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Hinge Health issues 2023 State of Musculoskeletal Care Report

Third annual report spotlights pressing trends of MSK care in America

 

SAN FRANCISCO — (BUSINESS WIRE) — Hinge Health, the leading digital clinic for joint and muscle care, on Friday, released its 2023 State of Musculoskeletal Care Report, an annual report to raise awareness on the issue of chronic pain and spotlight emerging trends impacting musculoskeletal (MSK) care in America.

 

The data from the report emphasizes the gaps between the need for physical therapy (PT) and the care, or lack of care, that most Americans are receiving today. The report shows that employers are increasingly the ones to fill these care gaps for their employees.


MSK conditions include more than 150 ailments and are characterized by impairments in the muscles, bones, joints, and connective tissues leading to temporary or long-term limitations in function.

 

Examples include back and neck pain, arthritis, osteoporosis, fibromyalgia, and carpal tunnel syndrome. This pain can have debilitating effects on people’s quality of life, comorbidities, mental well-being, and ability to work.

 

Among the findings in this year’s report:

The scope of MSK pain is too big to ignore. A staggering half of U.S. adults are experiencing MSK-related pain and the economy is suffering the weight of nearly $1 trillion in MSK treatment and lost wage costs.

 

There is a disconnect between the MSK care that is needed and the care that is often received today. Nearly half of people in pain say that they need professional treatment, but only 10% are getting in-person PT. While 70% of people in pain indicate that they understand the health benefits available to them, 64% say that they are not getting the help they need. The disparities are further emphasized when taking demographic differences into account:

  • 13% of lower income people in pain use in-person PT compared to 29% of higher income people in pain
  • 12% of women in pain use in-person PT compared to 26% of men in pain
  • 7% of boomers in pain use in-person PT compared to 29% of millennials in pain
  • 11% of rural residents in pain use in-person PT compared to 25% of urban residents in pain

 

Employers are stepping in to support the needs for MSK care. 92% of employers who don’t already have a digital MSK solution are taking action and likely to adopt one within the year. And, for women’s health in particular, 85% of large employers are looking to implement at least one new program to address inequities in women’s health.

 

“Many people suffering from chronic pain want help, but are struggling to find it and end up receiving ineffective, unnecessary, and costly interventions that leave them in continued pain,” said Dr. Jeff Krauss, chief medical officer, Hinge Health. “The findings in this report are an eye-opening reality of the challenges that those in pain face in getting the care they need, which is why it’s critical to continue educating and providing solutions that are truly accessible.”

 

The third edition of the State of MSK Care Report draws on primary data from Hinge Health surveys of 82 employers and 1,500 Americans in pain, as well as analysis of outside data sources.

 

To download the full findings of the 2023 State of MSK Care Report, visit: https://go.hingehealth.com/state-of-msk-care-2023

 

About Hinge Health

Hinge Health is creating a new health care system, built around you. Accessible to 25 million members across 1,250 customers, Hinge Health is the #1 digital clinic for joint and muscle pain, delivering superior member outcomes and proven claims reductions. We pair the industry’s most advanced motion technology and wearable pain relief with a complete clinical care team of physical therapists, physicians, and board-certified health coaches to help people move beyond pain and reduce surgeries and opioid use. Hinge Health’s HingeConnect integrates with 1 million+ in-person providers to enable earlier interventions for avoidable MSK surgeries. Four in five health plans and employers with a digital MSK solution trust Hinge Health, including Land O’Lakes, L.L. Bean, Salesforce, Self-Insured Schools of California, Southern Company, State of New Jersey, US Foods, and Verizon. Learn more at http://www.hingehealth.com.

Contacts

Erica Osian

media@hingehealth.com

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Business Healthcare Lifestyle News Now! Regulations & Security Science

Inflation led to insurance coverage gaps and disaster resilience problems for many companies: New report

WOODBRIDGE, N.J. — (BUSINESS WIRE) — A new report from Global Risk Consultants Corp., a TÜV SÜD company, reveals that many companies are at risk of insurance coverage gaps due to inflation. Losses from wildfires, hurricanes, or accidents are resulting in insurance claims that don’t cover rebuilding or replacement costs.

The free market trends report, How Inflation Led to Property Insurance Coverage Gaps, explains that many companies inadvertently underreport valuations of properties and equipment to insurance carriers. Mismatches between reported values and actual values mean companies are left with coverage gaps and won’t collect enough to restart the flow of business after a claim. Construction costs are a major culprit. Everything costs more from paint (+26%) to wallboard (+18%) to roofing contractors (+21%).

