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Former Medtronic and Zimmer-Biomet VP joins back pain startup as CEO

Jeff Cambra, CEO of SpinaFX [Photo courtesy of SpinaFX]

Jeff Cambra is the new CEO of SpinaFX Medical, the back pain therapy startup said on Friday.

Cambra was previously a vice president at Zimmer Biomet (NYSE:ZBH), “leading product management for their $5 billion global reconstruction business,” SpinaFX said in a news release. He served in that role from November 2020 to June 2021, according to his LinkedIn page.

He ended a nearly 11-year career at Medtronic (NYSE:MDT) in 2020, ultimately serving as vice president and general manager of interventional therapies. SpinaFX said he “led a successful turnaround of their $400 million vertebral augmentation and oncology business through new technology innovation, strategic partnerships, acquisitions and expanding margins.”

“With my passion for the interventional space, I constantly assess and monitor multiple promising technologies, I recognized the br…

Haemonetics wins FDA nod for same-day discharge following AFib ablation using Vascade MVP

Haemonetics today said that it has received FDA approval for same-day discharge after atrial fibrillation ablation using its Vascade MVP venous vascular closure system.

Vascade MVP is a vascular closure system that is designed for procedures that require multiple access site venous closures. It uses 6 to 12 Fr inner diameter sheaths that are commonly used in cardiac electrophysiology procedures to enable earlier ambulation, earlier discharge eligibility and a higher patient satisfaction, according to the Boston-based company.

“COVID has accelerated the need to enhance safety and efficacy to optimize the patient experience in meaningful ways. Vascade MVP earning the first and only indication for same-day discharge for AF ablation patients speaks to our industry leadership and continued commitment to improving the standards of care,” CEO and president Chris Simon said in a news release.

The same-day discharge labeling was granted following the …

Critical components, technologies, and designs to consider for catheter delivery systems

By Mike Schultz, Spectrum Plastics Group, Vice President of Innovation and Development

Minimally invasive surgeries (MIS) that utilize steerable catheter systems represent an expanding market in the healthcare space. As the variety of catheter-based procedures continues to grow, with physicians and therapies demanding tools and technologies that increase access and performance, the steerable catheter market is wide open for innovation.

MIS procedures, especially cardiovascular and neurovascular applications, must often navigate tortuous pathways to gain access to more distal vessels and specific targeted anatomy. The success of these procedures depends on advanced catheter systems that deliver therapies to precise locations through narrow access points, such as the femoral artery. As MIS procedures become more delicate and complex, physicians require enhanced control and steerability of catheters to precisely locate and deploy the treatment without dama…

NetSuite quality management solution for medical manufacturers

An Overview of NetSuite ERP and Quality Management

By Ben Katerberg, Luxent, NetSuite Solution Architect

For many medical manufacturing companies ensuring quality standards are being met by vendors and/or by internal manufacturing operations is critical towards external compliance standards and the lifeblood for long-term profitability and customer satisfaction. Many medical manufacturing companies have historically maintained separate quality management systems outside of their day-to-day ERP systems, leading to delays, a lack of visibility, and process bottlenecks. What if there was a way to fully integrate your ERP with your Quality Management system?

Fortunately, NetSuite offers a fully integrated Quality Management Solution that is flexible, allows for automation of pre-inspection quarantine and subsequent release of inspection-compliant material, and the ability to generate wide-ranging reporting metrics.

Flexibility: With reusable inspection…

Dealing with disruptive events

Don’t let a crisis become a disaster

The term “crisis” has become much too familiar in medical device companies. Whether it’s an FDA 483 or warning letter, plant audit, product recall, or other unplanned event, a crisis disrupts your operation and can pose a significant risk to your business. And the challenge doesn’t have to be large-scale to cause disruption. Compliance challenges require immediate attention and well-coordinated efforts, or you can face staff overload, lost focus, delayed product launches, and financial losses.

Plan for the unexpected—before it happens

Of course, the best way to handle a crisis is to prevent it. The next best way is to be prepared for how the organization will mobilize when a crisis arises.

Apply risk management. First, learn to “see the future.” This doesn’t require a crystal ball. It requires a concerted, ongoing effort to monitor the market, regulatory landscape, key business metrics, and economic, po…

Medtronic adds three new devices to minimally invasive spinal business

Medtronic (NYSE:MDT) this week announced that it has launched three new devices for its minimally invasive spinal technologies ecosystem.

The Dublin-based company launched its Catalyft PL and PL40 for the Catalyft expandable interbody system. Medtronic designed it for anterior rim engagement with a beveled tip for ease of insertion, integration with StealthStation Navigation, simplified bone graft delivery and active expansion at a precise angle and lift for minimally invasive sagittal alignment.

The company also launched its Space-D access system that enables pedicle-screw-based distraction, retraction and compression. It is compatible with Medtronic’s other screw system CD Horizon Solera Voyager.

