The Latest Cardiac and Vascular News
DURHAM, N.C., March 03, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced it will host an in-person and virtual investor event in New York on Thursday, March 6, 2025 at 12:00 PM ET. To register as an in-person or virtual attendee, please click here.
– Completed first quarter as a public company and raised $10.6 mil CAD concurrent with listing – Next-generation Novasight design freeze completed on schedule, usability testing and system validation expected to complete next quarter – U.S. FDA submission on track for Q3 calendar 2025 TORONTO, March 03, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (“Conavi Medical” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, today reported financial results for the fiscal quarter ended December 31, 2024. These unaudited interim results are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. “We made significant progress in the quarter towards our vision of being a leader in hybrid intravascular imaging,” commented Thomas Looby, Conavi Medical’s CEO. “Beyond our going-public transaction and significant revenue milestone with our Chinese partner, we maintained our progress toward a summer FDA filing. On the medical front, the peer-reviewed paper published by the American College of Cardiology added to the momentum we gained from the upgrade in European coronary imaging guidelines last summer. With Novasight’s design now frozen, we’re excited to have started usability testing and system validation, with completion expected next quarter.” Business HighlightsAll amounts are in Canadian dollars unless specified otherwise: During the quarter, the Company completed a reverse takeover of Titan Medical Inc. in an all-stock transaction and completed a concurrent private placement to certain institutional and accredited investors of subscription receipts for gross proceeds of approximately $10.6 million.Conavi Medical’s common shares (which, at the time, were Titan Medical Inc.) were voluntarily delisted from the Toronto Stock Exchange on October 15, 2024 and commenced trading on the TSX Venture Exchange under the symbol “CNVI” effective October 16, 2024. The Company subsequently engaged ICP Securities Inc. to provide automated market making services.Also in October 2024, the Journal of the American College of Cardiology: Cardiovascular Interventions published a peer-reviewed paper by Tufaro et al. (https://doi.org/10.1016/j.jcin.2024.07.007) that provided an overview of recent developments in hybrid intracoronary imaging and discussed its value in a range of clinical practice and research areas, including percutaneous coronary intervention (PCI) guidance, vulnerable plaque detection, and the assessment of focal and systemic therapies for atherosclerosis. One of the authors of the article, Christos V. Bourantas, MD, PhD, a Consultant Cardiologist at Barts Heart Centre and Professor of Cardiology (Hon) at Queen Mary University London, commented, “There is a large and growing body of evidence that the use of OCT or IVUS to guide PCI procedures has substantially improved patient event-free survival, enhancing both the long-term safety and effectiveness of the procedure. However, each imaging modality has unique advantages and limitations. Conavi Medical’s Novasight Hybrid System offers an elegant solution, providing simultaneous and complementary data with which to better inform patient care.”On December 9, 2024, the Company announced that its exclusive licensing partner in China, East Ocean Medical (Hong Kong) Company Limited (“EOM”), had received approval by the China National Medical Products Administration for its coronary imaging system, which is based on Novasight Hybrid™ System intellectual property licensed to it by the Company via a June 2021 technology transfer and licensing agreement (“TTLA”). The NMPA triggered a fourth and final US$5.9 million milestone payment from EOM to Conavi Medical, which the Company used to extinguish a US$5.9 million promissory note owed by it to EOM. With this milestone achieved, the Company expects to begin benefiting from a recurring royalty revenue stream, as detailed in its press release of December 9, 2024.Subsequent to FY Q1 2025, in January 2025, the Company completed the design freeze of the next-generation Novasight Hybrid System and initiated design verification testing in support of a regulatory application to the FDA.Also in January 2025, the Company announced that it had filed a preliminary short form prospectus with securities regulatory authorities in the Provinces of British Columbia, Alberta, and Ontario in connection with an offering of units (with each unit consisting of one common share and one common share purchase warrant). Upcoming Targeted MilestonesThe following targeted milestones use calendar dates: Q2 2025 Expected completion of usability and system validation with key opinion leadersExpected publication of whitepaper and submissions to journals to drive awareness Q3 2025 Targeted timeframe for U.S. FDA 510(k) submission for the next-generation Novasight system H1 2026 Estimated timeframe for U.S. FDA 510(k) clearance for the next-generation Novasight systemFirst-in-human clinical study to highlight safety and feasibility (subject to FDA clearance)Targeted U.S. commercial launch (subject to FDA clearance) Fiscal Q1 2025 Financial ResultsAll amounts are in Canadian dollars unless specified otherwise: As previously reported, in the two preceding fiscal years, the Company was focused on