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With multiple federal courts striking down the FDA's regulatory authority to prohibit truthful speech about medical products, the temptation to share independent information from surgeons using the bone graft for other purposes, will be great.Putting salary ranges in job advertisements may give employers a competitive advantage when trying to attract candidates. It will be interesting to watch how the company handles off-label uses of i-Factor. surgical market for biologic bone substitutes, according to the company, is estimated to be about $500 million. There were complications with Infuse, including growing too much bone and causing patients to have trouble breathing.Īs a result of the approval, the company says it has begun to engage a number of top-tier distributors, and is preparing to recruit a number of direct sales representatives, to support the U.S. He did not mention Infuse by name which has been used off-label in the cervical spine. spine businesses, said that up until now, the cervical spinal fusion market has been lacking "the ultimate product solution." Spine surgeons will now have access to a biologic bone graft based on the company's proprietary P-15 technology platform that is a "safe and effective alternative to a patient's own bone and other less studied products that are being marketed for cervical spine procedures." ![]() Glen Kashuba, Cerapedics' CEO and former head of Biomet, Inc.'s spine and DePuy's U.S. The proportion of the bone graft subjects with overall success was significantly higher than that of the autograft subjects (p = 0.0382).” In addition, says the company, a responder analysis for overall success in all four primary outcomes demonstrated 69% success for i-Factor bone graft versus 57% for autograft. The product “met all four pre-specified primary endpoints (fusion rate, NDI score, neurological outcomes, and safety success), demonstrating non-inferiority to autograft with p-values of < 0.0005 for each. ![]() The company provided data to the FDA from a pivotal clinical trial comparing i-Factor to autograft in ACDF procedures. “This unique combination replicates the organic (Type I human collagen) and inorganic (calcium phosphate) components of autograft bone and creates the ideal template for new bone formation.” It can be used as a substitute for autologous bone in ACDF procedures.Īccording to the company, i-Factor is the only biologic bone graft that combines the small P-15 peptide with anorganic bone mineral (ABM). I-Factor is a bone graft based on synthetic small peptide (P-15) technology developed by the company to support bone growth through cell attachment and activation. The PMA approval came pretty quickly as the company only submitted its PMA application in September 2014. ![]() In fact, the cooperation was so good that the FDA didn't even require a meeting of its orthopedic panel of experts to weigh in on whether or not the agency should approve the product. He called the process with the FDA "years of seamless cooperation" with the company's clinical investigators. The first was Medtronic plc's Infuse, which was approved for use for the lumbar region of the spine back in 2004.Ĭompany President and COO Jeffrey Marx, Ph.D., said this was "an historic milestone" for the surgical treatment of cervical disc degeneration. This is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine. announced the agency approved their i-Factor Peptide Enhance Bone Graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative disc disease. It's been a long, long time since the FDA gave their PMA (Premarket Approval) application blessing to bone graft for the spine.īut on November 3, 2015, Cerapedics, Inc. ![]() Dying Light 2: Stay human release on December. For digital players, there will be the Standard, Deluxe, and Ultimate edition, which can also be found at the pre-order link referenced earlier. For those interested in nabbing one for themselves, you can pre-order your collectors edition right here. The Dying Light 2 Stay Human Collector’s Edition is only available at retail and comes with all the content previously mentioned and the following additional items. The collectors edition will retail or 229.99. The Deluxe Edition includes: Dying Light 2 Game, Exclusive Weapons Charms DLC Steelbook (physical box only) Legendary Skin Pack DLC: Legendary Outfit Legendary. ![]() But wherever your actions take you, there's one thing you can never forgetstay human. The Dying Light 2 Ultimate Edition is digital-only and contains all the Standard and Deluxe Edition content and following items. Unravel the dark secrets behind the wielders of power, choose sides and decide your destiny. The Dying Light 2 StayHuman Deluxe Edition is available at retail and digitally and comes with the base game and the following content. ![]() If you pre-order Dying Light 2 Stay Human, you will gain the following exclusive bonus items. Collector’s Edition The Dying Light 2 Stay Human Collector’s Edition is only available at retail and comes with all the content previously mentioned and the following additional items. There are also digital and retail versions that differ slightly, so read carefully. We have all the details of the different editions below, so you know which to buy.