Avinger wins FDA nod for Pantheris SV small vessel atherectomy device

Avinger

Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system.

The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%.

The newly cleared device features a lower profile and longer length than the standard Pantheris, and is indicated for diagnosing and treating peripheral artery disease in small vessels between 2mm and 4mm.

“We are excited to receive U.S. pre-marketing clearance for Pantheris SV, which we believe could expand our addressable market for atherectomy procedures by as much as 50%. With the clearance of this new device, we are well-positioned to build on the positive momentum we have seen in our Pantheris business since the introduction of the next-generation system in 2018. Following our anticipated limited launch of Pantheris SV, we plan on leveraging our growing commercial infrastructure and installed base of Lumivascular accounts to efficiently scale up the introduction of Pantheris SV and drive growth of our Pantheris product family in the second half of 2019,” prez & CEO Jeff Soinski said in a press release.

The company said that it is planning to initiate a limited launch of the Pantheris SV at several U.S. sites, and that it expects distribution to expand as it builds product inventory and gains additional clinical experience.

“This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease. Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk patient population. Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and precise vessel measurement capabilities,” chief medical officer Dr. Jaafer Golzar said in a preapred statement.

Avinger said that the Pantheris SV won CE Mark approval in the European Union last October. The company submitted an FDA application for approval for the Pantheris SV last August.

Avinger shares rise despite Q4 earnings miss

Avinger

Shares in Avinger (NSDQ:AVGR) have risen today despite the medical device maker posting fourth quarter earnings that missed expectations on Wall Street.

The Redwood City, Calif.-based company posted losses of $6.9 million, or 31¢ per share, on sales of $2 million for the three months ended December 31, seeing losses shrink 31.8% while sales grew 6% compared with the same period during the previous year.

Losses per share were just behind the 29¢ consensus on Wall Street for the quarter.

For the full year, Avinger posted losses of $35.7 million, or $3.34 per share, on sales of $7.9 million, seeing losses shrink 26.8% while sales shrunk 20.3% compared with the prior fiscal year.

“We are excited with the continued momentum for our next-generation Pantheris atherectomy device, including treatment of our 500th patient in December. Pantheris fourth quarter revenue increased 18% quarter-over-quarter, with more than 65 of our Lumivascular centers now using the next-generation device. Feedback from the field continues to be excellent, with clinical results, product reliability and case volume all tracking positively for the next generation device. We continued to build our sales organization in the fourth quarter and expect to increase sales headcount in 2019 as we scale utilization and drive revenue growth. On the new product front, we remain enthusiastic about the potential for Pantheris SV to expand our available market with the first-ever image-guided atherectomy system for the treatment of small vessels. We received CE Marking for Pantheris SV in October and completed our first clinical cases in the fourth quarter. We were excited to have Pantheris SV featured in a successful live case transmission at LINC 2019, one of the top global forums for thought leadership in the field of vascular medicine. Our 510(k) application for U.S. pre-marketing clearance of Pantheris SV is pending and we have now submitted all additional data requested as part of the review process. By allowing for the treatment of lesions in smaller diameter vessels, we believe Pantheris SV has the potential to expand our available market by as much as 50%, which should allow us to address a significantly larger portion of the estimated $500 million atherectomy market. As we look to 2019, we intend to focus on five strategic goals as the pillars of our growth strategy. These include driving utilization at current sites and in current markets, launching new sites in underserved areas with high rates of PAD, launching new devices to expand our addressable market and revenue per site opportunity, continuing to produce compelling clinical data confirming the unique benefits of Avinger’s Lumivascular platform and maintaining a lean operating structure as we push to scale the business. We look forward to reporting our progress on these initiatives in the quarters ahead,” prez & CEO Jeff Soinski said in a press release.

Shares in Avinger rose approximately 7.2% today, closing at 63¢.

In December, Avinger released preliminary analysis results from its SCAN post-market study comparing optical coherence (OCT) to intravascular ultrasound (IVUS), touting that data indicated that OCT imaging with its Pantheris system showed statistical superiority or equivalence to IVUS.

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Avinger touts preliminary Pantheris OCT vascular imaging analysis data

Avinger

Avinger (NSDQ:AVGR) this week released preliminary analysis results from its SCAN post-market study comparing optical coherence (OCT) to intravascular ultrasound (IVUS), touting that data indicated that OCT imaging with its Pantheris system showed statistical superiority or equivalence to IVUS.