development of the next-generation Novasight system and incorporating clinical user feedback from its current system. This focus continued into FY Q1 2025. For the quarter ended December 31, 2024, the Company recorded revenue of approximately $8.6 million compared to approximately $0.7 million for the same period in the prior year. The increase in revenue in Q1 2025 corresponds to an approximate $8.4 million (US$5.9 million) milestone payment made under the TTLA with EOM. Operating expenses for the three months ended December 31, 2024, were approximately $6.8 million, compared to approximately $5.1 million for the same period in the prior year. The operating loss for FY Q1 2025 was approximately $0.3 million, compared to approximately $5.0 million for FY Q1 2024, with the change largely resulting from the payment received from EOM. Research & development expenses for FY Q1 2025 were approximately $4.7 million, compared to approximately $3.3 million for FY Q1 2024. The FY Q1 2025 net loss was approximately $7.6 million, or $0.19 per common share, compared to a net loss of approximately $7.3 million, or $1.19 per common share, in the three-month period ended December 31, 2023. The net loss in FY Q1 2025 was due to finance costs and operating costs, partially offset by the revenue from EOM; the loss in FY Q1 2024 was due to operating costs. In both periods, the majority of operating costs were attributable to research & development activities. As of December 31, 2024, cash and cash equivalents were approximately $5.1 million. For detailed financial results, please refer to Conavi Medical’s filings on SEDAR+ and the Company’s website. 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 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 and references to expected recurring royalties that may be received from EOM. 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 of the Preliminary Prospectus of the Company dated January 29, 2025 (each of which may be viewed at 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 ir@conavi.com(416) 483-0100
Acquisition to expand Interventional Cardiology Therapies offerings with ultrasound-based renal denervation therapy for treatment of hypertension MARLBOROUGH, Mass., March 3, 2025 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive…
SHANGHAI, March 2, 2025 /PRNewswire/ — Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), has announced the closing of nearly $100 million Series C financing. This round was co-led by Qiming Venture Partners and…
BURLINGTON, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) — LeMaitre (Nasdaq:LMAT), a provider of vascular devices, implants, and services, reported Q4 2024 results, announced an increased quarterly dividend of $0.20/share (+25%), and provided guidance.
Teleflex to create a new, independent publicly traded company (“NewCo”) consisting of Teleflex’s Urology, Acute Care, and OEM businesses.Teleflex RemainCo (“RemainCo”) will consist of Teleflex’s Vascular Access, Interventional, and Surgical businesses – focusing on high-growth, high-acuity, primarily hospital-focused emergent end markets.Separation expected to position RemainCo to deliver 6%+ constant currency revenue growth post-separation, to be accretive to Teleflex adjusted gross margin, initially neutral to Teleflex adjusted operating margin, and drive double-digit EPS growth in the first full year post separation.Separation will position each company to accelerate its growth profile with a simplified operating model, streamlined manufacturing footprint, better allocation of resources and increased management focus.Transaction intended to take the form of a distribution of newly issued shares of NewCo to shareholders that is tax-free for U.S. tax purposes and is expected to be completed mid-2026. WAYNE, Pa., Feb. 27, 2025 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced that following a comprehensive business portfolio evaluation, its Board of Directors has authorized Teleflex management to pursue a plan to separate the company’s Urology, Acute Care, and OEM businesses into a new, independent, publicly traded company via a distribution of newly issued shares of NewCo to shareholders that is tax-free for U.S. tax purposes. “The decision to pursue this separation was driven by our active portfolio management process and focus on driving shareholder value,” said Liam Kelly, Teleflex’s Chairman, President and Chief Executive Officer. “Following the separation, RemainCo will be well-positioned to accelerate growth in attractive, primarily hospital-focused, emergent end markets, with a simplified operating model, streamlined manufacturing footprint and increased management focus. We expect RemainCo to have increased flexibility to invest in and better compete in the markets in which it will operate with a focus on enhanced innovation. We believe NewCo will also emerge poised to deliver greater value via its enhanced ability to identify, invest in, and capitalize on the opportunities unique to its end markets. This transaction is designed to optimize the positioning of both companies in order to better meet the needs of patients and customers and maximize value for shareholders.” Teleflex RemainCo to Sharpen Focus on High-Growth, High-Acuity End Markets RemainCo, with approximately $2.1 billion in revenue in 2024 (pro forma for our announced acquisition of substantially all of Biotronik’s Vascular Intervention business), will focus on attractive, high-growth end markets addressing