Synchron’s thought-to-text tech starts clinical trial

Synchron’s Stentrode technology is designed to restore communication to people with paralysis. (Image from Synchron)

Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis.

The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications technologies.

Stentrode was designed to be small and flexible enough to safely pass through curving blood vessels in a procedure called cerebral angiography, eliminating the need for open brain surgery, according to Campbell, Calif.-based Synchron. By using blood vessels to deliver the technology to the brain, the technique may reduce risk of brain tissue rejection of the device, which has been a significant problem for other techniques, the company said. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.

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Catapult, Smithwise slated to merge

Medical device development firms Catapult Product Development and Smithwise have agreed to merge.

Founded in 2012, Catapult is a full-service medical device development firm, specializing in console-based diagnostic and therapeutic systems, minimally-invasive surgical and diagnostic tools, and an array of portable and handheld medical equipment. The Waltham, Mass.-based company works extensively with startups to enable their core technologies, and with established device manufacturers and academic centers as they accelerate device development projects toward commercialization.

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Loop Medical lands $3.2M grant for blood collection device

Loop Medical said today that it has received a $3.2 million grant from the Bill & Melinda Gates Foundation to support pre-production and clinical trials required for the global registration of its blood collection device. The foundation had previously given the company a $400,000 grant.

Based at the Swiss Institute of Technology (EPFL) in Lausanne, Switzerland, Loop Medical designed the device to be painless, easy-to-use and able to collect samples that are large enough for common high-throughput blood analyzers. The device was also designed to improve safety, particularly in countries with low medical resources.

In the standard venipuncture procedure, a long needle is used to collect blood from the vein. Loop accesses blood in capillaries that are just below the skin, through a minimally invasive and painless manner, according to its website.

Loop has been working with clinical pathology and histocytopathology company Cerba HealthCare since 2017 to design a device that can be fully integrated into existing centralized laboratories’ infrastructures and processes. The device targets clinical pathology laboratories, clinics, pharmacies, physician offices and patients at home. The technology addresses the need to empower patients, communities and healthcare professionals through a safe and effortless solution in a highly commoditized blood collection market under significant price pressure, according to Loop.

“We are thrilled to have received this second grant from the Bill & Melinda Gates Foundation. It shows trust in our project and is a recognition that our early development activities are well managed,” said Loop Medical founder & CEO Arthur Queval in a prepared statement. “We are convinced our painless and easy-to-use device is a major breakthrough. It will benefit both the blood collection procedure itself and the safety and convenience of the end-to-end diagnostic process for a variety of health conditions and geographies around the world.”

3M debuts long-wearing medical adhesive

3M (NYSE:MMM) said that it has added an extended-wear medical transfer adhesive to its lineup of advanced adhesives for medical devices.

Designed to laminate many substrates, 3M medical transfer adhesive 4075 features an extended-wear pressure sensitive-transfer adhesive and allows design engineers to use a variety of backings. The new adhesive also offers up to a 14-day wear time, depending on the backing material used.

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Is this the way to improve organ transportation?

Lisa Anderson Headshot

Lisa Anderson, president, co-founder and COO of Paragonix Technologies

Organ transplants are performed annually to remove diseased organs and replace them with healthy ones to extend the lifespan of patients. Potential transplant recipients are placed on a waiting list by a doctor who has determined that a transplant is the best course of action. Once a donor organ is available, the organ transportation system becomes one of the most critical medical devices of the transplantation process, according to Lisa Anderson, president, co-founder and COO of Paragonix Technologies.

Before Anderson helped found Braintree, Mass.–based Paragonix Technologies, she was working in the lab at Harvard Medical School and discovered that two important things were missing in the way organs were being transported:  preservation and respect.

“I was at Harvard Medical School doing research in Type 1 diabetes and one of the aspects of my research was to dissect the human pancreas. This was a revelation to me that when I first saw the human pancreas coming into the lab, I called my colleague and I said, ‘Oh my god, they messed up the packaging here. I can’t believe that organs are transported like that. Is this just for research?’” Anderson told Medical Design & Outsourcing in an interview. “I was really upset about it. I still remember it. We called the lab and the clinical staff and they said, ‘No, this is how organs are transported – even for transplantation.’”

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Treace Medical touts results of bunion surgery study

Treace Medical’s Lapiplasty bunion procedure is designed to correct foot bone alignment and stabilize the toe. (Image from Treace Medical)

Treace Medical Concepts said a study of its bunion implant surgery showed more rapid healing than traditional osteotomy.

The study of the Ponte Vedra, Fla.-based company’s Lapiplasty 3D bunion correction system showed that most patients were able to stand on their operative foot five days after surgery and had a high rate of healing nine months after the procedure.

