A Medical Device Daily
Synthes (Solothum, Switzerland) reported that it has signed an agreement to acquire privately-held N Spine (San Diego), which is developing devices to treat lumbar spinal disorders using posterior dynamic stabilization. N Spine’s products have been in clinical use in Europe and the U.S. for about a year.
The acquisition price includes a $30 million payment at closing, payments of up to $45 million based on the achievement of certain milestones, and additional unspecified earn-out payments based on product sales.
N Spine’s product portfolio includes a 6.0 mm diameter dynamic stabilization rod, which allows minimal-access techniques and helps avoid interference with the facet joints. It also enables close placement of pedicle screws, which Synthes said is important when used to treat the L5-S1 spinal segment or lumbar disorders in smaller patients.
Synthes touted the strategic fit of the two companies’ products, saying that N Spine’s 6.0 mm-diameter rods are compatible with the Swiss company’s Pangea and Click’X pedicle screws, systems that it distributes globally.
In a statement about the proposed acquisition, Synthes said the combined product offering “is easy to use, surgeon-friendly and enhances the range of choices available to surgeons and their patients.” It added that it would begin a “controlled rollout” of N Spine products upon closing of the deal, using its direct sales force.
N Spine recently received FDA 510(k) clearance to use one of its rod designs with Synthes’ Pangea and Click’X pedicle screws in lumbar fusion applications.
“The acquisition of N Spine gives [us] the opportunity to provide surgeons access to this innovative technology and deliver benefits to patients around the world,” said Sythes President and CEO Michel Orsinger. “It will strengthen our position in the treatment of spinal disorders, expand our core pedicle screw business and add a platform for further product development.”
Sean Na, president/CEO of the U.S. firm, said, “With [its] direct sales force and commitment to patient care and surgeon training, Synthes is the ideal company to realize the potential of our innovative technology.”
The N Spine organization and existing employees will continue to be based in San Diego and will serve as a development center for Synthes for new spine solutions.
Expanded Artelon marketing rights for Biomet
Biomaterials firm Artimplant (Vastra Frolunda, Sweden) has granted Biomet Sports Medicine (Warsaw, Indiana)global, non-exclusive rights to market Artelon Tissue Reinforcement for an additional four indications. At the same time, a previously exclusive rotator cuff agreement has been made non-exclusive.
The implant’s FDA clearance for reinforcement of the shoulder rotator cuff was extended in September to also include tendons in, and linked to, the knee, upper arm, front thigh muscle and heel.
Artimplant said that following renegotiation of the previously exclusive agreement, it now has the opportunity, alongside Biomet, to exploit Artelon Tissue Reinforcement for all cleared areas of use worldwide. Biomet also receives the right to sell a product specifically designed for Achilles’ tendon rupture, which is the largest market after rotator cuff repair.
Biomet markets and sells Artelon Tissue Reinforcement under the name SportMesh Soft Tissue Reinforcement.
Artimplant CEO Hans Rosén said, “With the new agreement, Biomet can address a considerably larger market than before. At the same time, Artimplant regains the opportunity to globally market Artelon Tissue Reinforcement on the large rotator cuff market, with a better profit margin.”
Kevin Stone, vice president of operations for Biomet Sports Medicine, said, “Biomet is exited about exploring further marketing opportunities through the expanded indication and is very encouraged by early clinical results from the use of SportMesh.”
Artelon Tissue Reinforcement is intended for use as reinforcement together with sutures in surgical procedures on patients with serious injuries or poor soft-tissue quality. The company said the implant “offers additional initial mechanical strength and at the same time functions as a degradable scaffold for the in-growth of the body’s native tissue.”
Chlamydia test in development by Enigma
Enigma Diagnostics (Porton Down, UK), a developer of rapid molecular diagnostics and detection systems, reported completion of a project commissioned by the UK’s Defense Science and Technology Laboratory to develop a rapid, point-of-care diagnostic system for screening and diagnosis of chlamydia infections, the most common treatable sexually transmitted infection (STI) in the UK.
The project was designed to meet the needs of the UK National Chlamydia Screening Program (NCSP), part of the National Strategy for Sexual Health and HIV.
Enigma has developed a specific DNA assay, reagents and instrumentation capable of rapidly detecting Chlamydia trachomatis DNA from multiple urine and swab samples at the point of care. The company said feasibility of the assay has been proven in the laboratory and product specifications have been validated.
The new system will be based on Enigma’s fully-automated diagnostics platform, which uses real-time polymerase chain reaction (PCR) technology to detect bacterial target DNA in samples and provides definitive results in a matter of minutes, enabling immediate treatment as necessary.
The company said the system also will be simple to use, requiring minimal training and experience, and will provide laboratory-quality results, reducing the need for samples to be sent to a laboratory.
Chairman John McKinley said, “This contract with the UK government demonstrates the utility of Enigma’s innovative molecular diagnostics and detection technology. We will develop a system that rapidly and simply delivers laboratory-quality results in a clinical environment and ... meets the needs of the UK National Chlamydia Screening Program, where speed, sensitivity and simplicity are of crucial importance.”
Enigma has an exclusive license from the Defense Science Technology Laboratory to a portfolio of patents that represent more than 15 years of Ministry of Defense-funded research.
The company’s own R&D activities have added additional patents and design rights based on its technologies to generate a portfolio in excess of 40 worldwide patents and patent applications dedicated to real-time PCR and wider rapid technologies. More than 25 of these patents are granted in core territories such as the U.S., EU and Japan.