HALO Diagnostics Partners with Ikonopedia to Offer Comprehensive Women’s Health Genetic Testing to Improve Early Breast Cancer Detection

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.

DURECT Announces 1-for-10 Reverse Stock Split

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.

CNS Pharmaceuticals Announces Reverse Stock Split

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.

GE Healthcare and ulrich medical announce an Agreement to Offer a Branded Multi-dose Contrast Media Injector in the U.S.

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.

ICPO Foundation and PreMIT Enter Strategic Partnership to Develop a Network of Precision Oncology and Theranostic Centers

On November 28, 2022 The International Centers for Precision Oncology (ICPO) Foundation and Melbourne-based PreMIT Pty Ltd (PreMIT), reported a collaboration to develop a global network of Precision Oncology and Theranostics centers (Press release, ICPO Foundation, NOV 28, 2022, View Source [SID1234624515]). Through their joint efforts, the parties intend to scale access to Radiomolecular Precision Oncology for cancer patients globally and to foster research & industry partnerships.

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At its core, theranostics uses radiopharmaceuticals to both diagnose and treat various forms of cancer. As theranostics is still an emerging medical field, both ICPO and PreMIT see the need for an acceleration in the number of clinical sites that:

Deliver precision medicine as their mission;
Employ physicians and clinical staff with a strong knowledge base in nuclear medicine and application of advanced molecular imaging techniques;
Deploy the most-advanced imaging equipment available to provide the most accurate diagnoses;
Use up-to-date protocols to deliver safe & effective treatment options to cancer patients; and
Facilitate the development of innovative and effective radiopharmaceuticals for diagnosis & therapy.
ICPO and PreMIT have signed an agreement to establish new Theranostic centers that deliver on those key principles. Using their vast collective medical and scientific experience, along with their broad networks, ICPO and PreMIT will work together, and with local development partners around the world. The facilities will be modeled on reference centers such as the Melbourne Theranostic Innovation Centre (MTIC), PreMIT’s flagship site that will begin clinical services in mid-February 2023. Construction at MTIC is nearly complete with the Siemens Biograph Vision Quadra PET/CT scheduled to be lifted into the building on 14 January. The partners will define, implement, and monitor best practices, as well as offer educational and qualification programs.

PreMIT through its MTIC site, will contribute its experience in planning, developing, and operating Theranostic centers, as well as in designing and running educational programs. The ICPO Foundation using its knowledge exchange and global community platform, will help establish and monitor quality and certification standards, as well as leverage its international reach to promote setting up new centers.

The network of Theranostic centers will help bridge the gap between research and improved patient access while also facilitating the development of novel radiopharmaceuticals. Partnerships with leading companies and pioneering academic institutions, already support the advancement of innovation in technology and education in Radiomolecular Precision Oncology.

Oliver Buck, Trustee of the ICPO Foundation said: "We are extremely encouraged to join forces with PreMIT and Professor Rodney Hicks who has been a pioneer in Theranostics and Precision Oncology for over 30 years. As a key opinion leader in nuclear medicine and oncology worldwide, Professor Hicks has the unparalleled credentials as well as industry and academic relationships to advance the development of new Theranostics paradigms and provide world-class value for the ICPO Theranostics centers network. We can think of no better partner to lead this important path towards democratizing and scaling patient access to Radiomolecular Precision Oncology worldwide."

"We are very much looking forward to this collaboration with the ICPO Foundation to accelerate the implementation of a shared vision to address the unmet needs of cancer patients in clinical practice and make innovative theranostic approaches accessible to all," added Professor Rodney Hicks, PreMIT Founder, Chairman, and Chief Medical Officer. "We strongly believe that the international ICPO-Community composed of medical experts, industry and investors will successfully empower and catalyse the establishment of new Theranostic centres of high added-value for cancer patients worldwide."