The study enrolled 195 patients, including 19.5% who had comorbidities known to compromise bone healing, with a mean follow-up of 9.5 months. Ninety-seven percent of the patients demonstrated a successful bony fusion of the joint and 98.9% maintained a stable joint position over the course of the study, which was published in The Journal of Foot & Ankle Surgery. The implant removal rate was 3.1% compared with conventional plate implants where published removal rates can be greater than of 17% for tarsometatarsal and 20% for big-toe joint fusion procedures.

The Lapiplasty procedure is designed to reproducibly correct all three planes of the bunion deformity and address the root cause of the bunion while allowing patients to get back to their active lives quickly. A bunion, or hallux valgus, is a foot deformity that affects about 60 million Americans and results in approximately 400,000 surgeries in the U.S. annually, according to the company.

“This study demonstrated positive bone healing rates over progressive timepoints when utilizing biplanar plating without a cross-joint compression screw in procedures used to treat bunions or arthritis of the big toe joint,” said lead author Dr. Paul Dayton of the Midwest Bunion Center (Des Moines, Iowa), in a prepared statement. “The bone healing rates were quite encouraging, given this unique fixation approach allowed patients to undergo an accelerated recovery protocol and to initiate weightbearing in a post-operative boot within their first week of surgery.

“Overall, I’m very pleased with these results as they reinforce that I can offer this fixation option to my patients with a high level of confidence that they will experience reliable bone healing under an accelerated weight-bearing protocol.”

“The outcomes of this new study are noteworthy in that they closely mirror those reported in our 13-month multicenter dataset presented at the 2018 American Orthopaedic Foot & Ankle Society’s (AOFAS) annual meeting in Boston,” added Dr. Robert Santrock of West Virginia University and co-author on this new publication. “In the AOFAS dataset, the 61 feet treated with Lapiplasty 3D Bunion Correction showed low 1.6% symptomatic non-union rate and 3% radiographic recurrence rate. Patients in the AOFAS study initiated weightbearing in a post-operative boot at an average of 10.5 days, which is consistent with this new study.”

“The rapid time to weightbearing, high rate of bone healing, and low implant removal rate reported in this study further highlight the patient benefits of biplanar plating — the fixation method used in the Lapiplasty procedure,” said Treace Medical CEO John  Treace. “The study represents the 9th peer review publication supporting the Lapiplasty procedure, another important milestone for our company.”

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ECRI Institute to open international medtech testing lab in Malaysia

ECRI Institute said it is launching its first medical device evaluation laboratory outside the United States.

The ECRI International Research Centre in Selangor, Malaysia will evaluate medical devices used across all care settings in Europe and Asia to help medical professionals make informed decisions that improve patient safety, according to the nonprofit, independent organization. It is scheduled to open April 11.

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Medtronic launches Shanghai-based medtech incubator

Medtronic logo updated

Medtronic (NYSE:MDT) said yesterday that it launched a new incubator and accelerator in Shanghai, China looking to support early-stage medtech companies both in the region and globally.

The newly launched incubator, dubbed the Medtronic MedTech Innovation Accelerator, resides in the Pujiang International Science and TechnologyCity in Shanghai’s Minhang District, the Fridley, Minn.-based company said.

“For nearly 70 years, Medtronic has been focusing on developing transformative medical technologies that improve lives. We promote meaningful innovation by continually investing in internal R&D, as well as expanding external partnerships. China represents a tremendous opportunity, given its significant market size, abundance of unmet clinical needs, and active entrepreneurship landscape. Establishment of the Medtronic MedTech Innovation Accelerator forms another bold step to continue to advance innovation through collaboration,” CEO Omar Ishrak said in a press release.

Medtronic said that it hopes the new incubator will contribute to Shanghai’s goal of becoming a science and technology innovation hub, adding that the company has received an endorsement from the Minhang District government of Shanghai.

“Shanghai’s plan to become a science and technology innovation hub is entering an advanced stage. As a key component in this plan, Minhang District is striving to improve technology commercialization capacity in its jurisdiction. The Medtronic MedTech Innovation Accelerator fits well into our plan. In the future, we will help further connect industry players, big or small, local universities, and research institutions to foster more medical innovation through collaboration and ecosystem building,” Minhang District deputy district governor Wu Bin said in a prepared statement.

The company said that it also received support from one of the city’s primary state-owned investment groups, Lingang Economic Development Group. The Lingang Group promised to provide subsidies and policy incentives for the incubator’s portfolio companies and other resources.

“Lingang Group is committed to building an industrial cluster in Shanghai that is focused on biotechnology. The Medtronic MedTech Innovation Accelerator will help us drive toward this goal by filling the gap in the existing MedTech innovation ecosystem,” Shanghai Lingang Economic Development Group VP Xu Bin said in a prepared release.

