Biotech Stocks - U.S. Holds On With Largest Medical Device Market Estimated at over $150 Billion

PALM BEACH, Fla., May 06, 2019 (GLOBE NEWSWIRE) -- Medical device and technology development is an area where the U.S. companies are at the forefront.   According to a SelectUSA.gov publication, the United States remains the largest medical device market in the world, with a market size of around $156 billion, and it represented about 40 percent of the global medical device market in 2017. U.S. exports of medical devices in key product categories identified by the Department of Commerce (DOC) exceeded $41 billion in that year. The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines that are used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological, or metabolic means.   According to the report one of the components fueling the growth includes Electro-medical equipment which includes a variety of powered devices, such as pacemakers, patient-monitoring systems, MRI machines, diagnostic imaging equipment (including informatics equipment) and ultrasonic scanning devices.  Recently an online journal focusing on the medical device industry seemed to echo this optimistic view of the industry publishing an article titled: "Moody's: Outlook strong for medical devices in 2019". The article said: "The medical device industry should see a stand-out year in 2019, according to a Moody's report on the industry, Medtech Dive reports."   Active healthcare stocks in news today include:  ViewRay, Inc. VRAY, Alexion Pharmaceuticals, Inc. ALXN, ImmunoGen, Inc., IMGN and Celgene Corporation CELG

The global medical device industry has demonstrated strong and sustainable growth in the recent past. Biotech companies are banking on an aging population, increasing incidence of chronic and lifestyle diseases, increasing adoption of innovative technology, many in this sector believe the industry appears to be in the robust growth.  Going by a recent KPMG analysis, the medical device industry's global annual sales is forecast to rise more than 5% a year to reach nearly $800 billion by 2030.

BioSig Technologies, Inc.  BREAKING NEWS - BioSig Technologies, which trades on the Nasdaq under symbol BSGM, is a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that the Company conducted patient cases using the PURE EP(tm) System at Indiana University School of Medicine. The cases were conducted under the leadership of Prof. John M. Miller, M.D. and Dr. Mithilesh K. Das, MBBS.

"We found that the clarity of the signals made a great difference in the confidence with which we could continue applying ablation energy to an abnormal pathway that was in the region of the normal conduction system; BioSig technology allowed us to see a clear signal from the normal conduction pathway during ablation that was obscured by noise on our standard recordings. It was a jaw-dropper!" commented Prof. M. Miller, M.D.

A recognized expert in catheter and intraoperative mapping and ablation of ventricular tachyarrhythmias, Dr. Miller initially received his training in cardiovascular and cardiac electrophysiology under the tutelage of Dr. Mark Josephson at the Hospital of the University of Pennsylvania. He joined the Indiana University School of Medicine as a full professor of medicine to lead its clinical cardiac electrophysiology group in 1998. Since then, he has continued to be an active clinician, educator, author and clinical investigator. Prof. Miller has authored more than 200 scientific publications and has served on many national committees. He oversees a nationally regarded, rigorous fellowship training program in cardiac electrophysiology at the IU School of Medicine.

The PURE EP(tm) System was used during procedures on patients with atypical flutter, atrioventricular nodal reentry tachycardia (AVNRT), atrial fibrillation, SVT, PVC and a rare case of dual septal pathway. 

"We are honored to be able to work with Dr. Miller and Indiana University as one of the first centers of excellence to conduct patient cases with our PURE EP(tm) System. We have tremendous respect for Dr. Miller and his team at IU School of Medicine for their collective achievements in clinical electrophysiology and look forward to building upon their findings during this pivotal phase," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies.     Read this and more news for BioSig at:  https://www.financialnewsmedia.com/news-bsgm      

In other healthcare industry news of note:

ViewRay, Inc. VRAY announced in April that the company has partnered with Minogue Medical Inc., a leading Canadian distributor of surgical devices, operating room disposables, hospital equipment, and simulators for medical education. As part of the exclusive distribution agreement, Minogue Medical will market, sell, and support ViewRay's MRIdian MRI-guided radiation therapy system throughout Canada.

"The medical device market in Canada is strong and sophisticated, with a high demand for innovative medical technologies," said Jim Alecxih, Chief Commercial Officer at ViewRay. "We're pleased to partner with Minogue Medical to bring MRIdian to the Canadian healthcare system and improve the accuracy and precision of radiation therapy throughout the country."

Alexion Pharmaceuticals, Inc. ALXN on Friday announced that the New England Journal of Medicine (NEJM) published positive data from the Phase 3 PREVENT study of SOLIRIS® (eculizumab), a first-in-class complement inhibitor, in adult patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare and devastating, autoimmune, inflammatory disorder of the central nervous system (CNS) characterized by sudden and unpredictable relapses, also known as attacks. Each relapse results in stepwise accumulation of disability, including blindness and paralysis and sometimes premature death. Uncontrolled complement activation triggered by anti-AQP4 auto antibodies is a major underlying mechanism of the disease.1,2,3 There is currently no approved therapy for patients with NMOSD. Today's NEJM online publication coincides with the American Academy of Neurology (AAN) Annual Meeting, May 4-10, 2019 in Philadelphia, where these data will also be presented in the Emerging Science session on May 7.

ImmunoGen, Inc., IMGN, a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, on Friday reviewed recent progress in the business and reported financial results for the quarter ended March 31, 2019.

"Following the readout of the top-line results from FORWARD I, we have undertaken a comprehensive analysis of the data and see a consistent efficacy signal across a range of parameters in the pre-specified subset of ovarian cancer patients with high folate receptor alpha (FRα) expression. Specifically, in comparison to chemotherapy, we have observed higher response rates, more durable responses, and longer progression-free and overall survival in patients with high FRα expression treated with mirvetuximab," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "With the benefit of this analysis and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss a potential path to registration for mirvetuximab as a monotherapy."

Celgene Corporation CELG and bluebird bio, Inc. last week announced that the New England Journal of Medicine (NEJM) has published interim results from CRB-401, the ongoing phase 1 study of bb2121, the companies' lead investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy candidate for patients with relapsed and refractory multiple myeloma.

The manuscript, "Anti-BCMA CAR T Cell Therapy bb2121 in Relapsed/Refractory Multiple Myeloma", published in NEJM includes key safety and efficacy results from the dose escalation and first expansion cohort, including a minimum of six months follow up on all subjects. As of the data cut-off date of April 30, 2018, manageable safety and deep and durable responses were reported in the first 33 patients infused with bb2121 BCMA-targeted CAR T-cells. Patients in the study were heavily pre-treated, with a median of seven prior multiple myeloma treatment regimens (range, 3 to 23), which included prior treatment with immunomodulatory drugs, proteasome inhibitors and daratumumab in the majority of patients. All but one patient had previously received an autologous stem cell transplant. 

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