Japan approves Inspire Medical’s obstructive sleep apnea neurostim device

Inspire Medical Systems said this week it won approval from Japan’s Ministry of Health, Labour and Welfare for its Inspire therapy system, now cleared to treat moderate to severe obstructive sleep apnea.

The Inspire system is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea.

Inspire Medical Systems said that it will pursue reimbursement in the country, with plans to launch the device in the second half of next year.

“With this approval for our Inspire therapy, we are able to provide patients and physicians in Japan with a new alternative for the treatment of moderate to severe OSA. Our Inspire therapy is supported by a strong body of evidence with more than five years of clinical experience demonstrating the efficacy and safety of our therapy for patients and physicians. We look forward to commercializing our Inspire therapy in Japan. We would like to thank Cobridge Co., Ltd., a leading regulatory affairs consulting firm that provides comprehensive product registration services for medical products in Japan, for their outstanding efforts and expertise in assisting us to gain approval in Japan,” prez & CEO Tim Herbert said in a press release.

Last month, Inspire Medical Systems up-sized its initial public offering to $108 million, or some $124 million if the underwriters option is exercised in full.

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Medtech cybersecurity group MedCrypt raises $2m in seed round

Medical device cybersecurity group MedCrypt said today it raised $1.9 million in a seed round of financing to help support its medtech-specific embedded cybersecurity software.

The round was led by Eniac Ventures and joined by Sway Ventures, Nex, Cubed, Oronoco Investments and Friedman BioVentures, the Encinitas, Calif.-based company said.

“Cyber threats are an exponentially increasing problem that is threatening businesses, governments, households and, in healthcare, even lives. MedCrypt has already set itself apart with a seasoned technical team and proprietary technology that is helping the largest medical device makers in the world protect their devices and the underlying users. Our team is excited to support Mike Kijewski and Eric Pancostin continuing to build out MedCrypt as the most comprehensive security layer for healthcare IT,” Eniac Ventures founding general partner Tim Young said in a press release.

MedCrypt is developing cryptographically embedded security software intended to help vendors protect their products from outside assault and monitor the behavior of the devices after they’ve been deployed.

“The FDA is cracking down on medical device cybersecurity by releasing more robust regulations by which medical device vendors and healthcare delivery organizations are required to abide. Our solution lets these organizations protect their devices – and patients – with just a few lines of code. We’re thrilled to gain additional funding and support to help accelerate our technology,” co-founder & CEO Mike Kijewski said in a prepared statement.

The financing brings the total the company has raised to date up to $3 million, MedCrypt said.

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Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.

The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.

“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery,” chief scientific officer Dr. Matthew Dowling said in a press release.

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How’d they do that? 7 innovations from medical device contract manufacturers

[Image from Rohan Makhecha on Unsplash]

Charles Darwin wrote, “In the long history of humankind (and animal kind, too) those who learned to collaborate and improvise most effectively have prevailed.”

Medical device manufacturers get the credit for many innovations, but many need the ingenuity and commitment of contract manufacturers who design and produce the components that make those big splashes possible. The end result of such collaborations may improve or even save lives.

Here are some examples of recent advances out of contract manufacturers that are enabling medical device innovation.

Next>>

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Pulmonx wins FDA approval for Zephyr endobronchial valve

The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema.

Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from entering the diseased alveoli but allow it to escape during exhalation.

The federal safety watchdog said it granted Zephyr’s PMA based on a 190-patient study comparing treatment with Zephyr, plus standard medical management and pulmonary rehabilitation, to treatment with standard medical management and rehab only. The trial’s benchmark was at least a 15% improvement in pulmonary function score.

Some 47.7% of patients in the Zephyr arm met that mark, compared with 16.8% of the control arm, according to the FDA. Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain, the agency said.

“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients,” Tina Kiang, acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control & Dental Devices, said in prepared remarks. “This novel device is a less invasive treatment that expands the options available to patients.”

Pulmonx said more than 14,000 patients have been treated with the Zephyr valve worldwide since 2007.

“It is gratifying to be able to tell the many US patients who have contacted us that help is on the way. We thank FDA for its swift review of the Zephyr Valve. By combining the Zephyr Valves and our patient selection tools, we are bringing precision medicine to the treatment of severe emphysema,” added Pulmonx CEO Glen French.

“Zephyr valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer. I have seen Zephyr valve-treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient’s confidence and change their life for the long term,” lead investigator Dr. Gerard Criner, of Temple University’s Lewis Katz School of Medicine, said in a press release.

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Neurologic-focused digital therapeutics group MedRhythms raises $5m

Early stage medtech company MedRhythms said today it raised $5.3 million in a Series A round of financing to help support its platform intended to use neurologic interventions to measure and improve walking.

The Portland, Maine-based company said it initially intended to raise $4 million, but found “substantial interest” and ended up netting extra funds. MedRhythms added that it has already closed $5 million from the round.