In the study, researchers compared 240 matched images, 120 OCT and 120 IVUS, captured at identical positions within vessel segments from 12 subjects at two clinical centers, the Redwood City, Calif.-based company said. The images were reviewed and ranked by three independent radiologists on image quality and their ability to display vessel morphology and disease, Avinger said.

Results from the analysis indicated that OCT imaging with Pantheris was significantly better than IVUS at visualizing plaque, calcification and stent struts, and OCT imaging was ranked to be statistically equivalent to IVUS in visualizing the layered structures of the vessel wall and for visualizing troughs following atherectomy.

Vessel management and artifact interference with image quality were also rated to be statistically equivalent between OCT and IVUS, Avinger said.

“The SCAN study does an excellent job demonstrating the clinical value of intravascular imaging with OCT and IVUS for the diagnosis of peripheral arterial disease. While OCT performed better on certain parameters, what is paramount to providing excellent clinical results is the capability to see what is present in the vessel so that diseased tissue can be removed without causing injury to healthy tissue. To our knowledge, SCAN is only the second study in the world and the first U.S.-based study comparing OCT with IVUS intravascular imaging in the peripheral vessels. We look forward to sharing more detailed findings of the study as they become available,” physician investigator Dr. Edward Pavillard of King of Prussia, Penn.’s PA Vascular Institute said in a press release.

Last month, Avinger said that it closed an approximately $11.5 million round of financing.

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Avinger closes $12m offering

Avinger

Avinger (NSDQ:AVGR) said late last week that it closed an approximately $11.5 million round of financing.

In the offering, the Redwood City, Calif.-based company floated approximately 3.5 million Class A units at a price of 40¢ per share. Each unit offered consists of a single share of common stock and a five-year warrant to purchase an additional share at 40¢ per share.

Avinger also offered 8,586 Class B units at a price of $1,000 per, with each unit consisting of one share of Series C convertible preferred stock at a conversion price of 40¢ and a five-year warrant to purchase 2,500 shares of common stock at an exercise price of 40¢ per share.

Convertible preferred stock issued in the offering includes a beneficial ownership limitation on conversion but has no dividend rights, liquidation preference or other preferences over common stock, and has no voting rights.

Avinger said that the round included a fully exercised underwriter’s over-allotment option to purchase an additional approximately 3.8 million shares of common stock and 3.8 million warrants.

The company said it plans to use net proceeds to support working capital and for general corporate purposes, according to an SEC filing.

In September, plaintiffs in a class action suit against Avinger approved a $5 million settlement that the company offered in March.

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Avinger registers for $17m offering

Avinger

Avinger (NSDQ:AVGR) has registered for a new offering, looking to bring in approximately $17.3 million through the offering of various shares and warrants according to a recently posted SEC filing.

The Redwood City, Calif.-based company said it will offer approximately 2.7 million Class A units consisting of a single share of common stock and a warrant to purchase an additional half of a share for $1.11 per unit.

Avinger will also offer purchasers of Class A units whose purchase would make them owners of more than approximately 5% of the company’s stock the opportunity to purchase 7,000 Class B units in lieu of Class A shares that would exceed the 5% ownership level.

Each Class B unit consists of a single share of Series C preferred stock which are convertible into 901 shares of common stock and include warrants to purchase an additional 450 shares of the company’s common stock.

The offering also includes a 45-day underwriter’s option to purchase up to approximately 1.3 million additional shares and/or warrants to purchase up to an additional 675,675 shares of common stock to cover over allotments.

Avinger said it will look to offer a maximum of $4.5 million in warrants to purchase its stock, $7 million in shares of Series C preferred stock and approximately $5.8 million in common stock issuable upon warrant exercise, according to an SEC filing.

Last month, plaintiffs in a class action suit against Avinger approved a $5 million settlement that the company offered in March.

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Avinger asks for FDA approval of small-vessel PAD device

Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD).

The Pantheris small vessel (SV) device extends the company’s line of  Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller-diameter vessels and more distal regions of the vasculature.

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

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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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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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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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Avinger inks $15m share purchase deal

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