Category Archives: Health

What is new in the field of Health. Trending topics, and cutting edge research in the are of Health. Press Releases that give us updates on Health.

CS Analytical to Host Laboratory Tours and Client Meeting Program During NYC Interphex Week


Interphex

While we routinely host client audits, the fact that Intephex is just around the corner enables us an opportunity to offer client tours and meetings for those contacts that are not local to our facility.

CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to package and container testing for the pharmaceutical, biotechnology, and medical device industries, in conjunction with the New York Interphex Show scheduled for May 24th through May 26th, will host an open house and laboratory tour program for visiting clients. Clients coming to the New York Metropolitan area for Interphex will have the opportunity to schedule meeting time slots at the CS Analytical Laboratory. With a brand-new state of the art laboratory that features the most up to date instrumentation and electronic quality system processes, Interphex week, provides an ideal setting for clients to see in person the CS Analytical facility and meets it team members to discuss current and future container and package system testing needs.

“There is no other contract service provider within the FDA regulated community that is exclusively dedicated to container and package system qualification testing,” commented Sandra Cincotta, Director of Quality. “We have built out a laboratory facility that is designed to meet all USP and EP routine qualification testing requirements, can develop and validate methods specific to all of the current USP 1207 technologies for container integrity testing, and implemented a custom designed electronic quality system. While we routinely host client audits, the fact that Intephex is just around the corner enables us an opportunity to offer client tours and meetings for those contacts that are not local to our facility.”

Intephex will take place in New York City at the Jacob Javits Convention Center located on 34th street on the West Side of Manhattan. CS Analytical is located 12.6 miles due west through the Lincoln Tunnel, directly off Route 3 West. The drive from the show to the CS Analytical Laboratory will only take approximately 20-25 minutes. Onsite meetings at Interphex and Laboratory Tours may be may be pre-scheduled using the following link: https://interphex.csanalytical.com/interphex.

About CS Analytical Laboratory

The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and Physicochemical Testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.

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FDA and Site Perspectives on Overreporting of Adverse Events Management Report


Safety Reporting Overload in Clinical Trials:

FDA and Site Perspectives on Overreporting of Adverse Events

https://www.centerwatch.com/products/564

Overreporting, sending in unnecessary safety reports “just in case”, hurts everyone: sponsors, trial sites and the FDA. Ultimately, it hurts patients, as the resulting backlog can make it harder for the agency to take action to protect the public.

While the FDA determines whether more guidance, clarification or enforcement action will fix this, there is something simple that can be done: order Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events.

This report provides information for sites and sponsors to be clear on the agency’s rules and expectations. But also acknowledges the effect of overreporting on trials and formulate answers to correct the problem. Do this and save time and money, streamline the process, have an easier time with the FDA and help reverse the bottleneck. All this can be done with usable information found in this report:


  • FDA reporting requirements and guidance
  • Criteria for reporting to the FDA
  • Key definitions and reporting timelines
  • How sites can seek reimbursement from sponsors for excessive reports
  • How to use a safety assessment committee to evaluate adverse events
  • FDA’s efforts to harmonize its safety reporting requirements with other regulators
  • Global reporting requirements and processes

Bonus: Features candid opinions from top FDA officials about where the concerns lie, what the impact is and what can be done about it; and input from representatives of sites and trial services organizations who have weighed in with perspectives and examples of successful approaches to lifting the burden.

Understand and take steps to solve overreporting-related issues with Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events.

Management Report Details:

Safety Reporting Overload in Clinical Trials:

FDA and Site Perspectives on Overreporting of Adverse Events

https://www.centerwatch.com/products/564

Price:

$397

Easy Ways to Order:

Online: https://www.centerwatch.com/products/564

By phone: 888.838.5578 or 703.538.7600

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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Allegheny Health Network’s Center for Inclusion Health Recognized with ‘Quality and Practice Innovation’ Award from Society of General Internal Medicine


AHN Center for Inclusion Health Team

Allegheny Health Network’s (AHN) Center for Inclusion Health, led by internist Elizabeth Cuevas, MD, has been recognized by the Society of General Internal Medicine (SGIM) with its 2022 Quality and Practice Innovation Award. Dr. Cuevas recently accepted the award in Orlando, Fla. at the society’s annual meeting.

