• Artes Medical (San Diego) reported that it has started a new 1,000-patient post-marketing study that will follow patients treated with the company’s FDA-approved non-resorbable dermal filler, ArteFill, for a period of five years. ArteFill is a non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds. ArteFill is a formulation comprised of polymethylmethacrylate (PMMA), microspheres and bovine collagen, and is the only PMMA-based injectable product that has been approved by the FDA for the treatment of facial wrinkles. Artes is a medical technology company specializing in aesthetic injectable products.

• FzioMed (San Luis Obispo, California) said that the FDA has completed its initial review of the company’s PMA application for Oxiplex spine surgery gel and has accepted the PMA for filing. FDA also confirmed that the Oxiplex PMA will receive expedited processing. Oxiplex is intended to reduce pain and symptoms following lumbar spine surgery. Oxiplex is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. Oxiplex gel is applied around the sensitive spinal nerve root and surrounding neural tissues, creating a protective environment during post-surgical healing. Oxiplex does not interfere with normal healing and clears naturally from the body. FzioMed makes absorbable, surgical biomaterials.

• IntraOp Medical (Sunnyvale, California) reported the introduction of the optimal boost approach to breast cancer treatment administered by its product, Mobetron. The optimal boost approach was used in a recent study of 378 patients in Europe and proved to significantly reduce breast cancer recurrence rates. Mobetron is a portable, self-shielding electron-beam linear accelerator that delivers radiation therapy in the operating room at the time of cancer surgery. Mobetron administers intraoperative electron-beam radiation therapy directly to the tumor bed once a cancerous growth has been excised during surgery. The Optimal Boost method, or as it is commonly referred to in breast cancer treatment, the bio-boost method, consists of applying a high dosage of radiation to the tumor bed at the time of lumpectomy followed by traditional post-operative radiation therapy. IntraOp Medical makes products for the treatment and eradication of cancer.

• HemoBioTech (Dallas) said it has gathered results from a pre-clinical study of its HemoTech blood substitute product in patients undergoing percutaneous coronary intervention (PCI) through angioplasty and stent implantation, the most common PCI procedures. In the ex vivo human study, HemoTech showed markedly reduced platelet aggregation, one of the major complications associated with PCI procedures. HemoTech also demonstrated the potential for preventing restenosis, another potentially dangerous side effect of PCI. HemoTech is composed of bovine hemoglobin that is chemically modified with adenosine triphosphate, adenosine, and glutathione. In addition to carrying oxygen through the bloodstream, HemoTech also induces erythropoiesis (red blood cell production). Based on preclinical studies and an initial foreign human clinical study, the company believes that HemoTech, due to its unique chemical composition, may significantly diminish or even eliminate the intrinsic toxicities that have plagued other attempts at developing blood substitutes. HemoBioTech is focused on developing the first commercial substitute for human blood.

• Paramed (Salt Lake City) reported the release of their Mobility Offers Versatility (MOV) chair, a fully motorized stair-chair capable of carrying fire, emergency medical, and rehabilitating patients safely and easily both up and down flights of stairs with the touch of a button. The MOV has been designed to significantly reduce the inherent risk of back and lower abdominal injury for the care giver when transporting a non-ambulatory patient up or down stairs. Paramed makes patient transport devices for non-ambulatory patients.