Avinger posts loss on disappointing sales

Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses.

The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with losses of -$12.8 million during Q2 2017 and amounts to a -14% top-line slide.

An analyst on The Street was looking for losses per share of -0.48¢ on sales of $2.6 million.

Positive news for the quarter included FDA clearance and initial sales of the company’s next-generation Pantheris image-guided atherectomy device and successful treatment of patients in several centers throughout the U.S. Avinger raised an additional $3.55 million in July 2018 from the sale of securities under a registered direct offering and hired new chief medical and financial officers.

“Receiving FDA clearance for our next generation Pantheris 3.0 was a key highlight of the second quarter and a significant milestone for Avinger. Following successful cases and positive physician feedback in initial U.S. sites, we are now focused on the commercial rollout of this next generation device to our installed base of accounts,” said Jeff Soinski, Avinger’s president & CEO, in a prepared statement. “We delivered strong sequential quarter revenue growth and made significant progress on the development of our pipeline products and in our clinical programs during the second quarter. We also added new capital to our balance sheet and made important new additions to our senior leadership team in recent months. I am pleased with the progress we are making as we return the company to growth and excited about our prospects for the future.”

Avinger’s share price fell by 6% to $1.20 at midday, nearly 10 times lower than one year ago.

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

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

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

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

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

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

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

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Avinger launches next-gen Pantheris in US

Avinger (NSDQ:AVGR) said today it launched its next-generation Pantheris in the US, touting that the first procedures with the device have already been performed.

Redwood City, Calif.-based Avinger said the newly launched Pantheris device features a single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added.

“We are very pleased to deliver an enhanced device that will help Dr. Schwartzberg, and other physicians like him, produce better outcomes for patients. Our first US cases confirm many of the design changes incorporated into the next-generation Pantheris have improved performance and durability of the technology. Gaining experience across multiple users in the United States, different physician specialties, and a variety of lesion characteristics further substantiates the results generated with the next-generation device in Europe over the past few months,” prez & CEO Jeff Soinski said in a press release.

The new system has been used to treat over 40 patients in the US at 13 sites, and adds to 30 initial cases performed in Germany earlier this year, Avinger said.

“I am very excited about the outcomes for patients that the next-generation Pantheris has helped me achieve in my initial 10 cases. Since the infancy of this technology, I have always thought onboard image-guided atherectomy represented the future of endovascular intervention for many types of disease because of its ability to target specific pathology as opposed to other atherectomy devices which indiscriminately engage both normal and abnormal tissue, potentially creating harm. While still early in our experience with the device, the new design features have already expanded the applicability of Pantheris to a wider variety of lesion types and I have observed a marked improvement in cutting efficiency and ease of use. I use Pantheris as my front-line therapy due to its safety profile with the reduction of radiation and contrast delivery to the patient and my firm belief that this approach will generate better long-term results for patients. The data from the Vision trial with the first-generation Pantheris demonstrated the longer-term efficacy and safety of this therapy, and the body of evidence should only grow from here,” Dr. Glen Schwartzberg, who was the first to use the next-gen device, said in a prepared statement.

Earlier this month, Avinger said it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries.

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LuxCath eyes the atrial fibrillation market

One problem with using ablation to treat atrial fibrillation is determining when the resulting lesion is sufficient to block the electric signals underlying the arrhythmia.

LuxCath thinks its OmniView catheter solves the dilemma by using an optical technology to assess metabolic activity in the ablated tissue, CEO Dr. Omar Amirana told MassDevice.com earlier this month during the annual Heart Rhythm Society meeting in Boston.

Amirana, a senior vice president at Allied Minds (LON:ALM), also helms Allied Minds subsidiaries SciFluor and Signature Medical and is a board member at CardioFocus. What drew him to LuxCath, he told us, is its ability to both visualize the ablated tissue and assess its viability.

“I’ve been in electrophysiology since 1992 and I have not been able to find a technology that actively can see a lesion, in real time,” Amirana said. “This looks into the tissue, whereas everything else we’re looking at is right on the surface of the tissue, so you don’t have an idea of what’s going inside the wall of the muscle, and that’s really where recurrences occur.

“It’s kind of like a stud finder. If you’re looking for where to put the nail, basically, we tell you where the stud is,” he explained.

OmniView uses an optic fiber threaded through the catheter to shine light into the myocardium. If there’s poor contact with the catheter, the device doesn’t return a signature, Amirana explained. But if there’s good contact, the returning light excites a specific molecule that delivers information on tissue composition and lesion quality.

“It tells us whether we’ve got collagen and elastin in the tissue or whether we’ve got a healthy dose of viable myocardium that’s capable of conducting,” he said. “The way we determine that is we’re looking at the fluorescence properties of collagen which fluoresces at one wavelength and the fluorescence of [nicotinamide adenine dinucleotide], which is a molecule that’s inside metabolically active cells that’s required for basic metabolic activity.”

