CartiHeal News
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Biomed company CartiHeal acquired by Smith & Nephew for up to $330 million | CTech
Israeli biomed company CartiHeal, which develops a coral-based implant for damaged joints, is being sold to Smith & Nephew (S&N) for up to $330 million. The deal includes an initial cash consideration of $180 million, and up to a further $150 million contingent on financial performance. The deal is expected to close in the first quarter of 2024. CartiHeals investors are expected to record an average return of up to 6 times, depending on the value of the final agreement. All CartiHeal employees in Israel and the U.S. are expected to continue working under the acquiring company.
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Israel-Made Healing Knee Implant Used For First Time In US
Israeli startup CartiHeals knee implant, which regenerates cartilage and bone, has been used for the first time in the US. The Agili-C implant has been approved by the US Food and Drug Administration after being implanted in over 400 patients with cartilage lesions in the knee, ankle, and great toe in a series of clinical trials. The company aims to reach every surgical facility in the US and beyond. CartiHeal was founded in 2009 and is based in Kfar Saba, central Israel.
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CartiHeal Announces First Commercial Implantation of Agili-C™ in the US
CartiHeal Ltd., an Israel and New Jersey-based medical device company, has announced its first commercial implantation of Agili-C in the US. The implant, which supports bone remodeling and cartilage regeneration, was used by Dr. Ken Zaslav, a specialist in Orthopedic Surgery and Sports Medicine at Northwell Health in New York City. The Agili-C implant received FDA breakthrough designation status in 2020 and demonstrated clinical superiority to the surgical standard of care in one of the largest cartilage clinical trials on record.
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הרוכשת של קרטיהיל מזהירה: לא בטוח שנוכל להשלים את...
Bioventus, which acquired Israeli biopharma company CartiHeal five months ago, is warning that it may not be able to complete the acquisition due to new financial difficulties. The company has already made the first payment to Elron and Nitsers, but if it fails to make the second payment in July, the deal could be cancelled. CartiHeal has developed a graft made from algae that encourages the growth of natural cartilage and bone in patients with joint injuries or inflammation. Bioventus invested $15 million in CartiHeal two years ago at a valuation of $180 million.
Acquisition
Bioventus to buy CartiHeal despite financing problems
Bioventus, a US orthologics company, is set to acquire Israeli cartilage treatment company CartiHeal. However, Bioventus faced difficulties in financing the $500 million deal and had to postpone payments to CartiHeal. Originally, Bioventus planned to raise $415 million to finance the acquisition but canceled the fundraising due to market conditions. Instead, Bioventus will pay $100 million immediately, followed by $50 million in one year, and the rest gradually over the subsequent 30 months. The milestone payment threshold has also been reduced. If Bioventus is late in its payments, CartiHeals shareholders have the right to claim back their stakes. Elron Ventures, with a 25% stake in CartiHeal, has notified the Tel Aviv Stock Exchange about the sale.
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Elron warns Cartiheal acquisition by Bioventus at risk
Bioventus has canceled its planned $415 million financing to acquire CartiHeal due to market conditions. The cancellation puts the $500 million sale of CartiHeal to Bioventus in jeopardy. Bioventus does not have enough cash to complete the deal and is seeking alternative financing.
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FDA approves CartiHeal's Implant for the Treatment of Cartilage and Osteochondral Defects
CartiHeal Ltd has received FDA approval for its Agili-C™ implant, which is used for the treatment of cartilage and osteochondral defects in knee-joints. The approval was based on the results of a two-year clinical study that demonstrated the superiority of the Agili-C™ implant over the current Surgical Standard of Care (SSOC). The study enrolled 251 subjects and showed that the Agili-C™ implant provided better outcomes in terms of pain, symptoms, quality of life, activities of daily living, and sports. The approval allows CartiHeal to initiate commercialization and offer a superior solution for patients compared to existing treatment options.
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$500m CartiHeal sale to go ahead after FDA approval granted
US orthologics company Bioventus is acquiring Israeli cartilage implants company CartiHeal for $350 million, with the potential for an additional $150 million based on future revenue. The acquisition was contingent on FDA approval for CartiHeals implants, which have now been received. The biggest winners from the deal are Elron Electronic Industries Ltd., Peregrine Ventures, and Accelmed, who have stakes in CartiHeal. The technology originated at Ben Gurion University of the Negev. CartiHeal CEO Nir Altschuler stated that the FDA approval makes their product the first in the world for growing unscarred cartilage tissues. After the acquisition, CartiHeals center is expected to remain in Israel, but CEO Nir Altschuler is likely to leave.
