World News – CA – Materialise – Multiple Personal Medical Devices CE Mark Certified

The company expects the CE marking to enhance the accessibility of dedicated devices to become more easily available

Leuven, Belgium, November 10, 2020 (GLOBE NEWSWIRE) – Materialize NV (Nasdaq: MTLS), a leader in 3D technology solutions in the industrial and medical markets, has announced that it has received CE Marking for most orthopedic procedures Maxillofacial (CMF)) solutions including 3D printed anatomical models, surgical guides and patient-compatible implants. Materialize is a leading and world leader in personalized solutions, helping patients and surgeons on six continents produce more than 350000 personal devices The company became one of the first companies to obtain this type of certification for a wide range of 3D printed and personalized medical devices This certification will make technology more accessible to surgeons

The approval of the CE mark indicates that the medical device meets the requirements of the European Medical Device Directive so far, Materialise’s custom devices have benefited from a specially designed procedure, which requires a prescription for each device. This procedure guarantees the quality of the devices and patient safety, but brings administrative obstacles to production In larger quantities

“When the European Medical Device Directive was issued in 1993, the use of personal devices was exceptional in the past 30 years, we developed planning and 3D printing to extend this technology to a much larger audience at Materialize, we’re talking about the thousands of devices being delivered. Around the world every year personal devices are no longer the exception. This CE marking certification demonstrates that these custom devices meet the same stringent quality requirements as regular devices, despite the challenges involved in getting each device to match the specific anatomy of a patient, ”says Brigitte. De Wit, Vice President and Managing Director of Matrials Medical

Materialize has a legacy of adhering to the highest possible safety standards and is one of the first companies to obtain a complete personal set with CE certification. The company believes that this type of certification will help raise the level of the industry to ensure patient safety and transparency in the production of personal devices

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The CE marking will also improve accessibility to make custom devices more readily available. With the implementation of the new process, surgeons will not need to sign a prescription for the devices they request and that means less paperwork and more flexibility for pharmacists who manage personal devices within the hospital.

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“The advantage of using dedicated devices is that it adds more predictability in the surgical setting and allows for any clinical condition to be handled, including the most difficult cases. Now, obtaining this CE mark for our largest business portfolio will help provide these personal devices to more numbers. Of patients, and removing some administrative restrictions for our clients, « adds Brigitte

Since its founding in 1990, custom solutions have been Realize Medical’s core business. Personalization begins with planning, the launch of Mimics in 1992 has enabled precision engineering based on 3D images, forming the basis for the advanced digital planning solutions available today. First company to introduce custom 3D printed solutions in the operating room with the launch of surgical knee guides in 2007 The launch of the personal CMF implant in 2009 introduced a design breakthrough with a titanium porous structure that allowed rebuilding of missing bone fragments

This CE certification is another milestone in achieving higher quality standards in personalized medicine. Although CE marking is a European concept, the system is widely accepted as evidence of compliance in other markets This certification joins other CE marks that have obtained Materialize already has them on medical software solutions, such as Mimics Innovation Suite and Mimics Enlight

Materialize integrates more than three decades of 3D printing experience into a suite of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Materialise’s open and flexible solutions enable players in a wide range of industries, including sponsorship. Health, automotive, aerospace, art and design and consumer goods, from creating innovative 3D printing applications aiming to make the world a better and healthier place Headquartered in Belgium, Materiales has subsidiaries all over the world, bringing together the largest group of software developers in the industry with one of the largest 3D printing facilities in the world

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Pfizer Inc. (NYSE: PFE) on Monday with strong interim efficacy data for the third stage of a coronavirus vaccine candidate Pfizer analyst: Morgan Stanley David Risinger got an equal rating on Pfizer with a price target of $ 42 the analyst at SVB repeated Lerink Jeffrey Burgess assesses market performance and increases target price from $ 43 to $ 44 Morgan Stanley On Pfizer’s Vaccine Economics, Timeline: Over 90% efficacy with 94 cases indicates that final analysis with 164 cases will in all likelihood exceed the FDA’s effectiveness criteria of 50% Building on this and not having any serious safety concerns, the analyst raised the probability of a vaccine success from 65% to 100%, as Risinger said in a note, with Pfizer planning to introduce emergency use permission in the third week of November – when it has two months of data. Medium safety – Risinger said he expects the Food and Drug Administration (FDA) to hold a meeting to discuss the data by early to mid-December and said approval of emergency use for health care workers and some population groups is End-to-end risk could come by late December, Risinger said that after six months of safety data, full approval is likely to come in the spring Related link: Biotech Next Week: Supernus, Sanofi Await FDA Decisions Morgan Stanley estimates economically adjusted vaccine revenues by 50% and a 100% risk rate of $ 488 million for Pfizer in 2020, with revenue increasing to $ 7 $ 2 billion in 2021 and then moderation to $ 3 $ 8 billion in 2023 How Pfizer’s high effectiveness could lead to early adoption: High efficacy of the vaccine The absence of new safety signals increases the likelihood of SVB Leerink’s success from 80% to 100%, Borg said in a note, and the analyst said: “We believe that this high efficacy could increase the initial adoption of the vaccine, and thus increase our expectations by 10-40% in 2022. -2023  » Given the likelihood that other candidates will demonstrate similar vaccine efficacy and compete for market share as unit prices fall in subsequent years, SVB Leerink lowered its estimate for BNT162b2 by 10% -20% for 2026 and beyond. The company’s global vaccine revenue forecast for Pfizer is $ 258 million in the fourth quarter. This will increase to $ 4 $ 6 billion in 2021 before it drops to $ 2 $ 8 billion by 2023 and the plateau is between $ 1 billion and $ 1 billion. Burgess said that $ 6 billion in the period from 2026 to $ 2029 therefore, SVB Leerink increased its total revenue and forecast. Pfizer’s earnings per share for the period 2022-2023 at 2% -3% p.a. PFE price action: Upon last examination, Pfizer shares traded down 14% to $ 38 Tue 61 Related link: Biotech investor attention: Flag your calendar for dates PDUFA for November These latest reviews for PFE DateFirmAction FromTo Nov 2020Bernstein Coverage begins in market performance in October 2020SVB LeerinkMaintainsMarket Leads October 2020 Stocks Coverage begins OnBuy View More Analyst Reviews for PFE View More Analyst Ratings Here to Trade Options From Benzinga * The Daily Biotech Pulse: Lilly’s COVID-19 Approved Antibody Treatment for Emergency Use Supernus Facing Double Regulatory Relapses, Revance, Arena Flunk Studies Midstage * What It Means New Corona Virus Vaccine Data From Pfizer For Moderna (C) 2020 Benzinga.com Does Not Provide Banzenga Investment Advice All Rights Reserved

With Joe Biden President-elect, the prevailing view is that alternative energy stocks are in line with consolidation however, some in the sector hardly need a helping hand, notably Plug Power (PLUG) the hydrogen fuel cell manufacturer has made the most of its thirst Investors for new energy stocks in 2020, as in this process achieved huge profits of 533% of shares over the year In addition to the bullish situation, the company just released another excellent quarterly financial report, in the third quarter, revenues reached US $ 106 99 million, worth a 799% annual increase and exceeded Estimates of $ 1 23 million PLUG scored a win over the bottom line as well with EPS Non-GAAP at a value – $ 0 04 comes in $ 0 03 ahead of estimates Moreover, outlook remains positive PLUG raised its overall billing estimate for fiscal year 2020 to between $ 325 and $ 330 million From $ 310 million Street was asking for $ 314 million Oppenheimer’s analyst, Colin Roche, was « encouraged » by the increasing adoption of the company’s forklift solutions, and is excited by PLUG’s bullish stance on potential Its solutions to replace diesel generator sets and provide backup power for data center applications While Rusch admits that PLUG’s massive stock gains may raise questions about the hot valuation, it is not enough to detract from the bullish case, the five-star analyst said: “As investors look to exposure to the growth of hydrogen vehicles, we believe that PLUG is the best to leverage all major areas of the supply chain with differentiated and commercially proven technologies “We believe valuation is the bigger question for investors as the market negotiates growth multipliers in the context of potentially stable tax policy and historically low interest rates. Given the size of the opportunity and the IP portfolio of the PLUG, we are raising our PT in line with our disruptive technology counterparts. And the current market dynamics where we maintain our constructive stance on stocks. ”The price hike is a significant increase – doubling from $ 13 to $ 26. The new figure denotes a 15% rise from current levels as a result. Rusch maintains its outperformance (i e buy) on Plug posts. Intact Power (to see Rusch’s record, click here) The Rise of Plug Power offers analysts an interesting puzzle.On the other hand, based on the critical 10 buy rankings with no comment or sell, analysts’ consensus is a strong buy however, fixed share gains mean 20 $ 89 Average Target Price Indicates Modest Rise ~ 4% Next Year (See PLUG Stock Analysis at TipRanks) To find good stock trading ideas with attractive valuations, visit Best Stocks to Buy From TipRanks, a newly launched tool that unifies all equity insights for TipRanks Disclaimer: The opinions expressed in this article are only those of a premium analyst. The content is intended for use for informational purposes only. It is very important to do your analysis before making any investment.