 

“Companies must defend their values because underwriters are now requiring more data on how they determined asset valuations. A lot of companies are not prepared for that, meaning claims won’t pay for rebuilding or replacement costs,” said David Rix, Global Sales Manager at Global Risk Consultants.

 

The report also includes:

  • Year-over-year inflation data on construction and labor costs
  • Why rising construction prices lead to inaccurate insurance claims and coverage gaps
  • Common mistakes like relying on market value or valuations over 3 years old
  • Frequently asked questions about insurance asset valuations
  • Best practices for establishing credible insurable values and SOVs in an inflationary economy

Peter Linn, Vice President of Risk Engineering Services at Global Risk Consultants, said: “Property valuation is a key foundation of property underwriting and impacts several aspects of the insurance risk transfer process. This includes projected claims values, replacement costs, adequacy of coverage, and inflation considerations impacting future physical asset and BI values. Properties values that were appraised years ago may no longer be valid which can leave companies under- or over-insured, both having cost and claim recovery ramifications.”

 

To establish property and equipment valuations that are credible for underwriting, risk managers should partner with a seasoned valuation specialist.

 

Justin Chen, Global Manager for Property Valuation Services at Global Risk Consultants said:

“If it’s been three years or more since you’ve assessed valuations, it’s time to get going. Start early. For companies with large real estate portfolios, updating the SOV can be a multi-year process.”

 

About Global Risk Consultants

Global Risk Consultants is a wholly owned subsidiary of TÜV SÜD America Inc, the worldwide leader in unbundled property loss control, providing the risk management community with accurately qualified site-specific risk recommendations and loss expectancies resulting from property related perils. The company has worked with 20% of the Fortune 500, conducted 56,000 onsite engagements, serviced facilities in excess of $4 trillion, and helped clients reduce their risk exposure by $683 billion. Visit www.tuvsud.com/grc.

 

About TÜV SÜD America

TÜV SÜD America Inc., a subsidiary of TÜV SÜD AG (Munich, Germany), is a leading globally recognized testing and certification organization. TÜV SÜD’s Business Assurance division provides management system certification services to ISO 9001, ISO 14001, AS9100, Safe Quality Food (SQF), and more. TÜV SÜD’s Product Service division offers electrical and mechanical product safety, Electromagnetic Compatibility (EMC) testing, environmental testing, NRTL and SCC certification, CE marking assistance, restricted substance services, international compliance services, and more. TÜV SÜD America also provides a comprehensive suite of services for the medical device sector as a European Union notified body for the medical device, active implantable medical device and in-vitro diagnostic device directives, and a complete service portfolio including ISO 13485 and MDSAP certification, FDA 510(k) and third-party inspections. The company’s Industry Services division offers a full suite of services for pressure equipment manufacturers and materials producers exporting products to the European Community. The Industry Services division also includes TÜV SÜD Risk Consulting, the leading global provider of unbundled property loss control services. Visit www.tuvsud.com/en-us.

Contacts

Jared Shelly

TÜV SÜD Global Risk Consultants

Jared.shelly@tuvsud.com
267-788-1993

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Education Healthcare Lifestyle Science Technology Travel & Leisure

Aetrex partners with Pensole Lewis College School of Business & Design to improve next generation of footwear design

Brand donates premium foot scanner to bring 3D data-powered shoe design capabilities to students

 

TEANECK, N.J. — (BUSINESS WIRE) — Aetrex, Inc., a global market leader in foot scanning technology, today announced a partnership with Pensole Lewis College School of Business & Design (PLC), the preeminent footwear design school in the world, to further the school’s mission to help diverse, budding designers break into the world of product creation and improve the industry for the next generation.


In late 2022, Aetrex met with PLC Founder and President D’Wayne Edwards to discuss how Aetrex’s state-of-the-art foot scanning technology uses 3D foot data to help shoe designers create better fitting and functioning footwear. Creating an anatomically correct shoe, a crucial component in the design process, starts with the development of a highly informed last (the solid form around which shoes are molded). Aetrex has used data and learnings from its foot scanners for years to create shoes that fit and perform better, helping wearers reduce injury and increase comfort.

 

After discussing the needs of the college, the benefits of foot scanning and ideas for course integration, the parties entered a partnership where Aetrex donated an Albert 2 Pro, the premier 3D foot scanner in its fleet.

 

“PLC relies on support from brands like Aetrex to make our programming possible and open up opportunities in the industry for our talented students,” said Edwards.

 

“Over the past year, PLC has served around 150 students – tuition-free, without prior educational requirements. We’re thrilled to integrate Aetrex Technology into our curriculum to further our goal of preparing the largest talent pool of progressive creatives to enter the industry and leave it better than we found it.”

