7/6/2023 0 Comments Four seasons mauiIf either offer is available over the precise dates of a stay, our site should display the offer when availability of rooms & rates is returned on a query. Credits will be applied towards incidental charges at check-out. Offers may be discontinued w/o prior notice. Featuring contemporary Hawaiian motifs and koa-inspired. Dine under clear blue skies by day or a canopy of stars at night at Waileas only beachside open-air restaurant. The Experience More Nightly Credit is NOT automatic on any booking as Blackout Dates & other restrictions apply. Four Seasons Resort Maui at Wailea offers an island escape on the golden crescent of Wailea Beach. * The Offer Code "Experience More/Credit" must be selected on a reservation in order to qualify. *$125 Nightly Resort Credit per paid night in the following accommodations: Deluxe Club Ocean-View Room, Club Ocean-View Room, Deluxe Ocean-View Room, Ocean-View Room, Deluxe Garden-View Room, Garden-View Room or Mountainside Room *$200 Nightly Resort Credit per paid night in the following accommodations: Ocean-View Prime Suite, Ocean-View Prime Executive Suite, Ocean-View Executive Suite, Garden-View Suite or Garden-View Executive Suite Located close to Wailea Beach and Polo Beach, Four Seasons Resort Maui at Wailea provides 18 holes of golf, 2 poolside bars, and a swim-up bar. Unequivocally the most luxurious resort on Maui, the Four Seasons enjoys an enviable location fronting Wailea beach, one of the largest golden sand beaches. This special offer will appear dynamically in the rate results if it is "available" during the precise dates of one's stay. For the offer to be applicable, the "20% OFF" Rate Code must be booked as all offers are subject to availability at time of booking, blackout dates and other restrictions may apply. Find sun-soaked tranquility at an enchanted enclave nestled on the. We stayed in room 507 (on the fifth floor the hotel has eight floors), an Ocean-View Prime Executive Suite. Welcome to the Four Seasons Resort Maui - Four Seasons Resort Maui at Wailea. Its clear that its an emphasis at this resort perhaps because people do tend to stick around after long. No refund will be issued for cancelled reservations, no-shows or early departures. The Four Seasons Maui’s rooms are large across the board standard rooms here are 600 square feet, making them the largest standard rooms in Maui. The food at Four Seasons properties is always good. ** A full, non-refundable prepayment will be charged by the resort within 48 hours of the time of booking.
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7/6/2023 0 Comments Fuel cell stick rpg 2Grenades were also used during the Golden Age of Piracy, especially during boarding actions pirate Captain Thompson used "vast numbers of powder flasks, grenade shells, and stinkpots" to defeat two pirate-hunters sent by the Governor of Jamaica in 1721. These grenades were not very effective owing both to the unreliability of their fuse, as well inconsistent times to detonation, and as a result, saw little use. The word "grenade" was also used during the events surrounding the Glorious Revolution in 1688, where cricket ball-sized (8.81 to 9 in (224 to 229 mm) in circumference) iron spheres packed with gunpowder and fitted with slow-burning wicks were first used against the Jacobites in the battles of Killiecrankie and Glen Shiel. In 1643, it is possible that "Grenados" were thrown amongst the Welsh at Holt Bridge during the English Civil War. By the mid-17th century, infantry known as Grenadiers began to emerge in the armies of Europe, who specialized in shock and close quarters combat, mostly with the usage of grenades and fierce melee combat. The grenades were most likely intentionally dumped in the moat of the bastion prior to 1723. Many of the grenades retained their original black powder loads and igniters. A hoard of several hundred ceramic hand grenades was discovered during construction in front of a bastion of the Bavarian city of Ingolstadt, Germany dated to the 17th century. The first cast-iron bombshells and grenades appeared in Europe in 1467, where their initial role was with the besieging and defense of castles and fortifications. In a 12th-century work, Mujmalut Tawarikh, based on an Arabic work which is itself based on original Sanskrit work, a terracotta elephant filled with explosives set with a fuse was placed hidden in the van and exploded as the invading army approached near. Grenade-like devices were also known in ancient India. If ten of these shells are fired successfully into the enemy camp, the whole place will be set ablaze. They are sent flying towards the enemy camp from an eruptor ( mu pào), and when they get there a sound like a thunder-clap is heard, and flashes of light appear. Inside they contain half a pound of 'divine