Acquisition
Bioventus to exercise option to buy CartiHeal for $500m
US orthologics company Bioventus is exercising its option to acquire Israeli medical device company CartiHeal, which has developed cartilage implants made from coral. The upfront payment for the acquisition is $360 million, with milestone payments that could bring the deal up to $500 million. Bioventus has made a $50 million escrow payment, indicating its intent to move forward with the acquisition once CartiHeals cartilage treatment receives FDA approval. CartiHeal recently completed a successful clinical trial and is expected to receive FDA clearance in the coming year. Elron Electronic Industries Ltd. and Accelmed Fund are among the investors in CartiHeal.
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CartiHeal Announces Pivotal Study Results Demonstrate Agili-C™ Superiority to Microfracture and Debridement for the Treatment of Cartilage and Osteochondral Defects Falcon News
CartiHeal Receives FDA "Breakthrough Device Designation" for the novel Agili-C Implant
CartiHeal has been granted Breakthrough Device Designation by the FDA for its Agili-C implant, which is used to treat cartilage lesions in arthritic and non-arthritic joints. The designation is part of the FDAs program to expedite the development and review of medical devices that provide more effective treatment for life-threatening or debilitating conditions. CartiHeal is currently conducting a clinical study to evaluate the superiority of the Agili-C implant over the current surgical standard of care. The company aims to provide a promising treatment option for patients suffering from cartilage defects. The Agili-C implant is not yet available for sale in the United States and is limited to use in the clinical study.
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Bioventus signs option to buy medical device co Cartiheal
Bioventus, a US orthologics company, has invested $15 million in Cartiheal, an Israeli medical device company. The investment values Cartiheal at $180 million. Bioventus also has an option to fully acquire Cartiheal if its cartilage treatment implant, Agili-C, receives FDA approval. The pivotal clinical trial for Agili-C is expected to be completed by October 2021, with final results published by the end of the year. If the results are positive and Cartiheal applies for FDA marketing approval, the process is estimated to take another year. Other investors in Cartiheal include Accelemed, Access Medical, aMoon, Johnson & Johnson, Pertec Fund, and Ben Gurion Universitys tech transfer company.
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Biomed Company CartiHeal Considers a Nasdaq IPO
Biomed company CartiHeal Inc. is considering a Nasdaq IPO to raise between $60 million and $80 million. The company has already hired Credit Suisse and Jefferies for this purpose. CartiHeal develops a coral-based implant for damaged joints and has raised $51 million to date. Elron Electronic Industries, Mori Arkin and Uri Geiger via Accelmed Ventures, Marius Nacht via aMoon, and Johnson and Johnson are shareholders. Elron is pushing for an IPO, while other stakeholders prefer to wait for FDA approval. The companys implant is already approved in Europe.
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CartiHeal Announces Positive Interim Analysis Results of Agili-C™ IDE Study
CartiHeal, a developer of the Agili-C implant for the treatment of cartilage lesions, announced that the first Interim Analysis (IA) on the study data has been performed. The external Endpoint Adjudication Committee (EAC) reviewed the IA safety and efficacy results and recommended to stop accrual for anticipated success. The Agili-C clinical study aims to evaluate the implant over the current Surgical Standard of Care for the treatment of joint surface lesions. Enrollment was stopped after the positive IA results, with a total of 251 subjects enrolled in the study. CartiHeal is a privately-held medical device company headquartered in Israel and New Jersey.
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CartiHeal Performs First Agili-C™ Cartilage Repair Implantation Procedure in Maryland
CartiHeal has announced the first implantation of its Agili-C implant as part of an Investigational Device Exemption (IDE) clinical study. The study aims to demonstrate the superiority of the Agili-C implant over current surgical standards of care for cartilage defects. The first patient to receive the implant was a 50-year-old male with moderate osteoarthritis and two large cartilage defects. CartiHeals CEO expects to perform an interim analysis once the remaining nine study patients are enrolled. The Agili-C implant is a cell-free, off-the-shelf implant that has been used in over 500 study patients in Europe and Israel. In the United States, the implant is not available for sale and is limited to use in the IDE clinical study.