 

PLC students started exploring the technology’s capabilities in a course with New Balance. In this program, students utilize the Albert 2 Pro to scan the feet of five different athletes to analyze and categorize shoe styles for better-fitting footwear designs.

 

“We recognize the footwear industry always has room to grow—both in developing better-fitting footwear, and in employing a more diverse and representative population of designers,” said Justin Dyszelski, national accounts manager at Aetrex.

 

“That’s why we’re working with Pensole to make industry-leading design technologies available to the next generation of students so that they can access and learn the innovative tools of the trade and use their passions to help propel our industry forward.”

 

As a technology-led company, Aetrex operates the largest technology team in the industry with AI and computer vision engineers fully involved in product development. Since 2002, Aetrex has placed over 12,000 foot scanners worldwide that have completed more than 50 million unique foot scans. Other Aetrex partners include BOA, Burton, Marathon Sports, Sun & Ski Sports, Rocky Brands, Pikolinos, and more.

 

To learn more about Aetrex’s technology suite, visit www.aetrex.com.

 

About Aetrex

Aetrex, Inc. is widely recognized as a global leader in foot scanning technology, orthotics and comfort and wellness footwear. Aetrex has developed state-of-the-art foot scanning devices, including Albert, Albert 2 Pro and Albert 3DFit (2022 and 2023 CES Innovation Award Honorees), Albert Pressure and iStep, designed to accurately measure feet and determine foot type and pressure points. Since 2002, Aetrex has placed over 12,000 scanners worldwide that have performed more than 50 million unique customer foot scans, currently averaging more than 2.5 million scans a year.

 

The company is renowned for its over-the-counter orthotics – the worlds #1 premium foot orthotic. With fashion, function and quality at the forefront, Aetrex also designs and manufactures stylish, performance footwear. Based in New Jersey, Aetrex is consistently named one of New Jersey’s Top 100 Privately Held Companies and was also included in NJBIZ’s Top 30 Manufacturing Companies. It has remained privately owned by the Schwartz family for three generations. For additional information, visit www.aetrex.com.

 

About Pensole Lewis College of Business & Design

Pensole Lewis College of Business & Design is the pipeline for career education and professional development in the design industry. We are the source for creative vision and progress; bearing the torch to push the culture forward — beyond what’s visible. At Pensole Lewis College, we offer a new path to break into the world of product creation. We prepare the largest talent pool of designers to enter the industry empowering them to make it better for the next generation, leaving our industry better than when we entered it.

Contacts

Media
Rajira Hernandez

Matter Communications

978-225-8082

aetrex@matternow.com

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Culture Healthcare Lifestyle Perks Science Technology

Oticon celebrates winners of the Annual Oticon Focus on People Awards

12 inspiring individuals recognized for empowering and advocating for people with hearing loss

 

SOMERSET, N.J. — (BUSINESS WIRE) — #FOP — Oticon, Inc. announced the winners of the 2022 Oticon Focus on People Awards, a national program dedicated to honoring outstanding individuals who have made a positive impact on the hearing loss community. Thousands of people from around the world voted during Fall 2022 to determine this year’s winners in four categories.

 

The 2022 first place winners are:

  • Student: Erin Cembrale of Dunedin, Florida views her hearing loss as a strength that motivates her to try harder and never give up. This commitment has fueled a successful soccer career. Since age 3, Erin has played for a variety of club, high school and college teams, including the U.S. Deaf Women’s National Team (USDWNT), with whom she won gold in the 2022 Deaflympics in Brazil. This year, she will travel to Korea with the USDWNT to compete in the World Cup. Off the field, Erin inspires and mentors young soccer players with disabilities.
  • Adult: Zina Jawadi of Los Altos Hills, California is an advocate for people with hearing loss among medical professionals. She believes accommodations are essential in establishing trust, formulating a diagnosis, creating an effective treatment plan, and ensuring patients play an active role in their health. A medical student herself, Zina is the youngest ever member of the Hearing Loss Association of America’s Board of Directors. Her long-term goal is to increase representation of people with hearing loss in medicine and to address accessibility barriers for people with hearing loss and with disabilities more broadly. Zina plans to donate all prizes, including the hearing aids, from this award to the Hearing Loss Association of America.
  • Advocacy: Gregory Scott of New York, New York drew on his personal experiences with hearing loss to create SoundPrint, a crowdsourcing app that enables anyone to measure and report the sound levels in bars and restaurants. SoundPrint serves as an important free resource for people with and without hearing loss who are looking for quieter venues that make conversation easier. Additionally, the SoundPrint database is shared with venue managers, public health researchers, and hearing health advocates to let them know people care about noise.
  • Practitioner: Jamie Marotto of Fairfield, Connecticut is the Director of the Sacred Heart University (SHU) Undergraduate Program in Communication Disorders and Director of the Audiology Clinic. She knows the value of integrating classroom teachings with clinical experience, especially when caring for patients in underserved communities. In the clinic, students learn how evaluating and treating hearing loss across a lifespan can improve a patient’s ability to work, interact socially and minimize health risks associated with hearing loss. To further drive home the importance of using their knowledge and skills to give back, Dr. Marotto leads students on an annual service-learning trip to Guatemala to provide hearing-related services and hearing aid fittings to in-need children and adults.