fire' ( shén huǒ, gunpowder). The shells ( pào) are made of cast iron, as large as a bowl and shaped like a ball. History Įarliest known representation of a gun (a fire lance) and a grenade (upper right), Dunhuang, 10th century AD Its first use in English dates from the 1590s. The word grenade is likely derived from the French word spelled exactly the same, meaning pomegranate, as the bomb is reminiscent of the many-seeded fruit in size and shape. A friction igniter inside the handle or on the top of the grenade head was used to initiate the fuse. The stick design provides leverage for throwing longer distances, but at the cost of additional weight and length, and has been considered obsolete by western countries since the Second World War and Cold War periods. Some grenades are mounted at the end of a handle and known as "stick grenades". Grenades are often spherical, cylindrical, ovoid or truncated ovoid in shape, and of a size that fits the hand of an average-sized adult. Most anti-personnel (AP) grenades are designed to detonate either after a time delay or on impact. In modern grenades, a pre-formed fragmentation matrix inside the grenade is commonly used, which may be spherical, cuboid, wire or notched wire. Their outer casings, generally made of a hard synthetic material or steel, are designed to rupture and fragment on detonation, sending out numerous fragments ( shards and splinters) as fast-flying projectiles. Fragmentation grenades ("frags") are probably the most common in modern armies, and when the word grenade is used in everyday speech, it is generally assumed to refer to a fragmentation grenade. Grenades work by dispersing fragments ( fragmentation grenades), shockwaves ( high-explosive, anti-tank and stun grenades), chemical aerosols ( smoke and gas grenades) or fire ( incendiary grenades). The user removes the safety pin before throwing, and once the grenade leaves the hand the safety lever gets released, allowing the striker to trigger a primer that ignites a fuze (sometimes called the delay element), which burns down to the detonator and explodes the main charge. A modern hand grenade generally consists of an explosive charge ("filler"), a detonator mechanism, an internal striker to trigger the detonator, and a safety lever secured by a cotter pin. Demonstration of a German stielhandgranate (shaft hand grenade), a high explosive grenade with time fuze, Netherlands, 1946Ī grenade is an explosive weapon typically thrown by hand (also called hand grenade), but can also refer to a shell (explosive projectile) shot from the muzzle of a rifle (as a rifle grenade) or a grenade launcher. The game also introduces six completely new stages ( Anger of the Earth, Electric Fountain, Fiesta del Tomate, Hidden Retreat, Lightning Storm and Tunnel Disaster), new "Item Move" features for specific characters, and a "Hair Customize System" which allows the player to change the styles and colours of the characters' hair all the characters are also more balanced out here, as several of them ( Robert "Bob" Richardson in particular) were found to be too overpowered in the original Tekken 6. Description: Tekken 6 is a Fighting video game published by Bandai Namco Games released on November 24th, 2009 for the PlayStation Portable. Introducing two new characters, Alisa Bosconovitch (the creation of Doctor Geppetto Bosconovitch who was introduced for the PlayStation version of Tekken 3), and Lars Alexandersson (described as "a strange foreigner") as well as a gold version of the final boss Azazel, all the Tekken-Net ID cards with the rank of "Conqueror" and below were also reset back to "1st Dan" for this update (but those with ranks higher than "Conqueror" were not affected) - and the game's hidden boss, Nancy-MI847J, also loses less energy from all players' attacks in this update. In PSP: Open CWCheat / Cheat searcher / Disassembler and scroll to 0407F98. Try AntiMicro graphical program used to map keyboard keys and mouse controls to a gamepad/controller.Tekken 6: Bloodline Rebellion ( 鉄拳6血統反乱,, Tekken 6: Kettō Hanran ?) is: a one-on-one fighting arcade game that was released by Namco for Tokyo on December 10, 2008, in the rest of Japan on December 18 of that very same year and in all other countries on Januit runs upon that company's System 357 hardware, and as its name suggests, it is an update of Tekken 6, which was released in the previous year. This game was categorized as Beat 'em up on our website. 3P Model Special outfit exclusive to consoles. 2P Model Outfit selected by pressing one of the kick buttons. (USA) ISO Tekken 6: Bloodline Rebellion is an updated version of tekken 6 psp free. Selectable only with Left Punch button if 3P Model exists. Download the Tekken 6 ROM now and enjoy playing this game on your computer or phone. Tekken 6 Nds Rom Download Tekken 6 (Japan) ROM Free Download for PSP. TEKKEN 6 HD Textures & Fonts + Speed-Up Cheat Code (Gameplay Links Instructions) PPSSPP 1080p 60fps. This is the USA version of the game and can be played using any of the PSP emulators available on our website. Bloodline Rebellion retains all features introduced in Tekken 6 (the bound and rage systems, as well as item moves), and all of the characters in Tekken 6 are set to return. Close text file and in ppsspp click cheats again and select FPS cheat u desire. Have fun playing the amazing Tekken 6 game for PlayStation Portable. Tekken 6: Bloodline Rebellion is an updated version of Tekken 6 (originally being an Arcade exclusive). If it still doesn't work for you, increase the cheat refresh rate to make sure the value of the cheat is changed before the game runs the FPS capped value. Now save that file with CTRL+S or File>Save.ĩ. The game sets the FPS cap only once at boot time, so to make the cheat work you must boot the game with the cheat enabled you can boot the game, enable the cheat and reset/restart it. (IF FILE CONTAINS ANY CHEATS ALREADY > press enter then press up), now either press CTRL+V or right click and paste. Now press escape, click cheats and click edit cheat fileĨ. In ppsspp launch a game for which you just copied codeħ. Tekken 6 is a one-on-one fighting arcade game that was released by Namco on November 26, 2007. Last Update YYYY-MM-DD (PAGE #POST) enable cheats or CTRL+T for lazy ones like me)Ħ. For the 2008 update, see Tekken 6: Bloodline Rebellion. Bannon joined the Trump campaign after an illustrious history at the alt-right website Breitbart. It was probably put there by his new campaign CEO Stephen Bannon. He’s appealing to black voters by saying “What do you have to lose?” The possibilities are terrifying.īeing the reflective person that he is, this week he called Hillary Clinton a bigot. The reality is they can’t attend a Trump rally without the possibility of being beaten up. Now he’s trying to increase his poll numbers from 1 percent among black voters by saying they have terrible schools, live in poverty, and can’t walk down the street without being shot. Taco Bowl, who tweeted “I love THE Hispanics” with the pic, says Democrats pander to minorities. He referred to a black man in one of his crowds as “my African American.” He’s referred to woman as “pigs” and said Megyn Kelly had “blood coming out of her wherever.” He condoned the beating of a Black Lives protester and said “maybe he should have been roughed up.” He called supporters who beat up a homeless Latino of “being passionate.” He’s stereotyped Jews and shared an anti-semitic meme created by white supremacists. He speaks of racial groups as monoliths as in, “the Muslims, the Hispanics, the blacks, etc.” He’s said some Native Americans “don’t look like Indians to me.” He’s mocked Elizabeth Warren by calling her “Pocahontas.” He’s encouraged mob justice for the Central Park Five, who were exonerated. He’s attracted white supremacists to his campaign and has been slow to disavow them. He’s questioned the first black president’s eligibility. He’s been accused of racial discrimination toward employees at his casinos. His company has been sued twice for not renting to black people. He’s insinuated a Muslim mother who lost her son in the Iraq war of being forbidden to speak because of her faith. He’s proposed surveillance of mosques and an outright ban on Muslim refugees. He’s said an American-born judge wasn’t qualified to oversee a lawsuit involving Trump University because of his Mexican heritage. Trump warrants it.ĭonald Trump has referred to Mexican immigrants as rapists and murderers. But I’m also tired of one of the major party’s candidate’s racism. I don’t like to use those comparisons unless the subject really warrants it. It’s just too easy of a trigger to pull, like Nazi imagery. Honestly, I am tired of using Kluxers in my cartoons. From Clay Jones on his political cartoon “Hillary Is A Bigot,” how Donald Trump accused Hillary Clinton of bigotry, and avoiding discussing whether or not she is 7/6/2023 0 Comments Quickshade strong toneIf we find the order was in fact defective or the wrong item was shipped to you, we will issue a refund. Once we receive the returned item we will then inspect the item thoroughly. We will ship you a printing label in the event the return is due to our error. *Minor imperfections in shrink wrap and product packaging may occur and does not qualify for a replacement.* This is to protect the quality of our inventory. We currently do not accept returns for trading cards and trading card games. Please and we will help you proceed.