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Medical Devices

Avanos Medical, Inc. Appoints Moji James as Senior Vice President & General Counsel

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ALPHARETTA, Ga., July 12, 2021 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS) today announced that Moji James has been appointed senior vice president & general counsel. In this role, James will oversee the Company’s legal, government relations and global security functions.

During her more than 25 years practicing law, James has supported the development and commercialization of innovative drugs, biologics and vaccines. She most recently served as executive vice president, chief legal and compliance officer of Tmunity Therapeutics, a biotherapeutics company, where she was responsible for legal affairs, compliance and risk management.

Prior to Tmunity, James served as senior vice president and general counsel of Iroko Pharmaceuticals, and she began her life sciences legal career at Wyeth Pharmaceuticals (now part of Pfizer). Before joining Wyeth, she was a litigator at major law firms including Shearman & Sterling in New York, focusing her practice on complex commercial and securities issues.

“Moji’s extensive global and diversified legal experience, along with her knowledge of the healthcare sector and exceptional track record of managing complex business and legal strategies, makes her uniquely qualified for this role,” stated Joe Woody, chief executive officer. “In addition to her role as general counsel, I am excited to have Moji’s broad business experience and capabilities add to our overall strategy and vision of getting patients back to the things that matter.”

James holds a Bachelor of Laws degree from Warwick University, England, a Master of Laws degree from London University, and is also a barrister at law.

About Avanos Medical, Inc.
Avanos Medical, Inc. (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients’ quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit Avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

SOURCE Avanos Medical, Inc.

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Source: https://www.biospace.com/article/releases/avanos-medical-inc-appoints-moji-james-as-senior-vice-president-and-amp-general-counsel/?s=93

Medical Devices

Sight Sciences Announces Multiple Presentations at the 2021 American Society of Cataract and Refractive Surgery Annual Meeting

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New safety and efficacy data from both retrospective and prospective studies of the OMNI Surgical System and a prospective study of the TearCare System to be presented

MENLO PARK, Calif., July 22, 2021 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), a growth-stage medical device company focused on addressing the underlying causes of the world’s most prevalent eye diseases, today announced that data from multiple retrospective and prospective clinical studies of the OMNI® Surgical System and TearCare® System will be presented at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The in-person conference will take place July 23-27 in Las Vegas.

A total of five papers have been accepted for presentation. Details of the presentations are as follows (all times are Pacific Daylight Time (PDT)):

Saturday, July 24

Session Title: “Efficacy of Ab Interno Canaloplasty Followed by Trabeculotomy in Pseudophakic Eyes with Open-Angle Glaucoma”
Session: Minimally Invasive Glaucoma Surgery (MIGS)
Presenter: Adam Bleeker, O.D.
Location: MBCR – Level 2, Surf CD
Time: 1:30 PM

Session Title: “Ab Interno Canaloplasty and Trabeculotomy in Pseudophakic Eyes with Mild-Moderate Open Angle Glaucoma: Prospective Multicenter Trial (ORION)”
Session: Minimally Invasive Glaucoma Surgery (MIGS)
Presenter: Mark J. Gallardo, M.D.
Location: MBCR – Level 2, Surf CD
Time: 2:00 PM

Session Title: “Novel Blink-Assisted Meibomian Gland Procedure for Safe and Effective Treatment of Dry Eye: A Prospective, Masked, Multicenter Trial (CHEETAH)”
Session: Ocular Surface
Presenter: David Wirta, M.D.
Location: MBCR – Level 2, Surf EF
Time: 2:11 PM

Session Title: “Effect of Canaloplasty and Trabeculotomy on Intraocular Pressure in Eyes with Open Angle Glaucoma Undergoing Phacoemulsification”
Session: Minimally Invasive Glaucoma Surgery (MIGS)
Presenter: Arkadiy Yadgarov, M.D.
Location: MBCR – Level 2, Surf CD
Time: 2:30 PM

Sunday, July 25

Session Title: “Canaloplasty Plus Trabeculotomy with Cataract Surgery for Mild-Moderate Open Angle Glaucoma: Prospective Clinical Trial Results (GEMINI)”
Session: Minimally Invasive Glaucoma Surgery (MIGS) II
Presenter: Mark F. Pyfer, M.D., F.A.C.S.
Location: MBCR – Level 2, Surf EF
Time: 10:10 AM

About Sight Sciences
Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world’s most prevalent eye diseases. The company currently markets two products, the OMNI® Surgical System and the TearCare® System. For more information, visit www.sightsciences.com.

