MEDICAL DEVICE INNOVATION - Medical Device Daily

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104 Private companies continue to draw value-minded investors By HOLLAND JOHNSON Medical Device Daily Managing Editor SAN FRANCISCO – As the Westin St. Francis Hotel began to empty out last Thursday as the annual J.P. Morgan Healthcare Conference was drawing to a close, there was enough interest in many of the private companies still to present to draw a crowd of investors looking for good value to add to their portfolios. Spiration (Redmond, Washington) is the maker of the IBV Valve, which is under investigation for use as a new treatment for patients with severe emphysema. President/CEO Richard Shea said the system is designed to redirect airflow from diseased portions of the lung to healthier areas. He said that during a minimally invasive procedure, the catheter is passed through a bronchoscope to deploy the small umbrella-shaped valves into the airways of the most diseased upper lobes of the lungs. Although the valves are intended to be permanent, they are designed to be removed via a minimally invasive procedure if necessary. Shea said the company already has done a 91-patient pilot study for use of the system in the U.S. as a new treatment option for patients with severe emphysema and is currently enrolling for a randomized, prospective, doubleblind, controlled pivotal trial. The company received a Humanitarian Device Exemption (HDE) for the system last October, specifically for patients who have lobectomy, segmentectomy or lung volume reduction surgery (Medical Device Daily, Oct. 28, 2008). This HDE, said Shea “represents the first for a bronchial valve implant for the lungs designed specifically to address this complication.” In Europe, the system already has received CE-mark clearance for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks. Spiration granted Olympus (Tokyo) and its distributors exclusive marketing and distribution rights for the IBV Valve System in 43 European countries, including the UK and other countries belonging to the European Union, representing what it said is the broadest distribution arrangement for a bronchoscopic treatment for emphysema in Europe. Shea called the market in the U.S. alone for this system a more than $1 billion opportunity. “There are clearly a bunch of other indications for the valve,” Shea said. “Over time, we would like to be able to help a broader group of patients.” Spiration is backed by an impressive group of MEDICAL DEVICE INNOVATION 2010 investors, including Three Arch Partners, New Enterprise Associates, Versant Ventures, New Leaf Ventures (Sprout Group), InterWest Partners, Investor Growth Capital, Saints Capital and Olympus. Presenting Flowcardia’s (Sunnyvale, California) portfolio of catheter-based technologies to facilitate crossing of totally occluded coronary and peripheral arteries was company President/CEO Wick Goodspeed. According to Goodspeed, chronic total occlusions (CTOs) are considered one of the last major clinical challenges in interventional therapy. He noted that the absence of a safe and effective CTO recanilization system is a major reason that a large number of patients are still referred to coronary and peripheral bypass surgery and lower limb amputation. The company received an FDA 510(k) clearance for peripheral arterial disease (PAD) in December 2007 and for coronary arteries in January of that same year. The company’s Crosser catheter uses high-frequency mechanical vibration, which acts like a jackhammer to unblock the vessel and allow for subsequent angioplasty or other device follow-up. Goodspeed said that recently, there have been dramatic improvements in both morbidity and mortality when CTOs are opened. He also noted that there have been “technology improvements that will follow opening of a CTO.” On the peripheral side he noted the use of arthrectomy, stents, cryoplasty and laser devices. On the coronary side, drug-eluting stents are still the rage. “Even though these [CTOs] are hard to treat, it’s really worth it to open them because the benefit is there and if you can get them open, you can keep them open with drug-eluting stents and through other means.” Goodspeed estimated the worldwide market for CTOs as being around $800 million. Offering spinal product platforms in both degenerative and scoliosis sectors is Paradigm Spine (New York). Currently the company markets four products for the treatment of degenerative spine diseases. These include: the coflex Interlaminar/Intespinous stabilization device; the coflex-F posterior stabilization device; the DCI system designed as a functionally dynamic cervical spine implant; and the recently released DSS spinal stabilization system. The DSS system is a pedicle screw-based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSS system incorporates a hybrid philosophy, combining elements of fusion and motion preservation. Chris Hughes, the company’s president of U.S. operations, said Paradigm also is working on a predictive diagnosis opportunity for pediatric scolisosis. The trials are being conducted at Sainte-Justine University Hospital Center (Montreal). Paradigm entered an agreement with Sainte-Justine to provide cash and “various To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 105 other resources” through 2008 to complete trials of a blood test developed by Dr. Alain Moreau, director of Sainte- Justine’s Bone Molecular Genetics and Skeletal Malformations Laboratory. Paradigm will receive the exclusive worldwide license to commercialize, make, distribute or sub-license any device, genetic tests, therapeutic agents or “any future technology” developed based on Moreau’s research. The blood test is for determining melatonin-signaling dysfunction in children. And the level of that dysfunction that can be correlated with the scoliotic curve and the evolution of that dysfunction. In the U.S. the company has launched the DSS Pedicle Screws and Slotted Couplers in August 2008. The company received FDA approval in November for the Rigid Couplers and launched these couplers earlier this month. Hughes noted that his company’s gross margins “are averaging around 91% right now.” (This story originally appeared in the Jan. 22, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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