pumping chamber of the heart, which causes more stress on the heart and leads to reduced pumping efficiency. Up to 50% of people who develop heart failure die within five years of diagnosis. 3 About the AccuCinch ® Transcatheter Left Ventricular Restoration System The AccuCinch System is an investigational device designed to augment the existing care cardiologists provide their heart failure patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant. During the minimally invasive AccuCinch System procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall. The AccuCinch System is under clinical evaluation to determine its potential benefits related to patient symptoms, quality of life and life expectancy. About the CORCINCH-HF Study The CORCINCH-HF Study (NCT04331769) is a prospective, randomized, open-label, multicenter, international, clinical safety and effectiveness investigation of the AccuCinch Transcatheter Left Ventricular Restoration System, which is designed to enroll 400 patients at centers worldwide. The study has a unique design allowing initial analysis of safety and clinical effectiveness for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. About Ancora Heart, Inc. Ancora Heart is a medical device company dedicated to providing new treatment options for people with heart failure (HF). The company's lead product is the AccuCinch ® Transcatheter Left Ventricular Restoration System, an investigational device currently being studied in the CORCINCH-HF pivotal trial. Ancora Heart is a privately held company located in Santa Clara, Calif. For more information, about Ancora Heart and its products, visit and follow the company on Facebook, LinkedIn and X. * Dr. Reisman reports travel support from Ancora Heart. 1 Martin SS, Aday AW, Almarzooq ZI, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee; Stroke Statistics Subcommittee. 2024 heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. 2024;149:e347–913. 2 Murphy S, Ibrahim N, Januzzi J. Heart Failure with Reduced Ejection Fraction, A Review. JAMA. 2020;324(5):488-504 3 Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-596.
Associated Press
13-03-2025
- Business
- Associated Press
United Health Products Provides Update on Capital Markets and Regulatory Processes
NEWMEDIAWIRE) - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's regulatory and capital markets activities. As precisely disclosed, UHP has submitted an application to OTC Markets to have its common shares quoted on the OTCQB market, which the company believes will increase the base of potential investors and boost trading liquidity, among other benefits. OTC Markets recently requested certain additional information from the company which it expects to submit by the end of March, allowing OTC Markets to complete its review of the application. In order to fund previously announced clinical activities related to its Premarket Approval application, UHP has raised over $500,000 through private placement transactions during the current and most recent fiscal quarters with existing and new investors, and has not relied on its Equity Line of Credit with White Lion Capital. The company expects that it will be able to raise sufficient capital through similar private placements to fund the remaining clinical study and other PMA application. As part of its PMA process the company submitted an Investigational Device Exemption application to the FDA. In its most recent discussion with UHP, the FDA has requested certain additional sterilization and biotoxicity tests, the last of which will be completed and submitted by the end of March, allowing the FDA to conduct final review of the IDE application. In parallel with this testing, UHP has completed negotiations of a Clinical Trial Agreement with a national hospital and surgical center operator that has identified three facilities within its network that will conduct the planned 27 surgical procedures requested by the FDA. Additional pre-enrollment tasks are being undertaken concurrently with the IDE application so that patient enrollment can begin as soon as possible following IDE approval. Recent actions by the Trump Administration to reduce the federal government workforce have included reductions in force and voluntary resignation packages affecting FDA staff. The company notes certain Administration statements to the effect that FDA employees who review new drug and device applications are excluded from voluntary resignation programs. As of the current date, UHP observes that the FDA response times to its correspondence are generally consistent with past practice. There can be no assurance that the Premarket Approval or the OTCQB uplisting applications will be granted. About United Health Products -- UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT is an all-natural product designed to control mild to moderate bleeding. UHP is seeking approval to access the human surgical market. For more information on UHP visit the company's new website: or contact the company at [email protected]. The company can also be reached by phone or text message at 475.755.1005. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words 'believes,' 'expects,' 'anticipates' or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
Yahoo
11-03-2025
- Business
- Yahoo
Interim analysis of 1-level BAGUERA®C IDE study meets threshold for non-inferiority
