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MassDevice.com +5 | The top 5 medtech stories for May 12, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Xtant Medical amends Orbimed credit line to $15m, taps restructuring advisors
Xtant Medical said today that it amended its senior credit line with OrbiMed Advisors, saying it plans to use the $15 million facility to pay off the ...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
No-touch ’ heart bypass surgery reduces strokes
Four surgical methods of coronary artery bypass grafting with increasing degrees of aortic manipulation. Percentages pictured represent the relative decrease in risk of perioperative stroke using anOPCABG compared to the other techniques. [Image from the researchers]]A recent study from the University of Sydney and Sydney Heart and Lung Surgeons has shown that a new “no-touch” beating heart bypass surgery technique has reduced post-operative stroke by 78%.
The procedure, known as an OPCABG, also reduced post-operative mortality by 50% compared to traditional coronary artery bypass grafting. It reduced renal failure by ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular CABG MedTech Sydney Heart and Lung Surgeons University of Sydney Source Type: news
Anaconda Biomed raises $17m for next-gen brain thrombectomy device
Anaconda Biomed said it raised nearly $17 million (€15 million) in a Series A round for the neurothrombectomy device it’s developing.
The round, led by new investors Ysios Capital, Omega Funds and Banco Sabadell and prior backer Innogest Capital, is enough to carry the ANCD Brain device through validation & verification and clinical studies ahead of a CE Mark bid in the European Union, co-founder & CEO Ofir Arad said in prepared remarks.
The proceeds are also earmarked for an initial approval submission to the FDA, Arad said. Ysios general partner Josep Sanfeliu and Omega Funds managing director Claudio...
Source: Mass Device - May 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Funding Roundup Neurological Anaconda Biomed Source Type: news
7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Dextera seeks expanded indications for MicroCutter 5/80 stapler
Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news
Finland extends due date on Nexstim R & D loans
Nexstim said today that the Finnish Funding Agency for Innovation has agreed to extend the due date for repayment of 2 of its research & development project loans.
According to the agreement, the company was supposed to provide cash repayments up to €1.8 million ($2 million) between 2017 and 2019. Now, that range has been pushed back to between 2020 and 2022. The company has to fully repay both loans to Tekes by the end of 2023, Nexstim said.
“This agreement, which reschedules our R&D loan repayment payments to Tekes, will have a positive effect on Nexstim’s cash flow and will help to support our workin...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Neurological Wall Street Beat Nexstim Source Type: news
SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage.
Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA approved an expansion of the study, which can now enroll another 500 patients after an independent data monitoring committee reviewed the data against preset safety and performance criteria, Redwood City, Calif.-based SentreHeart said....
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Cardiac Rhythm Management SentreHeart Source Type: news
ReWalk debuts Restore soft-suit exoskeleton prototype
ReWalk Robotics (NSDQ:RWLK) today debuted the prototype of its Restore soft suit exoskeleton designed to aid stroke survivors.
The company presented the prototype alongside collaborators from Harvard University’s Wyss Institute for Biologically Inspirde Engineering, and said it would focus on the suit as a “core company goal” for the fiscal year.
“We are thrilled with the progress of the Restore system, which will provide life changing technology to a whole new class of patients facing mobility issues. With the prototype finished, we are eager to begin clinical studies and pursue regulatory approva...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics ReWalk Robotics Source Type: news
FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery.
The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure.
“Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evo...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Cardiac imaging dev VerAvanti raises $5m
Previously-stealthy cardiac imaging developer VerAvanti said today it raised $5 million in a recent round of financing to support its Scanning Fiber Endoscope device development.
The Redmond, Wash.-based company’s SFE device uses technology licensed from the University of Washington and consists of an imaging station and micro-sized catheter which can take high-quality images inside of vessels to improve the diagnosis and treatment of stroke and other heart conditions.
VerAvanti said that it has received 2 NIH research Phase 1 grants totaling $586,000 in May and June, alongside support from the company’s founder Ge...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Imaging VerAvanti Source Type: news
Myomo wins CE Mark for next-gen MyoPro powered orthotic
Myomo said today it won CE Mark approval in the European Union for its next-gen MyoPro myoelectric arm orthosis device.
Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity.
Myomo touted the MyoPro as the only lightweight wearable device designed to restore function to paralyzed or weakened arms and hands in individuals who have suffered a stroke, spinal cord or nerve injury or other neuromus...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Myomo Inc Source Type: news
Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year.
The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device.
Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage.
The TriGuard 3 is designed to be anatomy independent and for a ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news
Neural Analytics launches study of transcranial doppler for evaluating mild-TBI
Neural Analytics said today it enrolled the 1st patient in a 2-year study exploring the use of its Lucid M1 transcranial doppler ultrasound system to evaluate cerebral blood flow in patients with mild traumatic brain injuries.
The Lucid M1 system is a portable all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities in patients with brain disorders, the Los Angeles, Calif.-based company said.
In the 240-patient trial, researchers at the University of California Los Angeles will examine high school and college age enrollees in 3 separate groups, including those who have been affected...
Source: Mass Device - August 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Neural Analytics Source Type: news
FDA clears Nordisk ’s Victoza as only Type II diabetes drug to cut cardio risks
The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke.
The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA clears Nordisk’s Victoza as only Type II diabetes drug to cut cardio risks appear...
Source: Mass Device - August 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news
Rapid Medical launches Tigertriever registry study
Neurovascular device maker Rapid Medical said it launched a registry study of its Tigertreiver controllable stent retriever.
The Israel-based company touts the Tigertriever as the only controllable, fully-visible stent retriever which can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.
The newly launched European multi-center registry study looks to enroll patients in France and Switzerland, and will be the 1st to examine the use of the Tigertriever in a real-life setting. The company said it has enrolled its 1st patient in the trial at Switzerland’s Cantonal Hospital of Lucerne.
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Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Stents rapidmedical Source Type: news
Qool Therapeutics raises $8m to support temp management device
Early stage med device developer Qool Therapeutics said today it raised $8 million in a Series A-1 round to support development and trials of its Qool device designed for targeted temperature management and exercise recovery.
Joining the funding round was Zhongji Holdings and Join Medical Technology, Tampcap LLC, BrilliMedical International, BioPacific Investors, Western Technology Investment and FundRx, the Silicon Valley-based company said.
Qool Therapeutics said that in addition to the funding, it has also received an award from the US Department of Defense’s Defense Innovation unit Experimental organization.
The ...
Source: Mass Device - November 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Respiratory qooltherapeutics Source Type: news