“What we’ve done essentially is added ports to the end of the catheter tip, so that we’re not only interrogating tissue that’s perpendicular, we’re interrogating all angles of contact. The big take-away for that is we’re not only going to assess catheter stability at all angles of contact and assess tissue composition, but also measure progression,” added LuxCath GM Arun Jaganathan.

With enough funding to carry through to CE Mark approval in the European Union, expected some time next year, and an 11-case first-in-human series under its belt using a prototype, Luxcath is developing the next iteration of OmniView and a clinical program to back the CE Mark bid and a parallel application with the FDA, Amirana said.

Dr. Vivek Reddy, who performed the first-in-human study, told us that although it’s early days yet, the OmniView catheter addresses an important gap in the EP toolbox.

“We assume that we’re ablating tissue based on the fact that electrograms diminish. But that’s a very crude way of interrogating information,” Reddy explained. “LuxCath is using a very clever way. Myocardium has a lot of [nicotinamide adenine dinucleotide]. So when you’re touching tissue, you suddenly see this peak of [nicotinamide adenine dinucleotide] and then when you ablate the tissue, that disappears. It’s an approach that will give you both contact information, as well as following lesion progression. I think it’s a very interesting, exciting one.”

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Getinge touts results from IABP study in MI patients with persistent ischemia

Getinge (PINK:GETI B) late last week released results from a pilot study of its intra-aortic balloon pump exploring its use with patients with extensive myocardial infarction complicated by persistent ischemia following primary percutaneous coronary interventions.

Results from the pilot study were presented by co-principal investigator Dr. Lokien van Nunen of Eindoven, The Netherlands’ Catharina Hospital at the EuroPCR 2018 annual meeting in Paris last week, the company said.

The prospective, randomized, comparative single-center Semper Fi pilot study aimed to evaluate the use of IABP in patients with extensive MI complicated by persistent ischemia after a PCI procedure, and included 100 patients with acute STEMI and insufficient ST-segment resolution as determined by an ECG 10 to 30 minutes after PCI in a cath lab.

Patients in the study were randomized to IABP for 12 to 24 hours or no IABP, and were followed up with at six months, Getinge said.

Results from the study indicated that those who presented with large acute MI trended towards decreased mortality, LVAD use and hospital readmission for heart failure within six months after IABP use. A total of 2% of patietns in the IABP arm experienced the primary endpoint versus 8% in the non-IABP group.

“Determining which STEMI patients will benefit from IABP has been difficult because of varying results from retrospective and prospective studies. We are encouraged by the results of the Semper Fi pilot study, which showed a strong signal that IABP may be beneficial in patients with extensive acute MI who continue to experience ischemia even after stenting. We expect that these results will bear out in a trial adequately powered to demonstrate a statistically significant reduction in the composite endpoint if this trend were to continue,” Dr. van Nunen said in a prepared statement.

“The trend toward a mortality benefit with the use of IABP observed in the Semper Fi pilot study is encouraging because the study was well controlled and did not allow crossover from the conventionally-treated group to IABP, which could have confounded the results. This pilot study is a testament to Getinge’s commitment to support clinical research to increase the body of knowledge for our life-saving therapies,” acute care therapies chief medical officer Dr. Claudius Diez said in a press release.

Earlier this year, Getinge said it won FDA 510(k) clearance for its PulsioFlex Monitoring System and PiCCO Module.

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7 medtech stories we missed this week: May 25, 2018

[Image from unsplash.com]

From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Mauna Kea wins FDA nod for neurosurgery indication

Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance for its Celivizio 100 series F400 and F800 with new Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures. The Cellvizio 100 with CranioFlex gives allows for imaging of tissue internal microstructures and allows for identification of cells and vessels and their organization in the central nervous system during cranial diagnostic and therapeutic procedures. The F400 series operates at 488 nm and the F800 model operates at 800 nm.

2. Bonesupport, Collagen Matrix ink deal

Bonesupport has signed a strategic agreement with Collagen Matrix to expand its product offering to the U.S., according to a May 24 press release. The agreement states that Bonesupport will start selling and marketing some of the Collagen Matrix bone graft substitute products under its own brand and through its own distribution network in the fourth quarter of this year.

3. Implanet launches Jazz Evo spine implant

Implanet announced in a May 23 press release that it has launched its Jazz Evo implant that is designed to respond to the constraints of vertebral fusion indications in adults. The implant is designed to facilitate the treatment of degenerative pathologies in adults and is part of the company’s Jazz range of products that block the braid with a single screw to ensure optimum clamping on the rod without damaging the braid.

