BUSINESS INSIGHTS

SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance

SurGenTec® | March 03, 2022

SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for ION™ Screw, its proprietary stand-alone spine fixation implant. This unique device can be used to treat a variety of pathologies throughout the spine from C2-S1. The patented ION implant is the smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – and can be placed through a tiny incision with minimal tissue disruption. ION screws are enhanced with Nanotex™ surface technology designed with bony interdigitation in mind. ION provides patients with a treatment option between conservative care and major interbody fusion in the algorithm of care.

The ION screw technology truly changes the game for spine surgery. Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option. Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants,” added Greenhalgh.

Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec

ION can be used in a variety of open or true minimally invasive surgery (MIS) applications including facet fusions, adjunct to decompressive procedures, the treatment of adjacent level disease or to provide added stability with interbody fusions. The ION facet screw system instruments were designed to minimize tissue trauma and incision size while delivering the ION implants to the surgical location. "The ION system is a great fit for the ambulatory surgery center environment by providing a cost-effective solution for physicians looking to minimize trauma while still providing a high level of spinal care to patients. Patients are demanding access to a more efficient operating environment with less risk of illness and disease transmission," said Andrew Shoup, Chief Operating Officer of SurGenTec.

“ION represents a tremendous paradigm shift in the ability to treat my patients suffering from chronic degenerative lumbar conditions more definitively and less invasively,” said Dawood Sayed M.D., Division Chief and Professor of Anesthesiology and Pain Medicine at The University of Kansas Medical Center in reference to the recent FDA cleared ION facet screw system. “Traditionally, our patients with chronic back pain from lumbar degenerative disc disease, spondylosis, and spondylolisthesis are offered temporary relief with injections and ablations or invasive open surgical procedures. ION bridges an important gap for patients and physicians seeking less invasive options for these debilitating conditions. I am very honored to be amongst the first in the world to offer this remarkable treatment at our medical center,” continued Sayed.

Unlike other spinal fixation options, the ION has zero profile above the bone which may prevent soft tissue contact and the potential for irritation. The implants may be packed with bone graft prior to and after insertion to help facilitate fusion while providing an opportunity for bone to bridge over the implant and prevent implant migration.

“Using the ION system was intuitive and safe. It allowed me to provide a less invasive solution than I would have typically provided. The standard of care is changing, and ION offers a simple solution to advanced spinal conditions,” said Dr. Raphael Roybal M.D., orthopedic spine surgeon Coral Gables, FL.

SurGenTec is a privately owned medical device company based in Boca Raton, Florida that is focused on unique technologies for the orthopedic and spine fields. SurGenTec develops and manufactures innovative products with patient and surgeon safety in mind. SurGenTec looks to launch ION immediately, with plans in the future of obtaining CE mark to market overseas. The vast pipeline of unique implants, instruments, biologics and ancillary solutions will continue to develop through a high level of internal research and development. SurGenTec currently has multiple products lines to market which are sold within the US and internationally. In 2018 and 2020, SurGenTec received the Spine Technology Awards for their ALARA™ target needle system and 3D Graftrasp presented at NASS.

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BUSINESS INSIGHTS

Deargen Annonuces Patent Application for a TNBC Target Novel Drug Candidate Using AI

