Latest news with #Carthera
Yahoo
01-07-2025
- Health
- Yahoo
Carthera's ultrasound system earns EMA endorsement as an orphan medical device
Carthera has received an orphan medical device status endorsement for its SonoCloud ultrasound system for treating brain disorders under a new pilot programme by the European Medicines Agency (EMA). The France-based company's SonoCloud system delivers ultrasound to temporarily open the blood-brain barrier. Activated ahead of drug administration, the skull implant is intended to allow therapeutic agents to better reach the brain. Past research has shown that the blood-brain barrier, a natural filtration system of the brain, limits the penetration of more than 98% of drugs. The endorsement means that Carthera will benefit from advice, including support around its clinical development strategy and clarification on the final steps before filing a European CE mark application for its SonoCloud system, from an EMA expert panel. Intended for medical device manufacturers and notified bodies, the endorsement is part of an EU pilot programme to support early access pathways for innovative devices targeting rare diseases. As part of the programme, the EMA has prioritised certain types of orphan medical devices such as those treating life-threatening medical conditions or those that could cause permanent impairment of a bodily function, and novel devices with potential major clinical benefits. 'This is a very important step for the company, since it creates a unique forum for dialogue with the expert panel prior to submitting the technical documentation for conformity assessment,' said Sandra Thiollière, director of regulatory affairs at Carthera. 'In parallel, we are continuing our early-stage contacts with our notified body to prepare for CE marking submission.' Carthera is currently evaluating SonoCloud in improving the treatment of recurrent glioblastoma (rGBM). In 2024, the Sorbonne University spinout shared results from a Phase I/II single-arm trial (NCT03744026) assessing the safety and efficacy of blood-brain barrier disruption with an implantable ultrasound system in rGBM patients receiving carboplatin. In 12 patients who received carboplatin just before using the device, the one-year overall survival rate (OSR) was 58%, with a median OS of 14 months from surgery. The historical rate of survival for patients living with rGBM is around 9-11 months. Carthera is currently recruiting patients for a pivotal trial of SonoCloud. The two-arm trial will enrol 560 patients and evaluate the system combined with carboplatin (CBDCA) versus standard of care, lomustine (CCNU) or temozolomide (TMZ), in patients undergoing planned resection for first recurrence glioblastoma. "Carthera's ultrasound system earns EMA endorsement as an orphan medical device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
03-05-2025
- Health
- Yahoo
Michael Bolton had strange symptoms before brain cancer diagnosis: ‘Something's wrong'
A Grammy-winning singer and his family have revealed the surprising early symptoms of his brain cancer. Michael Bolton, who was diagnosed in December 2023 with glioblastoma — the most aggressive and fastest-growing form of brain cancer — first exhibited signs that something was amiss the month prior, according to his daughters. During a family night at the bowling alley, Bolton, 72, bowled out of turn several times, they told People during a recent interview. Michael Bolton's Brain Cancer Treatments Have Harsh Side Effects, But Succumbing Is 'Not An Option' That same night, the singer had also fallen out of his chair, which was "very unusual," Taryn, 45, told the outlet. "He's super athletic, and he doesn't drink," she said. "So he fell, and we were like, 'What just happened?'" Read On The Fox News App "That was when we were like, 'Something's wrong with his brain." Looking back now, Bolton's daughters recognize "so many things" they missed. New Prostate Cancer Test Pinpoints Disease Better Than Psa Option, Study Finds Earlier that fall, the Grammy winner had struggled to keep his balance and experienced nausea while performing at a charity event. His daughters had assumed the strange symptoms were due to lack of sleep or excess stress, they said. "He'd been working nonstop that whole time," Taryn recalled while speaking to People. "Traveling, doing shows, doing all of these things. We were like, he's getting older, he's tired, he's stressed out. All of these things we sort of explained in a way, one by one." Following the strange symptoms while bowling, Bolton began experiencing headaches, his daughters shared. The following Monday, he received an MRI that detected a brain tumor, which was removed surgically and found to be glioblastoma. Alternative Cancer Treatment Could Replace Chemo And Surgery, Study Suggests While rare, glioblastoma is known for affecting people across all ages and for its fast, aggressive development, according to Michael Canney Ph.D., chief scientific officer of Carthera, a Colorado health tech company that develops medical devices to treat severe brain disorders. "Although glioblastoma's cause isn't fully known, the disease begins when genetic changes in brain cells cause them to grow out of control," Canney, who was not involved in Bolton's care, told Fox News Digital. "These cancerous cells rapidly invade surrounding brain tissue, making the tumor especially aggressive and hard to treat." Canney confirmed that the symptoms Bolton experienced — confusion, sudden falls and severe headaches — are consistent with glioblastoma warning signs. Woman Says Dog Detected Her Breast Cancer Before Doctors Did: 'He's Known This Whole Time' "Other potential red flags include nausea, memory loss, personality changes, speech difficulties and vision changes," he added. "While the symptoms of glioblastoma are not unique to this disease, anytime you or a loved one experience an unexplained change in behavior, mental awareness or motor control, it's important to see a medical professional." After surgery, Bolton completed radiation and chemotherapy, which