NEWS
 

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.

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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