SciBase submits application for pre-market approval to FDA

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
SciBase submits application for pre-market approval to FDA

The U.S. Food and Drug Administration (FDA) has confirmed that the organization has received SciBase’s application for a pre-market approval (PMA) of the Nevisense device for the US market. “We have been working with the clinical studies and documentation that the FDA requires for several years. It has been a long process that culminated in the completion of the application during this quarter. The US market is the world’s largest and represents a significant opportunity for SciBase. Even a limited penetration of our method and Nevisense has the possibility to transform our business”, says Simon Grant, CEO of SciBase. The PMA is the FDA’s most rigorous process for approval of new medical devices for the US market and is required for most so-called class III devices. Class III devices are usually based on a new method that has not yet been approved by the FDA. Due to the complex and resource-intensive process only about 30 companies apply for a PMA each year. If successful, SciBase will be one of only a handful of Swedish companies to complete a PMA process. A PMA application contains detailed information covering the device’s development, manufacturing as well as the clinical trials that confirm the device’s safety and effectiveness in use. In dialogue with the FDA, SciBase has developed and conducted the world’s largest clinical study on detection of malignant melanoma. In addition, SciBase presented the results from a so-called Reader study during the third quarter. The Reader study was the final piece needed in order to complete the application. The FDA is now starting the review of SciBase’s PMA application. The company estimates that a decision from the FDA will be reached by the end of 2016, a more exact date is however hard to estimate. Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly. The key to management is early detection, which is a challenge due to lack of objective tools for diagnosis, a problem that Nevisense addresses. For more information, please contact: Simon Grant, CEO Phone: +46 72 887 43 99 Email: simon.grant@scibase.com About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Luvme Hair Offers Wig Variety for Winter Fashion

Updated Category News Views 313

Adding Flair to Winter Looks A style kick-off from the fashion world: Luvme Hair is flipping the table on winter wardrobes with a new collection of wigs. As the weather ramps up the need for thick coats and cumbersome layers, these long hairstyles offer a little extra swing, bringing dimension into the mix. Fancy a change from traditional winter hibernation? Here’s what...

Continue Reading
HiTHIUM Joins Cambridge to Boost Global Energy Storage

Updated Category News Views 421

HiTHIUM and Cambridge's New Energy Venture There's a big splash coming out of Xiamen, folks. HiTHIUM, a heavyweight in the energy storage sector, has decided to team up with the University of Cambridge. They inked a deal aiming to bridge the academic ivory tower with industrial grit, focusing on long-duration energy storage. It was all sealed during the Global Energy...

Continue Reading
Uber Data Breach: Class Action Investigation Begins

Updated Category News Views 115

When Tech Meets Trouble: Uber's Data Breach Picture this: the hum of Uber rides weaving through your city, drivers none the wiser that personal info has been pried from the vaults thanks to their tech partner, Fireworks AI. Uber, folks, is in hot water once again. This isn’t just another tech hiccup; it's a legal whirlwind brewing up courtesy of Edelson Lechtzin LLP, a...

Continue Reading
El Pollo Loco Faces Class Action Over Wage Practices

Updated Category News Views 374

Alright, here's where things start sizzling—El Pollo Loco, the fast-food chicken chain whose name translates to 'The Crazy Chicken'—is in a legal pickle. The lawsuit hanging over their heads could spell a sticky situation for them and possibly ripple through the fast-food industry. The suit, filed by the steadfast firm Blumenthal Nordrehaug Bhowmik De Blouw LLP, has...

Continue Reading
Advanta's Game-Changer: Acquiring Misr Hytech to Expand in Africa

Updated Category News Views 249

Advanta's Strategic Move into Africa Alright, let's cut to the chase. Advanta is making a big splash with its acquisition of Misr Hytech, a move that's going to shake things up in Africa's agricultural sector. This isn't just another merger to gloss over with your morning coffee. We're talking about a deal that's supposed to wrap up by January 31, 2027, bringing together...

Continue Reading
BETR's Slide: Investors Face Big Losses, Leadership Shift

Updated Category News Views 170

BETR Investors Left in the Lurch It's a real trainwreck, folks. Better Home & Finance Holding Company, trading under NASDAQ:BETR, is in the spotlight for all the wrong reasons. The company expanded the class period for its investor lawsuit to include even more dates between March and August 2026, reflecting a torturous ride for shareholders. Their stock cratered by a...

Continue Reading
Lilly's Obesity Breakthroughs: A Step Beyond the Scale

Updated Category News Views 152

Pushing the Boundaries of Obesity Treatment Alright, let's cut through the noise and get to what really matters here. Eli Lilly is taking on obesity treatment like it's Clash of the Titans at this year's ObesityWeek 2026 in Washington, D.C. Forget just dropping pounds—Lilly wants to reshape how we think about obesity entirely. They're not just leaning into the scale,...

Continue Reading
SmallRig Boosts Art-Driven Innovation in AI Era

Updated Category News Views 158

The Interplay of Art and AI In a world where the lines between man and machine blur faster than ever, creators like SmallRig are boldly asking: what role should authenticity play when AI takes the stage? The Shenzhen International Art Museum and SmallRig stood shoulder to shoulder, tackling this head-scrambling question with a global gathering of art and tech giants. It's...

Continue Reading
Webull Faces Class Action: Key Details for Investors

Updated Category News Views 219

What's Really Going on With Webull? When you hear there's a class-action lawsuit brewing, you know something's gone real sideways. Webull Corporation (NASDAQ: BULL) finds itself neck-deep in a securities fraud class action alleging some dicey dealings with China. If you've got skin in the game—and if you bought Webull stock between April 26, 2025, and October 6,...

Continue Reading
CARsgen's CAR-T Breakthrough on China's Insurance List

Updated Category News Views 270

A Game Changer for CAR-T Therapies There's a breeze of optimism blowing from Shanghai these days—a rare sensation in this market of endless skirmishes. CARsgen Therapeutics Holdings Limited, a company entrenched in the development of cutting-edge CAR T-cell therapies, just notched a victory. They've announced that their CAR T-cell therapy product, satricabtagene...

Continue Reading

Top 5 Most Recently Viewed Articles

TransAlta Announces Q3 2025 Conference Call Details

Updated Category News Views 158

TransAlta's Upcoming Third Quarter Results Conference Call TransAlta Corporation is gearing up for an important announcement as it prepares to release its third quarter 2025 financial results. This eagerly awaited information will be made available before the markets open on a Thursday in early November. Conference Call Schedule On the morning of the announcement, at 9:00...

Continue Reading
Soma Gold Corp. Shares AGM Results and Stock Options Grant

Updated Category News Views 128

Insights from Soma Gold Corp.'s Recent Annual General Meeting Soma Gold Corp. (TSXV: SOMA) recently conducted its Annual General Meeting (AGM), where key decisions were made that will shape the company's future. With strong support from its shareholders, the AGM served as a platform for transparency and engagement, which are essential aspects of sustainable business...

Continue Reading
Pinnacle Financial Partners Enhances Growth Outlook Following Q3 Success

Updated Category News Views 102

Pinnacle Financial Partners Reports Stellar Q3 Performance Pinnacle Financial Partners (NASDAQ: PNFP) has shared impressive third-quarter results, highlighting significant advancements in loans, deposits, and earning assets. The company also took the opportunity to recalibrate its 2024 financial expectations while reaffirming its commitment to ongoing growth. Key...

Continue Reading
METLEN Posts Record 9-Month Revenue in 2026

Updated Category News Views 264

Record Revenue Achievement Oh boy, METLEN just broke the bank with its nine-month trading update for 2026, hitting €6.2 billion in revenue. It's the highest they've ever seen for this period. A 21% jump from the previous €5.1 billion in 9M2025—now that's saying something in these unpredictable markets. Drilling down, the company’s business units showed they can...

Continue Reading
InnoPhase IoT Launches Talaria 6 SoCs Boosting Connectivity & Security

Updated Category News Views 677

InnoPhase IoT's Revolutionary Talaria 6 Series of SoCs InnoPhase IoT, Inc., a leader in wireless semiconductor platforms, has recently unveiled the impressive Talaria 6 Family of System-on-Chips (SoCs). These advanced offerings come equipped with multi-protocol wireless connectivity, such as Wi-Fi 6 and Bluetooth 6.0, crafted to meet the contemporary demands of the...

Continue Reading