have so far kept cancer at bay, the report noted. He receives ongoing MRIs every two months to ensure that he is still clear of tumors. Glioblastoma is among the deadliest cancers, with patients living for an average of just over a year after diagnosis. The five-year survival rate is less than 5%. "It is truly among the most tragic diseases," Canney said. Part of what makes glioblastoma so severe is its resistance to treatment, according to the expert. "Around your brain, there's a natural protective barrier called the blood-brain barrier," he told Fox News Digital. Click Here To Sign Up For Our Health Newsletter "While this barrier keeps the brain safe from toxins and other harmful substances, it also blocks the life-saving chemotherapy drugs used in treating most cancers." In some cases, including Bolton's, glioblastoma treatment can begin with surgery to remove the tumor, provided it has not grown too deeply into the brain, Canney said. Other treatment options include radiation and chemotherapy, which can "modestly extend survival," he noted. "Although current treatment options are limited, a number of clinical trials are underway that give us an immense sense of hope," Canney said, pointing out a new form of ultrasound-based technology that is showing promise. For more Health articles, visit "If approved, this technology will enable doctors to safely and temporarily open the blood-brain barrier for the first time ever — allowing a greater number of potentially more effective chemotherapy drugs into the brain."Original article source: Michael Bolton had strange symptoms before brain cancer diagnosis: 'Something's wrong'
Fox News
03-05-2025
- Health
- Fox News
Michael Bolton had strange symptoms before brain cancer diagnosis: ‘Something's wrong'
A Grammy-winning singer and his family have revealed the surprising early symptoms of his brain cancer. Michael Bolton, who was diagnosed in December 2023 with glioblastoma — the most aggressive and fastest-growing form of brain cancer — first exhibited signs that something was amiss the month prior, according to his daughters. During a family night at the bowling alley, Bolton, 72, bowled out of turn several times, they told People during a recent interview. That same night, the singer had also fallen out of his chair, which was "very unusual," Taryn, 45, told the outlet. "He's super athletic, and he doesn't drink," she said. "So he fell, and we were like, 'What just happened?'" "That was when we were like, 'Something's wrong with his brain." Looking back now, Bolton's daughters recognize "so many things" they missed. Earlier that fall, the Grammy winner had struggled to keep his balance and experienced nausea while performing at a charity event. His daughters had assumed the strange symptoms were due to lack of sleep or excess stress, they said. "He'd been working nonstop that whole time," Taryn recalled while speaking to People. "It is truly among the most tragic diseases." "Traveling, doing shows, doing all of these things. We were like, he's getting older, he's tired, he's stressed out. All of these things we sort of explained in a way, one by one." Following the strange symptoms while bowling, Bolton began experiencing headaches, his daughters shared. The following Monday, he received an MRI that detected a brain tumor, which was removed surgically and found to be glioblastoma. While rare, glioblastoma is known for affecting people across all ages and for its fast, aggressive development, according to Michael Canney Ph.D., chief scientific officer of Carthera, a Colorado health tech company that develops medical devices to treat severe brain disorders. "Although glioblastoma's cause isn't fully known, the disease begins when genetic changes in brain cells cause them to grow out of control," Canney, who was not involved in Bolton's care, told Fox News Digital. "These cancerous cells rapidly invade surrounding brain tissue, making the tumor especially aggressive and hard to treat." Canney confirmed that the symptoms Bolton experienced — confusion, sudden falls and severe headaches — are consistent with glioblastoma warning signs. "Other potential red flags include nausea, memory loss, personality changes, speech difficulties and vision changes," he added. "While the symptoms of glioblastoma are not unique to this disease, anytime you or a loved one experience an unexplained change in behavior, mental awareness or motor control, it's important to see a medical professional." After surgery, Bolton completed radiation and chemotherapy, which have so far kept cancer at bay, the report noted. He receives ongoing MRIs every two months to ensure that he is still clear of tumors. Glioblastoma is among the deadliest cancers, with patients living for an average of just over a year after diagnosis. The five-year survival rate is less than 5%. "It is truly among the most tragic diseases," Canney said. "A number of clinical trials are underway that give us an immense sense of hope." Part of what makes glioblastoma so severe is its resistance to treatment, according to the expert. "Around your brain, there's a natural protective barrier called the blood-brain barrier," he told Fox News Digital. "While this barrier keeps the brain safe from toxins and other harmful substances, it also blocks the life-saving chemotherapy drugs used in treating most cancers." In some cases, including Bolton's, glioblastoma treatment can begin with surgery to remove the tumor, provided it has not grown too deeply into the brain, Canney said. Other treatment options include radiation and chemotherapy, which can "modestly extend survival," he noted. "Although current treatment options are limited, a number of clinical trials are underway that give us an immense sense of hope," Canney said, pointing out a new form of ultrasound-based technology that is showing promise. "If approved, this technology will enable doctors to safely and temporarily open the blood-brain barrier for the first time ever — allowing a greater number of potentially more effective chemotherapy drugs into the brain."