 

“From the youngest students to accomplished professionals and global brands, the winners of this year’s Oticon Focus on People Awards are redefining perceptions of hearing loss, encouraging inclusivity, and empowering others around them,” said Nancy Palmere Mucha, Director of Consumer Marketing and Public Relations for Oticon, Inc. “Through their leadership, advocacy, and resilience, they are inspiring change and making the world a better place for people with hearing loss.”

 

As part of this year’s program, Oticon has also recognized Barbie with Hearing Aids and leading toy manufacturer Mattel with a special award for the brand’s commitment to creating dolls with a variety of looks to represent everyone. The brand unveiled Barbie with Hearing Aids in 2022 as part of their ongoing efforts to amplify diversity and inclusion.

 

“The Barbie brand believes in the power of representation, and we are committed to continuing to introduce dolls, like Barbie with Hearing Aids, that reflect the diversity children see in the world around them,” said Lisa McKnight, Executive Vice President and Global Head of Barbie and Dolls, Mattel. “It’s important for young people to see themselves reflected in our products. And it’s equally important to encourage children to play with dolls that may not resemble them to help them understand and celebrate the importance of inclusion.”

 

The 2022 Oticon Focus on People Award winners were revealed on February 25 during the Oticon Next Conference, a gathering of hearing care professionals from around the country. As part of the event, Mattel donated more than 950 Barbie with Hearing Aids dolls to the hearing care professionals in attendance, equipping them with a valuable tool to connect with patients.

 

Established in 1997, the Oticon Focus on People Awards program has honored more than 300 outstanding individuals throughout the United States. This year’s second and third place winners are:

  • Student — Lauren Harris of Knoxville, Tennessee; Mercy Botchway of Everett, Massachusetts
  • Adult — Meaghan Thomas of Nashville, Tennessee; Shirley Forpe of Palatine, Illinois
  • Advocacy — Renee Polanco Lucerno of Culver City, California; Shanna Groves of Olathe, Kansas
  • Practitioner — Dawn Heiman of Woodridge, Illinois; Mary Frintner of Burbank, California

 

First place winners received a $1,000 prize as well as a $1,000 donation from Oticon to the non-profit organization of their choice. In addition, first place winners in the Student, Adult, and Advocacy categories received a pair of Oticon hearing aids.

 

To read the stories of all the Oticon Focus on People Awards finalists, visit Oticon.com/FOP.

Photos and videos from each of the 2022 Oticon Focus on People Award winners are available here.

 

Oticon, Inc. – Life-Changing Technology

Oticon is one of the world’s most innovative hearing device manufacturers, with more than 115 years’ experience in the design and development of hearing aids for adults and children. Our comprehensive portfolio of life-changing technology improves not only the quality of hearing but the overall quality of life for people with hearing loss. Oticon challenges conventions and pushes the limits of technology to bring to market hearing solutions that exceed the needs and expectations of people with hearing loss, so that they can live their lives without limit. Our groundbreaking BrainHearing™ technology is helping to provide better hearing with less effort by giving the brain the clearest, purest sound signals to decode. For more information visit oticon.com.

Contacts

Media
Allie Carroll

Gregory FCA

alliec@gregoryfca.com
267-294-7735

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Education Healthcare Lifestyle Local News Science

Amid record nurse shortages, a top-ranking NJ nursing school is filling in the gap

Leading NJ nursing school prepares students for successful healthcare careers

  • TCNJ’s nursing program boasts simulation labs to safely give students hands-on professional experience.
  • The program’s students consistently exceed testing standards.

 

“TCNJ’s reputation speaks for itself. We have consistently had a 94-100% pass rate…”

— Dr. Tracy Perron, Professor & Chair, Nursing, TCNJ

 

Image

EWING, N.J. – Healthcare faces a staffing crisis like it has never seen before.

 

One study finds nurse turnover surged 8.4% between 2020 and 2021, propelling the national average to ~27%. In the face of this unprecedented industry-wide challenge, the School of Nursing and Health Sciences (SNHS) at The College of New Jersey (TCNJ) is preparing young healthcare professionals to exceed standards and deliver best-in-class care.