OMNI® and TearCare® are registered trademarks of Sight Sciences.
© 2021 Sight Sciences. All rights reserved.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Sight Sciences’ current expectations and various assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, Sight Sciences may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including the factors discussed under the caption “Risk Factors” in its registration statements on Form S-1, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Sight Sciences may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Sight Sciences’ views as of any date subsequent to the date of this press release

Media contact:
Shay Smith
Health+Commerce
707.971.9779
[email protected]

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
[email protected]

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Source: https://www.biospace.com/article/releases/sight-sciences-announces-multiple-presentations-at-the-2021-american-society-of-cataract-and-refractive-surgery-annual-meeting/?s=93

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Medical Devices

BioSpace’s Business Report Highlights Sustained Growth and New Blood

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Industry_Business

The life sciences is always a frenetic sector when it comes to mergers & acquisitions, initial public offerings (IPOs) and Series A announcements (not to mention B and C rounds). But during the second quarter of 2021, these companies were especially busy bees – all positive signs that the industry is still booming coming out of the COVID-19 pandemic. 

With all of the activity, it would be impossible to go over every single transaction and announcement in detail, so here’s a glimpse at some of the real newsmakers. The rest can be found right here in BioSpace’s Industry Update: Vol. 2 Business Edition.

Mergers & Acquisitions

This space has been particularly busy the past two months. In June, AbbVie made good on its option to acquire strategic partner, Teneobio Inc. and its BCMA-targeting immunotherapeutic for relapsed or refractory multiple myeloma (R/R MM). AbbVie made the call following positive interim data from a phase I study of the compound, TNB-383B, which saw the drug achieve an objective response rate (ORR) of 79%, and a very good partial response rate of 63% at doses of at least 40 mgs.

Also in June, Bayer boosted its portfolio of targeted alpha radionuclide therapies for prostate cancer, with the purchase of Noria Therapeutics Inc. and its subsidiary, PSMA Therapeutics Inc. The acquisition of the companies and their investigational compound could help to make up for declining sales of metastatic castration-resistant prostate cancer, Xofigo. 

Germany-based MorphoSys AG strengthened its position in the hematology-oncology space with the pick-up of clinical-stage biopharma company, Constellation pharmaceuticals. In the deal, which has a total value of $1.7 billion, MorphoSys added two mid-to-late stage assets, BET inhibitor, pelabresib (CPI-0610) and CPI-0209, a second-generation EZH2 inhibitor. Both have wide-ranging potential for patients with hematological and solid tumors. 

SPAC Mania

It’s a SPAC parade again this year – and 2021 is still a long way from over. Ginkgo Bioworks led the way, going public through a massive deal with Soaring Eagle Acquisition Corp. that saw “the organism company” valued at $15 billion. Ginko uses genetic engineering to produce bacteria that has potential in a wide range of areas, including food and agriculture, antibiotics, vaccines, and therapeutics.

Less than a year after its official debut, Boston-based Valo Health hit the Nasdaq in June through a SPAC merger with Khosla Ventures Acquisition Co. Valo, which was founded by Flagship Pioneering, claimed a valuation of approximately $2.8 billion. The company’s Opal Computational Platform is designed to speed up the rate of drug discovery for cancer, neurodegenerative and cardiovascular diseases.

Popular genetic testing company, 23andMe also decided to skip the traditional route, entering into a deal with Sir Richard Branson’s VG Acquisition Corp. 23andMe began trading on the Nasdaq on June 17th, valued at $3.6 billion and trading under the ticker symbol “ME”. The company’s stock rose 21% on the first day of trading.