AHN’s Center for Inclusion Health (CIH), part of the AHN Medicine Institute, was formed in 2014 as one of the nation’s first comprehensive programs of its kind focused on meeting the health care needs of individuals in underserved or marginalized populations. Through a coordinated and compassionate care delivery model, and using evidence-based interventions, its programs address obstacles that can make it difficult for people to access care, including addiction, food insecurity, HIV/AIDS, homelessness, gender diversity, incarceration, immigration, and more.

Dr. Cuevas was instrumental in launching the Center and was named its division chief in 2020. As part of her role, she works to ensure consistent delivery of CIH’s mission to provide compassionate, accessible care to individuals with unmet health and wellness needs.

According to SGIM, the Quality and Practice Innovation Award recognizes general internists and their organization that have successfully developed and implemented innovative systems of practice improvement in ambulatory and/or inpatient clinical practice.

“Congratulations to Dr. Cuevas and to the entire team for this much deserved recognition. The CIH team’s highly skilled, selfless approach to caregiving impacts their patients’ lives beyond measure, and is a shining example for how health care can and should transform lives,” said Susan Manzi, MD, MPH, chair of the AHN Medicine Institute.

To learn more about the AHN Center for Inclusion Health, visit http://www.ahn.org/center-for-inclusion-health.

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About Allegheny Health Network

Allegheny Health Network (AHN.org) is an integrated healthcare delivery system serving the greater Western Pennsylvania region. The Network is composed of 14 hospitals, ambulatory surgery centers, Health + Wellness Pavilions, an employed physician organization, home and community-based health services, a research institute and a group purchasing organization. The Network provides patients with access to a complete spectrum of advanced medical services, including nationally recognized programs for primary and emergency care, cardiovascular disease, cancer care, orthopedic surgery, neurology and neurosurgery, women’s health, diabetes and more. AHN employs approximately 21,000 people, has more than 2,600 physicians on its medical staff and serves as a clinical campus for Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.

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An Evolutionary Vision Correction Procedure to Treat Nearsightedness is Now Available in Houston, TX


Leaders in Eye Care

Eye Center of Texas

“This procedure is exciting because the EVO lens delivers sharp, clear vision, excellent night vision and UV protection without causing dry eye syndrome or needing to remove any corneal tissue,” said Edward C. Wade, M.D., F.A.C.S.

EVO Visian® ICL is now available at the Eye Center of Texas, making it the first ophthalmologist practice in Houston to offer this breakthrough vision correcting procedure. This procedure involves implanting an evolutionary, clinically proven lens that corrects common vision problems such as nearsightedness and nearsightedness with astigmatism. EVO is now FDA-approved in the United States and can offer a new solution for those who seek sharp, clear vision and want freedom from the inconveniences of contact lenses or eyeglasses.

“This procedure is exciting because the EVO lens delivers sharp, clear vision, excellent night vision and UV protection without causing dry eye syndrome or needing to remove any corneal tissue,” said Edward C. Wade, M.D., F.A.C.S. “I see patients who struggle with their eyesight every day, and I am thrilled that there is a new lens-based solution available in the U.S. to help people break free from glasses and contacts.”

The EVO procedure is a 20-30 minute outpatient procedure with a quick recovery and little downtime. The EVO Visian ICL lens is made from Collamer, a collagen copolymer that is biocompatible, stable, and flexible, thus making it an ideal lens material for the eye. Patients now require only one procedure instead of the two needed for earlier ICL models, which makes the experience easier and saves time for both the patient and the surgeon.

Eye Center of Texas is one of a few providers in Houston to offer Visian EVO.

Dr. Wade from the Eye Center of Texas is the first in Houston to offer the latest evolutionary procedure, EVO Visian ICL. Yasir Ahmed, M.D. is also certified and will be offering the EVO procedure this coming May.

ABOUT THE EYE CENTER OF TEXAS

Eye Center of Texas is a leading ophthalmology practice in Houston, Texas with six locations serving Greater Houston and its surrounding areas: Clear Lake, Houston, Katy, Pasadena, Sugar Land, and The Woodlands/Conroe. Eye Center of Texas is a premier refractive correction center offering personalized vision procedures including EVO ICL, LASIK, PRK, and Laser Cataract Surgery.

