Concordia University-Wisconsin

Throughout recent memory the United States Congress has pinned the high cost of healthcare on the pharmaceutical industry, citing sometimes exorbitant prices for disease-modifying therapies. But drug prices are only one aspect of a much larger issue. To put the problem in perspective, before the pandemic, “Healthcare spending in the U.S. was 18% of the gross domestic product (GDP), the highest in the developed world,” Daniel Sem, Ph.D., professor of pharmaceutical sciences at Concordia University Wisconsin, told BioSpace. “That equated to $10,222 per person.” According to The World Bank, the country with the next highest healthcare spending per capita was Switzerland, at $9,666. Canada, Australia and Japan spend between $4,200 and $5,500 per person on healthcare. Their outcomes are comparable to those of the U.S. (These are all pre-pandemic spending levels.) In 2020, U.S. healthcare spending grew 9.7% to $4.1 trillion – $12,530 per person – and accounted for 19.7% of the GDP, according to the Centers for Medicare & Medicaid Services’ National Health Expenditure Accounts. In the U.S. the two largest contributors to healthcare costs are physicians and clinical services (20%) and hospital care (33%), Sem writes in his book, Purple Solutions. Prescription drug costs in 2020 far exceeded $348 billion, according to the National Health Expenditure Accounts data (the official estimates of total health care spending in the U.S.). Still, that accounts for only 12% of healthcare spending in the U.S., according to the Organization for Economic Cooperation and Development (OECD). Nonetheless, the OECD points out that this is actually lower than in much of the developed world. One of the big issues contributing to the high cost of healthcare is the lack of transparency. Even now that hospitals are required to post their pricing, the data is so complex that patients still don’t know what a procedure costs. “There’s a lack of transparency and non-value-added middlemen (such as pharmacy benefit managers) are taking advantage of that,” Sem said. The Cost of Innovation “People don’t realize the costs of innovation, (particularly) around some of the newer therapies,” Denise Juliano, group vice president of life sciences at Premier Inc., a healthcare improvement company, told BioSpace. The cost of bringing a drug to market averaged nearly $1 billion between 2009 and 2018, according to a 2020 report in JAMA, although some therapeutic areas topped $2.7 billion. The drugs’ list prices reflect that, but, Sem said, “The pharmaceutical companies, in reality, are receiving only about 60% of the list cost of the drug.” Restricting drug pricing, the industry says, would limit innovation. Pay-for-Performance Trends Payers around the world, however, say the costs for some therapies are still too high. In an effort to bring innovative medicine to patients, the pharmaceutical industry has been moving toward a pay-for-performance model for several years, with some success. Something similar happened in the hospital industry in the 1980s when diagnosis-related groups were first used for Medicare reimbursements to hospitals. Under that system, hospitals were reimbursed a set amount for certain diagnosis-related categories of patients and were entitled to any overages for efficiency, but could not bill extra if the patient was readmitted within 30 days for that condition or its complications. “That (outcomes-based reimbursement) movement has slowed a bit in the past several years. But, there are a lot of reasons to believe that having the right data to prove the efficacy and to see the total cost of care…leads to better pricing and better quality of care,” which will help with preferential selection of providers, Juliano said. Standardization of Costs Too Narrow a Focus While Sem acknowledged that hospitals are “making incremental improvements,” they also face high levels of uncollectable expenses. The American Hospital Association (AHA) says uncompensated care has cost hospitals nearly $745 billion since the year 2000. The figure for 2020 alone was $42.67 billion, up $1 billion from 2019. Underpayment by Medicare and Medicaid – which combined accounts for more than 60% of hospital care in the U.S. – cost hospitals $100.4 billion in 2020, up from $75.8 billion in 2019. One strategy calls for increased standardization within hospitals and hospital systems. “Standardizing around items that work really well (and improve outcomes) improves quality and efficiency, and therefore decreases costs,” Juliano said. The solution isn’t simply to standardize or even to trim expense items, however. “People need to think more broadly about the actual cost to the system,” Juliano said. This requires looking beyond their own budgets to consider the overall consequences of their decisions. For example, the cost savings of choosing the least expensive drug for an indication can be negated if the results are suboptimal. Likewise, discharging a patient too early can lead to complications and readmissions that could have been prevented. Such costs affect the hospital’s bottom line. Insurance Costs Rise While the AHA says hospital prices increased an average of 2% per year between 2010 and the beginning of the COVID-19 pandemic, health insurance premiums have increased an average of 4.4% per year during that time. Payers also have a disincentive to pay upfront for cures (when cures are possible). They argue that they would bear the expense but not reap the savings, because U.S. healthcare plans are largely linked to employers. To underscore that point, the Bureau of Labor Statistics reports the median employee tenure in January 2020 was 4.1 years. The pandemic appears to be shortening that. BLS statistics aren’t yet available for 2022, but Achievers Workforce Institute’s 2022 Engagement and Retention Report says that 66% of surveyed employees plan to look for a new job this year. With so many factors contributing to high healthcare costs, focusing primarily on drug pricing reform is short-sighted and will stifle innovation. More bluntly, Duane Schulthess, CEO of Vital Transformation recently said, “Proposed drug price controls will rip apart the thriving U.S. biotech ecosystem.” In BIO’s words, if the drug price control plan becomes law, “The U.S. biotech sector will be decimated.” The nation should look at the healthcare system holistically.

