FDA Grants Breakthrough Device Designation for CTEPH Pattern Recognition Artificial Intelligence Software from Bayer and Merck

Software in development intends to support clinical decision-making of chronic thromboembolic pulmonary hypertension (CTEPH) - a progressive and life-threatening condition

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Bayer

Dec 03, 2018, 08:00 ET

WHIPPANY, N.J. and PITTSBURGH, Dec. 3, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence (AI) Pattern Recognition Software, which Bayer is currently developing jointly with Merck, known as MSD outside the U.S. and Canada.

A rare form of pulmonary hypertension, CTEPH affects an estimated 5 individuals per million per year globally.ⁱ CTEPH can be difficult to diagnose because its symptoms are similar to those of other conditions such as asthma or Chronic Obstructive Pulmonary Disease (COPD). ⁱ^,ii Being a rare disease, physicians may not always recognize CTEPH. Computed Tomography Pulmonary Angiography (CTPA) as well as a ventilation/perfusion scan (V/Q scan) are used to determine if thromboembolic occlusion is causing the pulmonary hypertension. Radiologists may have the first opportunity to identify CTEPH in a patient; therefore it's important they accurately detect CTEPH indicators on CTPA scans and images.

Development of the CTEPH Pattern Recognition AI Software will use deep learning methodology to support radiologists by identifying signs of CTEPH in CTPA scans. This software analyzes image findings from cardiac, lung perfusion and pulmonary vessels in combination with the patient's clinical history. If the development is successful, the software could be deployed via Bayer's Radimetrics software, an informatics technology platform that connects contrast medium, injector and scan information to provide important insights.

"Bayer is looking forward to leveraging our expertise in radiology to develop a software to support radiologists and treating physicians in the complex diagnostic decision making process of this rare disease," said Prof. Dr. Olaf Weber, Head of Radiology Research & Development of Bayer AG's Pharmaceuticals Division. "We hope that greater awareness of CTEPH in conjunction with a decision-support tool will eventually assist in diagnosing patients earlier and more reliably, thereby allowing earlier treatment."

The FDA Breakthrough Device Program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases by expediting their development, assessment, and review. While the FDA Breakthrough Device Designation is expected to expedite the software's assessment and review, its development remains complex given the nature of the disease and technology.

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
CTEPH is a progressive type of pulmonary hypertension, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually builds up and subsequently leads to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart. CTEPH may evolve after prior episodes of acute pulmonary embolism. The standard and potentially curative treatment for CTEPH is pulmonary thromboendarterectomy (PTE), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material. However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35 percent of patients, the disease persists or reoccurs after PTE.ⁱⁱⁱ

As many as 1 out of every 25 people who had a PE (even if they were treated with at least 3 months of anticoagulants) could go on to develop CTEPH.^{^iv}^{,^v} Symptoms of CTEPH include shortness of breath, edema, fatigue, and chest pain and are therefore similar to other, more common diseases, resulting in an often delayed diagnosis of CTEPH. ii^,vi

About Bayer's Radimetrics™By automating manual processes, Bayer Radimetrics reduces regulatory workloads while improving accuracy, accessibility and consistency of radiology documentation. Radimetrics helps deliver more personalized care and achieve reproducible quality, in line with radiation standards and regulation. As a true multi-modality solution, spanning Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Nuclear Medicine (NM), X-ray, ultrasound and mammography. Radimetrics seamlessly integrates with the existing IT infrastructure and radiology equipment through respective interfaces.

About Bayer
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.us.

About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Contact:
Jennifer May
Bayer
+1 412.406.3736
[email protected]

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PP-RADI-US-0215-1 November 2018

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

ⁱ Lang and Madani Circulation 2014;130:508-518.)
ⁱⁱ Symptoms & Risk Factors. (2018). Retrieved November 16, 2018, from https://www.cteph.com/basics/symptoms-and-risk/
ⁱⁱⁱ Bayer Launches 'myMentor' Peer-to-Peer Support Program for Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension. (2018, June 29). Retrieved November 16, 2018, from https://www.bayer.us/en/newsroom/press-releases/article/?id=123227
^iv Fedullo P, Kerr KM, Kim NH, Auger WR. Chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2011;183(12):1605-1613
^v Wilkens H et al. Chronic thromboembolic pulmonary hypertension (CTEPH): Updated Recommendations of the Cologne Consensus Conference 2011. Int J Cardiol. 2011; 154(suppl1): S54-S60.
^vi Feldman, J. (2018). Pulmonary Hypertension Symptoms. Retrieved November 16, 2018, from http://pulmonaryhypertensionrn.com/pulmonary-arterial-hypertension-pah-symptoms/