Request an appointment by calling us at 713-797-1010 or online. For more information about the Eye Center of Texas, visit https://www.eyecenteroftexas.com, follow us on Facebook, and YouTube.

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For more information, please contact Claudia Beseda-Burns at 713-962-6452 or email Cburns@eyecenteroftexas.com.

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Nanovis’ Best-In-Class Nanotechnology Enables Record Sales Growth


Nanovis, a technology-driven company committed to discovering unmet clinical needs, developing innovative and enabling solutions, and validating new technologies for clinical and market acceptance, announces subsidiary, Nanovis Spine, achieved record sales for FY 2021, driven by their best-in-class nanotechnology portfolio of interbodies and pedicle screws. The company’s revenue growth has remained strong in 2022 with Q1 performance of 37% over the same period in 2021, the largest period growth in company history.

Following on the success in the spinal implant market with over 13,000 technology products implanted in over 10,000 patients, Nanovis is exploring opportunities to partner their best-in-class nanoVIS Ti Surface Technology™ across the entire $41 billion orthopedic market to include knee, hip, extremity, and trauma.

“nanoVIS Ti Surface Technology™ is our first technology where we discovered an unmet need in the market with implant fixation, developed an innovative and science driven technology to address it, and validated it successfully both clinically and commercially in the market,” said Brian More, Nanovis Chief Executive Officer.

“It is this strategy that helps bring our mission of Enable and Engage to fruition. Seeing the engagement, we have had with physicians and health care providers, that has allowed them to enable patients to engage life again, brings a strong sense of fulfillment to the Nanovis team.”

nanoVIS Ti Surface Technology™ at a glance:


  • IP & Clinical Validation: defensible intellectual property with a patent portfolio consisting of 33 owned or licensed patents. Possesses a controlled nano structured surface composed of nanotube arrays having an average pore size between 60-80 nanometers. These nanotube arrays have been shown to increase and accelerate calcified extracellular matrix production on human osteoblasts and human mesenchymal stem cells at 21 days, in vitro, compared to other surfaces commonly used in orthopedics.
  • Regulatory Validation: demonstrated the elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document, on both commercially pure titanium and titanium alloy. Nanovis was the first company in the world to receive FDA clearance and nanotechnology designation for enhanced PEEK Titanium Hybrid Interbodies (Nano FortiCore®) and is the first and only company in the world to receive FDA clearance and nanotechnology designation for Open and Minimally Invasive Pedicle Screws (Nano FortiFix®).
  • Operational Validation: validated manufacturing process that can happen in the production line. Protocols call for sterile packaging of all nanotechnology products reducing the requirements for excessive field inventory and reducing the risks from repeated sterilizations. The application is both economical and efficient. Based on our research, applying the surface and subsequent sterile packaging, the cost could be 1/2 of the cost of applying alternative technologies like hydroxyapatite (“HA”) without the various clinical issues associated with HA.
  • Commercial Validation: currently cleared on five implant systems in the spine market segment. Nanovis has served over 10,000 patients with over 13,000 technology implants They were recognized in 2020 by Global Health and Pharma as the best nanotechnology driven implant company, and in 2019 by Med Tech Outlook as a Top 10 Orthopedic Solution Provider.


“Nanotechnology enables growth. In an industry facing constant pricing pressures, vendor compression, and commoditization of implants, nanoVIS Ti Surface Technology™ has proven market share and price growth, hospital contract access, formulary carve outs, on label marketing campaigns, and surgeon and sales force excitement,” said Jeff Shepherd, Nanovis Chief Commercial Officer.

To request more information, or discuss specific opportunities, please contact Jeff Shepherd, Nanovis Chief Commercial Officer, at jeff.shepherd@nanovistechnology.com

About Nanovis Nanovis is a technology-driven company committed to discovering unmet clinical needs, developing innovative and enabling solutions, and validating new technologies for clinical and market acceptance. Founded in 2008, Nanovis has become the market leader in nanotechnology used to improve the biological response of orthopedic implants.

Through its subsidiary Nanovis Spine, Nanovis commercialized its proprietary and best-in-class nanoVIS Ti Surface Technology™ on a family of spinal implants to include Open and Minimally Invasive Pedicle Screws (Nano FortiFix®), and PEEK Titanium Hybrid Interbodies (Nano FortiCore®), enhanced with Osteosync, a technology licensed from Sites Medical.