4. MC10 wins FDA nod for BioStamp nPoint wireless patient monitor

MC10 recently received FDA 510(k) clearance for its BioStamp nPoint System, according to a May 16 press release. The system is a wireless, biometric data collection platform that is designed to be used by healthcare professionals and researchers for collecting physiological data continuously in the home or in traditional healthcare settings. It is specifically designed for clinical trials or research studies where continuous collective data is needed. It features flexible, body-conforming rechargeable sensor patches that are reusable and can record data for up to 24 hours. It can be configured to measure, record and display general activity, postural classifications, vital signs and sleep metric with clinical validated accuracy.

5. FDA clears second XableCath peripheral catheter

XableCath announced in a May 24 press release that it has received FDA clearance for its XableCath abrasion tip support catheter. This clearance marks the second clearance for the company after its blunt tip catheter was cleared at the end of 2017. Both XableCath’s designs are designed to easily slide past occluding atheroma through the true lumen of the vessel.

6. CrossRoads Extremity Systems launches DynaForce foot implant

CrossRoads Extremity Systems has launched its Active Stabilization MPJ Implant System, according to a May 22 press release. The company launched the product after it received FDA clearance for its DynaForce system. The DynaForce Active Stabilization MPJ Implant System combines stability and an anatomic plate with active compression of a nitinol clip that is delivered to the operating room in a sterile package.

7. FDA clears Medacta pedicle screw guide

Medacta announced in a May 23 press release that it has received FDA clearance for its MySpine Midline Cortical Pedicle Screw Placement Guide. The MySpine MC system allows surgeons to optimize procedures for both outpatient and inpatient settings for a more rapid patient recovery through accurate and reliable muscle-sparing approaches to posterior lumbar surgery. The system guides the screw to a trajectory in the pedicle that has evolved from a cortical bone trajectory. The system also avoids interference with cranial facet joins and can accommodate larger screw diameters and lengths with four points of cortical bone purchase.

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Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB

QT Vascular said today it inked a deal to sell its non-drug coated coronary products to Teleflex (NYSE:TFX), including its Chocolate XD and Glider, with an option to purchase its Chocolate Heart drug-coated coronary balloon catheter which is currently under development.

Singapore-based QT Vascular has not released any financial details of the deal, but said that it will continue to develop and market its other products, including its Chocolate Touch drug-coated percutaneous transluminal angioplasty balloons. The company said it is currently enrolling patients in an IDE trial of the Chocolate Touch device.

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

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Avinger wins FDA nod for next-gen Pantheris

Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease.

Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added.

“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States. After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations,” prez & CEO Jeff Soinski said in a prepared statement.

The system won CE Mark approval in the European Union last December, and has been actively used in Germany since winning approval, the company said.

Avinger said it plans to launch two version of the device at initial sites in the US immediately, and will incoporate the new design into an IDE clinical trial currently in progress examining the use of the system for treating in-stent restenosis in lower extremity arteries.

“The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention. Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure,” Dr. Barry Tedder of Jonesboro, Ark.’s St. Bernards Medical Center said in a press release.

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InspireMD wins regulatory nod in Ecuador for CGuard, MGuard

InspireMD (NYSE:NSPR) said this week it won regulatory approval in Ecuador for its CGuard embolic prevention system and MGuard Prime devices.

The approval comes shortly after the company inked an exclusive distribution agreement with Ecuadorian medical device distributor Cardiobene, Israel-based InspireMD said. Both companies have worked together to secure regulatory approvals in the country, InspireMD added.

“We have been working with key opinion leaders as well as the top hospitals in the country in anticipation of these approvals in order to start selling the products. The clinical advantages for both of these products is compelling and we expect our physicians to start using the products very quickly,” Cardiobene’s Patricio Erazo said in a press release.

Sale of both devices is slated to begin immediately, InspireMD said.

“This approval enhances our footprint across Latin America. We are very excited to work with Cardiobene, one of the most successful distributors of endovascular products in Ecuador,” InspireMD chief commercial officer Agustin Gago said in a prepared statement.

In late March, InspireMD said it won regulatory approval from Peru’s Ministry of Health for its CGuard embolic prevention system and MGuard Prime.

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Teleflex launches TrapLiner cath in the EU

Teleflex (NYSE:TFX) said yesterday it launched the TrapLiner catheter, designed for use in vascular procedures, in Europe.

The Wayne, Penn.-based company said that its TrapLiner cath is similar in design to its GuideLiner V3 cath but also features an integrated balloon for trapping standard 0.014″ guidewires within a guide catheter.

The newly launched TrapLiner catheter is designed to operate as an alternative method to the trapping technique which requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position, Teleflex said.

The catheter is intended for use alongside guide catheters to access regions of the coronary or peripheral vasculature and to aid in placing interventional devices and for the exchange of interventional devices while maintaining the guidewire position, according to a press release.

Earlier this month, Teleflex posted first quarter earnings that beat the consensus on Wall Street and announced a manufacturing consolidation plan it hops will save $25 million to $30 million annually.

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