Category: Health

Health

Curiteva Announces World’s First 3D Printed PEEK Device With Regulatory Clearance Reaches Full Commercial Launch in the United States

Curiteva Announces World’s First 3D Printed PEEK Device With Regulatory Clearance Reaches Full Commercial Launch in the United States

The company pioneered and received clearance earlier this year on the world’s first 3D printed, fully interconnected porous PEEK interbody.


HUNTSVILLE, Ala., July 18, 2023 (Newswire.com)
–
Curiteva, a privately held technology and manufacturing company based in Huntsville, AL announces the commercial launch of its Inspire Porous PEEK HAFUSE Cervical Interbody System. 

The company pioneered and received clearance earlier this year on the world’s first 3D printed, fully interconnected porous PEEK interbody. This extraordinary advancement in additive manufacturing of polymers creates a new classification of interbody fusion devices with optimal characteristics for bony healing.

“We are very pleased with the positive surgeon feedback we received during our limited release in April. Now with full commercialization, the team is excited to see continued adoption of our novel 3D printed porous PEEK implant with HAFUSE Technology,” stated Mark Mohlman, EVP. “This launch is just the beginning as we continue to develop our additional lumbar portfolio scheduled for launch in 2024.”

The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva. This ground-breaking additive process produces a fully interconnected and integrated porous structure traversing the entire implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics. The first-to-market combination of the HAFUSE nanotechnology surface treatment and novel porous PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.

“Curiteva received FDA clearance in February, initiated our alpha release in April and scaled to a commercial launch in July. I am proud of the entire Curiteva team for another milestone achievement and grateful to our surgeons and distributors for their patience and support,” commented CEO Mike English. 

The Inspire technology will be featured at the NASS meeting later this year. 

Curiteva is a privately held technology and manufacturing company dedicated to advancing spine surgery and improving clinical outcomes by partnering with providers and suppliers to deliver innovative and intuitive implant systems to the market. Our business is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering novel technology to meet the evolving needs of our customers and the patients they serve. 

Contact Information:

Kristen Kyzer

Director of Business Development

[email protected]

256.213.1057

Original Source:

Curiteva Announces World’s First 3D Printed PEEK Device With Regulatory Clearance Reaches Full Commercial Launch in the United States

The post Curiteva Announces World’s First 3D Printed PEEK Device With Regulatory Clearance Reaches Full Commercial Launch in the United States first appeared on Enrose Magazine.

Continue Reading

Health

Radiology Patient Action Network Urges Congress and CMS to Prevent ‘Cruel’ Cuts to Medicare Access

Radiology Patient Action Network Urges Congress and CMS to Prevent ‘Cruel’ Cuts to Medicare Access

“With nearly half of Medicare-eligible women having gone years without receiving a mammogram,” noted Bob Still, the Executive Director of RBMA, “it is unconscionable for Congress to again decrease Medicare reimbursement for providers.”


FAIRFAX, Va., July 17, 2023 (Newswire.com)
–
The Radiology Business Management Association’s Radiology Patient Action Network (RPAN) urges Congress and the U.S. Center for Medicare and Medicaid Services (CMS) to safeguard Medicare funding for physicians in light of proposed cuts in payments to providers under the proposed 2024 Medicare Physician Fee Schedule (MPFS).

“With nearly half of Medicare-eligible women having gone years without receiving a mammogram, it is unconscionable for Congress to again decrease Medicare reimbursement for providers, particularly those who perform screenings and procedures that aid in detecting and treating life-threatening diseases,” said Bob Still, the Executive Director of RBMA. “These cruel cuts not only hinder access to healthcare for Medicare recipients, but they could harm Medicaid patients too since many states link Medicaid to Medicare rates. The continued cycle of reimbursement cuts will further reduce access, worsen health disparities, and cost the country an incalculable amount of money over the long term. Congress must take action to halt these substantial cuts to independent Medicare doctors and their patients.”

