Rainier Technology Secures Funding for Implants

Rainier Technology Secures Funding for Implants

Two investment firms in the United Kingdom are funding the market launch of spinal discs from Rainier Technology Limited.

FirstVentures Ltd. and Alliance Trust

Equity Partners have provided a total of $8 million (5 million British pounds) for the European launch and commercialization of Ranier’s total disc replacement implants, the Cadisc-L (for the lumbar spine) and the Cadisc-C (for the cervical spine). The money also will be used to fund a clinical trial for the Cadisc-C, according to a news release from the company.

“This investment from our investors represents both recognition of the progress we have made in the development and clinical testing of our Cadisc lumbar and cervical products, together with recognition of the commercial value of our compliant discs which are the next generation in spinal arthroplasty,” Geoffrey Andrews, Ph.D., Rainier’s founder and CEO, said in a prepared statement.

Ranier’s Cadisc devices are designed to replicate the physiological biomechanics of a spinal disc. The polymeric, shock absorbing design of the Cadisc implants aims to restore the normal sharing of loads between the disc, vertebrae and the other anatomical structures of a healthy spine, according to product information supplied by the company. The implants are designed to replace diseased spinal discs in the lumbar (lower back) and cervical (neck) regions of the spine.

Ian Quirk, director of clinical and regulatory affairs at Ranier, said initial outcomes in the Cadisc-L clinical study were pleasing. “By using the Cadisc-L spinal disc replacement, we found patients had significant reductions in average leg and back pain, and overall disability, and coupled with an increase in quality of life there are very strong indications of early phase performance.”

Ranier received CE Mark approval for the Cadisc-L in September.

The worldwide market for replacement discs is expected to undergo strong growth in the next several decades as aging baby boomers seek to maintain their active lifestyles and younger patients seek relief to debilitating osteoarthritis pain. Ranier estimates the replacement disc market to grow by more than $2 billion annually by 2015.

Testing Shows Integrity of Interface Catheter’s Extrusion Process

The extrusion process used by Interface Catheter Solutions doesn’t result in degradation of the polymer material afterward, acording to testing conducted by an independent laboratory.

The Laguna Niguel, Calif.-based company submitted six samples of Nylon 12, PEBAX, and a Nylon 12/PEBAX blend to Polymer Soutions Inc., a polymer testing laboratory based in Blacksburg, Va. The samples—both in pellet form and with tubing extruded from the pellets—were submitted for analysis of their molecular weight distributions before and after extrusion, using gel permeation chromatography.
Test results on the samples showed no significant changes in molecular weights and molecular weight distributions.

“For many manufacturers, a breakdown in polymer molecular weight during the extrusion process can lead to the development of structural flaws or gel spots that compromise the integrity of balloon tubing,” said Kenny Mazzarese, director, balloon development for Interface Catheter Solutions. “These new test results confirm our extrusion process does not degrade polymer chains and that the molecular weight of the final extruded product is essentially the same as the raw material. This greatly reduces the possibility of gel spots or other defects during balloon production.”

Interface Catheter Solutions provides outsourced solutions for balloon catheter manufacturing. The ISO 13485:2003-certified firm has created more than 2,000 balloon designs and operates several class 10,000 (ISO Class 7) and 100,000 (ISO Class 8) clean rooms in three facilities.

Omni Components Expands Capabilities

Omni Components Corp. has enhanced its capabilities with the addition of five-axis machining services.
The Hudson, N.H.-based company is providing five-axis machining services to customers through the Okuma MU-400VA five-axis vertical machining center. The system, according to the company, is ideal for the manufacturing of irregular and non-symmetrical parts.

The Okuma MU machining centers feature positional accuracy and thermal stability with THINK control for precisely performing simultaneous five-axis machining and/or multisided operations in one chucking. The technology produces accurate machining and high-quality surface finishes on commercial or implant components, a company news release stated.

“Okuma five-axis technology is a great fit for Omni in that it complements our multi-axis precision machining forte, strengthens our business model and opens new markets for the company,” Omni President Rick Holka said. “We will continue to grow this segment of our business.”

Omni Components provides multi-axis, precision turnkey machining services and engineered solutions to customers through CNC (computer numerical controlled) Swiss, mill/turn, vertical milling and EDM (electric discharge machining) technology. The firm is certified to both ISO 9001 and 13485 standards.

Camstar Acquisition to Boost Product Quality

Score one for product quality and the global supply chain. (Technically, it’s score two but nobody’s counting.)

The latest acquisition by software solutions provider Camstar Systems Inc. is a boon to global manufacturers looking to improve product quality across the entire supply chain. The Charlotte, N.C.-based company has purchased SigmaQuest Inc., a provider of SaaS (software as a service) supply chain intelligence solutions. Financial terms of the deal were not disclosed.

Camstar executives described the acquisition as “a very clean merger—a near-perfect alignment of solutions, industries and vision.” Camstar officials expect the merger to boost revenue by 30 percent next year.

“Global manufacturers and brand owners are wrestling with optimizing and leveraging the cost advantages of growing global supply networks while ensuring product quality to protect their brands,” noted Scott Toney, Camstar president and CEO. “With the acquisition of SigmaQuest, we are positioned to provide the service and technology for global manufacturers to have the transparency and collaboration required to efficiently manage their contract manufacturers and suppliers.”

SigmaQuest executives said the acquisition will create a single platform that will give companies the ability to aggregate and contextualize data, provide actionable intelligence, and drive corrective and preventative actions to eliminate product quality issues at the source.

An analysis of the merger by Gartner, an information technology research and advisory firm, claims the move is focused on data capture and management to support device history record generation and engineering changes, as well as a review of parametric, as-built and other bill of material data. “The end goal is to use a blend ofon- and off-premises application approaches to help companies close the loop between customer feedback and all aspects of product supply from design to development to commercial manufacturing,” the analysis stated.

“SigmaQuest’s focus on high-tech and medical devices matches Camstar’s core markets. Additionally, SigmaQuest’s SaaS offering for capturing and analyzing product quality detail from both customers and tiers of suppliers will complement Camstar’s on-premises approach. Camstar’s platform provides an embedded capability for analysis, identification and early warning of adverse events with feedback loops for implementing engineering and process changes into the production environment.”

Didier Chavet, IT senior director, JAPAC Operations for SanDisk, a global supplier of flash memory cards, said the acquisition creates new tools that will give companies the ability to better analyze incidents from both their internal and external supply chains.

Camstar is acquiring SigmaQuest in its entirety. The two companies’ brands will be integrated by the end of the year under the Camstar label, and all employees will become part of Camstar. Workers at SigmaQuest’s headquarters in San Jose, Calif., will merge with Camstar’s Silicon Valley location, according to a news release about the acquisition. Camstar employs 60 people in San Jose, Singapore, Malaysia and Shanghai, China. It also has more than 40 contract employees in Belarus and an additional 100 people at its Charlotte, N.C., headquarters.

Camstar’s purchase of SigmaQuest is its second acquisition in the past year. In October 2009, the company announced its acquisition of Technology Resources Group, an Asian systems integrator in the semiconductor, solar and electronics manufacturing industries. Headquartered in Singapore with offices in China and Malaysia, Technology Resources Group offered customers various services including manufacturing equipment automation, manufacturing applications development and program management for enterprise solution deployments.