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Fossa Medical receives European Approval and
announces study results- September 9, 2005
Fossa Founder Gloria Kolb featured in Hi
International Magazine - June 2005
TECHNOLOGY REVIEW, MIT'S Magazine of Innovation, Names Fossa
President Gloria Kolb as "One of the World's Top Young
Innovators" - September 20, 2004
Fossa Receives FDA Clearance for Open Lumen Stent - December
2, 2003
Fossa President Gloria
Kolb voted one of the 40 Under 40 by Boston Business Journal - 3
October, 2003
Fossa
one of 14 Hot Startups by Fortune Small Business - 29 January, 2003
Fossa
contributes to Chicago Tribune article - 18 December, 2002
Fossa
president Gloria Kolb interview by Women's Business Boston - October,
2002
Fossa
president Gloria Kolb speaks at Babson College's "Women Building
Businesses" - October 9, 2002
Fossa
Makes the Boston Herald - August 14, 2002
Fossa Receives Second FDA Clearance - August 13, 2002
Fossa
Interviewed by Boston Business Journal - July 19, 2002
(free subscription required)
Fossa Makes Front
Page of Medical Device Daily - July 10, 2002
(subscription required)
Fossa Receives FDA Clearance - July 9, 2002
Fossa
Interviewed by Mass High Tech - July 1, 2002
Fossa Funding - June 18, 2002
Carrot Capital Business Plan Competition - April 2,
2002
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Needham, Mass -
September 9, 2005
FOSSA MEDICAL ANNOUNCES STUDY RESULTS PRESENTED AT WORLD CONGRESS OF ENDOUROLOGY
AND CE MARK APPROVAL
Fossa Medical announced today that favorable clinical and
pre-clinical results of studies using the Fossa Stone Sweeper and
Open-I ureteral stents were featured at the World Congress of Endourology held in Amsterdam on August 22-26, 2005.
From a study of 25 patients with large kidney stones, and who would
be at risk for multiple treatments, Dr. Mitchell Bamberger from the
Worcester Medical Center in Worcester, Massachusetts presented
conclusions that "...the Stone Sweeper is a new and useful tool that
should speed stone removal rate and reduce secondary treatment."
Dr. Manoj Monga from the University of Minnesota presented results
of an in-vitro evaluation of ureteral stent compression that could
shed light on how the Open-I stent design might impact stent
performance in cancer patients. Dr. Monga concluded that the novel
design of the Open-I stent was one of the top performers out of 14
stents under compression and deserves further study in the cancer
patient. In a related animal study done by Dr. David Hoenig,
Montefiore Medical Center, NY, both the Stone Sweeper and Open-I
stents "demonstrated significantly better extraluminal and total
flow" in an obstructed urinary system, when compared to a standard
stent product.
Fossa is also pleased to announce that it has achieved certification
to CE mark its product for the European market.
"These World Congress results are very encouraging and indicative of
the progress that Fossa Medical is making to bring new product
solutions to the practicing urologist," said Fossa CEO Tom Keenan.
"Coupled with the achievement of the CE Mark, the Company is poised
to move forward to develop markets both inside and outside the
United States."
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Needham, Mass -
March 31, 2005
FOSSA MEDICAL NAMES THOMAS M. KEENAN AS CEO AND JOHN M. CARNUCCIO
AS BOARD MEMBER
Together bring a wealth of commercialization experience to
Fossa
Fossa Medical, a medical device company whose lead products
include a new generation of stents to treat patients with kidney
stone disease, today announced that Thomas M. Keenan has joined
Fossa as Chief Executive Officer. Mr. Keenan has an extensive
background in sales, marketing and commercializing new technology in
the medical device industry. “Tom joins Fossa at a time of real
opportunity” says Gloria Kolb, President and co-founder of the
Company. “We all look forward to Tom’s leadership and energy as
Fossa makes the transition to a worldwide commercial organization.”
Early in his career, Mr. Keenan spent thirteen years at Boston
Scientific Corporation in sales and marketing positions, including
Vice President International and Vice President of Marketing,
Meditech Division. Tom served as President and CEO of EKOS
Corporation; a Washington based medical device company, from 1996 to
2001. Immediately prior to joining Fossa, he was Vice President, US
Sales and Marketing for Biosphere Medical, and before that their
Vice President for International Sales and Marketing.