Funds will support continued development and a potential launch of MedRhythm’s digital therapeutics platform intended to aid individuals with neurologic injuries and diseases and improve walking.

MedRhythm’s first product will focus on the post-stroke population, while pipeline products aim at treating Parkinson’s Disease, Multiple Sclerosis, Aging-In-Place and traumatic brain injury.

In connection with the funding, MedRhythms said it expanded its board from three to five members, adding Chemwerth prez & chair Peter Werth, who led the Series A round, and former Biogen and Novartis CIO Ray Pawlicki.

“Developing digital therapeutics based on music requires the right mix of talent on the team, including experts in music, biotech, healthcare and technology. We are thrilled to have Peter Werth lead this financing round, as his track record of success building and investing in healthcare businesses is the right balance of expertise that will allow us to achieve MedRhythms’ mission and vision of making a high-quality clinical impact in the lives of millions of people,” CEO & co-founder Brian Harris said in a press release.

“We found MedRhythms’ strategy and business plan to build digital therapeutics for walking a compelling investment opportunity. MedRhythms has excellent growth prospects with a pipeline of therapeutic and diagnostic products in large, growing markets and is building the right team to execute,” Werth said in prepared remarks.

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Ocular Therapeutix resubmits NDA for ocular pain relief implant

Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA.

The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time.

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

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Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system

Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes.

The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce the system into the US market.

The newly cleared accessory makes the system, which was previously limited in compatibility to a select number of dual-channel endoscopes, compatible with a wider range of endoscopes, Apollo said in a press release.

Earlier this month, Apollo Endosurgery said it closed a $23.7 million round of financing.

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Precision Therapeutics finalizes Helomics buy, completes pivot to personalized medicine

Precision Therapeutics (NSDQ:AIPT) said yesterday it inked a definitive merger agreement with Helomics, completing the company’s plan to pivot towards artificial-intelligence powered personalized medicine.

Minneapolis-based Precision Therapeutics inked a deal to acquire the remaining 75% equity stake in Helomics in April, after having purchased preferred stock in the company convertible into a 20% stake in January and converting a previous $500,000 loan with Helomics into a 5% equity stake in March.

Pittsburgh, Penn.-based Helomics developed and maintains the D-Chip database which contains de-identified data from clinical tests of tumor responses to drugs and uses artificial intelligence powered bioinformatics to generate insights from the data, Precision Therapeutics said.

The acquisition will provide Precision Therapeutics full access to Helomics artificial intelligence, precision diagnostic and integrated CRO capabilities to improve patient care. The company added that it hopes the addition will make it more competitive in the precision oncology department, and will drive revenue generation for the current year.

“Completing this definitive merger agreement represents a milestone in our strategy to cement our leadership position in the precision oncology market. Upon completion of the merger, we will have complete ownership of Helomics’ one of a kind tumor database, which has been developed over 15 years of clinical testing and contains drug response profiles of over 149,000 patient cancer tumors, and its D-CHIP bioinformatics engine that provides actionable insights into this data. There is significant demand from pharma companies for rich molecular data as it has the potential to revolutionize the effectiveness of clinical trials and drug development, and we believe that Helomics has a truly unique and best-in-class offering, combining artificial intelligence with personalized oncology. Our focus now will be on monetizing this offering to drive revenue generation to Precision Therapeutics in 2018 and beyond,” Precision Therapeutics CEO Dr. Carl Schwartz said in a press release.

Through the deal, all outstanding shares of Helomic’s stock not already held by Precision will be converted into the right to receive a proportionate share of 7.5 million shares of newly issued Precision stock, in addition to 1.1 million Precision shares already issued for its 20% ownership.

The merger includes a condition of at least 75% of Helomic’s $7.6 million in outstanding promissory notes being exchanged for additional Precision shares at $1 per share, the company said.

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Silk Road Medical touts TCAR study data

Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease.

Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston.

The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system, and is intended to treat blockages in the carotid artery that are at risk of causing a stroke.

Results from a two-year study which compared outcomes from 1,182 patients who received treatment with the TCAR procedure to 10,797 patients who received carotid endarterectomy indicated comparable rates of in-hospital stroke or death between the two at 1.6% versus 1.4%, respectively.

Data also indicated lower rates of acute cranial nerve injury for TCAR at 0.6% versus a 1.8% rate in CEA patients, shorter operative times at 78 minutes and 111 minutes, respectively, and shorter hospital stays for TCAR patients despite increased age and sickness factors versus the CEA cohort.

Results from a separate study comparing TCAR with CEA indicated similar results, with 30-day stroke rates of 1% in TCAR versus 1.1% in CEA. Acute and six-month cranial nerve injury rates were also shown to be smaller in the TCAR cohort than CEA.

“Our overall findings showed that while patients receiving TCAR were sicker and more likely to be symptomatic with a higher degree of stenosis, the stroke and death rate compared to CEA was the same. With TCAR, there were significantly lower cranial nerve injuries, less time spent in the operating room and fewer patients with a prolonged length of stay. I believe that clinicians should more widely adopt the TCAR technology as it has demonstrated both safety and efficacy and is an excellent alternative to CEA,” study presenter Dr. Marc Schermerhorn of Beth Israel Deaconess Medical Center said in a press release.

