MEDTECH

Medtronic Expands Minimally Invasive Spine Surgery Ecosystem with Next-Generation Spinal Technologies

Medtronic plc | October 01, 2021

Medtronic plc, the global leader in medical technology, today announced the latest additions to its minimally invasive spine surgery ecosystem, making it the only company to combine spinal implants, biologics, navigation, robotics, and AI-powered data to surgeons and patients.

New additions to the Medtronic MIS+ portfolio include:

Catalyft™ PL and PL40, the first releases in the new Catalyft™ Expandable Interbody System. Catalyft™ PL and PL40 feature a unique design for anterior rim engagement, a beveled tip for ease of insertion, seamless integration with StealthStation™ Navigation, simplified bone graft delivery, and active expansion at the precise angle and lift that surgeons need for minimally invasive, patient-specific solutions to meet sagittal alignment goals.

The Space-D™ Access System, which enables pedicle-screw-based distraction, retraction and compression, compatible with Medtronic's leading MIS screw system, CD Horizon™ Solera™ Voyager™, enabling simpler, all-in-one access for surgeons, making procedures more efficient and reproducible.

Accelerate™ Graft Delivery System with Grafton™ DBF enables more controlled and efficient delivery of graft material into the disc space or other locations. Accelerate enables placement of more bone graft2 to facilitate fusion and is nine-times faster than traditional graft delivery methods.3 Bone grafting is also more controlled and easier for surgeons to visualize.

At Medtronic, we continue to raise the bar in minimally invasive spine surgery through our commitment to driving innovation and expanding our MIS capabilities, Our seamless integration of implants, instrumentation, and enabling technologies into a single ecosystem is helping surgeons remove variability in the surgical procedure, streamline and personalize care, and enable better patient outcomes.

- Carlton Weatherby, vice president and general manager of Spine & Biologics within the Cranial & Spinal Technologies business

Advancing Care with MIS+ TLIF
More than 450,000 spinal fusion procedures4 are performed in the United States each year to reduce pain, improve stability, or correct deformities of the spine. About 200,000 are lower or lumbar fusion procedures,5 which treat conditions such as degenerative disc disease, herniated disc, fractured vertebrae, spinal stenosis, and other conditions. One of the most common spinal fusion procedures is transforaminal lumbar interbody fusion (TLIF). During a TLIF procedure, a disc is removed from the lumbar spine, and two vertebrae are joined together using screws or rods. An interbody fusion spacer is inserted into the space, and a bone graft or bone substitute is placed into the space. As the bone heals, it fuses the vertebrae together to form one bone.

The new additions to Medtronic's MIS+ portfolio create the most complete MIS+ TLIF solution available for surgeons. A complete procedural solution allows surgeons to provide the benefits of minimally invasive spine care – including lower infection and complication rates,1 less blood loss,1 smaller incisions, reduced hospital stays,1 and less pain6 – to more patients. Compared to open TLIF, MIS+TLIF requires a smaller incision and less muscle and tissue disruption, which can mean a faster recovery time after the operation.7, 8, 9 Together, these technologies improve clinical and economic value while reducing OR time with a fully streamlined procedure1.

About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services, and solutions companies alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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MEDICAL

Aspect Biosystems Announces Partnership with JDRF to Advance Development of a Bioengineered Tissue Therapeutic to Treat Type 1 Diabetes

Aspect Biosystems | April 07, 2022

Aspect Biosystems ("Aspect"), a biotechnology company developing bioengineered tissue therapeutics to transform how we treat disease, is pleased to announce a partnership with JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization. The JDRF-Aspect partnership supports Aspect's focus on developing a bioengineered tissue therapeutic for type 1 diabetes that will provide insulin independence and control of blood sugar without the need for chronic immune suppression. In addition to funding, JDRF is also contributing strategic support through its deep expertise and vast network in the diabetes field. Aspect is leveraging its proprietary bioprinting technology, therapeutic cells, and materials science to create a pipeline of cell-based tissue therapeutics that replace or repair damaged organ functions. These therapeutics are rationally engineered to be biologically functional, immune-protective, and suitable for surgical implantation to treat diseases such as type 1 diabetes. For more than 20 years, JDRF has been a leader in cell-based tissue therapy research for type 1 diabetes, This funding partnership with Aspect Biosystems will support and continue scientific advancements in the field and undeniably take us closer to finding a cure." Esther Latres, Assistant Vice President of Research at JDRF. Together with JDRF, we are aligned on the mission to develop a curative therapy for the millions of patients around the world who are affected by type 1 diabetes, This partnership will help advance our cutting-edge pancreatic tissue program and bring us a step closer to human trials." Tamer Mohamed, CEO at Aspect Biosystems. About Aspect Biosystems Aspect Biosystems is a biotechnology company creating bioengineered tissue therapeutics to transform how we treat disease. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced therapeutics and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine. About JDRF International JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D.