Ĭertain types of items cannot be returned, like perishable goods (Candy) and custom products (such as special orders or personalized items). Most board games, card games & miniatures with missing/damaged components must have their parts replaced via the manufacturer. Please inspect your order upon reception and contact us immediately if the item is defective, damaged or if you receive the wrong item, so that we can evaluate the issue and make it right. You can always contact us for any return questions at call us at: 33 Item costs, minus the shipping cost, will be refunded. Items sent back to us without first requesting a return will not be accepted. To start a return, you can contact us at If your return is accepted, we’ll send you instructions on how and where to send your package. If the return was due to an error on our part we will send a prepaid shipping label for you to use. You’ll also need the receipt or proof of purchase. To be eligible for a return, your item must be in the same condition that you received it, unworn or unused, with tags, and in its original packaging. We have a 30-day return policy, which means you have 30 days after receiving your item to request a return. 7/6/2023 0 Comments The eyes of ara coin locationsThe one good thing I can definately say about this game is it's puzzles. So from the price point perspective, you're getting decent mileage. When it comes to playtime, I would say mine was around 6-7 hours when I got near to the end, I did go AFK plenty of times and left it on for a night (I currently have over 17 hours total.) Obviously your playtime will vary on how long you spend searching and analyzing puzzles. In essence, I cannot recommend it since it does cater to a more completionist mindset. Personally, while I did enjoy it for the first few hours, knowing what I know now, I wouldn't have gotten it. This game has its high points but ultimately suffers from some major annoyances. Also, this review will feature slight puzzle spoilers. I`ll include a screenshot at the end with my accurate playtime. Especially of the Point and Click style (Such as Myst, Riven, etc)ĥ0 / 50 Eyes, would play again if I could wipe my mind of all the solutions.įor whatever reason, the steam timer says I have only a few minutes of playtime. It's a game, aaaall about observational skills, and some puzzle solving skills at several points, such as the ceiling tiles! Especially the basement tiles, you need to understand how they work, and be able to spot all the tiles to solve the puzzle )įantastic game, got 100% achievements, its a grand shining example of a perfect point and click game, and I would recommend it a MUST HAVE for any fans of puzzle games. I think Backtracking is just a normal part of puzzle games, to double check everywhere and find any hidden secrets or clues that you can use for progressing. I've seen several reviews of people complaining about having to constantly backtrack to areas already passed.clearly they never grew up with old classics such as Spyro, Tomb Raider, Resident Evil, etc. One of the best puzzle games ever! Since I'm known for my love of puzzle games, I was gifted this as a birthday present, and I can gladly say, it's a very great one! Lovely graphics, flawless mechanics, excellent gameplay, and overall a gem in the puzzle game point-and-click genre. Will you pay heed to the unsettling tales and legends surrounding the castle, or will you set fear aside and venture in with an open and inquisitive mind to uncover the truth for yourself? The Eyes of Ara is a game about exploration, puzzle solving, and discovery. Investigate the castle’s secrets through a sleek, minimalist interface that with a click, can be hidden entirely off-screen. Manipulate complex mechanisms, solve elaborate puzzles, and interact directly with the environment in a tactile, hands-on experience. Explore abandoned rooms, discover lost writings, and recover forgotten keepsakes to piece together the stories of those who once called the castle home.
7/6/2023 0 Comments Zombie highway 2 tap to turnThis is a problem but you get some help here you get to drive an SUV, which protects you some and you even have a gun with a few bullets. Zombie Highway 2 takes you to a fictional highway, which is infested with zombies. There are five different settings, and the game starts you off in the middle setting (normal) – if you can’t get the hang of it, then set it to low if oversteering is an issue, or set it to high if understeering is an issue. There’s more to it, though you will try to survive here for as long as possible. Go to the options menu and change the sensitivity if steering and control are an issue. Whenever you eventually and inevitably run out of videos to watch, all you have to do is wait for about 15-30 minutes or so and then go back to the IAP store, and most likely there will be a video again unless you are not connected to the internet. For every advertisement video you watch, you earn gold for free. Another way to earn more gold is to go to the in app purchase store and then watch videos. Zombies will earn you coins when they are killed as well, and the tougher zombies will earn you more coins per kill.