Bruder Consulting & Venture Group

Notable developments catching our attention this week: 1. CytexOrtho received IDE approval to begin first-in-human clinical studies to evaluate its ReNew Hip Implant in patients with degenerative arthritis 2. Nature Cell’s JointStem received RMAT designation as potential treatment for knee OA 3. OrthoCell completed a $17MM funding round that will support  US launch of Remplir for nerve repair How can BCVG help you make sense of the market? Direct message us to learn more! #CytexOrtho #JointStem #Orthocell #regenerativemedicine #BCVG

“It was my pleasure to recently serve as a ‘Pitch Doctor” at the 22nd New York Life Sciences Summit in Manhattan on a gorgeous October day!  Kate Hutchinson and her team have run an exceptional Summit for years, where entrepreneurs and investors meet regarding cutting-edge opportunities.  This year, I had the pleasure of reconnecting with Sid Angle and Gautam Ghatnekar of Regenosine, privately held pharmaceutical company focused on developing a first-in-class regenerative therapy for #osteoarthritis. I encourage readers to reach out to the Center for Biotechnology, NYS Center for Advanced Technology to learn more about their tremendous capabilities." -Dr. Scott Bruder, founder and CEO of BCVG Want to work with our team? DM us! #ClientPartners #biotech #managementconsulting

BCVG is on the pulse! Check out this recent publication by Jonathan Rivnay at Northwestern University on nerve regeneration. It was found that combining decellularized nerve grafts with Rivnay’s conductive polymers enhances directed motor axon outgrowth. The figure (specifically F on the lower left) shows some of the promising results. What recent studies have you found interesting or helpful to the growth of your business? Put them in the comments below! #ClientPartners #biotech #managementconsulting #diabetes #obesity #NorthwesternUniversity #IntegratedInsights

Notable product advancements catching our attention this week: 1. Peytant Solutions’ AMStent was granted marketing authorization through the De Novo pathway for the management of tracheobronchial airway obstruction 2. Paradigm Biopharma plans to submit its Phase 3 clinical trial protocol to the FDA this month to evaluate Zilosul for the management of knee osteoarthritis 3. Celularity intends to submit 510(k) applications for its placental-derived tendon wrap and bone void filler products starting in early 2025 BCVG can help you make sense of the market. Direct message us to learn more! #Celularity  #Peytant  #Zilosul  #regenerativemedicine  #BCVG

#DidYouKnow BCVG is accelerating the manufacturing and regulatory for this grant focused at Carnegie Mellon and Rice’s Biotech Launch Pad. The product is bioelectrical implant containing encapsulated cells for the treatment for obesity and type 2 diabetes. How can we help your business reach new goals in 2025? DM us or connect with us in the comments! #ClientPartners #biotech #managementconsulting #diabetes #obesity #RiceBiotech #IntegratedInsights

REMINDER! Submit Your Manuscript by November 3, 2024 Caplan Award The Arnold I. Caplan Award for Distinguished Research in Orthobiologics recognizes groundbreaking work in the field. Honoring the legacy of Arnold Caplan, PhD, this annual award will recognize researchers in orthobiologics and MSCs. One $10,000 award will be given to the researcher(s) whose work has advanced the development of new therapeutic solutions in orthobiologics and MSCs.  The winner(s) will be celebrated at the AAOS 2025 Annual Meeting.

Three recent biomaterial partnerships we are watching: 1. Celularity acquired ReboundTM placental-derived matrix from      Sequence LifeScience 2. Enovis signed an agreement with Ossium Health to distribute its      line of OssiGraft allograft products 3. Johnson & Johnson MedTech launched PliaFX Pak, extending      its development partnership with LifeNet Health How can we help you make sense of the market? Direct message BCVG today. #Celularity #Enovis #JNJ #regenerativemedicine #BCVG

Is collaboration the key to success? Working collaboratively with FDA/EMA and adhering to published Guidance Documents is a smart strategy. Why? Because FDA appreciates early contact and opportunities to collaborate, and we recommend you take advantage of this. Evaluate the reimbursement landscape and implications of a device, drug or exempt designation before you forge ahead because planning for the future helps ensure that your product has the right portfolio of clinical studies to publish in support of maximal payment as soon as possible after FDA approval. Examine the market model, COGS, and margins for profitability well before investing in capital-intensive elements. If you are wondering what this means… reach out! BCVG can help. DM us for more information. #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights

#DidYouKnow BCVG is a proud subcontractor for this grant partnering with Carnegie Mellon University, supporting the product development, regulatory and manufacturing efforts to enable clinical investigation. So, what’s it all about? A Carnegie Mellon University-led team has secured an award of up to $42 million from the Advanced Research Projects Agency for Health (ARPA-H) to accelerate the development of implantable, cell-based bioelectronic devices that deliver patient-specific therapy and monitor disease status, for conditions like hypothyroidism and hyperthyroidism, in real time. This award is part of the ARPA-H REACT program which supports the advancement of implantable bioelectronic devices to improve patient management of chronic diseases. How can we take your vision into focus? Connect with us today to learn more! #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights #CarnegieMellonUniversity #CMU

#TodaysAdvice There is enormous potential for biologic-based therapies in orthopaedics, plastic surgery, advanced wound care, aesthetics, neurology and endocrinology. Inventor, investigator and company focus begins by defining the unmet clinical need. Said another way, try to avoid being a technology looking for a problem to solve. The “therapy of choice” should be selected upon satisfying the least rigorous, indication-specific performance criteria. With success achieved here, you can move on to the more complex clinical challenges and technical approaches. BCVG is here to help. Stay in the loop by visiting our website to sign up for our newsletter. Connect with us today to learn more! #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights