onmedic news: de setembre 2018

divendres, 28 de setembre del 2018

Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization

Biologics and other targeted therapies are creating opportunities for innovative device solutions to meet the needs of the formulations as well as specific patient groups. These therapies may require lower annual volumes, and the device manufacturing strategy must fit commercial expectations at those volumes. Optimal manufacturing solutions should mitigate risk while meeting the quality, financial, timeline, and patient needs of the product.

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Obalon Therapeutics wins FDA nod for Obalon Touch inflation system

Obalon Therapeutics (NSDQ:OBLN) said this week it won approval from the FDA for a premarket approval supplement application for its Obalon Touch inflation system.

The newly cleared Obalon Touch is an automated system designed to inflate the Obalon balloon, a gas-filled balloon intended to promote weight loss in obese patients, the San Diego-based company said.

“We are pleased to have received FDA approval of the Obalon Touch inflation system. Our near-term product pipeline is dedicated to further improving safety, reliability and ease of use of the Obalon Balloon System,” clinical & regulatory affairs VP Amy VandenBerg said in a press release.

Obalon said that it plans to commercialize the Obalon Touch in combination with its Obalon navigation system, which is intended to eliminate the need for X-ray imaging during balloon placement. It added that it filed a PMA-S application for the navigation system during the third quarter of this year, and that it is currently pending a decision from the FDA.

Last month, Obalon Therapeutics saw shares rise after it closed a private placement that brought in gross proceeds of $10 million.

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Report: Jawbone to pivot into remote patient health monitoring

Mobile tech company Jawbone is looking to pivot into the healthcare market, according to a recent report from Recode.

The San Francisco-based company, which produced bluetooth earpieces and speakers, announced in July it was liquidating its assets. Now, Jawbone is looking to take a small portion of its staff – only approximately 110, compared to its previous 600 – as it transitions into Jawbone Health, according to the report.

The newly formed Jawbone Health will offer a subscription system to help users monitor their health and catch problems early on, according to Recode. The company will offer a wearable device to paying subscribers, but said that it will be “device and sensor agnostic.”

Jawbone Health said that it will partner with other “clinical-grade” device makers for its system, which will be able to accept data from devices including Apple‘s (NSDQ:AAPL) iPhone and Watch, according to the report.

“Two-thirds of all deaths today are lifestyle-disease related, which means it’s just bad living, right?. But the reality is, if you catch that stuff early and you change your behavior or whatnot, you can push out half of those deaths and save 70% of the cost. The problem is, we have no information,” CEO Hosain Rahman told Recode. “We don’t know where we stand. What’s going on with us, right? We have half a million minutes a year in our lives. If you’re good, you spend 15 minutes a year with a doctor, maybe four times a year. That’s a very small percentage of the population. So the idea is to give people tools.”

Rahman suggested that the new service would be similar to a “check engine light for humans,” according to the report.

Jawbone Health has not yet stated what metrics it will look to monitor for customers, but did say that the company will work with a product called Health Cloud to protect user data and securely share it with physicians, according to Recode.

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Oscor issues voluntary recall for TB bipolar pacing leads

Oscor is voluntarily recalling a select number of TB temporary bipolar pacing leads with 2mm unshrouded connectors over issues which may expose the connection wire, according to a recently posted FDA alert.

The company said that the connector cap housing on the leads may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables, which can cause an interruption to the pacing system.

Oscor said that an analysis of the returned devices indicated that the failure is due to a design change to the pin cap housing.

The company said that over the past six years, it has received reports of four serious injuries attributed to the connector cap malfunction which in turn can lead to an interruption to pacing.

No deaths were reported related to the issue, according to an FDA posting, though the agency warned that risk of possible injuries is possible if the connectors separate during use.

A total of 18 different serial numbers were indicated in the recall, which includes straight, atrial j, 60 degree curved and right heart curved leads. The recall affects leads with sizes between 4 French and 6F, according to the FDA release.

Oscor suggested that patients should continuously monitor the situation if they have leads indicated in the recall, and urged them to contact the company.

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Stryker pays $8m to settle second SEC beef

Stryker (NYSE:SYK) agreed to pay nearly $8 million, but admitted no wrongdoing, to settle a second round of charges leveled by the U.S. Securities & Exchange Commission today.

The federal securities watchdog said the orthopedics giant broke the Foreign Corrupt Practices Act by failing to institute the required fail-safes in its book-keeping procedures for its businesses in India, China and Kuwait.

The Kalamazoo, Mich.-based company agreed in 2013 to pay $13.2 million to settle FCPA charges that its subsidiaries in Argentina, Greece, Mexico, Poland, and Romania made some $2 million in illicit payments “that were incorrectly described as legitimate expenses in the company’s books and records,” the SEC said at the time, resulting in $7.5 million in illicit profits.

Today the SEC said Stryker agreed to settle the latest charges with a $7.8 million fine after the agency found that Stryker’s internal accounting controls “were not sufficient to detect the risk of improper payments” in India, China and Kuwait and that the company’s India business “failed to maintain complete and accurate books and records.”

“Stryker’s failures to implement sufficient internal accounting controls and keep accurate books and records are unacceptable, especially as this is not the first time the company has been charged for these types of violations,” Marc Berger, director of the SEC’s New York office, said in prepared remarks. “The penalty ordered along with the imposition of a compliance consultant are appropriate and necessary.”

