HighLife raises $36m Series B for mitral valve replacement

HighLifeHighLife said today that it raised a Series B round worth more than $36 million for the transcatheter mitral valve replacement it’s developing.

HighLife’s TMVR uses a ring around the diseased valve’s leaflets that’s designed to guide the replacement valve into position. It’s designed to be delivered through the inter-atrial septum, rather than via a trans-apical approach involving a puncture in the heart muscle.

The Paris-based company said proceeds from the $36.4 million (€32 million) Series B round are earmarked for completing regulatory approval trials aimed at winning CE Mark approval in Europe, and for an early feasibility trial in the U.S. HighLife raised a $14 million Series A round in October 2017.

U.S. Venture Partners and Andera Partners led the Series B, with Sectoral Asset Management and chairman Jose Calle Gordo also participating. Sofinnova Partners, which led the Series A, also joined this round.

“I am very pleased to announce the closing of the Series B financing round, which is essential to funding the development program of the company. The funds will support our mid-term strategy with a pivotal trial in Europe and a clinical trial in the U.S.,” founder & CEO Georg Börtlein said in prepared remarks. “We remain committed to bringing the best treatment option for the broadest patient population to market. Over the long term, we want to address any limitation that the field of TMVR faces and we will continue working towards that goal.”

“HighLife’s creative approach has already generated convincing data in this competitive field of mitral valve replacement. I am confident that the experienced management team will bring this technology to the level where it becomes an undisputed treatment option for mitral valve regurgitation patients,” added USVP general partner Casey Tansey, who is joining the board in connection with the financing.

“With our already solid experience in the structural heart field, we are very happy to contribute to and support HighLife. The exceptional level of collective experience brought together with the existing team and the new investors is a favorable omen for HighLife’s success,” said Olivier Litzka, of Andera Partners, who also joining the HighLife board.

($1 = €0.877939)

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Johnson & Johnson, Apple ink collab for AFib study

Johnson & Johnson‘s (NYSE:JNJJanssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation.

The study is slated to measure the impact of the Apple Watch on the early detection and diagnosis of AFib, as well as the efficacy of a medication adherence program.

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

 

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Philips touts new gantry design for Azurion

Philips Azurion with FlexArmPhilips (NYSE:PHG) today touted the launch of its Azurion with FlexArm, which the company said enables physicians to more easily perform image-guided procedures.

As the clinician moves the system, the image bean maintains alignment with the patient and provides consistent visualization, according to Philips.

Azurion with FlexArm moves on eight axes, controlled by the Axsys controller. In simulation tests, use of the system significantly reduced patient repositioning. This is of particular importance during minimally invasive procedures that require access through the patient’s wrist, Philips said, because it reduces the risk of unintentional pulling of wires and tubes.

Philips launched Azurion in February of 2017 and more than 450,000 people have been treated around the world since then, according to the Amsterdam-based company.

“With FlexArm, Philips’ engineers have overcome near-impossible geometric and mechanical barriers to enable clinicians to achieve clinical excellence in image-guided therapy,” Dr. Barry Katzen, founder & CMO of the Miami Cardiac & Vascular Institute, said in prepared remarks.

“FlexArm enables us to dramatically optimize procedures around the patient: we can get the optimal view of what’s going on inside the patient without encumbering all of the clinicians that are working around the table. The result is an innovation that’s not only clinically important but also very simple and intuitive to use – a critical factor in the heat of a complex procedure,” Katzen added.

“Two years on from its launch, Azurion is now established as our leading platform for interventional procedures, favored by clinicians for its intuitive, seamless approach that enables them to focus on treating the patient, and by hospital administrators for its positive impact on productivity and efficiency,” Ronald Tabaksblat, business leader for Philips’ image guided therapy systems unit, said. “FlexArm is the natural next step in our Azurion innovation journey, combining clinical and operational benefits to improve patient care and reduce costs, while opening up opportunities for new image-guided procedures as the field continues [sic] grow.”

