Iterative Scopes | September 23, 2022
Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. SKOUT, a real-time computer-aided polyp detection device developed by Iterative Scopes, uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The device was evaluated in the largest U.S.-based multicenter clinical study for a computer aided polyp detection (CADe) device completed to date, which determined that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy.1
In March 2021, Provation and Iterative Scopes entered a partnership focused on delivering artificial intelligence-based solutions to healthcare providers and researchers. Provation is a market leader in gastrointestinal (GI) documentation, with more than 3,500 customer facilities including 80% of the top academic and large health systems, and the company will act as an exclusive distributor of SKOUT to help broaden the technology’s reach among the country’s top GI-focused organizations.
Colorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2 3 due in part to the high volumes of adenomas – approximately 26%4 – that endoscopists miss when conducting a colonoscopy. In its registration trial, SKOUT was found to improve adenoma detection, as measured by adenomas per colonoscopy (APC). Furthermore, increased detection was not limited to diminutive polyps. Higher APC rates have been shown to lead to improved patient outcomes; a recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.5
“Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes. We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency, and ultimately change the standard of gastrointestinal care.”
Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes
SKOUT is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. SKOUT demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, with an average of one additional adenoma resected for every 4.5 patients examined. Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall.1 These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so.
“Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” said Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.”
“We are thrilled that our partner Iterative Scopes has received FDA clearance for their AI-Assisted Polyp Detection device, SKOUT. We have been very impressed with its study results and are eager to share our vision for integrating this technology into our solutions,” said Daniel Hamburger, CEO at Provation. “SKOUT is a true game-changer for the field of gastroenterology, and we can’t wait to start seeing its impact on patient care.”
SKOUT’s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1 When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it and tracking the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician’s view during polyp removal.
About Iterative Scopes
Iterative Scopes is a pioneer in the application of artificial intelligence-based precision medicine for gastroenterology with the aim of helping to optimize clinical trials investigating treatment of inflammatory bowel disease (IBD). The technology is also designed to potentially enhance colorectal cancer screenings. Its powerful, proprietary artificial intelligence and computer vision technologies have the potential to improve the accuracy and consistency of endoscopy readings. Iterative Scopes is initially applying these advances to impact polyp detection for colorectal cancer screenings and working to standardize disease severity characterization for inflammatory bowel disease. Longer term, the company plans to establish more meaningful endpoints for GI diseases, which may be better predictors of therapeutic response and disease outcomes. Spun out of MIT in 2017, the company is based in Cambridge, Massachusetts.
Provation is a leading provider of healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Our purpose is to empower providers to deliver quality healthcare for all. Provation’s comprehensive portfolio spans the entire patient encounter, from pre-procedure through post-procedure, with solutions for physician and nursing documentation anesthesia documentation patient engagement, surgical care coordination, quality reporting, and billing capture order set and care plan management and EHR embedded clinical documentation. Provation has a loyal customer base, serving more than 5,000 hospitals, surgery centers, and medical offices, and 700 physician groups globally, including 19 of the top 20 U.S. hospitals. In 2021, Provation was acquired by Fortive Corporation, a Fortune 1000 company that builds essential technology and accelerates transformation in high-impact fields like workplace safety, engineering, and healthcare.
Ora, Inc. | September 29, 2022
Ora, Inc., the world's leading ophthalmology clinical research firm, has formally launched a revolutionary mobile research platform, Ora EyeCupTM, which promises to transform patient data capture through high-resolution imaging, artificial intelligence (AI) analysis, and real-time patient feedback. The Ora EyeCupTM, a finalist in the Most Valuable Clinical Technology Award category at the Reuters Events Pharma Awards USA 2022, will be presented by Dr. Gustavo De Moraes, Chief Medical Officer at Ora, at this year’s Eyecelerator Conference in Chicago, IL, September 29th.
The Ora EyeCupTM platform is a powerful combination of hardware and software — a smartphone attachment and software application which allows patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. With over 138,000 images captured to date, 98% are considered gradable by researchers and AI. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability, and corneal health. Along with this, the Ora EyeCupTM ensures protocol adherence through compliance assurance diaries for both symptom tracking and therapy dosing.
“At Ora, our technologists have spent the past two years developing this revolutionary system to capture patient data and provide a deeper understanding of therapeutic effect. The result is a trailblazing technology that captures high quality therapeutic data and improves the likelihood of study success.”
Dr. De Moraes
About Ora, Inc.
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 55 product approvals and create vision beyond what they see. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and operations management to maximize the value of new product initiatives. Think ophthalmology, think Ora.
KiOmed Pharma and Hansoh Pharma | September 27, 2022
KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited a leading biopharmaceutical company in Asia, today announced a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan.
Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets.
Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking.
“We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China. We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan,” added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed.
Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma
“KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem,” said Eliza Sun, Executive Director of the Board of Hansoh Pharma. “We are also very excited to partner with them and bring this unique product to much needed patients in China.”
KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine® CM-Chitosan. KiOmedine® CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021.
About KiOmed Pharma
Based in Belgium, KiOmed Pharma has a history of innovation and expertise in exclusive natural chitosan chemistry. The company develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as osteoarthritis, skin aging and ophthalmology. KiOmed Pharma's innovative pipeline is based on a solid building block exclusive technology: KiOmedine®, a medical-grade highly pure natural chitosan-derivative.
About Hansoh Pharmaceutical Group
Hansoh Pharma one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders.