The document summarizes news from the medical device industry. Specifically, it discusses: 1) The FDA clearance of Lumendi's Dilumen endoscopic accessory, which uses balloons to help position an endoscope and treat colonic lesions. This represents a minimally invasive alternative to surgery. 2) Varian Medical Systems' plan to spin off its imaging components business to boost its valuation after a difficult year. 3) Continued growth in patent filings from China, including in medical devices, cementing its status as an innovation leader according to the World Intellectual Property Organization. 4) Blackfynn's neurology data platform that aims to advance research by aggregating data, with

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VOLUME 20, NO. 241WEDNESDAY, DECEMBER 14, 2016
ENHANCES ENDOSCOPIC TREATMENT
ONCOLOGY EXTRA
MORE THAN 40% OF TOTAL
IN THIS ISSUE
Other news to note, p. 2, 3
Appointments & advancements, p. 2
Product briefs, p. 8
Daily M&A, p. 8
WHAT’S ‘MINED,’ WHAT’S YOURS
See Lumendi, page 3 See Varian, page 4
See Patents, page 5 See Blackfynn, page 6 See FDA, page 7
Regulatory Editor Mark McCarty,
IPD Editor Shyama Ghosh and Senior
Science Editor Anette Breindl
on one of med-tech’s key sectors
Read this week’s Wednesday Special
FDA gives green light to Lumendi’s
new platform to treat colonic lesions
By Liz Hollis, Staff Writer
With an eye toward promoting minimally invasive procedures and treating colorectal
disease within a patient’s intestine, Westport, Conn.-based Lumendi LLC has scored a
win at the U.S. FDA with its new device.
This week, the company reported that the agency has cleared the Dilumen
endoscopic accessory, which is intended to help with positioning an endoscope in the
large intestine.
The accessory includes a single-use, soft flexible sheath that fits over standard
and small-diameter colonoscopes. It utilizes two balloons – one behind the
bending section of the colonoscope and the other in front of the tip – to help create
INVESTORS SAY ‘DO IT AGAIN’
Varian revs up for
public spin off of
imaging business
By Stacy Lawrence, Contributing writer
Varian Medical Systems Inc. (VMS) of
Palo Alto, Calif., saw its valuation peak
in early 2015 at around $9.5 billion.
Since then, the company’s valuation
has never regained quite those heights.
After a tough year last year, it is working
to regain momentum on Wall Street.
Core to that is the planned spinout of
its imaging components business as a
Chinese patents continue
torrid pace, med-tech is
a key area of progress
By Pearl Liu, Staff Writer
HONG KONG – China is becoming an
innovation powerhouse with record high
patent filings last year and innovative
medical devices are a key area of
progress.
The United Nation’s World Intellectual
Property Organization (WIPO) says China
continued to set the pace worldwide for
Gone fishing: Blackfynn’s
data platform likely lure
for partners in neurology
By Randy Osborne, Staff Writer
“We’re on the precipice of being able to
crack open the science [in neurology],”
Amanda Christini, president of Blackfynn
Inc., told Medical Device Daily. Spun out
at the start of 2015 from the University
of Pennsylvania, the organization
consists of an 11-person team of experts
in neurology, neuroscience, computer
REGULATORY
FDA strikes more
measured tone in
emerging signals final
By Mark McCarty, Regulatory Editor
The FDA draft guidance for emerging
safety signals prompted two dozen
responses to the docket, a measure of
the concerns industry had about the
potential for overreaction to reports
of adverse events. However, the final
guidance includes the observation that
any information that is “unconfirmed,

2. WEDNESDAY, DECEMBER 14, 2016 MEDICAL DEVICE DAILY™ PAGE 3 OF 8
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Lumendi
Continued from page 1
“therapeutic zones” that allow for better visualization of
lesions.
These zones are created after the balloons are deployed
and inflated in a patient’s intestine. The device helps
stretch out the intestinal wall and straighten folds and
bends, aiding in visualization. Upon the conclusion of the
procedure, the balloons are deflated and removed with the
colonoscope.
