News and Resources from the WTWH Media Life Science Network - Page 4 of 968

Iambic Therapeutics and NVIDIA partner to slash cancer drug development timelines

Using generative AI in drug discovery, Iambic Therapeutics (formerly Entos) has advanced its IAM1363 drug candidate from program launch to clinical studies in fewer than 24 months — a process that often takes several years. Iambic Therapeutics’ AI drug development milestone relied on an alliance with NVIDIA researchers and engineers and through the use of AI tools, including NeuralPLexer, a generative AI model designed to predict the three-dimensional structure and binding interactions of protein-ligand complexes.

The company has since developed the next generation of the model, dubbed NeuralPLexer2 that boasts higher accuracy and new features for biomolecular structure prediction and drug design.

IAM1363 is a selective, brain-penetrant inhibitor designed to treat HER2-driven cancers. It is designed to target metastatic tumors throughout the body, including the brain, while offering a wider therapeutic index and reduced toxicity over existing therapies. Read more

Schott Pharma commits $371 million to new U.S. manufacturing facility for GLP-1, mRNA therapies

Pharma packaging company Schott Pharma has unveiled plans to establish a new manufacturing facility in Wilson, North Carolina. Schott Pharma says the $371 million investment in the U.S. facility will create more than 400 jobs in the region and significantly expand the company’s presence in the U.S., an increasingly important strategic market for the German company.

Schott also announced an expansion of its Müllheim manufacturing plant in February, which is shown on our map of 2024 facility openings and expansions.

Polymer syringe production a focus

The new site will be the first in the U.S. to manufacture prefillable polymer syringes, which are stored under deep-cold storage in the case of mRNA medications. It will also produce glass prefillable syringes for GLP-1 therapies used to treat diabetes and obesity. The company expects the facility to triple Schott Pharma’s contribution of glass and polymer syringes to the U.S. market by 2030.

Schott P…

Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today.

Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system.

“We are planning for a limited launch starting in the U.S. as we optimize manufacturing and supply chains, and progressively expand our manufacturing capacity,” CFO Jamie Samath said. “We expect to be in this limited launch phase into 2025. During this period, we will be focused on customers that collaborated with us during the development period and those customers who have mature robotic programs and have a need to expand capacity.”

Others who…

Carlsmed raises $52.5M Series C for spine surgery platform

Carlsmed announced today that it raised $52.5 million in a Series C funding round co-led by B Capital and U.S. Venture Partners.

The Carlsbad, California-based AI-enabled personalized surgery company plans to use the funds to accelerate commercialization efforts. It wants to boost the commercialization of its aprevo personalized spine surgery platform for lumbar fusion procedures, in particular.

The company also hopes to put the funds toward developing aprevo for cervical fusions. Carlsmed plans to launch that offering in 2025.

Carlsmed already holds FDA breakthrough device designation for the aprevo lumbar and cervical patient-specific interbody fusion devices. Its implantable devices and software platforms hold FDA clearance for lumbar spine fusion. That includes in anterior, lateral and transforaminal approaches.

Dr. Robert Mittendorff, general partner and head of healthcare at B Capital, said in a news release that Carlsmed is “transform…

FDA clears Ventris Medical Amplify standalone bone graft putty

Ventris Medical recently received FDA 510(k) clearance for its Amplify standalone bone graft putty in the intervertebral disc space.

The Newport Beach, California-based company designed Amplify to optimize cell proliferation and bone formation. It comprises the Amplify biphasic (HA-to-βTCP) ceramic granules suspended in an alkaline oxide polymer carrier. It can be used standalone or combined with autograft bone as a bone graft extender.

“We are very pleased to receive FDA clearance for Amplify Synthetic Bone Graft Putty for the intervertebral disc space. This technology combines 2 heavily studied biphasic mineral components, which are surface activated through our patented process and suspended in our proprietary polymer carrier,” CEO Russell Cook said in a news release. In a market crowded with a plethora of commodity offerings, our company mission is to develop next-generational devices that bring excitement to the surgeon community as well as our…

Siemens Healthineers to close Fast Track Diagnostics unit

Siemens Healthineers announced today that it intends to close its Fast Track Diagnostics Unit in a move that affects just shy of 100 workers.

The business closure affects about 90 employees, mostly based in Luxembourg. The company has conversations underway with local employee representatives and plans to follow local labor regulations and guidelines in accordance with standard company practice. It expects to complete the closure by September 2024.

Fast Track Diagnostics first became a part of the Siemens Healthineers portfolio through an acquisition completed in December 2017. The collection of polymerase chain reaction (PCR) testing products comprised part of the company’s overall Diagnostics business. Siemens Healthineers said in a news release that it primarily sells this portfolio in Europe.