 

To get a better idea of just how SNHS accomplishes this, look no further than TCNJ alumnus and Penn Medicine Princeton Health Labor & Delivery nurse, Sydney Doyle, BSN, RN. “My experience studying nursing at TCNJ helped me after graduation by equipping me with the tools to succeed in both clinical and professional environments. Through rigorous coursework and studying under highly-esteemed nurse leaders and experts, I was able to refine my time management, clinical, and critical thinking skills and develop professional etiquette,” says Doyle.

 

Beyond academic and hands-on experience, Doyle suggests TCNJ’s alumni network adds equal value. She explains, “TCNJ’s School of Nursing and Health Sciences has afforded me a network of colleagues both near and far that fostered my growth while I earned my BSN and continually support me in my professional endeavors.”

 

TCNJ’s SNHS offers an undergraduate Bachelors of Science in Nursing (BSN) program, as well as a BSN to Registered Nurse (RN) track.

 

Dr. Tracy Perron, Professor and Chair of TCNJ’s Nursing Department, argues SNHS stands out as a leader in accelerating students directly into professional healthcare careers or advanced studies. “TCNJ’s reputation speaks for itself. We have consistently had a 94-100% pass rate and our students are gainfully employed within six months of graduation in some of the most notable healthcare facilities, such as Duke, Hopkins, CHOP, NYU, Sloan Kettering just to name a few. Also, our alumni get into some of the top graduate programs, like Duke, PENN, NYU, Rutgers, Hopkins, and Jefferson,” Perron says.

 

The success of TCNJ’s nursing program at state and national levels has increasingly attracted students seeking a high-quality education in healthcare. For transfer student Adriana Pagnillo, the unique benefit of pursuing TCNJ’s nursing track is access to hands-on experience before graduation. “One experience at TCNJ that has helped to shape my understanding of the nursing field has been the lab experiences the program provides. The hands-on simulation labs, including mannequins that mimic real-life scenarios, give students the closest thing possible to a human experience. This allows the students to make errors and learn from their mistakes without the risk of harming real patients.”

 

TCNJ’s School of Nursing and Health Sciences’ Dean Carole Kenner explains, “The national healthcare staffing shortage should worry just about everyone in the industry. Our School is honored to do its part to prepare medical professionals to perform at the top of their license.” The School rebranded in 2022 to reflect its robust and diverse, cross-disciplinary health science curricula.

 

TCNJ’s School of Nursing and Health Sciences educates aspiring health professionals to become future leaders across the healthcare industry. Faculty work closely with local healthcare partners to provide students with applicative skills and foundational knowledge. The nationally acclaimed school is dedicated to preparing individuals—through programs in nursing, public health, exercise science and physical education teaching—for the many rewards of guiding people, communities, and populations toward improved health outcomes. The School is nationally recognized as a Healthy People 2030 Champion.

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Business Healthcare Science

Teva announces FDA approval of AUSTEDO® XR (deutetrabenazine) extended-release tablets, a new once-daily formulation of AUSTEDO® (deutetrabenazine) tablets

  • New once-daily AUSTEDO XR regimen now approved in 6, 12, and 24 mg tablet strengths
  • AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor approved for both tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD) indications1,2
  • AUSTEDO is the only VMAT2 inhibitor with 3-year long-term data for both TD and HD chorea1,2

 

TEL AVIV, Israel & PARSIPPANY, N.J. — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.

 

“The approval of AUSTEDO XR is a reflection of our ongoing innovation for people living with TD and HD chorea,” said Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer at Teva. “For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address.”

 

Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three extended-release tablet strengths – 6 mg, 12 mg, and 24 mg – and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.

 

“Today’s approval marks an exciting milestone for patients with TD and HD chorea,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva. “Our commitment to patients suffering with these diseases is unwavering and we will continue our mission to address the needs of patients with neurodegenerative disorders.”

 

Since 2017, Teva has been supporting patients with TD and HD chorea and their prescribers by providing an effective treatment. AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor with 3-year data for both the TD and HD chorea indications. TD is a highly debilitating movement disorder affecting one in four people who take certain mental health treatments. Chorea associated with HD is involuntary, random and sudden, twisting and/or writhing movements associated with this devastating disease.

 

AUSTEDO XR is expected to be available in the U.S. later this year.

 

About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets

AUSTEDO XR/AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia (TD) and for the treatment of chorea associated with Huntington’s disease (HD). AUSTEDO XR is the once-daily formulation of AUSTEDO. TD is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals. HD is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately 90% of patients. Chorea can have a significant impact on daily activities and progressively limit peoples’ lives. Safety and effectiveness in pediatric patients have not been established.

