A Medical Device Daily
In an early clinical results report, Pearsalls (Taunton, UK) said it was seeing good progress for nine patients implanted with its cervical disc at the Royal Orthopaedic Hospital (Birmingham, UK).
The Pearsalls Cervical Disc – also known as the neodisc – is a composite of an elastomeric core encapsulated by a textile structure, and is designed to mimic the biomechanical properties of the natural disc.
The surgeries were performed by Andre Jackowski, MD, a co-inventor of the device.
Jackowski said, "The first four patients have now passed their six-month evaluation. Their original symptoms have been cured, and significant improvement has been noted in all scores measured." He added, "All nine patients are progressing extremely well and are highly satisfied with their results."
Artificial disc replacements are expected to be the most successful product class in recent medical device history. While first-generation lumbar devices have begun commercialization in the U.S. market, many feel cervical applications could offer an even larger opportunity.
"We are extremely pleased that our device is performing so well," said Lawson Lyon, managing director of Pearsalls. "We are on track as planned, to apply to the FDA to begin clinical trials in the U.S."
Jackowski will be presenting his full clinical results, including independent range of motion analysis, at the annual meeting of the Spine Arthroplasty Society (North Palm Beach, Florida) in New York in May.
Pearsalls said that the neodisc is the first of a series of products enabled by Pearsalls' platform technology, focused on engineered matrices of fibers positioned with computer-controlled "embroidery" that encourage the propagation of biological tissue. Future products include an artificial lumbar disc and a family of non-fusion devices developed from the same core technology.
Pearsalls is privately owned by AMI Holdings, a portfolio company of RoundTable Healthcare Partners (Lake Forest, Illinois).
BMC in marketing pact with Mavand
American Bio Medica (ABMC; Kinderhook, New York) reported a distribution agreement from Mavand Solutions to exclusively market and sell ABMC's product line across Europe, with the exception of the UK and Ireland. Mavand's distribution rights in these countries is non-exclusive, and it is not permitted to sell ABMC products in Spain or Portugal, as ABMC currently has authorized distributors for these countries. Mavand is a diagnostic system vendor for the European market.
Stan Cipkowski, CEO of American Bio Medica, said the agreement should be "a profitable endeavor for both ABMC and Mavand . . . The principals at Mavand are the same people we have worked so successfully with on our Rapid Reader project, which is an integral part of road side testing pilots in several countries. Our partnership with Mavand will ensure that our European endeavors are successful."
ABMC is a developer of immunoassay diagnostic test kits, including some of the world's most effective point-of-collection tests for drugs of abuse. ABMC's Rapid Drug Screen, Rapid One, Rapid TEC and RDS InCup products test for the presence or absence of drugs of abuse in urine, while OralStat tests for the presence or absence of drugs of abuse in oral fluids.
Argonaut amends Biotage buy
Argonaut Technologies (Redwood City, California) reported that it has amended its agreement with Biotage (Uppsala, Sweden) to increase the purchase price to $21.2 million in cash and to include the sale of certain assets (excluding receivables) and the assumption of specified liabilities, including warranty service and maintenance, and accounts payable of up to $350,000 associated with its remaining Process Development Products and Services.
Under the amended agreement, Biotage will also take on the employment responsibility for additional Argonaut employees associated with its Process Development Business. On Feb. 21 the company entered into a definitive agreement with Biotage under which Argonaut agreed to sell stock and certain assets of its consumables and flash chromatography business for about $19.9 million in cash.
Argonaut said the agreement with Biotage was amended in response to "an unsolicited proposal from a third party."
The agreement is part of Argonaut's ongoing effort announced in November 2004 to evaluate and pursue strategic alternatives. Argonaut said it intends to distribute "a significant portion" of the net proceeds received in the sale to stockholders promptly after the closing of the transaction, which is subject to stockholder approval and other customary closing conditions.
Argonaut said that the stockholder meeting to approve this sale would be held during 2Q05.
Argonaut is a provider of consumables, instruments, and services designed to help the pharmaceutical industry accelerate drug development. The company's products enable faster testing of drug targets and chemical compounds available for development.
Biotage offers solutions in the areas of genetic analysis and medicinal chemistry.
Smiths' LCAD deliveries to start
Smiths Detection (Watford, UK) will begin deliveries of the latest chemical warfare agent detection equipment for UK troops, recently accepted into service by the Ministry of Defense (MoD). Smiths Detection has a contract worth some 20 million under the MoD's Lightweight Chemical Agent Detectors (LCAD) program.
Together with the Manportable Chemical Agent Detector (MCAD), also from Smiths Detection, LCAD forms a two-tier detection system to provide a real-time battlefield identification and alarm capability. MCAD entered service in 2003 under a 16 million contract, and more units have been ordered by the MoD. Both products detect chemical warfare agents and toxic industrial chemicals.
LCAD's technology combines ion mobility spectrometry with Corona discharge and thus no radioactive sources are required. Designed for continuous operation, it is a highly sensitive product, Smiths said, detecting and identifying chemical threat agents at levels that could be fatal or cause serious incapacitation.
Robert Judd, president of Smiths Detection-Military, said, "This is an important milestone, following an intensive development program by our Watford team in partnership with the Ministry of Defense. MCAD and LCAD form a very strong two-tier detection system and maintain our proud record of equipping UK troops with the most advanced battlefield identification and alarm capability."
Smiths Detection is one of four operating divisions of Smiths Group.