Ensovibep

In Part 1 of our series covering the major medtech, biotech and healthcare players in the world, we take a look at the medtech companies in Europe driving pioneering change in the industry. The last few years have seen exponential acceleration in how technology is a major driving force amongst medtech companies, being used to pioneer medical devices for varied purposes of medical aid and healthcare, such as to diagnose and cure diseases, or prevent them from occurring in the first place. This also comprises medicinal products which are meant for pharmacological, metabolic and immunological purposes. Medicinal products can assist medical devices, but as long as the product does not achieve its purpose via pharmacological, metabolic and immunological means, it is a medical device. It is primarily used for treatment, therapy, surgery and contraceptives. A medical device also comprises standalone software and mobile phone apps which provide assistance in medical purposes. The world market today comprises 2 million varied kinds of medical devices with more than 7000 classifications into generic device groups. Med tech companies and medical device manufacturers have to meet directives, regulations and coordinate system regulations in order to carry out their business. Medical Device Regulations Medical device regulations are generally taken care of by medtech companies by hiring expert regulatory writers and other medical device consultants, who can help you develop and maintain a regulatory dossier of relevant documents. These generally pertain to information required to be submitted to the concerned regulatory authorities, and involve permissions relating to the safety and efficiency of the medical device in question. Qualified medical device consultants such as expert medical writers can help you accelerate the process of obtaining the necessary authorization to take your product to market effectively. Conformité Européenne (CE) Mark is a certificate that indicates a product’s conformity with European standards for safety, health and environmental protection requirements. To receive such a certification a company/manufacturer of medical devices needs to prepare a Technical File or a Design Dossier that signifies its products’ compliance with the MDD, IVDD, or AIMDD and as per MDR and IVDR as well. Kolabtree’s on-demand medical device consultants can help you prepare a checklist for a technical file. Read our exhaustive guide and free checklist sample here. Medtech also comprises sophisticated healthcare systems which predominantly operate on information technology (IT) and internet of things (IoT) for diagnosis, patient care, treatment and overall improvement of a person’s health. A merger of technology and medical interventions gives us Medtech. Like Medical Devices, MedTech too, is categorized as per Medical Device Directive (MDD) and is regulated by Medical Device Regulation (MDR). All Medtech companies and manufacturers also have to comply with EU legal framework and get CE certification completed for their products. With a CAGR forecast at 4.7%, from USD 48.9 billion in 2020 the European medical devices market is projected to reach USD 61.4 billion in 2024. Due to shift in demography towards geriatric population, success of medical technology industry, rise in surgical procedures, growing demand for cushioning costs in the healthcare industry, and increased availability of funding for research and product innovation especially after pandemic, have contributed as major growth drivers of this sector. Often we don’t account for the importance of technological intervention for treatment of any minor or major health issue. Medical devices that have now become an integral part of our lives were once game changers in the field of medicine. We forget to wonder what we would have done if simple devices like bandages, forceps, x-tubes etc or sophisticated devices like endoscope, dialysers etc., were never created, and the role of manufacturers and medical device consultants in facilitating these advances. Medical devices and technology play a pivotal role in delivery of medical treatment to cater and cure patients ailments. The constant evolution in innovations, discovery and inventions of MedTech is so great that it’s mind bending to realize how far modern medicine has come along. Let’s take a look at some of the key medtech companies and see what new technological interventions in medicine are in store for us for it to become part of our lives in near future. As per markets and markets, Germany takes up a major market share of European medical devices but Poland has been forecast to grow at fastest pace compared to any other country in the EU. Research also shows immense opportunities in areas of diagnostic, surgical, cardiovascular, oncology, and nuclear medicine that can be tapped into for expansion. Some of the major front runners in the market for medical devices in European market are: Top Medtech Companies – Siemens Healthineers This healthcare arm of German multinational conglomerate Siemens was established in 2008. However, it made a breakthrough