RPAN strongly urges Congress to pass H.R. 2474 on behalf of healthcare providers and patients nationwide. This legislation marks the beginning of a comprehensive reform to Medicare, including an adjustment for inflationary factors. These reforms mirror recommendations from MedPAC and other groups.

“While independent providers with high Medicare volumes face significant reductions in reimbursement, other provider types continue receiving inflationary updates and reimbursement increases,” explained Still. “This growing disparity in reimbursement will only foster more consolidation among healthcare providers, aggravating inequities between provider types, and ultimately limiting patient access to care.”

Contact Information:

Will Sweet

RBMA

[email protected]

Original Source:

Radiology Patient Action Network Urges Congress and CMS to Prevent ‘Cruel’ Cuts to Medicare Access

Radiology Patient Action Network Urges Congress and CMS to Prevent ‘Cruel’ Cuts to Medicare Access

The post Radiology Patient Action Network Urges Congress and CMS to Prevent ‘Cruel’ Cuts to Medicare Access first appeared on Enrose Magazine.

Continue Reading

Health

POP Biotechnologies and EuBiologics’ EuCorVac-19 COVID-19 Vaccine Hits Target in Phase 3 Trial

POP Biotechnologies and EuBiologics’ EuCorVac-19 COVID-19 Vaccine Hits Target in Phase 3 Trial

POP Biotechnologies and EuBiologics’ EuCorVac-19 COVID-19 Vaccine Hits Target in Phase 3 Trial
EuCorVac-19
EuCorVac-19, a recombinant protein vaccine displaying the SARS-CoV-2 receptor-binding domain (RBD) antigen on the immunogenic liposomes


BUFFALO, N.Y., July 14, 2023 (Newswire.com)
–
 POP Biotechnologies (POP BIO), a Buffalo, NY-based biopharmaceutical startup, announces top line interim results of a Phase 3 clinical trial of EuCorVac-19, a COVID-19 vaccine candidate being developed by South Korean partner EuBiologics (KOSDAQ: 206650). EuCorVac-19 is a protein-based vaccine consisting of a vaccine antigen displayed on immunogenic nanoparticles, using POP BIO’s spontaneous-nanoliposome antigen particle (SNAP) technology.

The phase 3 trial of EuCorVac-19 was conducted in the Philippines in approximately 2,600 adults (NCT05572879). EuCorVac-19 demonstrated superior antibody immunogenicity compared to a World Health Organization Emergency Use Authorized adenoviral vector vaccine, thereby meeting the primary endpoint of the phase 3 trial.

The formation of neutralizing antibodies, which prevent COVID-19 infection, was more than twice as high in EuCorVac-19 compared to the control vaccine. EuCorVac-19 exhibited a high serological response rate with neutralizing antibody titers increasing after vaccination. In particular, the neutralizing antibody titers and serum response rates in subjects aged over 65 exceeded those of the control vaccine. In immunogenicity analysis against the Omicron BA.5 strain, EuCorVac-19 induced more than twice the neutralizing antibody titer compared to the control vaccine.

EuCorVac-19’s safety profile was further established in this phase 3 study. EuCorVac-19 showed a slightly lower incidence than the control vaccine of solicited adverse events and there was no difference between EuCorVac-19 and the control vaccine in the incidence of unsolicited adverse events.

These results further validate the strength and synergy of POP BIO’s SNAP and EuBiologics’ EuIMT platform technologies used in the EuCorVac-19 vaccine. Further development of booster vaccines, new strain vaccines, and combination vaccines for COVID-19 will be significantly more straightforward in the future. 

“Achieving the completion of this Phase III trial is an enormous milestone for our technologies. These results provide validation towards not only solving this unprecedented global crisis but also provides invaluable support towards our platform’s development, further enabling the creation of new vaccines with tremendous potential to alleviate suffering worldwide,” said POP BIO co-founder Jonathan Smyth.

