Titan Medical (CVE:TMD) said today it inked a 3-month extension on negotiations with Longtai Medical to distribute its Sport surgical robot in the Asia Pacific region and it initiated usability studies for its Sport system to comply with newly published FDA guidance.
The company said it extended the negotiation of exclusive rights for distribution in the Asia Pacific region until August 19 this year. Titan originally inked the dea with Longtai, which included a private placement deal of more than $24 million, last November.
“We have had very productive discussions with Longtai regarding our two companies teaming up to maximize the potential of Titan’s Sport Surgical System in the China market. This three month extension enables both companies to continue to discuss a wide variety of topics designed to negotiate a potential comprehensive agreement benefiting both companies,” Titan Medical prez Reiza Rayman said in a press release.
Titan also reported it initiated usability studies of its Sport surgical system to comply with the newly published “Applying Human Factors and Usability Engineering to Medical Devices” FDA guidelines.
The usability studies aim to inform final design on the Sport system and outcomes from the study are slated to icnlude identification of system use-related issues that the company will address through further engineering to reduce use-related hazards, Titan Medical said.
“As we recently reported, on April 3rd the FDA published updated guidelines titled “Applying Human Factors and Usability Engineering to Medical Devices” and Titan has revised its timeline and milestones for submission of a 510(k) application to the FDA to include detailed attention to these new guidelines. The first step in this process is the initiation of usability studies. We are well into these studies, which are conducted to enable Sport to comply with FDA requirements, and expect to complete the current studies by the end of the current year. Successful outcomes will play a major role in the system design freeze during the first half of 2017,” CEO John Hargrove said in a prepared statement.
Last month, Titan Medical said it grossed about $11.5 million (C$15.1 million) in a public offering of shares and warrants.
The Toronto-based robot-assisted surgery company said it sold nearly 15.1 million unit at 76¢ (C$1) apiece. Each unit consisted of a common share and a 5-year warrant priced at 92¢ (C$1.20). The offering included the sale of 191,000 units to a company insider, Titan said.
