Intelligent Bio Solutions Inc. Announces Progress Toward Completion of Clinical Study Plan Required for FDA 510(k) Submission
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has announced progress in its clinical study plan for FDA 510(k) submission. The company has completed one-third of subject enrollment for its method comparison study, which involves 135 healthy adults across three sites. INBS has also finished the in-clinic portion of a pharmacokinetic study on opiates in human fingerprint sweat. The company aims to complete the in-clinic part of the method comparison study by September end, aligning with their goal to prepare the FDA 510(k) submission in Q4 2024. These studies are designed to demonstrate the ease of use and accuracy of the Intelligent Fingerprinting Drug Screening System in detecting opiates.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) ha annunciato progressi nel suo piano di studi clinici per la presentazione della domanda FDA 510(k). L'azienda ha completato un terzo del reclutamento dei soggetti per il suo studio di confronto dei metodi, che coinvolge 135 adulti sani in tre sedi. INBS ha anche terminato la parte in clinica di uno studio farmacocinetico sugli oppiacei nel sudore delle impronte digitali umane. L'azienda mira a completare la parte in clinica dello studio di confronto dei metodi entro la fine di settembre, in linea con il loro obiettivo di preparare la richiesta FDA 510(k) nel Q4 2024. Questi studi sono progettati per dimostrare la facilità d'uso e l'accuratezza del Sistema di Screening per Farmaci tramite Impronte Digitali Intelligenti nella rilevazione degli oppiacei.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) ha anunciado avances en su plan de estudios clínicos para la presentación de la solicitud FDA 510(k). La compañía ha completado un tercio de la inscripción de sujetos para su estudio de comparación de métodos, que involucra a 135 adultos sanos en tres sitios. INBS también ha terminado la parte en clínica de un estudio farmacocinético sobre opiáceos en el sudor de las huellas dactilares humanas. La compañía tiene como objetivo completar la parte en clínica del estudio de comparación de métodos para finales de septiembre, alineándose con su meta de preparar la solicitud FDA 510(k) en Q4 2024. Estos estudios están diseñados para demostrar la facilidad de uso y la precisión del Sistema de Detección de Drogas mediante Huellas Dactilares Inteligentes en la detección de opiáceos.
Intelligent Bio Solutions Inc. (Nasdaq: INBS)는 FDA 510(k) 제출을 위한 임상 연구 계획에서 진전을 발표했습니다. 이 회사는 시험자 모집의 3분의 1을 완료했습니다. 이 연구는 세 개의 사이트에서 135명의 건강한 성인을 포함합니다. INBS는 또한 인간의 지문 땀에서 오피오이드에 대한 약리학적 연구의 클리닉 부분을 완료했습니다. 이 회사는 9월 말까지 방법 비교 연구의 클리닉 부분을 완성할 목표를 가지고 있으며, 이는 2024년 4분기에 FDA 510(k) 제출을 준비하기 위한 것입니다. 이러한 연구는 Intelligent Fingerprinting Drug Screening System의 사용 용이성과 오피오이드 검출의 정확성을 입증하기 위해 설계되었습니다.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) a annoncé des avancées dans son plan d'études cliniques pour la soumission 510(k) à la FDA. L'entreprise a terminé un tiers de l'inscription des sujets pour son étude de comparaison des méthodes, impliquant 135 adultes en bonne santé sur trois sites. INBS a également achevé la partie clinique d'une étude pharmacocinétique sur les opiacés dans la sueur des empreintes digitales humaines. L'entreprise vise à terminer la partie clinique de l'étude de comparaison des méthodes d'ici fin septembre, conformément à son objectif de préparer la soumission 510(k) à la FDA au Q4 2024. Ces études sont conçues pour démontrer la facilité d'utilisation et la précision du Système de Détection de Drogues par Empreinte Digitale Intelligente dans la détection des opiacés.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) hat Fortschritte in seinem klinischen Studienplan für die FDA 510(k)-Einreichung angekündigt. Das Unternehmen hat ein Drittel der Probandenrekrutierung abgeschlossen für seine Vergleichsstudie der Methoden mit 135 gesunden Erwachsenen an drei Standorten. INBS hat auch den klinischen Teil einer pharmakokinetischen Studie zu Opioiden im menschlichen Schweiß von Fingerabdrücken abgeschlossen. Das Unternehmen plant, den klinischen Teil der Vergleichsstudie bis Ende September abzuschließen, um ihr Ziel zu erreichen, die FDA 510(k)-Einreichung im Q4 2024 vorzubereiten. Diese Studien sind darauf ausgelegt, die Benutzerfreundlichkeit und Genauigkeit des Intelligent Fingerprinting Drug Screening Systems bei der Detektion von Opioiden zu demonstrieren.