EuCorVac-19 was already shown to be safe and immunogenic in a Phase I/II clinical trial, the results of which were announced in December 2021. The Philippine Phase 3 trial, conducted since third quarter of 2022, were supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the ministry of Health & Welfare, Republic of Korea.

Based on the results of this clinical study, EuBiologics plans to apply for product approval in the Philippines shortly. Later this year, results will become available from a second independent Phase 3 clinical study being carried out in the Democratic Republic of Congo.

About POP Biotechnologies: POP Biotechnologies, Inc. is a privately held biotechnology company focused on the research and development of novel therapeutics and vaccines employing their proprietary porphyrin-phospholipid (PoP) liposome technologies. The PoP technology, exclusively licensed from the State University of New York Research Foundation (SUNY-RF), was developed by company co-founder Dr. Jonathan Lovell at his academic facilities at The State University of New York at Buffalo (SUNY Buffalo). POP Biotechnologies is currently a resident of the SUNY Buffalo incubator at Baird Research Park.

About POP BIO’s SNAP Technology: POP BIO’s Spontaneous Nanoliposome Antigen Particleization (SNAP) technology enables the rapid development and manufacturing of highly immunogenic particle-based vaccines and immunotherapies directed against infectious disease and cancer through the use of a cobalt modified variant of the PoP technology (CoPoP). The SNAP technology enables the seamless generation of stable particle-formation and liposome-display of protein and peptide antigens resulting in substantial improvements in immune responses.

About EuBiologics: EuBiologics is a South Korean Biotechnology company that is advancing the EuCorVac-19 COVID-19 vaccine and other vaccine products. EuBiologics has two main animal-based bioreactors (1,000L) to produce recombinant protein antigens at Chuncheon Plant 1(C-Plant) and EcML(Monophosphoryl Lipid A) which is adjuvant at Chuncheon Plant 2(V-Plant). The total capacity of the COVID-19 vaccine is currently in the hundreds of millions of doses per year.

About EuBiologics’ EuIMT Technology: EuBioloigcs’ Immune Modulation Technology using genetically engineered Monophosphoryl Lipid A (MLA), called EcML that is a unique TLR4 agonist. EuBiologics has IP protection around EcML and various adjuvant systems including EcML. Eubiologics’ EcML and POP BIO’s SNAP technologies synergize to create ultrapotent next-generation vaccines.

Contact Information:

Jonathan Smyth

President

[email protected]

+13152200087

Original Source:

POP Biotechnologies and EuBiologics’ EuCorVac-19 COVID-19 Vaccine Hits Target in Phase 3 Trial

The post POP Biotechnologies and EuBiologics’ EuCorVac-19 COVID-19 Vaccine Hits Target in Phase 3 Trial first appeared on Enrose Magazine.

Continue Reading

Health

Whittier Street Health Center’s 24th Annual Men’s Health Summit a Triumph

Whittier Street Health Center’s 24th Annual Men’s Health Summit a Triumph

Whittier Street Health Center’s 24th Annual Men’s Health Summit a Triumph
Men’s Health Honorees
William Watkins, Rev. John Finley, David Morales, Leverett Wing, Frederica M Williams, Jean Prezeau


BOSTON, July 14, 2023 (Newswire.com)
–
Whittier Street Health Center, a community health center with a mission to serve as a center of excellence that provides high quality and accessible health care and social services that achieve health equity, social justice, and the economic well-being of a diverse patient population, is thrilled to announce that its 24th Annual Men’s Health Summit held June 24 at the Frederica M. Williams Building, 1290 Tremont Street, Roxbury, was a tremendous success with an estimated 150 community leaders and residents in attendance.

The theme at this year’s summit, “UNITED for Men’s Health: Grounded in Equity,” prompted open and engaging discussion on how, across the country, gaps and disparities in health care continue to increase and persist. 

