On November 28, 2022 Lunit (KRX:328130.KQ), a global provider of AI-powered cancer solutions, reported that it unveiled real-world data (RWD) validating the clinical efficacy of AI in actual medical settings for the first time in the field of breast cancer research at this year’s RSNA meeting (Press release, Lunit, NOV 28, 2022, View Source [SID1234624520]). The company will be presenting a total of 12 abstracts—8 oral presentations and 4 poster presentations—at the 108th RSNA Annual Meeting to be held from Nov. 27 – Dec. 1.

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The highlight of Lunit’s program is an oral presentation on a large-scale population-based prospective study of Lunit’s AI solution for mammography as a potential replacement for radiologists. While past retrospective studies have shown promising performance by AI in mammography screening, this clinical trial conducted in a prospective screening setting truly reflects the real-world impact of AI in a breast screening workflow.

A Swedish team of researchers, led by radiologist Dr. Fredrik Strand at the Karolinska Institutet, conducted a prospective interventional study using Lunit INSIGHT MMG; the CE- and FDA-cleared AI solution for mammography analysis is currently in clinical use across numerous medical institutions around the world. Study results were collected over approximately 14 months (April 1, 2021 – June 9, 2022) analyzing 55,579 patient cases of breast cancer screening in actual clinical settings.

Interpreting mammograms is an inherently difficult task. Once suspicious lesions are found through mammograms, women are recalled to the clinic for further tests and biopsies. While recalls are aimed to increase the detection of cancer, only fewer than 1 in 10 women called back are diagnosed with breast cancer. These false-positive mammograms can cause patient anxiety and physical discomfort, as well as cost significant time and money due to extra tests, potentially doing more harm than good. To tackle this problem, most European countries have adopted a system of double reading in which two radiologists decide whether the patient should be recalled or not.

In keeping with this practice, the study included three independent readers: Radiologist 1, Radiologist 2, and Lunit INSIGHT MMG. This study design allows for results to be reviewed according to different reader combinations: two radiologists, Lunit AI + one radiologist, and each reader separately.

Comparison of the Cancer Detection Rate (CDR) Between Lunit INSIGHT MMG and Radiologists

Results from the study showed that Lunit INSIGHT MMG, when combined with a single radiologist, can detect more cancers compared to two radiologists. Furthermore, using AI alone showed non-inferior cancer detection rate (CDR) performance compared to the traditional double reading setting: the CDR per 1,000 exams of two radiologists, one radiologist + AI, and AI alone was 4.1, 4.3, and 4.1, respectively.

Comparison of the Recall Rate (RR) Between Lunit INSIGHT MMG and Radiologists

Lunit INSIGHT MMG also showed a lower recall rate (RR) in combination with one radiologist as well as alone, compared to the traditional double reading setting. The RR per 1,000 exams of two radiologists, one radiologist + AI, and AI alone was 29.3, 28.0, and 15.5, respectively. This result indicates that AI use for breast screening analysis, in combination with a radiologist as well as alone, leads to better performance for RR.

"While double readings have been established as the common practice across Europe and Australia, many countries are experiencing great difficulties due to the shortage of radiologists," explained Dr. Strand, breast radiologist and associate professor at Karolinska Institutet. "This prospective study lays the groundwork for the widespread adoption of AI in breast cancer screening by filling the role of one radiologist, which in turn can reduce medical costs and lead to healthcare reimbursement."

"AI will eventually become the standard of care for breast cancer screening. While developing a high-performing product has always been critical, this study is key in that Lunit is the first to prove the effectiveness of AI through a large-scale prospective clinical trial in actual medical settings," remarked Lunit CEO Brandon Suh. "With our recent contract to supply our AI for the BreastScreen NSW State program in Australia, Lunit’s AI is continuing to prove its positive impact in the medical field."

On November 28, 2022 HALO Diagnostics, the leader in early disease detection using precision diagnostics, and Ikonopedia, a next-generation breast imaging reporting and tracking solution, reported a genetic testing partnership to improve breast cancer detection and patient outcomes (Press release, HALO Diagnostics, NOV 28, 2022, View Source [SID1234624519]).

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Genetic testing is the most effective way to determine if a patient has specific pathogenic mutations linked to a higher risk for developing cancer, yet only one in five women appropriate for hereditary cancer testing are offered the option.1 Without integrated genetic testing and supplemental breast MRI, traditional imaging centers miss two out of three cancers in high-risk women.2

HALO and Ikonopedia use genetic testing to catch cancers early and increase adherence to critical follow-up imaging. Under the new partnership, Ikonopedia’s cutting-edge mammography software for follow up tracking and one-click radiology reporting will be seamlessly integrated with HALO’s proprietary genetic lab and precision diagnostic software services. This integrated approach is expected to drive a 40% increase in compliance for follow-up imaging,3 aiding early detection and less invasive treatment.

