Bruder Consulting & Venture Group

Circle the date! The Las Vegas Regenerative Medicine and MSK Ultrasound Course will be held Jan. 9-11, 2025. The course is limited to 60 participants, so make sure to reserve your spot! (Link in the comments below). #ClientPartners #biotech #managementconsulting #FDA #IntegratedInsights #RegenerativeMedicine #Orthosono https://lnkd.in/eAn2y9YY

Happy New Year from all of us at BCVG! #HappyNewYear #BCVG

#DidYouKnow that chemical characterization and toxicological risk assessment can be used to address selected biocompatibility endpoints for medical devices, but it is challenging to get aligned with FDA on all the details. FDA’s new Draft Guidance on Chemical Analysis provides insight into the Agency’s thinking, but there’s still considerable variation from team to team within FDA. We can get formal FDA feedback on your chemical characterization plans to give you certainty that your completed testing will meet FDA’s expectations!   How can we support your business goals? DM us or visit our website to connect! #ClientPartners #biotech #managementconsulting #FDA #IntegratedInsights

A note from Dr. Scott Bruder, founder and CEO of BCVG: “Looking back over 2024, I'm proud to share that we have enjoyed another year of remarkable progress, capping off a decade of sustained and reproducible double-digit growth.  “This year, we brought in over 130 new projects from around the world, ranging from custom-written surveys for physicians, numerous FDA clearances / approvals, and execution of non-clinical studies to M&A due diligence, complex portfolio analyses, and sophisticated PMA / BLA preparation activities. “In some cases, we have resurrected programs from their "death bed” and turned them into flourishing success stories through creative problem solving and perseverance.  “The BCVG team has never been stronger, yet we cannot rest on our most recent success stories. “In this next decade, we intend to grow BCVG by delighting even more Client Partners in these therapeutic verticals, and adding more clinical areas as the relevant technologies mature.   “We are committed to becoming the consulting firm recognized as an international leader in shepherding these novel ideas through the product development process and onto the market.” How can we help you reach your goals in 2025? Connect with us! #ClientPartners #biotech #managementconsulting #FDA #IntegratedInsights

CDRH’s 2024 Breakthrough Designation Numbers are out! Cardiovascular, neurology, orthopedic, and general & plastic surgery devices have the highest number of breakthrough designations. Although the FDA benefits like expedited timelines are resource dependent, Breakthrough Designation does offer companies opportunities for publicity both at the time of designation and future marketing submission. Talk to us about obtaining a Breakthrough Designation for your device today!  #regenerativemedicine #BCVG #ClientPartners #biotech #managementconsulting #FDA #IntegratedInsights

#DidYouKnow Established in 2008, the Las Vegas Regenerative Medicine and MSK Ultrasound Course is the longest running private combined MSK Ultrasound and Regenerative Medicine course.  This year, the event will be held  in Las Vegas from Jan. 9-11, 2025. Learn more and register with the link in the comments below. #regenerativemedicine #BCVG #orthosono #MSK #Ultrasound https://orthosono.com/

Notable developments catching our attention this week: 1. Ossio raised $27MM in growth capital to support continued commercialization efforts for its resorbable bio-integrative  orthopedic fixation technology. 2. Orthocell successfully completed a pre-clinical study in a nerve regeneration model which will support a forthcoming 510(k) submission for its nerve repair product, Remplir. 3. Paradigm Biopharma announced plans to initiate a pivotal Phase 3 clinical trial for its knee OA product, Zilosul, in the first quarter of 2025.   How can BCVG help you make sense of the market? Direct message us with to learn more! #Ossio  #Orthocell #Zilosul  #regenerativemedicine #BCVG

Happy Holidays from all of us at Bruder Consulting & Venture Group This holiday season, we are grateful to all of our Client Partners and associates who inspire us to listen more, learn more, and deliver more with every new project. We would love to hear from you, our trusted Client Partners and followers, regarding your unmet needs and those you see in the community. We promise to personally get back to all of you who provide feedback or suggestions here. DM us or visit our website: bruderconsulting.com. #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights

#ICYMI The American Academy of Orthopaedic Surgeons (AAOS) released "Orthobiologics: Scientific and Clinical Solutions for Orthopaedic Surgeons." BCVG founder Dr. Scott Bruder is the lead editor, along with Dr. Roy Aaron. (See our profile of Dr. Aaron in our April 2023 newsletter.) It provides authoritative, comprehensive coverage of the field of orthobiologics, including everything from the basic science of orthobiologics to specific clinical applications. “This book represents AAOS’ tangible and visible commitment to the legitimacy of biologic solutions in our chosen field,” Dr. Bruder says. The textbook is now available online and in print. AAOS members get a 25% discount. Are you looking to accelerate your business goals? DM us or visit our website: bruderconsulting dot com. #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights

Notable developments catching our attention this week: 1. Novadip Biosciences received IND approval to begin a Phase 2/3 clinical study in cervical spine fusion with NVD-X3, its allogeneic cell-free graft 2. Kuros Biosciences announced a strategic expansion into extremities, with a focus in foot and ankle surgery 3. Pacira Biosciences provided an overview of 2-year data for its investigational gene therapy PCRX-201 in knee OA Let BCVG help you make sense of the market. Direct message us to learn more! #Novadip #Kuros #Pacira #regenerativemedicine #BCVG