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Itamar Medical to raise $12m with private placement

Itamar MedicalItamar Medical (TASE:ITMR) said today that it stands to raise nearly $12 million in a private placement with American and Israeli investors.

Caesarea, Israel-based Itamar, which makes sleep apnea and heart failure diagnostic devices, said the round consists of $8 million raised from Deerfield Management, Triple Gate Capital, West Elk Partners, and Alpha Capital Anstalt. Another $3.5 million came from Israel’s More Investment House, the company said.

The placement was priced at ₪1.1693 per share (31.67¢) or $9.55 per American Depositary Share, each of which is worth 30 ordinary shares, Itamar said. The proceeds are earmarked for sales and marketing efforts for its flagship WatchPAT sleep apnea and EndoPAT heart disease devices.

Itamar said that, although the Israeli tranche is slated to close “within the next several weeks,” the U.S. tranche’s timing is uncertain “in light of, among other things, the continuing federal shutdown in the U.S.”

ITMR shares closed down -0.9% today in Tel Aviv, at ₪136.20 apiece (about $36.87).

($1 = ₪3.69187)

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Sandoz launches PFS alternative to epinephrine auto-injector

Novartis division SandozNovartis (NYSE:NVS) division Sandoz said today that it launched its Symjepi epinephrine pre-filled syringe in the U.S.

The company’s product is designed as an alternative to epinephrine auto-injectors to treat emergency allergic reactions.

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

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Medtronic kicks off study for pain pump

Medtronic SychroMed II pain drug pumpMedtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids.

The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II pump as a viable alternative for people with chronic intractable non-malignant primary back pain.

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

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Becton Dickinson’s fiscal Q1 prelims beat The Street

Becton DickinsonBecton Dickinson (NYSE:BDX) beat the consensus forecast on Wall Street today with its preliminary fiscal 2019 first quarter results and confirmed its outlook for the rest of fiscal 2019.

The Franklin Lakes, N.J.-based healthcare giant said it expects to post adjusted earnings per share of $2.70 on sales of $4.16 billion for the three months ended Dec. 31, 2018. Analysts on The Street were looking for adjusted EPS of $2.61 on sales of $4.11 billion.

The company chalked up the earnings gain to “the timing of certain tax items, as well as better-than-expected performance across all three segments.”

BD said the adjusted EPS gain amounted to 8.9%, or 14.9% on a constant-currency basis, with sales up 35.1% compared with fiscal Q1 2018, “primarily due to the acquisition of C. R. Bard.” Fiscal Q1 revenues were up 5.2% compared with the same period last year on a constant-currency basis that includes Bard sales, the company said.

For the full fiscal year, BD said it still expects to report adjusted EPS of $12.05 to $12.15, representing growth of roughly 10.0% compared with fiscal 2018. Full-year sales growth is still pegged at 8.5% to 9.5%, primarily due to the Bard buyout, or 5.0% to 6.0% in constant-currency terms.

BDX shares closed up 0.2% at $231.27 apiece yesterday.

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Henry Schein pushes back date for animal health spinout

Henry Schein One

Henry Schein (NSDQ:HSIC) said today that it is shifting the date for the spin-out of its animal health business, now dubbed “Covetrus,” from February 4 to February 7.

The change was implemented by the Melville, N.Y.-based company’s board of directors, according to company press release.

The new date reflects the new anticipated date for distribution of shares in the spinoff company to shareholders of Henry Schein, according to the release.

Each prior shareholder in Henry Schein will receive a 0.4 share dividend of Covetrus stock for each Henry Schein share held as of January 17. The newly spun-out company is slated to trade under the symbol “CVET,” Henry Schein said.

The company warned that it has filed an amended registration related to its recently announced spinoff ‘s merger with Vets First Choice, but that it now anticipates the amended statement “will become effective no later than February 4, 2019 (assuming a continuation of the U.S. federal government shutdown), rather than January 28, 2019,” according to a press release.

