Photocure appoints Anders Neijber, MD, PhD as Chief Medical Officer, Global Medical Affairs and Clinical Development

On September 1, 2022 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the appointment of Dr. Anders Neijber to the position of Chief Medical Officer, Global Medical Affairs and Clinical Development and R&D, effective September 1, 2022 (Press release, PhotoCure, SEP 1, 2022, View Source [SID1234618924]).

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Dr. Neijber is Photocure’s current VP Medical Affairs and Clinical Development and joined the company in August 2021. He brings over 25 years of substantial experience in the Uro-oncology area and successful leadership in the pharmaceutical industry. He has had global and regional leadership roles, both in the U.S. and Europe, within Clinical R&D and Medical Affairs, having worked for Pfizer, AstraZeneca, Johnson & Johnson, Allergan, Ferring, and Novartis.

Dr. Neijber is a board-certified urologist, and has held an Assistant Professor position at the Department of Clinical Pharmacology, Robert Wood Johnson Medical School, New Jersey.

"In the time that Anders has been with Photocure, he has proven his ability to apply his extensive experience and deep knowledge in the field of Urology, together with his business acumen in leading our Global Medical Affairs strategy" said Dan Schneider, President and Chief Executive Officer of Photocure. "As Photocure continues to grow and expand its global reach, Medical Affairs will have an increasingly important role in navigating the complex health-care environment. Anders will be able to provide a strategic approach beyond addressing the heightened regulatory and compliance regulations, to further build a Global Medical Affairs organization that will have a strong foundation for future scalability and capability globally."

Nuvalent to Participate in the Wells Fargo 2022 Healthcare Conference

On September 1, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will participate in a fireside chat at the Wells Fargo 2022 Healthcare Conference on Thursday, September 8, 2022, at 2:35 p.m. ET in Boston (Press release, Nuvalent, SEP 1, 2022, View Source [SID1234618923]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

Ibex Reports Excellent Outcomes for AI-supported Diagnosis of Breast Cancer

On September 1, 2022 Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported outstanding outcomes for the Galen Breast solution in diagnosing multiple cancer types and further expansion of its AI portfolio for breast cancer diagnosis (Press release, Ibex Medical Analytics, SEP 1, 2022, View Source [SID1234618922]). The CE-Marked AI solution is generally available as Ibex partners with laboratories, hospitals and health systems across Europe to deploy Galen Breast into their routine workflow, supporting improved quality and efficiency in the diagnosis of breast biopsies.

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Breast cancer is the most common malignant disease in women worldwide, with over two million new cases each year. As such, accurate and timely diagnosis is key to guiding treatment decisions by oncologists and improving patient survival rates.

Over the last several years, rapid advances in personalized medicine have resulted in a growing complexity of cancer diagnosis. Coupled with the increase in overall cancer incidence and a global decline in the number of pathologists, these trends have led to growing workloads imposed on pathology departments. Clearly, there is a growing need for automated solutions and decision-support tools that help pathologists detect cancer to the utmost accuracy more rapidly.

Galen is Ibex’s integrated diagnostics platform supporting pathologists in the diagnosis of breast, prostate, and gastric biopsies. Galen is the most widely deployed AI technology in pathology, and laboratories, hospitals and health systems worldwide already use it as part of their everyday practice. The combination of a skilled pathologist together with the accuracy, speed and objectivity provided by Artificial Intelligence has the potential to improve the quality of diagnosis, user experience, operational efficiency, and ultimately patient outcomes.

Galen Breast demonstrated excellent outcomes in a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. The study evaluated the performance of pathologists who used Ibex AI for diagnosing breast biopsies and compared them to pathologists who used only a microscope across multiple types of breast cancer including invasive and in-situ carcinoma as well as rare subtypes, such as metaplastic, mucinous, and other types of breast cancer. The study results showed very high accuracy and utility of Galen Breast across multiple scanning and staining platforms, and established its potential for improving the quality of diagnosis, compared to using a microscope alone. The full study results will be presented by Judith Sandbank, MD, Director of the Pathology Institute at Maccabi Healthcare Services5 and one of the principal investigators in the study, at the European Congress of Pathology which takes place in Basel, Switzerland, between September 3-7 (Ibex presents at booth no. 1).

Previous studies on Galen Breast established its AI algorithm’s accuracy in detecting cancer, distinguishing between multiple subtypes such as ducal and lobular carcinomas, grading DCIS (ductal carcinoma in-situ) and identifying rare tumors. Moreover, the solution successfully detected clinically important cancer-related and non-cancer features, including tumor infiltrating lymphocytes, angiolymphatic invasion, microcalcifications and more1,2. Galen also enables automated pre-ordering of the breast immunohistochemistry (IHC) panel and other tests which may help shorten the turnaround time for diagnosis of cancer cases, maximizing efficiency gains for laboratories and enabling patients to start treatment earlier3. Ibex is also working to expand its technology to support improved prognosis of breast cancer, by providing automated quantification of HER2, Ki67, ER and PR receptors in immunohistochemistry stained slides as part of its product portfolio. These innovative AI algorithms are intended to assist pathologists in their diagnosis which may help further enhance diagnostic efficiency and enable more accurate and objective scoring of breast biomarkers, allowing for improved treatment decisions and patient care.