- Completed one-third of subject enrollment for the method comparison study
- Finished in-clinic portion of pharmacokinetic study on opiates in fingerprint sweat
- On track to complete in-clinic portion of method comparison study by end of September
- Progressing towards FDA 510(k) submission planned for Q4 2024
- None.
Insights
The progress in INBS's clinical study for FDA 510(k) submission is a significant step towards potential market entry. The one-third completion of subject enrollment and the finished in-clinic portion of the PK study are positive indicators. However, it's important to note that this is just a milestone, not a guarantee of FDA approval. The targeted completion by September end and planned 510(k) submission in Q4 2024 suggest a relatively fast timeline, which could be advantageous if successful. The focus on opiate detection in fingerprint sweat is innovative, potentially offering a non-invasive alternative to current drug screening methods. This could be a game-changer in the
While the progress in clinical studies is encouraging, investors should remain cautious. INBS, trading on Nasdaq, is still in the pre-revenue stage for this product. The company's ability to fund operations through to potential FDA approval and market launch is crucial. Investors should scrutinize INBS's cash position and burn rate. The timeline for potential revenue generation extends well into 2025, assuming FDA approval. Market adoption post-approval will be critical, considering competition from established drug screening methods. The global opioid crisis could drive demand, but pricing and reimbursement strategies will be key to commercial success. Until revenue materialization, INBS remains a speculative investment with high risk-reward potential.
The Intelligent Fingerprinting Drug Screening System represents an innovative leap in drug testing technology. Its non-invasive nature and potential for rapid results could disrupt traditional urine or blood-based tests. The system's accuracy, comparing favorably with LC-MS/MS methods, will be important for FDA approval and market acceptance. The ease of use for intended users is a significant factor, potentially expanding the application beyond clinical settings to workplace or roadside testing. However, the technology's specificity to opiates might limit its initial market. Future expansion to detect other substances could enhance its value proposition. The integration of this technology with data analytics and AI could further differentiate INBS in the competitive drug screening market.
NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its progress toward completion of the clinical study plan required for its FDA 510(k) submission.
In August 2024, INBS announced its partnership with CenExel to perform the method comparison study as part of the Company’s clinical study plan. The study involves the recruitment of 135 healthy adult subjects across three sites under an IRB-approved protocol and comparing the results of fingerprint sweat opiate screening tests with those obtained using a validated, traceable liquid chromatography-mass spectrometry (LC-MS/MS) method in a laboratory.
The Company has successfully completed approximately one-third of the subject enrollment targets for its method comparison study, including screening, consenting, and fingerprint sweat specimen collection activities. Additionally, the Company recently completed the in-clinic portion of a pharmacokinetic (PK) study on opiates in human fingerprint sweat and is currently analyzing the collected specimens and data from the study.
Harry Simeonidis, President and CEO at INBS, commented, “Our team and CRO partner are working together effectively to remain on track with our plan to complete the in-clinic portion of the method comparison study by the end of September. This progress aligns with our overarching goal of preparing a 510(k) submission for the FDA in the fourth calendar quarter of 2024.”
Through these clinical studies, the Company intends to demonstrate that the Intelligent Fingerprinting Drug Screening System is easy to use and performs accurately in the hands of intended users to detect the presence of opiates.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, 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 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. Additionally, the Company’s biosensor platform has the potential to test for various indications, ranging from immunological conditions to communicable diseases. The Company’s current customer segments include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.
For more information, visit: http://www.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
Investor & Media Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
FAQ
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