Nearly all patients (97%) with positive genetic test results comply with additional screening recommendations.3
There is a threefold increased cancer detection rate with supplemental breast MRI screening in high-risk women.4
Over 99% of patients survive more than five years with an early-stage breast cancer diagnosis.5
The joint offering aims to maximize identification of patient risk by using Tyrer-Cuzick 8, HALO’s Hereditary Gene Panel, and HALO’s Polygenic Risk Score. The partnership provides radiology centers:

HALO’s proprietary genetic lab and precision diagnostic software services with integrated genetic counseling, and a dedicated lab liaison who will work onsite at the radiology center.
Seamless intake integration, auto eligibility checks, auto lab ordering, and lab processing.
Comprehensive precision diagnostic report including recommended follow-up imaging for patients identified as high risk for breast cancer.
"We’re proud to partner with Ikonopedia and their robust breast imaging reporting and risk-assessment tools," said Brian Axe, Founder and Chief Product Officer of HALO. "Our combined solution will save lives by improving early detection through fast, accurate diagnosis and personalized care."

As part of the collaboration, Ikonopedia’s integrated risk assessment tool will identify patients eligible for hereditary testing. When medically indicated, physicians will place an order for HALO’s proprietary Women’s Health Precision Diagnostic suite, which combines advanced imaging, a risk calculator, and genetic test results to identify patients who may benefit from additional supplemental breast cancer screening and management.

"HALO and Ikonopedia’s goals for early detection and personalized treatment are incredibly well aligned. We’re excited to partner with a forward-thinking, precision diagnostics company to enable broader access to genetic testing and improved follow up," said Emily Crane, CEO & President of Ikonopedia.

On November 28, 2022 DURECT Corporation (Nasdaq: DRRX), a biopharmaceutical company focused on developing epigenetic regulator programs for the treatment of acute organ injury and chronic liver diseases, reported that DURECT’s board of directors today determined that the Company will effect a reverse stock split at a ratio of 1-for-10 as of 5:01 p.m. Eastern Time on December 5, 2022 (Press release, DURECT, NOV 28, 2022, View Source [SID1234624518]). Beginning with the opening of trading on December 6, 2022, the Company’s common stock will trade on a split-adjusted basis.

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At a Special Meeting of Stockholders held on November 22, 2022, DURECT stockholders voted to approve a proposal authorizing the board of directors of the Company to amend the Company’s certificate of incorporation to effect a reverse stock split of DURECT’s outstanding common shares at an exchange ratio of not less than 1-for-10 and not greater than 1-for-20, and a reduction in the number of authorized shares of common stock from 600,000,000 to 150,000,000 shares. The reduction in the authorized number of shares will also be effective as of 5:00 p.m. Eastern Time on December 5, 2022.

"We appreciate the support of our shareholders in granting our board the authority to effect a reverse split. After in-depth consideration of our options, the board determined that a reverse split of the Company’s common shares is in the best interest of shareholders," said James E. Brown, D.V.M., President and Chief Executive Officer of DURECT. "Implementing the reverse stock split will help us maintain compliance with Nasdaq’s $1.00 minimum bid price requirement and potentially make our stock more attractive to a broader range of institutional and other investors."

Upon the effectiveness of the reverse stock split, each ten shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.0001 per share. As a result of the reverse split, there will be approximately 22.8 million shares of common stock issued and outstanding. The reverse stock split will not materially affect any shareholder’s ownership percentage of DURECT’s common shares. Any fraction of a share of common stock that would be created as a result of the Reverse Stock Split will be cashed out at a price equal to the product of the closing price of the Company’s common stock on December 5, 2022 and the amount of the fractional share. In addition, proportionate adjustments will be made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options.

The Company’s common stock will continue to trade on The Nasdaq Stock Market LLC ("Nasdaq") under the symbol "DRRX." The common shares will trade under a new CUSIP number, 266605 500, effective December 6, 2022.

Computershare has been appointed by the Company to act as its exchange agent for the Reverse Stock Split. Stockholders owning pre-split shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split and will not be required to take further action in connection with the Reverse Stock Split, subject to brokers’ particular processes. Similarly, registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are also not required to take further action in connection with the Reverse Stock Split. Holders of certificated shares will be contacted by the Company or its exchange agent with further details about how to surrender old certificates.

On November 28, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported a 1-for-30 reverse split of its common stock (Press release, CNS Pharmaceuticals, NOV 28, 2022, View Source [SID1234624517]). Beginning on November 29, 2022, the Company’s common stock will continue to trade on The Nasdaq Capital Market ("Nasdaq") on a split adjusted basis under the trading symbol "CNSP", but will trade under the following new CUSIP number: 18978H201.

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The reverse stock split was approved by CNS Pharmaceuticals’ stockholders at the 2022 annual meeting of stockholders. The reverse stock split is primarily intended to increase the Company’s per share trading price and bring the Company into compliance with the Nasdaq’s listing requirement regarding minimum share price.

As a result of the reverse stock split, every 30 shares of common stock issued and outstanding as of the effective date will be automatically combined into one share of common stock. Outstanding warrants, equity-based awards and other outstanding equity rights will be proportionately adjusted by dividing the shares of common stock underlying the securities by 30 and multiplying the exercise/conversion price, as the case may be, by 30. No fractional shares will be issued as a result of the reverse stock split. Stockholders of record who would otherwise be entitled to receive a fractional share will be entitled to the rounding up of the fractional share to the nearest whole number. The par value of the common stock will remain unchanged at $0.001 per share after the reverse split, and the number of authorized shares of common stock will remain at 75 million shares. The reverse split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse split results in some stockholders owning a fractional share as described above.

On November 28, 2022 GE Healthcare has reported an agreement with ulrich medical for a GE Healthcare branded contrast media injector in the U.S. The CT motion multi-dose syringeless injector, which delivers iodinated contrast media for Computed Tomography (CT) imaging procedures, reduces procedure setup time and increases patient throughput by eliminating time consuming preparation steps, while helping to optimize patient dosing and reduce wasted contrast media (Press release, GE Healthcare, NOV 28, 2022, View Source [SID1234624516]).

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Recent research, led by Dushyant Sahani MD, Professor and Chair of Radiology at the University of Washington and presented at the 2022 Radiological Society of North America (RSNA) Congress, demonstrates that when compared to a typical dual-syringe based injector using single or multi-dose vials, the CT motion may enable six additional patient CT exams each day in a busy Emergency Department, with up to three minutes saved per patient. The research, which analyzed over 6,000 patients who received Contrast Enhanced CT or CT Angiography, also shows CT Motion reduces cost from consumables and saves an average 30 mL of contrast per procedure.

The U.S. contrast media injector market is estimated to grow at 4.3 percent annuallyi between 2022-2030, attributed to its developed healthcare infrastructure and the prevalence of chronic diseases.

Today, the majority of contrast enhanced CT imaging involves radiology technicians filling a syringe with contrast media prior the injection procedure. With the syringeless CT motion, the required dose is drawn and injected directly from the injector’s contrast media container, saving time, facilitating the optimal volume of contrast media will be used, reducing wasted leftover contrast and generating less disposable waste. CT motion also provides injection reports accessible via RIS/PACS for dose management systems and records of prior injections to further optimize dose and improve patient safety.

Marco Campione, Americas General Manager at GE Healthcare Pharmaceutical Diagnostics said: "Radiology departments are focused on managing increasing demand and on conserving contrast media. The CT motion supports efficient operational practices – saving time, saving contrast, saving on consumables, improving workflows and facilitates better patient throughput. We expect demand for iodinated contrast media to double in the next decade, so we are investing, both in production capacity expansion and also in technologies like this that conserve volumes and reduce leftover contrast media."

Klaus Kiesel, CEO ulrich medical, said: "We are delighted to be working even more closely with our long-standing partner GE Healthcare, who have already been distributing our injector CT motion in the US market. With GE Healthcare’s nationwide brand recognition and great distribution power, we are sure to significantly expand our market share on injectors in the world’s largest medical technology market."

As part of its broader commitment to address growing demand for iodinated contrast media, GE Healthcare recently opened a new 30 million USD additional manufacturing line at its facility in Cork, Ireland, announced an 80 million USD investment to increase capacity at its Active Pharmaceutical Ingredients site in Lindesnes, Norway, and signed an agreement with the Chile based mining company, SQM, to secure an increasing supply of the key raw material, iodine. These milestones are contributing to GE Healthcare’s aim to produce 30 million more patient doses of iodinated contrast media annually by 2025.

GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. All stages of its contrast media manufacturing, from development of API to finished product, are managed entirely by GE Healthcare, adhering to current Good Manufacturing Practices (cGMP). With over 4000 employees globally and seven manufacturing sites, the business also develops and supplies radiopharmaceuticals used to support diagnosis, monitoring and treatment selection across Neurology, Cardiology and Oncology clinical pathways.

Dr Sahani will present an abstract from the GE Healthcare funded study "Improving CT workflow and in a busy subspeciality emergency room using a novel power injector technology" on November 30th at 8:00 am – 9:00 am CT, during Session W1-SSNPM03: Noninterpretive Skills/Quality Improvement/Practice Management (Optimizing Radiology Care Delivery)

About CT motion
Developed by ulrich medical, based in Ulm, Germany, the design of the CT motion draws on 30 years of medical imaging experience and is already used globally. For the U.S. market, the CT motion injector is manufactured in Germany and shipped, distributed and serviced by GE Healthcare. The injector is indicated by the U.S. Food and Drug Administration (FDA) for intravenous use in CT of head and body with GE Healthcare’s iodinated contrast media.