"We are impressed with the successful study outcomes and the performance of Galen Breast, that was evaluated in a diagnostic setting which is identical to how our pathologists review cases in their daily routine," said Anne Vincent-Salomon, MD, Director of Pathology at Institut Curie and one of the principal investigators in the study4. "Our team demonstrated that when pathologists use Ibex’s AI technology they achieve very high accuracy levels in diagnosing breast cancer over a broad range of subtypes, with higher quality than when using a microscope alone. With these results, and as more and more laboratories transition to digital pathology workflows, I look forward to seeing Artificial Intelligence broadly adopted in the field."

"AI is going to be a critical adjunct to diagnostic pathology going forward. Pathologists reviewing whole-slide images, in combination with an AI algorithm, will provide better diagnoses and better care than either a pathologist alone or AI alone," said Stuart Schnitt, MD, Chief of Breast Oncologic Pathology at the Dana-Farber/Brigham and Women’s Cancer Center and Professor of Pathology at Harvard Medical School4. "AI has already demonstrated its value in helping pathologists improve the quality of breast cancer diagnosis and reduce misdiagnosis, and I am impressed with the outcomes of this new study, demonstrating the robustness and utility of Ibex AI in a primary diagnosis setting. I look forward to seeing the impact this solution will have on the overall performance of pathology departments and patient outcomes, as it becomes widely adopted."

"We are excited to announce this milestone results and enable breast pathologists to further adopt AI into their routine diagnosis of breast biopsies, following excellent outcomes in a clinical study" said Chaim Linhart, PhD, Co-founder and CTO of Ibex at Ibex Medical Analytics. "We believe that AI has an essential role to play in pathology and cancer diagnosis, extending beyond cancer detection to ultimately support pathologists across most of the diagnostic pathway, as demonstrated by the scope of clinical features available with Galen Breast, as well as the expansion toward automated quantification and scoring of breast biomarkers".

Recursion to Participate in Upcoming Investor Conferences

On September 1, 2022 Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported its participation in the following investor conferences (Press release, Recursion Pharmaceuticals, SEP 1, 2022, View Source [SID1234618920]):

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Morgan Stanley Global Healthcare Conference — September 12 through September 14, 2022
Goldman Sachs Global Sustainability Forum — September 29, 2022

bioAffinity Technologies Announces Pricing of IPO

On September 1, 2022 bioAffinity Technologies, Inc., a cancer diagnostics company that develops noninvasive, early-stage diagnostics to detect cancer and diseases of the lung and is researching targeted therapies to treat cancer, reported that its initial public offering of 1,282,600 units of securities has been priced at $6.125 per unit (Press release, BioAffinity Technologies, SEP 1, 2022, View Source [SID1234618919]). Total gross proceeds from the offering is estimated to be $7,855,925 before deducting underwriting discounts and commissions and other estimated offering expenses.

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Each unit, which has no stand-alone rights and will not be certificated or issued as a stand-alone security, consists of one share of common stock, one tradeable warrant to purchase one share of common stock at an exercise price of $7.35 per share, and one non-tradeable warrant to purchase one share of common stock at an exercise price of $7.656 per share. Each warrant is immediately exercisable and will expire five years from the date of issuance. The shares of common stock and the tradable warrants may be transferred separately immediately upon issuance. In addition, bioAffinity has granted the underwriters a 45-day option to purchase up to 192,390 shares of common stock, and/or 192,390 tradeable warrants, and/or 192,390 non-tradeable warrants, or any combination of additional shares of common stock and warrants representing, in the aggregate, up to 15% of the number of the units sold in this offering to cover over-allotments in this offering.

The shares and the tradeable warrants will begin trading on September 1, 2022, on the Nasdaq Capital Market under the ticker symbols "BIAF" and "BIAFW," respectively. The Company intends to use the net proceeds for the commercialization of its diagnostic called CyPath Lung, a non-invasive test for the early detection of lung cancer that has completed a clinical trial showing 92% sensitivity and 87% specificity in detecting lung cancer in individuals at high risk who have lung nodules less than 2 centimeters. Proceeds also will be used for development of tests, additional clinical trials, regulatory filings, and for working capital and general corporate purposes.

WallachBeth Capital, LLC and Craft Capital Management, LLC are co-managers and co-book running managers for the offering.

bioAffinity’s registration statement relating to these securities was declared effective as of August 29, 2022, by the U.S. Securities and Exchange Commission. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, View Source and by contacting WallachBeth Capital, LLC, Attention: Capital Markets, 185 Hudson Street, Jersey City, NJ 07311, by telephone at 646-998-7608, or by email at [email protected]

This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.