Teleflex reports promising results for coronary perforation management device

WAYNE, Pa. - Teleflex Incorporated (NYSE: TFX), a global provider of medical technologies with annual revenues of $3.05 billion, has announced preliminary results from its Ringer™ PBC study, which investigates the device’s efficacy in managing coronary perforations during percutaneous coronary intervention (PCI) procedures. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, with analysts expecting net income growth this year. The findings were presented at the CTO Plus Conference in New York by Dr. David E. Kandzari, the study’s principal investigator.

The Ringer™ PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter featuring a helical balloon design that allows for continuous blood flow during prolonged inflations. The study, a limited prospective, multi-center, single-arm investigation, enrolled 30 participants across four U.S. sites to evaluate the catheter’s performance in emergent situations.

According to the study, the primary efficacy endpoint—successful device delivery and inflation at the perforation site, control of extravasation, and preservation of antegrade coronary flow—was met in 22 participants (73.3%). The device was successfully delivered in 26 cases (86.7%), with control of extravasation achieved in 22 (84.6%) of those instances. Following perforation management with Ringer™ PBC, 12 participants received a covered stent. Despite successful control of extravasation, there were three deaths and one emergency surgery due to complications.

Dr. Kandzari emphasized the importance of these results, noting the limited treatment options currently available for coronary artery perforations during PCI. The Ringer™ PBC has received the FDA’s Breakthrough Device Designation, which aims to expedite the development and review process for devices that could significantly improve treatment for life-threatening or irreversibly debilitating diseases.

Teleflex’s Medical Director, Dr. Christopher Buller, reiterated the company’s dedication to generating clinical evidence to support physicians in product selection for patient care. The Ringer PBC is currently indicated for balloon dilatation of coronary artery or bypass graft stenoses, allowing for improved myocardial perfusion during inflation.

The data from this study is intended to support a premarket application recently submitted to the FDA. However, the Ringer PBC remains an investigational device and is not yet available for sale.

This report is based on a press release statement and the information contained herein has not been independently verified. The Ringer PBC study’s preliminary results indicate a potential advancement in the management of coronary perforations, but further research and regulatory approval are required before the device can be made widely available. For deeper insights into Teleflex’s financial outlook and comprehensive analysis, including 8 additional ProTips and detailed valuation metrics, visit InvestingPro, where you’ll find expert research reports covering 1,400+ top stocks.

In other recent news, Teleflex Incorporated has announced significant developments affecting its business strategy and financial outlook. The company reported its fourth-quarter 2024 earnings and 2025 guidance, revealing plans to acquire BIOTRONIK’s Vascular Intervention business for approximately €760 million. This acquisition, alongside a $300 million accelerated share repurchase program, will be financed through a combination of debt and cash on hand. Moody’s has revised Teleflex’s outlook to negative, citing increased operational risks associated with the acquisition and a planned spin-off of certain business segments.

Teleflex plans to separate its Acute Care, OEM, and Urology businesses into a new publicly traded entity, a move expected to decrease its revenues and EBITDA by 40% and 20%, respectively. Needham has maintained a Hold rating on Teleflex, highlighting concerns about the future growth rates of the two new entities post-spin-off. Truist Securities also adjusted its price target for Teleflex from $200 to $149, maintaining a Hold rating due to uncertainties surrounding the spin-off and integration of the BIOTRONIK acquisition.

The company’s strategic initiatives aim to enhance shareholder value, but they come with substantial execution risks, as noted by both Moody’s and Truist Securities. Teleflex’s liquidity remains strong, supported by its cash flow and credit facilities, despite the increased leverage from recent transactions. Investors are closely monitoring these developments as Teleflex navigates through these transformative changes.

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