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Eargo Appoints Katie Bayne to Board of Directors

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28-year Coca-Cola Executive and Global Brand Builder Joins Effective June 9, 2021

SAN JOSE, Calif., June 10, 2021 (GLOBE NEWSWIRE) — Eargo, Inc. (Nasdaq: EAR), a medical device company on a mission to improve the quality of life of people with hearing loss, today announced the appointment of Katie Bayne to its Board of Directors, effective June 9, 2021. Ms. Bayne will serve as a member of the Nominating and Corporate Governance Committee. The appointment of Ms. Bayne fills the seat vacated by Juliet Tammenoms Bakker, following her resignation from the Board on June 9, 2021.

Christian Gormsen, President and CEO, said, “We are incredibly fortunate to welcome Katie to the Eargo team. She is exceptionally qualified and brings decades of experience building one of the most recognizable brands in the world, Coca-Cola. We believe she will make significant contributions in continuing to build Eargo’s national and eventually global brand.”

Josh Makower, MD, Chairman of the Board added, “Katie is a phenomenal addition to our Board. We believe she will help us accelerate executing one of our most important long term strategic initiatives: building the Eargo brand. We are fortunate to acquire this level of talent, and I am confident she will add tremendous value to our team. We would also like to thank Juliet for her contributions to the Board.”

Ms. Bayne brings more than 30 years of consumer marketing and operations experience to her new position on the Board of Directors, including over two decades at The Coca-Cola Company, where she served as President of North America Brands and Chief Marketing Officer for North America. The Founder and President of strategic consulting and advisory firm Bayne Advisors, Ms. Bayne also serves as a Senior Advisor at Guggenheim Securities, LLC. She has also served as an independent director at Acreage Holdings since January 2021, where she serves on the Audit Committee and at Jessica Alba’s purpose-driven lifestyle brand, The Honest Company since November 2018, where she serves as Chair of the Compensation Committee and a member of the Audit Committee. She brings over a decade of public Board experience in varied industries, including retail.

Ms. Bayne commented, “I have been extremely impressed with the way that Eargo has quickly established itself as a highly differentiated, disruptive player in the hearing health space. I look forward to working with the team to leverage the company’s solid foundation and recent growth as a launchpad for accelerating brand awareness and product adoption. The success of these initiatives will help us address the significant stigma and social isolation associated with hearing loss.”

About Eargo
Eargo is a medical device company dedicated to improving the quality of life of people with hearing loss. Our innovative product and go-to-market approach address the major challenges of traditional hearing aid adoption, including social stigma, accessibility and cost. We believe our Eargo hearing aids are the first and only virtually invisible, rechargeable, completely-in-canal, FDA regulated, exempt Class I or Class II devices for the treatment of hearing loss. Our differentiated, consumer-first solution empowers consumers to take control of their hearing. Consumers can purchase online or over the phone and get personalized and convenient consultation and support from licensed hearing professionals via phone, text, email or video chat. The Eargo solution is offered to consumers at approximately half the cost of competing hearing aids purchased through traditional channels in the United States.

The company’s 4th generation product, the Eargo Neo HiFi, was launched in January 2020 and features improved capabilities across audio fidelity and bandwidth. The Eargo Neo HiFi is available for purchase here.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding Ms. Bayne’s contributions to our Board, our strategic initiatives and accelerating brand awareness and product adoption. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks, uncertainties and assumptions related to: our expectations concerning additional orders by existing customers; our expectations regarding the potential market size and size of the potential consumer populations for our products and any future products, including our ability to maintain or increase insurance coverage of Eargo hearing aids; our ability to release new hearing aids and the anticipated features of any such hearing aids; developments and projections relating to our competitors and our industry, including competing products; our ability to maintain our competitive technological advantages against new entrants in our industry; the pricing of our hearing aids; our expectations regarding the ability to make certain claims related to the performance of our hearing aids relative to competitive products; our expectations with regard to changes in the regulatory landscape for hearing aid devices, including the implementation of the pending over-the-counter hearing aid pathway regulatory framework; and our estimates regarding the COVID-19 pandemic, including but not limited to, its duration and its impact on our business and results of operations. These and other risks are described in greater detail under the section titled “Risk Factors” contained in Eargo’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, are based on current expectations, forecasts and assumptions, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Related Links
http://eargo.com

Investor Contact
Nick Laudico
Vice President of Investor Relations
[email protected]

Media Contact
Brad Sheets
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4c85e176-1d4c-4b25-bef4-cf0b575c3175

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Source: https://www.biospace.com/article/releases/eargo-appoints-katie-bayne-to-board-of-directors/?s=93

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FDA Grants Humanitarian Use Device Designation to Bionaut Labs for Treatment of Dandy Walker Syndrome

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LOS ANGELES, Sept. 23, 2021 /PRNewswire/ — Bionaut Labs, a company focused on revolutionizing the treatment of central nervous system (CNS) disorders with its Bionaut™ precision medicine treatment modality, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company humanitarian use device (HUD) designation for BNL-201 for the local treatment of Dandy Walker Syndrome, a rare pediatric neurological disorder.