Last week, Henry Schein set an initial timetable for the spinout of its animal health business in a merger with Vets First Choice, branding the soon-to-be-public company as Covetrus. The spin-out was first announced last April.

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Neuromodulation: Using the brain’s internal language to relieve pain

Abbott's neuromod systemWhen a patient walks into Dr. Jason Yong’s clinic at Brigham & Women‘s Faulkner Hospital complaining of pain, his work has just begun.

“Pain is a common symptom and it’s totally generic,” Yong explained to MassDevice. “The other thing that makes it challenging is that it’s so subjective.”

After Yong exhausts the pharmaceutical possibilities for managing his patient’s pain, he turns to technological options such as implantable neuromodulation systems.

Neuromod devices use electrodes to deliver stimulation directly to a patient’s brain, spinal cord or peripheral nerves, inhibiting pain signals or triggering neural impulses. Although commonly associated with managing pain relief, neuromod systems are used to treat an array of conditions, including Parkinson’s disease, incontinence and vascular disease.

“This is a defining moment in neuroscience: for the first time, we are using the ‘language’ of the nervous system to alter its responses. We can now pinpoint pain signals and deliver personalized therapy,” the medical director for Abbott’s neuromod business, Dr. Allen Burton, said in a statement.

The global market’s appetite for these systems shows no signs of slowing down – it’s expected to grow from $8.4 billion last year to $13.3 billion in 2022, according to Neurotech Reports.

The perspective from one industry leader
Keith Boettiger, president of Abbott‘s (NYSE:ABT) neuromod division, has been working in the space since 2004. A lot has changed since then, he told us.

“I’ve been in this space for 14 years and in the first 10 years of my career, we really only saw incremental innovation related to hardware or devices, such as increasing the number of electrodes on leads or adding components such as accelerometers and MRI compability,” Boettiger said. “All these things are interesting and can take the technology forward, but none of them had clinical data to support their use and none of these advancements were specifically designed with the patient in mind.

“It was really more about being competitive in the market in the doctors’ eyes versus actually creating better efficacy long-term for the patients with these devices,” he added.

Abbott, which has a number of FDA-approved neuromod systems on the market, decided to rethink how it went about creating these products.

“We sat down in 2013 and we changed our philosophy of how we were going to develop products and we took really this people-centered, patient-centric philosophy around development,” Boettiger said.

As an example, Boettiger pointed toward rechargeable neuromod systems, which were all the rage in the mid-2000’s.

“People sunk a lot of money into rechargeable devices because everybody thought that the longer the battery lasts in the patient, the better. That was the philosophy, but there was no data to support that,” he said. “That was driven by physicians saying, ‘I don’t want to have to manage patients needing a device replacement, so the longer the battery can conceivably last, the better.’”

After surveying the market and studying outcomes, Abbott discovered that the rechargeable systems were being removed from patients at twice the rate as their non-rechargeable counterparts.

So the company moved to a recharge-free platform for its neuromod systems. Abbott was aiming to develop a system that would require minimal interaction, similar to a cardiac pacemaker.

“We drew the conclusion that these devices are going to be better for patients if we’re not drawing attention to their device every day by having them recharge, by giving them a medical grade patient programmer that they pull out of their purse or they pull it out of their pocket and people are staring at them and trying to figure out what’s wrong with them,” Boettiger said. “What was better for the patient was to receive a system they never had to recharge, that would last for years, and that managed their pain in a way they rarely had to think about.”

From a doctor’s point-of-view
To treat his patients’ pain, Yong uses what he calls a “step-wise approach.” First, he will try pharmaceutical interventions, like non-steroidal anti-inflammatories, even if medicines haven’t helped in the past for a particular patient.

“As we exhaust all these other steps, we may start to think about the implantable devices. We don’t like to implant a device in someone if we can avoid it, so we will exhaust every single step,” he said.