Medtronic added the Accelerate graft delivery system with Grafton DBF to its minimally invasive product line. It allows for more controlled and efficient delivery of graft material into the disc space or other locations. The company said that it enables …

AI technology automates tedious cell culture work and analyses

By Joanna Hawryluk, PhD, Product Manager, Olympus Life Science

Since the early 20th century, cell culture has been considered the gold standard in various research, drug development, and diagnostic labs. Within drug discovery, cell cultures are used to develop and test compounds to determine compound efficiency and efficacy.

Before you begin growing cell cultures, you must first select the cell line that most appropriately complements the compound. The reason is that the activity may be specific to a certain cell type or protein expressed by the cells. Then you must outline the optimal conditions for both the cell culture media and the drug solvent, as well as other reagents that will be used in the process. A variation in each of these factors could affect the robustness of the downstream cell-based assay by influencing the live cells and, therefore, the assay’s results.

This brings up some important questions. How do you make sure your procedur…

Decibel Therapeutics announces study on noise-related inner ear damage

Decibel Therapeutics (NSDQ:DBTX) has a working hypothesis that molecular characterization of the cell biology of the inner ear could pave the way for treatments for hearing and balance disorders.

The Boston-based biotech company has announced that a recent study published in Cell Reports supports that hypothesis.

“We were thrilled to leverage our data and expertise in inner ear biology to help fuel this analysis, which may help enable identification of therapeutics that counter the observed trends in gene expression that occur following noise exposure,” said Joe Burns, vice president, discovery at Decibel Therapeutics, in a statement.

The company partnered with the University of Maryland School of Medicine and the Karolinska Institute on the research.

Decibel Therapeutics had its IPO on February 12. Its shares have since fallen from $18.03 apiece to $7.71 today.

Lexington, Massachusetts–based Frequency Therapeutics has also seen its stoc…

India’s Gennova developing mRNA COVID-19 vaccine

India is vying to create domestic mRNA COVID-19 vaccines, with Gennova Bio (Maharashtra) emerging as a frontrunner. The company’s investigational HGCO19 vaccine will be the focus of a Phase 2/3 study.

The vaccine, developed in collaboration with privately-held Seattle-based HDT Bio, has received funding from India’s Department of Biotechnology and Ministry of Science and Technology.

Lyophilized (freeze-dried) HGCO19 has less stringent storage requirements than the vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA), making it a better fit for developing nations.

Gennova’s experimental vaccine is also unique in that it uses self-amplifying mRNA in place of the non-replicating mRNA found in vaccines from Pfizer and Moderna.

Gennova aims to win emergency use authorization for the vaccine candidate in India by the end of the year.

India has also approved a DNA-based vaccine from Zydus Cadila (NSE:CADILAHC) known as ZyCoV-D.

mRNA quic…

REGEN-COV cuts viral load within 7 days in COVID-19 patients

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen.

REGEN-COV, known as Ronapreve outside of the U.S., led to a 36% reduced risk of death by day 29 in the overall treatment population.

“These new results, combined with the nearly 10,000-patient RECOVERY trial, further validate how REGEN-COV can change the course of illness for patients even after they are hospitalized with COVID-19,” said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron, in a statement.

Roche has partnered with Regeneron (NSDQ: REGN) to help manufacture and distribute REGN-COV2, which Regeneron first developed.

Roche’s chief medi…

How a future-minded medtech engineer finds inspiration, innovation and creativity

Marie Ottum, principal R&D engineer in TE Connectivity’s Advanced Technology Group [Photo courtesy of Marie Ottum]The future of medtech is the focus of TE Connectivity’s Advanced Technology Group, a team of experienced engineers tasked with identifying trends and developing new technology for devices and challenges that might not yet even exist.

Marie Ottum, principal R&D engineer in TE Connectivity’s Advanced Technology Group and global leader of the TE women’s networking group, is an expert on single-use endoscopes who was recently featured on MassDevice’s DeviceTalks Tuesdays.

Medical Design & Outsourcing caught up with Ottum to learn more about how and where she finds inspiration, innovation and creativity.

Get the full story at our sister site Medical Design & Outsourcing.

Merck picks up Acceleron for $11.5B

Merck (NYSE:MRK) has agreed to acquire the biopharma Acceleron Pharma (NSDQ:XLRN) for $180 per share in cash, bringing the purchase price to roughly $11.5 billion.

The companies expect the deal to close in the fourth quarter of 2021.

Cambridge, Massachusetts–based Acceleron specializes in developing drugs that aim to balance transforming growth factor (TGF)-beta, which plays a role in regulating cell growth and wound healing.

Acceleron’s lead therapeutic candidate, sotatercept, inhibits TGF-beta. The drug could potentially find use for patients with pulmonary arterial hypertension (PAH). The company has a Phase 3 study underway testing sotatercept as an adjunct to standard of care PAH treatment.

“This is a very exciting transaction for us and one that provides Merck with cutting-edge science, and aligns perfectly with the business development strategy we’ve spoken about previously,” said Rob Davis, CEO and president of Merck, in a call with …