Cocaine Hydrochloride

NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided an update on its FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System. In December 2024, INBS submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System. As expected, the FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025. This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and expert third-party partners, INBS responded to the FDA’s questions and submitted additional information in August 2025. The FDA appeared to be satisfied with the majority of responses to the items and has responded with a request for new additional information that requires the Company to resubmit a new 510(k) notification. As a first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market, the Company’s Intelligent Fingerprinting Drug Screening System requires extensive supporting information to validate its performance. The practical feedback received from the FDA is not uncommon for breakthrough technologies. INBS is in the process of evaluating the FDA’s questions and is currently in consultation with its specialized FDA consultants. The Company expects to have an investor update in the next ten days outlining an updated timeline for FDA clearance. “The FDA’s feedback provides constructive clarity on the additional information it requires to advance our application,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “We are confident in the capabilities of our technology, and we remain fully committed to bringing our innovative solution to the U.S. market. We will work to respond to the FDA’s additional questions to support validation of our device, in order to resubmit our 510(k) Notification as soon as possible. The progress we have made so far in terms of additional data collected to substantiate the strength of our product throughout this process places us in a strong position as we work toward clearance. Importantly, our international business continues to grow, enabling us to maintain commercial progress globally while pursuing U.S. clearance outside of the Forensic Use Only market.” The Company continues to advance its commercial activities outside the U.S., developing new partnerships and driving sales growth while pursuing further international market penetration. About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners. For more information, visit https://ibs.inc/ Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions’ public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Company Contact Intelligent Bio Solutions Inc. info@ibs.inc LinkedIn | Twitter Investor & Media Contact Valter Pinto, Managing Director KCSA Strategic Communications PH: (212) 896-1254 INBS@kcsa.com

Clinicians at Ascendant warn that long-term stimulant use can leave people drained, anxious, and vulnerable to depression. NEW YORK, NY, UNITED STATES, September 3, 2025 / EINPresswire.com / -- Ascendant Intensive Outpatient Program NYC , a boutique addiction treatment center in Midtown Manhattan, is calling attention to the growing dangers of stimulant misuse—from prescription drugs like Adderall ® to street drugs such as methamphetamine and crack cocaine. These substances are often prescribed or used with the intent to help, yet misuse has fueled a steady rise in dependence and treatment admissions nationwide. Prescription stimulants can be effective when taken as directed, particularly for conditions like ADHD. Still, misuse is common. Adderall ® , for instance, is sometimes taken without a prescription by students or professionals chasing sharper focus or more energy. Methamphetamine, though available in limited medical use under the name Desoxyn ® , is more often found in illicit forms that are unpredictable and highly addictive. Crack cocaine, a potent stimulant with a notorious reputation, continues to circulate on the streets under names like “snow” or “blow.” Misuse often goes beyond simply taking too many pills. Crushing and snorting Adderall ® , injecting meth, or smoking crack are all methods that intensify the high but dramatically increase health risks. Overdose, seizures, heart problems, and long-term cognitive decline are not rare outcomes. Federal data show that in 2021, more than 3.7 million people in the U.S. misused prescription stimulants, and cocaine was linked to nearly two out of five overdose deaths in 2016. Clinicians at Ascendant warn that long-term stimulant use can leave people drained, anxious, and vulnerable to depression. Withdrawal is another hurdle: cravings, paranoia, and mood swings make quitting extremely difficult without medical oversight. To support individuals and families, Ascendant NYC provides: 24/7 medical detox to manage withdrawal safely. Residential and outpatient programs for different stages of recovery. Therapies such as Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and trauma-focused care. Wellness services including mindfulness, art therapy, and peer counseling for lasting support. The center emphasizes that stimulant misuse doesn’t follow one profile. High school students, college athletes, busy executives, or individuals with existing mental health struggles may all be at risk. Recognizing early warning signs—such as erratic sleep, paranoia, or “doctor shopping”—can open the door to timely treatment. About Ascendant NYC Ascendant NYC is a boutique addiction treatment center located in Midtown Manhattan, offering detox, residential, and outpatient programs. Since 2018, the center has provided compassionate, evidence-based care for individuals struggling with substance use. With an emphasis on safety, privacy, and individualized treatment, Ascendant helps clients rebuild their lives with the tools and support needed for long-term recovery. Admission Office Ascendant Intensive Outpatient Program NYC +1 (917) 924-4456 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.