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.
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 from debilitating osteoarthritis pain. Ranier estimates the replacement disc market to grow by more than $2 billion annually by 2015.
Millstone Medical Expands Massachusetts Facility
Millstone Medical Outsourcing is adding space near its Fall River, Mass., headquarters.
The company signed an agreement to lease a 26,000-square-foot building in within steps of its existing facility. According to the company, the new building will provide significant expansion space for materials management, post sterile release processes, kitting and assembly work, and warehousing and distribution activities.
The addition of this facility increases Millstone’s active square footage in Fall River to 80,000 square feet and to 125,000 square feet overall, including its location in Memphis, Tenn. Earlier this year, the Memphis facility expanded its services to manufacturers of products containing human cells or tissues used in surgical procedures.
“The new Fall River building is a clean, open environment we can tailor to support our service offerings as we expand to meet the growing needs of our customers,” said Chris Ramsden, Millstone's CEO. “Benefits of the expansion space are the ability to easily load in materials that enable us to offer tier-one material purchasing and management services, extra space for post sterile release services, and an ample, streamlined area for kitting and assembly.”
Millstone, which is ISO 13485-certified, provides inspection, clean room packaging, loaner kit processing, and distribution services to medical device—primarily orthopedic—and dental device manufacturers worldwide.
Nanotech Firm Teams with Smith & Nephew on Cartilage Repair
Having conquered a good portion of the orthopedic market, Smith & Nephew Inc. is now setting its sights on a new sector: regeneration technology.
The hip and knee implant manufacturer has teamed up with a nanotechnology company to develop a product that regrows cartilage. Under the agreement it forged with Nanotope Inc., a Skokie, Ill.-based regenerative medicine firm, Smith & Nephew will assume all clinical trial costs related to the development of the product.
The accord—Nanotope’s first commercial transaction—can potentially be a lucrative one for the biotechnology company. According to terms of the agreement, the firm can receive up to $26.6 million in milestone payments and additional sales royalties from London, England-headquartered Smith & Nephew.
“Smith & Nephew is ideal for the commercialization of Nanotope’s cartilage repair technology given its global reach in orthopedics and potential synergies of a new cartilage regeneration capability with its suite of existing orthopedic products,” said Christopher Anzalone, Ph.D., president and CEO of Arrowhead Research Corporation, a Pasadena, Calif.-based holding company with a minority investment in Nanotope. According to its website, Arrowhead forms, acquires and operates portfolio companies that commercialize innovative nanotechnology products.
“We view this agreement as a validation of Nanotope’s technology and business strategy,” Anzalone continued.
Smith & Nephew executives said the deal with Nanotope will help the company address unmet market needs.
“We are always searching for alliances with businesses whose technologies address the major unmet needs of our market,” said Mark Augusti, president of Smith & Nephew’s Memphis, Tenn.-based Biologics and Spine business unit. “Cartilage repair is a clear area of interest to us.”
It also is a clear area of interest to Northwestern University researchers, who earlier this year designed a bioactive nanomaterial that promotes the growth of new cartilage in vivo without the use of costly growth factors. The minimally invasive therapy activates bone marrow stem cells to produce natural cartilage, according to data published in ScienceDaily.
Damaged cartilage can lead to joint pain and loss of mobility, which eventually can lead to osteoarthritis, a degenerative joint disease that costs the United States nearly $65 billion. That cost is expected to escalate in future decades as the baby boom generation ages and younger patients seek treatments that enable them to retain their active lifestyles.
Type II collagen is the major protein found articular cartilage, the smooth, white connective tissue that covers the ends of bones where they meet to form joints. The material designed by the Northwestern research team consisted of nanoscopic fibers which stimulate bone marrow stem cells that produce cartilage with type II collagen. The new cartilage can repair damaged joints.
“A procedure called microfracture is the most common technique currently used by doctors, but it tends to produce a cartilage having predominantly type I collagen, which is more like scar tissue,” said Ramille N. Shah, an author of the research and an assistant professor of materials science and engineering at Northwestern’s McCormick School of Engineering and Applied Science and assistant professor or orthopaedic surgery at the Feinberg School of Medicine.
