“This investment is a great vote of confidence in Clear Catheterʼs mission to deliver technology that will improve post surgical outcomes and reduce healthcare costs,” said Clear Catheterʼs CEO, Ed Boyle. “These investors have significant experience working with high-growth medical device companies like ours, and weʼre thrilled to have Ned and Alex joining the team.”

“Clear Catheterʼs Active Tube Clearance System is a groundbreaking technology to aid in the post operative recovery from surgery,” said Ned Scheetz. “We believe Clear Catheterʼs PlueraFlow system can improve hospital profitability by reducing the high costs associated with post surgical complications, and simultaneously improve patient care.”

About Clear Catheter Systems, Inc.

Clear Catheter Systems is a Bend, Oregon based medical device company developing an anti-clogging platform of surgical drainage devices. Its lead product is the PleuraFlow Active Tube Clearance System, which addresses the problem of chest tube clogging after heart and lung surgery. In addition, Clear Catheter has a pipeline of products based on its proprietary tube clearance technology to treat tube clogging in other medical market segments, including a system for the urinary catheter drainage market, the enteral feeding sector as well as systems for standard surgical drains.

www.clearcatheter.com www.pleuraflow.com

MEDIA CONTACT

Kelly Herman

(541) 419-8855

kelly@kellyherman.com

http://newsite.pleuraflow.com/wp-content/uploads/2011/01/Sunday-EACTS09_front-page.pdf

June 29, 2011

The PleuraFlow® Active Tube Clearance™ System has been recognized as a one of the winners of the 49th Annual R&D 100 Awards, which salute the 100 most technologically significant products introduced into the marketplace over the past year. This award comes on the heels of winning a 2011 MDEA Gold award, as well as an I.D. Design Distinction recognition and the European Association of Cardiothoracic Surgeons (EACTS) Techno Innovation awards. 

As the first chest tube with a mechanism for actively clearing blood clots, the PleuraFlow® Active Tube Clearance™ System represents the most significant innovation in chest tubes in half a century. The PleuraFlow® Active Tube Clearance™ System incorporates a metal loop at the end of a guide wire inside the tube. A guide sleeve outside the tube is connected via magnetic coupling to the guide wire. Clots can be cleared, without breaking the sterile field, by shuttling the guide sleeve back and forth along the along the tube. The device was designed and developed by Clear Catheter Systems and Carbon Design Group. Xeridiem designed and developed the manufacturing process as well as manages logistics including order fulfillment.

“The PleuraFlow Active Tube Clearance System is being used in the US, EU, and Canada to help patients recover from heart surgery safely and comfortably. “We appreciate the contribution from Carbon and Xeridiem to help us bring this product to market,” said Edward Boyle, the CEO of Clear Catheter Systems. “This award demonstrates our ability to work closely with medical innovators to bring novel products to market quickly, effectively, and on budget,” said Joseph Lee, Xeridiem’s President.

The R&D 100 Awards have long been a benchmark of excellence for industry sectors as diverse as telecommunications, high-energy physics, software, manufacturing, and biotechnology. Since 1963, the R&D 100 Awards have identified revolutionary technologies newly introduced to the market. Many of these have become household names, helping shape everyday life for many Americans. These include the flashcube (1965), the automated teller machine (1973), the halogen lamp (1974), the fax machine (1975), the liquid crystal display (1980), the Kodak Photo CD (1991), the Nicoderm anti-smoking patch (1992), Taxol anticancer drug (1993), lab on a chip (1996), and HDTV (1998).

Winners of the R&D 100 Awards are selected by an independent judging panel and the editors of R&D Magazine. The publication and its online portal serve research scientists, engineers, and other technical staff members at high tech industrial companies and public and private laboratories around the world.

Winners will be recognized at the R&D 100 Awards Banquet on Oct. 13, 2011, in Orlando, Fl. A list of winning innovations is on the R&D 100 Awards website, www.rdmag.com. Additional information, including registration for the Orlando event, will be available at that website on July 1, 2011.

Cardiothoracic surgeon Edward Boyle was a man on a mission when he partnered with Cleveland Clinic heart surgeon Marc Gillinov to establish Clear Catheter Systems Inc. (Bend, OR). After years of observing clogs and blood clots form in chest tubes and their resulting adverse effects on patients, Boyle was determined to develop a solution that overcame this dangerous design flaw. Responding to this unmet clinical need, Clear Catheter has introduced the PleuraFlow Active Tube Clearance system to prevent chest tube occlusion and improve patient safety.

Following heart, lung, or trauma surgery, chest tubes are inserted into patients and coupled to a drainage system in order to remove excess fluid or air from the body. “A lot of what is drained is blood,” Boyle, CEO of Clear Catheter, explains. “If blood clots or coagulates in those tubes, which it tends to do, then they don’t drain very well. If that happens, it can contribute to complications and impair outcomes.” Complications resulting from clogged chest tubes can include a pneumothorax, pericardial tamponade, and excessive blood loss—the latter of which can occur if blood pools unnoticed in the chest cavity as a result of a clot formation in the portion of the tube positioned inside the body. Difficulty even arises when a clot is quickly identified in the chest tube, Boyle adds, because current methods of removal are undesirable for clinicians and may cause additional discomfort or risk for patients.  

In an effort to avoid these unnecessary complications, Clear Catheter developed the PleuraFlow system. The product consists of a standard chest tube that is inserted into the patient and then connected to a guide tube, over which is a shuttle guide set. The guide tube is then connected to a standard chest drainage system. Located within the guide tube, a guidewire featuring a distal loop moves backward and forward in the chest tube via a proprietary drive system to prevent clot formation. “We call this active tube clearance,” Boyle comments. “No other products have anything on the inside; they’re just a tube. With the PleuraFlow system, we’re moving from passive drainage to active drainage.”

To develop the PleuraFlow system, Clear Catheter Systems, armed with the initial concept for the clog-preventing device, sought the expertise of product development consultancy firm Carbon Design Group (Seattle) to help take the idea to the next level. Together, engineers and designers from both companies participated in brainstorm sessions to determine the optimal design of the system. “One of the most important design elements was that we had to figure out how to move the guidewire inside the tube from outside the tube,” Boyle recalls. “You can’t have an opening or a hole in the tube because that breaks the sterile barrier on the inside.”

A design epiphany came in the form of magnets, notes Robert Hubler, an industrial designer at Carbon. “There’s a magnet on the inside of the plastic tube that’s attached to the guidewire; on the outside, you have another magnet,” he explains. “The magnets will attract each other through the tube because the tube is naturally very slick on the inside and the magnet is a polished metal piece. So, it’s easy for the magnet to move on the inside of the tube with that attraction to the other magnet that’s moving back and forth without breaking the sterile barrier.” This back-and-forth movement of the guidewire in the tube serves to break up blockages, thus encouraging fluid flow and preventing coagulation.

Once the use of magnets was agreed upon, Carbon launched into the industrial design, mechanical engineering, and testing of the PleuraFlow system based on feedback from Boyle and his surgeon colleagues. “Once Clear Catheter decided it wanted to go with the magnetic solution, we figured out a scheme for the use of the device pretty quickly,” Hubler says. “The basic architecture is that the shuttle gets released, moves back and forth, and then docks back in the home position.”

As part of the design and development process, Carbon took a close look at the forces required for the system. One challenge it faced was striking a balance so that the magnets provided enough force to drive the guidewire without interfering with nearby telemetry and other electronic systems. Achieving a balance in decoupling force also proved to be challenging. It needed to be strong enough to withstand the force of clot removal but forgiving enough to allow for separation of the wire in the shaft, if necessary, for safety reasons.

Upon finalizing the design and engineering with Carbon, Clear Catheter approached Xeridiem Medical Devices (Tucson, AZ), a company specializing in the design, development, and manufacture of complex, single-use medical devices. “We optimized the design for manufacturability,” says Mike Cusack, director of business development at Xeridiem. “We developed a manufacturing process and ensured that the device would work within the requirements of the ICU.”

Xeridiem also molded the silicone housings, and assembled, tested, packaged, and sterilized the device. The company helped with regulatory filings for the PleuraFlow system as well. In essence, Cusack remarks, Xeridiem has served as the bricks and mortar of Clear Catheter Systems in that it manufactures the PleuraFlow in addition to taking orders, providing technical support, answering phones, maintaining inventory, shipping for distribution, and invoicing.

