Healthcare Industry News:  AngioSculpt 

Devices Interventional

 News Release - July 29, 2015

Spectranetics Completes Enrollment in ILLUMENATE Pivotal Study to Assess Safety and Efficacy of Stellarex(TM) Drug-Coated Balloon Technology

300 Patients Enrolled at 42 Sites; Completion of Enrollment a Milestone in Timeline for U.S. Food and Drug Administration Approval of Stellarex(TM)

COLORADO SPRINGS, Colo., July 29, 2015 -- (Healthcare Sales & Marketing Network) -- The Spectranetics Corporation (SPNC) today announced it has completed enrollment of 300 subjects in the ILLUMENATE Pivotal clinical study, a prospective, randomized controlled, multicenter study designed to assess the clinical performance of the Stellarex(TM) drug-coated angioplasty balloon used to restore and maintain blood flow to above-the-knee arteries of the leg in patients with peripheral arterial disease (PAD).

The ILLUMENATE Pivotal study includes patients with superficial femoral or popliteal artery lesions, three to 14 cm in length, and will assess the safety and efficacy of Stellarex at 12 months, with follow-up to five years. Enrollment is now complete for all five studies in the ILLUMENATE series of clinical studies.

"When it comes to patient care, physicians demand clinical results that demonstrate evidence-based outcomes," stated Prakash Krishnan, MD, Mount Sinai Medical Center, New York, N.Y., co-primary investigator and leading enrollment site. "As lesion complexity increases among patients being treated with minimally invasive techniques for peripheral arterial disease, I'm pleased to be part of this trial and the study of a new technology that will give physicians proven treatment outcomes and durable options for vascular care."

Completion of clinical study enrollment is a major step toward premarket approval (PMA) with the U.S. Food and Drug Administration, which will be filed after one-year follow-up visits with all patients are completed.

"Based on early clinical evidence from our First-In-Human study demonstrating the favorable impact of Stellarex, we are pleased ILLUMENATE Pivotal has achieved this critical milestone toward our FDA submission. Drug-coated balloons are a significant part of the vascular landscape and Dr. Krishnan and ILLUMENATE Pivotal trial investigators are producing the clinical data that physicians require and patients deserve," states Amanda Johnson, Vice President, Regulatory and Medical Affairs, Spectranetics.

About the Stellarex(TM) DCB Platform

The Stellarex drug-coated balloon platform is designed to treat peripheral arterial disease. Stellarex uses EnduraCoat(TM) technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The Stellarex DCB platform received European CE mark approval in December 2014 and launched in Europe in January 2015. It is not approved in the United States.

About ILLUMENATE Pivotal Study

The ILLUMENATE Pivotal study is a prospective, randomized controlled, multicenter study designed to assess the clinical performance of the Stellarex DCB in the United States. ILLUMENATE Pivotal is studying the treatment of above-the-knee peripheral arterial disease in 300 patients at 42 sites in the United States and Austria.

About ILLUMENATE Clinical Trials

There are four ILLUMENATE clinical studies in addition to the ILLUMENATE Pivotal trial, described above:
  • ILLUMENATE First-In-Human (FIH) -- a non-randomized, multicenter study; 80 patients; primary patency rate at 12 months was 89.5% and 80.3% at 24 months; freedom from clinically driven target lesion revascularization rate at 12 months was 90.0% and 85.8% at 24 months
  • ILLUMENATE Pharmacokinetic Study -- designed to evaluate the drug levels in the blood; 25 patients enrolled at up to two sites
  • ILLUMENATE European Randomized Trial -- similar to the U.S. Pivotal trial; 328 patients enrolled at 19 sites
  • ILLUMENATE Global Registry -- non-randomized; 371 patients enrolled at 37 sites
These five clinical studies are being used to evaluate the safety and effectiveness of the Stellarex DCB platform and support United States and Canada regulatory filings.

About Spectranetics

SPNC develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.

The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee, the AngioSculpt(R) scoring balloon used in both peripheral and coronary procedures and Stellarex(TM) drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.

The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.

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Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. You can identify these statements because they do not relate strictly to historical or current facts. Such statements may include words such as "anticipate," "will," "estimate," "expect," "look forward," "strive," "project," "intend," "should," "plan," "believe," "hope," "enable," "potential," and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, clinical trials, regulatory or competitive environments, our intellectual property and product development. These forward-looking statements include, but are not limited to, statements regarding our competitive position, product development and commercialization schedule, expectation of continued growth and the reasons for that growth, growth rates, strength, integration and product launches, and 2015 outlook including projected revenue and expenses, net loss and gross margin. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements and to note they speak only as of the date of this release. These risks and uncertainties may include financial results differing from guidance, inability to successfully integrate AngioScore and Stellarex into our business, market acceptance of excimer laser atherectomy technology and our vascular intervention and lead removal products, lack of cash necessary to satisfy our cash obligations under our outstanding 2.625% Convertible Senior Notes due 2034, our debt adversely affecting our financial health and preventing us from fulfilling our debt service and other obligations, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of our strategic direction, dependence on new product development, loss of key personnel, uncertain success of or delays in our clinical trials, adverse results in any ongoing legal proceeding, or any legal proceeding in which we may become involved, adverse impact to our business of the health care reform and related legislation or regulations, including changes in reimbursements, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with any planned improvements to our manufacturing processes, and share price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause our actual results, performance or achievements to materially differ from any anticipated results, performance or achievements, please see our previously filed SEC reports, including those risks set forth in our 2014 Annual Report on Form 10-K. We disclaim any intention or obligation to update or revise any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.

Source: Spectranetics

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