An interim update on the company’s Roadster 2 post-market study trial indicated a 30-day stroke rate of 0.6% and stroke or death rate of 0.9% with 470 patients of an expected 600 patients enrolled.

“The large body of real-world data presented at VAM18 demonstrates that TCAR can achieve neuroprotection similar to CEA despite being performed in sicker, more frail and ‘at-risk’ patients. These results reiterate the compelling data previously published in the Roadster pivotal trial. Carotid endarterectomy has been the gold standard for 65 years, but with the growing body of evidence, the medical community is showing that TCAR is fulfilling the promise of a less invasive, more efficient, and more patient friendly procedure,” prez & CEO Erica Rogers said in a prepared statement.

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Sage Therapeutics’ chief scientist on discovering drugs and taking risks

When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk.

But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY) significantly downsized their neuroscience units.

Robichaud couldn’t shake the feeling that the industry was on the verge of walking away from what is at the very core of drug discovery.

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

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Venture investing in medtech and digital health: What the entrepreneurs see

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Medtech entrepreneurs at the Series A level agree that the funding environment remains challenging. 

Bill Evans

Entrepreneurs at the Series A funding level tend to report that their part of the funding lifecycle remains very challenging, as has been for the last decade. They also report that many A Round investors are angels, often knowledgeable of the sector such as medtech executives, and physicians and surgeons active in the startup’s area.

The is article No. 2 in a three-part series about medtech investing trends:

• Part 1 looks at what is driving the underlying trends.
• Part 2, the present article, looks at these trends from the entrepreneur’s perspective.
• Part 3, coming soon, gives advice from the trenches, to guide entrepreneurs looking to tune up their business plans to be in the best position when Series A comes around.

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

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Senseonics closes $150m public offering

Senseonics (NYSE:SENS) said today that it closed an underwritten public offering of its common stock, reeling in $149.5 million in total proceeds.

The Germantown, Md.-based company plans to use its newly-acquired funds to support the commercialization of its implantable continuous glucose monitoring system, Eversense.

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

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Jury hits DaVita with $384m verdict in Fresenius dialysate deaths case

DaVita Healthcare (NYSE:DVA) owes $383.5 million in damages, $375 million of which is in punitive damages, to relatives of dialysis patients who died after treatment at DaVita’s dialysis centers, according to court documents.

Plaintiffs in the case claimed that their relatives on dialysis care died due negligence and DaVita  using GranuFlo and NaturaLyte solutions, made by Fresenius Medical Care (NYSE:FMS; ETR:FRE), which had been recalled by the FDA.

A jury for the US District Court for the District of Colorado, under Judge Brooke Jackson, awarded a total of $8.5 million in compensatory damages and $375 million in punitive damages.

DaVita issued a response to the verdict, saying it “strongly disagrees” and that it will pursue all its appeal rights.

The company said that the GranuFlo solution it uses has been in use for more than 25 years, and added that the alleged negative clinical side effects “have been debunked” and that it is still in use. DaVita goes on to claim that facts in the trial “contradict the allegations upon which the verdict is premised.”

DaVita said it also believes there are grounds to eliminate or reduce damages in the award, and said that the punitive damages “dramatically exceeds the limits imposed under the applicable state laws in California and Illinois, as well those set forth by the United States Supreme Court.”

“Our first priority is the safety of our patients. Our clinical outcomes – among the best in the industry – demonstrate our commitment to providing the highest level of care.   We will pursue any and all avenues of appeal to overcome this unjust verdict and believe today’s verdict is unlikely to stand,” DaVita wrote in a press release.

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8 Alzheimer’s disease breakthroughs you need to know

 

[Image from dierk schaefer on Flickr]

Alzheimer’s is a form of dementia that can cause problems with memory, thinking and behavior, according to the Alzheimer’s Association. It is the most common form of dementia that gets worse over time. Nearly 6 million Americans presently live with Alzheimer’s— and there’s no cure for it.

The disease is caused by protein buildups called plaques and tangles that occur in the brain and kill nerve cells. Our brains have 100 billion nerve cells that connect parts of the brain to form communication networks. When those communication lines are interrupted, it can cause a breakdown in some parts of the brain.

An incorrect diagnosis can be dangerous as certain medications can cause neuroleptic sensitivity, irreversible parkinsonism or neuroleptic malignant syndrome.

In honor of Alzheimer’s & Brain Awareness Month, here are 8 Alzheimer’s breakthroughs you need to know.

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Novartis to spin out Alcon ophthalmic subsidiary

Novartis (NYSE:NVS) said today that it’s planning to spin its Alcon ophthalmology subsidiary into a publicly traded company after years of speculation that it wanted to sell the ill-starred division.