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U-o-The presidential election is nearing its end, Wall Street is not opposed to a change of administration Last week saw the S&P 500 achieve its second best performance in an election week ever, even as Trump’s chances of re-election diminishJohn Stoltzfuss, chief investment strategist, pointed out to Oppenheimer, “What seems clear so far is that stock markets are not averse to a change of administration at the state level at least as long as Republicans maintain control of the Senate checks and balances are known to be ‘on the Hill’. A mission for investors throughout present history in our view is not an exception. ”However, there is some ambiguity surrounding the Senate, as the second election for seats in Georgia is scheduled for January 5, just 15 days before the inauguration day however, Stoltzfus points out that the continuation of Better-than-expected third-quarter results from companies listed on S&P 500, economic data related to job gains and a sharp drop in unemployment rate have also helped support stocksWith Stoltzfus’ view in mind, we wanted to take a closer look at three stocks that garnered a round of applause from Oppenheimer, with the company’s analysts predicting a 100% probability increase for each of them using the TipRanks database, knowing that the rest of the street is in agreement, the three boast. By consensus analysts Strongbridge Biopharma (SBBP) First we have Strongbridge Biopharma, which focuses on developing treatments for rare diseases with high unmet need before introducing a master regulatory file. Oppenheimer believes that SBBP $ 2 a share price reflects 12 attractive entry points Company Representative, Analyst Hartag Singh indicates that investor focus has fallen squarely on Recorleaf, the company’s investigational cortisol synthesis inhibitor, in Cushing’s syndrome the company is preparing to introduce a non-disclosure agreement for treatment in the first quarter of 2021, and the analyst is optimistic about his potential approval In the LOGICS study, the treatment achieved its primary endpoint , Where SBBP reported that the number of cases of loss of the urine-free cortisol response (mUFC) was 545% higher among patients who withdrew from placebo versus those who remained In addition, there was a rapid reversal of the benefits of Recorleaf treatment on cholesterol after switching to placebo given the 8-week time frame. Meanwhile, in the SONICS study, a significant benefit in normalizing mUFC was observed in 30% of patients and many secondary procedures. Cardiovascular It should also be noted that none of the 44 randomized patients were discontinued due to adverse events’ Post-LOGICS, we continue to view Recorlev as a differentiated treatment for Cushing, compared to off-label ketoconazole and the branded nature of the treatment the administration has reiterated its confidence. In drug niche, based on market research with payers and clinicians as LOGICS reaffirms the clinical benefits profile observed in SONICS, we have been encouraged by its ability to become an essential treatment for disease, ‘Moreover, management does not expect the AdComm meeting, Singh thinks the speculation Safety and efficacy may increase prior to potential PDUFA decision on labeling and to that end, it expects more visibility as the application approaches NDA and is accepted. Add to the good news. , The launch of Keveyis, the FDA-approved treatment for hyperkalemia, hypokalemia and related variants of primary periodic paralysis (a very rare neuromuscular disorder) is progressing well despite the COVID-19 pandemic, according to Singh, « with a quarter of sales. Annual of approximately US $ 8 0 million, higher than our estimates of about US $ 7 million, the increased path to launch has been encouraging, with additional room for long-term growth highlighted by management we expect more credit to be credited to these efforts, following additional updates of LCM strategies. To this end, Singh rates SBBP shares in an outperformance (i e buy) with a price target of $ 7, ”the analyst commented. What’s the benefit of that for investors? Upside potential of 233% (To see Singh’s record, click here) Overall, other analysts echo Singh’s sentiments. 3 Buying, no holding or selling adds to the solid buy consensus rating with an average target price of $ 8, the potential upside comes at 272% (See SBBP stock analysis on TipRanks) Molecular Templates (MTEM) Molecular Templates are bringing the next generation of immunotoxins called Engineered Toxin Bodies (ETBs), a new class of therapies with unique biology and a different mechanism of action, to the market despite comments One of her clinical trials in part, except that Oppenheimer still believes that the narrative of long-term growth is robust. A phase II monotherapy trial was developed to evaluate the main candidate MT-3724, ETB targeting CD20 (a B cell marker that is expressed in 90 percent of Non-Hodgkin’s B-cell lymphoma (NHL)), in partial clinical comment on November 4 post-treatment-related management indicated capillary leak syndrome (CLS) as the cause of patient death MT-3724 is being evaluated in three ongoing trials of phase II, one treatment and one treatment It should be noted that six patients (one who died and five were treated in the mono-DLBCL study) received the drug from the same batch, and the first five completed the study without evidence of CLS. The subsequent PK analysis found the highest levels of drug exposure (Cmax) 3-4 times the levels expected in five of the All six patients receiving treatment from the batch, management plans to investigate why Cmax levels are so high, Kevin Dejeter