Dandy Walker Syndrome is a congenital brain malformation usually diagnosed in childhood. It varies in severity and may cause a wide range of symptoms, including intellectual disabilities, delayed motor development, muscle stiffness and partial paralysis, seizures, hearing loss, and vision problems. The only treatment options available today involve invasive intracranial surgical procedures and are prone to infections and complications, and many patients with Dandy Walker Syndrome suffer from shorter life spans with poor quality of life. BNL-201 offers a minimally invasive local microsurgery procedure to fenestrate the cyst that causes this condition and eliminate surgical trauma, to restore patient brain function and development.

“The granting of humanitarian use device designation by the FDA for BNL-101 is an important regulatory milestone for Bionaut Labs and represents a novel treatment modality for Dandy Walker patients and their families,” said Michael Shpigelmacher, co-founder and CEO, Bionaut Labs. “This designation is a critical step in getting BNL-201 into the clinic and, ultimately, to those who suffer from this debilitating disease. We look forward to working with the FDA as we pursue our mission of giving new treatment options to patients suffering from this and many other devastating CNS disorders.”

A HUD designation is intended to benefit patients in the treatment or diagnosis of a condition that affects less than 8,000 people in the United States per year. The FDA’s HUD program is an alternative pathway for getting market approval for medical devices that may help people with rare diseases or conditions like Dandy Walker Syndrome, which affects only one out of every 25,000 to 30,000 people. In June 2021, the Company received orphan drug designation for BNL-101, an investigational treatment modality comprised of the chemotherapy doxorubicin in combination with BNL-201 for the localized treatment of all malignant gliomas.

Aya Jakobovits, Ph.D., appointed to advisory board

Bionaut Labs also announced that Aya Jakobovits, Ph.D., former CEO of Kite Pharma, has joined its advisory board and will serve as the Company’s senior corporate advisor. Dr. Jakobovits has a 25-year track record of starting and growing biotech companies that have developed and progressed therapies. 

“Dr. Jakobovits is one of the industry’s most respected leaders in targeted therapeutics, and she comes to Bionaut Labs with a decades-long career of developing companies that generate novel technologies and therapeutic products,” said Mr. Shpigelmacher. “Her scientific and business-development expertise will be invaluable as we continue to explore the therapeutic potential of Bionauts in treating diseases that lack conventional and successful therapies.”

Dr. Jakobovits was president and CEO of Adicet Bio until March 2018. From 2010 to 2013, she was president and founding CEO of Kite Pharma, acquired in 2017 by Gilead for $11.9 billion. She has also served in executive roles at Agensys (acquired by Astellas in 2007 for $537 million) and Abgenix (acquired by Amgen for $2.2 billion).

Dr. Jakobovits serves on the Board of Directors of Dorian Therapeutics, Adicet Bio, Dyve Biosciences, UCLA Technology Development Corporation and Yeda Research and Development. She received her bachelor’s degree from Hebrew University of Jerusalem and her master’s in chemistry and Ph.D. in life sciences from the Weizmann Institute of Sciences in Israel. Dr. Jakobovits was a postdoctoral fellow at the University of California San Francisco and Genentech, has authored more than 50 scientific publications, and is the inventor of more than 120 issued patents.

About Bionaut™ Treatment

A Bionaut is a novel treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, small molecule, gene or cellular therapies locally to targeted CNS disease areas. Through precise targeting, Bionaut™ therapeutics could offer better efficacy and safety that cannot be achieved by other traditional treatment or delivery modalities.

Bionauts can be constructed in different designs with custom geometries and surface characteristics. Smaller than a millimeter, they contain moving parts controlled remotely by a magnetic controller, allowing them to safely reach the target and release a therapeutic payload from the cargo compartment. Engineering flexibility provides a broad foundation for designing Bionaut therapies for nearly any disease of interest.

Bionaut Labs has demonstrated safe and controlled navigation of its therapeutic Bionaut to and from the treatment locus in the brain, in a large animal in vivo model. Furthermore, the Company has successfully treated human glioma tumors established in mice, utilizing guided delivery of therapeutic cargos directly into these tumors to eliminate systemic toxicity. These results pave the way to the clinical trials of the Bionaut platform.

About Bionaut Labs

Bionaut Labs is focused on revolutionizing the treatment of central nervous system disorders with its Bionaut precision medicine treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, or small molecule therapies locally to targeted disease areas. With the Bionaut medical modality, Bionaut Labs can transform the way the biopharmaceutical industry develops treatments, allowing the Company to engineer the therapeutic index for better efficacy and safety. Led by a world-class team of medical, engineering, and drug development experts, Bionaut Labs’ headquarters is in Los Angeles, California, with additional R&D sites in Israel and at the Max Planck Institute in Germany. For more information, please visit www.bionautlabs.com.

