Johnson & Johnson MedTech announced today that it has completed its acquisition of Laminar, Inc. This privately owned medical device manufacturer focuses on getting rid of that left atrial appendage (LAA) in patients suffering from the condition known as non-valvular atrial fibrillation (AFib).
Johnson & Johnson MedTech acquired Laminar in exchange for an upfront payment of $400 million, subject to normal adjustments and potential milestones for clinical and regulatory purposes by 2024 or later. Laminar is now part of Johnson & Johnson MedTech as part of Biosense Webster, Inc. A global leader in the treatment of cardiac arrhythmias.
There are currently 38 million people around the globe suffering from AFib, which causes them to be five times more likely to suffer stroke3. It is a tiny pouch located in the heart’s left atrium. It could be the source of clots, which could be absorbed into the bloodstream, possibly creating stroke. The LAA is the most significant contributor to thromboembolic strokes for patients with non-valvular fibrillation.
Contrary to current catheter-based commercial devices, which use plugs to block laparoscopy, the unique method uses rotational motion to remove the LAA. Laminar recently obtained FDA approval for its U.S. pivotal study, which will start enrollment at the beginning of 2024.
LAA closure is a therapy that the FDA has approved to lower the chance of developing thromboembolism among atrial fibrillation patients that are recommended for long-term oral anticoagulation therapy; however, have a valid reason to look for a non-pharmacologic alternative to oral anticoagulants for chronic use4. This is crucial for the 40 per cent of AFib patients who are not able to endure long-term treatment with blood thinners.
“For many of the people suffering from AFib, the risk of stroke is a serious worry. Our team here at Laminar is motivated by our goal to design and provide a revolutionary solution that will allow patients to remain free of the threat of a stroke or the necessity to use long-term blood thinners,” stated Randy Lashinski, the President and CEO of Laminar. “We look forward to developing this idea as part of Johnson and Johnson MedTech.”
“We are delighted to be able to welcome Laminar to Johnson and Johnson MedTech,” said Jasmina Brooks, president of Biosense Webster. “Laminar’s innovative approach will allow Biosense Webster to expand our portfolio in this high-growth market, complement our electrophysiology and Intracardiac Echo strengths, and deepen our presence with interventional cardiologists and electrophysiologists. Invigorated by the global scale and the clinical and commercial power of Biosense Webster, we are eager to discover the opportunities ahead to serve more patients with a pressing unmet demand.”
In connection with taking over Laminar, Inc., Johnson & Johnson will adjust its adjusted EPS forecast for the fiscal year 2023. The acquisition of the asset will result in an internal research and development expense that will decrease the adjusted EPS for both reported and operational operations by around $0.17 from the guidance previously released. The anticipated operating and reported Adjusted EPS ranges for 2023 are $9.85 up to $9.91 and $9.90 to $9.96 in the respective ranges. Furthermore, the asset purchase is anticipated to have an approximately negative $0.15 impact on EPS in the fiscal year 2024.
About Johnson and Johnson MedTechÂ
At Johnson and Johnson, MedTech unleashes a wide range of knowledge of healthcare, innovative technologies, and love for helping people transform the medical treatment of the future and help everyone lead the best life possible. For more than a century, we’ve been driving revolutionary scientific advancements to address the unmet health needs of patients and redefine the future of health. In orthopaedics, surgery vision, and interventional solutions, we continue to save lives and build an environment where healthcare solutions are less invasive, more intelligent and more personalized. For more information, visit thenext.jnjmedtech.com.
About Biosense Webster
Biosense Webster is the leading global Company in research and technology that underpins diagnosing and treating heart arrhythmias. It is part of Johnson & Johnson MedTech, the medical-tech Company with specialized expertise in Irvine, California. It is active around the globe to develop instruments and solutions that aid electrophysiologists in detecting, treating and managing treatment. Please find out more on biosensewebster.comÂ
Cautionary Statement on forward-looking statements
The press release includes forward-looking information about an acquisition by Laminar, Inc. The reader is warned not to put too much trust in the forward-looking information contained in this press release. They are made based on expectations for future events. Suppose the assumptions underlying them are inaccurate, known, or undiscovered risks or uncertainties are realized. In that case, real-world results may differ from the forecasts and expectations from the MedTech entities or Johnson & Johnson. The risks and uncertainties are among others, but not restricted to: the possibility that the anticipated benefits and potential from the acquisition might not be realized or take longer than anticipated; the challenges that arise from product development and research and the uncertainty of the clinical efficacy and getting the necessary regulatory approval; uncertainties regarding the commercial success of new products manufacturing issues or delays in the production of products; effectiveness or safety concerns that lead to recalls of products or regulatory actions and economic conditions, such as rates of exchange and currency fluctuations; the risks that come with global operations; competition such as technological advancements, innovative patents and products developed by rivals; challenges to patents; changes in relevant laws and regulations including taxes and health reforms and adverse government action; changes to the habits and spending patterns of the financial difficulties of those purchasing health-related products and services and the trend towards healthcare cost reduction. There will also be uncertainties and risks that relate to the capacity of Laminar, Inc.’s Johnson & Johnson family of companies to successfully integrate its operations and products of its employees and the clinical activities from Laminar, Inc., and the capacity to maintain the product performance or growth of Laminar Inc.’s products.
Further information and descriptions of the risks, uncertainties, and other elements are available in Johnson and Johnson’s Annual Report on Form 10-K for the fiscal year that ended on January 1st, 2023 and in particular, the parts titled “Cautionary Note Concerning Forward-Looking Statements” as well as “Item 1A. Risk Factors” as well as in Johnson &Johnson’s Quarterly Reports on Form 10-Q and other filings filed from Johnson & Johnson with the SEC. These documents can be found online at sec.gov and jnj.com or on request from Johnson & Johnson. The Company neither Johnson & Johnson nor any of the Johnson & Johnson MedTech entities will update any forward-looking statements due to the emergence of the release of information or other future developments or events, except the law requires it to do so.
Non-GAAP Financial Measures
This press release contains Adjusted EPS, which is a non-GAAP financial indicator. We believe that offering this financial measure that is not GAAP enhances the investors and the Company’s knowledge of the Company’s financial performance. Non-GAAP financial measures shouldn’t be considered an alternative to, or superior to, financial measures calculated or determined according to GAAP. The Company’s definitions of non-GAAP financial metrics are not necessarily equivalent to similar measures that other companies have reported. The closest GAAP measure to Adjusted earnings per share is earnings per share or EPS. The Company does not provide a reconciliation of the Adjusted EPS to EPS. However, this is because Johnson & Johnson does not offer GAAP financial metrics on a forward-looking basis, as the Company is not able to accurately predict the outcome of any adjustments to items like legal proceedings, extraordinary gain or loss, the cost of acquisitions as well as fair value adjustments to purchase accounting without a lot of effort. Depending on various circumstances, these variables are speculative and could significantly impact Johnson & Johnson’s financial results calculated according to GAAP.
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