ĭiscovering new zombies is a great way to earn more gold. Of course, get the toughest of the zombies first, including the fat zombies, red zombies and strong zombies, as they are much tougher to kill by shooting and they will bring down your vehicle far more quickly. Hottest Codes: Active Promo Codes for Genshin Impact: The Full List and How to Redeem Them Most Popular Codes: Active Promo Codes for Survivor!.io: The Full List and How to Redeem Them Concentrate on one side at a time because you can only have 4 zombies on your vehicle at a time, two per side other zombies won’t jump on your vehicle if this is the case because they won’t have room to hang around. Once they do jump on your vehicle you can scrape them off using cars and other road debris if you want to get them off without shooting them. This obviously won’t work on anywhere near all of them, but it works on quite a few of them. To avoid having zombies jump on you in the first place, either run straight into them or drive behind zombies to stop them from seeing you. Zombies jump on your vehicle as they pass by, and while they might not seem dangerous at first, they will eventually start messing with your steering and eventually flip your vehicle. Read on for some tips and tricks for Zombie Highway 2! In this one, much like in the original, your task is to drive down a seemingly endless highway while trying to shake zombies off (or just hit them so they don’t jump on your vehicle), shoot them, and avoid all of the obstacles that get in your way. Zombie Highway 2 is the new full-on sequel to the original Zombie Highway, which came out four years ago and was one of the biggest of the original free-to-play hits on the App Store. 7/6/2023 0 Comments Remove paragon extfs for macMicrosoft NTFS for Mac by Paragon Software supports ALL the versions of NTFS (from Windows NT 3.1 to Windows 10). What versions and features of the Microsoft NTFS file system are supported? The data transfer rate is fully the same as with the native macOS file system. What data transfer rate I will get using Microsoft NTFS for Mac by Paragon Software? You can perform create/read/modify/copy/delete operations as usual. What operations do you mean saying “Full read/write access”? If an update is released, you will be able to download it there. How can I get the update if I have bought the previous version of Microsoft NTFS for Mac by Paragon Software? Yes, Microsoft NTFS for Mac by Paragon Software works with the latest available macOS versions. Yes, Microsoft NTFS for Mac by Paragon Software is built for being used with both types of processor architectures. Please contact our Support Service at to reclaim your update.ĭoes it work with the latest Apple Silicon M1/M2 based Macs? You are eligible for a special update for you current version of Microsoft NTFS for Mac by Paragon Software. I’m a user of a Seagate or Western Digital device with pre-installed NTFS for Mac. After that it will be locked until you activate a purchased license. Sure, you can try Microsoft NTFS for Mac by Paragon Software for ten days completely for free. Microsoft NTFS for Mac by Paragon Software is compatible with popular virtualization and encryption applications including VMware Fusion and Workstation, Parallels Desktop, TrueCrypt and its forks.Ĭould I try your product for free before buying? Microsoft NTFS for Mac by Paragon Software is fully compatible with Apple Boot Camp software and provides direct read and write access to Mac partitions from Windows installed on Boot Camp. Microsoft NTFS for Mac by Paragon Software supports all alphabets supported by your operating systems, including those that use non-Roman and non-Latin characters, so you will never face the problem of not getting access to file names on volumes mounted in non-native OS. Microsoft NTFS for Mac by Paragon Software easily formats, checks integrity and repairs corrupted volumes. However, this feature can be disabled at any time in the program interface. Microsoft NTFS for Mac by Paragon Software mounts supported volumes automatically at startup, so you don’t need to worry each time you restart the operating system or power your computer on. When a volume is mounted in write mode, you can do everything with the files and folders it contains: read, edit, delete, rename, create new. ARM-based Mac devices (Apple Silicon M1/-Pro/-Max/-Ultra/M2)Īll Microsoft NTFS versions are supported (from Windows NT 3.1 to Windows 10).(I’m hoping both utilities will eventually be consolidated into a single app. If you already have Paragon ExtFS for Mac 11 installed (which provides similar read/write access for Linux volumes), you’ll wind up with two identical menu bar apps, but it’s easy to disable one or both via preferences. Mount or unmount any volume on your Mac using the optional menu bar app in Paragon NTFS for Mac 15.