The annual event included a health fair, health screenings, and a panel discussion and conversation about men’s health and wellness. A highlight of the Summit was the presentation of this year’s Men’s Health Champion Awards to the following:

  • Mr. Wilner Auguste, founder, Haitian American United (HAU), Mattapan;
  • Rev. John Finley, co-founder and head of Epiphany School, Dorchester; 
  • Rev. Art Gordon, pastor, St. John Missionary Baptist Church, Roxbury; 
  • Mr. David Morales, general manager, UniCare, Lynn (formerly of Lynnfield); 
  • Mr. Jean Prezeau, men’s health ambassador, Whitter Street Health Center, Roxbury; 
  • Mr. William Watkins, MBA, vice president of digital strategies and partnerships, Urban League of Eastern Massachusetts, Roxbury; and 
  • Mr. Leverett Wing, president and CEO, Commonwealth Seminar, Chelsea and Boston.

Serving as guest speaker was NBC10 News Anchor Glenn Jones.

The Annual Men’s Health Summit aligns with Whittier Street Health Center’s mission to serve as a center of excellence that provides high-quality, and accessible health care and social services that achieve health equity, social justice, and the economic well-being of our diverse populations. 

“Open, honest, and genuine discussions were once again a high point of this year’s Men’s Health Summit,” said Frederica M. Williams, president and CEO of Whittier Street Health Center. “This important annual event aims to shine a light on and help to address preventable causes that contribute to increased morbidity and mortality rates, and decreased life expectancy for men, and in particular those of color.”

About Whittier Street Health Center

Whittier Street Health Center is an independently licensed community health care center with a mission of providing high-quality, reliable and accessible primary healthcare for diverse populations while promoting wellness and eliminating health and social disparities. A champion of equitable access to high-quality, patient-focused care, social justice and economic equity, Whittier Street Health Center serves more than 30,000 patients and 20,000 community outreach visits annually; its ethnically and racially diverse patient base is primarily made up of individuals from Roxbury, Dorchester, Jamaica Plain, the South End and greater Boston. For more information, please visit www.wshc.org as well as Facebook (www.facebook.com/WhittierStreetHealthCenter), Twitter (@Whittier_Boston), or LinkedIn (https://www.linkedin.com/company/whittier-street-health-center), or call 617-989-3221.

Contact Information:

Nicole Hales

President, PRfirst

[email protected]

617-947-7983

Frederica Williams

President & CEO

[email protected]

617-989-3221

Original Source:

Whittier Street Health Center’s 24th Annual Men’s Health Summit a Triumph

The post Whittier Street Health Center’s 24th Annual Men’s Health Summit a Triumph first appeared on Enrose Magazine.

Continue Reading

Health

The Men at Shoreline Recovery Center and Park Mental Health Learn Self-Care Techniques to Sustain Them Along Their Addiction Recovery Journey

The Men at Shoreline Recovery Center and Park Mental Health Learn Self-Care Techniques to Sustain Them Along Their Addiction Recovery Journey

SAN DIEGO, July 14, 2023 (Newswire.com)
–
Taking care of one’s physical well-being is essential on the road to addiction recovery. For the men at Shorel…

The post The Men at Shoreline Recovery Center and Park Mental Health Learn Self-Care Techniques to Sustain Them Along Their Addiction Recovery Journey first appeared on Enrose Magazine.

Continue Reading

Health

Curated Mental Health Emphasizes the Importance of Professional Support in Psychedelic Therapy for Optimal Mental Health Outcomes

Curated Mental Health Emphasizes the Importance of Professional Support in Psychedelic Therapy for Optimal Mental Health Outcomes

NEW YORK, July 14, 2023 (Newswire.com)
–
Is ketamine a powerful tool for therapeutic purposes? Absolutely. But are there risks associated with its misuse? The…

The post Curated Mental Health Emphasizes the Importance of Professional Support in Psychedelic Therapy for Optimal Mental Health Outcomes first appeared on Enrose Magazine.

Continue Reading