Deargen Inc. | December 23, 2021

Deargen, a company specializing in the development of novel NCE drugs using artificial intelligence, announced on the 22rd that it had discovered and synthesized a new anticancer target compound using its own AI platform and had already applied for a patent for it. Deargen has the technology to predict candidates for a novel drug without the 3D structure data of proteins. Deargen's technology, which uses amino acid sequence data rather than the structure information of proteins, possesses global-level differentiated artificial intelligence technology that enables the rapid development of novel drugs even for proteins whose 3D structure has not yet been identified. "The new compound for which we have applied for a patent this time is a first-in-class candidate, and we plan to develop a therapeutic agent targeting triple-negative breast cancer. TNBC is an area where there are few novel drugs available and it is difficult to find innovative targets, so it is a disease with a high demand for new therapeutics…Deargen confirmed the efficacy of the new compound discovered through in-vitro experiments." An official from Deargen Also, the substance that Deargen discovered through this study is an NCE. An NCE refers to a new chemically synthesized drug, which requires a great deal of time and money because it is difficult to develop such a drug that has not been previously approved by the FDA. However, it is within an area with high needs by many global pharmaceutical companies as it has the advantage of being able to receive market monopoly rights for 5 years in the U.S. and 10 years in Europe after product approval. In particular, Deargen's achievements are significant in that it discovered the new compound in a shorter time than the existing novel drug discovery process through its collaboration of advanced AI and in-house experts for novel drug development. The target discovery and substance design process, which usually takes about 3 to 4 years in the existing traditional drug development process, was carried out in just 10 weeks, and it took merely 2 weeks for target discovery and 8 weeks for substance design and synthesis. Currently, Deargen is establishing a large-scale R&D center. With this R&D center, the plan is to further shorten the period of the discovery of candidates by efficiently managing the time required for designing and synthesizing substances. The R&D center will be in charge of fast verification of substances by conducting the design and synthesis verification of substances under joint research with Deargen's internal pipeline, along with the production of high-quality data. Daniel Bae, Chief Business Officer of Deargen said : "We plan to continuously derive new substances with patentability through our synthesis research center, which will be established in the first half of next year. We plan to not only build our own pipeline centered on anticancer drugs, but also to introduce various business models with our partners that go beyond the existing joint research contracts." He also said, "Deargen plans to establish its position among global AI drug developers as a company specializing in NCE drug development, from target discovery to compound design and synthesis." About Deargen Inc. Established in December 2016, Deargen is an AI-based drug discovery and development company. In February 2020, the company released study results on predicting the development of COVID-19 treatments. Candidate compounds for treating COVID-19 predicted by Deargen include remdesivir, which was first approved as an emergency therapy. The company conducts research on and owns core AI technologies in-silico, such as 'prediction of bio-markers', 'selection of disease targets', and 'extraction of candidate substances for new drugs', utilizing techniques of meta analysis of genome big data and its unique AI technologies. Building on these outcomes, the company is developing new drugs in collaboration with multiple pharmaceutical companies and research institutions, demonstrating its outstanding technology capabilities as being named as top awardees at the ILSVRC, a world-prominent deep-learning competition, and Dream Challenge, an international AI-based new drug development competition.

