Johnson & Johnson shares rise on Street-beating Q1, lifted guidance

Shares in Johnson & Johnson (NYSE:JNJ) have risen today after the medical giant posted first quarter earnings that topped expectations on Wall Street and lifted its EPS guidance for the full fiscal year.

The New Brunswick, N.J.-based company posted profits of approximately $3.75 billion, or $1.39 per share, on sales of $20 billion for the three months ended March 31, seeing the bottom line shrink 14.2% while sales grew 0.1% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $2.10, ahead of the $2.04 consensus on Wall Street where analysts expected to see sales of $19.6 billion, which the company also topped.

“Our strong first-quarter results reflect continued underlying operational sales and adjusted EPS growth. At the same time, we remain focused on investing in innovative technologies and platforms that will make a meaningful difference in the lives of patients around the world. I am proud of our global colleagues’ collective efforts to deliver on our long-term goals and our ability to create value for all of our stakeholders,” chair & CEO Alex Gorsky said in a press release.

Johnson & Johnson lifted its guidance for the remaining fiscal year, now expecting to see adjusted diluted EPS of between $8.53 and $8.63 up from previous guidance of between $8.50 and $8.65. The company maintains its sales expectation of between $80.4 billion and $81.2 billion.

Shares in Johnson & Johnson have risen 2.6% so far today, at $140.08 as of 9:47 a.m. EDT.

Earlier this month, Johnson & Johnson said that its  its Ethicon biz completed its $3.4 billion acquisition of robotic surgery dev Auris Health and the $2.8 billion divestiture of its Advanced Sterilization Products to Fortive (NTSE:FTV).

from MassDevice http://bit.ly/2XhKmSy

Egypt fast-track medical device registration pathway speeds up market access timeframes

By Stewart Eisenhart, Emergo Group

A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

from MassDevice http://bit.ly/2DrDqLt

Glaukos touts 5-year study of glaucoma stents

Glaukos  (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said.

The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two iStents achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg. The prospective, controlled, multi-surgeon clinical trial pitted evaluated the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. The results were published in Ophthalmology Glaucoma.

Treatment success — defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery — was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04). Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.

The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes. The safety profile was excellent in both groups throughout follow-up, according to the San Clemente, Calif.-based company.

“Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors,” said ophthalmic surgeon and lead author Dr. Robert Fechtner in a prepared statement from Glaukos. “This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.”

Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.

“This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez & CEO Thomas Burns. “Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.”

Today’s announcement was good news for Glaukos, whose iStent recently fared worse in a two-year study that compared it to competitor Ivantis’ Hydrus Microstent. The Ivantis study touted reductions in medication use and no reoperations for patients in the Hydrus arm.

 

 

 

from MassDevice http://bit.ly/2Pf9ruD

More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health)

More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant.

Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned.

The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure catheter until early August. This device is placed inside a pregnant woman’s uterus to monitor uterine contractions during labor. The letter from Guerbet (Villepinte, France) said that disposable power injectors used with its Optistar, Optivantage and Illumena contrast delivery systems may experience shortages. Officials from those companies did not immediately respond to requests for comment.

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

from MassDevice http://bit.ly/2v58oUX

Penumbra VR device wins FDA clearance

Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system.

The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the Real Immersive System are designed to be done in a seated position in a clinical environment, according to Penumbra.

The system features a clinician tablet, head-mounted display component, small sensors, large sensor, sensor charger, router, router battery, HMD controller, power cords and USB cables. The small and large sensors have mechanical and electrical components that can measure motion and direction in the physical space and then translate that information into a virtual environment.

from MassDevice http://bit.ly/2UiVDQX

Corindus touts first Japanese CorPath GRX procedures

Corindus Vascular Robotics (NYSE:CVRS) said today that the first Japanese procedures using its CorPath GRX robot-assisted device took place as part of a post-market surveillance study.

Waltham, Mass.-based Corindus, which last June won clearance from Japan’s Pharmaceutical & Medical Device Agency for CorPath GRX, inked a distribution deal for Japan in February 2017 that included a $2 million advance and provision for 12 of the devices; the system used in the initial cases there was the first placement of that deal and followed A1 technical fee reimbursement approval last month, Corindus said today.

CorPath GRX is used to assist cardiologists during percutaneous coronary interventions including stenting procedures.

“The acceptance of robotic-assisted PCI in Japan is an important next step for Corindus to bring this critical medical advancement to additional markets across the globe. Japan represents one of the largest markets for PCI globally, with over 1,200 hospitals performing nearly 250,000 PCI procedures annually,” president & CEO Mark Toland said in prepared remarks.

