Miach Orthopaedics adds two executives ahead of FDA submissions
Photo | Courtesy
Michael O'Hara
Photo | Courtesy
Rita Paparazzo
Westborough biotech Miach Orthopaedics has added two senior executives with expertise in regulatory submissions and clinical trials as the company looks to bring its ACL repair technology to market.
The new executives are Michael O’Hara, a former quality assurance expert at biotechs like TransMedics, Abiomed, Medtronic and Baxter, and Rita Paparazzo, an experienced clinical trials research expert with previous roles at Boston Biomedical Associates and Inverness Medical/Biosite, Inc.
O’Hara led the premarket approval submissions for two new products at TransMedics and oversaw U.S. Food & Drug Administration manufacturing inspections.
As vice president of quality assurance, O’Hara will develop, implement and manage Miach’s quality function and management systems, including overseeing manufacturing and ensuring compliance with FDA regulations and standards.
Paparazzo managed multiple clinical trials at her previous two positions, including an investigational device trial from its inception through to the product’s FDA submission. At Miach, she will do the same with the company's clinical trials for an implant as the senior director of clinical operations.
The implant is a bio-engineered scaffold used to facilitate healing of a torn ACL, the main ligament in the knee. The ACL is source of one of the more common injuries in professional sports and requires surgery for athletes to return.
The company is undergoing clinical trials after securing $22.5 million in series A financing in September from Amzak Health Investors LLC and DSM Venturing with participation from the NFL Players Association and additional investors.
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