ĭying Light 2 Stay Human comes in Standard, Deluxe, Ultimate, and Collector’s editions and they are packed full of goodies. It launches for PlayStation 4, PlayStation 5, Xbox Series X and Series S, Xbox One, and PC. Techland’s hotly-anticipated zombie survival game, Dying Light 2 Stay Human, will finally release December 7, 2021. Furthermore, you can encrypt the PDF files with a password if they contain confidential information. Along with that, it is possible to insert the links or add bates numbering in PDFs. It turns them into an editable copy.īesides conversion, you can add/remove images, text, pages, comments, and much more. Even its OCR feature assists in recognizing scanned PDFs in multiple languages. Also, it never compromises PDF quality while all the converting and other processing. Supporting formats like Word, Powerpoint, and others, allows you to convert PDF to these formats. EaseUS PDF EditorĮaseUS PDF Editor is counted among the most credible and high-performing software to aid you in management, conversion, and editing tasks. Here, an efficient and quick PDF editor is the one that can help you out. Moreover, you may need to convert or edit PDFs before converting them to Keynote. If you deal with PDFs on a regular basis, you must have software to edit and view them. ![]() Step 3. In the end, press the "Convert" button to get the conversion process done.Ī PDF Editor and Converter You Can Never Miss Step 2. In the second step, you should select the "Keynote" as the target file format. Now, open the PDF that you need to convert. Step 1. First of all, download, install, and open the software on your system. Let's move forward toward the steps of converting PDF to Keynote through PDF2Office: Though some advanced features can't be converted accurately, generally, it is a good one! Moreover, you can convert PDFs into batches to save time. Its most significant advantage is to provide the converted keynote as an editable file, a unique feature compared to the Keynote Mac application. All the uploaded PDFs will remain in the local storage. It is a desktop application where you have the complete security of your documents since they are not on someone's server like in online tools. It aids you in converting PDF to keynote files however, you have to purchase a license for exporting more than 5 slides. PDF2Office for iWork is a fantastic application in Mac offered by Mac App Store. How to Convert PDF to Keynote with PDF2Office for iWork 2017 After you are done with resizing and reorganizing the pages, click the "File" and then the "Save" button to save the file in its local folder. These pages will be imported as images where it is possible to reorder them as per your requirements. Step 2. Open the PDF in a reader and then drag and drop the pages of the PDF one by one in the left thumbnail of the Keynote application. Now, select a Keynote theme to start processing from a blank file. Step 1. First of all, you have to open the Keynote on your system. Here is a detailed procedure to convert PDF to Keynote by using the Keynote Mac application: Above all, its clear, catchy, and intuitive interface makes the work processing easier. That is why the uploaded PDF will only get imported as an image file, and the converted keynote will also not be editable like in PDF2Office. Though it offers you the free conversion of PDF to the keynote, it does not support the opening and viewing of documents in PDF format. You can also select the style and images and arrange PDF page icons. Since it handles all the presentations, it is possible to save files as keynotes. ![]() Also, you can work across various Apple devices. Keynote application on Mac is an excellent and coherent tool for designing an attractive and impressive presentation by adding images, text, charts, etc. ![]() PAGE CONTENT: Convert PDF to Keynote with Keynote Convert PDF to Keynote with PDF2Office for iWork 2017 A PDF Editor and Converter You Can Never Miss How to Convert PDF to Keynote with Keynote ![]() Offer expires on Saturday, April 8, 2023. No rainchecks for specific brands/weights will be issued if product within the same brand/weight range is available. Program excludes prescription medications, gift cards, postage stamp sales, money orders, money transfers, lottery tickets, bus ticket sales, fuel and Metro passes, as well as milk, cigarettes, tobacco products and alcoholic beverages or any other items prohibited by law. 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