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San Clemente Device Companies Make FDA Moves

Two small medical device makers in South County have had recent dealings with the Food and Drug Administration.

San Clemente-based Dallen Medical Inc. said it received 510(k) clearance from the FDA for a disposable version of its Compressyn device to fix small bones. It said in a news release that it developed the device and staple in order to respond to doctors’ demands for less-expensive equipment to complement its existing reusable device.

Dallen said the Compressyn staples are more rigid than traditional staples used in bone fixation procedures, a feature that minimizes the risk of splaying.

The device maker also said it submitted a request for a ligament repair device for its Tensyn band product line.

Separately, fellow San Clemente device maker ReShape Medical Inc. submitted a premarket approval application to the FDA for its ReShape Integrated Dual Balloon device for weight loss. The device is designed for people with a body mass index of 30 to 40, which is classified as medically obese.

It’s inserted endoscopically during an outpatient procedure and remains in a patient’s stomach for six months, helping to take up space and creating a feeling of fullness.

ReShape is a venture-backed company with several Orange County device veterans on its board, including Robert Grant, chief executive of Newport Beach-based lifestyle medicine company Alphaeon Corp., and Kenneth Charhut, a former executive of Baxter International Inc.’s cardiovascular division, which eventually evolved into Irvine-based heart valve maker Edwards Lifesciences Corp.

CardiAQ, Neovasc

Irvine-based CardiAQ Valve Technologies Inc. said this month that the European Patent Office’s legal division issued a temporary stay of further proceedings in rival Neovasc Inc.’s pending patent application covering transcatheter mitral replacement heart valve implantation.

CardiAQ sued Vancouver-based Neovasc last month in domestic and international courts.

The U.S. lawsuit, which it filed in federal court in Massachusetts, sought an injunction against Neovasc over development and commercialization of Tiara, a less-invasive mitral heart valve. CardiAQ alleged in its complaint that Neovasc improperly used its proprietary technology to develop Tiara, saying it obtained the technology from CardiAQ when the pair had a confidential supply relationship in 2009 and 2010. It also alleged fraud, breach of contract, and unfair and deceptive trade practices.

That lawsuit is in its early stages.

CardiAQ’s second lawsuit was filed at the end of June in Germany over Neovasc’s pending European patent application.

CardiAQ said in a news release that Neovasc “is attempting to block” it from using its own technology through pending patent applications.

“As pioneers in this new field, CardiAQ set the standard for [transcatheter mitral valve implantation] positioning and anchoring and we will defend our intellectual property and trade secrets vigorously. Thus, CardiAQ had no choice but to also file a lawsuit in Germany and pending the outcome of that lawsuit, seek a temporary stay of Neovasc’s pending European patent application,” CardiAQ Chief Executive Rob Michiels said.

Tumor Treatment Deal Signed

The Innovation Institute, a La Palma-based provider of business services, products and investment management to health systems, signed a deal with Corona del Mar-based Bone-Rad Therapeutics Inc. for developing a bone cancer treatment.

The institute will work with Bone-Rad to accelerate development of the latter’s Spine-Rad Brachytherapy Bone Cement, which targets spinal tumors with local radiation while simultaneously restoring bone strength to the affected vertebrae.

Bone-Rad Chief Executive Craig Fortier said in a news release that the Innovation Institute “has the expertise, resources and hospital affiliations needed by early stage medical device companies to greatly facilitate movement through the product development, regulatory and clinical evaluation stages that we all must navigate. Our team at Bone-Rad is thrilled to have the opportunity to work with the Innovation Institute.”

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