The settlement requires Stryker to hire an independent compliance consultant to review and evaluate its internal controls, record-keeping, and anti-corruption policies and procedures, the SEC said.

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DelCath closes $8m rights offering

Delcath Systems (NSDQ:DCTH) said yesterday it closed a previously announced rights offering bringing in approximately $8.1 million.

The New York-based company said that it received approximately 4.3 million basic subscriptions and 418,207 oversubscriptions for a total of approximately 4.7 million subscriptions.

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

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Checkpoint Surgical raises $9m for neurostim device

Checkpoint Surgical said today that it raised another $9 million for the handheld nerve monitor it’s developing.

The Cleveland-based company said the $8.8 million round was led by Mutual Capital Partners and included prior backers First Analysis, the JumpStart NEXT Fund and several individual investors.

Checkpoint said it plans to use the proceeds to build out its sales and marketing footprint, develop new products and markets and expand its executive roster.

“We spoke with many of Checkpoint’s surgeon-users and distributors and were impressed with the enthusiasm expressed by key opinion leaders at world-renowned medical institutions using Checkpoint’s technology. Checkpoint has the core technology and team needed to build a significant business in a large high-growth market. We look forward to helping the team build on prior success in the nerve protection and repair space,” Mutual Capital Partners co-founder Wayne Wallace said in prepared remarks.

“First Analysis has witnessed firsthand Checkpoint’s impressive growth and watched as Checkpoint’s core products have moved from acceptance to adoption throughout the surgical community the past several years. We look forward to our continued partnership with Checkpoint and now welcome Mutual Capital Partners to the team,” added First Analysis managing director Tracy Marshbanks.

Checkpoint also said it tapped Derek Lewis to be its operations and R&D head.

“Derek’s proven track record in developing and launching new medical device products with established firms as well as early-stage technology companies makes him a perfect fit for Checkpoint, which is poised for rapid growth in its core markets and expansion into new markets,” president & CEO Len Cosentino said in a press release. “We are excited to add a person of Derek’s caliber and experience to our team and we expect him to contribute quickly to our growth.”

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LeMaitre Vascular ponies up $14m for Applied Medical’s clot management tech

LeMaitre Vascular (NSDQ:LMAT) this week ponied up $11 million in cash and another $3 million in post-closing payments for the vascular clot business at Applied Medical Resources Corp.

The Burlington, Mass.-based company said the $14.2 million deal includes a one-year transition services provision that will see Applied Medical manufacture the devices for LeMaitre.

The deal covers the Syntel embolectomy and thrombectomy catheters, Python over-the-wire embolectomy catheters, Latis graft cleaning catheters and irrigation catheters. LeMaitre said the product line brought in about $3.4 million during the last year.

“We are pleased to expand our clot management product offering through this acquisition, which adds a latex-free over-the-wire embolectomy catheter to our sales bag,” president Dave Roberts said in prepared remarks.

“We are confident that our vascular customers will continue to receive the highest level of service and support from LeMaitre,” added Applied Medical Gary Johnson.

LeMaitre said it expects the Applied Medical products to add $500,000 to $600,000 in sales during the fourth quarter.

In April, the company dealt its Reddick general surgery assets to Symmetry Surgical for more than $7 million.

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dijous, 27 de setembre del 2018

J&J inks collab deal to develop MERS vaccine

Healthcare giant Johnson & Johnson (NYSE:JNJ) today announced a new collaborative deal as it looks to develop a vaccine against Middle East Respiratory Syndrome Coronavirus.

The collaborative deal is between J&J’s Janssen Vaccines & Prevention division, the Coalition for Epidemic Preparedness Innovations and The Jenner Institute at the University of Oxford, J&J said. Through the deal, Janssen will provide its expertise in tech and vaccine development, and will also work on novel vaccines against the Lassah and Nipah viruses.

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

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Gerresheimer’s Sensile Medical wins CE Mark for infusion pump

Gerresheimer subsidiary Sensile Medical said today it won CE Mark approval in the European Union for its wearable micropump intended for use in the treatment of Parkinson’s disease.

The newly cleared device features automatic filling for use with liquid medicines, and includes a color display, charging unit and leather bag which allows the device to be worn on the owner’s belt.

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

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Don’t make these mistakes in your clinical trial: The most common FDA violations

John Lehmann, Director of Business Development, IMARC

The FDA’s Bioresearch Monitoring (BIMO) inspection program ensures the protection of the rights, safety and welfare of human subjects during clinical research trials.

The most recent results represent findings from more than 1,300 clinical research audits of clinical investigators, sponsors and IRBs for the 2017 fiscal year.

This whitepaper covers the seven most common ones and how you can avoid them.

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

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Cardiawave raises $8.2 million for non-invasive aortic stenosis device

(Image courtesy of Cardiawave)

Parisian startup Cardiawave has raised more than $8 million to boost development of its ultrasound device to treat calcific aortic stenosis.

Nearly $3 million came from the European program Instrument PME, which finances disruptive European technologies developed by potentially high-growth companies. Family-controlled investment groups and the company’s traditional shareholders — Sofimac Innovation, Business Angels des Grandes Ecoles, Paris Business Angels, Angels Santé and Angels’ Bay Invest — put in another $5.3 million.