By combining the fixation and infection fighting benefits from the same surface, the nanoVIS TI Surface Technology platform continues to show promise in pre-clinical studies to be upgraded to an antimicrobial surface in select markets.

In addition to nanoVIS Ti Surface Technology™ for fixation and infection, Nanovis has invented and is developing a next generation antimicrobial technology to fight or prevent localized infections in skin, transcutaneous devices, and orthopedic implants.

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Deborah DiSanzo, President of Best Buy Health, joins The Game-Changing Women of Healthcare Podcast on its Season 1 Finale


The Game-Changing Women of Healthcare Podcast Cover Art

The Game-Changing Women of Healthcare, available on all major platforms.

“Being a CEO, being present, and being a general manager is all about teaching. If you want people to follow you, you need to teach them what you know, why you’re thinking the way you’re thinking.” -Deborah DiSanzo

The Krinsky Company, a growth strategy and healthcare innovation consultancy, announced today that it will be featuring Best Buy Health’s Deborah DiSanzo on its podcast, The Game-Changing Women of Healthcare. Conceived to celebrate exceptional female leadership in a vital, complicated, and ever-changing industry, the podcast features innovative and inspiring women leaders pushing healthcare and health tech into the future. Producer and Host Meg Escobosa draws on more than a decade of healthcare innovation consulting experience to examine these bold, brilliant leaders’ successes, failures, lessons learned, and current projects.

Deborah DiSanzo, President of Best Buy Health, will be the featured guest for the final episode of the podcast’s first season. In this masterclass of an episode, Meg and Deborah discuss the unexpected career turn that launched DiSanzo’s career in healthcare technology, including the strategic decisions she faced when launching a disruptive technology, the portable automated external defibrillator (AED), into a new market while CEO of Philips Healthcare. DiSanzo and her team brought easy-to-use, consumer-grade AEDs to market, making them first available in public places and ultimately into many homes. DiSanzo shares what it’s like to once again be on the cutting edge of the most significant industry change since the application of AI in healthcare. Today, at Best Buy Health, Deborah is responsible for the company’s health strategy, focusing on enabling care at home by building on Best Buy’s strengths in three focal areas: consumer health, active aging and virtual care.

As Deborah DiSanzo comments in the episode, “Being a CEO, being present, and being a general manager is all about teaching. If you want people to follow you, you need to teach them what you know, why you’re thinking the way you’re thinking.”

Season 1 of The Game-Changing Women of Healthcare is chock-full of insight, inspiration, and expert guidance from a wide array of lauded leaders in healthcare, including Tracy Byers, GM, Enterprise Imaging, Change Healthcare; Lisa Rometty, President, CVS Kidney Care; and Dr. Shikha Anand, Chief Medical Officer, Withings. With over 30 years of experience in the field, Deborah Disanzo caps off the season with a magnificent bang.

The Game-Changing Women of Healthcare is produced, engineered, edited, mixed and scored by Calvin Marty. The podcast, which launched in October 2021, is available on Apple Podcasts, Spotify, Google Podcasts, Amazon, and more.

Media contact: Host Meg Escobosa, 415-690-6922

Meg@TheKrinskyCo.com

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Mount Sinai Receives Grant to Enhance Patient-Centric, Team-Based Pancreatic Cancer Care


“The Canopy Cancer Collective grant award in combination with our Pancreatic Cancer Multidisciplinary Team and our Center of Excellence deepens our commitment to provide seamless patient-centric treatment of pancreatic cancer,” said Dr. Karyn A. Goodman.

The Canopy Cancer Collective, a national nonprofit organization that strives to fuel better treatments and outcomes for pancreatic cancer patients, has awarded The Tisch Cancer Institute at Mount Sinai a $500,000 grant to support continued innovation in its multidisciplinary treatment of pancreatic cancer.

The Canopy Cancer Collective partners with leading health care institutions to create new patient-centric learning health networks, connecting top medical care providers, cancer researchers, and wellness specialists to formulate and foster best practices in cancer care all while empowering patients throughout their cancer journey. Mount Sinai is the only institution in New York City to receive this prestigious grant award and is among only 14 centers nationally.

