Bolt Medical’s Post

With the presentation of MODULAR ATP and APPRAISE ATP clinical trial data, it’s an exciting day here at #HRS2024. Together, these data reinforce the promise of the groundbreaking mCRM System, and illustrate a clear path forward for physicians to offer therapies that prevent sudden cardiac death and deliver antitachycardia pacing (ATP) for the patients who benefit from it. The investigational mCRM System offers a potential upgrade pathway for patients currently implanted with the EMBLEM™ S-ICD System who develop a need for ATP or pacing, allowing physicians to tailor therapy to a patient’s individual needs. Congratulations to the team at Boston Scientific who made the study a success, principal investigators Reinoud Knops M.D. PhD and Claudio Schuger, and those who have supported these important studies! Congratulations also on the simultaneous publication of the MODULAR ATP results in the New England Journal of Medicine, where the results are now available: https://lnkd.in/eEE72t77 * Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.

Modular ATP & APPRAISE ATP data continues to show the importance of evidence-based medicine and BSC’s commitment to this space. We are excited about these results to help further advance CRM therapy. #BSCCardiology #HRS2024

As Sarcoma Awareness Month comes to a close, we would like to spotlight the progress we are making with Ozekibart (INBRX-109) in the fight against sarcoma. From initiating our Phase 1 trial in 2018 to receiving the FDA's Fast Track designation, we continue to advance the clinical program and are actively enrolling our Phase 1 study in Ewing sarcoma and SDH-deficient GIST and our Phase 2 registration-enabling study, ChonDRAgon, in Chondrosarcoma. Stay informed about our clinical trials: https://lnkd.in/eqJyVGQh #SarcomaAwarenessMonth #ClinicalTrials #Inbrx109

We are excited to share data from the first cohort of the LIGHTHOUSE study, our ongoing Phase I/II clinical trial evaluating our investigational #GeneTherapy ATSN-201 for the treatment of X-linked retinoschisis (#XLRS). For the first time in patients, we have validated the ability of AAV.SPR, our novel spreading #capsid, to spread laterally well beyond the subretinal injection blebs. Additionally, we have demonstrated the ability to safely administer subretinal injections in patients with extensive retinal schisis. Subretinal injection of ATSN-201 was well tolerated in all three patients in the first cohort with two patients showing extensive resolution of schisis beginning at 8 weeks after dosing. Additional and continued resolution of schisis was observed through week 24, the latest time point available. Read more about the data in our press release: https://lnkd.in/eAcpdUHS

Last week, the jury in Natera v. Guardant Health, located in the U.S. District Court for the North District of California, found that Natera must pay $292.M in actual and punitive damages for false advertising about their liquid biopsy-based cancer screening tests. Meanwhile, the court dismissed the precision oncology defendant’s counterclaims of false advertising against Guardant Health. Further, the jury, whose decision is one of the largest Lanham Act false advertising verdicts in U.S. history, also found that Natera engaged in a deliberate campaign to mislead clinicians about Guardant’s laboratory developed tests (LDTs). Since the case served as a central pillar of my Student Note, the verdict’s consequences are intriguing and may validate companies that advertise their assays as LDTs, versus more rigorously reviewed and expensive 510k-approved tests. This decision will also likely act as impetus for future companies’ efforts to advertise cancer liquid biopsy tests, despite recently established regulation by the FDA’s on LDTs this past spring. However, with the incoming presidential administration and the demise of the Chevron Doctrine, we will have to see whether the FDA (and by extension the FTC), will have power regarding what diagnostic companies can truly claim about their LDTs. While this will likely apply regardless of a company’s plans to advertise to a learned intermediary (like physicians) or directly to consumers, I look forward to seeing how it eventually shakes out (either in the regulatory or litigation sphere).