The Swiss pharma giant said it intends to hold on to Alcon’s $4.6 billion ophthalmic pharmaceuticals business under the Novartis Innovative Medicines umbrella, continuing a transition begun in January 2016. If consummated as expected during the first half of 2019, the separation of the remaining the surgical and vision care business would create a $7 billion enterprise with more than 20,000 employees, Novartis said.

Alcon CEO Mike Ball, tapped in 2016 to lead a turnaround, was named chairman-designate effective July 1, reporting to Novartis CEO Dr. Vas Narasimhan. Alcon COO David Endicott was tapped for Alcon’s chief executive spot, also effective July 1.

“This promises to be the beginning of an exciting new chapter for everyone associated with Alcon. The planned spinoff will be key to strengthening our leadership in the large, attractive and growing global eye care devices market. As chairman-designate, I look forward to working closely with David Endicott and the entire team at Alcon to deliver continued innovation for our customers and patients, while creating shareholder value through long-term, sustainable growth,” Ball said in prepared remarks.

“We continue to execute our strategy to focus Novartis as a leading medicines company. Alcon has returned to a position of strength and it is time to give the business more flexibility to pursue its own growth strategy as the world’s leading eye care devices company,” Narasimhan added.

Novartis also said it plans to use the proceeds from the sale of its stake in a consumer health joint venture with GlaxoSmithKline (NYSE:GSK) to fund a $5 billion stock buyback, expected to be complete by the end of next year.

“The share buyback is fully aligned with our strategic capital allocation priorities, reflects our strict financial discipline and our confidence in future top line growth and margin expansion,” Narasimhan said.

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Renovis wins FDA nod for Tesera ALIF interbody spinal fusion system

Renovis Surgical Technologies said today that it won 510(k) clearance from the FDA for its Tesera SA hyperlordotic ALIF interbody spinal fusion system.

The company’s porous, titanium, stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate designed to prevent screw backout.

Renovis’ Tesera implants are made using additive manufacturing, according to the company, and include a porous surface structure to enable bone attachment and in-growth to the implant.

With its latest regulatory win, Renovis’ portfolio of 3D-printed titanium implant systems include anterior cervical, anterior lumbar and posterior lumbar devices.

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Medtronic launches outcomes-based reimbursement program for MiniMed 670G system

Medtronic (NYSE:MDT) today launched an outcomes-based reimbursement program for its MiniMed 670G automated insulin delivery system.

As part of its ‘MiniMed 670G Performance Guarantee Program,’ the medtech giant will dole out flat-fee reimbursements of up to $25,000 per pump over four years for diabetes-related inpatient hospitalization and ER admissions.

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

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Embolx wins FDA nod for next-gen Sniper balloon occlusion microcath

Embolx said today that it won FDA 510(k) clearance for its next-gen Sniper balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy.

The Sunnyvale, Calif.-based company said that improvements to its next-gen Sniper microcath are intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 cm, 130 cm and 150 cm lengths to allow for access in either femoral or radial artery sites.

“The great thing about Sniper’s enhanced design and longer lengths is that it allows me to perform procedures using a transradial approach with the benefits of pressure-directed embolization. The ability to reverse blood flow using Sniper’s balloon helps me to not have to worry about non-target embolization. I can perform the procedure the way I want because of Sniper’s wide range compatibility with different guidewires, guide catheters, coils and therapeutic agents,” Dr. Aaron Fischman of the Icahn School of Medicine at Mount Sinai said in a prepared statement.

The Sniper Microcatheter is intended to alter blood flow dynamics by controlling pressure to allow for increased therapeutic agent delivery into target areas, and is currently used for treating cancerous tumors in the liver and other organs.

“Our next generation devices incorporate experience from more than 1,000 Sniper balloon occlusion microcatheters used to date. Now, interventional radiologists can do everything they would do with standard microcatheters, but with the added benefits of balloon occlusion. This is a big step forward and provides physicians with the most advanced transarterial delivery system for tumor and prostate treatment,” prez & CEO Michael Allen said in a press release.

In April, Embolx said that it landed a $2 million grant from the National Cancer Institute to fund development of its next-generation Sniper balloon occlusion microcatheter.

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Endologix reports 1-year data from Ovation registry

Endologix (NSDQ:ELGX) this week touted 1-year results from its Lucy registry – a study that prospectively assessed endovascular aneurysm repair outcomes in women compared to men.

The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system compared to other EVAR systems.

The study enrolled 225 people, 76 women in the treatment group and 149 men in the control group, and the primary endpoint was the 30-day major adverse event rate. Secondary endpoints included serious and non-serious adverse events after one year.

Endologix reported that despite having more complex anatomy, women experienced similar outcomes to men following treatment with the Ovation device, including 100% freedom from AAA-related mortality compared to 98.6% in men. Freedom from reintervention for Type 1a endoleak was 98.6% in women and 97.9% in men, the company reported, and freedom from rupture and conversion was 100% across both groups.

Freedom from all device-related reintervention was 97.2% in both men and women, Endologix noted.