 

INDICATIONS AND USAGE

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

 

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

 

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.

 

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

 

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

 

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

 

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

 

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

 

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

 

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.

 

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

 

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

 

Please see accompanying full Prescribing Information, including Boxed Warning.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AUSTEDO (deutetrabenazine) tablets and AUSTEDO XR (deutetrabenazine) extended-release tablets; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO, AJOVY® and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

_____________________________

1 Hauser, R. A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia is Associated with Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study. Frontiers in Neurology (2022). https://doi.org/10.3389/fneur.2022.773999.

2 Frank, S., Testa, C., Edmondson, M.C. et al. The Safety of Deutetrabenazine for Chorea in Huntington Disease: An Open-Label Extension Study. CNS Drugs (2022). https://doi.org/10.1007/s40263-022-00956-8.

Contacts

IR

United States
Ran Meir

(267) 468-4475

Yael Ashman

972 (3) 914-8262

PR

United States
Doris Yiu

(973) 265-3752

Yonatan Beker

(973) 917-0851

Categories
Education Healthcare Local News Regulations & Security

County Exec. Brian M. Hughes makes statement on mass shooting at Michigan State University

TRENTON, N.J. — Unthinkable. Senseless. Terrifying. Devastating. Once again, these words invade our worlds as we mourn for the loss of life that has occurred at Michigan State University in East Lansing, Michigan on Monday.

 

As we again try to make sense out of a senseless act, our thoughts and prayers are with the families who lost loved ones.

 

We are learning more about the assailant, his ties to Mercer County and Ewing Township and his longtime struggle with

mental illness, remarked Hughes.

 

In response to what was deemed an unconfirmed threat to Ewing schools, Ewing Township temporarily closed its schools Monday out of an abundance of caution, while police investigated.

 

Fortunately, no incident occurred, and the investigation determined there was no threat to Ewing schools. I commend the Ewing Police Department and Ewing school officials for their swift action that put the safety of the community first, and the police department’s Mercer County law enforcement partners for their assistance. This illustrates how important it is to have a plan in place – as was the case here — so appropriate action can be taken in the event of an emergency, Hughes said.

 

Our County mental health team reached out to the Ewing School District  to offer their services, and I have reached out to Mayor Bert Steinmann and offered any other assistance that the County might be able to provide, he stated.

 

I ask that we also use this as an opportunity to refocus our efforts on the safety and security of our schools, our children, and our neighbors.

 

https://www.fox7austin.com/news/threat-michigan-state-shooter-anthony-mcrae-promots-closure-ewing-schools

Categories
Business Healthcare Lifestyle Local News Science

Investigational therapy UGN-102 may be delivered at home for the treatment of bladder cancer

–In a Small Feasibility Study, UGN-102 Achieves a Complete Response in 75% (6 of 8) Patients

–UGN-102 is Being Studied in Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

 

PRINCETON, N.J. — (BUSINESS WIRE) — UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.

 

“Many bladder cancer patients are elderly and suffer from comorbidities that make frequent office visits for treatment a real burden,” said study investigator David Morris, M.D., F.A.C.S., Urologist at Urology Associates PC, Nashville, TN. “Moving healthcare out of the clinical setting and into a patient’s home would represent a new treatment paradigm for bladder cancer, which may reduce clinic and hospital costs while increasing patient comfort and convenience.”

 

Eight patients were enrolled and treated with UGN-102 by 4 investigators. Median age was 75 years (range 55-84). Six patients completed treatment (6 doses), and 2 patients discontinued the study (5 doses and 4 doses, respectively) due to adverse events (AEs) unrelated to treatment. All 8 patients were evaluable for treatment response, and 6 of 8 (75%) achieved a complete response 3 months after starting treatment. The 2 patients who discontinued were assessed as non-responders. Treatment-related AEs were mild to moderate in severity (most common: dysuria and fatigue in 2 patients), and 3 patients with significant comorbidities had a serious AE, all of which were unrelated to treatment with UGN-102.

 

Patients, nurses and investigators completed home instillation feasibility questionnaires. These standardized feasibility questionnaires highlighted that all 8 patients preferred at-home to in-office treatment, and 5 of 6 patients recommended UGN-102 home instillation instead of transurethral resection of bladder tumors (TURBT). Home instillation was reported as feasible for visiting nurses, and 3 of 4 investigators considered at-home treatment “not different” than in-office treatment.