The Northwestern material is injected as a liquid to the damaged joint, where it self-assembles and forms a solid, Shah told ScienceDaily. This extracellular matrix, which mimics what cells usually see, binds by molecular design one of the most important growth factors for the repair and regeneration of cartilage. By keeping the growth factor concentrated and localized, the cartilage cells have the opportunity to regenerate, ScienceDaily reported.
The matrix grew new cartilage in about one month. The matrix, based on self-assembling molecules known as peptide amphiphiles, biodegrades into nutrients and is replaced by natural cartilage.
Straumann Introduces New Oral Bone Regeneration Gel
Straumann, based in Basel, Switzerland, recently announced the launch of its MembraGel product, a membrane for use in guided oral bone regeneration procedures.
MembraGel is a polyethylene glycol membrane that is applied as a liquid and sets in situ. Because the technology requires different handling than conventional membranes, the company is combining the launch with an education program that includes hands-on product training. In addition, the product only will be available to dental professionals who have participated in the program.
“Throughout development, we have worked closely with leading independent experts and have decided to launch the product in combination with an education program because we want customers to achieve optimum results from the outset,” said Sandro Matter, executive vice president of products at Straumann.
According to the company’s market research, at least one in four implant procedures requires bone augmentation either prior to, or concurrent with, implant placement. Guided bone regeneration involves the use of a barrier membrane to help stabilize the bone graft and prevent unwanted growth of soft-tissue into the defect. The firm estimates the global market for these products is worth more than $200 million.
Commonly used conventional membranes are supplied as prefabricated sheets and have to be cut to fit the defect—often using a template. In some cases, the membrane also needs to be secured by pinning. Furthermore, non-resorbable membranes need to be surgically removed after the healing process has taken place.
MembraGel is applied in liquid form and molds to the defect precisely. Within 20-50 seconds after application, the liquid components solidify, stabilizing the bone graft and providing an effective barrier to tissue infiltration. Preclinical studies have shown that the surgical site is protected over the period required for bone formation with no abnormal soft-tissue reaction.
The substance then subsequently biodegrades.
MembraGel initially is being launched in key European markets, North America and Australia, where it has receivedregulatory approvals.
U.K. Implant Firm Buys Orthopedic Robotics Company
In a deal illustrative of the growing influence of medical robotics, Stanmore Implants has purchased the Acrobot Company Limited, a firm specializing in computer-assisted orthopedic surgery. Terms of the deal were not disclosed.
Stanmore bigwigs expect the merger to boost the company’s presence in the orthopedic implant sector. The British firm designs and manufactures patient-specific and modular implants, including artificial knees, extendible prostheses and hydroxyapatite collars.
“Accurate placement of orthopedic implants has been shown to be of critical importance to the longevity of the implant and thus avoiding early revision,” said Brian Steer, Stanmore’s executive chairman. “
Robotics and navigation, widely used in other surgical specialties, is one of the fastest-growing sectors in orthopedics.”
Precisely how fast can be determined by the sheer number of computer-navigated systems now on the market. Such systems encompass MAKOplasty from MAKO Surgical Corp.; the PiGalileo Computer-Assisted Orthopedic Surgery System and the Achieve CAS, both from Smith & Nephew; the OrthoPilot Navigation System from B. Braun (which, incidentally, received a Best Practices Award 2010 from global market research firm Frost & Sullivan); and the Navitrack Navigation System from ORTHOsoft Inc.
Acrobot’s computerized navigation system uses software to produce a 3-D surgical planning and visualization tool for doctors. The United Kingdom-based firm is developing a bone sculpting robotic tool called Acrobot Sculptor. The system consists of a motorized programmable device based on Acrobot’s key “Active Constraint” patented technology, which prevents the surgeon from accidentally moving a bone cutting tool outside a specified area.
Acrobot, founded in 1999, is a spin-out from the Imperial College London.