A Medical Device Daily

Spinal Restoration (Austin, Texas) and Baxter Healthcare (Deerfield, Illinois) said they have entered into an exclusive, long-term partnership to develop and commercialize Biostat Biologx fibrin sealant, a key element of Spinal Restoration's new biologic therapy for chronic low back pain. Baxter's fibrin sealant will be combined with the company's technologies to create the Biostat disc augmentation system, a minimally invasive product that will be developed and tested for the treatment of painful degeneration of intervertebral discs.

Biostat Biologx fibrin sealant will be developed to augment the healing and repair of painful defects within the intervertebral disc area of the spine. The product is intended to exploit the biologic benefits of fibrin, the human-based, protein polymer used by nature to guide and stimulate all human tissue wound repair.

Baxter says it is the world's leading manufacturer of fibrin sealants and one of only two companies with FDA approval to market products in the U.S.

"The therapeutic benefits of our fibrin sealants have been proven in a wide variety of clinical applications," said Ronald Lloyd, VP and general manager of Regenerative Medicine at Baxter. "Baxter is excited to partner with Spinal Restoration to expand the application of our technologies with the potential to help the millions of people who suffer from chronic back pain."

Baxter joins an already impressive list of Spinal Restoration business partners, including its device development partner Accellent, the world's largest OEM manufacturer of medical devices, and Regulatory & Clinical Research Institute, the largest medical device CRO in the U.S. Spinal Restoration will use this partnership with Baxter to further enhance their preparation for an investigational device exemption (IDE) clinical study scheduled for 1Q08.

"We are honored to have Baxter as our partner for the development of Biostat Biologx fibrin sealant," said Gary Sabins, president/CEO of Spinal Restoration. "Baxter's fibrin sealants have a long history of safety and clinical success and we are excited about applying the technology to create an effective non-surgical therapy for this large patient population."

Baxter Healthcare is the principal U.S. operating subsidiary of Baxter International. Baxter International, through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma.

Spinal Restoration says it restores patients' lives by delivering new therapies that address unmet needs in spine health management. These therapies are minimally invasive, early interventions with clinically proven results, the company said.

In other agreement news: Cook Medical (Spencer, Indiana), a private medical device company, and Gynecor (Richmond, Virginia), a global anatomic pathology laboratory devoted to gynecology, reported their partnership to provide the Tao Brush to Ob/Gyn offices across the country, thus offering a fast and gentle method of endometrial biopsy with minimal patient discomfort, the companies said.

The Tao Brush is designed and made by Cook Medical, and this partnership makes Gynecor the exclusive distributor of the device in the U.S. and the UK.

The Tao Brush is an integral part of Gynecor's TruTest endometrial biopsy kit, which incorporates a gentle brushing technique to collect a uterine biopsy from a patient, the company said. The brush is enclosed in a sheath that protects the bristles from contamination during insertion and protects all collected biopsy tissue during removal. The brush and the tissue specimen are then sent to the Gynecor laboratory for processing and interpretation.

Unlike other forms of endometrial biopsy that incorporate suction or cutting to remove multiple pieces of uterine tissue, the Tao Brush uses soft bristles to procure an adequate representative sample of the patient's endometrium, facilitating early detection of abnormal cells.

Tissue collection with the brush minimizes patient discomfort, potential damage to the uterus and the potential for cancer cells being missed, the companies noted. The Tao Brush is able to sample up to 60% of the endometrial lining, as compared to roughly 4% with the most commonly used suction-based device, they said.

In addition to the brush, Gynecor's TruTest kit contains a fixative that allows pathologists to evaluate both the tissue and the cells the Tao Brush collected. No other current diagnostic test provides both tissue and cell testing from one specimen, according to Gynecor. STD results such as HPV, chlamydia and gonorrhea can also be ordered as part of the TruTest.

In reporting the partnership, Christina Anné, the Women's Health strategic business unit leader, emphasized Cook's focus on quality of life for the female patient. "The strategic partnership between Cook and Gynecor helps meet two of our important objectives. First, TruTest with the Tao Brush improves the quality of life of the female patient by providing a more gentle procedure that minimizes the pain from conventional uterine biopsies while providing specimens that can be better tested. The test's fast turnaround time may also help stem the patient's anxiety. Secondly, together, our partnership provides physicians with a state-of-the-art diagnostic test that can effectively detect early signs of endometrial cancer. As we know, early detection most often means early treatment and potentially better outcomes."

"Cook's objectives align with Gynecor's core value of putting the patient above all else," said Alison Lippincott, director of marketing for Gynecor. "No woman should have to go through a painful procedure, wait over a week for results, and risk not getting a clear diagnosis. Our goal is to address these issues by offering a comprehensive picture of the patients' uterine health with less discomfort and a more definitive result in the shortest amount of time possible."

Cook Medical says it was the first company to introduce interventional devices in the U.S. The company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotechnology to enhance patient safety and improve clinical outcomes.

The Cook Women's Health Strategic Business Unit specializes in interventional and biodesigned technologies that support assisted reproduction, pelvic reconstruction, incontinence, high-risk obstetrics and gynecologic procedures.

Gynecor is the only full-service anatomic pathology laboratory devoted exclusively to gynecology with a special focus on the diseases of the female tract.