Obtaining FDA approval in December, the PleuraFlow system offers a simple solution to the common—and life-threatening—problem of chest tube clogging. And if that weren’t enough, it offers the additional benefit of enabling the use of smaller chest tubes. “Rather than using large chest tubes that look like a garden hose, our goal is to eventually be able to use a tube that is smaller and maybe only the size of a drinking straw,” Boyle says. “We think that it will not only help reduce complications, but it will also improve patient comfort.”

Published in MPMN, June/July 2011, Volume 27, No. 5

© (PleuraFlow ATC) was honored with the Gold Medical Design Excellence Award (MDEA). The 2011 MDEA Winners Ceremony was held June 8, 2011 in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition (www.MDMEast.com) in New York City’s Jacob K. Javits Convention Center.  The PleuraFlow Active Tube Clearance System product is being used in the US, EU, and Canada to help patients recover from heart surgery safely and comfortably. “We appreciate the contribution from Carbon and xeridiem to help us bring this product to market,” said Edward Boyle, the CEO of Clear Catheter Systems. “This award demonstrates our ability to work closely with medical innovators to bring novel products to market quickly, effectively, and on budget,” said Joseph Lee, xeridiem’s President.

PleuraFlow ATC prevents chest tube clogging after heart and lung surgery. It consists of a magnetically driven guide wire that is advanced into the PleuraFlow Chest Tube to remove any tube obstructions or clogging. Pleuraflow ATC was design and developed by Clear Catheter Systems, Inc, (Bend, OR) in conjunction with Carbon Design Group (Seattle, WA). Clear Catheter Systems teamed up with Xeridiem Medical Devices (xeridiem, Tucson, AZ) to design and develop the manufacturing process as well as manufacture and distribute the product. 

The Medical Design Excellence Awards competition (www.MDEAwards.com) is organized and presented by UBM Canon (Los Angeles) and is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives. A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics. A select number of recipients were given the prestigious Gold designation.  Xeridiem orchestrates medical device development with an emphasis on design for manufacturability. Our services help client’s bridges the gap between concept and commercialization. Whether you are an established medical device company or just getting started, we offer a full menu of services designed to simplify your life. We have a track record of on-time, on-budget project completion; no surprises. Xeridiem is backed by the financial strength of Fenner plc, the parent company and is ISO 13485:2003 certified, FDA registered. Learn more about xeridiem at www.xeridiem.com.

About xeridiem Xeridiem is a designer, developer and manufacturer of complex single use medical devices. For over 25 years xeridiem has enabled major companies and venture-backed entrepreneurs to launch over 200 medical devices that have become standards of care.

About Clear Catheter Systems, Inc.

Clear Catheter Systems is a Bend, Oregon-based medical device company developing an anti-clogging platform of surgical drainage devices. Its lead product is the PleuraFlow Catheter, which addresses the problem of chest tube clogging after heart and lung surgery. In addition, Clear Catheter has a pipeline of products based on its proprietary tube clearance technology to treat tube clogging in other medical market segments, including a system for the urinary catheter drainage market and the enteral feeding sector as well as systems for standard surgical drains.

More information about Clear Catheter Systems is available at www.clearcatheter.com. 

About Carbon Design Group

Carbon Design Group is a full-service product development consultancy based in Seattle, Washington. Carbon delights clients by blending insightful research, thoughtful design, and end-to-end engineering expertise. We apply informed intuition and inspired ingenuity to create stand-out products and experiences that connect. Our holistic approach minimizes risk, speeds time to market, and delivers results that resonate. Carbon is widely recognized for innovation and for the development of iconic product families. Our portfolio of clients includes GE, Intel, Medtronic, Microsoft, Panasonic, Philips, Xbox, and many more.

More information about Carbon Design Group is available at www.carbondesign.com.Media Contact:
Renae Moomjian
1-520-882-7794 x173
RMoomjian@xeridiem.com

Media Contact:

Renae Moomjian
1-520-882-7794 x173
RMoomjian@xeridiem.com

Clear Catheter Systems, Inc., today announced that thePleuraFlow™ Active Tube Clearance™ System will be featured in the “ICU of the

Future” exhibit at the annual American Association of Thoracic Surgery Meeting in

Philadelphia.