“After completing the first cases with CorPath GRX, I am impressed with the capabilities of the system, including the level of precision and control during complex procedures,” added Dr. Takafumi Ueno of Kurume University Hospital. “Robotics will provide Japan with cutting-edge technology in interventional medicine, and we are pleased to be one of the first facilities in the Asia-Pacific region to offer this treatment to our patients.”

“We are thrilled to have partnered with Dr. Ueno, Kurume University Hospital, and Japan Medicalnext to launch the first vascular robotic program in Japan, offering these patients the benefits of robotic-assisted PCI,” Toland said.

from MassDevice http://bit.ly/2ZaXcUy

FDA approves Intact Vascular’s Tack dissection repair device

The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.

The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.

The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray.

Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures.

“FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president & CEO Bruce Shook said in prepared remarks. “Now with the Tack endovascular system available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.”

“I look forward to having the Tack implant available for my patients,” added Gray, of Wynnewood, Pa.’s Lankenau Heart Institute. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

Intact said it’s planning a limited U.S. release “that will progress toward broader market commercialization.” The company raised a $20 million Series C round in April 2018.

from MassDevice http://bit.ly/2XkdnNL

FDA clears Gelesis weight-loss hydrogel pill Plenity

 

[Image from Gelesis]

Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.

 

The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.

“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and CEO of Gelesis, said in a press release. “With Plenity, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”

Plenity is taken in the form of capsules with water before lunch and dinner. It is made by cross-linking cellulose and citric acid to make a 3D hydrogel matrix. When taken, the capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach to create small gel pieces that have the elasticity of plant-based foods with no calories. The gel pieces help by increasing the volume and elasticity of the stomach and small intestine, helping the body feel more full to induce weight loss.

“More than 150 million Americans struggle with excess or unhealthy weight. Unfortunately, the majority of individuals with weight issues have important weight-related medical problems. There is no doubt that making a significant impact on this issue should be America’s number one public health priority,” said Dr. Ken Fujioka, a weight loss expert and endocrinology researcher at Scripps Clinic and scientific advisor to Genesis. “The scientific data supporting PLENITY’s positive effects on weight make it a powerful tool to help with weight management. The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data. This approach creates another arm in the treatment algorithm of weight management and could be used by an overwhelming majority of people struggling with weight issues.”

The drug, which is a non-stimulant and non-systemic treatment for obesity, has been shown in clinical studies as being effective, safe and well-tolerated. The studies showed that Plenity had a combination of effectiveness and highly favorable safety and tolerability profile.

“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options. We welcome Plenity’s addition as a treatment option for people affected by obesity,” Joe Nadglowski, president and CEO of the Obesity Action Coalition.

from MassDevice http://bit.ly/2P8ded6

U.K. government requests Brexit deadline extension

By Ronald Boumans, Emergo Group

The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

from MassDevice http://bit.ly/2IlBbNs

EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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

from MassDevice http://bit.ly/2UzbkYX

NuVasive launches X360 lateral single-position surgery device

NuVasive Inc. (NSDQ:NUVA) said yesterday that it launched its X360 system intended for lateral single-position surgery in the U.S.

The newly launched X360 system features improvements intended to accommodate advanced techniques and technologies for enhanced operating room workflow and efficiency, the San Diego-based company said.

The system also features integration with NuVasive’s Pulse surgical automation platform to allow surgeons to perform multiple procedures from the lateral position.

“X360 has transformed my approach to treating patients, allowing me to customize my surgical workflow, reduce patient anesthesia time, and efficiently treat the patient in a single, lateral position. Integrating planning, imaging, navigation, and automation throughout this entire surgical approach has become an integral component to the clinical outcomes of my patients,” Dr. Anand Veeravagu of Stanford University Medical Center said in a prepared statement.

NuVasive touted that because the system allows surgery to be performed without repositioning, it can reduce operating times by up to 60 minutes, saving hospitals on average of approximately $5,000 per patient.

“The X360 system is the most comprehensive approach to lateral single-position surgery available on the market. NuVasive continues to extend its global leadership position in lateral surgery with the integration of X360 and Pulse, the only surgical automation platform designed for spine surgery. By incorporating Pulse and, in the future, robotic automation, with X360, we are enhancing the overall OR workflow and helping surgeons deliver greater clinical predictability and reproducible outcomes for their patients,” NuVasive prez Matt Link said in a press release.

In February, NuVasive said that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system.

from MassDevice http://bit.ly/2IzVHtn

Stryker wins FDA PMA, launches Lifepak CR2 AED

Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system.

The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said.

The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature.

The system can be connected to the LifelinkCentral AED program manager to allow an organizations AED manager to remotely monitor and manage the device to improve readiness, Stryker said.

