PALO ALTO, Calif.--(BUSINESS WIRE)--Mar 18, 2013--SinuSys Corporation, an innovative sinus health company, today announced recent additions to its management team as it expands its global commercialization activities for the SinuSys Dilation System and continues its progress toward FDA 510(k) clearance. The Company has appointed Michael Daniel as acting Vice President, Regulatory; Eric Schaefer as Director, Commercial Development; and Sagar Pushpala as Operations Advisor.
“Messrs. Daniel, Schaefer, and Pushpala each bring significant strengths to our team,” said Thomas Schreck, Chief Executive Officer of SinuSys. “Their respective expertise in regulatory affairs, commercialization, and technology operations management will further ensure our success as we expand internationally, scale up manufacturing, and prepare for entry into the US market.” The Company has received the CE Mark, Health Canada license, and Australian Therapeutic Goods Administration (TGA) Certificate for the SinuSys Dilation System.
Mr. Daniel has more than 30 years of regulatory, clinical, and quality system experience and has served as Vice President of Regulatory and Clinical Affairs on a full-time or a part-time consulting basis for a number of medical device companies including FemRx, Intuitive Surgical, Coalescent Surgical, LuMend, NeoGuide, EndoGastric Solutions, Cardiva Medical, and LAAx, Inc. He has obtained over 100 510(k), IDE, and PMA medical device clearances and approvals from the FDA and has facilitated several successful IPO and acquisition exits. Mr. Daniel holds a BS in Microbiology from Michigan State University, an MS in Biology from the Illinois Institute of Technology, and an MBA from the University of California, Berkeley.
Mr. Schaefer possesses more than 16 years of medical device sales management experience, including 11 years in surgical products for otolaryngology. Most recently, he served as Director, National Sales for ArthroCare Corporation’s ENT business unit. There, he played a leading role in expanding that division’s direct sales force to 55 territories in seven regions and growing the U.S. revenue to more than $85M on the strength of the Coblation® and Rapid Rhino™ product lines. He also served as District Sales Manager with the Neuro and Orthopedic Surgical Division for PMT Corporation. Mr. Schaefer holds a BA in Business from the University of St. Thomas in St. Paul, MN.
Mr. Pushpala is currently CEO of TSI Semiconductors. Over his 25-year career, he has held senior-level operations, engineering, and technology management positions at Intersil, Maxim Integrated Products, National Semiconductor, Saratoga Semiconductor, and Advanced Micro Devices. Formerly an Operating Partner at Khosla Ventures, he currently serves in advisory and board positions for several of that firm’s portfolio companies in the medical device and system fields. Mr. Pushpala holds an MS in Chemical Engineering from the University of Kansas and a Bachelor of Technology degree in Chemical Engineering from the Indian Institute of Technology (IIT) in Madras, India.
Chronic sinusitis affects more than 31 million people in the United States. It is more prevalent than heart disease and asthma, and has a greater impact on patients’ quality of life than chronic back pain or congestive heart failure. The U.S. healthcare system currently spends more than $8 billion annually on improving the health of patients with sinus conditions. However, approximately 20 percent of sinusitis patients do not experience adequate relief from current pharmaceutical treatments, which can have unpleasant side effects even when effective. For these patients, the most effective treatments to-date have been Functional Endoscopic Sinus Surgery (FESS) and high-pressure balloon dilation, which can cause significant patient discomfort and are conducted in a surgical suite under general anesthesia or IV sedation.
About SinuSys Corp.
SinuSys Corp. ( www.sinusys.com ) develops medical device therapies to improve the health of millions of patients suffering from chronic sinusitis worldwide. The company’s proprietary self-expanding, osmotic technology is designed to be atraumatic, tissue-sparing, and easy to use, potentially enabling clinicians to intervene at earlier stages of sinus disease. The company seeks to provide improved options for the 20 percent of sinusitis patients whose disease is not resolved with drug therapy. The Company’s first commercial product is designed to treat chronic sinusitis by gently opening the sinus ostia, thereby restoring natural sinus drainage and ventilation using a simple, two-step interventional approach. The low-pressure, gradual expansion and simplicity of the device are designed to make it compatible for use in office-based procedures under local anesthesia.