FDA deems Orchestra BioMed's sirolimus-eluting balloon a breakthrough device for coronary restenosis

CONOR HALE | April 29, 2019 | 14 views

Orchestra BioMed has received an FDA breakthrough device designation for its drug-eluting angioplasty balloon, designed to open up the coronary arteries of the heart after they’ve reclogged following the placement of a stent. While physically widening the artery, the company’s Virtue system delivers sustained-release sirolimus directly to the walls of the blood vessel without the use of a traditional drug coating. The porous balloon instead elutes the drug enclosed in a bioabsorbable nanoparticle, which Orchestra said allows it to avoid using a coating that may produce downstream particulates or small blood clots as well as the hazards that come with an additional permanent metal implant.

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AUM BioTech

AUM BioTech is a Philadelphia based biotechnology company that offers next-generation genetic research tools in the area of gene silencing and regulation. AUM's products are globally being used by biomedical scientists and researchers working on basic, transitional and pre-clinical research.

OTHER ARTICLES

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | April 13, 2020

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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Top 10 biotech IPOs in 2019

Article | April 17, 2020

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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MEDICAL

Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | August 2, 2021

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | February 12, 2020

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Spotlight

AUM BioTech

AUM BioTech is a Philadelphia based biotechnology company that offers next-generation genetic research tools in the area of gene silencing and regulation. AUM's products are globally being used by biomedical scientists and researchers working on basic, transitional and pre-clinical research.

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

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.”

Read More

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

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