Cardiawave’s pulsed cavitational ultrasound therapy (PCUT) treatment consists of applying ultrasound through a very high-precision mechanical effect (cavitation) to micro-fracture the calcifications and thus make the flaps of the heart valve flexible again immediately during the procedure, according to the company. An integrated imaging device coupled with the ultrasound treatment procedure makes it possible to monitor the treatment’s progress and its effects in real time, the company said.

Cardiawave was created in October 2014 by French-American entrepreneur Benjamin Bertrand and physicists Mickaël Tanter, Mathieu Pernot and Mathias Fink from the Langevin Institute, a world leader in ultrasound imaging and treatment, as well as cardiologist Emmanuel Messas, department head and laboratory director of Georges Pompidou European Hospital.

The first human clinical study will begin in the spring of 2019 and enable Cardiawave to plan for the CE Mark at the beginning of 2021 and treatment deployment the same year. The company plans to seek an additional $17.5 million in funding in late 2019 and early 2020.

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Inari begins ClotTriever outcome study

Inari Medical said it has enrolled the first patient in the ClotTriever Outcomes Registry (“CLOUT”) using its ClotTriever thrombectomy system.

The ClotTriever device is designed to remove blood clots from large vessels in the peripheral vasculature via access sites as small as 6 mm.

CLOUT is a 500-patient prospective, multicenter, single-arm registry to evaluate real-world outcomes after treatment of patients with thrombosis in the deep veins of the lower extremity with ClotTriever. Dr. William Marston, chief of vascular surgery at the University of North Carolina, and Dr. Robert Beasley, section chief of vascular and interventional radiology at Mount Sinai Medical Center, are co-principal investigators.

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

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NASS 2018: Robotic platforms take center stage

Here’s a roundup from the North American Spine Society’s annual meeting in Los Angeles

Medtech companies in the spinal market are rushing to join the robotic revolution, with Medtronic (NYSE:MDT) and Globus Medical (NYSE:GMED) leading the pack, according to a Leerink Partner analyst’s note from the North American Spine Society’s 2018 annual meeting.

In a letter to investors, analyst Richard Newitter suggests that a “growing number of companies,” including Johnson & Johnson (NYSE:JNJ), Zimmer Biomet (NYSE:ZBH) and NuVasive (NSDQ:NUVA), are focused on developing their own spine-focused robotics platforms, and that spinal robotic technologies are “clearly picking up steam and gaining surgeon mindshare.”

Fridley, Minn.-based Medtronic made its move to the front of the pack with its recent $1.6 billion acquisition of Mazor Robotics (NSDQ:MZOR), Newitter wrote. During the company’s analyst session, management commented that “robotics is the most differentiated technology it believes it has seen in spine for over a decade and one that will represent [Medtronic]’s next chapter and point of differentiation going forward to drive share gains,” according to the letter.

Medtronic reportedly said that they felt it was “necessary to own Mazor as some of its integration plans/efforts were just taking too long within the context of separate organizations.” With the acquisition, the medtech giant said it can now accelerate product development initiatives as it looks to maintain its leading position in the category, according to the letter.

The company has plans to release a system which combines Medtronic’s Stealth navigation system with Mazor’s X robotics platform by the end of the year, which Newitter said will be the system Medtronic uses to make a “big incremental push on robotics.”

With the accelerated development and commercialization, Medtronic’s management said they estimate that robotics has the potential to comprise 30% of all spine procedures over the next decade, equating out to approximately $2.4 billion in recurring revenue opportunity, Newitter wrote.

Medtronic’s increased interest in robotics “essentially validates the category,” which will be of big benefit to Globus Medical, Newitter wrote. Medtronic and Mazor’s strategy to place the robotic platforms in exchange for minimum volume commitments opens the door for Globus to do the same, he added, which has the potential to “disproportionately benefit [Globus] given the company’s current low 6-7% US market share position.”

NuVasive put its Pulse integrated navigation platform on display at the conference, Newitter said, and is taking steps to position the platform at the core of its robotic efforts. And while he views the Pulse as a “step in the right direction,” he added that “it still feels like the company is behind on the robotics front.”

Zimmer Biomet showed off a next-gen version of its Rosa robotic platform, which it picked up with its buy of French Medtech SA in 2016. The new platform features upgraded functionality, including integrated navigation and intra-operative planning, but is currently waiting on FDA 510(k) approval, Newitter wrote.

But the system requires k-wires, Newitter said, “which is something that competitive robotic systems don’t require (or are soon moving away from – MDT/Mazor) so this could be an initial disadvantage.” He added that even with approval, he doesn’t think the platform will be a “meaningful player in spine robotics before 2020 at best, and competitive systems could see increased functionality by this time, potentially putting [Zimmer Biomet] at a disadvantage.”

Johnson & Johnson recently inked a deal with Brainlab, and is looking to integrate spinal applications into its Orthotaxy orthopedic robotic platform, which isn’t likely to debut until after 2020, Newitter said.

The company is looking to release an earlier-to-market system as well, which will use Brainlab’s Cirq robotic arm, which is currently pending 510(k) clearance. The system could become available by the end of this year, Newitter wrote, with a next-gen version which could be available as early as next year.