“The small team at Fossa is recognized for their entrepreneurial
spirit and focus on improving patient outcomes with some very
innovative product designs” says Mr. Keenan. “I am very pleased to
join the team and to work with physicians around the world to bring
these products to market” he added.
John M. Carnuccio adds significantly to the team with direct
urology experience as Vice President and General Manager,
Microvasive Urology Division of Boston Scientific from 1992 to April
1998. Carnuccio was also co-founder, President and CEO of BioSphere
Medical, Inc. until 2002.
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Cambridge, Mass -
September 20, 2004
TECHNOLOGY REVIEW, MIT’S MAGAZINE OF INNOVATION, NAMES GLORIA
KOLB ONE OF THE WORLD’S TOP YOUNG INNOVATORS
<Link to Technology Review Article>
Kolb To Be Honored September 29 – 30 at
Technology Review’s Emerging Technologies Conference at MIT
Fossa Medical, a medical device startup
in Urology, today announced that Gloria Kolb, President and Founder,
has
been named to the 2004 list of the world’s 100 Top Young Innovators
by
Technology Review, MIT’s Magazine of Innovation. The TR100, chosen
by the
editors of Technology Review and an elite panel of judges, consists
of 100
individuals under age 35 whose innovative work in technology has a
profound
impact on today’s world. This year’s nominees are recognized for
their
contributions in transforming the nature of technology and business
in
industries such as biotechnology and medicine, computing, and
nanotechnology.
Gloria Kolb has developed medical products from concept to product
launch
and holds many patents for her innovative designs. Her products work
with
the body’s natural properties to help patients recover quickly and
more
effectively.
The 2004 TR100’s unparalleled panel of judges includes senior
executives
from the following organizations:
Boston University, Caltech, Cambridge University, CombinatoRx,
Concept2Company, Cornell University, General Electric, Geekcorps,
Georgia
Tech, Harvard Medical School, Hewlett-Packard, IBM, Intellectual
Ventures,
Microsoft, MIT, Northwestern University, PureTech Ventures,
Singapore
Institute of Bioengineering and Nanotechnology, TIAX, Wharton,
Xerox, and
YankeeTek Ventures.
“In the five years since we began naming our annual selection of the
world's
top innovators under age 35, inclusion among the TR100 has become
one of the
most prestigious awards for young innovators around the world," said
David
Rotman, executive editor of Technology Review. "This year's winners
are all
pioneering fascinating innovations in the fields of biomedicine,
computing
and nanotechnology, and were chosen after a rigorous selection and
judging
process. The result is an elite group whose visions and inventions
will
shape the
future of technology."
Kolb will be honored September 29 - 30 at Technology Review’s
Emerging
Technologies Conference at MIT. The event features keynotes, panels
and
breakout discussions on the transformative technological innovations
that
have the potential to fuel new economic growth and dramatically
change the
future. Keynote speakers include Vinod Khosla, founding CEO of Sun
Microsystems and General Partner at Kleiner, Perkins, Caufield &
Byers; Ray
Kurzweil, renowned inventor, author and founder of Kurzweil
Technologies;
and Rick Wagoner, chairman of General Motors. More information on
ETC2004
can be found at www.tretc.com.
About Technology Review, Inc.
Technology Review, Inc., an MIT Enterprise, delivers essential
information
about emerging technologies and their impact on business leaders.
Since
1998, paid circulation for the company’s magazine, Technology
Review, has
more than tripled, climbing from 92,000 to 315,000. Combined with
its
signature events, newsletters, and online businesses, Technology
Review
reaches over two million business leaders throughout the world each
month.
Fossa Medical creates innovative medical devices that keep small
body
passageways open and unobstructed. Fossa’s first product, the Kidney
Stone
Sweeper, is effective in direct removal of kidney stones and reduces
cost of
care. Since being founded in 2001, Fossa has gained four FDA
clearances,
and have the Stone Sweeper and other products currently being used
by the
top urologists. Most recently, Fossa Medical was named as one of
Fortune
Small Business’ “14 Hot Startups” of the year.