emergent procedures performed primarily in the hospital setting across the Intensive Care Unit, Emergency Department, Catheter Lab, and Operating Room. The product portfolio will be highly complementary with significant breadth across the hospital, with leading market positions and opportunities for growth across three core product categories: Vascular Access, offering devices that facilitate a variety of critical care therapies and other applications with a focus on helping reduce vascular-related complications. These products primarily consist of our Arrow branded catheters, catheter navigation and tip positioning systems, and our intraosseous access systems. Post-separation, Vascular Access will also include our emergency medicine portfolio, including our hemostatic products branded under our QuikClot trade name.Interventional, offering devices that facilitate a variety of applications to diagnose and deliver treatment of coronary and peripheral vascular disease. These products primarily consist of a variety of coronary catheters and structural heart support devices used by interventional cardiologists, interventional radiologists and vascular surgeons. The Interventional product category will also include the Biotronik Vascular Intervention business, significantly expanding our portfolio in both coronary and peripheral cath lab procedures1.Surgical, offering single-use and reusable devices designed for use in a variety of surgical procedures, primarily consisting of metal and polymer ligating clips, fascial closure surgical systems used in laparoscopic surgical procedures, percutaneous surgical systems, a powered bariatric stapler, and other surgical instruments used in ear, nose and throat and cardiovascular and thoracic procedures. Following the separation, RemainCo is expected to generate constant currency revenue growth of 6%+. The separation is expected to be accretive to Teleflex adjusted gross margin and neutral to Teleflex adjusted operating margin initially, partially as a result of higher anticipated investment in R&D. RemainCo will have a simplified and nimble operating model with a streamlined manufacturing footprint, transitioning from 19 manufacturing facilities anticipated at Teleflex as of year-end 2025 to 7 facilities at RemainCo post-separation with the remaining 12 expected to transfer to NewCo. This simplification will provide opportunities for margin improvement over time and will create capacity for additional focused R&D investment. The transaction is also expected to be accretive to EPS growth, with RemainCo anticipated to deliver double digit EPS growth in the first full year following the separation. With this enhanced financial profile, RemainCo will have increased flexibility to better align its capital allocation philosophy and growth strategy. RemainCo will remain disciplined, planning to prioritize allocating capital to internal investment into high-ROI growth drivers, growth-accretive acquisitions to help RemainCo more effectively compete in highly innovative end markets, repaying debt as appropriate to optimize leverage profile, and continuing to return capital to shareholders via quarterly dividends and opportunistic share repurchases. RemainCo is targeting a net leverage ratio below 3.0x through 2026. Liam Kelly will continue to lead RemainCo as its Chairman, President and CEO. NewCo Will Have Undivided Management Focus to Unlock Potential in Urology, Acute Care, and OEM End Markets NewCo, with approximately $1.4 billion in revenue in 2024, is also expected to benefit from a simplified operating model, increased management focus, and a tailored investment and capital allocation strategy. NewCo will be better positioned to identify, invest in, and capitalize on opportunities unique to its businesses, with established leadership positions across three categories: Urology, to include the company’s Interventional Urology and bladder management portfolios. Key brands and products include the UroLift System, a minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia in men 45 years of age or older, Barrigel, the company’s hyaluronic acid gel-based rectal spacing product used in connection with radiation therapy treatment of prostate cancer, and the Rüsch brand of catheters and bladder management products.Acute Care, to include the majority of Teleflex’s Anesthesia product category, as well as the company’s Respiratory product category, portfolio of intra-aortic balloon pumps, and select other products. Anesthesia products will include our airway management portfolio consisting of laryngoscopes, supraglottic airways, and endotracheal tubes, as well as our pain management portfolio, consisting of epidurals, catheters and disposable pain pumps for regional anesthesia, designed to improve patients’ post-operative pain experience.OEM, focused on the design, manufacture, and supply of devices and instruments for other medical device manufacturers. The OEM segment specializes in custom extrusions, micro-diameter film-cast tubing, diagnostic and interventional catheters, balloons and balloon catheters, film-insulated fine wire, coated mandrel wire, conductors, sheath/dilator introducers, specialized sutures and performance fibers, bioabsorbable sutures, yarns and resins. Following the separation, NewCo is expected to generate low-single digit constant currency revenue growth with a mid-50% adjusted gross margin profile. Over the medium term, NewCo will have the potential to improve growth into