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Orthofix Announces Appointment of Wayne Burris to Board of Directors

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LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced that Wayne C. Burris has been named to the Company’s Board of Directors and appointed to the Audit and Finance Committee.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923005067/en/

Wayne Burris joins Orthofix Board of Directors (Photo: Business Wire)

Wayne Burris joins Orthofix Board of Directors (Photo: Business Wire)

Mr. Burris served as the Senior Vice President and Chief Financial Officer (CFO) at Roche Diagnostics Corporation from 1996 through his retirement in July 2019. He was a member of the Global Roche Diagnostics Finance Executive Committee where he was recognized as one of their top senior leaders.

“We are very pleased that Wayne is joining the Orthofix Board of Directors,” said Catherine Burzik, Chair of the Board. “His strong background in U.S. and international accounting and finance, coupled with his more than 35 years of experience at Roche in various diagnostics, pharma, and orthopedic businesses, makes him well suited to serve on the Orthofix Board as we continue to grow and accelerate our business.”

During his time as Senior Vice President and CFO at Roche, Mr. Burris held various roles of increasing responsibility, including as the head of global finance for the diabetes care business where he provided financial oversight for all aspects of the business including sales and marketing, research and development, operations, regulatory and quality. In these roles, he provided strategic and business development guidance broadly across the Roche organization. Before joining Roche Diagnostics, Mr. Burris was a senior manager for Price Waterhouse LLP.

Mr. Burris is a Certified Public Accountant and has a Bachelor of Science in Accounting and Finance from Butler University. He has been instrumental in expanding and cultivating the State of Indiana Lifesciences environment while serving within numerous community organizations, including being a founding board member of the Indiana Biosciences Research Institute and on the Board of Directors and Executive Committee for BioCrossroads.

About Orthofix

Orthofix Medical Inc. is a global medical device with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic products are distributed in more than 60 countries via the Company’s sales representatives and distributors. For more information, please visit www.Orthofix.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “2020 Form 10-K”). As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements.

We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

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Source: https://www.biospace.com/article/releases/orthofix-announces-appointment-of-wayne-burris-to-board-of-directors/?s=93

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Pixium Vision announces implantation of first patient in Germany in Prima System European pivotal trial PRIMAvera

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Pixium Vision announcesimplantation of first patient in Germany inPrima System
European pivotal trial PRIMAvera

  • Successful first implantation of a patient in the PRIMAvera study in Germany
  • PRIMAvera clinical sites opening in five locations in Germany
  • Additional clinical sites to open in additional European countries

Paris, France, September 23, 2021 – 07.00 CET– Pixium Vision SA (Euronext Growth Paris – FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the successful first implantation of a patient in Germany in the PRIMAvera pivotal trial.

This follows approval of the PRIMAvera study by Germany’s Federal Institute for Drugs and Medical Devices, which aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe. PRIMAvera clinical sites have now opened in Bonn, Sulzbach, Hamburg, Munich and Ludwigshafen with one more in Tuebingen to follow. The PRIMAvera study was initiated in Q4 2020 and the first patient was implanted in March 2021.

We are pleased to initiatethe patient treatmentin Germany as part of the PRIMAvera pivotal trial, which is continuing to make good progress,said Prof. Frank Holz, the lead investigator for Germany and scientific coordinator of the study.The bionic vision Prima System has demonstratedimproved vison function and could potentially make a significant impacttopatients’ quality of life. We are looking forward to studying the Prima System further in the PRIMAvera trial and bringing it to more patients in need.”

I have followed the development of the PRIMASystem for some time and am very proud to implant the first PRIMA device in Germany. I consider the Prima System to bring true innovation to patients and me and my team are keen to see the results of this pivotal trial” said Prof. Peter Szurman, Chief Physician at the Augenklinik in Sulzbach, Germany.

The PRIMAvera study design is based on the positive data generated in a French feasibility study, showing the ability of patients with dry AMD to improve in visual acuity with the Prima System.

A total of 38 patients will be enrolled in PRIMAvera, an open label, baseline-controlled, nonrandomized, multi-center, prospective, single-arm confirmatory trial. The primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 month and the primary safety endpoint is the number and severity of device and procedure related serious adverse events at 12 months follow-up. The study will include three years of follow-up, with assessment of the primary endpoints at 12 months after implantation.

About Pixium Vision

Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as: Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.

For more information: http://www.pixium-vision.com/fr

Follow us on @PixiumVision; www.facebook.com/pixiumvision

www.linkedin.com/company/pixium-vision

Contacts

Pixium Vision
Offer Nonhoff
Chief Financial Officer
[email protected]
+33 1 76 21 47 68
Media Relations

LifeSci Advisors
Sophie Baumont
[email protected]
+33 6 27 74 74 49

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
[email protected]
+41 76 735 01 31


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Source: https://www.biospace.com/article/releases/pixium-vision-announces-implantation-of-first-patient-in-germany-in-prima-system-european-pivotal-trial-primavera/?s=93

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