Pancreatic cancer is called the “silent killer” because symptoms do not usually appear until it has already spread to other organs, leading to low survival rates. Pancreatic cancer is a complex disease that can affect each patient in different ways, both from the effects of the cancer itself and as a consequence of therapy, especially because multimodality therapy is often required.

Because of these complexities, multidisciplinary care is essential to achieving optimal outcomes for patients, underscoring the importance of the Canopy Cancer Collective grant award as well as two other important new milestones that further streamline pancreatic cancer patients’ care at Mount Sinai. In April, Mount Sinai is launching the Center of Excellence for Pancreatic Cancer Multidisciplinary Team (Pancreas MDT) at Mount Sinai West, and The Tisch Cancer Institute is launching the Center of Excellence for Pancreatic Cancer at Mount Sinai.

“As one of the most experienced pancreatic disorders treatment programs in the United States, Mount Sinai is recognized for excellence in the management of pancreatic diseases by esteemed organizations such as the National Pancreas Foundation,” said Karyn A. Goodman, MD, MS, Professor and Vice Chair for Research and Quality in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai, and Associate Director for Clinical Research at The Tisch Cancer Institute at Mount Sinai. “The Canopy Cancer Collective grant award in combination with our Pancreatic Cancer Multidisciplinary Team and our Center of Excellence deepens our commitment to provide seamless patient-centric treatment of pancreatic cancer. We will provide the most comprehensive and compassionate care through a multidisciplinary pancreatic cancer team providing the highest-quality diagnostic evaluation, treatment, and care and access to innovative therapies through clinical trials.”

The Pancreas MDT will have a team of specialists who are national leaders in the field who will provide the highest-quality diagnostic tools, treatment, and care for patients with pancreatic cancer. The team includes experts from gastroenterology, surgery, medical oncology, radiation oncology, pathology, and radiology, as well as nutritionists, social workers, and genetic counselors.

The team will deliver cutting-edge treatment for pancreatic cancer patients, informed by Mount Sinai’s extensive translational research program. In a one-day visit with the multidisciplinary team, patients will receive an individualized treatment plan that would otherwise take weeks elsewhere.

Patients will also have access to innovative therapies through clinical trials at multiple locations throughout the Health System. Patients and their family members will also receive extensive supportive care services.

The Pancreas MDT will fall under the overall umbrella of the Center of Excellence for Pancreatic Cancer at Mount Sinai, which is committed to streamlined, quality pancreatic cancer care. Dr. Goodman; Daniel Labow, MD; and Deirdre Cohen, MD, MS, will lead the Center of Excellence.

Together, they have internationally recognized expertise in radiation oncology, clinical trials, surgical oncology, and medical oncology, which will fuel the streamlined approach to team care across the health system. The Center is part of The Tisch Cancer Institute at Mount Sinai, a National Cancer Institute-designated Cancer Center. In 2021, Mount Sinai announced the establishment of the Mount Sinai Tisch Cancer Center and the construction of a new state-of-the-art cancer hospital in Manhattan thanks to a generous donation by James S. and Merryl H. Tisch.

“At the Center of Excellence for Pancreatic Cancer, we believe everyone deserves personalized and excellent care, so we develop an individualized treatment plan for our patients, using the latest technologies and advances,” said Dr. Labow, who is also Executive Vice Chair of the Department of Surgery at the Mount Sinai Health System.

Dr. Cohen, who is also Director of the Gastrointestinal Oncology Program at the Mount Sinai Health System, added, “Through this center, and our ongoing research, we will continue to make progress in the diagnosis and treatment of pancreatic cancer, keeping a patient centric focus to treat the whole person.”

About the Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai advances medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture ambulatory surgery centers; more than 415 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked on U.S. News & World Report’s “Honor Roll” of the top 20 U.S. hospitals and is top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. Mount Sinai Kravis Children’s Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

COVID-19 Has Consumers More Comfortable with Tests for Infectious Diseases


Kalorama Information Logo

COVID-19 has changed things as more consumers become confident with doing at-home tests. COVID-19 has demonstrated how IVD tests can be safely and easily made available to consumers.