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CartiHeal Performs First Agili-C™ Cartilage Repair Implantation Procedure in Texas
CartiHeal, a medical device company, announced the first implantation of its Agili-C implant as part of an Investigational Device Exemption (IDE) clinical study. The study aims to demonstrate the superiority of the Agili-C implant over current surgical standards of care for cartilage defects. The first patient treated with the Agili-C implant was a 30-year-old male with two large cartilage defects. The company is expecting to perform an interim analysis later this year once all study patients are enrolled. CartiHeal has developed the Agili-C implant for the treatment of cartilage and osteochondral defects in joints.
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CartiHeal Performs First Agili-C™ Cartilage Repair Implantation Procedures at Hospital for Special Surgery (HSS), New York, NY
CartiHeal has successfully enrolled and operated on the first two patients in the Agili-C Investigational Device Exemption (IDE) pivotal study at the Hospital for Special Surgery (HSS) in New York. The study aims to show the superiority of the Agili-C cartilage regeneration implant over current standards of care. The surgeries were performed by Prof. Andreas Gomoll, a sports medicine orthopedic surgeon. The study involves a minimum of 250 patients, with 228 already enrolled. CartiHeals CEO expects the study to provide a viable treatment option for millions of patients in need.
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CartiHeal Enrolls the 200th Patient in Its Pivotal Clinical Study in San Diego, CA
CartiHeal has successfully enrolled the 200th patient in its Agili-C IDE pivotal clinical study. The study aims to show that the Agili-C implant provides superior treatment for cartilage and osteochondral defects compared to the current surgical standard of care. The enrollment rate has exceeded expectations, with 200 patients enrolled within a year and a half. CartiHeals CEO estimates that enrollment will be completed in the upcoming months. The Agili-C implant is a cell-free, off-the-shelf implant that has been implanted in over 400 patients in Europe and Israel. In the United States, the implant is limited to use in the IDE clinical study. CartiHeal is a privately-held medical device company based in Israel.
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CartiHeal's Agili-C™ Implant Enhances In-vitro Osteogenic Differentiation of Human Bone Marrow-derived Mesenchymal Stem Cells
CartiHeal, developer of Agili-C™, announced the publication of a study demonstrating that the Agili-C™ implant enhances osteogenic differentiation of human bone marrow-derived mesenchymal stem cells. The study was led by Prof. László Hangody and his scientists at the University of Debrecen. The goal of the study was to investigate the mechanisms induced by the bone phase of the Agili-C™ implant on the osteogenic differentiation of MSCs. Study results showed that the implant supports osteogenic differentiation and enhanced proliferation of MSCs, suggesting its suitability for bone healing and regeneration. CartiHeal develops implants for the treatment of cartilage and osteochondral defects.
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CartiHeal Performs First Agili-C™ Cartilage Repair Implantation Procedures in the US West Coast
CartiHeals Agili-C cartilage regeneration implant is being tested in a randomized and controlled study in the US. The implant, made of natural biomaterial, aims to regenerate articular cartilage and subchondral bone. Dr. Scott Hacker, a sports medicine orthopedic surgeon, has enrolled and treated the first four patients on the US West Coast. The study involves 15 principal investigators and has already enrolled over 180 patients. The company is pleased with the fast enrollment rate and believes it is a positive sign of trust in the study. CartiHeal is a privately-held medical device company based in Israel.
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First Patient in New England Treated With the Agili-C™ Implant at CartiHeal's Pivotal Study
CartiHeals Agili-C cartilage repair implant is being tested in a clinical study in the US, EU, and Israel. Dr. Christian Lattermann at Brigham and Womens Hospital in Boston enrolled the first patient in New England for the study. The implant is designed to regenerate articular cartilage and subchondral bone in patients with cartilage defects in the knee. The study aims to demonstrate the superiority of the Agili-C implant over standard surgical procedures for cartilage and osteochondral defects. CartiHeal is targeting FDA premarket approval if the study is successful.