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Study: Wearable defibrillators don’t work unless you wear them

(Image courtesy of Zoll)

An electric-shock vest that can detect arrhythmias in heart attack patients reduced deaths among those who wore it as prescribed, according to a study published today in the New England Journal of Medicine.

The highly sensitive wearable cardiac defibrillator (WCD) known as the Zoll LifeVest can deliver an electric shock when the heart beats out of rhythm. It was designed for around-the-clock wear to bridge the sensitive period before a pacemaker can be implanted.

Current medical guidelines recommend waiting at least 40 days after a heart attack before placing an implantable cardiac defibrillator (ICD), and 90 days if the patient has had a vascular stent implanted or has undergone bypass surgery. The international study led by researchers at the University of California San Francisco (UCSF) had aimed to determine whether the vests significantly reduce sudden cardiac death. It appears today in the New England Journal of Medicine.

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

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Acquisitions hit earnings for AngioDynamics Q1

AngioDynamics (NSDQ:ANGO) took an earnings hit during its fiscal first quarter on increased acquisition expenses, but raised its sales outlook for the rest of the year.

Losses grew 1,240% to -$469 million, or -1¢ per share, on flat sales of $85.3 million for the three months ended August 31.

Adjusted to exclude one-time items – including the acquisitions of Surgical Specialties’ BioSentry Tract Sealant assets and dose monitoring tech developer RadiaDyne and a $13 million settlement with the U.S. Justice Dept. – Latham, N.Y.-based AngioDynamics reported earnings per share of 16¢, two pennies below the consensus forecast on Wall Street, where analysts were looking for sales of $84.0 million.

“Our operating and financial accomplishments during the first quarter reflect our ongoing commitment to building a more cohesive, patient-focused product portfolio. As evidenced by our two recent acquisitions, we are making progress on our portfolio optimization efforts with a focus on the continuum of care within oncology, as well as on disruptive and differentiated technologies,” president & CEO Jim Clemmer said in prepared remarks. “Our first-quarter results give us continued confidence in meeting our financial goals for fiscal 2019.”

AngioDynamics stood pat on its prior outlook for adjusted EPS of 82¢ to 86¢ for fiscal 2019, but raised its top-line forecast to $354 million to $359 million, compared with $344 million to $349 million previously.

Still, investors sent ANGO shares down -5.7% to $22.85 apiece today in mid-morning trading.

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Cantel Medical slides in Q4 earnings miss

Cantel Medical (NYSE:CMN) shares came under pressure today after the medical device company missed expectations with its fiscal fourth-quarter and full-year earnings.

Little Falls, N.J.-based Cantel posted profits of $16.9 million, or 41¢ per share, on sales of $228.9 million for the three months ended July 31, for flat profit growth on an 11.4% top-line gain compared with fiscal Q1 2017.

Adjusted to exclude one-time items, earnings per share were 54¢, a full nickel below the consensus forecast on Wall Street, where analysts were looking for sales of $226.0 million.

Full-year profits came in at $91.0 million, or $2.18 per share, on sales of $871.9 million, for a bottom-line gain of 27.5% on sales growth of 13.2% compared with fiscal 2017. Adjusted EPS were $2.08, 44¢ below the consensus on The Street, where analysts were expecting sales of $869.0 million.

“We are pleased to report record sales and strong earnings performance this quarter. Our 11.4% reported sales increase was driven by organic growth of 7.5%, the impact from acquisitions of 3.4% and a favorable impact from foreign currency of 0.5%. We continue to perform well internationally where sales were up 30.2% overall, driven by Germany and China. Our U.S. business grew 5.7% in the period,” president & CEO Jørgen Hansen said in prepared remarks.

CMD shares were off -7.1% at $89.89 apiece today in mid-morning trading.

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Ra Medical prices up-sized $66m IPO

Ra Medical yesterday priced an initial public offering worth more than $66 million, significantly higher than the range it indicated last week.

The Carlsbad, Calif.-based company said Sept. 17 that it planned to float 3.3 million shares at $14 to $16 apiece, for gross proceeds of $46.7 million to $53.3 million. At the midpoint the flotation would gross $50.0 million, according to a new filing with the U.S. Securities & Exchange Commission. That’s well below the more than $86 million Ra Medical indicated in a regulatory filing last month.

But yesterday Ra said it issued 3.9 million shares at $17 apiece, for gross proceeds of $66.3 million. The IPO includes a 30-day underwriters option on another 585,000 shares that would fetch an additional $9.9 million if exercised in full.

Shares are expected to open today on the New York Stock Exchange under the “RMED” symbol, with the IPO slated to close Oct. 1, the company said.

Ra Medical makes the Dabra atherectomy catheter laser to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the company touts as having significant advantages over traditional balloon angioplasty systems.

Ra, which won FDA 510(k) clearance for the system last May and CE Mark approval in the European Union in 2016, originally planned to launch the offering in February before renewing the registration in July.

Piper Jaffray & Co. and Cantor Fitzgerald are joint book-runners, with SunTrust Robinson Humphrey as lead manager and Nomura Securities International and Maxim Group as co-managers.

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Hologic to buy Focal Therapeutics for $125m

Hologic (NSDQ:HOLX) said today it inked a $125 million deal to acquire bioresorbable tissue marker developer Focal Therapeutics.

