Avinger Announces Treatment of First Patients Globally With Next Generation Pantheris
REDWOOD CITY, Calif., Jan. 03, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, has successfully treated the first seven patients with the next generation Pantheris Lumivascular atherectomy system. Dr. Schwindt, an experienced operator of Lumivascular technology, used the next generation Pantheris to treat seven separate patients with a variety of lesion types, including in-stent restenosis (ISR), a calcified lesion, and a chronic total occlusion, in arteries above and below the knee.
The next generation Pantheris design includes a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design. This device is available in limited supply for commercial sale in the EU; it is not available commercially in the United States at this time.
In each of the seven cases, Pantheris performed as intended, and Dr. Schwindt made note of the design features that enabled significant performance improvements as compared to previous versions of the device, including better directional control of the cutter blade for more precise atherectomy. Dr. Schwindt also provided feedback about the increased maneuverability of the system, greater tissue capture versus the similarly sized previous version of Pantheris, increased efficiency and ease of cleaning the device between insertions, and high quality imaging in a variety of vessel diameters.
In commenting on his initial cases, which included a patient with a total occlusion of a stent and multiple below-the-knee lesions, Dr. Schwindt noted, ?Next generation Pantheris with real-time image guidance enabled me to see the stent struts and precisely target and remove substantial amounts of tissue that had grown into the stent. In two patients the disease extended below the knee. Image-guided atherectomy with the next generation Pantheris made it possible to precisely target and remove atherosclerotic plaque in this region while conserving the deep wall components and thus reducing the risk of perforations in these small vessels. The angiographic outcome was excellent.?
?We are thrilled that Dr. Schwindt was the first in the world to use the next generation of Pantheris, especially given the excellent outcomes for patients in this initial experience with the device,? said Jeff Soinski, Avinger?s president and CEO. ?These cases helped to validate the enhancements we have made to Pantheris, both in terms of performance and reliability. We believe the initial results generated by Dr. Schwindt with the device represent an important step both for Avinger and for the evolution of treatment for patients with PAD.?
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger?s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
About Avinger, Inc. Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the PantherisÒ family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
The Series B preferred stock issued in the public offering is convertible into shares of the company’s common stock at a conversion price of $2.00 per share. Each share of Series B preferred stock will be accompanied by (a) a Series 1 warrant, which expires on the earlier of (i) 60 days following the clearance by the FDA of a new lower-profile version of the company’s Pantheris atherectomy system and (ii) the seventh anniversary of the warrant’s issuance, to purchase 500 shares of the company’s common stock at an exercise price of $2.00 per share, and (b) a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 500 shares of the company’s common stock at an exercise price of $2.00 per share.
da kann man froh sein, wenn diese erstmal gesperrt sind
, aber die Bs nicht... mal schauen ob deine 5 kommen
On February 14, 2018, the Company entered into a Series A Purchase Agreement with CRG, pursuant to which it agreed to convert $38,000,000 of the outstanding principal amount of its senior secured term loan (plus $3,800,000 in back-end fees and
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prepayment premium applicable thereto), totaling $41,800,000, into a newly authorized Series A preferred stock. The Series A preferred stock is initially convertible into 20,900,000 shares of common stock subject to certain limitations contained in the Series A Purchase Agreement. Under the terms of the Series A Purchase Agreement, the holders of Series A preferred stock are entitled to receive annual accruing dividends at a rate of 8%, payable in additional shares of Series A preferred stock or cash, at the Company’s option. The shares of Series A preferred stock have no voting rights and rank senior to all other classes and series of the Company’s equity in terms of repayment and certain other rights. The Series A preferred stock and any of the Company’s common stock issued upon conversion of the Series A preferred stock are subject to a lockup agreement through February 14, 2019.
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