the low-single-digit to mid-single digit range as the UroLift business recovers, Barrigel growth remains strong, and the OEM business seeks to return to historical growth empowered by greater flexibility to further expand customer base and enhance capabilities. Teleflex intends to initiate an executive search for key management positions at NewCo shortly. The NewCo Board of Directors, management and headquarters will be announced as they are finalized. Transaction Details The transaction is intended to take the form of a distribution of newly issued shares of NewCo to shareholders that is tax-free for U.S. tax purposes. The company expects the transaction to be completed mid-2026. The transaction is subject to satisfaction of customary conditions, including final approval from the Teleflex Board of Directors, filing and effectiveness of a Form 10 registration statement with the U.S. Securities and Exchange Commission, receipt of a tax opinion from Teleflex’s tax advisor, receipt of a private letter ruling from the Internal Revenue Service, satisfactory completion of financing, and receipt of other regulatory approvals. No assurance can be given regarding the form that a separation transaction may take or the specific terms or timing, or that a separation will in fact occur. Advisors Centerview Partners LLC is serving as financial advisor to Teleflex. Simpson Thacher & Bartlett LLP is acting as legal advisor to Teleflex. Conference Call and Webcast Teleflex separately reported today fourth quarter and full-year 2024 financial results and announced its entry into a definitive agreement to acquire substantially all of Biotronik’s Vascular Intervention business. The company will host a conference call at 8:00 am ET on Thursday, February 27, 2025 to discuss the results and today’s announcement. To participate in the conference call, please utilize this link to pre-register and receive the dial-in information. The call can also be accessed through a live audio webcast on the company’s website, teleflex.com. An audio replay of the call will be available beginning at 11:00 am Eastern Time on February 27, 2025, either on the Teleflex website or by telephone. The call can be accessed by dialing 1 800 770 2030 (U.S. and Canada) or 1 609 800 9909 (all other locations). The conference ID is 69028. About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. References: Teleflex announced today that it has entered into a definitive agreement to acquire substantially all of the Vascular Intervention business of BIOTRONIK SE & Co. KG, which it expects to close by the end of the third quarter of 2025. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements about the company’s plans to separate certain of its businesses into an independent company, the expected timetable for completing the transaction, the tax-free nature of the transaction, the future financial and operating performance of each company following the transaction, the benefits and synergies of the transaction, strategic and competitive advantages of each company, and future growth and other opportunities for each company. Actual results could differ materially from those in the forward-looking statements due to, among other things, any changes in or abandonment of the proposed transaction and our ability to satisfy the conditions to the proposed transaction; unanticipated costs and length of time required to comply with legal requirements and regulatory approvals applicable to the transaction; customer and shareholder reaction to the transaction; disruption from the transaction making it more difficult to maintain business and operational relationships; significant transaction costs; changes in general and international economic conditions, including fluctuations in foreign currency exchange rates; and other factors described or incorporated in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2024. CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Other names are the trademarks of their respective owners. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this document is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. © 2025 Teleflex Incorporated. All rights reserved. Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Development investor.relations@teleflex.com610-948-2836
Acquisition will further advance Teleflex’s Interventional portfolio with a differentiated global suite of coronary vascular and peripheral vascular intervention devices Acquisition will further advance Teleflex’s Interventional portfolio with a differentiated global suite of coronary vascular and peripheral vascular intervention devices
MENLO PARK, Calif.–(BUSINESS WIRE)–Jupiter Endovascular, Inc., a medical technology startup transforming endovascular medicine with a new class of interventions, announced today that experienced medtech finance and operations executive Fred Ong has joined the company as Chief Financial Officer. “Fred is joining us at a pivotal time as we build upon […]
February 25, 2025 04:01 PM Eastern Standard Time SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the underwriter of its previously announced public offering of HeartBeam’s common stock has exercised its option to purchase an […]
PLANTATION, Fla., Feb. 26, 2025 /PRNewswire/ – Akumin, a leader in managed radiology and oncology services, is pleased to announce the formation of its new Physician Advisory Board (APAB), composed of esteemed experts in the field. The APAB will advise on innovation, clinical and…