Oppenheimer told clients, “We are looking to pool MTEM stocks at any weakness based on expectations: 1) Manufacturing batch inconsistency may have increased Cmax in a limited number of patients Who provide a clear pathway to remedy the problem, 2) a limited reading on immunity from MT-3724 (produced only on the backbone of ETB first-generation backbone) to other pipeline programs, and 3) a cautious expectation of commercial opportunities for MT-3724 prior to clinical waiting with Market opportunity focused primarily on rescue patients’ Even if CLS is identified as dose-related, the five-star analyst argues that there may still be a way forward for MT-3724, as a monotherapy study evaluates a dose of 50 mcg / kg During studies, pain Knee with a rating of 10-25 mcg / kg dose, reflecting another positive, the comment does not affect product studies on the backbone of the second generation of ETB, including MT-5111, TAK-169 and MT-6402 In addition, the company is set to provide Clinical update on CTX001, a potential treatment for sickle cell anemia (SCD), DeGeeter said, “Our investment thesis is based, at least in part, on the ETB platform’s ongoing partnership with large biotechnology companies to achieve goals outside of MTEM’s primary oncology focus despite commentary Clinical on MT-3724, MTEM is still in active discussions with potential partners. We will look at additional partnership deals as verification of the overall security profile of the platform « In line with his optimistic approach, DeGeeter ranks MTEM as Superior (i e Buy) along with price target 20 USD This number indicates a 123% possibility of a rise from current levels (to see DeGeeter’s track record, click here) Do other analysts agree? They only have buy valuations released, 3 to be exact, in the last three months so, the message is clear: MTEM is a strong buy given the $ 1,833 average target price, stocks could rise 108% in the next year (see stock analysis MTEM at TipRanks) Provention Bio (PRVB) At the forefront of the autoimmune disease field, Provention Bio is improving the lives of patients from all over the world As the company makes significant progress in its efforts to gain approval for one of its treatments, Oppenheimer thinks it is time to grab the stock. November, Provention Bio announced that the rolling submission of the BLA to the FDA for regulatory approval for teplizumab to delay or prevent clinical type 1 diabetes (T1D) in at-risk individuals has completed the filing includes chemistry, manufacturing and controls (CMC) modules and administrative information now, The FDA has 60 days to review the final submission to determine if the BLA has been completed, after which, the date of the PDUFA will be determined. Writing for Oppenheimer, analyst Justin Kim indicates that acceptance of the BLA will be a milestone for PRVB. « We believe external verification Of the application and its review will positively reflect on Provence’s great efforts in order to complete this registration i.e. expanding the scope of manufacturing As the potential advisory committee meeting and regulatory decision subsequently provide further validation, we trust these events based on the clinical profile of teplizumab Going forward, Kim believes treatment marketing will become a major topic in 2021.Based on teplizumab’s 14-day infusion cycle, the logistics and physician / patient reception for this method, especially during the COVID-19 pandemic, are attracting great interest, according to the analyst at Case Grant. Candidate approval Ultimately, screening and outreach work could reflect a large backwind, in Kim’s view by establishing meaningful relationships across major T1D support groups and institutions, “Precaution is well-connected and building momentum for screening and identification initiatives.” The analyst added: “While the hurdle is Successful implementation is high, the reward, in our opinion, will be proportional. “When it comes to long-term opportunity, the“ TN-10 Population Standards ”remains a major area of ​​focus for Kim, Hayy. D « These opportunities may not only expand market opportunities for teplizumab, but also greatly enhance its position in the treatment model. It also states that re-dosing and additional use models after implantation for teplizumab are other strengths. Summarizing all of this, Kim said, » PRVB remains in place. An appreciation in our world, macro topics about COVID-19 and the intense focus on momentum names will likely be given. However, given that ongoing implementation carries PRVB through successful regulatory, pre-commercial and commercial milestones, we believe stocks could enter a significant reclassification period. «  All that PRVB has to offer in order to get Kim to leave his outperformance (I’m buying) rating as it is along with the call keeps the target price at $ 29, indicating a 106% potential rise (to see Kim’s record, click here) by moving on to The rest of the street, the bulls put it into this with 4 buys and no bookings or sales in the last three months, the common word on the street is PRVB is a strong buy at $ 28 75, the average target price indicates a potential up 104% (See analysis of A. PRVB Stock on TipRanks) To find good stock trading ideas with attractive valuations, visit Best Stocks to Buy from TipRanks, a newly launched tool that unites all share insights for TipRanks Disclaimer: The opinions in this article are only those of featured analysts The content is intended for use for purposes Informational only It is very important to do your own analysis before making any investment

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CE Mark, Materialize NV, Medical Device, Medicine