BOCA RATON, Fla., July 20, 2022 /PRNewswire/ -- Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, announces the presentation of data demonstrating the potential utility of its novel Reverse Hip Replacement System (Reverse HRS) in addressing instability following total hip arthroplasty (THA, also referred to as total hip replacement). In a poster presentation at the annual meeting of the Canadian Orthopaedic Association (COA), researchers reported Phase 1 data showing radiographic stability, as assessed by radio-stereometric analysis (RSA, a state-of-the-art x-ray technique used to evaluate device micro-motion and wear), in patients who underwent THA with the Reverse HRS. The results suggest a low risk of aseptic loosening of the Reverse HRS, and a high likelihood of long-term implant fixation. "Instability following total hip arthroplasty is a common mode of failure," commented lead investigator Thomas Turgeon, MD, who is Director of Arthroplasty Research, Concordia Hip and Knee Institute and Board Member of the Orthopaedic Innovation Centre. "The Reverse Hip Replacement System is designed to increase stability at the extremes of motion, and to offer a potentially more forgiving implant positioning without reducing range of motion. The clinical outcome metrics we have observed thus far are consistent with well-functioning hip replacement, and support the stability of this novel implant device." Dr. Turgeon and colleagues reported findings from 22 patients (11 female, 11 male; mean age at surgery: 70.6 ± 3.5 years) implanted with the Reverse HRS. The mean 24-month acetabular migration in these patients was 0.09 ± 0.15mm (p=0.005), which compared favorably to the maximum acceptable migration of 0.2mm. Similarly, the mean 24-month femoral migration was 0.002 ± 0.19mm (p<0.001), compared to the maximal acceptable migration of 0.5mm. At 24 months post-THA, the Reverse HRS was also associated with significant improvements in patient-reported outcome measures including the hip disability and osteoarthritis outcome score (HOOS), Oxford Hip Score (OHS), Harris Hip Score (HHS), and the 36-item short-form survey (SF-36) physical score (p<0.001 for all). "The results from this ongoing RSA assessment trial bolster the clinical rationale for the Reverse HRS and its unique implant design," said George Diamantoni, Hip Innovation Technology's Co-Founder and Chief Executive Officer. "The findings further validate and strengthen the importance for our soon to launch FDA approved IDE pivotal trial, which will evaluate the effectiveness and safety of the Reverse HRS in subjects undergoing primary THA. We believe the potential benefits of the Reverse HRS include hip stability at extended ranges of motion, reduced risk of device dislocation, and greater latitude for placement of hip components." About the Reverse HRS The Reverse HRS is a Metal-on-Polyethylene reverse geometry hip prosthesis designed to improve stability at extended ranges of motion and reduce the risk of dislocation. Like most conventional systems, the Reverse HRS consists of a femoral stem, an acetabular cup and a cobalt-chrome ball that articulates within a polyethylene liner. Unlike existing total hip replacement systems, the ball is placed on a trunnion within the acetabular cup instead of the femoral stem, and the polyethylene liner is attached to a femoral cup, which then attaches to the femoral stem, as opposed to the polyethylene liner being attached to the acetabular cup. About Hip Innovation Technology, LLC Hip Innovation Technology, founded in 2011, provides market-leading orthopedic device solutions that advances quality of life and quality of care for patients. In partnership with healthcare professionals worldwide, our goal is to design, manufacture and ultimately market innovative orthopaedic reconstructive and related surgical product solutions in areas of high unmet medical need. For more information, visit . Cautionary Statement Regarding Forward-Looking Statements This news release may contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Hip Innovation Technology's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. Hip Innovation Technology disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release. Contact: George Diamantoni, CEO Hip Innovation Technology [email protected] Media: John F. Kouten JFK Communications, Inc. (609) 241-7352 [email protected] SOURCE Hip Innovation Technology