New for 2011, the ICU of the Future allows AATS surgeon members to view first hand

what the future holds for cardiothoracic critical care. The PleuraFlow Active Tube

Clearance System will be featured along with a wide range state-of-the-art technologies

that advance the standard of care in the ICU.

Chest tubes are used after every heart and lung procedure. The PleuraFlow Active

Tube Clearance System is a novel chest tube clearance accessory developed to

maintain chest tube patency after heart and lung surgery. Clogging of a chest tube with

a clot in the setting of continued postoperative drainage can contribute to impaired

patient outcomes and increased costs of care. Chest tube clearance with the

PleuraFlow Active Tube Clearance System is achieved by advancing the specially

designed clearance member back and forth within the chest tube under sterile

conditions, breaking down and pulling clots back out of the tube, thereby leaving the

inner portion of the chest tube clear of any obstructing material.

About Clear Catheter Systems, Inc.

Clear Catheter Systems is a Bend, Oregon based medical device company developing

an anti-clogging platform of surgical drainage devices. Its lead product is the PleuraFlow

Active Tube Clearance System, which addresses the problem of chest tube clogging

after heart and lung surgery. In addition, Clear Catheter has a pipeline of products

based on its proprietary tube clearance technology to treat tube clogging in other

medical market segments, including a system for the urinary catheter drainage market,

the enteral feeding sector as well as systems for standard surgical drains.

www.clearcatheter.com

www.pleuraflow.com

MEDIA CONTACT

Kelly Herman

Clear Catheter Systems

(541) 419-8855

kelly@kellyherman.com

More on Device Innovation Group

Presentation of the 2011 MDEA awards will take place on Wednesday, June 8^th in a ceremony at the Medical Design & Manufacturing (MD&M) East 2011 Conference and Exposition, in New York City.

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About Clear Catheter Systems, Inc.
Clear Catheter Systems is a Bend, Oregon based medical device company developing
an anti-clogging platform of surgical drainage devices. Its lead product is the
PleuraFlow Catheter, which addresses the problem of chest tube clogging after heart
and lung surgery. In addition, Clear Catheter has a pipeline of products based on its
proprietary tube clearance technology to treat tube clogging in other medical market
segments, including a system for the urinary catheter drainage market, the enteral
feeding sector as well as systems for standard surgical drains. (www.clearcatheter.com.

About MDI Partners
MDI Partners specializes in early stage medical device development. The company was founded as a result of the mutual recognition by four experienced medical device leaders that there is an unmet need for financial support and management expertise in the development of promising medical device technologies for smaller markets that are below the threshold of interest for traditional venture capital. In general, these products are innovative medical devices with strong patents, a fairly straightforward design, development and regulatory pathway and multiple potential acquiring companies with an interest in the specific area of technology. The entire MDI Partners team is actively involved in every project, each bringing their expertise to ensure success. For more information, visit www.MDIPartners.com.

ClearSpec is a disposable, inexpensive translucent sheath that can be inserted over any speculum to create a transparent lateral wall and prevent lateral tissue from obstructing the view of the cervix through the end of the speculum during a vaginal or cervical exam. It provides an all-on-solution so examiners do not need to use a second instrument to view the walls in patients with excessive tissue.

The SURCAG (State University Research Commercialization Assistance Grant) Program was established in 2010 to promote commercialization of university research products to enhance Florida’s economy and its public universities.  A state university may apply for early stage funding for the purpose of developing products and services resulting from university research. Funding may be used for premarketing or product development activities. In 2010, the sum of $2 million was provided via Senate Bill 1752 which also stipulates that the Program is to be administered in accordance with the original statute.  Phase 3 grants assist with the final stages of development – the implementation and execution of a completed business plan for a university research project.

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About MDI Partners
MDI Partners specializes in early stage medical device development. The company was founded as a result of the mutual recognition by four experienced medical device leaders that there is an unmet need for financial support and management expertise in the development of promising medical device technologies for smaller markets that are below the threshold of interest for traditional venture capital. In general, these products are innovative medical devices with strong patents, a fairly straightforward design, development and regulatory pathway and multiple potential acquiring companies with an interest in the specific area of technology. The entire MDI Partners team is actively involved in every project, each bringing their expertise to ensure success. For more information, visit www.MDIPartners.com.

More on the PleuraFlow Catheter