“I think the biggest part of our job is expectation management. So I tell them that, ‘Listen, we’re not going to get you to zero. We’re looking to reduce [the pain] by 50% at least, and make you more functional.’ So that’s our primary objective, is to make you more functional, to get you through this, not to take away your pain, just to reduce it and manage it.”

After a patient has qualified for an implantable device to manage their pain, Yong takes them on a trial run with the system for seven days. More than 80% of people who try neuromodulation experience a reduction of pain worthy of a more permanent implant at his clinic.

“For the patients that we are able to help, they are very happy with it,” he said.

For some patients, the pain relief they experience during the trial run is not enough to justify the risks of the implant procedure.

“You get the patients that are like, ‘I feel 30% better. I want it in,’ and you have to tell them no. That’s a difficult conversation to have with them,” Yong said.

Tackling the opioid crisis
The history of pain management in the U.S. is complicated and nothing has made that more clear than the staggering statistics linked to the opioid crisis. More than 115 people die every day from opioid overdoses, according to the Centers for Disease Control & Prevention.

Both Abbott and Yong see neuromodulation as one way to help get the crisis under control. In January of 2017, Abbott touted data from a 5,400-patient study evaluating daily opioid use following spinal cord stimulation therapy in people with chronic pain. The researchers found that average daily opioid use declined or remained steady in people with a spinal cord stim device. People who had the device removed experienced greater opioid use over time.

“We’re seeing that it’s moving the needle on reducing the overall doses of the opioids on these patients. Not many patients. We do have some patients with the neuromodulation systems, but not many, where they will come completely off. But if you’re able to reduce it quite a bit, then that has a big impact on the epidemic as well,” Yong said. “So, I do see neuromodulation as helping to reduce the overall burden of opioids in society for these people who are these complicated, refractory patients. I’m not saying that this is the answer to the opioid epidemic, but I’m saying it’s part of the answer for part of the problem.”

Ryan Lakin, Divisional VP of R&D with Abbott’s neuromod unit, agreed.

“People living with chronic pain are now more than ever able to resume normal and healthier lives thanks to neuromodulation systems using Apple iOS, Bluetooth connectivity and familiar consumer tech. These non-opioid treatments allow people to better manage their disease and focus on living full lives, pain free,” he said in an emailed statement.

Looking ahead
Compared to his early days within the industry, Boettiger predicted that Abbott will continue to rely more heavily on long-term clinical data and the patient perspective to support its product development efforts.

“I think the appetite now is much higher for clinical evidence, not only for clinicians and patients but for payers. For these devices and for this space to be successful long-term, you’re going to have to invest in the clinical research to support the innovation that you’re doing,” he said.

Yong said he also wants to see more rigorous clinical studies for implantable neuromod devices but added that those studies should be independent of the companies creating the products.

“In an ideal world, I think we should be taking the funding out of the device company’s burden and putting it under some other funding source that’s a little bit more objective. I think it’s a problem inherently in research that there is bias based off of what the funding source is,” said Yong, who reported no conflicts of interest with Abbott.

“Right now it’s really tough to get that kind of funding because it’s so expensive to run these trials. Especially when we’re talking about an implantable device. So I don’t think that’s a reasonable or realistic way to do it, but in an ideal world, that’s what we would be doing, is doing a completely unbiased design of these studies,” he said.

It would be helpful to have a registry of all the outcomes associated with implantable neuromod devices, Yong added. Observing patients in his own clinic, he’s seen the tangible relief delivered by updated neuromod systems.

“With some of the newer systems, we’re seeing more robust and durable relief and we think maybe that’s because of what we’ve learned from previous patients,” Yong said. “It’s an exciting time to be in neuromodulation.”

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Researchers question use of antibiotic shunts in hydrocephalus patients

Boston Children's Hospital - updated logoLed by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus.

Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess fluid and antibiotic shunts have become the standard of care in the U.S.

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

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