b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System

09:00 EDT 21 Sep 2018 | Businesswire

b-ONE Ortho Corp.

b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, today announced it has received 510(k) clearance for its first device, the b-ONETM Total Hip System, from the U.S. Food and Drug Administration (FDA).

The b-ONETM Total Hip System is a cementless total hip system with advanced coating technology and intuitive instrumentation, designed to optimize patient fit in the modern patient demographic. The system comprises the JuvenoTM Femoral Hip, a bone-conserving femoral prosthesis, and the b-ONE Primary Acetabular System, which are compatible with b-ONETM 12/14 Taper Femoral Heads.

“This milestone for the company will officially introduce b-ONE’s product line to the U.S. market,” said Dr. Mark Kester, the Chief Scientific Officer. “With our first U.S. surgery quickly approaching, we are eager to provide surgeons with a versatile system designed to accommodate the majority of today’s expanding patient demographic. In addition, with the support of Dr. Richard Rothman, a prolific designer and developer in the orthopedic industry, our strong R&D team will continue the development and expansion of our product portfolio with a focus on quality, affordability and speed to market.”

The b-ONETM Total Hip System will have a limited launch in the first half of 2019, followed by a full commercial release in the second half of 2019.

This news follows b-ONE Ortho Corp.'s recent US$20 million Series A financing led by Eight Roads Ventures and F-Prime Capital Partners. Proceeds are being used to fund the growth of b-ONE Ortho Corp.’s product portfolio and expansion into international markets.

About b-ONE Ortho Corp.

Based in Cedar Knolls, New Jersey, b-ONE Ortho Corp. is an emerging orthopedic technology company dedicated to the development of innovative orthopedic healthcare solutions that restore patient mobility and improve surgical outcomes. Every day we are committed to becoming the most credible choice for orthopedic products worldwide.

About Eight Roads

Eight Roads Ventures is a global venture capital firm that backs entrepreneurs with aspirations for greatness. As the proprietary investment arm of Fidelity International Limited, Eight Roads is committed to building bold and meaningful businesses and together with its associated funds has invested almost US$6bn globally into growing companies in the past 10 years.

Eight Roads Ventures has led successful investments in China and across the world, including Wuxi PharmaTech, Hile, Innovent, Adagene, Hua Medicine, DeltaHealth, Denali, doctorlink, Laurus Labs, Alibaba, China PnR, AsiaInfo, iSoftStone, Wisers, GShopper, Rulai and PingPong. It launched a dedicated US$250m China Healthcare Fund in September 2017.

About F-Prime Capital

F-Prime Capital Partners is a global venture capital firm investing in life sciences, healthcare, and technology. Since 1969, F-Prime has worked closely with entrepreneurs and academics to create innovative solutions to some of the world's most significant challenges in healthcare and technology.

Caution Concerning Forward-looking Statements

This press release may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding the Corporation’s expectations for future events. Such statements are based on currently available information and current expectations. If these assumptions prove incorrect or inaccurate, or known or unknown risks occur, actual results could differ materially from the expectations and projections of b-ONETM Ortho Corp. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

For press enquiries, please contact:
b-ONE Ortho Corp.
Corinne Zappacosta
+1 (917) 733-8088
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