Funding round brings in $20M for EBR Systems | AngioDynamics gains license for EmboMedics' microspheres | Improved sales productivity drives Q1 revenue growth for Bacterin
 

April 13, 2015
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Funding round brings in $20M for EBR Systems
A financing round involving former Medtronic executive Stephen Mahle has pulled in $20 million for EBR Systems. The Sunnyvale, Calif.-based firm said it will use the money to push the development of its wireless cardiac resynchronization tool and to support efforts to get the technology an investigational device exemption in the U.S. and CE mark approval in Europe. MassDevice.com (Boston) (4/10)
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Halyard Health Builds on its 278% ROI with MarketView
Halyard Health, a large manufacturer of medical device products, realized a 278% return in its first year investment of Health Market Science's MarketView. The market intelligence solution for the health care industry helped them identify new physician opportunities, secure sales from physicians it otherwise might have overlooked and more. Download the case study now.
 
Business & Market Trends
AngioDynamics gains license for EmboMedics' microspheres
EmboMedics has agreed to license its resorbable microspheres to AndioDynamics, a Latham, N.Y.-based firm, for $11 million. The deal, which includes an exclusive buy option and milestone fees, calls for AngioDynamics to make an initial equity investment of $2 million and a possible additional investment of $9 million. MassDevice.com (Boston) (4/10)
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Improved sales productivity drives Q1 revenue growth for Bacterin
Bacterin generated between $9.4 million and $9.5 million in total net revenue in the first quarter, a 5% to 7% increase over the same period last year, according to a preliminary report. The growth was driven by the firm's continued improvement in sales productivity. BeckersSpine.com (4/10)
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Q4 sales jump for molecular imaging firm
Advanced Accelerator Applications generated $24.6 million in sales for the fourth quarter of 2014, compared with $18.6 million in the same period a year earlier. The molecular imaging firm also recorded a lower net loss of $10.4 million for the quarter, compared with $12.6 million in the same period a year earlier. AuntMinnie.com (free registration) (4/10)
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Finance veteran named CFO of Cepheid
Ilan Daskal, who has over 20 years of experience in finance, has been tapped to serve as the CFO of Cepheid. Daskal previously served as CFO at the semiconductor technology firm International Rectifier. GenomeWeb Daily News (free registration) (4/10)
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Want to Be a Better Salesperson? Build Relationships
Today's knowledge-hungry consumers often know as much about a product as the people trying to sell it. So what's your sales edge? Learning to build stronger relationships with your clients. Read the featured article.

Science & HealthSponsored By
Trial enrollment for Vertos Medical's back pain treatment completed
Vertos Medical has completed patient enrollment for a multisite, randomized and controlled trial of its minimally invasive lumbar decompression system. The study, which involves about 300 patients, seeks to supplement available data on the effectiveness of minimally invasive lumbar decompression or epidural steroid injection as treatment for back pain caused by lumbar spinal stenosis. BeckersSpine.com (4/10)
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Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

Emerging Technologies
HemCon wins approval for wound care products in China
Chinese regulators have granted Portland, Ore.-based HemCon Medical Technologies approval to market its entire wound care products portfolio. The firm said it has already accepted an order via a distributor in China. MassDevice.com (Boston) (4/10)
Hot Topics
Government & Regulatory
Senate hearings on repealing medical device tax planned
Hearings on repealing the 2.3% tax on medical devices could happen in the Senate Finance Committee in the near future. The deliberations will be initiated by the Subcommittee on Health Care, which is chaired by Sen. Pat Toomey, R-Pa. The No Taxation on Device Innovation Act, sponsored by Sen. Ed Markey, D-Mass., and the Medical Device Access and Innovation Protection Act, sponsored by Sen. Orrin Hatch, R-Utah, are being considered in the Senate. FDAnews (4/13)
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FDA approves study of CardiAQ's mitral valve implant
CardiAQ Valve Technologies has received an investigational device exemption from the FDA to conduct an early feasibility study of its implantable second-generation transcatheter mitral valve system. The Irvine, Calif.-based firm said the trial will involve 10 patients using a transapical approach, and another 10 subjects will be treated via a transfemoral approach. MassDevice.com (Boston) (4/10)
Medtech price control order endorsed in India
India's Task Force on Medical Devices has endorsed the inclusion of medical devices in the Essential Commodities Act and their regulation under a medical devices price control order. The task force also emphasized the need to authorize the country's drug price regulator to monitor and fix medical device prices. The Economic Times (India)/Press Trust of India (4/12)
AdvaMed News
Adaptive Designs: Overview, Hurdles & Examples
April 28
Westin Crystal City, Arlington, Va.

Preceding our 8th Annual Statistical Issues Workshop, the American Statistical Association is co-sponsoring a short course on Adaptive Design. The course will be taught by Dr. Christopher Coffey, University of Iowa. Learn more.
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8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30
Westin Crystal City, Arlington, Va.
This annual workshop, co-sponsored by the FDA and AdvaMed, brings together leading authorities from the FDA, industry and academia to address statistical topics in both therapeutic device and diagnostics tracks. Topics in the past have included missing data in studies of medical devices and diagnostics, adaptive designs in device trials, design and analysis of clinical trials with recurrent event endpoints, limit of detection methodologies, traceability and uncertainty of measurement, novel clinical trial design, clustered data and more. Learn more.
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