Aliso Viejo, Calif.-based Focal Therapeutics produces the BioZorb bioresorbable, three-dimensional tissue marker which is intended to improve lumpectomy surgeries by marking the tumor excision site for monitoring and future treatments.

Hologic said that it will add the BioZorb marker to its breast health product portfolio. The Marlborough, Mass.-based company said that the deal, in conjunction with its recent acquisition of Faxitron Bioptics which closed in August, significantly strengthens the company’s position in the breast conserving surgery market.

“Acquiring Focal Therapeutics strengthens our position in an attractive, adjacent breast health market, and is consistent with our capital deployment goals. The transaction is accretive to our revenue growth rate and gross margin, broadens our recurring revenue base, and provides attractive return on invested capital,” Hologic prez & CEO Steve MacMillan said in a prepared release.

Focal Therapeutics has raised approximately $16 million in revenue over the last year, Hologic said. The company expects the acquisition to be neutral to its non-GAAP earnings per share for the fiscal year 2019, and accretive after.

“We are very excited to become part of Hologic. Hologic’s long-standing commitment to early cancer detection is key for success in breast conserving surgery. Hologic is the perfect fit for our company,” Focal Therapeutics co-founder & chief medical officer Dr. Gail Lebovic said in a press release.

Earlier this month, Hologic lowered the revenue expectations for its Cynosure division by $15 million to take into effect lost and reduced sales associated with an FDA warning from last month which raised concerns about the validity and functionality of “vaginal rejuvenation” products and procedures.

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dimecres, 26 de setembre del 2018

How K2M Tackled UDI and What Comes Next with help from Reed Tech

Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people who need it outside K2M. A big challenge facing his team came in 2015, when labelers of Implantable, Life-Supporting, of Life-Sustaining (IL/LS/LS) devices faced a compliance deadline from FDA to assign Unique Device Identifiers (UDIs) to their products, update their labels and submit the data records to the agency.

Now, Zellers and his teammates face additional demands for their product data. Customers are requesting data through the Global Data Synchronization Network (GDSN) for use in their product catalogue systems, the National Health Service (NHS) in the U.K. is requesting a similar, but distinct, dataset for their eProcurement program and the new EU MDR data submission requirements loom large on the horizon. Zellers spoke with the team at Reed Tech® to share his challenges and lessons learned from the approach K2M is taking to ensure the data needs of all its downstream stakeholders are being met.

This is an excerpt from a larger case study. You can access the full document here.

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Avita Medical lands tax credit Down Under

Avita Medical (ASX:AVH) said today that it received a $730,000 (AUD $1 million) Research and Development Tax cash rebate from the Australian Tax Office for its year ending June 30, 2017.

The Valencia, Calif.-based company said the incentive program is designed to provide a cash rebate to support companies in Australia undertaking R&D projects. Avita said that the development of its Recell autologous cell harvesting device.

The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Avita Medical said.

“We appreciate the support of the Australian government in the development of our regenerative medicine platform, including the Recell System. Last week’s FDA approval of the RECELL System was a major undertaking and resulted from the contributions by patients, clinical trial investigator teams and our dedicated employees. The non-dilutive funding provided by the R&D Credit over the past several years helped make this success possible,” CEO Dr. Michael Perry said in a press release.

Last week, Avita Medical said that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter.

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FDA clears Baxter’s Altapore bone graft for spinal indications

Baxter (NYSE:BAX) said today it won FDA clearance for its Altapore bioactive bone graft, indicated for use as an autograft extender in posterolateral spinal fusion.

The Altapore bone graft is designed to enhance bone growth and features improved porosity which the company said promotes earlier vascularization and can improve the bone formation process. Baxter said that the Altapore’s porosity is also intended to increase cellular activity by providing more surface areas for cells to travel along the surface of the graft to promote new bone formation.

“Altapore utilizes Baxter’s proprietary silicate-substituted technology and has an enhanced porosity that provides for earlier vascularization, increased cellular activity and improved volume of new bone growth. I’ve had a good experience with Actifuse bone graft substitute, and am looking forward to taking advantage of the novel characteristics of Altapore for my patients,” Dr. Roger Härtl of New York’s Weill Cornell Medicine Center for Comprehensive Spine Care said in a prepared statement.

The Deerfield, Ill.-based company said that the Altapore bone graft had been previously cleared for use in orthopedic surgical procedures in the extremities and pelvis.

“Providing surgeons with versatile tools like Altapore is critical to our commitment to partner with clinicians to advance healing in the operating room,. With this clearance, more surgeons will have access to this innovative bone graft substitute as we look to improve outcomes across our entire portfolio of surgical products,” Baxter advanced surgery business prez Wil Boren said in a press release.

Baxter said that it has begun packaging inventories with new FDA-approved labeling, and expects to start selling it in the US by the end of the year.

Earlier this month, Baxter said that it won FDA clearance for its Actifuse Flow bone graft substitute, indicated for use in a variety of orthopedic surgical procedures.

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FDA green-lights Insightec’s Exablate for use with select Seimens MRI scanners

Insightec said today that it won expanded FDA approval for its Exablate Neuro, which is now cleared as compatible with a number of Siemens (NYSE:SI) Healthineer’s magnetic resonance imaging scanners.