🚀 Exciting Developments in Antibody Drug Conjugates! 🔬 🔔 Follow our page for interesting ADC updates! 🌟 Explore the latest edition of ADC Digest for this week of November 2024, featuring groundbreaking advancements in the field of Antibody Drug Conjugates. 💊 CrossBridge Bio secures $10 million financing to advance the development of next-generation dual-payload ADC therapies 💊 BigHat unveils next-gen ADC designed with Lonza’s Synaffix as lead program 💊 AstraZeneca to build Antibody Drug Conjugate (ADC) manufacturing facility in Singapore 💊 ADC Therapeutics axes lead solid tumor drug after phase 1 setback, pivots to preclinical programs 💊 NextCure reports preclinical data for LNCB74 and additional clinical biomarker data for NC410 combo at Society for Immunotherapy of Cancer Annual Meeting 💊 Celltrion unveils development of two cancer drugs 💊 MacroGenics pauses work on vobra duo ADC pending mature survival data #ADC #MedicalInnovations #Innovation #ADCnews #CIScientists #Antibodydrugconjugate #cancer #competitiveintelligence

Learn how biopharma and patient recruitment organizations are overcoming clinical trial recruitment challenges. In this webinar Sara Riordan MS, CGC, Genome Medical;  Bryan Federowicz, xCures; and Jill Pellegrino, AutoCruitment discuss solutions being implemented now to quickly identify and activate qualified clinical trial patients. Register: https://lnkd.in/gRg3gwC4

$OCS $16.31 bid. DAC (dollar average cost) $10.50 (11.10.23). EXIT $25.00 - Legacy Holding. OVERVIEW: Today announces the acceleration of patient enrollment for both Phase 3 DIAMOND trials of OCS-01 eye drops in DME and expansion of the DIAMOND program committees with globally renowned retina experts. Substantial enrollment progress was achieved since the end of Q2 2024 through early October, with ~70% of patients enrolled in the Phase 3 DIAMOND-1 trial, and ~40% of patients enrolled in the Phase 3 DIAMOND-2 trial. The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consists of two (2) Phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME.

👉 Meet us live at the #DGK Annual Meeting! Our CCO Harald Kuhlmann will be attending the DGK - German Society of Cardiology Annual Meeting #DGK2024 at the Rosengarten in Mannheim this week, from today to Friday April 5th, 2024. Harald is eager for engaging discussions, in-person meetings, and experiencing the dynamic interfaces of medical and economic realms in #Cardiology. This year's theme, "Interfaces of Cardiovascular Medicine," delves not only into interdisciplinary aspects but should also explore the interface between medicine and economics, e.g. in terms of Market Access and Reimbursement. #Cardiology thrives on innovcation! Whether in the #pharmaceutical, #MedicalDevice or #diagnostics industry, every year many companies with great new products are looking for market entry and commercial success in Europe. From the intricate workings of the heart to navigating complex market landscapes, there's a synergy that drives progress and success. inspiring-health GmbH understands the importance of navigating these intersections. We help manufacturers chart their course through the complexities of #MarketAccess & #reimbursement in #Germany and across #Europe, offering strategic insights, guidance, and support. Join us for a conversation at the conference! We're excited to exchange ideas and explore the possibilities together. Connect with Harald Kuhlmann and let's embark on this journey towards innovation and success! #Inspiring_Health #DGK #DGKAnnualMeeting Image source: Shutterstock / Leonid Andronov

The European Parliament is expected to vote on the proposed transitional rules applying to the legislations on medical devices and in vitro medical devices (IVDs) via the urgent procedure.   The proposal, which was assigned to the ENVI committee and is expected to be voted in the April plenary, includes:   ◾️Extension of the transitional periods for certain IVDs to reduce shortages   ◾️Shorter transitional period for high-risk IVDs until 31 December 2027   ◾️Longer periods for medium-risk (e.g. cancer tests) and lower-risk IVDs until 2028/2029   ◾️Individual modules of European database on medical devices (Eudamed) once operational https://bit.ly/49rqX6o #IVDR #MedicalDevices #invitrodiagnostics