The global at-home in vitro diagnostics (IVD) market had sales of $20.5 billion in 2021, up more than 35% from the previous year, largely due to increased testing in the infectious disease segment. Glucose testing and COVID-19 testing accounted for the majority of sales, according to leading medical market researcher Kalorama Information in the new report At-Home Diagnostic Testing Markets and Trends (COVID-19, FOB, Glucose, HIV and Other Tests).

Although the at-home IVD testing market is not new, it had primarily been limited to glucose and pregnancy testing. COVID-19 testing has opened the door for at-home infectious disease testing and more. Due to the COVID-19 factor, among others, growth in the at-home IVD testing market will likely continue in the short term and the market has a very good foundation for continuing to grow in the future.

“COVID-19 has changed things as more consumers become confident with doing at-home tests. COVID-19 has demonstrated how IVD tests can be safely and easily made available to consumers,” says Bruce Carlson, publisher for Kalorama Information. “Besides the pandemic, glucose testing has been the mainstay of at-home testing followed by pregnancy testing both showing exemplary track records.”

Despite the industry growth, other types of at-home tests have been slow to be utilized. One of the biggest barriers for the acceptance of some at-home tests has been people’s reluctance to stick themselves to provide a blood sample. However, with advancements in sample testing, other methods have provided acceptable alternatives.

“Advancements in technology have provided new methods of testing such as nasal and buccal swabs and increased accuracy of immunoassays and molecular tests. Some of the barriers to the market have been addressed but there is still more to be done,” says Carlson.

Ultimately, consumers are taking a greater role in their own healthcare with testing being a big part of that. It is Kalorama Information’s assertion that telemedicine and internet connection have also played a role in consumer empowerment making it easier to reach the provider to discuss the at-home test results.

For more information, or to purchase a copy of At-Home Diagnostic Testing Markets and Trends (COVID-19, FOB, Glucose, HIV and Other Tests), visit Kalorama Information’s sales page at: https://kaloramainformation.com/product/at-home-diagnostic-testing-markets-and-trends-covid-19-fob-glucose-hiv-and-other-tests/.

About Kalorama Information:

Kalorama Information is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, medical devices, and pharmaceuticals. Science and Medicine Group supports companies seeking to commercialize the rapidly changing marketplace at the intersection of science, medicine, and technology. Comprised of industry-leading brands, Science and Medicine Group serves analytical instrument, life science, imaging, and clinical diagnostic companies by helping them create strategies and products to win markets and provide platforms to digitally engage their markets through a variety of innovative solutions. Kalorama Information produces 30 reports a year. The firm offers a Knowledge Center, which provides access to all published reports.

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CrossWork’s Venture Fund Named “Best Pre-IPO Fund”; Expanding Life Sciences Advisory Board With Accomplished Medical Doctors, Scientists, And Industry Executives


Crosswork.us Best Pre-IPO Fund

CrossWork.us Pre-IPO Fund

CrossWork’s pre-IPO VC fund is selectively expanding its life sciences board. Highly accomplished doctors that serve (or are interested in serving) on corporate boards or who have participated or invested in venture capital can schedule a preliminary call with CrossWork at meetmidas.crosswork.us

While CrossWork is a multi-sector, late-stage, pre-IPO fund with roots in technology sector investing it is building out a significant life sciences investment capability. Because senior medical doctors live and breathe on the cutting edge of life sciences, and often have critical direct patient feedback, CrossWork is making a particularly strong push to add accomplished senior doctors to its advisory board. Highly accomplished / senior doctors that serve (or are interested in serving) on corporate advisory boards or who have participated or invested in the venture capital or pre-IPO spaces can schedule a time to have a preliminary discussion with CrossWork’s investment team at meetmidas.crosswork.us

Advisory board members provide strategic insights from a real-world point of view into the financial investments that CrossWork’s fund considers. They can exclude themselves, or are excluded from any potentially conflicting discussions. A recent addition to CrossWork’s advisory board, Dr. Moti Ramgopal, a medical doctor and senior leader in medicine as well as a senior member of the Cleveland Clinic health system informally provided his first-hand general view of the pace of development of CRISPR gene-editing technologies for the treatment of diseases. These types of unique insights help the CrossWork team shape its thoughts around life sciences sector focus and life sciences investments.