“Women have specific anatomical challenges in iliac access and proximal aortic neck morphology and have historically had worse outcomes from EVAR than men. The results of the LUCY study suggest that the unique features of the low-profile Ovation system may overcome these challenges and achieve similar outcomes in men and women,” Dr. Jennifer Ash, of the Christie Clinic Vein and Vascular Center, said in prepared remarks.

“We are excited to have completed follow-up on the Lucy study and are pleased that the one-year results suggest, for the first time in a prospective study, that female AAA patients can be treated with EVAR as effectively as men, when using the Ovation System. Lucy’s evidence provides physicians with new information to confidently engage female patients with prospectively derived outcomes previously realized only by male patients,” Endologix CEO John Onopchenko added.

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CMS opens NCA to reconsider TAVR coverage

The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures.

Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers.

Requirements in the 2012 decision included specific procedural volume requirements for heart teams and hospitals’ as well as mandatory participation in a registry.

In a letter requesting reconsideration of the decision, Providence Health & Services of Southern California’s Dr. Peter Pelikan, Dr. Richard Wright and Dr. John Robertson said that since 2012, TAVR procedures have become more standard and safer, and urged for reconsideration of coverage.

The doctors said that initial approval of TAVR hospital programs were based on volumes of non-TAVR procedures, and that procedural volume was used “as a surrogate for program quality,” which was understandable given the novel nature of the procedure.

“Today, TAVR has become a commonplace and safe procedure, with indications now expanded from high risk to intermediate risk patients as well. Procedural volumes across the country are increasing, with excellent outcomes. Thus, the early motivation for the NCD, insuring quality for a new and high risk procedure, is no longer relevant,” Providence Health & Services authors wrote in their letter.

Medtech dev Edwards Lifesciences (NYSE:EW), maker of the Centera and Sapien lines of TAVR devices, also showed support for the reconsideration and urged CMS to expand availability to reach more patients.

“As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients’ access to this life-saving care,” Edwards wrote in a press release.

CMS said that on July 25, it will convene a panel of its Medicare Evidence Development & Coverage Advisory Committee seeking its recommendations “regarding the evidence on procedural volume requirements for hospitals and heart team members” necessary to launch and maintain TAVR programs.

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Neuronetics prices $94m offering

Neuronetics today priced its upcoming initial public offering, expecting to raise approximately $93.5 million to support its NeuroStar transcranial magnetic stimulation system designed to treat patients with major depressive disorder who aren’t responding to medication.

The Malvern, Penn.-based company said it is looking to float 5.5 million shares of its common stock at $17 per share in its IPO. The offering also includes a 30-day underwriter’s option to purchase an additional 825,000 shares, which could net an additional $14.5 million for the company.

Shares are expected to begin trading today under the ticker symbol “STIM”, Neuronetics said, and is expected to close on July 2, according to a press release.

The company’s NeuroStar device uses MRI-strength magnetic fields to stimulate specific areas of the brain associated with mood. The device initially won 510(k) clearance from the FDA in December 2008, for treating adults with major depressive disorder who previously failed to respond to one medication. The federal safety watchdog expanded NeuroStar’s indication in May 2014 to cover adult patients who failed to respond to one or more medications in their current depressive episode.

There are 781 NeuroStar installations across 615 psychiatry practices, with some 50,000 patients treated in roughly 1.8 million sessions, the company said in its SEC filing. The company reported losses last year of -$16.1 million, or -$2.97 per share, on sales of $40.4 million, increased its red ink by 42.9% on sales growth of 18.1% compared with 2016.

First-quarter losses grew 21.8% to -$5.5 million, or -84¢ per share, on sales of $10.2 million for the three months ended March 31, for a top-line gain of 34.9% compared with Q1 2017.

The company registered for the IPO earlier this month, with Piper Jaffray and William Blair & Co. maned as joint book-runners and Canaccord Genuity and JMP Securities as co-managers.

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PQ Bypass touts 1-year Detour study data

PQ Bypass touted 12-month data today from a trial evaluating its Detour percutaneous femoropopliteal bypass system.

Results from the Detour I trial showed “promising 12-month durability” for patients with extremely long blockages in the superficial femoral artery, the company reported.

The study included lesions that were longer and more complex than typically seen in SFA trials: the average lesion length was 37 cm, PQ Bypass said.

“The lesions treated in Detour I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dr. Dainis Krieviņš, vascular surgeon & director of the Institute of Research at Pauls Stradins Clinical University Hospital. “Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average Detour lesion and fail approximately 40% of the time by the 12-month milestone. This truly highlights the need for the minimally invasive Detour procedure for long, complex SFA lesions.”

PQ Bypass’ percutaneous femoropopliteal bypass procedure uses the company’s stent grafts to make a path that sends blood around the blocked part of the artery, restoring blood flow to a patient’s lower leg and foot.