“In order to save more lives from sudden cardiac arrest, we must save time. The Lifepak CR2 is designed to help rescuers provide higher quality CPR and to provide the fastest first shock when defibrillation is needed. Everything about it is designed to increase user confidence. The Lifepak CR2 harnesses the benefits of connectivity to provide a foundation for better care throughout the entire chain of survival and to simplify AED program management for our customers,” Stryker emergency care public access GM Ryan Landon said in a press release.

The Lifepak CR2 was previously released in Europe and Canada in 2017 and in Japan in 2018, Stryker said.

In March, Stryker said that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device.

from MassDevice http://bit.ly/2v2FQeE

TissueTech raises $55m

TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing.

The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business).

Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing.

The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, according to the SEC filing.

TissueTech said that it plans to use a $10 million of the proceeds to repurchase from common stockholders on a pro rata basis, according to the SEC filing.

The company has not yet announced any other plans for the funds.

from MassDevice http://bit.ly/2IB7kQP

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix

Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures.

The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites.

The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said.

“We continue to expand our product portfolio for the Spine market with the development of this unique line of Bioactive bone graft matrices that combines a carefully-selected ratio of three powerful components. This innovative moldable version offers surgeons options for better ensuring predictable outcomes,” CEO Bart Doedens said in a press release.

from MassDevice http://bit.ly/2P5udNj

Philips to private-label Demant hearing aids

William Demant (CPH:WDH) said this week that it inked a deal to market its line of hearing aid devices under Royal Philips (NYSE:PHG) brand.

Denmark-based Demant said that Amsterdam-based Philips will offer a complete range of hearing aids, accessories and applications under the Philips HearLink brand

“Based on a shared vision of improving the lives of people through innovative healthcare this new cooperation will not only change the way we see hearing healthcare, but also widen the definition of hearing healthcare, supporting healthier lifestyles and active aging. Combining Demant’s world-leading hearing aid technology with Philips’ global brand presence in healthcare, the cooperation will enrich the hearing healthcare experience,” Philips brand licensing senior director Spencer Ramsey said in a prepared statement.

The companies said that the HearLink devices can be connected to other devices, including smartphones and televisions, and that the products are available now.

“The Philips hearing aids will provide users with an innovative, future-proof hearing solution. We live in an age where user engagement and digital services are shaping the future of healthcare technology. More and more people are conscious of taking control of their own personal healthcare and are using electronic devices to do so. In this light, Philips hearing solutions offers new and exciting premium solutions alongside Philips’ healthcare ecosytem, which will attract interest and generate significant benefits to users, ultimately supporting our valued customer base of hearing care professionals. With this partnership, we take connected hearing healthcare to the next level and offer new and exciting solutions within integrated healthcare services to the benefit of both professionals and people suffering from a hearing loss. Health, caring and innovation are cornerstones in the vision of both Demant and Philips, which makes the partnership a great match for the future. Furthermore, it will strengthen and add value to both companies’ ambition to improve people’s lives,” Demant prez & CEO Søren Nielsen said in a press release.

Earlier this month, Philips won a $450 million contract to supply the U.S. Department of Defense with patient monitoring systems, accessories and training.

from MassDevice http://bit.ly/2UyHOTb

Ajax Health raises $85m for medtech investment

Ajax Health, the company formed in 2017 by a pair of private equity giants to manage their medical device investments, said today that it has raised more than $85 million to help fund operations and expansions of select medical device companies.

The round was led by HealthQuest Capital and joined by Aisling Capital and Polaris Partners, the Menlo Park, Calif.-based company said.

“Ajax Health approaches medical device innovation in a novel way, applying best-in-class strategies to pinpoint technologies with the greatest opportunity to take off, then rapidly developing them into a fully integrated business. Ajax Health’s proven executive team, led by Duke Rohlen, Doug Koo and Aftab Kherani, has shown an exceptional ability to develop medical technologies successfully and cost efficiently,” HealthQuest founder & managing partner Dr. Garheng Kong said in a prepared statement.

Ajax Health said that it will seek to invest in companies with disruptive medtech devices with its newly raised funds, focusing on businesses with a potential for high-exit demand where returns could be realized within 48 months.

“I am extremely grateful to our partners HealthQuest, Aisling and Polaris for backing Ajax II. These firms have been exceptional partners for a long time and I look forward to working with them again,” Ajax Health chair & CEO Duke Rohlen said in a press release.

In May 2017 KKR and Aisling Capital joined to launch Ajax, tapping Spirox chairman & CEO Rohlen to lead it. Rohlen is the former president of FoxHollow Technologies and the founder & former chief executive of CV Ingenuity.

Last July, Ajax said that it raised a Series B round of $120 million.

from MassDevice http://bit.ly/2uZjPO1

FDA: Duodenoscope reprocessing is dirtier than we thought

The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear.

Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the scopes; last year it sent the trio another set of warning letters over their failure to comply with that order.

Today Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, warned of possible “additional action” if the companies don’t meet their deadlines.

“While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies. If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action,” Shuren said in prepared remarks.

Although the number of adverse event reports for the devices fell 62%, from 250 in 2015 to fewer than 100 in 2017, a spate of 205 reports from last October to the end of March included 45 patient infections, one patient exposure and 159 contaminated devices; there were three U.S. deaths reported last year from duodenoscope infections, according to the FDA.

And as of last December the FDA thought that the contamination rate for high-concern bugs like E. coli and Pseudomonas aeruginosa was 3%. New data show that number to be more like 5.4%, the agency said.

“Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further,” Shuren said, noting that the FDA is considering whether more stringent action is necessary to get infection rates under 1%.

“For example, we are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might offer a more effective option. This will take careful consideration because we know some sterilization methods could damage the duodenoscope over time and lead to a shorter lifespan for the expensive device,” he said.

The FDA is also consulting the Centers for Disease Control & Prevention and other health agencies “to obtain their input and guidance on the issue of infection control and reprocessing of these difficult-to-clean scopes,” Shuren said.

from MassDevice http://bit.ly/2DbrJs2

Synaptive Medical raises $5m

Synaptive Medical has raised approximately $5 million in a new round of debt and options financing, according to a recently posted SEC filing.

The Toronto-based company has not yet stated how it plans to spend funds raised in the round.

Synaptive Medical produces medical devices intended to facilitate surgical planning, navigation, robotic automation, digital microscopy and informatics through an interconnected platform, according to its website.

Money in the round came from a single unnamed investor, according to the filing, with the first date of sale noted as having occurred on March 26.

Last month, Synaptive Medical said that it named Sandra Clarke as its new finance chief.

from MassDevice http://bit.ly/2uZHg9M

Ex-MiMedx CEO Petit mounts proxy war

MiMedx (NSDQ:MDXG) is facing a proxy battle being led by former CEO Parker Petit, who was ousted last July “for cause”, according to a recently posted SEC filing.

The ex chief-exec nominated himself alongside former Pulte Home Corp tax director David Furstenburger and George & Lorenson partner Shawn George as candidates for the company’s board of directors, set to be elected at an upcoming shareholder’s meeting.

Petit said that he believes that the current MiMedx board has “failed shareholders with disappointing performance, failure to ensure competent leadership and lack of engagement with MiMedx shareholders.” He added that he “felt compelled to launch a contest seeking changes on the board,” according to the filing.

“In my opinion, the current board has done a major disservice to MiMedx’s shareholders and there is no sign the board has the ability, judgment or commitment to return MiMedx to its former growth and profitability as a NASDAQ listed company. Shareholders have been left in the dark while the company’s value has significantly dropped. I could no longer sit on the sidelines. Together with Shawn and David, we, if elected, will bring a wealth of experience working on and resolving expeditiously highly contentious and complicated matters. I believe that our slate of candidates will instill the much needed accountability and reason in the boardroom that MiMedx is now lacking, while supporting its valuable employees and expanding its best in class intellectual property patents,” Petit said, according to the SEC filing.

MiMedx faced a number of troubles last year, including the ouster of Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June.

At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into the matter.

The company later said that all four executives’ departures were for cause, triggering the forfeit of all equity and incentive awards for the executives and Petit’s resignation from the board. Petit and Taylor denied the allegations in a statement from their lawyer.

In December, the accounting firm tapped to audit MiMedx’s books resigned in the wake of the financial issues the company faced.

from MassDevice http://bit.ly/2VHKElA

Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case

A state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products.

Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the court adding some $238,000 in delay damages.

Ethicon and Carlino cross-appealed, with the company pressing seven arguments seeking to overturn the decision and Carlino arguing that the delay damage award should have been calculated on both compensatory and punitive damages, not just the compensatory award.

Yesterday the Pennsylvania Superior Court ruled on the cross-appeals, backing the lower court’s decision on all fronts, including Ethicon’s challenge to the punitive damages award and the delay damages ruling.

“Taken as a whole, and viewed in the light most favorable to the verdict winner, this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of Ms. Carlino’s rights and that this conduct caused her injuries. The evidence showed that Ethicon knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction, because of its mesh weight, pore size, pore collapse, and particle loss. Despite this knowledge, Ethicon promoted the TVT for patients who sought to fix SUI, knowingly understated the risks of the TVT in its IFU, and consistently misled physicians that the TVT produced few adverse results,” the Superior Court found.

“The evidence demonstrates that Ethicon knowingly understated the risks of the TVT in all six versions of the [instructions for use] published between 2000 and 2015. The IFU’s adverse reactions section did not change during that time, and it failed to acknowledge new information Ethicon was obtaining from treaters and its own researchers on adverse effects associated with the TVT. In addition, Ethicon consistently and misleadingly informed physicians that the TVT produced few adverse results and was intentionally evasive about common complications,” according to the ruling.

