What is a Biomedical Device?

TODD SMITH | May 28, 2019 | 24 views

Medical devices are rapidly advancing from traditional hardware-based systems to include, or be, biological materials. In many cases these biomaterials are derived from an individuals's own cells. To recognize the convergence of bio-engineering and medical devices the term biomedical device is used. Regenerative medicine, CAR-T, and gene therapy are three significant areas of biomedical device research and development. As the industry grows, so do the jobs and demand for technical personnel to support the manufacturing processes.

Spotlight

RaNA Therapeutics

Translate Bio is a leading biotechnology company focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system (CNS).

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MEDTECH

Next-Gen Gene Therapy to Counter Complex Diseases

Article | July 16, 2022

Gene therapy has historically been used to treat disorders with in-depth knowledge caused by a single genetic mutation. Thanks to the introduction of new generation technologies, the potential of gene therapy is expanding tAo treat diseases that were previously untreatable. Evolution of Gene Therapy One of the major success stories of the twenty-first century has been gene therapy. However, it has not been the same in the past. The field's journey to this point has been long and mostly difficult, with both tragedy and triumph along the way. Initially, genetic disorders were thought to be untreatable and permanently carved into the genomes of individuals unfortunate enough to be born with them. But due to the constant technological advancement and research activities, gene therapy now has the potential to treat various genetic mutation-causing diseases with its ability to insert a new copy and replace faulty genes. Gene Therapy is Finding New Roads in the Medical Sector Gene therapy can help researchers treat a variety of conditions that fall under the general heading of epilepsy, instead of only focusing on a particular kind of disorder brought on by a genetic mutation. Following are some of the domains transformed by gene therapy. Neurology – Gene therapy can be used for the treatment of seizures by directly injecting it into the area causing an uncontrolled electrical disturbance in the brain. Furthermore, by using DNA sequences known as promoters, gene therapy can be restricted to specific neurons within that area. Ophthalmology – Genetic conditions such as blindness can be caused due to the mutation of any gene out of over 200 and resulting in progressive vision loss in children. With advanced gene therapies such as optogenetics, lost photoreceptor function can be transferred to the retinal cells, which are responsible for relaying visual information to the brain. This might give patients the ability to navigate in an unknown environment with a certain level of autonomy. The Future of Gene Therapy The news surrounding gene therapy has been largely favorable over the past few years, with treatment after treatment obtaining regulatory approvals, successful clinical trials, and garnering significant funds to begin development. With more than 1,000 clinical trials presently underway, the long-awaited gene therapy revolution might finally be here.

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RESEARCH

Expansion of BioPharma: Opportunities and Investments

Article | July 11, 2022

Biopharmaceutical innovations are among the most ingenious and refined achievements of modern medical science. New concepts, techniques, and therapies are emerging, such as the cell therapy Provenge, which can be used to treat cancer, and gene therapies, which provide even more amazing promises of disease remission and regenerative medicine. In addition, the COVID-19 pandemic has caused a huge boom in the pharmaceutical industry. This is because more and more attention is being paid to increasing manufacturing capacity and starting new research on drug development. Biopharma: Leading the Way in the Pharma Sector In the past couple of years, the biopharmaceutical sector has deepened its roots across the medical and pharmaceutical industries, on account of the transformation of pharmaceutical companies towards biotechnology, creating opportunities for growth. Also, growing advancements in technologies such as 3D bioprinting, biosensors, and gene editing, along with the integration of advanced artificial intelligence and virtual and augmented reality are estimated to further create prospects for growth. According to a study, the biopharmaceutical sector makes nearly $163 billion around the world and grows by more than 8% each year, which is twice as fast as the traditional pharma sector. Massive Investments Directed Towards Biopharma Investing in biotech research and development (R&D) has yielded better returns than the pharma industry average. Hence, a number of pharmaceutical companies are shifting their presence toward biopharma to capitalize on the upcoming opportunities by investing in and expanding their biotechnology infrastructure. For instance, Thermo Fisher Scientific Inc., an American manufacturer of scientific instrumentation, reagents and consumables, and software services, announced an investment of $97 million to expand its bioanalytical laboratory operations into three new locations in the U.S. With this investment, the company will add 150,000 square feet of scientific workspace and install the most advanced drug development technologies to produce life-changing medicines for patients in need.

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MEDTECH

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | July 12, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MEDTECH

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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Spotlight

RaNA Therapeutics

Translate Bio is a leading biotechnology company focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system (CNS).