The company’s Detour I trial enrolled 77 patients and treated 81 lesions. Primary patency at 12 months in all lesions was 73%, while primary-assisted patency was 80%. Secondary patency was met in 94% of the study’s participants.

PQ Bypass also noted that the trial had 100% freedom of amputation, 99% freedom from acute limb ischemia and Rutherford improvement of greater than or equal to two classes in 90% of patients.

“These results represent exciting promise for patients with long, complex SFA lesions, a growing, yet severely underserved population,” Heather Simonsen, VP of global therapy development, said. “By routing blood around the disease, rather than forcing a way through it, the Detour System is designed to treat extremely long lesions that are not well-addressed by current endovascular devices.”

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Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding

Data from a collaboration between Ferring Pharmaceuticals, Merck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth.

Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent the deadly condition. But oxytocin has to be stored and transported at 2 – 8°C, which is not always possible in countries where adequate storage and distribution resources are scarce.

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

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Medtronic wins $472m cardio device DoD contract

Medtronic (NYSE:MDT) won a $471.6 million contract with the US Department of Defense to provide it with cardiovascular products, according to a DoD release posted yesterday.

The fixed-price with economic-price-adjustment, indefinite-deliver/indefinite-quantity contract is a sole-source acquisition deal for cardiovascular products, according to the release. The deal comes with a single year base contract and four one-year option periods, and a performance completion date of July 1 2023.

Through the contract, the Fridley, Minn.-based company will supply cardiovascular products to the Army, Navy, Air Force, Marine Corps and federal civilian agencies, according to the release.

Last week, Medtronic won expanded FDA clearance for its MiniMed 670G hybrid closed-loop diabetes management device, which is now indicated to include people ages 7 to 13 with Type I diabetes.

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Cochlear launches Nucleus app for Android devices

Cochlear Ltd. (ASX:COH) said today it launched a Google (NSDQ:GOOG) Android compatible version of its Nucleus smart application designed for use with its Nucleus 7 sound processor.

With the update, users of the Nucleus 7 with Android devices can control their hearing through the linked application, and will gain access to a number of new features previously unavailable to them, the company said.

Along with the release, Cochlear said it added the ForwardFocus feature to its Nucleus 7 devices, allowing wearers to hear better in “challenging listening environments.”

“We are committed to giving people who are living with disabling hearing loss greater choices when it comes to controlling their hearing experience. ForwardFocus is designed for users who want to manage their hearing in very noisy situations, and enhance it in situations where even people without hearing loss would struggle. It’s anticipated that this will resonate with the 62% of the baby boomers surveyed who say the enhancement they would most want from their hearing technology is the ability to block out or ‘switch off’ background noise and focus in on a specific sound. ForwardFocus allows users to listen to a specific sound source near them – such as hearing a friend across the table in a noise restaurant,” chief tech officer Jan Janssen said in a press release.

In March, Cochlear said it donated $10 million to the Johns Hopkins Bloomberg School of Public Health to found the Cochlear Center for Hearing and Public Health, which it touted as the first academic institute looking to address hearing loss as a global health priority.

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CEL-SCI wins $2.9M in CRO legal battle

Score one for the little guy.

After a four-year legal battle, immunotherapy maker CEL-SCI Corporation has won the first-ever breach-of-contract case against a contract research organization, or CRO.

In a final and binding decision, an arbitrator concluded that CRO inVentiv knowingly and fraudulently misled CEL-SCI with regard to enrollment projections for a clinical trial of CEL-SCI’s immunotherapy treatment for head and neck cancer. The arbitrator also said inVentiv used “scorched earth” litigation tactics and awarded CEL-SCI $2.9 million in damages, according to a statement from Vienna, Va.-based CEL-SCI.

The arbitrator denied inVentiv all but one of its counterclaims against CEL-SCI, which was for $429,649 for certain unpaid invoices.

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

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Philips inks 11-year enterprise monitoring deal with Jackson Health

Royal Philips (NYSE:PHG) said today it inked an 11-year enterprise monitoring deal with Jackson Health System.

Through the deal, the Amsterdam-based company will provide patient monitoring services on a per-patient fee basis, which Philips touted will eliminate up-front costs and allow the health system to standardize patient monitoring across the network.

“For Jackson, patient safety is paramount and trying to balance patient safety with the rapidly changing technology landscape requires innovative business models and a true partnership that will allow us to manage our IT needs, while enhancing our quality of care. This model will assist our drive for operational and clinical excellence through best practices, continuing education, and shared accountability, allowing us to focus on what matters most – empowering our staff to deliver the best possible care to our community,” Jackson Health System CEO Carlos Migoya said in a prepared statement.

The deal will cover services for all of Jackson Health’s hospitals, urgent care centers, primary care and specialty care centers and long-term care nursing facilities, Philips said.

Philips will maintain ownership of the patient care monitoring system and will provide technical support, workflow optimization, education and data management.

