The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for many such applications. However, the draft states that clinical testing may be required when a manufacturer intends to claim that their guides could reduce surgical times.
Conformis Inc. has inked a definitive agreement to be acquired by Restor3d Inc., in a move that could potentially create a formidable presence in the personalized orthopedics space. Under the agreement, Restor3d will acquire all outstanding shares of Conformis common stock (NYSE:CFMS) at $2.27 per share in cash. The purchase price represents a roughly 96% premium to Conformis’ closing price on June 22, 2023.
Think Surgical Inc. has just received a $100 million investment from a new investor, South Korea’s KDB Investment Global Healthcare, a private equity firm that is wholly owned by Korea Development Bank. The Fremont, Calif.-based orthopedic surgical robotic company will use the funds to bring new products to market. Stuart Simpson, president and CEO of Think Surgical, confirmed that it will go towards supporting “successful new product commercialization.”
Think Surgical Inc. is deepening ties with South Korean company Curexo Inc. through a new development and distribution deal. Under the terms of the agreement, Think will have exclusive rights to distribute Curexo’s Cuvis-Joint robotic platform, including any additional technology, in the U.S. and other countries. The orthopedic robot is currently used by surgeons in Korea and India for pre-planning surgery.
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
The Persona IQ combines a knee implant created by Zimmer Biomet Inc. with sensor technology developed by Canary Medical Inc. to capture performance data on range of motion, walking speed, step count and other orthopedic metrics. Liane Teplitsky, Zimmer Biomet’s president of global robotics likens the Persona IQ to a cardiac pacemaker, in this instance collecting important data on the knee implant so doctors working remotely can better understand how the device is performing post-surgery.
Shanghai Sanyou Medical Co. Ltd. will be working with Implanet SA to get the latter’s Jazz platform for treating spinal pathologies approved and distributed in China. “Through this partnership, Sanyou Medical will be Jazz’s exclusive distributor. We are currently working on obtaining registration in China with the authorities. We will have a better view on the commercial launch timing later this year,” Ludovic Lastennet, CEO and founder of Implanet, told BioWorld.
Ganymed Robotics SAS raised a €21 million (US$21.2 million) series B round to develop its robotic system for total knee arthroplasty (TKA). Health care fund Cathay Health led the round, with participation from Credit Mutuel Innovation, Kurma Partners, BNP Paribas Developpement, and individual surgeons. The funds will be used to finalize development of Ganymed’s TKA surgical assistant and support the company’s expansion in France and the U.S.
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.
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