For TR100 and Technology Review:
Kristen Collins, KMC Partners, 617.833.5574,
kristen@kmcpartners.com
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BOSTON, Mass - December
2, 2003
FOSSA MEDICAL RECEIVES FDA CLEARANCE TO MARKET THE URETERAL OPEN
LUMEN STENT
Regulatory Clearance Allows Fossa to Market the Device for Use
in Human Patients
Fossa Medical, a medical device developer with patented innovative
technologies for removing obstructions and restoring patency of
the urinary and biliary systems, today announced it has received
FDA clearance by the U.S. Food and Drug Administration (FDA) for
its second product, the Ureteral Open Lumen Stent, for use in human
patients. Market clearance allows the device to be used as an indwelling
ureteral catheter for draining urine from the kidney to the bladder,
specifically targeting long-term stent use. Patients with extrinsic
compression around the ureter, caused by tumors, pregnancy, and
endometriosis among other indications, often suffer from blocked
or restricted urine flow and require a stent to maintain an open
passageway.
Fossa’s Ureteral Open Lumen Stent uses the same deployment
method and materials as common ureteral stents. However, its unique
open-lumen geometry allows urine to flow in and out of the stent,
providing alternate passageways around localized encrustation or
compression and longer product life. In a recent in-vitro flow study,
the Open Lumen Stent exhibited greater flow rates and less encrustation
than traditional ureteral stents of similar material and size.
"We are excited at the opportunity this product has in solving
a classic problem of the urinary tract and improving patients lives."
says Gloria Ro Kolb, President, Fossa Medical. "Initial review
by urologists have been very positive and Fossa looks forward to
a rapid market adoption of the Open Lumen Stent."
Earlier this year Fossa introduced the Kidney Stone Sweeper, designed
to remove small stones or stone fragments, such as those generated
by ESWL, obviating the time and pain associated with the patient
passing them. The device is being sold domestically and internationally
and is well received by Urologists.
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BOSTON, Mass- August 13,
2002
FOSSA MEDICAL OBTAINS REGULATORY CLEARANCE TO MARKET REVOLUTIONARY
DEVICE FOR REMOVING KIDNEY STONES
Fossa Enters the $2 Billion Stone Removal Market with The Ureteral
Stone Sweeper®, the First Expanding Ureteral Device Designed
for both Ureteral Drainage and Removal of Kidney Stones
Fossa Medical, a medical device developer with patented innovative
technologies for removing obstructions and restoring patency of
the urinary and biliary systems, today announced it has received
clearance by the U.S Food and Drug Administration (FDA) for the
Fossa Ureteral Stone Sweeper . The Sweeper is the first expanding
ureteral device to be used for both ureteral drainage and for removing
3-5 mm kidney stones. The recent FDA approval came earlier than
expected and is the second indication cleared for Fossa’s
market entry product. The Fossa Stone Sweeper gently expands once
inside the ureter, promoting ureteral drainage and enabling direct
removal of small kidney stones. Small stones have typically been
left to pass without surgical intervention, usually causing severe
discomfort for patients.
"We are pleased to have reached this milestone sooner than
expected," said Gloria Kolb, President and co-founder of Fossa
Medical. "Consistent, positive results during development are
evidence of our solid technology and ability to provide the market
with a less invasive, more time-efficient and cost-effective method
of kidney stone management."
The most common stone removal treatment, Extracorporeal Shockwave
Lithotripsy (ESWL), works to reduce the size of the stone by fragmentation.
"The Sweeper is designed to remove small stones or stone fragments,
such as those generated by ESWL, obviating the time and pain associated
with the patient passing them," says Kolb. "Devices for
use in conjunction with ESWL is an area of significant market growth.
We are already seeing demand from Urologists eager to improve patient
outcomes with our stone removal technology."
Once inserted, a sheath surrounding the Sweeper is removed, enabling
a series of baskets along the length of the device to expand. This
action gently dilates the ureter, promotes drainage, and traps the
stones, providing direct and atraumatic removal.
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BOSTON, Mass- July 9, 2002
FOSSA MEDICAL RECEIVES FDA CLEARANCE FOR EXPANDING URETERAL STENT
Regulatory Clearance Allows Fossa to Market the Device for Use
in Human Patients
Fossa Medical, a medical device developer with innovative technologies
for removing obstructions and restoring patency of the urinary and
biliary systems, today announced it has received FDA clearance for
its first product, the Expanding Ureteral Stent, for use in human
patients. Market clearance for this first indication allows the
device to be used as an indwelling ureteral catheter for draining
urine from the kidney to the bladder. Second indication clearance
for removal of kidney stones, which often blocks urine flow, is
expected in early Fall.
"We are very pleased to have received clearance for our first
product," says Gloria Ro Kolb, President, Fossa Medical. "The
speed with which the Expanding Ureteral Stent was conceptualized,
designed, tested, and ultimately granted FDA clearance is evidence
of Fossa’s engineering strength, ability to innovate, and
corporate efficiency. Our immediate next step is to get the Expanding
Ureteral Stent into the hands of Urologists to improve patient care."
