Xtant Medical Holdings Inc (OTCMKTS:BONE) a pioneer in the advancement of regenerative medical devices and medicine products reported that its subsidiary firm, Bacterin International, Inc., has obtained FDA 510(k) approval of OsteoSelect PLUS DBM Putty. This new product launch will help the company to enhance its market share.

The details

Xtant reported that OsteoSelect PLUS is next-gen DBM putty, having OsteoSelect Putty and demineralized cortical chips. It will offer a sterile grafting solution to clients, and will remove the need to mix DBM putty and bone chips intra-operatively, reducing graft variability and saving time.

The expert view

Dr. Gregory Juda, the CEO of Bacterin, said that they are very delighted with the FDA’s decision to permit OsteoSelect PLUS for commercialization. They have developed this next-gen bone graft component following the increased surgeon demand utilizing design input from numerous surgeon customers. Due to customers’ involvement in the advancement process, the team is sure that OsteoSelect PLUS will get positive response in the market. It will serve to turn Xtant’s product portfolio even stronger.

The significance

With this approval from the U.S. FDA, Xtant Medical Holdings Inc (OTCMKTS:BONE) is set to introduce OsteoSelect PLUS in market in 4Q2015. The Company will work together with its primary IDN and GPO clients to include this new product to current contracts. This will help to achieve the immediate availability of the product after launch. The new product is the first 510(k) accepted product for Bacterin International since it became a subsidiary firm of Xtant Medical. Also, the product is the first of numerous planned product launches, as the company focuses on the combined product portfolio.

In last trading session, the stock price of Xtant Medical surged more than 1% to close the trading session at $3.70. The gains came at a share volume of 25,154 compared to average monthly share volume of 14,425. The market cap stands at $43.46 million.