New Medical Device

OMS721 Stem Cell Transplant Therapy On 26 July 2018, Omeros Corporation announced that the European Medicines Agency's (EMA's) Committee for Orphan Medicinal Products (COMP) have positively recommended the lead human monoclonal antibody named OMS721 for stem cell transplantation therapy.   This antibody targets the effector enzyme named mannan-binding lectin-associated serine protease-2 (MASP-2). Around three OMS721 phase 3 clinical programs are continuing across immunoglobulin A (IgA) nephropathy, hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA), and atypical hemolytic uremic syndrome (aHUS). This positive declaration will soon be adopted by the European Commission in August. The Orphan Drug Designation in Europe will be made available to the companies in order to treat chronically debilitating conditions. This designation allows for regulatory and financial incentives including 10 years of marketing exclusivity in the European Union af...

Nucala (mepolizumab) was first approved as the first anti-IL5 treatment for adults and adolescents with severe asthma accompanied by eosinophilic phenotype in the United States during November 2015. Later it was approved to treat eosinophilic granulomatosis with polyangiitis (EGPA). GSK pursued the U.S. approval in eosinophilic chronic obstructive pulmonary disease (COPD) in November 2017, in addition to Phase 3 METREX and METREO data studies. Nucala's crucial rivals in asthma treatment were Teva Pharmaceutical's Cinqair (reslizumab), which was approved for indication in March 2016, and Fasenra in November 2017. Since COPD is a hard nut to crack, it will be the next market according to the GSK's predictions. Nucala would be used as an add-on maintenance treatment for people with COPD. During May, AstraZeneca withdrew from submitting Fasenra for COPD and Teva is not following this market for Cinqair. The results of yesterday's panel will be eagerly watched,...

Age-related Macular Degeneration (AMD) is the leading cause of blindness among the elderly. The most commonly used drugs to slow the progression of the disease is Roche’s Lucentis and Regeneron’s Eylea. These drugs are injected into the eye which, needless to say, leads to more inconvenience. Scientists from Birmingham University have developed an alternative treatment in the form of eye drops. These eye drops consists of a peptide which could penetrate retinal cells. After testing the eye-drops and rabbits and pigs, the results were reported in  Investigative Ophthalmology & Visual Science journal . These eye drops are currently being developed in a U.S. startup company named Macregen. Felicity de Cogan, a research fellow from the University of Birmingham’s Institute of Microbiology and Infection, said  "From the outset, we [realized] that delivering drugs through eye drops would mean that patients can administer their treatment themselves, and this would be less c...

In a recent launch, Novartis’ Galaxies of Hope neuroendocrine tumor app received an additional bump from Apple. The “Featured App” status in the first week itself helped in receiving positive reviews and downloads for the community-building app. This neuroendocrine tumor app was developed with Numinous Games, which imagined the award-winning “That Dragon, Cancer” app about a young boy and his family’s journey through terminal cancer. The company used visual storytelling and music to depict the perspectives of doctors, patients, and caregivers by spending a year on research before launching the app in Apple's store. According to SimilarWeb, this app has been ranked as the No. 4 medical app on iPads and No. 41 on iPhones respectively by the end of last week. The app will be available in the Google Play store in the coming weeks. Eric Althoff, the head of global media relations at Novartis, said  “To develop the Galaxies of Hope app, we interviewed actua...

Telemedicine helps Nashville-based Vanderbilt University Medical Center take its kidney transplant program to the people of Tennessee and give them the prospect to be screened for a transplant and bring constant care within their reach. The Vanderbilt Transplant Center newly started its first telemedicine clinic in Jackson, two hours away from Tennessee. Specialists will be able to assess candidates who possibly need kidney transplants and organize check-ups every month in this clinic. In  a press release  issued by Vanderbilt, James Ross, President and CEO of West Tennessee Healthcare, said,  “We appreciate Vanderbilt bringing much-needed telemedicine services to our patients who have been referred for kidney transplants. This type of care delivery enhances access to sub-specialty care in our region and supports our mission of improving the health and well-being of the communities we serve.” Health system officials at Vanderbilt estimate evaluations of at leas...

UK-based medical device manufacturer, Lumendi obtained the European CE-Mark for its DiLumen Endolumenal Interventional Platform (EIP) which is used as an endoscope accessory. The device, designed to enable absolute positioning of a conventional endoscope in the large intestine and enhance optical visualization, diagnosis and treatment, is a non-sterile, single-use, close-fitting sleeve. Lumendi is currently developing a distribution network to commercially launch the device in the European Union (EU) market, post its successful achievement of acquiring the CE-Mark. Distributors for Italian and British regions have already been established, said the company. Lumendi CEO Peter Johann said:  “Receiving approval to apply the CE-Mark in Europe is critical to Lumendi’s overall global strategy to open markets around the world to continue improving endoscopic interventions and migrating many gastrointestinal surgeries to less invasive endoluminal procedures.” “To make the DiLu...

German Based Medical Tech Company Siemens Healthineers recently launched “Acuson Sequoia” a new imaging ultrasound system which enables imaging of different sized patients with unchanging clarity. The newly developed devices provide advanced high-powered architecture Deep Abdominal Transducer (DAX) and other improvements to elastography and contrast-enhanced ultrasound. To enable better diagnosis the device can produce penetration of up to 40cm to offer high-resolution imaging. Robert Thompson, Siemens Healthineers Ultrasound Head said:  “Ultrasound imaging has been messed by variability. Patients’ varied physical characteristics and user-dependent variabilities can impact a clinician’s ability to deliver an accurate diagnosis. With the new Acuson Sequoia, we provide users with a solution that enables real-time imaging for varying patient types, including those with high BMI, without sacrificing image quality and potentially reducing the need for repeat scans and unclear dia...

EchoNous announced that it has been granted FDA 510(k) clearance for its EchoNous Vein ultrasound device which could improve peripheral IV catheter placements. This system could provide real-time clear mages of superficial and deeper veins. Nancy Moureau, the CEO from Picc Excellence said,  “EchoNous Vein’s simple on-screen controls allow clinicians using ultrasound to clearly identify veins in the center of the display, helping to not just locate veins but to evaluate their health and quality prior to peripheral IV placement. As clinicians, we know that IV insertion selecting a healthy vein for catheter placement can help to reduce the chance of post-insertional complications. To have a tool specifically designed to easily select veins and guide catheter placement is extremely valuable as we’re always looking to improve the patient experience.” EchoNous is planning to integrate the EchoNous Vein with the already existing Uscan intelligent medical tool to form th...