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Implants

FDA: ReGen’s Menaflex data inadequate

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The Food & Drug Administration said ReGen Biologics Inc. (OTC:RGBO) failed to produce adequate evidence that its Menaflex knee implant was safe before it was cleared to hit the market in late 2008.

Documents released by the federal watchdog agency question whether the Hackensack, N.J.-based company supplied enough data on pre-clinical mechanical testing of the device, which is designed to repair damage to the meniscus cartilage in the knee. The documents also question ReGen’s claims that the device is similar enough to other devices for shoulder, bladder and hernia repair to merit the FDA’s fast-track 510(k) clearance process.

Former NMT Medical CEO John Ahern returns to the company’s board

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John Ahern is back at the company he ran for nine years, just one year after giving up his board seat and resigning his post as CEO.

NMT Medical Inc. (NSDQ:NMTI), a Boston-based device company developing implants that allow interventional cardiologists to treat structural heart disease through catheter-based procedures, said it is bringing Ahern back as a member of the company’s board. His addition means the company will increase the number of seats on its board to seven.

NMT registers for $30 million stock sale

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NMT Medical Inc. (NSDQ:NMTI) is looking to raise $30 million through a public stock offering to bring its STARFlex cardiac implant through the regulatory process and into the marketplace.

The Boston-based cardiac implant maker said it needs the money because it’s low on cash reserves and heavily leveraged. NMT only has about $9 million in cash reserves and has amassed more than $50 million in debt, according to a prospectus filed with the federal Securities & Exchange Commission.

MedGadget’s MedTech Monday: Flexible rubber sheets to power implantable devices?

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Flexible rubber sheets to power implantable devices?: Princeton and Caltech researchers have developed special silicone rubber sheets with embedded nanorods that, when bent, generate electricity with impressive efficiency. The technology is projected to be used as a power source for implantable devices such as pacemakers, by harnessing energy from moving organs such as the thoracic cage.

Symmetry Medical to shutter Maine plant

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Symmetry Medical Inc. (NYSE:SMA) plans to shutter its plant in Auburn, Maine, and consolidate its operations into other facilities as it gears up for an anticipated recovery for the orthopedics industry.

The Warsaw, Ind.-based orthopedic implant maker said the move is aimed at streamlining the business and reducing costs. The consolidation is slated to be complete by the middle of next year; the company did not reveal how many employees would be affected.

NMT Medical narrows Q3 net loss despite top-line slide

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NMT Medical Inc. cut its third-quarter net loss by more than 34 percent despite posting a revenue decline of nearly 28 percent and announced a new distribution deal in Germany

The Boston-based cardiac implant maker reported sales of $3 million for the three months ended Spet. 30, down 27.7 percent compared with $4.2 million during the same period last year.

Net losses narrowed from $4.4 million during Q3 2008 to $2.9 million during the just-ended period, as NMT slashed its total expenses by 31 percent to $5.9 million. As a percentage of revenues, total expenses dropped 9.3 percent.

Preemption in action

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A federal judge’s decision in a lawsuit over allegedly defective silicone breast implants highlights the preemption rules enshrined by the Supreme Court in Riegel vs. Medtronic (PDF).

In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law.

MassDevice Q&A: Philipp Lang

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Philipp Lang wears a lot of hats. Besides being the founder, president, chairman and CEO of ConforMIS Inc., he’s a radiologist and former director of the Musculoskeletal Radiology and Distinguished Weissman Chair at Brigham and Women’s Hospital in Boston and associate professor at Harvard Medical School.

But ConforMIS and its breakthrough custom knee implant technology aren’t Lang’s first forays into the startup medical device world. He also founded Imaging Therapeutics Inc. (where he remains chairman) and served on the board at ViOptix Inc.

Texcel Medical adds staff, spends $1 million to boost manufacturing capacity

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Texcel Medical is adding capital equipment and staff as it gears up to meet growing demand from global markets.

The East Longmeadow, Mass.-based implantable device contract manufacturer added four experts in regulatory affairs, design and engineering and spent about $1 million expanding its manufacturing capacity.

John Mulvihill, vice president of sales and marketing for Texcel, told MassDevice that the global recession hasn’t seemed to impair the market for implantable medical devices and systems.