CrossWork provides advisory board members with complimentary equity allocations in some of the companies in which it holds equity stakes. CrossWork takes great care of its advisory board members who include a former CFO of Yahoo, former CEO of Spirit Airlines, a Shark Tank judge and the co-founder of WordPress. Recent speakers at CrossWork Advisory board meetings include Mohan Ananda, the founder of Stamps.com (acquired after reaching $6 billion market value) and Charles Bisgaier, himself an advisory board member, the co-developer of Lipitor – a top-selling drug of all time that reached $13 billion a year in sales at its peak.

CrossWork’s fund was recently announced “Best Pre-IPO Fund-US” in connection with the 2021 M&A Awards. CrossWork’s Midas Pre-IPO Fund investors and advisors include current and former employees of Facebook, Yahoo, LinkedIn, Morgan Stanley, Goldman Sachs, and other executives. The team is one of the most experienced in the pre-IPO space having participated in IPOs since the 1990s and having been involved in pre-IPO opportunities including Facebook, Twitter, LinkedIn, and many more.

Overall market pre-IPO returns have been strong with the 2020 IPO cohort returning a whopping 117% over approx. 2 years for those companies that were valued at over $1 billion in their last institutional funding round prior to IPO.

According to the publisher of the 2021 M&A Awards “Long-term relationships, innovation, persistence, integrity, optimization, and clear results are all pillars upon which CrossWork.us has been built. Leveraging unique access to, hard-to-access pre-IPO investment opportunities, CrossWork is building a coveted portfolio of companies in a sector that produced market returns of over 117% in the two years ended 2020. Its investors and advisors include numerous high-profile leaders from a broad range of industries. We are hopeful that investment access to a CrossWork fund will not only be reserved exclusively for ultra-high net worth investors and their family offices. According to a Crunchbase article, late-stage investors in pre-IPO unicorns were rewarded with 2020 IPO returns of over 117% over a median time frame of just over 2 years. M&A exit returns were even higher than IPO returns. One of the things that makes CrossWork’s Midas fund stand out from other funds, is that it employs powerful risk reduction and return enhancements that cannot be found elsewhere. It runs a mid-stage accelerator and allocates a portion of the stock from accelerator companies on a complimentary basis to Midas fund investors. This increases the fund’s return profile significantly while also reducing its risk profile. CrossWork.us stays ahead of its competitors through this and other ground-breaking pre-IPO investment strategies.”

About CrossWork

CrossWork.us named “2021 Best Pre-IPO VC Fund Manager – USA”. CrossWork manages the CrossWork Midas pre-IPO fund. CrossWork’s Midas fund investors and advisors include current and former employees of Facebook, Yahoo, LinkedIn, Morgan Stanley, Goldman Sachs and other successful executives. CrossWork’s Midas fund invests in grade A pre-IPO opportunities and employs powerful risk reduction and return enhancements not available in other funds.

Invest In CrossWork’s Midas Fund: midasdocs.crosswork.us

Meet With A CrossWork Professional: meetmidas.crosswork.us

A CrossWork Midas investment may only be purchased by accredited investors. Further, past results do not guarantee future results. See risks at https://crosswork.us/risk-factors-disclosures-2/

Important: Investments in private companies are illiquid, carry increased risks and may result in losses. Past results are no guarantee of future performance. Investment strategies referenced herein may not be exactly replicable. No financial advice is provided herein. Please seek financial advice to determine your suitability for the matters herein. This is not an offering document and no offer is made, implied, or may be assumed by virtue thereof. IRA accounts may have fees charged by the IRA custodian. The information herein is for accredited investors, i.e. only those with an annual income over $200k ($300k combined with a spouse) or net worth of $1 million either alone or combined with a spouse. Also includes certain family offices, trusts, entities, and institutions with more than $5 million in assets.

Contacts:

Investor Relations

Las Vegas, Nevada

CrossWork.us

(213) 327-5920

ir@crosswork.us

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Nanovis’ Best-In-Class Nanotechnology Enables Record Sales Growth


Nanovis, a technology-driven company committed to discovering unmet clinical needs, developing innovative and enabling solutions, and validating new technologies for clinical and market acceptance, announces subsidiary, Nanovis Spine, achieved record sales for FY 2021, driven by their best-in-class nanotechnology portfolio of interbodies and pedicle screws. The company’s revenue growth has remained strong in 2022 with Q1 performance of 37% over the same period in 2021, the largest period growth in company history.