Through the efforts of a strong management and engineering team,
Fossa secured angel funding earlier this year to bring the device
through the development and regulatory processes. The company will
continue to focus on raising capital for a national product launch,
marketing and additional R&D.
"We will continue to be aggressive in meeting a demand for
innovative new products," states Kolb. "We are already
in the process of filing patents for new devices, and for additional
indications and markets."
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BOSTON, Mass.- June 18, 2002
FOSSA MEDICAL ENTERS DEVICE MARKET WITH FUNDING FROM ANGEL INVESTORS
Funds Will be Used to Bring Fossa's Innovative Device for Definitive
Removal of Kidney Stones Through Regulatory Process
Fossa Medical, a new and vigorous medical device development company,
announces it has received funding from private individuals to bring
its first product through FDA clearance and enter the $2 billion
dollar kidney stone removal market. The company's premier product,
the Stone Sweeper®, provides for quick and easy removal of kidney
stones and is currently under FDA review. Fossa's product line will
focus on new and enhanced methods of removing obstructions and restoring
patency of the urinary and biliary systems. In doing so, Fossa's
patented technologies offer substantial benefits over those of existing
devices by improving patient outcomes and lowering cost of care.
"We are pleased to have received this private round of funding
to complete trials and move ahead with FDA clearance," said
Gloria Kolb, founder and President of Fossa Medical. "Animal
trials for our first device resulted in excellent outcomes for passively
dilating the ureter and removing kidney stones. The resulting data
from these trials is a key factor allowing us to file for clearance
very quickly," she added. "It also allows us to take the
next steps with additional products and patents for other markets."
"Fossa is focused on leading the market by meeting a demand
for unique products, beginning with The Stone Sweeper," said
Michael Mitchell, MD, co-founder of Fossa Medical. "This is
the only device that allows for quick and gentle removal of 3-5mm
stones. I expect we will experience higher patient satisfaction
with shorter hospital stays and cost reductions."
Fossa's small size promotes nimble decision-making and consensus-building,
and a lean management team that actively seeks favorable partnerships,
such as Boston law firm Hill & Barlow's Incubator Program. The
program is designed to provide legal services to Incubator clients
during their critical, early phases of development at very cost-effective
rates. "We selectively choose companies that have high growth
potential and a strong team, like Fossa Medical," said Anne
Showalter, Hill & Barlow counsel for Fossa. "The Fossa
team recognizes our extensive legal experience in guiding early
stage ventures and in assisting their growth into financially viable
companies. We are also assisting Fossa in establishing relationships
with other key service and capital providers who are similarly committed
to working with early-stage companies."
Fossa is led by a strong management team including award-winning
entrepreneur, Gloria Kolb, Founder and President, a former Johnson
& Johnson engineer and MIT, Stanford and Babson MBA graduate;
Mark Manasas, VP of Engineering, a former Johnson & Johnson
engineer with over 75 product introductions to his credit; Glenn
Schneider, VP of Sales & Marketing, strong industry executive
with credentials from companies such as E. Merck. Fossa's active
board is led by Jeffery Otten, former President of Brigham &
Women's Hospital in Boston and Jean-luc Boulnois, successful medical
device entrepreneur.
About Fossa Medical
Founded in 2001, Fossa Medical designs and markets innovative devices
that improve clinical procedures and outcomes for conditions that
affect the small passageways of the body. Its patented technology
keeps passageways open and removes obstructions like kidney stones
and gallstones. The company's first product for the removal of kidney
stones is expected to be available in the 4th quarter of 2002.
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NEW YORK, NY - April 2, 2002
Fossa Industries of Babson College won second place and $10,000
in cash in the Carrot Capital Business Plan Challenge, a nationwide
business plan competition. Fossa and 23 other finalist teams were
flown to New York City on April 27, all expenses paid, to present
their business plans to a celebrated panel of finalist judges made
up of distinguished business and thought leaders, and compete for
$100,000. There were exceptional plans from 450 registered teams
from all over the nation, making it a difficult field to narrow
down.
Fossa Industries creates innovative medical devices that reduce
pain, procedure, time and costs, while increasing efficiency. Their
patented technology is focused on keeping small body passageways
open and unobstructed. Fossa's first products will be effective
in direct removal of kidney and gall stones.
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