On September 14, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company’s Focal One and ExactVu technologies were featured in several poster presentations at the American Urological Association (AUA) 2021 Annual Meeting, which was held virtually from September 10-13 (Press release, EDAP TMS, SEP 14, 2021, View Source [SID1234587704]). EDAP was a Gold sponsor of the event.

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Details of two noteworthy presentations are as follows:

Title: Focal Ablation Versus Radical Prostatectomy for Intermediate-Risk Prostate Cancer: Interim Analysis of a Randomized Controlled Trial

Lead author: Eduard Baco, MD, Oslo University Hospital, Norway

Summary: This is the first randomized controlled clinical trial comparing focal therapy with robotic surgery. The data suggest that at one-year post treatment, Focal One achieved good oncological efficacy while preserving erectile function and urinary continence better than radical prostatectomy.

Title: High-Intensity Focused Ultrasound (HIFU) vs Radical Prostatectomy (RP) in the Curative Treatment of ISUP 1-2 Localized Prostate Cancer: Oncological Intermediate Results of the HIFI Study

Lead author: Pascal Rischmann, MD, Toulouse University Hospital, France

Summary: In this prospective comparative study sponsored by the French Association of Urology and financed by the French Ministry of Health, 3364 patients (HIFU: 1988, radical prostatectomy: 1376) were prospectively included across 42 French treatment centers. The intermediate results presented show a salvage-treatment-free survival rate significantly higher in the HIFU arm (97.5%) compared to the radical prostatectomy arm (90.3%).

"The data from these studies presented at this year’s AUA Annual Meeting once again strongly support high intensity focused ultrasound as an alternative to far more invasive radical prostatectomy," stated Marc Oczachowski, Chairman & Chief Executive Officer of EDAP. "In terms of both efficacy and long-term survival, Focal One offers patients a superior treatment option without the debilitating side effects associated with surgery. Data such as these, together with the growing roster of healthcare institutions in the US and elsewhere who champion our technology and the progress we are making securing reimbursement, are key to our long-term growth and we are pleased to add to the expanding body of evidence at this prestigious urology conference showing the many benefits of HIFU."

On September 14, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, is scheduled to present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit being held virtually from September 20th to 23rd (Press release, Beyond Air, SEP 14, 2021, View Source [SID1234587703]).

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Presentation Details:

Date and Time: Wednesday, September 22, 2021 at 9:05 AM – 9:45 AM ET
Webcast: View Source
Participation: Management will participate in additional 1-on-1 meetings virtually
Please contact your representative at Oppenheimer to schedule a virtual one-on-one meeting with Beyond Air during the conference.

On September 14, 2021 Nordic Nanovector ASA (OSE: NANOV) reported the appointment of Erik Skullerud as Chief Executive Officer (CEO) (Press release, Nordic Nanovector, SEP 14, 2021, View Source [SID1234587700]). He will take up the position on 20 September 2021 and will be based in the company’s office in Zug, Switzerland, splitting his time between Zug and Nordic Nanovector’s head office in Oslo.

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Mr Skullerud joins the Company from Element Consulting GmbH, a globally focused boutique advisory and consultancy specializing in the life science industry where he was co-founder and managing partner.

Prior to establishing Element Consulting, Mr Skullerud spent 25 years in the biopharma industry with increasing responsibility in global sales and marketing management roles. This included more than 15 years at Amgen, where his most recent role was as Marketing Director Europe Oncology/ Hematology. Prior to that, he worked for Bayer Pharma for seven years, most recently as Product Group Manager for Cardiovascular/ Diabetes Scandinavia.

Mr Skullerud has launched numerous highly innovative products in therapeutic areas such as oncology, haematology, cardiology, and nephrology and he has significant business management exposure to EU, Asian and US markets. As a consultant he has worked with some of the world’s top pharma and biotech companies as well as small, highly specialised start-ups on projects ranging from corporate strategy, through early to mid-stage launch and commercialization to late-stage life cycle projects.

Mr Skullerud is a Norwegian national and a Swiss resident. He has a BSc, Marketing, Finance and Management from Gothenburg Business School, University of Gothenburg and has been a Guest Lecturer, INSEAD MBA Program, Paris, France.

Jan H. Egberts, Chairman of Nordic Nanovector’s Board of Directors, said: "I am very pleased that Erik has agreed to join Nordic Nanovector. His commercial leadership experience combined with his knowledge of the oncology/haematology space will be vital as we evolve into a larger and more valuable business based on maximising the commercial potential of Betalutin. I would like to thank Malene Brondberg for stepping up to the role of Interim CEO over the last few months, a period when the company has made good progress in delivering on its key objectives. Malene will continue in her role as CFO."

Mr Skullerud added: "I am very much looking forward to this new role at Nordic Nanovector. I believe my experience from around the world in strategy, commercialisation, and sales and marketing can help the company achieve the next important stage of its development as we work to bring Betalutin to patients for the first time, a key step in realising the wider value of the business."

When joining Nordic Nanovector, Mr Skullerud will be granted 350,000 PSUs (performance share units).

For further information about the PSUs and the related warrants, see page 28 in the company’s annual report for 2020.

On September 14, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development reported their participation at the Bio-IT World Conference & Expo occurring virtually and in Boston, MA September 20-22, 2021 (Press release, Applied BioMath, SEP 14, 2021, View Source;expo-301376645.html [SID1234587699]).

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John Burke, PhD, Co-founder, President and CEO of Applied BioMath will present "Applied BioMath Assess – An Early Feasibility Assessment Tool for Biotherapeutics" within the Software Applications and Services track on Tuesday, September 21st at 10:30 a.m. ET. In this presentation, Dr. Burke will demonstrate Applied BioMath Assess*, an interactive, web-based application that helps assess the difficulties and risks in developing a therapeutic very early-on. Dr. Burke will explain how Applied BioMath Assess can help project teams answer questions such as:

How does affinity impact target inhibition? Will it impact TMDD if membrane bound?
How does dosing interval impact success criteria?
How does target expression, especially in the site of action, impact design criteria?
How to think about therapeutic index prior to Lead Generation?
"Applied BioMath Assess provides rational go/no-go guidance while also helping project teams manage their resources efficiently," said Dr. Burke. "Our software has an exciting roadmap and will continue to evolve as we add new drug modality models and tools to best inform therapeutic R&D."

Additionally, Sharvari Gujja, Senior Principal Scientist, Bioinformatics at Applied BioMath will present a poster titled, "Leveraging ML/AI Tools for Robust Identification of Potential Biomarkers in Drug Response." The poster provides an overview of Applied BioMath’s open source, easy-to-use and flexible command line interface (CLI) to access the state-of-the-art Machine Learning and Deep Learning frameworks to build predictive models for assessing cancer drug response using gene expression data from The Cancer Genome Atlas Program (TCGA) and Genomics of Drug Sensitivity in Cancer (GDSC).

On September 14, 2021 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported the pricing of its upsized initial public offering of 10,800,000 shares of common stock at an initial public offering price of $16.00 per share (Press release, Tyra Biosciences, SEP 14, 2021, View Source [SID1234587698]). All of the shares are being offered by Tyra. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Tyra, are expected to be $172.8 million. The shares are expected to begin trading on the Nasdaq Global Select Market on September 15, 2021 under the ticker symbol "TYRA." The offering is expected to close on September 17, 2021, subject to the satisfaction of customary closing conditions. In addition, Tyra has granted the underwriters a 30-day option to purchase up to an additional 1,620,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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BofA Securities, Jefferies and Cowen are acting as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on September 14, 2021. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by telephone at 877-821-7388; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

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