The FDA granted breakthrough device designation for the Hyalex Cartilage System, a biomimetic materials platform designed to restore function and repair cartilage defects in the knee. The system, developed by Hyalex Orthopaedics Inc., combines two polymers that improve adhesion on one side and create a low-friction surface that protects the cartilage counterface on the other.
PARIS ‒ Kiomed Pharma SA reported it has signed an exclusive agreement with fellow Belgian company, Moveup SA for the development and licensing of a mobile companion application intended for personalized conservative management treatment for patients suffering from intra-articular osteoarthritis.
Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy.
With 10 cases of serious shock and anaphylaxis, including one death, in the month since Seikagaku Corp.’s osteoarthritis drug, Joyclu (diclofenac etalhyaluronate sodium), launched in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a blue letter to health care professionals and is adding a warning section to the drug’s Japanese label.
LONDON – Cell transdifferentiation specialist Mogrify Ltd. has raised $17 million in the second close its series A, taking the round to $33 million and enabling the company to progress three cell therapy programs to the clinic.
TORONTO – Robotics researchers at Ontario’s University of Waterloo are stealing a page from makers of autonomous or self-driving vehicles, developing wearable, motor-controlled technology to restore physical mobility in people with disabilities without the need to think about or guide the system. The project, called Exonet, is being led by Brokoslaw Laschowski, who contrasts this approach with engineers ramping up the ability of users to control the exoskeleton.
If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration.
With the December PDUFA date already blown, Pfizer Inc. is headed into a day-and-a-half FDA advisory committee meeting this week to make the case for 2.5-mg tanezumab, a potential first-in-class treatment in the U.S., partnered with Eli Lilly and Co. Inc., for chronic pain due to moderate to severe osteoarthritis.
PERTH, Australia – Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell (MSC) and secretome therapy, Progenza, to Japan’s Kyocera Corp. for osteoarthritis of the knee for the Japan market.
Two-and-a-half years after regenerative medicine company Mimedx Group Inc. came under federal investigation for improper sales and marketing practices and nearly two years since it was delisted by Nasdaq, the company is back on track financially and pursuing an active pipeline of new products. Marietta, Ga.-based Mimedx recently reported second quarter sales of $61.7 million, a 7.2% decline from the same period the prior year. The second quarter 10Q Form – one of seven SEC financial statements submitted in the last five months as the company worked to regain compliance – brings Mimedx up to date, paving the way for it to relist its stock.
