Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
Inovedis GmbH received clearance from the U.S. FDA for its Sinefix implant system, which can be used to repair rotator cuff tears. Sinefix allows surgeons to refix the rotator cuff tendon to the bone using a simplified surgical technique that aims to significantly reduce the time and cost of the procedure.
Curvafix Inc. sealed a $39 million series C financing round to support availability of its device, which treats fragility fractures of the pelvis (FFP). MVM Partners led the round with support from Sectoral Asset Management and other returning investors. Sectoral Asset Management led the $10.7 million series B for the company in 2020. The company has raised more than $60 million to date.
Cymedica Orthopedics Inc. is relaunching its wearable knee pain relief treatment under the Motive Health Inc. brand, following U.S. FDA clearance for direct-to-consumer (DTC) use. The muscle stimulating Motive Knee band is now available without a prescription for anyone suffering from knee pain.
The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for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.
Novadip Biosciences SA has raised an additional €40 million in a series B equity round and nondilutive funding to accelerate the clinical development of two of the company's investigational adipose stem cell (ASC)-derived tissue regeneration products.
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.
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