Dilumen aims to help in the treatment of colonic lesions, such
as polyps, reducing the need for open surgical or laparoscopic
procedures. Eric Coolidge, vice president of marketing at
Lumendi, confirmed that the company plans to roll out the
device nationwide in May 2017.
Peter Johann, CEO of Lumendi Ltd., said the device represents
a “first step in a family of devices to enhance endoscopic
treatment,” adding that the company sees “great potential in
endolumenal interventions and is committed to build on this
opportunity.”
HELP FROM MINT
Development of the accessory came about as a result of an
agreement between the Minimally Invasive New Technologies
Program (MINT) at Weill Cornell Medical College and New
York- Presbyterian Hospital, which linked up with investors to
establish Lumendi in 2014.
Originally prototyped at MINT, the endoluminal surgical
platform saw further development and refinement at Lumendi
ahead of a submission at the FDA. Lumendi holds an exclusive
worldwide license from Cornell on the ESP platform and related
ancillary products.
There are a number of advantages for this approach versus
endoscopic procedures, especially as they typically are
performed in older patients who have a more difficult time
recovering from invasive procedures and the accompanying
anesthesia.
Last year, MINT co-director Jeffrey Milsom touted another
advantage of the proposed platform, noting that current
offerings do not have the same level of stability. A problem with
existing options is that the endoscope tip is difficult to control,
thereby affecting the precision of surgery. “With this device, you
can better control and manipulate the surgical environment
inside the intestine,” he added.
Further, Cornell researchers have estimated that ESP-
enabled procedures will spare 200,000 patients each year
from having to undergo invasive surgical procedures for
difficult-to-treat polyps. In addition, the platform could
help save the U.S. health care system more than $650
million a year.
Following the clearance, Milsom expressed further optimism.
“Dilumen’s use during flexible colonoscopy is an important
technical advance in a field that has previously been defined by
laparoscopic and open surgical procedures,” he said. “Although
reporting of results in patients awaits clinical studies, we are
extremely optimistic that this technology will be transformative
in treating digestive diseases,” he added.
Work is not finished, however, as MINT plans to develop a
series of products to enhance the ESP platform as it aims
to boost the number of procedures that can be performed
endolumenally. Among the proposed tools are flexible
surgical instruments to help in the performance of complex
surgical procedures within the intestinal channel. However,
the program has stated that its goal is to establish a new
field of endoluminal gastrointestinal surgery and has eyed
therapeutic areas such as diverticular disease, stricture,
intestinal fistulae, prolapse, volvulus, anastomosis leaks,
and early cancers.
On its website, MINT has listed other products in its pipeline,
including ESP+, which will aim to allow clinicians to deliver
multiple surgical tools simultaneously into the therapeutic
zone to perform advanced endolumenal surgical procedures. In
addition, it is eyeing work on flexible articulating surgical tools
to work with ESP+.
That said, Coolidge told Medical Device Daily that it was
“premature” to discuss what’s next in terms of product
development on Lumendi’s end; however, he did note
that the company is eyeing partnerships. It also is looking
to launch in other markets, starting with the European
Union.
Lumendi estimated that there are about 1 million new
colorectal cancer cases diagnosed each year globally.
Polyps, which can be precursors to colorectal cancers, are
missed up to 40 percent of the time during colonoscopies. //
Ion Beam Applications SA (IBA), of Louvain-la-Neuve,
Belgium, signed two new contracts with Proton Partners
International Ltd. (PPI), of Wales, to install two Proteusone
compact proton therapy solutions in Reading and an
undisclosed site in the U.K. The contracts are effective as
of Dec. 13. The contracted Proteusone solutions include
Pencil Beam Scanning (PBS) and Cone Beam CT (CBCT)
capabilities. The contracts also include a maintenance
agreement. These new centers will be the fifth and sixth
that IBA will install for PPI. Previously ordered centers
by PPI are currently being installed in Wales (Newport),
England (Northumberland and London) and Abu Dhabi,
United Arab Emirates. These latest contracted Proteusone
will be the 15th and 16th installation of IBA’s compact
single-room proton therapy solution, globally. IBA has now
sold 45 proton therapy centers worldwide.
OTHER NEWS TO NOTE