in the Medtech industry long ago in 1896 with the invention of the first industrially manufactured X-ray tubes for medical diagnostics. In the 21st century it continues its legacy to disrupt and enhance the market of Medtech. Siemens Healthineers became one of the first to secure emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG (COV2G) antibody test. It was the firm’s fifth antibody test to secure EUA that delivers sensitivity and specificity of more than 99%. It is changing the way the medical sector operates, quite literally. It collaborated with PrecisionOS to offer VR-based training to surgeons. This new age high tech program places a surgeon in the virtual operating room, and enables them to practice new procedures and chart out a scheduled surgery even before it commences. AI-Rad Companion is another fascinating device that evaluates MRI scans of the brain with the help of Artificial Intelligence (AI) to readily provide volumetric and quantifiable changes in the brain. This MedTech is especially useful for neurodegenerative diseases like Alzheimer. Siemens has focussed its R & D towards integration of upcoming technologies like robotics, Artificial Intelligence (AI) and Augmented Reality (AR) in the medical field. The most interesting medical technology they are exploring is – Digital Twin. They envisage creating a digital version of a patient using biomarkers, data from blood tests and other diagnostic data. This accurate mapping of someone’s physical self and translating it into digital form to make a digital “you” will aid in personalizing healthcare for them and to predict, maybe even prevent disease. Top Medtech Companies – Philips Philips has been ranked as world’s most innovative medtech company by Boston Consulting Group’s (BCG) Annual Report of 2020. Its drive for innovation is also quite reflective in its ranking for medical technology patent filings in Europe which stands at number one in Europe Patent Office. It is noteworthy to know that most of its patents are AI related. OncoSignal’s use of machine learning for diagnosis and therapy response of tumors,  SmartSleep DeepSleep Headband’s application of  deep learning to help patient get more rest and Intellivue Guardian’s  use of predictive analytics for elderly care are just some of the examples of Philips pioneering AI driven MedTech innovation. Philips & Co was founded in 1891 in Eindhoven, the Netherlands, by Frederik Philips and his son, Gerard. Although it started out as a company to exploit the opportunity presented by introduction of mass-market electricity by supplying cost-effective, reliable electric incandescent light bulbs, it has ventured into various other businesses over the years. Rotary electric razor, Compact Cassette audio player, use of UV light to kill bacteria, tubular fluorescent lights, a hearing aid, a gramophone as well as miniaturizing and modernizing its radio and shaver technologies, are some of its path breaking innovations. With its breakthrough in X-ray tubes by making it narrow to protect patients from undesirable and excessive radiation, by introducing a rotating anode to it and enhancing clarity and sharpness of its images via its Philips Nat Lab, the company stepped into health technology in the 1910s. However, it was 2010 when it fully directed its focus towards heath tech and now aims to improve the lives of 2.5 billion people each year by 2030. It seems like it is going beyond its metes and bounds to fulfil its vision. During Covid-19 wave, its app-based handheld ultrasound- Lumify, first of its kind, proved to be particularly valuable in improving lives and healthcare response. It has entered into an alliance with cognizant to develop HealthSuite. It is a cloud based platform for end-to-end digital health solutions. It aims to better manage treatments, have deeper patient engagement and accelerate development of patient specific treatments. With more than half of its R & D focussed on achieving deep technological, clinical expertise and consumer insights we can expect to see more such ground breaking Medtech from Philips in near future. Top Medtech Companies – Novartis Novartis is a Switzerland based company formed in 1996 from the merger of a German and Swiss drug company, Sandoz and Ciba-Geigy respectively. It is the largest medical device firm in Europe and one of the biggest pharmaceutical companies in the world. The first device of any kind to get certification under the European Union’s new MDR (Medical Device Regulation) was none other than Novartis’s Concept1 inhaler, in 2019. The spirit of the firm to provide the best healthcare via its medical technology intervention was quite evident from its response during covid-19, when Novartis was able to quickly mobilize its research and development, ramp up production, clinical trials and philanthropic aid to fight COVID-19 pandemic. They have partnered with various research institutes and pharmaceutical companies to develop antiviral molecules that could not only treat the virus that causes COVID-19 but also possibly treat all coronaviruses. Novartis collaborated with Molecular