In January a Philadelphia jury hit Ethicon with a $41 million decision in another pelvic mesh suit brought over its Gynemesh, Prolift and TVT-O meshes. That verdict includes $25 million in punitive damages, $15 million in compensatory damages and $1 million for loss of consortium.

Ethicon has said it intends to appeal the decision and that it stands by its pelvic mesh products.

from MassDevice http://bit.ly/2Z9rc2X

Align Technology puts $31m price tag on forced retail store closures

Align Technology (NSDQ:ALGN) yesterday put a price tag of as much as $31 million on the forced closure of its Invisalign retail outlets after losing arbitration with SmileDirectClub last month.

The March 4 decision required San Jose, Calif.-based Align Technology to close the stores by April 3 and enjoined it from opening new Invisalign stores or providing clear aligner devices in brick-and-mortar stores.

First piloted in 2017, the number of Invisalign stores had risen to 12 by last year. Yesterday the company said it expects the closures to result in first-quarter charges of between $26 million and $31 million, including cash payments of $12 million to $17 million this year.

The charges involve $11 million to $16 million in right-of-use lease assets, $14 million in leasehold improvements and other fixed assets and severance expenses of $1 million, Align said in a regulatory filing.

from MassDevice http://bit.ly/2VEeWpj

Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown

By Stewart Eisenhart, Emergo Group

Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

from MassDevice http://bit.ly/2G7LsJK

5 digital health startups you need to watch in 2019

(Image from Unsplash)

Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).

Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most funding of any function in 2018, $3 billion across 193 deals.

Here are five of the up-and-coming digital health companies to watch in 2019:

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

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Smith & Nephew expands robotics R&D footprint in Pittsburgh

Smith & Nephew (NYSE:SNN) is slated to open a new robotics R&D and medical education center in Pittsburgh in 2020, according to a report from the Pittsburgh Post-Gazette.

The facilities are located in the city’s Strip district, according to the report, and will triple the floor space for London-based Smith & Nephew’s robotics business, which currently employs approximately 100 individuals in the area, according to the report.

“Pittsburgh is the R&D headquarters of our rapidly expanding robotics business and we are very excited to be the first tenants at The Stacks at 3 Crossings. This state-of-the art facility will be a key innovation center for Smith & Nephew that will provide an engaging environment for both current and prospective new employees to create next generation surgical robotic platforms,” Smith & Nephew R&D robotics and surgical enablers VP Brian McKinnon told the Post-Gazette.

The new facility will focus on robotics and allow an expansion of Smith & Nephew’s Navio surgical system and the development of next-generation products, according to the report. It will also include a medical training center focused on the company’s robotic platforms.

Earlier this month, Smith & Nephew said that it inked a deal to acquire patient monitoring system developer Leaf Healthcare for an undisclosed amount.

from MassDevice http://bit.ly/2X3XdrG

Second Sight Medical releases early feasibility data on Orion cortical implant

Second Sight Medical (NSDQ:EYES) today announced preliminary results from a small feasibility study of its Orion cortical implant, which is designed to give eyesight to the blind.

Sylmar, Calif.-based Second Sight’s Orion is designed to connect the camera in a pair of eyeglasses with an implant that receives the camera signal and translates it to the visual cortex in the brain, bypassing the eye and the optic nerve entirely. The company’s Argus II device, which uses a retinal implant to receive the camera’s signal, is already on the U.S. market.

Interim data from a five-year early feasibility study, presented today at the annual meeting of the Brain Research through Advancing Innovative Neurotechnologies conference in Washington, D.C., involved five patients with bilateral blindness from any cause other than damage to the visual cortex.

The primary safety outcome for the study is the rate of adverse events, with secondary outcomes including phosphene production, long-term device function, benefit to visual function and quality of life. The first subject was implanted  in January 2018.

The study showed a significant improvement in the ability to locate a high-contrast target for three of five subjects at six months. Two of the five patients showed significantly better at determining the direction of motion of a high-contrast target. All five patients were rated by certified specialists as having improved functional vision and well-being.

“Observations from rehabilitation sessions include that subjects are able to use Orion to visually detect parked cars, identify the direction of motion of a person walking by, and visually order small objects by size,” Second Sight said.

There was one serious adverse event when a patient had a seizure and four non-serious adverse events, the company said, noting that there were no unanticipated adverse device effects as of Feb. 8.

“We are delighted to share preliminary Orion feasibility study findings with this esteemed group of investigators. This conference provides a forum for discussing exciting advancements and to continue to engage with other scientists who are conducting cutting-edge research in the field,” president & CEO Will McGuire said in prepared remarks. “We are encouraged by the progress Orion subjects are making on visual function endpoints like square localization and direction of motion. With the help of our highly-trained low-vision specialists, our subjects are using Orion at home to perform everyday visual tasks that they cannot do without the system. We look forward to completing the analysis of 12-month data from the Orion Early Feasibility Study and to future refinements that enhance Orion’s ability to provide useful artificial vision to blind individuals.”

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DarioHealth touts updated diabetes management software

DarioHealth (NSDQ:DRIO) said yesterday it launched a new version of its Dario system and DarioEngage platform.

The new V4.2.0 update to both digital health programs are intended to improve user engagement, lower barriers to behavioral change and to streamline the experience and process efficiency for both users and their coaches, the Israel-based company said.

Read the whole story on our sister site, Drug Delivery Business News

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Obalon taps Cowen to explore ‘strategic alternatives’

Obalon Therapeutics (NSDQ:OBLN) today tapped an advisory firm to explore “strategic alternatives,” a week after revealing plans to cut its workforce in half.

The Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, said April 3 that it would lay off 49 of its 100 employees, including all of its direct sales force, in a pivot toward retail.

Today the company said it hired investment bank Cowen “as an independent financial advisor to assist in exploring financial and strategic alternatives” to explore “a wide range of financial and strategic alternatives.”

“Obalon will proceed in an orderly manner to identify and evaluate possible financial and strategic alternatives for the company and their implications,” Obalon said “No assurance can be given as to whether any particular financial or strategic alternative will be recommended or undertaken, and if so, upon what terms and conditions.”

The company said it plans to stay mum until its board approves a transaction or until a statement is required by law.

OBLN shares, which plunged -21% last week after the restructuring news broke, were off by as much as -11.6% today before rallying to 58¢ apiece today in late-morning activity, down -1.0%.

from MassDevice http://bit.ly/2U6P6Zm

Elucent Medical wins FDA nod for EnVisio breast surgery navigation device

Elucent Medical said today that it won FDA 510(k) clearance for its EnVisio surgical navigation system.

The Eden Prairie, Minn.-based company said that the EnVisio navigation system is designed for use in conjunction with the company’s SmartClip soft tissue marker during breast cancer procedures.

The SmartClip soft tissue marker is an alternative to hook-wire localization procedures used to identify malignant tissue for removal, the company said. When used with the Envisio system allows physicians to mark difficult lesions and navigate distances, depths and directions in real-time 3D during breast cancer procedures.

“Elucent Medical is offering a cost-effective solution that addresses a key challenge for breast surgeons: how to easily find the location of a malignant biopsy during surgery, especially in tissue that lacks anatomical landmarks. We developed a system designed by surgeons to be intuitive, efficient, and precise, eliminating the need for a localization procedure. We believe this innovation has the potential to improve cosmetic and clinical outcomes, with other possible applications for lymph and thoracic surgeries,” co-founder Dr. Lee Wilke said in a press release.

“Our vision is to disrupt the standard of care for women who receive localization prior to their lumpectomy as part of their breast cancer treatment. Today we take a significant step toward achieving this goal. The EnVisio Navigation System and SmartClip Soft Tissue Markers will provide patients and surgeons with a wire-free, minimally invasive alternative for pre-surgical planning and navigation throughout surgery,” co-founder and CEO Laura King said in a prepared statement.

from MassDevice http://bit.ly/2Z2CnKW

Intrinsic Therapeutics raises $52m for Barricaid annulus seal

Intrinsic Therapeutics said today that it raised $52 million in a new round of equity financing to support the U.S. commercialization of its Barricaid annulus seal.

The Boston-based company’s Barricaid implant is a polymeric mesh that is designed to sit at the posterior intervertebral disc space and is connected to a metal anchor that is attached to the vertebral body. The device is intended as an adjunct for lumbar limited discectomy to replace missing or damaged parts of the annulus to prevent re-herniation, disc collapse, the return of sciatica and potentially to help stave off low back pain.

Intrinsic Therapeutics won FDA approval for the Barricaid in February despite the fact that the prosthesis received a 5-8 advisory panel against recommending approval in December 2017.

“Recurrent lumbar disc herniations have been shown to cause significant disability for patients and expense for our healthcare systems. The Barricaid clinical trial highlights a technology that can reduce the burden from this spinal condition which deserves close evaluation from all who manage this complication,” Dr. Wellington Hsu of Northwestern University said in prepared remarks.

The Series Growth equity round was led by Questa Capital and joined by existing investors New Enterprise Associates, Greenspring Associates, Quadrille and Delos Capital.

“Questa invests in healthcare innovations that deliver value by providing improved clinical outcomes at an acceptable cost.  By cutting reoperation rates in half, Barricaid can help prevent chronic disability, improve quality of life, and prevent a degenerative spiral. The odds of a patient not returning to work are nearly three times higher after a revision surgery, therefore preventing reherniation is critical,” Questa Capital founder & managing director Ryan Drant, who will join the company’s board of directors in connection with the financing, said in a prepared statement.

“We are extremely pleased that Questa led this financing to support our U.S. commercialization efforts for the Barricaid device. Meaningful clinical data demonstrate that treatment with Barricaid can reduce reherniations and repeat surgeries for patients, and we’re excited to welcome Questa to our fantastic group of investors as we execute a strategic market release in the United States,” Intrinsic Therapeutics CEO Cary Hagan said in a press release.

from MassDevice http://bit.ly/2Z3zWHU

Helius Medical shares tank on FDA denial

Shares in Helius Medical Technologies (NSDQ:HSDT) tanked yesterday after the company said the FDA shot down its clearance bid for the portable neuromodulation device it developed.

The Newtown, Pa.-based company’s PONS system is designed to treat neurological symptoms through electrical stimulation of nerves in the tongue. A trial of the PONS device in treating patients with chronic balance deficits from traumatic brain injuries failed to meet its efficacy endpoint in November 2017. Helius said the control group showed a significant therapeutic effect from the low-frequency pulse treatment used in that arm, skewing the study into missing the effectiveness endpoint.

Yesterday the company said that the FDA denied its application for de novo 510(k) clearance, saying the the federal safety watchdog “did not have sufficient information” to determine whether PONS treatment is better than physical therapy, based on the studies Helius used to back the application.

“We are understandably disappointed by the agency’s decision to decline our request for de novo classification and 510(k) clearance, but Helius remains committed to generating the data to pursue a de novo classification and 510(k) clearance of our PONS device in the future,” CEO Philippe Deschamps said in prepared remarks. “In addition to working on generating this new data, we will continue to focus on expanding our commercial efforts and treating patients in Canada, where we do currently have regulatory clearance.”

The news sent HSDT shares down -66.2% to a $2.10-per share close yesterday; the stock opened at $2.06 today and was off -15.2% to $1.78 apiece as of 10 a.m. Eastern.

from MassDevice http://bit.ly/2UtIw49

5 issues for medical device risk management and design controls

By Mark Leimbeck, Emergo Group

Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

from MassDevice http://bit.ly/2IaJhZr

Bedfont wins FDA nod for ToxCO carbon monoxide monitor

British medical device firm Bedfont said today that it won FDA 510(k) clearance for its ToxCO breath analysis monitor designed to measure exhaled carbon monoxide to indicate levels of CO in the blood.

The newly cleared system is intended for use in triaging cases of CO poisoning as it provides instant results at the point-of-care, the Maidstone, UK-based company said.

Samples can be taken via a low-cost mouth piece or a face mask option for patients who are either unconscious or injured, the company said. The system also automatically samples the ambient air and alarms when CO in the environment reaches a harmful level.

“Not only can our breath analysis monitor help to evaluate patients quickly and effectively for CO poisoning, but it can also reduce emergency department visits and hospitalizations. We are thrilled with the FDA approval of the ToxCO; we believe it will be game-changer for healthcare personnel in America,” managing director Jason Smith said in a press release.

Bedfont said that it has already inked an exclusive U.S. distribution deal with CoVita.

“The ToxCO will be a useful tool for healthcare professionals such as paramedics in Firefighter Rehab. We believe it will fundamentally change how people are assessed for CO poisoning in the United States,” CoVita prez Jason Aversano said in a prepared statement.

from MassDevice http://bit.ly/2P3HyFV

CMS proposes improved ambulatory BP coverage

The U.S. Centers for Medicare & Medicaid Services recently released a proposed decision memo stating that it believes there is evidence sufficient to support the use of ambulatory blood pressure monitoring for diagnosing and treating hypertension in its beneficiaries.

The agency laid out circumstances for reimbursement coverage, including white coat hypertension verified through at least two separate clinic or office visits with separate measurements three months apart or suspected masked hypertension, measured similarly.

To qualify for coverage, the devices must be quality certified and validated for use in the intended patient population, capable of producing standardized plots of blood pressure measurements for 24 hours, include written and oral instructions and be read by treating physicians or a treating non-physician practitioner, according toe the release.

CMS said that ambulatory blood pressure monitoring will be covered once a year, and that other indications for it would come at the discretion of the Medicare Administrative Contractors.

The agency said that it is seeking comments on the proposed decision, and that it will respond to public comments in a final decision memorandum, according to the release.

from MassDevice http://bit.ly/2Pa8J21

House members introduce companion medical device tax repeal bill

A quartet of U.S. representatives today introduced a companion bill to a Senate measure that would do away with the medical device tax altogether.