Since the COVID-19 pandemic’s peak, the company observed a significant decline in demand for the portfolio’s offerings. Fast Track Diagnostics…

Surgeons perform first total knee arthroplasty with Polaris mixed-reality surgical guidance tech

The Stellar Knee mixed-reality surgical guidance system. [Image courtesy of Polaris]Polaris announced today that surgeons performed the first total knee arthroplasty (TKA) during its Stellar Knee mixed-reality system.

Stellar Knee uses mixed-reality for surgical navigation and guidance. It guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The system acts as a spatial computer, creating continuous data exchange between the surgeon and software. Polaris says this enhances surgical decision-making while simplifying operating room workflow.

Polaris won FDA 510(k) clearance for the Stellar Knee system in November 2023 for use in TKA procedures. The first commercial case took place at New York-Presbyterian/Columbia University Irving Medical Center in New York.

“Stellar Knee represents a paradigm shift in the OR, as we aim to offer surgeons robot-like precision and real-time guidance throughout TKA procedures,” s…

Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold

The Freesolve scaffold. [Image courtesy of Biotronik]Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold.

The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions.

Lake Oswego, Oregon-based Biotronik based its system on the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company says it delivers proven safety, improved deliverability and optimal performance, plus vessel support during and after implantation. Previous data demonstrated 99.6% degradation of magnesium 12 months after implantation into coronary arteries.

In BTK interventions, Biotronik says the Freesolve’s characteristics can offer particular value. In these situations, vessel scaffolding in the short-term resists vessel reco…

FDA clears automated insulin delivery system from Sequel Med Tech

The twiist automated insulin delivery system. [Image courtesy of Sequel]Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system.

The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market the system, which is cleared for people ages six and up with type 1 diabetes.

Sequel CEO and co-founder Dr. Alan Lotvin said clearance marks “a pivotal first step” on the company’s mission. The company expects to distribute the system through the pharmacy channel as well. That should offer a convenient, affordable way to start on an AID system, Lotvin said.

Get the full story at our sister site, Drug Delivery Business News.

Titan Medical enters merger with Conavi Medical

Titan Medical announced today that it entered into a definitive amalgamation agreement to combine with Conavi Medical.

The companies aim to combine in an all-stock transaction, focusing on commercializing Conavi’s Novasight Hybrid system. Conavi designed Novasight Hybrid to guide common minimally invasive coronary procedures.

This merger comes after more than a year of uncertainty around the future at Titan Medical. In late 2022, Titan suspended a special meeting of shareholders meant to vote on a share consolidation plan. Management decided to begin a strategic review, with a sale of the company considered a possibility. Titan also announced cost-cutting measures that included the furloughing of 40 employees.

In a news release, the company said it conducted outreach to more than 40 potential counterparties and halted the development of its ENOS surgical robot in February 2023. To avoid insolvency, the company began selling assets and licensed its …

Q&A: How Insilico Medicine’s AI identified a new IPF drug target in record time

Alex Zhavoronkov, Ph.D.

Idiopathic Pulmonary Fibrosis (IPF), a devastating lung disease affecting millions with increasing incidence, may have a new treatment hope thanks to a novel inhibitor of TNIK, a kinase newly implicated in fibrosis, identified using generative AI drug discovery platforms in just 18 months.

Researchers at Insilico Medicine, along with international collaborators, harnessed the power of AI platforms PandaOmics and Chemistry42 to make a breakthrough discovery. Nature Biotechnology recently published the group’s findings, showcase the potential of AI to accelerate drug discovery. The scientists identified TNIK as a promising therapeutic target for fibrotic diseases and developed INS018_055, a potent TNIK inhibitor. Preclinical models demonstrated INS018_055’s superior anti-fibrotic and anti-inflammatory effects compared to current treatments.

Beyond fibrotic diseas…

Gamma brain waves might prevent cognitive effects of chemotherapy

Caption:A noninvasive treatment may help to counter “chemo brain” impairment often seen in chemotherapy patients: Exposure to light and sound with a frequency of 40 hertz protected brain cells from chemotherapy-induced damage in mice, MIT researchers found.[Image courtesy of Christine Daniloff, MIT; iStock]

MIT researchers say a noninvasive treatment could stimulate gamma frequency brain waves and potentially help treat chemo brain.

In a study of mice, the researchers delivered daily exposure to light and sound with a frequency of 40 hertz. They found that this protected brain cells from chemotherapy-induced damage — also called chemo brain. The treatment also helped to prevent memory loss and the impairment of other cognitive functions.

Originally developed as a way to treat Alzheimer’s disease, the team at MIT says this treatment could have more widespread effects capable of helping with a range …