Partners for the development of Ensovibep, which would block the receptor binding to SARS-CoV-2 spike protein through highly potent and cooperative binding, making it challenging for mutants to escape. Novartis is changing the way we approach diagnosis and cure. The firm is working with Cibiltech for application of predictive analysis to forecast disease progression in transplant patients. Usually, clinical trials take a long time to ensure that the therapy is safe and effective for patients. This is where Novartis’s digital tool comes in, reducing the time it takes to decide if a physician can go ahead with an experimental therapy. Another compelling development of the firm is its collaboration with Microsoft to leverage on machine learning. The goal here is faster drug discovery and medicine delivery to patients, by utilizing machine learning which can run thousands of simulations of experiments and analyze thousands of variables simultaneously. Further, its creation of a digital ecosystem named Novartis Biome, a global network of digital innovation labs, disrupted the healthcare industry by empowering several health-tech start-up companies. The companies’ resources are pivoted towards providing high quality medicines, discovering and developing nuclear medicine for cancer and gene therapy to preserve people’s sight and fight blindness. It aims for increased integration of technological advancement to fulfil its vision. Top Med Tech Companies – B. Braun Medical Inc. Braun commands the market of infusion therapy and pain management. This can be attributed to its first break in the Medical Devices market in 1956 with the introduction of the first plastic container for IV solution. The introduction of Braunule and Infusomat for drug administration further rooted it deeply into the market. It is a medical and pharmaceutical device company with its headquarters in Germany and with presence in over 60 countries. From starting out as a pharmacy selling medicinal herbs via mail in Melsungen, it slowly built itself to sell several of its medical products, mainly surgical sutures to hospitals nearby. The company’s joy and pride is Aesculap, which modernized surgery overnight. This was a new suturing apparatus that used metallic staples to secure closure of the gastrointestinal region. Now Aesculap is a pioneer in the area of orthopaedic implants. Today the firm carries out 95% of manufacturing for more than its 5000 different healthcare products. Barun now aspires to lead Anaesthesia Devices Market as well. Its spinal needles, namely Spinocan, Penca, epidural anaesthetic equipment, peripheral/regional anaesthetic equipment, and other products play an important role in the anaesthesia device market as per report by Technavio. Medical treatment especially for chronic diseases is long and painful. Braun’s R&D is primarily directed towards easing this problem. It merged forces with Merck for development of a new bioelectronic called Neuroloops GmbH. This device is able to selectively stimulate nerves by creating localized and specific therapeutic effects thus facilitating targeted treatment of chronic inflammatory diseases. Its invention of SightCall visual assistance for patients who dialysate themselves has been another game changer for easing the lives of kidney failure patients. With Braun’s dedication to improve accessibility and comfort to receive medical treatment, there is absolutely no doubt that the company will continue with its pioneering spirit and ground-breaking contributions in the field of MedTech and Medical Devices. Top Med Tech Companies – Karl Storz Karl Storz SE & Co. KG is a market leader in manufacturing and sale of endoscopes and surgical instruments. In Tuttlingen, Germany Dr. Karl Storz founded the company in 1945.  The company disrupted the MedTech field with the introduction of the first endoscope that delivered light using fiber optics, in 1963. To introduce endoscopes with high resolution lenses, it licensed the patent for the Hopkins relay lens in 1965. Even in modern times Karl Storz continues with its innovation to make medical treatment via technological intervention, a cakewalk. Its Innovative Miniature Nephroscope System was a game changer for kidney stone treatment. Further, its Image1 Hub HD was the first medical device with a full HD camera that allowed a doctor to investigate the inside of the body without performing major surgery. Due its ingenious innovations and inventions of MedTech, it has become one of the highly acclaimed and awarded Medtech companies. Its disruptive innovation is what got it “Land of Ideas” award for its touchless gesture control system MI Report. In its feat to increase precision in neurological procedures, it developed a fluorescence endoscopic contact probe, for which it received DGBMT’s Prize for Patient Safety in Medical Engineering. For easing the probe of the small intestine, in 2019 it received the Red Dot Award for product design of its duodenoscopy system called The HYDOME. Tapping into new age technology it has introduced virtual reality simulators for gynecology, urology, and arthroscopy. Video