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BUSINESS INSIGHTS

OPTEL ACQUIRES PHARMA TRACK-AND-TRACE UNIT OF KÖRBER

OPTEL Group | January 12, 2022

OPTEL GROUP, already a world leader in supply chain traceability, is expanding its expertise and global reach with the recent acquisition of the track-and-trace unit of the Körber Business Area Pharma, formerly known as Traxeed, based in Germany. Körber is a leading international technology group. The acquisition, announced today, will allow OPTEL to leverage the unit's expertise in pharmaceutical and agrochemical track-and-trace technologies, provide the company with a second foothold in the European marketplace and contribute to its diversification plans. "Creating a strong presence in the German market is key to the success of our strategic objectives because Germany is a well-established manufacturing hub, with a strong history of developing innovative manufacturing efficiency solutions and Industry 4.0 technologies," Louis Roy, founder and president of OPTEL "We are pleased that we have found a solid and future-oriented new owner with a broad international market access, from whose global network and years of experience in the highly specialized track-and-trace sector customers will clearly benefit. We are furthermore convinced that the new strategic owner can open up attractive development opportunities for the team," said Dr. Jürgen Krebs, Chief Technology Officer and Chief Operating Officer in the Körber Business Area Pharma. The acquisition allows OPTEL to welcome highly skilled pharma track-and-trace experts from Körber, complementing OPTEL's existing strengths in traceability, vision technologies, software and hardware. Furthermore, it will solidify and expand the company's presence in the European market by providing a second base of operations after Limerick, Ireland. In addition to the acquisition, a close collaboration between OPTEL and Körber's Business Area Pharma is planned in the future. The two companies plan to sign a partnership agreement whereby OPTEL becomes Körber's preferred partner for track-and-trace solutions for the pharmaceutical industry. Since its founding in 1989, OPTEL has become the world's foremost provider of track-and-trace solutions to the pharmaceutical industry. Its acquisitions in recent years have positioned it as the only company with the ability to provide complete, full-stack supply chain traceability. The Canadian multinational has since diversified into other industries, including consumer-packaged goods, metals and minerals, and agrochemicals. The acquisition of the track-and-trace unit of the Körber Business Area Pharma is expected to accelerate further expansion. ABOUT OPTEL OPTEL is a leading global provider of traceability systems whose goal is to use its innovative technologies to build a sustainable world through the Intelligent Supply Chain. OPTEL is the only company with the ability to offer complete end-to-end traceability, providing granular data at every step of the supply chain – from raw materials to the consumer and beyond. Founded in 1989, OPTEL is a Certified B Corporation headquartered in Canada, with facilities in Ireland, India and Brazil, as well as employees worldwide. ABOUT KÖRBER We are Körber – an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

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PHARMACY MARKET

Standigm Signs MOU with Merck Korea for AI drug Discovery Research

Standigm | June 02, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the signing of a Memorandum of Understanding (MOU) with Merck Korea, for AI-based drug discovery research. The MOU signing took place on May 30 at the headquarters of Standigm, attended by Sojeong Yun, CEO of Standigm, and Stephen Namkoo Lee, the Head of Science and Lab Solutions, Life Science business sector of Merck Korea. Under the MOU, Standigm will accelerate its drug discovery research by adopting Merck's AI software SYNTHIA™. which can help Standigm's novel compound synthesis. SYNTHIA™ is a computer-aided retrosynthetic design tool and unites network theory, modern high-power computing, and expert chemical knowledge to rapidly design synthetic pathways. "Applying AI to the drug discovery process can dramatically reduce time in discovering novel drug candidates and finding optimized synthesis paths. By pooling know-how in AI synthesis of Merck and Standigm's AI technology together, we expect better results in drug discovery faster, compared to the traditional AI drug discovery method," Sojeong Yun, co-founder and CEO of Standigm "Candidate chemical discovery using AI technology for new drug development is playing a crucial role in the growth of local bioindustry," said Stephen Nam-Koo Lee, Head of Science and Lab Solutions for South Korea, Life Science business sector, Merck Korea. As a leading workflow AI drug discovery company, Standigm has actively conducted research on AI technology in organic synthesis at its own Synthetic Research Center, established last year. About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and Standigm has expanded its operations across the world, recently opening offices in the U.S. and UK. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation. About Merck Merck a leading science and technology company, operates across life science, healthcare and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

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RESEARCH

DisperSol Technologies Announces Collaboration with Ajax Therapeutics to Develop Enhanced KinetiSol Drug Formulations

DisperSol Technologies | December 18, 2021

DisperSol Technologies LLC announced that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies. “Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates. This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need.” Dr. Edward Rudnic, CEO of DisperSol Technologies About DisperSol Technologies DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder and DST-2970 in Phase 2 for refractory metastatic prostate cancer. Additional earlier-stage programs include DST-5407 for non-squamous non-small cell lung cancer. About Ajax Therapeutics Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms from our founding partner, Schrödinger, Inc., we aim to discover and develop more precisely designed therapies to address significant unmet needs for patients with hematologic malignancies.

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Charles River’s translational platform for immuno-oncology supports the collection of rich data to inform better decision making, moving you effectively from target discovery and validation through to humanized mouse models and on to the clinic.

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