The 2.3% levy on U.S. medical device sales went into effect in 2013 but was only in place for two years before Congress put a moratorium in place. When that ended in January 2018, a second moratorium was enacted that’s due to expire at the end of this year. In 2018, the U.S. House of Representatives passed a bill to repeal the tax 283-132, but the Senate failed to act.

Last month Democratic presidential candidate Sen. Amy Klobuchar (D-Minn.) and Sen. Pat Toomey (R-Penn.) reintroduced a bill to permanently repeal the excise tax on medical device sales. Today, Reps. Ron Kind (D-Wis.), Jackie Walorski (R-Ind.), Scott Peters (D-Calif.), and Richard Hudson (R-N.C.) introduced a companion measure in the lower chamber, also called the Protect Medical Innovation Act.

In a February letter seeking to drum up co-sponsors, Kind called the 2.3% excise tax “extremely punitive to medical technology investors,” and said that since its inception there has been “growing bipartisan support” to end it. He must have been persuasive, as the H.R. 2207 bill introduced today enjoys 227 co-sponsors from both sides of the aisle, according to a press release.

“Medical devices and new technologies improve the lives and health of millions of Americans every year. Given that this tax applies to revenues – not profits – it is extremely punitive to medical technology innovators. It’s time we permanently repeal this outdated tax on innovation, and support jobs and well-being across the country,” Kind said in prepared remarks.

“The medical device tax would limit patient access to lifesaving technologies and put countless jobs at risk in northern Indiana, where Hoosiers are proud to be leaders in innovation and manufacturing. It’s time to end this job-killing tax once and for all. Permanently repealing the medical device tax will boost American manufacturing, support good-paying jobs, encourage research and innovation, and protect patients who depend on these products. The Protect Medical Innovation Act has broad, bipartisan support in Congress, and I hope we will vote on this bill without delay,” Walorski added.

CardioFocus chairman Paul LaViolette, who is also chairman of the Medical Device Manufacturers Assn., said the group has been working on killing the tax for a decade.

“MDMA continues the tireless work we began in 2009 with the numerous stakeholders who recognize how important it is that the United States leads the world in medical technology innovation, and repealing the medical device tax is a critical part of achieving this common goal,” LaViolette said in a statement. “MDMA thanks Congressman Kind and Congresswoman Walorski for building a broad bipartisan coalition of 227 original cosponsors who are committed to repealing the medical device tax. The harm this policy caused when it was in place is well known, and we cannot allow the device tax to divert one more dollar away from research and development into the cures and therapies of tomorrow or to destroy one more job.”

from MassDevice http://bit.ly/2X1bGnY

BioCardia registers for $18m offering

BioCardia (NSDQ:BCDA) has registered for an upcoming offering of its common stock, looking to raise approximately $18 millions according to an SEC filing.

The company has not yet set a price range for the offering, nor has it stated how many shares it is looking to float.

San Carlos, Calif.-based BioCardia did note the closing price of its stock on April 8 as being $1.33 per share.

The offering will include warrants to purchase additional common stock, according to the filing.

Last December, BioCardia said that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

from MassDevice http://bit.ly/2G3WqQp

Australia’s TGA considering, but not yet implementing, textured breast implant ban

Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.

The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release.

The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada and France to remove select implants from the market.

The implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The TGA said that the panel it convened discussed current data on the implants associated with BIA-ALCL and identified gap in the data that affected estimation of the true rate of the cancer in the country.

The regulatory body said that as of April 8, it has received 76 reports of BIA-ALCL in Australian women. The agency said that there are approximately 13,000 to 17,000 breast implant procedures performed in the country each year.

The panel also discussed the benefits of textured implants, particularly for reconstructive new surgery, and made suggestions including a need to update the TGA’s website with risks and benefits and to better encourage use of the Australian Breast Device Registry.

The TGA said that like the FDA and many other regulatory bodies, it has been monitoring BIA-ALCL cases since 2011, adding that the first adverse event report it received related to the cancer came in in 2009.

The agency said that textured implants of varying roughness are used in 82% of operations in the country.

Last month, a panel of experts convened by the FDA said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer.

from MassDevice http://bit.ly/2Ge0cb8

FDA warns against unapproved concussion diagnosis devices

The FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians.

“The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without the FDA’s approval or clearance,” the federal safety watchdog said. “To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment or management of head injury, including suspected concussion and other traumatic brain injuries. Additionally, the FDA has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries without an evaluation by a health care provider.”

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” added Center for Devices & Radiological Health director Dr. Jeffrey Shuren. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law. The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. The FDA has alerted companies to our concerns and asked them to remove such claims. We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary.”

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