choledochoscope, IMAGE1 modular video platform, TELE PACK+ endoscopy unit, CollaboratOR surgical management tool, visual enhancement tools for surgeries and laparoscopy instruments, are some latest of its disruptors. Top Med Tech Companies – Fresenius Medical Care Fresenius Medical Care AG & Co. KGaA expertises in providing kidney dialysis, especially for acute kidney failure and for end-stage renal disease (ESRD), a stage at which patients undergo dialysis 3 times per week for the rest of their lives. The company’s great innovations in its early days, made it a pioneer in kidney treatment and care. Its manufacture of infusion solutions and medical disposables along with Polysulfone dialyzers gave a ray of hope to people with kidney malfunction. Further, its first peritoneal dialysis solution bags with a safe lock standard system and production of synthetic polysulfone fiber membrane for blood purification have set the quality standard for the market of dialysers to this day. Fresenius has consistently kept its reputation to revolutionize the kidney dialysis and treatment arena. Its recent breakthrough came when its new haemodialysis system got approval from US Food and Drug Administration (FDA). This new system negates the use of blood thinner medication as it is designed to prevent blood clotting in patients. Another, immensely helpful is its device providing Ci-Ca CRRT therapy. Patients with Acute Kidney Injury/Failure (AKI) have to undergo continuous renal replacement therapy (CRRT) which is a process of blood purification. With Fresenius’s machine assisted Ci-Ca CRRT, chances of bleeding complications and filter clotting is reduced significantly thus ensuring excellent patient treatment. Its Renal IT solution is something to look forward to. It envisages to provide an integrated software solution with help of decision support and analytical insights into therapy and patient data in order to provide efficient, reliable and economical chronic kidney disease care.  It is also developing various such data management systems to make treatment of kidney problems an effortless task. However, the company has not restricted itself to one area of medical devices and technology. It has ventured into treatment of lungs and the cardiovascular system as well. Its introduction of Synchronized Cardiac Support and Novalung therapy has marvelously eased heart and lung treatment respectively. Top Med Tech Companies – Smith & Nephew Smith and Nephew is a multinational medical device brand based out of Watford, England. It has presence in over 120 countries, with the largest presence being in its home country – UK. It is a market leader in selling medical devices for wound care management, orthopaedic devices, trauma fixation tools and ENT (ear, nose and throat) surgeries. It prides itself in providing devices and technology that aids people live life with full potential by restoring their health and mobility. This endeavour started in 1977, when they introduced the first moist wound healing product – OPSITE dressing. It took its pioneering innovation to the next stage when it launched a new product- Oxinium that enhanced performance and life of the total joint replacement system. Ventured into catering for emotional needs along with physical needs of patients living with wounds with the launch of Allevyn life. It further revolutionized the wound therapy market with the introduction of a new knee implant called Journey II BCS, which restores the normal motion of patients. Smith+Nephew seeks to integrate its Real Intelligence enabling technology solutions with Movendo Technology personalized robotic patient rehabilitation capability to create a fully digitized patient pathway from the pre-op stage to post-rehab phase of a patient. It also established its long-term collaboration with University of Hull recently, for driving research to continue its pioneering streak in advanced wound care. This partnership envisions one of the world’s largest Wound Care Research Clusters, which would bring together leading academicians, scientific insights and innovative treatments for advanced wound treatment and care. In the next part, we’ll bring you detailed information on similar companies and the ground-breaking projects they undertake on a regular basis. Freelance Medical Device Consultants Freelance experts, such as product development consultants and medical writers, are increasingly gravitating towards on-demand consultancy roles.  This is not only a leading consequence of the great resignation, but a growing phenomenon in academics looking for a more balance lifestyle. This also offers med tech companies companies a chance to hire experts on short-term consultancy roles, testing innovative ideas and working on short projects without having to hire someone on a minimum duration contract. Kolabtree’s medical device consultants, for instance, work according to your schedule and offer the guarantee of complete data security whilst collaborating on the Kolabtree platform. Looking to speak to medical device consultants on Kolabtree? Browse our global roster of on-demand experts here.