Press Release – To post on March 11, 2025 Interim analysis of 1-level BAGUERA®C IDE study meets threshold for non-inferiority Geneva, March 11, 2025 – Spineart, a fast-growing company in spine surgery innovation, today announces that it has completed a planned interim analysis for its 1-level BAGUERA®C IDE study, which showed that BAGUERA® C, its innovative cervical disc prosthesis, met the threshold for a non-inferiority claim against the study control. Spineart has now agreed on a timeline with the U.S. FDA for the submission of Premarket Approval (PMA) for BAGUERA® C in three components (modules) which will be submitted and reviewed separately. Completion of the PMA submission is now scheduled for the end of August 2025, potentially enabling an earlier approval than had originally been anticipated. The BAGUERA®C 1-level IDE trial is a prospective, multi-center, randomized clinical study evaluating the safety and efficacy of BAGUERA®C compared with the Mobi-C® cervical disc in the treatment of symptomatic cervical disease at a single level in the cervical spine. The study enrolled 285 patients at 25 sites in the U.S. Results of this clinical trial are intended to be the basis of a PMA submission to the U.S. FDA. Jerome Trividic, Chief Executive Officer at Spineart, commented: 'This interim analysis data is extremely promising. We look forward to working with the FDA as we prepare to submit our PMA modules later this year, bringing us closer to making our innovative cervical disc prosthesis available to patients in the United States.' CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. About the BAGUERA®C Cervical Disc Prosthesis The BAGUERA®C cervical disc prosthesis, developed by Spineart, is an investigational device in the U.S., designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA®C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations). About Spineart Spineart is a global fast-growing company in spine surgery innovation, dedicated to accelerating the adoption of cutting-edge technologies for surgeons and hospitals worldwide for the benefit of their patients. Renowned for its commitment to Quality, Innovation, and Simplicity, Spineart continues to push the boundaries of spinal surgery with its comprehensive portfolio of procedural solutions and digital technologies. Spineart was awarded the "Prix de l'Economie Genevoise 2022" for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles. Please visit and follow on LinkedIn. For media inquiries or further information, contact press@ or visit in to access your portfolio
Associated Press
25-02-2025
- Health
- Associated Press
CereVasc Announces First Patient Randomized to eShunt® System Treatment in STRIDE Pivotal Trial
Patient treated at VCU Health BOSTON, Feb. 25, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that the first patient has been randomized to and treated with the eShunt® System in its STRIDE clinical trial, a head-to-head comparison of the novel eShunt System versus the standard of care ventriculo-peritoneal (VP) shunt in patients with normal pressure hydrocephalus (NPH). The patient was treated at VCU Health in Richmond. Multiple trial site locations are now open across the United States. STRIDE is a multi-center, randomized, controlled trial designed to assess the safety and efficacy of the eShunt System compared with the current standard of care, the VP shunt, in elderly patients diagnosed with NPH. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA). NPH is a life-threatening form of communicating hydrocephalus that affects 800,000 people in the United States alone. 'I was honored to perform the inaugural treatment in the STRIDE trial. This investigation could lead to a safer and less invasive way to address the gait disturbance, cognitive deficits, and urinary incontinence that are experienced by people with NPH,' said John Reavey-Cantwell, M.D., Neurosurgeon and Director of Cerebrovascular and Endovascular Neurosurgery at VCU Health. 'Because the eShunt System is less invasive than the VP shunt, this trial will assess its potential to improve recovery times and reduce post-operative complications such as infection. As a result, I'm hopeful it will make treatment possible for more patients living with this devastating neurological disease — including those who have comorbidities.' The eShunt System is the only endovascular shunt and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago. 'The treatment of the first patient with the eShunt® System in the STRIDE trial marks an important milestone for CereVasc by providing a potential new treatment option for patients with NPH and for the medical community, which has expressed considerable enthusiasm about the promise of the eShunt System,' said Dan Levangie, CereVasc's Chairman & CEO. 'As the first randomized controlled trial comparing a modern alternative with the standard-of-care treatment for NPH, this trial is an important step in evaluating the safety and effectiveness of the eShunt System. This trial could provide a way for elderly patients with NPH to improve their quality of life while supporting an overall movement toward minimally invasive procedures across the field of neurosurgery.' For more information, please visit About CereVasc, Inc. Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at The eShunt® Device is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. Company Contact: DJ Cass CereVasc, Inc. Media Contacts: Ethan Metelenis Precision AQ