Following on the success in the spinal implant market with over 13,000 technology products implanted in over 10,000 patients, Nanovis is exploring opportunities to partner their best-in-class nanoVIS Ti Surface Technology™ across the entire $41 billion orthopedic market to include knee, hip, extremity, and trauma.

“nanoVIS Ti Surface Technology™ is our first technology where we discovered an unmet need in the market with implant fixation, developed an innovative and science driven technology to address it, and validated it successfully both clinically and commercially in the market,” said Brian More, Nanovis Chief Executive Officer.

“It is this strategy that helps bring our mission of Enable and Engage to fruition. Seeing the engagement, we have had with physicians and health care providers, that has allowed them to enable patients to engage life again, brings a strong sense of fulfillment to the Nanovis team.”

nanoVIS Ti Surface Technology™ at a glance:

  • IP & Clinical Validation: defensible intellectual property with a patent portfolio consisting of 33 owned or licensed patents. Possesses a controlled nano structured surface composed of nanotube arrays having an average pore size between 60-80 nanometers. These nanotube arrays have been shown to increase and accelerate calcified extracellular matrix production on human osteoblasts and human mesenchymal stem cells at 21 days, in vitro, compared to other surfaces commonly used in orthopedics.
  • Regulatory Validation: demonstrated the elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document, on both commercially pure titanium and titanium alloy. Nanovis was the first company in the world to receive FDA clearance and nanotechnology designation for enhanced PEEK Titanium Hybrid Interbodies (Nano FortiCore®) and is the first and only company in the world to receive FDA clearance and nanotechnology designation for Open and Minimally Invasive Pedicle Screws (Nano FortiFix®).
  • Operational Validation: validated manufacturing process that can happen in the production line. Protocols call for sterile packaging of all nanotechnology products reducing the requirements for excessive field inventory and reducing the risks from repeated sterilizations. The application is both economical and efficient. Based on our research, applying the surface and subsequent sterile packaging, the cost could be 1/2 of the cost of applying alternative technologies like hydroxyapatite (“HA”) without the various clinical issues associated with HA.
  • Commercial Validation: currently cleared on five implant systems in the spine market segment. Nanovis has served over 10,000 patients with over 13,000 technology implants They were recognized in 2020 by Global Health and Pharma as the best nanotechnology driven implant company, and in 2019 by Med Tech Outlook as a Top 10 Orthopedic Solution Provider.


“Nanotechnology enables growth. In an industry facing constant pricing pressures, vendor compression, and commoditization of implants, nanoVIS Ti Surface Technology™ has proven market share and price growth, hospital contract access, formulary carve outs, on label marketing campaigns, and surgeon and sales force excitement,” said Jeff Shepherd, Nanovis Chief Commercial Officer.

To request more information, or discuss specific opportunities, please contact Jeff Shepherd, Nanovis Chief Commercial Officer, at jeff.shepherd@nanovistechnology.com

About Nanovis Nanovis is a technology-driven company committed to discovering unmet clinical needs, developing innovative and enabling solutions, and validating new technologies for clinical and market acceptance. Founded in 2008, Nanovis has become the market leader in nanotechnology used to improve the biological response of orthopedic implants.

Through its subsidiary Nanovis Spine, Nanovis commercialized its proprietary and best-in-class nanoVIS Ti Surface Technology™ on a family of spinal implants to include Open and Minimally Invasive Pedicle Screws (Nano FortiFix®), and PEEK Titanium Hybrid Interbodies (Nano FortiCore®), enhanced with Osteosync, a technology licensed from Sites Medical.

The nanoVIS Ti Surface Technology® platform continues to show promise in pre-clinical studies to be upgraded to an antimicrobial surface in select markets. By combining the fixation and infection fighting benefits from the same surface, the nanoVIS TI Surface Technology platform continues to show promise in pre-clinical studies to be upgraded to an antimicrobial surface in select markets.

In addition to nanoVIS Ti Surface Technology™ for fixation and infection, Nanovis has invented and is developing a next generation antimicrobial technology to fight or prevent localized infections in skin, transcutaneous devices, and orthopedic implants.

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