 

“As a urologic oncologist, I feel confident that the home instillation study results, appearing on the heels of our Phase 2 program and following the complete enrollment of our pivotal Phase 3 ENVISION study for UGN-102, provide us with even more reasons to believe that our novel approach to treating LG-IR-NMIBC has the potential to address genuine unmet needs of patients with bladder cancer,” said Arie Belldegrun, M.D., Board Chair of UroGen.

 

The study enrolled patients with recurrent LG-IR-NMIBC who agreed to receive UGN‑102 at home. Six weekly doses of UGN-102 were administered. The first dose was administered on-site by a physician and the five remaining doses were administered at home by a visiting nurse. Patients were followed for AEs and treatment response was evaluated by visual observation, for cause biopsy, and urine cytology 3 months after treatment initiation. Complete response was defined as the absence of disease by white light cystoscopy, cytology, and histopathology.

 

“This study is another example of how UroGen continues to advance its mission to pioneer the way urothelial cancers are treated,” says Liz Barrett, President and Chief Executive Officer, UroGen. “2023 will be a pivotal year for UroGen as we report on the ATLAS study of UGN-102 and start combinatorial treatments in the Phase 1 study of UGN-301. UroGen is in a strong position to achieve leadership in uro-oncology.”

 

About LG-IR-NMIBC

Approximately 800,000 people are living with bladder cancer in the U.S., of that 80,000 suffer from LG-IR-NMIBC. Patients with LG-IR-NMIBC face a future of recurrence and additional surgeries. Currently, the only primary treatment available is a surgical procedure known as TURBT, which requires anesthesia. Every time TURBT is performed it may impose more burden and serious risks on patients, including pain, bleeding, infection and injury (including perforation).

 

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

 

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.

 

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the Home Instillation Study of UGN-102, and the encouraging results from this study; the design and potential benefits of UGN-102 for the treatment of LG-IR-NMIBC, including benefits related to at home administration; the ongoing Phase 3 ENVISION trial and the design, timing and potential benefits thereof; UroGen’s plans to submit an NDA for UGN-102 and the expected timing thereof; UroGen’s optimism regarding the clinical potential of UGN-102, including UroGen’s belief that UGN-102 meets unmet needs of patients with bladder cancer; UroGen’s expectations for 2023, including that 2023 will be a pivotal year, the reporting on the ATLAS study of UGN-102 and start of combinatorial treatments in the Phase 1 study of UGN-301; management’s belief that UroGen is in a strong position to achieve leadership in uro-oncology; the potential of UroGen’s proprietary RTGel® technology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results from the Home Instillation Study of UGN-102 may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety or other complications thereof, including the Phase 3 ENVISION trial; unforeseen delays that may impact the timing of progressing clinical trials and reporting data; the ability to obtain regulatory approval within the timeframe expected, or at all, and to maintain regulatory approval; complications associated with commercialization activities; UroGen’s ability to attract or retain key management, members of the board of directors and personnel; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; and UroGen’s RTGel technology may not perform as expected and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates our RTGel technology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the SEC on November 10, 2022 and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

Contacts

INVESTORS:
Vincent Perrone

Sr. Director, Investor Relations

vincent.perrone@urogen.com
609-460-3588 ext. 1093

MEDIA:
Cindy Romano

Director, Communications

cindy.romano@urogen.com
609-460-3583 ext. 1083

Categories
Business Healthcare Lifestyle

Aetrex Footwear continues year-over-year sales growth momentum with new fall 2023 styles

Following nearly 50% growth in footwear sales, brand to exhibit new data-driven footwear collection at Atlanta Shoe Market, Booth #1441

 

TEANECK, N.J. — (BUSINESS WIRE) — Aetrex, Inc. “(Aetrex),” a global market leader in foot scanning technology, orthotics and comfort & wellness footwear, today announced plans to showcase its new Fall/Winter 2023 collection at this year’s Atlanta Shoe Market, Feb. 18-20.

 

Building off a year of significant sales growth, Aetrex will present new footwear constructions based on global data and learnings from its 3D foot scanning technology. The collection features an assortment of dress, classic and retro-inspired footwear, as well as on-trend color expansions and fan-favorite athleisure and cozy styles.


“In 2022, we experienced nearly 50% growth in footwear sales – a pivotal moment for Aetrex. This dramatic increase is testament to our growing assortment of on-trend, year-round styles developed with a unique data-driven approach to creating anatomically correct designs that offer superior comfort for better foot health,” said Renee Newman, VP Footwear Sales at Aetrex.

 

The new collection is poised to meet consumer demand for more versatile options. “For the past few years, dressier styles have been on the rise and retailers have repeatedly asked Aetrex to continue expanding this category,” said Newman. “This collection is designed for consumers who want premium comfort without sacrificing fashion, featuring easy-to-wear styles that combine dressier, occasion-based, and cozy-chic silhouettes with all-day functionality and comfort.”