Related News

Chemotherapy or not? New discoveries help determine who will benefit from chemotherapy

medicalxpress | April 24, 2019

Case Western Reserve University researchers and partners, including a collaborator at Cleveland Clinic, are pushing the boundaries of how "smart" diagnostic-imaging machines identify cancers—and uncovering clues outside the tumor to tell whether a patient will respond well to chemotherapy. The recent findings in breast and lung cancerresearch build off work pioneered by biomedical engineering professor Anant Madabhushi, founder of the Center for Computational Imaging and Personalized Diagnostics. He is senior author on a pair of recent journal publications and joined by scientists from the Case School of Engineering, Cleveland Clinic and New York University Langone Medical Center. This work, in total, heralds a more personalized future in medical diagnoses, Madabhushi said. "And it is further evidence that information gleaned by computational interrogation of the region outside the tumors on MRI (magnetic resonance images) and CAT (computed tomography) scans is extremely valuable and can predict response and benefit of chemotherapy in lung and breast cancer patients," said Madabhushi, the F. Alex Nason Professor II of Biomedical Engineering at the Case School of Engineering.

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Gyroscope Therapeutics merges with Orbit Biomedical creating a leading retinal gene therapy company

STEVENAGE | April 12, 2019

Gyroscope Therapeutics (Gyroscope), a biotechnology company developing gene therapies for retinal diseases, announces its merger with Orbit Biomedical (Orbit), a medical device company focused on the precise and targeted delivery of gene and cell therapies into the retina. Under the Gyroscope name, the organization will become the first fully- integrated retinal gene therapy company with clinical, manufacturing and delivery capabilities. As it enters the next phase of growth towards bringing medicines to patients, Gyroscope will be led by newly appointed Chief Executive Officer, Khurem Farooq. Prior to joining the company, Khurem was the Senior Vice President of the Immunology and Ophthalmology business unit at Genentech and responsible for managing the commercial success of Lucentis and the pre-launch activities for lampalizumab for age-related macular degeneration. Khurem Farooq, Chief Executive Officer of Gyroscope Therapeutics, said: “It is an exciting time to join Gyroscope with our first clinical study in patients with geographic atrophy due to dry AMD underway. By joining forces with Orbit, we can combine our expertise in developing gene therapies and our high-quality manufacturing processes with a surgical platform that can support accurate, safe and consistent delivery of medicines that will hopefully cure eye diseases that today leave people blind.”

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Promising new class of antibodies protects against HIV-1 infection

Phys.org | July 24, 2018

A group of scientists at Texas Biomedical Research Institute has zeroed in on a new defense against HIV-1, the virus that causes AIDS. Led by Ruth Ruprecht, M.D., Ph.D., the team used an animal model to show for the first time that an antibody called Immunoglobulin M (IgM) was effective in preventing infection after mucosal AIDS virus exposure. Worldwide, an estimated 90% of new cases of HIV-1 are caused by exposure in the mucosal cavities like the inside lining of the rectum or vagina.

Read More

Chemotherapy or not? New discoveries help determine who will benefit from chemotherapy

medicalxpress | April 24, 2019

Case Western Reserve University researchers and partners, including a collaborator at Cleveland Clinic, are pushing the boundaries of how "smart" diagnostic-imaging machines identify cancers—and uncovering clues outside the tumor to tell whether a patient will respond well to chemotherapy. The recent findings in breast and lung cancerresearch build off work pioneered by biomedical engineering professor Anant Madabhushi, founder of the Center for Computational Imaging and Personalized Diagnostics. He is senior author on a pair of recent journal publications and joined by scientists from the Case School of Engineering, Cleveland Clinic and New York University Langone Medical Center. This work, in total, heralds a more personalized future in medical diagnoses, Madabhushi said. "And it is further evidence that information gleaned by computational interrogation of the region outside the tumors on MRI (magnetic resonance images) and CAT (computed tomography) scans is extremely valuable and can predict response and benefit of chemotherapy in lung and breast cancer patients," said Madabhushi, the F. Alex Nason Professor II of Biomedical Engineering at the Case School of Engineering.

Read More

Gyroscope Therapeutics merges with Orbit Biomedical creating a leading retinal gene therapy company

STEVENAGE | April 12, 2019

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Read More

Promising new class of antibodies protects against HIV-1 infection

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A group of scientists at Texas Biomedical Research Institute has zeroed in on a new defense against HIV-1, the virus that causes AIDS. Led by Ruth Ruprecht, M.D., Ph.D., the team used an animal model to show for the first time that an antibody called Immunoglobulin M (IgM) was effective in preventing infection after mucosal AIDS virus exposure. Worldwide, an estimated 90% of new cases of HIV-1 are caused by exposure in the mucosal cavities like the inside lining of the rectum or vagina.

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