The Israel-based company’s Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

“This important milestone is directly attributed to the commitment and collaboration of the teams at Insightec and Siemens Healthineers, who met the challenge head-on. Expansion of MRI compatibility for Exablate Neuro substantially increases the potential reach of incisionless brain surgery for essential tremor patients,” Insightec CEO & board chair Dr. Maurice Ferré said in a press release.

Insightec said that with the clearance, its Exablate Neuro is now indicated for use with Siemen’s Healthineer’s Magnetom Skyra, Prisma and Prima[fit] MRI machines for treating patients with essential tremor.

“With the compatibility of Insightec’s innovative technology with our MRI scanners, Siemens Healthineers is staying true to its mission of delivering best-in-class diagnostic imaging with advanced therapy solutions in the neurological space. This joint development underlines our commitment to expanding precision medicine, and paving the way for offering focused ultrasound to more hospitals and patients in our worldwide network,” Siemens Healthineers magnetic resonance GM Dr. Christoph Zindel said in a prepared statement.

In July, Insightec said that it won Medicare benefit coverage for its MR-guided focused ultrasound system for the treatment of essential tremor in six new states, bringing the total number of states with Medicare coverage for its tech to 16.

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Valeritas kicks off device registration process in China

Valeritas (NSDQ:VLRX) said today that it began the process to register its wearable insulin delivery device, V-Go, in China.

The company noted that it signed an agreement with an unnamed contract research organization to work directly with the China National Drug Administration, in the hopes of winning regulatory approval for V-Go in China.

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

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dimarts, 25 de setembre del 2018

Abbott touts low rates of stroke, death in 1-year Portico TAVR study

Abbott (NYSE:ABT) today released one-year results from a study exploring the use of its Portico transcatheter aortic valve replacement system in patients with symptomatic, severe aortic stenosis, touting low rates of stroke, death and leaks between the valve and native heart tissue.

Results from the Portico 1 study were presented during a late-breaking session at the Transcatheter Cardiovascular Therapeutics conference in San Diego and published in the Journal of the American College of Cardiology, the Chicago-based company said.

“These real-world data demonstrate that Portico is safe and performs as intended to help patients suffering from severe aortic stenosis. Portico reduces the need for open-heart surgery to replace an aortic valve, and is an important part of Abbott’s mission to provide life-changing technologies to treat people with structural heart diseases,” structural heart biz chief medical officer Dr. Neil Moat said in a prepared statement.

One-year results from the real-world, multi-center 941-patient study indicated a 12.1% rate of all-cause mortality and a 6.6% rate of cardiovascular mortality. The average rate of disabling stroke was 2.2%, while the rate of myocardial infarction was 2.5%, Abbott said.

Mean aortic valve area increased from 0.72 ± 0.37 cm2 at baseline to 1.79 ± 0.48 cm2 at 30 days, durable out to one year. Rates of moderate paravalvular leak were reported at 3.9% at 30 days, down to 2.6% at one year, the company said. The proportion of patients classified with NYHA Class III or IV heart failure fell from 63.8% at the baseline to 7.7% at one year.

“Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence. These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery,” principal investigator Dr. Lars Sondergaard of Copenhagen, Denmark’s Rigshospitalet said in a press release.

Abbott said that its Portico valve won CE Mark approval in the European Union in 2012, and that the company is engaged in a US pivotal study of the device. The company said it recently received approval in Europe for a sheathless introduction of the valve, which it claims improves ease of use and could lower adverse event rates.

Yesterday, Abbott reportedly received applause from the audience at TCT 2018 after releasing positive results from a clinical trial of its MitraClip heart valve device.

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Teleflex’s NeoTract touts data from multiple UroLift BPH-treatment studies

Teleflex (NYSE:TFX) subsidiary NeoTract this week presented results from a number of studies of its UroLift system, touting cost reductions and quality of life improvements.

The Wayne, Penn.-based company said it presented data from seven studies of the UroLift system exploring its use for patients with benign prostatic hyperplasia at the World Congress of Endourology 2018 annual conference this week.

Results from a 156-patient real-world experience study comparing outcomes for BPH patients indicated improvements on the International Prostate Symptom Score, improved quality of life and peak flow rate at both three and six months post-treatment. At three months, patients reportedly experienced an average improvement of 10 points in IPSS, 2.2 points in QoL and 4.8ml in Qmax, the company said.

“The excellent results of this large study were consistent with the pivotal L.I.F.T. study. These outcomes demonstrate that the UroLift System can be used to treat patients with BPH in the real world safely and effectively,” study presenter Dr. Mark Rochester of the Norfolk and Norwich University Hospitals said in a prepared statement.

In a separate study evaluating the use of UroLift as a treatment for BPH in men with small and large prostate volumes, results indicated that such patients experienced statistically significant improvements in both symptoms and quality of life. At six months, mean IPSS was reported to decrease by 17.6 and 13.2, while quality of life improved 2.5 and 2.6 in the small and large prostate groups, respectively.

“Results from this study demonstrate the versatility of the UroLift System as an effective treatment for a wide range of patients and that it can be safely performed in an office setting. It is especially gratifying to see that results at an experienced center such as ours can meet or exceed those observed in the L.I.F.T. study,” study presenter Dr. Thomas Mueller of New Jersey Urology said in a prepared release.