 

The collection brings versatility to timeless silhouettes in a variety of on-trend colors such as dark cognac, dark olive, honey, burgundy and dark teal. New, notable styles include the Brianna, a sleek ballet flat-inspired wedge with an elasticized topline and a soft, unstructured upper for a glove-like fit, and the Dawn, a 2 3/4” slip-on wedge boot with a lightweight, cork midsole—a signature material anchored across Aetrex’s collections. The Scarlett, a 3 ¼” heeled suede boot, brings a pop of shearling with a roll-over top, while the Mila ankle boot brings a bohemian touch with a tasseled lateral side zip and a pleated upper.

 

As wider-legged pants continue to grow in popularity, chunky, retro footwear, like clogs, are rising along with them. Expanding upon existing clog styles like the Finley and Corey with new materials and colorways, the brand also introduces two new wedge styles with this collection: the leather Beckie, which includes a functional heel strap, and the suede Madison.

 

All Aetrex shoes feature an orthotic footbed with proprietary arch support for proper alignment. Every shoe in the collection is designed based on scientific data and learnings sourced from more than 50 million global foot scans conducted on Aetrex’s foot scanners (i.e. Albert 2 Pro, Albert 3DFit, etc.) to ensure maximum comfort, support and a better overall fit.

 

Available in August 2023, this collection will also include sparkly athletic sneakers, fur-lined, casual slip-on boots, a knee-high boot and more. Atlanta Shoe Market attendees can stop by the booth (#1441) to experience the new collection.

 

To learn more about Aetrex, please visit www.aetrex.com.

 

About Aetrex

Aetrex, Inc. is widely recognized as a global leader in foot scanning technology, orthotics and comfort and wellness footwear. Aetrex has developed state-of-the-art foot scanning devices, including Albert, Albert 2 Pro and Albert 3DFit (2022 and 2023 CES Innovation Award Honorees), Albert Pressure and iStep, designed to accurately measure feet and determine foot type and pressure points. Since 2002, Aetrex has placed over 12,000 scanners worldwide that have performed more than 50 million unique customer foot scans, currently averaging more than 2.5 million scans a year.

 

The company is renowned for its over-the-counter orthotics – the worlds #1 premium foot orthotic. With fashion, function and quality at the forefront, Aetrex also designs and manufactures stylish, performance footwear. Based in New Jersey, Aetrex is consistently named one of New Jersey’s Top 100 Privately Held Companies and was also included in NJBIZ’s Top 30 Manufacturing Companies. It has remained privately owned by the Schwartz family for three generations. For additional information, visit www.aetrex.com.

Contacts

Media
Rajira Hernandez

Matter Communications

978-225-8082

aetrex@matternow.com

Categories
Healthcare Science Technology

Accutar Biotechnology announces FDA clearance of IND application for Phase 1 trial of AC0676 in B-cell malignancies

CRANBURY, N.J. — (BUSINESS WIRE) — Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0676 for the treatment of patients with relapsed/refractory B-cell malignancies. AC0676 is an orally bioavailable, chimeric degrader molecule designed to target and degrade Bruton’s Tyrosine Kinase (BTK) with high potency, selectivity, and broad mutant coverage. BTK plays a crucial role in the B-cell receptor (BCR) signaling pathway, and its constitutive activation is essential to the pathophysiology of many B-cell malignancies. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0676 in the beginning of the second quarter of 2023.

“The IND clearance for AC0676 is another important validation that our protein crystallography and AI platforms can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders. It marks Accutar as the first company to successfully bring oral chimeric degraders against three different targets into clinics,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “The IND clearance for AC0676 is also critical towards offering a potential new treatment option for B-cell malignancies based on a differentiated mechanism of action from covalent and non-covalent BTK inhibitors by removing both kinase and scaffolding functions of BTK. We look forward to the clinical benefit that AC0676 treatment can potentially provide to patients.”

 

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0676 treatment in patients with relapsed/refractory B-cell malignancies.

 

About AC0676

AC0676 is an investigational orally bioavailable, chimeric degrader of Bruton’s Tyrosine Kinase (BTK) for the potential treatment of relapsed/refractory B-cell malignancies. In preclinical studies, AC0676 has demonstrated potent and selective BTK protein degradation with broad coverage of BTK wildtype and mutants (including C481S, L528W, and others), favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

 

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-empowered drug discovery, and its application to the discovery and development of clinically differentiated medicines.

 

Be transformative. For patients.

 

To learn more about Accutar, please visit us at www.accutarbio.com.

Contacts

Jiaqiren@accutarbio.com