Benvenue Medical (Santa Clara, California), a maker of minimally invasive solutions for spine repair, today announced that it has signed a group purchasing agreement for the Kiva VCF Treatment System with Novation (Irving, Texas), a healthcare services company. The three-year contract became effective March 1, paving the way to offer the Kiva System through the Novation portfolio to the more than 100,000 members and affiliates of VHA, UHC, Children's Hospital Association and Provista served by Novation.
The Kiva System was selected through the Novation Innovative Technology program, which is designed to ensure that members have access to innovative health care technology. The rigorous process includes review by a clinical member council or task force to determine whether the technology represents incremental advantage for members. The Kiva System is the first clinically proven new approach to the treatment of vertebral compression fractures (VCFs) in over a decade.
"We are committed to providing the health care facilities we serve new technologies that are clinically validated and cost-effective," said Olya Carter, senior clinical manager at Novation. "The decision to offer the Kiva system was based on compelling treatment effectiveness data from multiple clinical studies."
Kiva clinical data submitted to Novation include a prospective, randomized, controlled clinical study comparing Kiva outcomes against those of balloon kyphoplasty (BKP), a commonly used treatment for spinal fractures. In addition, in multiple published studies comparing Kiva to BKP, Kiva consistently improved patient outcomes in cement extravasation, cement volume and improvement in kyphotic correction (spinal realignment). Kiva has also been shown to reduce the adjacent level fracture rate as compared to balloon kyphoplasty, as well as to significantly reduce the rate of readmissions relative to BKP.
The Kiva VCF Treatment system provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is commercially available in Europe. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
In other agreements/contracts news:
• Columbia Laboratories (Boston), a company focused on the development of therapeutics for women's health, has licensed rights to a novel intra-vaginal ring (IVR) technology for the delivery of one or more pharmaceuticals at different dosages and release rates in a single segmented ring.
This technology was developed by renowned scientists Robert Langer from the Massachusetts Institute of Technology (MIT) and William Crowley from Massachusetts General Hospital (MGH) and Harvard Medical School (HMS). Under separate agreements, Langer and Crowley have joined the company as strategic advisors to support the deployment of this technology and guide development of future product candidates.
Currently available IVRs have simplified the delivery of medicine and are convenient and discrete however, few diseases or conditions have been addressed due to technological limitations. Challenges include drug solubility, molecular characteristics and desired controlled release profiles.
Due to its unique polymer composition and segmentation capability, the segmented IVR developed by Crowley and Langer has the ability to deliver drugs at different dosages and release rates within a single ring system. Drugs such as progesterone and leuprolide have already been tested using the technology and demonstrated sustained release for up to three weeks. The company has identified a number of product concepts that could address large market segments and will be prioritizing development of the first candidates in the coming months.
Columbia has agreed to minimum annual expenditures to develop products using the vaginal ring technology, and will make milestone-based payments to MGH/MIT when various stages of product development and commercialization are achieved. The company will also share a portion of any royalties or sublicense revenues received from products utilizing the segmented IVR technology with MGH and MIT.
• Philips Medical Systems (Andover, Massachusetts), has been awarded a maximum $77,172,660 modification (P00107) exercising the sixth one-year option period of a one-year base contract (SPM2D1-09-D-8349) with nine one-year option periods for patient monitoring systems, subsystems, accessories, consumables, spare/repair parts, and training.
This is a fixed-price with economic-price-adjustment contract. Location of performance is Massachusetts, with a March 29, 2016, performance completion date.
Using military services are Army, Navy, Air Force, Marine Corps, and federal civilian agencies. Type of appropriation is fiscal year 2015 defense working capital funds. The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pennsylvania.