Researchers describe a new platform technology called direct sound printing (DSP), which uses soundwaves to produce new objects. The paper explains show how focused ultrasound waves can be used to create sonochemical reactions in minuscule cavitation regions. Extremes of temperature and pressure lasting trillionths of a second can generate pre-designed complex geometries that cannot be made with existing techniques. Most 3D printing methods currently in use rely either on photo (light)- or thermo (heat)-activated reactions to achieve precise manipulation of polymers. The development of a new platform technology called direct sound printing (DSP), which uses soundwaves to produce new objects, may offer a third option. The process is described in a paper published in Nature Communications. It shows how focused ultrasound waves can be used to create sonochemical reactions in minuscule cavitation regions -- essentially tiny bubbles. Extremes of temperature and pressure lasting trillionths of a second can generate pre-designed complex geometries that cannot be made with existing techniques. "Ultrasonic frequencies are already being used in destructive procedures like laser ablation of tissues and tumours. We wanted to use them to create something," says Muthukumaran Packirisamy, a professor and Concordia Research Chair in the Department of Mechanical, Industrial and Aerospace Engineering at the Gina Cody School of Engineering and Computer Science. He is the paper's corresponding author. Mohsen Habibi, a research associate at Concordia's Optical-Bio Microsystems Lab, is the paper's lead author. His lab colleague and PhD student Shervin Foroughi and former master's student Vahid Karamzadeh are co-authors. Ultraprecise reactions As the researchers explain, DSP relies on chemical reactions created by fluctuating pressure inside tiny bubbles suspended in a liquid polymer solution. "We found that if we use a certain type of ultrasound with a certain frequency and power, we can create very local, very focused chemically reactive regions," Habibi says. "Basically, the bubbles can be used as reactors to drive chemical reactions to transform liquid resin into solids or semi-solids." The reactions caused by ultrasound-wave-directed oscillation inside the micro-sized bubbles are intense, though they only last picoseconds. The temperature inside the cavity shoots up to around 15,000 Kelvin and pressure exceeds 1,000 bar (the Earth's surface pressure at sea level is around one bar). The reaction time is so brief the surrounding material is not affected. The researchers experimented on a polymer used in additive manufacturing called polydimethylsiloxane (PDMS). They used a transducer to generate an ultrasonic field that passes through the build material's shell and solidifies the targeted liquid resin and deposits it onto a platform or another previously solidified object. The transducer moves along a predetermined path, eventually creating the desired product pixel by pixel. The microstructure's parameters can be manipulated by adjusting the duration of the ultrasound wave's frequency and the viscosity of the material being used. Versatile and specific The authors believe that DSP's versatility will benefit industries that rely on highly specific and delicate equipment. The polymer PDMS, for instance, is widely used in the microfluidics industry, where manufacturers require controlled environments (cleanrooms) and sophisticated lithographic technique to create medical devices and biosensors. Aerospace engineering and repair can also benefit from DSP, as ultrasound waves penetrate opaque surfaces like metallic shells. This can allow maintenance crews to service parts located deep within an aircraft's fuselage that would be inaccessible to printing techniques reliant on photoactivated reactions. DSP could even have medical applications for remote in-body printing for humans and other animals. "We proved that we can print multiple materials, including polymers and ceramics," Packirisamy says. "We are going to try polymer-metal composites next, and eventually we want to get to printing metal using this method." The study received funding from ALIGO INNOVATION, Concordia and the Fonds de recherche du Québec -- Nature et technologies (FRQNT). Video: