Wavegate Corporation | January 14, 2022
Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
"We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux™ technology. This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain. We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art."
Erich Wolf, MD, PhD, Chief Executive Officer
"This designation underscores the urgent need within our society for more effective treatments of chronic, debilitating pain."
StimuLux™ is a component of Wavegate Corporation's Ellipse neuromodulation platform which integrates multiple patented technologies which aim to systematically address unmet clinical needs within the neuromodulation industry.
About Wavegate Corporation
Wavegate Corporation is a privately-held start-up neuromodulation company focused on developing and commercializing a suite of technological innovations including: waveform-independent closed-loop adaptive stimulation, a stimulation paradigm for modulation of both ascending and descending spinal cord pain pathways, new implant geometry for reduced surface contact pressures, rapid lead anchoring, and others.
ERT | April 16, 2021
ERT, the worldwide pioneer in clinical endpoint data collection, today declared that its demonstrated Business Intelligence suite has extended to incorporate detailing for clinical preliminary imaging, making study data all the more effectively available and noteworthy. The new imaging capabilities give an elevated degree of data that empowers study pioneers to guarantee consummation, and successfully oversee locales, expenses, and profitability.
"Imaging studies are complex, and customers are under great pressure to monitor and manage their performance. With the power of our Business Intelligence suite, study leaders can achieve the deep insights they need to act quickly, and keep studies on track for success," said Tim Kulbago, Vice President, Imaging, ERT. "Our clinical trial imaging customers can now track their study progress all the way from first image capture to database lock, with the ability to pivot with confidence whenever a potential challenge arises."
ERT's Business Intelligence suite permits numerous CROs and patrons to acknowledge new operational efficiencies and better data quality, alongside diminished investigation courses of events and lower costs, through its effectively edible and thorough perspectives into preliminary execution. Clients can utilize the new imaging functionality to coordinate investigations utilizing a profundity of data at no other time accessible. With the new capabilities, they approach a straightforward dashboard for surveying early markers of likely postponements in the imaging process.
Clients will track down a natural interface that permits them to get to consider data in an assortment of ways. They can undoubtedly channel data for an undeniable level view or jump down into points of interest by district, site and picture peruser, among others. Checking consistence is straightforward, as clients can rapidly see a general investigation level or take a gander at consistence in explicit territories like quality control, by site, and even by picture peruser. Opportune data permits study pioneers to intercede as vital, for instance, if a site has a high number of inquiries or if a peruser has all the earmarks of being going amiss from the convention.
ERT (eResearch Technology) is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what's next, so it can adapt without compromising standards.
Powered by the company's EXPERT® technology platform, ERT's solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. In 2019, 75% of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs, and CROs have relied on ERT solutions across 16,000 studies, spanning more than five million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.
Moberg Pharma | November 06, 2020
The Board of Directors of Moberg Pharma AB (publ) (OMX: MOB) ("Moberg Pharma" or "the Company") has today resolved to carry out a fully guaranteed issue of new ordinary shares and warrants ("Units") with preferential rights for existing shareholders (the "Rights Issue") of approximately SEK 150 million before transaction costs. The Rights Issue requires the approval of an extraordinary general meeting (the "Extraordinary General Meeting"). The proceeds will be used for registration activities and clinical work for MOB-015. When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement. By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021.