Results from a study exploring patient outcomes and cost differences between treatment with UroLift and transurethral resection of the prostate indicated that patients treated with the UroLift system had hospital stays on average of 0.4 days, compared to 4.6 days for acute TURP and 1.8 days for elective TURP. Data also indicated that the use of the UroLift system reduced overall costs by 42% compared with TURP.

Data from a real-world study of the device comparing outcomes and cost between UroLift and TURP indicated that average costs between the two treatments were similar, but that no hospital stays or follow-up procedures were required with the UroLift, and that the procedure had a lower rate of complications. Estimates indicated a 50% reduction in complications and 50% adoption in patients who would otherwise undergo a TURP procedure, and approximate savings of $35.6 million (GBP £27 million) from reduced complications.

“The results of this study demonstrate that the UroLift System moves BPH procedures into day-case settings, achieving positive patient outcomes without financial investment or increased complications in patients with BPH. Data from this study also suggests that adoption of the UroLift System would increase overall capacity, allowing for healthcare centers to focus on critical cancer targets and waiting times, while reducing delays in both urgent and non-urgent surgery,” study presenter Dr. Oliver Kayes of Leeds Teaching Hospitals NHS Trust said in a press release.

The company also presented three additional real-world studies at the conference, touting that they showed favorable results for BPH patients who were treated with the UroLift system.

“The real-world results from these studies of diverse patient populations on three continents reaffirm the sustained benefits of the UroLift System as an accepted standard of care treatment for patients with BPH. We are pleased that we continue to see results from real-world studies in line with our randomized pivotal study, demonstrating that the UroLift System is a safe and effective minimally invasive treatment that offers men long-term relief from the symptoms of BPH,” NeoTract interventional urology biz unit prez Dave Amerson said in a press release.

In May, NeoTract said that the American Urological Association now recommends the use of NeoTract’s UroLift system as a standard of care treatment for lower urinary tract symptoms due to benign prostatic hyperplasia.

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11 pediatric cardiovascular devices you need to know about

(Photo by wang dongxu on Unsplash)

A bandage-sized heart monitor, an extracorporeal blood pump that mimics the human heart, and a heart valve that can grow with a child were among the six winners of a contest in Philadelphia for innovative pediatric cardiovascular devices.

The Pediatric Device Innovation Symposium organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System awarded each winner $25,000 and advisory services from the Sheikh Zayed Institute’s innovation resource network. The symposium holds this contest annually to encourage the development of devices that address significant unmet needs in children’s healthcare. It is a joint effort with this week’s The MedTech Conference powered by AdvaMed.

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

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Motus GI taps Moran as CEO | Personnel Moves – September 25, 2018

Motus GI said today that it named Timothy Moran as its new chief executive officer, effective October 1, replacing former CEO Mark Pomeranz who will assume the role of president and COO.

Moran has previously served ConvaTec‘s (LON:CTEC) Americas president and helped lead the company through its initial public offering in 2016. Prior to ConvaTec, Moran spent 18 years with Covidien and joined Medtronic (NYSE:MDT) after it’s acquisition, taking on the role of patient care and safety division GM and VP.

“I am thrilled to welcome Tim, an industry leader with significant experience in the commercialization of medical devices for hospitals, to the Motus GI team. We have made great progress over the last year in positioning Motus GI for the next stage of commercial growth. Recognizing the scope of our market opportunity, it was clear to me that bringing in a leader with the right commercial scale-up expertise would have a positive impact on Motus GI’s ability to maximize our potential. In Tim Moran, we have secured a highly talented commercial leader who will enable me to focus on continuing to strengthen our operations, clinical execution and innovation pipeline. We believe Tim’s leadership style, business acumen, and commercial track-record from ConvaTec, Medtronic and Covidien made him the best candidate to lead the company. I really look forward to working alongside Tim and the rest of our management team to pursue our vision of establishing Pure-Vu as the new standard of care for in-hospital colonoscopy,” Pomeranz said in a press release.

“Motus GI has a very compelling new medical product opportunity. The Pure-Vu System has the potential to improve the colonoscopy process, particularly in the inpatient setting where it may improve and accelerate patient care while potentially saving hospitals thousands of dollars per episode of care. I am excited and honored to assume the role of chief executive officer alongside Mark and the team who have made great strides in establishing the foundation for future growth. I believe my experience in sales, marketing and general management of critical care product portfolios will help drive Motus GI forward and build a strong commercial organization focused on the successful launch of the Pure-Vu System. I look forward to working closely with the board of directors, Mark and the rest of the team to advance our efforts in establishing Motus GI as a preeminent medical technology company,” Moran said in a prepared release.

“The combination of Tim’s commercial leadership expertise with Mark’s operational track record give Motus GI a powerful leadership team that we are confident can position our company to take advantage of the commercial opportunity in front of us. Along with the recent appointment of Jeff Hutchison as our VP of U.S. sales and commercial Operations, Tim solidifies a dynamic leadership team with the skills and experience that we believe is capable to build and grow a market-leading medical technology company,” board chair David Hochman said in a press release.

MedX Health names Spearn as new CEO

MedX Health said yesterday it named current president Scott Spearn as its new chief executive officer, with former CEO Rob von der Porten taking on the role of board chair from a retiring Gary Van Nest.