“By applying the software as a service model to enterprise patient monitoring in healthcare, Philips and Jackson can re-invent how health systems adopt technology. As an innovative health system, Jackson Health is partnering with us to not only offer the communities they serve the very latest in patient care monitoring systems with predictive analytics, they are pioneering a business model that could have a meaningful impact for other health systems across the country. This model will allow them to manage costs on a per patient basis and future-proof their monitoring technology, all while increasing patient and staff satisfaction through a more seamless monitoring experience,” Philips NA CEO Vitor Rocha said in a press release.

Earlier this month, Philips said it acquired U.K.-based Remote Diagnostic Technologies for an undisclosed amount.

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FDA grants de novo clearance to Avenu Medical for Ellipsys vascular access system

Vascular access system maker Avenu Medical said today it won FDA de novo clearance for its Ellipsys vascular access system designed for use with end-stage renal disease patients who require hemodialysis.

The San Juan Capistrano, Calif.-based company touted that its Ellipsys EndoAVF technology acts as an alternative to traditional AV fistula creation. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF.

“Using the Ellipsys vascular access system is very similar to common procedures such as obtaining venous and arterial access with ultrasound. Most physicians involved in vascular access have the endovascular skills required and will learn to use the Ellipsys System quickly,” Dr. Jeffrey Hull of Virginia’s Richmond Vascular Center said in prepared remarks.

The procedure is minimally invasive, does not cause scarring and does not require sutures, Avenu Medical said. Clearance from the FDA came based on data from a non-randomizes US multi-center study of 103 patients, the company added.

“This approval marks a seismic shift for the patients and physicians within the ESRD community. We can now offer a faster, more efficient and less-invasive option for patients requiring vascular access here in the US and worldwide. For too long there has been a shortage of dedicated vascular surgeons who can create AV fistulas leading to delays in performing the surgery and requiring expensive, temporary catheter access. Our Ellipsys system has the potential to significantly increase the number of clinicians performing vascular access procedures, thereby reducing these delays. This, in turn, will result in reduced morbidity and the cost associated with temporary catheter access. In short, it represents a quality of life improvement opportunity for this patient community,” prez Mark Ritchart said in a prepared statement.

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Eli Lilly touts data for concentrated insulin delivered via Insulet’s Omnipod tech

Eli Lilly (NYSE:LLY) touted data this week from a Phase III study evaluating its Humulin R U-500 concentrated insulin delivered via Insulet‘s (NSDQ:PODD) investigational Omnipod U-500 device.

The company reported that people with Type II diabetes taking Humulin R U-500 using the Omnipod device experienced greater A1c reductions and needed less daily insulin compared to adults using multiple daily injections to deliver high doses of insulin.

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

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HeartFlow wins UnitedHealthcare coverage for FFRct analysis

HeartFlow said today that it won reimbursement coverage from insurer UnitedHealthcare, which will now cover its HeartFlow FFRct fractional flow reserve analysis for its 45 million members.

HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

The Redwood City, Calif.-based company touted that with the new coverage, its HeartFlow FFRct is available to 235 million individuals in the US.

“This decision by UnitedHealthcare underscores the significant value that the HeartFlow Analysis brings to payers, physicians and patients, from both a clinical and economic standpoint. Not only is the HeartFlow Analysis now accessible to tens of millions of additional people, but this advancement also positions HeartFlow as an integral part of the standard approach to heart disease diagnosis and treatment,” prez & CEO Dr. John Stevens said in a press release.

The company said that UnitedHealthcare also adopted a policy which allows for the use of coronary CTA as a first-line test for symptomatic individuals, and that its FFRct analysis is approved to further assess coronary disease seen on a coronary CTA.

In March, HeartFlow said it inked a collaborative research agreement deal with the Imperial College London for research in the areas of medical imaging and deep learning using the company’s FFRct technology.

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Medtronic, IBM Watson Health launch AI-powered diabetes management app

Medtronic (NYSE:MDT), in partnership with IBM Watson Health, this week announced commercial availability of its AI-powered Sugar.IQ diabetes management app.

Using artificial intelligence, the Sugar.IQ app evaluates how a user’s blood sugar levels respond to variables such as food intake, insulin dosing and other daily routines.

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

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Relievant Medsystems heads for Minnesota after $58m Series E

Relievant Medsystems said yesterday that it plans to move to Minnesota now that it’s closed on a $58 million Series E round.

Led by Endeavour Vision, joined by new backer RK Mellon and existing investors New Enterprise Assoc., Canaan Ventures, Morgenthaler and Emergent Ventures, the round is earmarked for U.S. commercialization of Relievant’s Intracept intraosseous nerve ablation system for treating chronic lower back pain.

Although it plans to maintain its R&D and operations facility in Sunnyvale, Calif., Relievant said it plans to move its HQ to Minneapolis.

The cash infusion is also slated for a second randomized trial of the Intracept device; one-year results from a prior study released in February showed a statistically significant difference between patients treated with Intracept and a sham treatment cohort.

