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SRDX

Surmodics

$27.25

0.2 (0.74%)

19:07
09/13/17
09/13
19:07
09/13/17
19:07

Surmodics 'encouraged' by early patient data from PREVEIL study

Surmodics announced that data from the PREVEIL early feasibility study of the company's SurVeil drug-coated balloon was shared in a late-breaking clinical trial presentation at the Vascular Interventional Advances 2017 conference in Las Vegas. PREVEIL is a prospective, U.S., multi-center, single-arm trial designed to assess the safety and feasibility of the SurVeil DCB in the treatment of subjects with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. Gary Ansel, MD, system medical chief of the Vascular Program at OhioHealth, presented six-month results from 13 patients (Rutherford class 2 to 4) at 3 clinical sites who were treated with the SurVeil DCB. Average lesion length was 56 mm. Clinical assessments included primary patency and late lumen loss through six months, plasma paclitaxel levels, and changes in Rutherford classification, resting ankle brachial index/toe brachial index, 6-minute walk test, and walking impairment questionnaire at 1, 6, 12, 24 and 36 months. Key secondary safety endpoints included freedom from major vascular complications, evidence of paclitaxel toxicity, or thrombolysis in myocardial infarction. Data from the study show that acute success measures of safety were achieved in 100 percent of subjects. Results also showed primary patency of 100 percent and mean late lumen loss of 0.27+/-0.54 mm at six months. Significant improvement in Rutherford classification, ABI/TBI, 6-minute walk test, and WIQ were seen at 30 days and six months. Median paclitaxel plasma concentration peaked immediately post-procedure and was undetectable at 30 days. Secondary technical, device, and procedure success criteria were achieved. "We are encouraged by the early patient data using the Surmodics SurVeil DCB platform and are excited to continue clinical evaluation of the product in the U.S. pivotal trial," said Dr. Ansel, who is a principal investigator in both the PREVEIL trial and the SurVeil DCB pivotal trial, TRANSCEND.

SRDX Surmodics
$27.25

0.2 (0.74%)

11/21/16
BRRR
11/21/16
DOWNGRADE
BRRR
Market Perform
SurModics downgraded to Market Perform from Outperform at Barrington
11/21/16
11/21/16
DOWNGRADE

Market Perform
SurModics downgraded to Market Perform at Barrington
As previously reported, Barrington analyst Michael Petusky downgraded SurModics to Market Perform from Outperform after the company's guidance for FY17 was meaningfully below consensus and his expectations. The analyst, who said he continues to like "much of what he sees" at SurModics, said he would revisit his rating if shares weaken "materially" from current levels.
06/27/17
AGIS
06/27/17
INITIATION
Target $43.5
AGIS
Buy
SurModics initiated with a Buy at Aegis
Aegis analyst Benjamin Haynor initiated Surmodics with a Buy and a $43.50 price target saying the current pipeline has a dozen products seeking FDA 510 clearances as well as a third-generation drug-coated balloon platform which will require a PMA approval. He expects SurModics to seek partnering for each device and does not believe earnings power is appreciated by investors.
07/14/17
LSCM
07/14/17
INITIATION
Target $40
LSCM
Buy
Surmodics initiated with a Buy at Lake Street
Lake Street analyst Brooks O'Neil started Surmodics with a Buy rating and $40 price target. Positive news flow from the company's new product offerings should be a catalyst over the next few quarters, the analyst contends.

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CHRS

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NRCIA

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CC

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