Īs someone who already has too many menu bar icons, this feature seemed gratuitous at first, but I soon found myself using it often. You can also mount or eject disks from the menu bar, thanks to a helper app that works even when the main application is closed. The app includes options to enable Spotlight indexing, mount disks read-only, or disable auto-mount on a per-volume basis. There’s even a lovely color-coded space indicator like the one introduced with Mac OS X El Capitan, displaying content by Audio, Video, Apps, Images, and Other categories. Dual-boot users also have the option to reboot into a compatible mounted Mac or Windows startup volume. I’m happy to report version 15 restores the ability to format NTFS drives alongside the usual Mac OS Extended, exFAT, and FAT options, but the software now works as a standalone application as well.Īnd what a gorgeous app it is! The user interface is tastefully designed, with buttons for mounting, unmounting, verifying, or erasing the selected volume. NTFS for Mac 14, formatting tools were briefly exiled to System Preferences after years of working directly inside Apple’s Disk Utility. Paragon NTFS for Mac 15: Hey, good-lookin’ Now available as a standalone app, Paragon NTFS for Mac 15 features a gorgeous new user interface. 7/6/2023 0 Comments Direct mail advertisingWould you prefer to measure by foot traffic? We’ll include a promotion within the mail pieces that the customer must present to redeem.Are you looking for prospects to call your business? BPM can set up a unique tracking number specifically for your business’ direct mail campaign.One significant benefit of direct mail is that it allows your business to effectively track and measure each campaign down to individual recipients. Ranging from simple postcards to monthly newsletters or elaborately-designed packagesīPM will also ensure your campaign is compliant with any co-op requirements your organization must meet.Contrary to what people may think, most marketers still prefer to add direct mail marketing in their marketing plans, and the number is rapidly growing. This value shows a 3.5 increase from the amount in 2020. BPM’s turnkey direct mail services include: The market spending for direct mail marketing in the U.S is expected to rise to 43.3 billion by the end of 2022. Fear not! Baer Performance Marketing (BPM) will help you navigate the entire process. 14 A truly potent marketing campaign incorporates both digital and print tactics, allowing mail to garner interest and move consumers closer to purchase, be it in. If you’ve never used direct mail to market your business you likely have several questions about how to start a campaign, how the mailing process works and what type of results to expect. Direct mail has actually been a successful sales driver for this demographic, and studies show that physical ads leave a lasting impression on both younger and older demographics. Direct mail marketing is a tangible medium, which immediately creates a memorable and engaging brand experience. Studies using fMRIs show that physical media leads to a more emotional response than digital media, and can lead to improved recall and a more memorable experience. These days, the marketing world is largely digital. Email marketing is the digital equivalent. Postcards, flyers, and catalogs are common examples. For example, if your message needs to reach a targeted zip code or demographic, or if your target market is “off-line” more than they are on, a direct mail campaign could deliver a phenomenal return on investment. According to writer and researcher Roger Dooley, direct mail is easier to process mentally and uses 21 less cognitive effort than digital advertising. Direct mail marketing is a type of direct marketing that’s delivered physically to a prospect’s mailbox through the United States Postal Service or other delivery service. However, the tactic has had long history of success, and it still has its place in a comprehensive marketing strategy. During these technology-driven times, it is easy to overlook the power of a direct mail marketing campaign. 7/6/2023 0 Comments Megan pham ifactorIn February, iFactor marked a first: it became the first Romanian company to be listed on Seedrs, one of the largest online investment platforms. In 2021, its founders aim for a European expansion, which will start with UK and Germany.It brings forward a Hybrid Marketplace, geared towards small and medium-sized enterprises.iFactor is the first Romanian company to be listed on Seedrs, one of the largest online investment platforms.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. 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. |