New Beginnings (Series A Launches)

An impressive cadre of investors demonstrated their faith in ArriVent Biopharma, which launched in June with a whopping $150 million in Series A financing. The financing was led by Hillhouse Capital Group, and saw the Pennsylvania-based ArriVent receiving $90 million upfront to advance its potential best-in-class epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), furmonertinib. The lung cancer treatment, licensed from Allist Pharmaceuticals, was approved in March by China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Mnemo Therapeutics now holds the record for France’s largest-ever Series A, raking in $90 million USD (€75 million) in a round led by Casdin Capital and Sofinnova Partners. The Paris-based biotech will use the funds to advance its proprietary EnfiniT platform which identifies a new class of antigens with greater tumor specificity. The broad group of technologies comprising the platform is collectively aimed at significantly improving persistence, sensitivity and T-cell memory.

It didn’t take long for Roger Perlmutter to emerge from stealth mode. After leaving his post as president of Merck Research Laboratories at the end of 2020, Perlmutter is back as the CEO of drug discovery startup Eikon Therapeutics, Inc., which officially debuted in May with $148 million in Series A financing. Eikon is using its super-resolution microscopy platform to track and measure the movement of individual proteins in living cells in order to gain a better understanding of disease biology. Perlmutter will be tasked with translating this novel technology into feasible therapeutics. 

Taking the Helm

Speaking of leadership – and Merck – Timothy (Tim) Noyes, the new CEO of Aerovate Therapeutics, began his career at the German multinational. He will now lead the charge to develop lead compound, AV-101, an investigational anti-proliferative therapy for pulmonary arterial hypertension (PAH).

 Bio North Texas Foundation (BioNTX), which represents the bioscience industry in 26 counties including Dallas and Fort Worth, has a new chief executive. Kathleen M. Otto, who brings experience from the north in New York and New Jersey, began her tenure on the first of June.

Peter Arduini has parted ways with Integra LifeSciences to become the new CEO of GE Healthcare. William L. Greene, M.D. will tackle age-related diseases as the new CEO at Fountain Therapeutics, and biopharma veteran, Yizhe Wang, Ph.D., is the new leader at rapidly rising licensing-based biotech, LianBio.

Job Creation Superstars

With all of this action, it might go without saying that this has been a promising quarter for job creation in the Life Sciences. With the 2019 and 2020 additions of cell and gene therapy companies, BlueRock Therapeutics and AskBio, Bayer is in growth mode. With the company’s ardent commitment to cornering this space and planned expansion at its Berkeley facility, Bayer expects to add 1000 new jobs. Meanwhile, the Bio Capital region continues to explode, with Australian diagnostic company, Ellume, establishing its first U.S.-based manufacturing site in Frederick County, Maryland. The new operation is expected to bring more than 1,500 new jobs to the state by the end of 2022.

For more in-depth insight on all of the action, click here to download a free copy of BioSpace’s Industry Update: Vol. 2 Business Edition

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Source: https://www.biospace.com/article/biospace-s-business-report-highlights-sustained-growth-and-new-blood/?s=93

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Design Week 2021

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Design Week 2021, starting August 10, is an online event featuring six days of live and on-demand content presented by industry thought leaders – presenting on megatrends and topics such as AI and machine learning, e-Mobility and Advanced Driver-Assistance Systems (ADAS), ease of use, IoT, medical and network infrastructures. Our speakers are subject matter experts that will share how to take your designs to the next level by applying these applications to your designs. 

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Source: https://www.iotforall.com/events/design-week-2021

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Medical Devices

LumiThera Announces Valeda Treatments Improve Vision and Retinal Function in Top Line Data from the ELECTROLIGHT Pilot Study in Dry AMD patients

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SEATTLE, July 21, 2021 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company offering a photobiomodulation (PBM) treatment for ocular damage and disease, today announced the final topline data from the ELECTROLIGHT pilot study in intermediate dry AMD patients.

