Minos Medical Inc Announces FDA 510k Clearance of Megachannel™ Endolumenal Access Device for Advanced Natural Orifice Surgery

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Minos Medical today announced they received marketing clearance from the FDA for their revolutionary endolumenal access device used for advanced natural orifice surgery.

Natural Orifice Surgery (NOS) and Natural Orifice Translumenal Endoscopic Surgery (NOTES) are gaining momentum across the globe. They offer patients the hope of scarless surgery, faster recovery and innovative new therapies. Minos Medical is one of the new companies that is focused exclusively on developing procedures and new products to make scarless surgery a reality.

Today they are announcing the launch of their key base technology known as Megachannel™. The initial product launched is a 22mm diameter flexible tube that rides along with a colonoscope to the target site. Once in place it creates a 20mm working channel (or super highway) that allows rapid access beyond the sigmoid colon.

"This is something new and revolutionary," says Prof Christoph Gasche from the Medical University of Vienna. "It is not designed to assist in delivering the colonoscope, instead it is about delivering a very important access device. A device that allows new ways to approach colonic surgery beyond the sigmoid colon."

To date, the tight turns and folds in the colon make it difficult to deliver a colonoscope beyond the sigmoid, and almost impossible to deliver less flexible instruments, or large instruments. Megachannel™ changes that by delivering a smooth tunnel beyond the sigmoid colon. The wire-reinforced design ensures the curves stay open and there is always a 20mm working channel down which instruments can be passed or tissue retrieved.

The Megachannel delivers four key benefits once in place:

1.    Rapid Exchange: The colonoscope can be pulled out and returned to the right colon in seconds. This allows scopes to be exchanged (large scope in and out, large for small scopes or even double balloon scopes)

2.    Protection: The wire reinforced, clear plastic wall acts as a strong physical barrier. Sharp instruments, or bulky instruments such as staplers can be passed safely down the Megachannel™ reducing the risk of perforation.

3.    Bulky Instrument Insertion: With the channel in place, bulky instruments can be added to the colonoscope, such as banders or suction cups and they can easily be passed along the channel to reach the right bowel in seconds. The channel eliminates the need to steer the scope so inserting instruments with a reduced view is less of a challenge. Also large instruments with no steering, such as stapling devices, can be placed along side a 5mm scope and both inserted to the right bowel with ease. The Megachannel™ also opens up the possibility to introduce endoscopic ultrasound scopes (EUS) with ease. The reduced steerability is less of a problem when inserted through the Megachannel™

4.    Tissue Removal: Currently the 3.8mm working channels limit the ability of tissue to be removed from the right colon. Large polyps, parts of sessile polyp resections or cluster polyps create a challenge for tissue removal. Often pieces are left "floating" in the bowel for later collection, or nets are required to collect up pieces and remove them. Large masses such as lipomas are not considered suitable for removal. Megachannel™ with its 20mm working channel allows for bulky tissue to be removed using just the scope. The scope with the specimen is simply pulled out of the Megachannel™, and then the scope reintroduced straight back to the site of operation (in seconds). Cluster polyps can be rapidly removed one by one, and the scope returned in seconds.

"We think the Megachannel™ is a revolution," said Steve Bell, Chief Marketing officer of Minos Medical. "It is not designed to be used in every colonoscopy, but rather for current advanced endolumenal procedures and new emerging procedures. The technology allows new ways to approach endolumenal surgery. We envision staplers, EUS and even robots passing down the system. Allowing rapid delivery of such instruments. The largest working channels so far have been about 6mm, we offer something very different with a 20mm working channel."

The product was tested clinically by endoscopists and colorectal surgeons in Austria, India and Equador, following extensive animal and cadaver testing. Improvements have been made to make the commercial version more user friendly. The innovative "Peel Plug™" technology allows the rapid conversion of the Megachannel™ from a 15mm to a 20mm working channel should the clinician desire.
Other features include a duel durometer design and quick release foam seal cap that allows multiple scope sizes to be used. The wire wound design is critical to ensure that the system does not kink even in tight bends.

"This is a key strategic step for Minos," said Brad Sharp, CEO. "This product starts to get clinicians used to access devices which will be essential in advanced endolumenal surgery, but even more so in NOTES procedures. We believe this product helps to facilitate procedures which were previously difficult or impossible to perform. It will also form the basis of two more advanced systems we have in development. The Appendoectomy® colonic appendectomy system and the Diverlite™ colonic diverticulosis repair system. Both of which require a Megachannel™ as a core access system. Clinicians will be able to build up to more complex systems prior to traversing the bowel walls for NOTES procedures."
The Megachannel™ is FDA cleared, CE marked and being launched worldwide in August 2008. Go to http://www.minosmedical.com for more details.

About Minos Medical Inc:
Minos is a privately owned California based medical device company focused on Natural Orifice Surgery (NOS) and Natural Orifice Translumenal Endosocpic Surgery (NOTES). The company holds a substantial IP estate of both procedural method and devices. The company has also attained CE mark for their colonic appendectomy system - Appendoectomy®. In development are systems for Trans-urinary bladder NOTES procedures, Scarless hysterectomy, Colonic diverticulosis repair and a range of other NOS procedures. Please visit the website for investment opportunities.

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STEVE BELL
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