MEDICAL DEVICE INNOVATION - Medical Device Daily

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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
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