BioMedical Enterprises Sues Solana Surgical Over Patent

BioMedical Enterprises Inc. is heading to court.

The San Antonio, Texas-based shape memory implant provider is suing Solana Surgical LLC of Memphis, Tenn., for patent infringement. A lawsuit filed Jan. 30 in U.S. District Court for the Western District of Texas claims that Solana’s FuseFORCE Fixation System line of products has infringed and continues to infringe on Biomedical’s U.S. Patent No. 8,584,853; moreover, BioMedical claims to have suffered sales damage because of the infringement.

BioMedical President/CEO Keith M. Peeples underscored the company’s due diligence in ensuring its orthopedic technologies are properly and thoroughly patented. ”Through great effort and ingenuity, BME has secured strong intellectual property rights to cover our unique bone healing technologies, and we will do all in our power to protect those rights,” he said.

The lawsuit seeks to “permanently enjoin Solana from further infringing the claims of the ’853 patent, require Solana to withdraw from distributing all infringing products, and to award damages adequate to compensate BME for the damages it has suffered as a result of Solana’s willful infringement,” according to a company press release.

BioMedical’s orthopedic implants feature are fabricated from Nitinol, a nickel-titanium alloy that changes shape when exposed to certain temperatures in order to provide fixation of bone or soft tissue to bone. The implant technology comes in sterile ready-to-use packaging for various procedures and markets under several brands, including Speed, HammerLock, OSStaple, OSSforce, and Speed Continuous Active Compression System.

Solana Surgical did comment on the lawsuit.

The looming court battle could coincide with the marketing of BioMedical’s HammerLock Nitinol Intramedullary Fixation System, which received clearance from the U.S. Food and Drug Administration late last fall.

Made of Nitinol, the HammerLock Intramedullary Fixation System is designed to treat hammertoe deformities without wires. The HammerLock features a flat body design that resists rotation, barbs to provide secure fixation and high strength. In addition, the tabbed HammerBlock Insertion System allows for fast, simple and precise placement of the HammerLock implant, the company claims. The upgraded HammerLock is designed with a linear body that results in a greater bone fusion area at the joint interface, enhanced flexibility in positioning and easier reduction. In addition, the insertion process is further simplified by the new Squeeze-Tab Retention System.

“The upgraded HammerLock system is a simple but impressive improvement. This offers the surgeon easier insertion, prevents gapping at the arthrodesis site, and the new tab has just the right tension for keeping it on during reduction and for easy removal,” said BioMedical surgeon consultant, Todd Stewart, D.P.M.

The company did not specify a timeframe for commercial release of the HammerLock Intramedullary Fixation System, saying only it “will be available soon for clinical use.”