“We are pleased to have the support and confidence of this highly respected group of investors,” president & CEO Kevin Hykes said in prepared remarks. “These new funds will facilitate the U.S. commercial launch of the Intracept procedure, providing a new, clinically-proven option to the more than five million indicated patients for whom today’s limited CLBP treatment options have proven ineffective.”

“Endeavour Vision is proud to partner with Relievant to support the launch of this important new therapy,” added Endeavour Vision senior investment director Alexander Schmitz, who joined Relievant’s board in connection with the financing. “The ability to intervene early in the CLBP treatment continuum with the Intracept procedure has the potential to significantly reduce pain and disability, decrease use of healthcare resources, and positively impact the opioid epidemic.”

Relievant raised a $36 million round back in October 2016.

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Analyst’s rating changes push Cardiovascular Systems up, NuVasive and Globus down

Ratings changes by an analyst with Bank of America-Merrill Lynch elevated one medical device company’s stock today in pre-marker trading but pushed two others down.

Appearing this morning on Bloomberg television, BAML’s Bob Hopkins said Wall Street isn’t foucsed enough on the July 31 investor day at Cardiovascular Systems (NSDQ:CSII), according to Seeking Alpha. The St. Paul, Minn.-based company plans to emphasize new product releases in the near term and could be in store for sustained double-digit earnings growth, Hopkins said.

The analyst upgraded his rating on CSII shares from “underperform” to “buy” and boosted his price target from $30 to $40, representing a 33% premium on yesterday’s $30.78 closing price. The upgrade sent the stock up 1.1% to $31.12 today before the market’s opening.

NuVasive Inc. (NSDQ:NUVA) and Globus Medical (NYSE:GMED) didn’t fare as well, as Hopkins downgraded both stocks to “underperform.

That sent NUVA shares down -2.2% to $51.60 apiece pre-market and pared -2.7% from GMED shares, which were at $51.85 before the open.

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Sensile Medical partners with Verily, Sanofi to develop connected insulin patch pump

Swiss medical device-maker Sensile Medical announced this week that it struck a deal with Verily and Sanofi (NYSE:SNY) to develop and commercialize a connected insulin patch pump.

The pre-filled insulin patch pump will be designed primarily for people with Type II diabetes, according to the Olten, Switzerland-based company.

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

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Stryker readies $110m Michigan facility

Stryker (NYSE:SYK) is reportedly readying a nearly $110 million facility in its home base of Michigan that’s slated to add as many as 260 jobs.

Construction of the 253,000-square-foot, $109.8 million campus in Portage, just south of Kalamazoo, is expected to conclude by the end of 2020, according to MiBiz.com. The Mich. Strategic Fund yesterday approved a $2.6 million grant for the project, which could add up to 260 jobs by 2025, and the Portage City Council last night approved a tax exemption.

In addition to a manufacturing plant, the company’s proposal for the site includes administrative offices, training space and an employee café and patio.

“Portage has played an important role in the history of our company – our founder started the business here and today we have multiple manufacturing and corporate offices in Kalamazoo County. Southwest Michigan offers a great quality of life and cost of living, and our company and our employees are a big part of the community. This expansion will support the manufacturing of an array of medical technology and deepen our roots even further in southwest Michigan,” a Stryker representative told WWMT.

“The expansion further positions Stryker to innovate and respond effectively to the worldwide medical community for generations to come,” MEDC CEO Jeff Mason said in prepared remarks. “Stryker has been one of Michigan’s most innovative companies and solid corporate citizens.”

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Can placental tissue implants limit back and leg pain?

Regenerative technology company StimLabs has enrolled the first patient in a clinical trial using shelf-stable placental tissue to reduce complications following herniated disc surgery.

The multi-center, randomized controlled trial will evaluate the safety and efficacy of Revita, StimLabs’ full-thickness placental allograft, which surgeons will place following lumbar microdiscectomy procedures. Microdiscectomy is a common, minimally invasive procedure to remove the herniated or protruding portion of the intervertebral disc that is compressing the traversing spinal nerve root. Common post-surgical complications include scar tissue formation and reherniation.

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

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InVivo closes $15m round

InVivo Therapeutics (NSDQ:NVIV) said today it closed a new public offering, bringing in approximately $15.2 million.

In the round, the Cambridge, Mass.-based company floated 388,000 shares and another 388,000 warrants at a combined price of $2 per unit, plus 6.2 million pre-funded warrants and 6.2 million standard warrants at $1.99 apiece.

The round also included an exercised underwriter’s option for an additional 989,977 shares of common stock and warrants to purchase 989,977 shares.

The warrants have an exercise price of $2 per share and expire five years from the date of issue; the pre-funded warrants have an exercise price of 1¢ each and expire 20 years from the date of issue, according to a press release.

InVivo said it raised approximately $13.6 million in net proceeds after adjusting for underwriting discounts and commissions, but has not stated how it plans to spend funds raised.

In May, the company saw its share prices rise as much as 75% after it released complete six-month results from the company’s Inspire study of its neuro-spinal scaffold, which it ended in January after halting enrollment last July.

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