A total of 23 eyes from 15 subjects with Dry AMD were enrolled into the prospective clinical study and treated with PBM using the Valeda® Light Delivery System (3 times per week for 3 weeks). Eight Caucasian males and seven females were enrolled with a mean age of 75.1 years (65-93 years). The mean time since AMD diagnosis was 5.0 years (0-14 years). Subjects were tested for safety and functional vision improvements using the Diopsys electroretinogram (ERG) device. ERG is a diagnostic test that measures the electrical activity of the retina of the eye in response to a light stimulus. All subjects were tested at weekly intervals for ERG function prior to the start of the next week of PBM treatments. The study followed the patients out to 6 months. The study was conducted by Dan Montzka, M.D. and Larry Perich, D.O. at the Perich Eye Center (New Port Richey, Florida).

Multi-luminance Electroretinogram (ERG) Magnitude AUC improved by 14.4% from baseline after completion of the Month 1 treatment and showed a 9% improvement at 6 months in the ITT population. A positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was seen (p < 0.05) following initial PBM treatment. Positive correlations between multi-luminance ERG and fixed luminance (R = 0.870) and chromatic ERG outcomes (R = 0.676) were also reported in the Month 1 interim analysis.

Subjects showed approximately 12.8 ± 0.98 letter improvement in BCVA at Month 6 compared to BL scores. Mars Contrast Sensitivity (CS) also showed improvement from BL to Month 6 at 40 cm (0.202 log + 0.02), 80 cm (0.197 log + 0.02) and 120 cm (0.28 log + 0.03).

“Valeda provided statistically significant and sustained improvements in BCVA, CS and multi-luminance ERG function from baseline out to Month 6 time point following 9 PBM treatments,” stated Dan Montzka, M.D. “Diopsys multi-luminance ERG is an early, sensitive and quantitative measure of visual dysfunction in dry AMD patients.”

“The study further confirms previous LIGHTSITE I and II studies that the Valeda Light Delivery System improves visual function,” stated Larry Perich, D.O. “The subjects were very pleased with the results of their treatments and no safety issues were seen.”

Diopsys ERG testing is a powerful and quantitative diagnostic that can be coupled with LumiThera’s PBM treatments to characterize early patient benefits on visual function,” indicated Joe Fontanetta, CEO, Diopsys. “These results of this work will allow physicians to diagnose, treat and monitor patients and provides physicians a solution for a disease with limited treatment options.”

“We are strong supporters of treating degenerative disease early to slow the progression of vision-threatening disease.” stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. “The key in chronic ocular disease is early diagnosis, treatment and monitoring and we hope studies such as this pilot pave the way to a more preventative approach. The patients in the ELECTROLIGHT study are similar in demographics as the LIGHTSITE III US study in terms of time from dry AMD diagnosis, AREDs use and age. Previously, we reported the US LIGHTSITE III dry AMD trial fully enrolled 100 subjects in 1Q of 2021 and is continuing to move forward with the 13-month efficacy timepoint for all patients in 1Q of 2022.”

About AMD

AMD is a leading cause of vision loss for people age 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

About Diopsys

Diopsys, Inc. is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. The company provides both Visual Evoked Potential (VEP) and Electroretinography (ERG) vision testing technology. It is this technology that powers Diopsys, Inc.’s medical devices – the Diopsys® NOVA, Diopsys® ARGOS, and Diopsys® RETINA PLUS ERG and VEP Vision Testing System product series and the Enfant® Pediatric VEP Vision Testing System.

About LumiThera Inc.

LumiThera is a commercial-stage medical device company focused on treating people affected by ocular damage and disease including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of visual disorders. The company is commercializing the office based Valeda Light Delivery System to be used by eye care specialists as medical treatments.

The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.

Visit the Company’s website at www.lumithera.com.

2021 LumiThera, Inc., All rights reserved.

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Source: https://www.biospace.com/article/releases/lumithera-announces-valeda-treatments-improve-vision-and-retinal-function-in-top-line-data-from-the-electrolight-pilot-study-in-dry-amd-patients/?s=93

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