Spearn has held senior executive roles at multinational medical device companies and has spent 30 years in the industry, Ontario-based MedX Health said.

“With the recent launch of our DermSecure telemedicine platform and anticipating a global roll-out of this leading product, the transition of Scott’s role to CEO represents a natural evolution at MedX. Scott’s experience in building sales organizations and developing international markets in the medical device field will help accelerate our growth from our SIAscopy technology and our therapeutic and dental laser products,” von der Porten said in a press release.

“On behalf of the board, we want to thank Rob von der Porten for his leadership during challenging times over the past few years and developing with the MedX team solid product roadmaps such as the delivery of DermSecure,” Van Nest said in a prepared release.

“I am excited to be taking on the CEO role, leading a dedicated team of hard-working people. MedX is a great Canadian company with innovative products and robust technology that is making a big difference in the health of people’s lives around the world,” Spearn said in prepared remarks.

NorthStar Medical Technologies said earlier this month it appointed prez and COO Stephen Merrick as its president and CEO, replacing outgoing chair and CEO George Messina, who has been named chairman emeritus and president and CEO of wholly-owned subsidiary NorthStar Nuclear Therapies.

Prior to joining NorthStar, Merrick served as Baxter (NYSE:BAX) International’s hospital product biz international marketing VP, and also held positions with Mallinckrodt Pharma, Bristol-Myers Squibb and Eli Lilly.

NorthStar said that Hendricks Holding Co chair Diane Hendricks assumed the chairperson role for both companies.

“As founder, George has been the driving force from NorthStar’s inception through FDA approval of the RadioGenixSystem to the initial commercial sale of domestically produced Mo-99. We thank George for his successful leadership in NorthStar’s effort to become the first US-based producer of Mo-99. George’s passion and dedication were critical to building NorthStar into a global leader in the development of novel technologies for the production of medical isotopes for medical imaging. We are excited that George is assuming the leadership of NNT as president and chief executive officer. Targeted alpha therapy isotopes, including Actinium-225, produced by NNT have been identified as potential options in the treatment of certain cancers and infectious diseases. NNT’s therapeutic isotopes will offer more patients the potential for improved outcomes that were previously constrained by inadequate TAT isotope supply. We are looking to George to achieve similar success leading NNT as he has done with NorthStar,” Hendricks said in a prepared statement. “NorthStar is at a transformative point in its evolution from a development stage company to being the first domestic supplier of Mo-99, and we are excited that Steve has agreed to become NorthStar’s president and cEO. This company is strongly positioned for rapid growth in the US market, and there are attractive opportunities for NorthStar to grow outside the United States as well. Steve’s broad executive experience in the pharmaceutical industry at Bristol-Myers Squibb, Mallinckrodt and Baxter Healthcare, as well as his expertise in product development and driving domestic and global market demand are invaluable to NorthStar’s future success. The board of managers believes that this organizational realignment allows NorthStar to capitalize on both George and Steve’s strengths.”

Lumicell said last week it added former ReWalk Robotics (NSDQ:RWLK) CFO Kevin Hershberger as its new chief financial officer.

The Wellesley, Mass.-based company said that Hershberger has spent more than 25 years in global finance management, and has held finance VP, controller and chief accounting officer positions with NxStage Medical (NSDQ:NXTM).

“In addition to his broad financial acumen and decades-long career in manufacturing and life sciences companies, Kevin has an excellent reputation for building strong teams and structuring successful companies. At Lumicell, we know that great companies start with great technology – but great technology doesn’t come to fruition without great people implementing a strong strategy. Kevin will join our leadership team and help pave the way for the future success of our organization,” CEO Kelly Londy said in a press release.

“It’s an exciting time to be joining the team at Lumicell. The company is on the precipice of significant innovations and making far-reaching strides in bringing its drug and device therapy to the market where it can help physicians and patients. But what I’m most excited about is Lumicell’s mission. Cancer, infection, wound care—battling these tough diseases is personal. And I look forward to supporting this mission, helping raise the profile of Lumicell’s technology, and improving people’s lives,” Hershberger said in a prepared statement.

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Natus Medical taps Davies as CFO

Natus Medical (NSDQ:BABY) said last week it appointed Drew Davies as its new chief financial officer and exec VP, effective October 1, replacing interim Sharon Villaverde who will continue as finance VP.

Prior to joining Natus Medical, Davies served as CFO and exec VP of Extreme Networks, and as VP and corporate controller at Marvell Semiconductor before that.

“We are pleased to add a leader of Drew’s caliber to the Natus team. Drew brings a wealth of experience in financial and operational management across the technology industry, where innovation, cost management and constant change are critical to success. I am confident that Drew will complement the strengths of Natus’ executive team and play a key role as we progress forward. On behalf of everyone at Natus, I would also like to thank Sharon for serving as the company’s Interim CFO for the past 2 months. We are grateful that Sharon assumed this role at such an important time, and we look forward to continuing to benefit from her expertise,” prez & CEO Jonathan Kennedy said in a press release.

“I am excited to join Natus during a transformative time in the company’s history. Natus has a demonstrated track record of growth and earnings expansion and I look forward to working with Jonathan and the rest of the management team to drive further success,” Davies said in a prepared release.

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