Medtronic said it has already signed up a number of startups from both in and outside of China for its initial roster, and that moving forward it will prioritize supporting early-stage innovations focused on applied artificial intelligence, surgical robotics and neuromodulation.

Companies in the incubator will have access to advanced lab equipment supplied by Medtronic, as well as expert advice from Medtronic China R&D staff, with possible equity investments from its Medtronic China Ventures group possible, the company said.

“The Medtronic MedTech Innovation Accelerator will promote closer partnerships between the company and a new generation of MedTech innovators and entrepreneurs to better advance our enduring mission to alleviate pain, restore health and extend life in China. Together, we are better positioned to upgrade China’s MedTech industry, help transform the domestic healthcare system with technology breakthroughs, and drive further toward the realization of the ‘Healthy China’ vision set out by the central government,” Medtronic Greater China prez Alex Gu said in prepared remarks.

Last week, the U.S. Dept. of Homeland Security released a medical advisory warning of exploits within a number of Medtronic implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data.

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Ethicon seeks data on Neuwave liver ablations


Ethicon’s Neuwave is a target ablation tool for small to large lesions, as well as a resection tool. (Image from Ethicon)

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it has launched a global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company’s Neuwave microwave ablation system.

The multicenter, observational registry will follow approximately 1,500 patients worldwide for five years from the date of their first liver ablation procedure with the Neuwave system, a minimally invasive microwave ablation technology that uses heat transmitted through image-guided needle-like probes to destroy soft tissue lesions.

The company will collect data from up to 30 centers throughout the world on the technical aspects of the procedure, including ablation time under varying liver tissue and lesion conditions. Efficacy and other outcome data will also be documented and assessed at various time points over the course of the study, according to the company, which announced the registry at the Society of Interventional Radiology (SIR 2019) meeting in Austin, Texas.

Neuwave is a minimally invasive system designed to enable physicians to tailor ablations for lesions of varying shapes and sizes with consistency and control, according to Ethicon. Most patients leave the hospital the same day with only a bandage at the probe insertion site, according to a 2014 study published in the Journal of Vascular Interventional Radiology.

“The goal of the registry is to systematically and comprehensively develop ablation parameter guidance for the microwave ablation of liver lesions with the Neuwave system,” said University of Wisconsin School of Medicine and Public Health interventional radiologist Dr. Paul Laeseke in a prepared statement.

“Microwave ablation is an important treatment option that is increasingly being utilized throughout the world, and this data may provide new insights into factors that are critical for successful outcomes across a range of patients, clinical settings and health care providers,” added Laeske, who consulted on the registry’s design. “The registry will be an important contribution to our understanding of microwave ablation and support its further adoption.”

The registry will also include data from consenting patients enrolled in other Ethicon-sponsored studies on microwave liver ablation with the Neuwave system in Korea and China and a multicenter study that is evaluating the device using Neuwave’s ablation confirmation software, which is designed to help physicians identify ablation targets, assess appropriate probe placement and confirm the technical success of each procedure.

“Microwave is the fastest growing ablation modality, and as this treatment grows, Ethicon is committed to working with clinicians throughout the world to generate robust clinical evidence for the innovative Neuwave microwave ablation system,” said Piet Hinoul, global head and leader of Ethicon’s medical and clinical franchise. “This will help inform treatment decisions and improvements in procedural efficiency and patient outcomes.”

Neuwave is cleared for the ablation of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. It is not cleared for the treatment of any specific disease or condition and is not indicated for use in cardiac procedures.

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Titan Medical, Teleflx ink collab robotic ligation dev deal

Teleflex, Titan Medical

Titan Medical (NSDQ:TMDI) said today that it inked a collaborative development deal with Teleflex (NYSE:TFX) to integrate its polymer ligation technology into Titan’s Sport single-port robotic surgical platform.

Toronto-based Titan Medical said that Wayne, Penn.-based Teleflex’s polymer ligation system is intended for vessel sealing and includes an enhanced clip security feature that has been previously used in millions of cases.

“Our patented, multi-articulating instruments have been developed to facilitate the integration of advanced tools and technologies. This collaboration with Teleflex permits the expansion of our robotic instrument portfolio to offer market-leading, proven technology in a variety of surgical disciplines. Teleflex is a leading and innovative medical technology company with whom we share a common purpose of improving patient outcomes with clinically-inspired technology. We are proud to be working with them,” Titan Medical prez & CEO David McNally said in a press release.

“We continue to partner with leading robotic companies to allow surgeons globally to use our trusted Weck ligation solutions. We are excited about Titan Medical integrating our technology into its single-port robotic surgery system,” Teleflex surgical division GM James Ferguson said in a prepared statement.

Late last week, Titan Medical said that it closed a $25 million public offering.

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