Medical Industry Today
Companies: FzioMed Inc.
The FDA recently approved the multicenter study of Oxiplex/SP, which is applied within the surgical site to reduce post-operative peridural scarring, or post-surgical adhesions.
Adhesions are an abnormal, fibrous type of internal scar tissue that forms attachments, often between tissues and organs, tethering organs that normally would remain separate and move freely. Adhesions can cause pain and are a leading complication of many surgical procedures.
Oxiplex is a patented polymer technology developed by FzioMed to produce bioresorbable materials for a variety of surgical and medical applications, the company said. Bioresorbable materials are naturally absorbed by the body and do not need to be removed after surgery. Oxiplex materials can be made to adhere to tissues and can be engineered for different uses, such as injectable gels or implantable films.
The adhesion prevention market is FzioMed’s first target for Oxiplex, the company said.
According to the company, adhesions develop in up to 93 percent of patients after abdominal and pelvic surgery, and up to 74 percent of intestinal obstructions are caused by post-surgical adhesions.
More than 5 million surgical procedures each year comprise the adhesion prevention product market potential, and that market may reach $1.5 billion within 10 years, FzioMed said. More than 400,000 patients undergo lumbar surgery in the United States each year, according to the company.
The first Oxiplex product, a bioresorbable film for adhesion prevention in pelvic surgery, is in a human clinical trial in the United States. The recently begun clinical trial for the spine surgery application involves the second Oxiplex product.
“The start of this, our second Oxiplex clinical trial, is a key milestone in expanding the market potential for FzioMed technology,” Ronald Haynes, the company’s president and CEO, said in a statement. “There is a great unmet need for an effective anti-adhesion product in spine surgery, and we believe that Oxiplex/SP can be an important tool for surgeons.”
FzioMed potentially faces competition from GLIATECH (Cleveland, OH), maker of Adcon-brand products for the prevention of adhesions after lumbar and other surgical procedures. However, Gliatech has suffered a number of dire setbacks in the past year.
Most recently, Gliatech voluntarily recalled Adcon-L, its lead and only FDA-approved product, which is used in lumbar and spinal surgeries, as reported by Medical Industry Today. The action was taken last month after a raw material used by Gliatech was itself recalled by the supplier because of possible contamination with particulates from the material’s aluminized paper lid liner. Gliatech’s recall also extends to Adcon-T/N, which is sold outside of the United States for tendon and peripheral nerve surgeries. The recall continues until Gliatech’s manufacturing processes with new supplies of the raw material can be tested, validated and approved by the FDA and European health authorities.
Even prior to the recall, Gliatech had been under intense FDA scrutiny in connection with Adcon-L. Last year the agency determined that data from a post-approval clinical study of Adcon-L had been altered. That FDA investigation caused a $203 million merger for Gliatech to crumble and the company’s stock to fall 60 percent in one day.
According to company literature, FzioMed believes the Oxiplex technology may yield competitive advantages over other products in performance and costs. Future targeted markets for Oxiplex products include hemostasis, cartilage preservation and drug delivery.
FzioMed is a privately held biomedical company that develops and manufactures bioresorbable products based on its Oxiplex technology. Products are at various stages of clinical and preclinical development.
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