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CELL AND GENE THERAPY

c-LEcta Continues Its Growth in 2021 and Sees Itself Excellently Positioned for the Future With the ENESYZ Technology Platform

c-LEcta | December 20, 2021

c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, continued its growth in 2021. The high expectations for the fiscal year have been fully met and were even significantly exceeded. Thus, the management expects annual revenue in the range of EUR 20 million, which equates to a doubling of last year’s result. With an expanded team, further investments in the product range and the ENESYZ technology platform are expected to keep up the pace of growth in the coming year. The continued growth confirms the Leipzig-based company’s strategy of placing its development on a solid foundation with a broad range of specialized enzymes for the pharmaceutical and food industries. With average revenue growth of 56% from 2018 to 2020 and further growth expected to reach around EUR 20 million in 2021, even during the Covid-19 pandemic, the business performance illustrates the strength and resilience of this strategy. “We are very proud of our performance in recent years. Our products provide good growth momentum and also great resilience due to the diverse application fields and this has supported us over the last two years. To continue to drive this growth in the long term, we have continued to build our team again this year and now employ 108 people. Moving forward, we plan to continue to invest in additional staff and equipment,” Thomas Pfaadt, CFO of c-LEcta GmbH c-LEcta managed to launch its new product NuCLEANase in October 2021. NuCLEANase is an enzyme that is used to remove unwanted DNA residues, in the food industry, for example, but also helps to dissolve deposits on machines and manufacturing equipment. The high demand from customers already at its launch confirms the high market potential for this product. “NuCLEANnase is an incredibly versatile product that holds great potential. However, the development also demonstrates the versatility of our ENESYZ technology platform, which allows enzyme developments based on different production systems for a wide range of applications. ENESYZ is constantly being further developed. For example, this year we were able to integrate an additional expression host, Bacillus, into our enzyme engineering platform,” explained Dr. Marc Struhalla, founder and CEO of c-LEcta. The company also made significant progress in the area of machine learning and artificial intelligence in 2021. “We were recently able to achieve some very promising results in this innovative area. The topic is a very important building block for future product developments and we are extremely motivated to rapidly expand our expertise in this area,” Dr. Struhalla added. Many new customers were once again acquired over the course of 2021. There was strong demand for the products from the DENARASE family, which also address the gene and cell therapy market. A total of more than 500 mailings were sent out to more than 200 customers from nearly 30 countries. The largest sales market was the USA. The ELISA kit launched in 2020 was also a particular success, with very significant growth in demand in 2021. c-LEcta’s most important markets, the food and pharmaceutical industries, are subject to strict regulations worldwide. An enzyme dossier submitted by c-LEcta facilitates the approval of its products for customers from the food industry. With the filing of a master file with the FDA, c-LEcta supports its customers in terms of regulatory compliance and demonstrates the quality of its manufacturing processes and products. In October, c-LEcta secured itself its own building complex with more than 10,000 m2 of space in the new biotechnology campus that spans a total area of 27,000m2 and is to be built at the “Alte Messe” site in Leipzig starting in the second quarter of 2022. “We want to and will indeed continue to grow. Great new space is being built at Alte Messe, which will allow us to set up state-of-the-art office and laboratory areas for our growing team. This will provide us with the space to continue our growth,” Dr. Struhalla concluded. About c-LEcta c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. The company is based in Leipzig, Germany, and has established itself as a leading player in the realization of high-value biotech products, either in the form of in-house developments or in close cooperation with industry. The company currently employs more than 100 people.

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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib. We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel, TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines." Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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MEDICAL

ABC Opens Commercial MEL BioSurfactant Production in Irvine, CA

ABC | May 19, 2022

Advanced BioCatalytics (ABC) is pleased to announce the opening of our new biosurfactant commercial pilot plant in Irvine California. The plant reflects the successful collaboration of the ABC R&D team and Dr. Wenjie Xia, professor of Microbiology at Nankai University in Tianjin China. The commercial pilot plant is the first step in commercial scale up of new glycolipid (biosurfactants) and is the first plant to produce commercial quantities of mannosylerythritol lipids (MEL) in North America. ABC pioneered the use of microbiology to produce metabolites and sustainable chemistry in 1996. Our products are used in water treatment, the energy sector, for agriculture uses, and in personal and home care applications. By using microbiology, we can create natural alternatives to petrochemicals. For our production we upcycle waste feed stocks such as used vegetable oils or other sources of bio-waste material. As a result, our chemistry also offers an alternative to plant based materials which have the unfortunate reliance on certain plant species which are contributing to global deforestation and destruction of biodiversity. The MEL material can be used in a variety of ways in the homecare and personal care sectors. MEL is free of 1,4 dioxane, mild on the skin, and produces minimal foam. This superfatting agent is ideal for delivering moisture in personal care products and can be used along with anionic and amphoteric surfactants for improved efficacy. The addition of MEL production compliments ABC's rhamnolipid and BioSS RL fermactant production. About Advanced BioCatalytics: Advanced BioCatalytics is an industrial biotechnology company that leverages its innovative Fermactant technology for applications in the Home and Personal Care, Energy, Agriculture, and Wastewater markets. These products have demonstrated the ability to be highly cost-effective, without depending on harmful chemistries such as caustics, acids or dangerous solvents, which can be harmful to the user and/or the environment. Advanced BioCatalytics was founded in 1996 and we are excited to be introducing a new technology that will change the future performance, and cost, of the world's cleaning products.

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