SAN DIEGO, July 16, 2022 /PRNewswire/ -- The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Molecular Partners AG (NASDAQ: MOLN): (a) American Depositary Shares ("ADSs") pursuant and/or traceable to the offering documents issued in connection with Molecular Partners' initial public offering conducted on or about June 16, 2021 (the "IPO"); and/or (b) securities between June 16, 2021 and April 26, 2022, inclusive (the "Class Period") have until September 12, 2022 to seek appointment as lead plaintiff in the Molecular Partners class action lawsuit. The Molecular Partners class action lawsuit – captioned Freudiger v. Molecular Partners AG, No. 22-cv-05925 (S.D.N.Y.) – charges Molecular Partners as well as certain of its top executive officers and directors with violations of the Securities Act of 1933 and/or Securities Exchange Act of 1934. If you suffered substantial losses and wish to serve as lead plaintiff, please submit your information here: You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected]. CASE ALLEGATIONS: Molecular Partners is developing, among other products, ensovibep as a treatment for COVID-19 in collaboration with Novartis AG. One of Molecular Partners' most important development strategies for ensovibep includes securing Emergency Use Authorization ("EUA") for ensovibep from the U.S. Food and Drug Administration ("FDA"). Additionally, Molecular Partners is developing MP0310 (AMG 506) for the treatment of certain types of cancer in collaboration with Amgen Inc. Molecular Partners granted Amgen, among other licenses, the right to progress MP0310's development program into later stage development, including into combination trials, following Phase 1 data. Molecular Partners via its June 2021 IPO issued 3 million of its ADSs to the public at the price $21.25 per ADS, for proceeds to Molecular Partners of over $59 million, after underwriting discounts and commissions, and before expenses. As the Molecular Partners class action lawsuit alleges, the IPO's offering documents and defendants made false and/or misleading statements and/or failed to disclose that: (i) ensovibep was less effective at treating COVID-19 than defendants had led investors to believe; (ii) accordingly, the FDA was reasonably likely to require an additional Phase 3 study of ensovibep before granting the drug EUA; (iii) waning global rates of COVID-19 significantly reduced Molecular Partners' chances of securing EUA for ensovibep; (iv) as a product candidate, MP0310 was less attractive to Amgen than defendants had led investors to believe; (v) accordingly, there was a significant likelihood that Amgen would return global rights of MP0310 to Molecular Partners; (vi) and as a result, the clinical and commercial prospects of ensovibep and MP0310 were overstated. On November 16, 2021, Molecular Partners disclosed that "a planned futility analysis of ensovibep in [an] ongoing [Phase 3] clinical study . . . has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting." On this news, Molecular Partners' ADS price fell by more than 31%. Then, on April 26, 2022, months after applying for EUA from the FDA for ensovibep, Novartis' CEO disclosed that "given the latest feedback . . . in our discussions with the [FDA], we would expect the agency to require a Phase 3 study before granting an EUA approval or a general approval" for ensovibep, and that "we need to make a kind of sober evaluation as to is it a doable study in light of the waning rates of COVID around the world." Later that day after the market close, Molecular Partners further "announced that Amgen . . . has informed [Molecular Partners] of their decision to return global rights of MP0310 to Molecular Partners following a strategic pipeline review." On this news, Molecular Partners' ADS price fell by more than 47%, further damaging investors. THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Molecular Partners ADSs during the Class Period to seek appointment as lead plaintiff. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Molecular Partners class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Molecular Partners class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Molecular Partners class action lawsuit. ABOUT ROBBINS GELLER: Robbins Geller is one of the world's leading complex class action firms representing plaintiffs in securities fraud cases. The Firm is ranked #1 on the 2021 ISS Securities Class Action Services Top 50 Report for recovering nearly $2 billion for investors last year alone – more than triple the amount recovered by any other plaintiffs' firm. With 200 lawyers in 9 offices, Robbins Geller is one of the largest plaintiffs' firms in the world and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information: Attorney advertising. Past results do not guarantee future outcomes. Services may be performed by attorneys in any of our offices. Contact: Robbins Geller Rudman & Dowd LLP 655 W. Broadway, Suite 1900, San Diego, CA 92101 J.C. Sanchez, 800-449-4900 [email protected] SOURCE Robbins Geller Rudman & Dowd LLP