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CartiHeal Performs First Hungarian Case in the Agili-C™ Implant IDE Multinational Pivotal Study
CartiHeal, a medical device company, announced the successful enrollment of the first Hungarian patient in the Agili-C IDE pivotal study. The study aims to demonstrate the superiority of the Agili-C implant over the current surgical standard of care for the treatment of joint surface lesions. The study is ongoing in the US, EU, and Israel, with over 80 patients already enrolled. The Agili-C implant is CE marked for use in cartilage and osteochondral defects and has been used in trials in Europe and Israel. In the United States, the implant is not available for sale and is limited to use in the IDE study.
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CartiHeal Performs First Belgium Case in the Agili-C™ Implant IDE Multinational Pivotal Study
CartiHeal, a medical device company, announced the successful enrollment of the first Belgian patient in the Agili-C IDE pivotal study. The study aims to demonstrate the superiority of the Agili-C implant over surgical standard of care for the treatment of joint surface lesions. The companys CEO expressed excitement about adding Belgium to the participating countries in the study and continuing their collaboration with Professor Verdonk. CartiHeals implant has been used in previous trials to treat cartilage lesions in over 400 patients. The Agili-C implant is currently an investigational device limited for use in the IDE study in the United States.
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CartiHeal and LSU Health successfully enroll first two patients in Agili-C IDE pivotal study
CartiHeal has successfully enrolled the first two US patients in the Agili-C IDE pivotal study. The study aims to demonstrate the superiority of the Agili-C implant over surgical standard of care for the treatment of cartilage or osteochondral defects. The first patient who received the implant is a 53-year-old male with a chronic painful cartilage lesion. The enrollment rate for the study has been positive, and CartiHeal plans to open more US sites in the future. In Europe and Israel, 80 patients have already been enrolled and treated in the study. The Agili-C implant has been used in over 400 patients in previous trials for various cartilage lesions.
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First Israeli patient gets startup's knee cartilage-regrowing implant
Israeli startup CartiHeal has developed an implant made of aragonite, a form of calcium carbonite, to regenerate cartilage and bone. The company is conducting a global clinical trial and seeking approval from the US FDA. The goal is to commercialize the product and provide a breakthrough solution for millions of patients with cartilage knee pain. The implant, called Agili-C, is made of aragonite and interacts with the implantation site, allowing bone and cartilage to regrow. CartiHeal has raised $60 million in funding from investors including Elron Electronic Industries, Accelmed, Access Medical Ventures, Peregrine Ventures, aMoon Fund, Johnson & Johnson, and Bioventus. The company has already received CE certification in Europe and is waiting for the completion of patient enrollment in the US before commercialization.
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CartiHeal launches pivotal trial of Agili-C knee implant
CartiHeal has launched an FDA investigational device exemption clinical study for its Agili-C implant, which aims to repair cartilage, osteochondral defects, and treat joint surface lesions. The study has enrolled 16 patients at European centers and plans to engage US and international centers. The company hopes that the data from the trial will support an FDA premarket approval submission. In a previous financing round, CartiHeal raised $18.3 million to support the clinical trial.
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Bone regeneration co CartiHeal raises $18.3m
CartiHeal, an Israeli company developing technology for regenerating damaged cartilage and bone, has announced an $18.3 million financing round led by aMoon Partners. The investment will support the companys preparation for a human clinical trial of its implant, Agili-C, which aims to regenerate damaged cartilage and bone. CartiHeal has already obtained CE marketing approval for Agili-C. The companys product is based on synthetic materials and is implanted by injection, eliminating the need for surgery. The market for treatment of damaged cartilage is estimated at $2 billion. The financing round includes participation from previous CartiHeal investors Elron Electronic Industries Ltd., JJDC, and Peregrine Ventures.
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CartiHeal Performs First Clinical Cases with its New Unicondylar Implant
CartiHeal, an Israeli medical device company, has announced the successful use of its new unicondylar implant in two clinical cases in Europe. The implant is designed to treat large cartilage lesions, common in patients suffering from osteoarthritis. The unicondylar implant is an advancement on the Agili-C implant, which has been used in nearly 250 patients across Europe. The new implant has the potential to become an alternative to metal prosthesis used in partial and full knee replacements. The first two cases were performed by Dr. Matej Drobnic at the University Medical Center, Ljubljana, Slovenia.
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CartiHeal Granted Four Patents Covering Agili-C™ Cartilage Regeneration Technology
CartiHeal Announces $5 Million Raised in Continued Funding Round
