Albany, New York-based ReVivo Medical, LLC, a medical device company focused on spinal products, is making the necessary moves to start raising funds….specifically, the company has decided to change its corporate status from limited liability corporation to a C-corp.
ReVivo Medical Moves Into Fund Raising Mode
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According to ReVivo Medical President and CEO Gary Mittleman, “Private Equity Funds, Venture Capital and Angel Investor Groups are known to prefer investments in C-Corporations rather than LLCs where they receive K-1s each year making for more complex accounting and reporting.”
Mittleman continued, “We expect that by eliminating the accounting issues for potential investors, it will increase our likelihood of attaining the $1 million of funding we seek.”
The company is in the initial stages of preparing for a FDA sanctioned clinical trial and has already raised $2.6 million. However, it still needs additional funding to complete the 50 patient clinical study. In the trial, participants will be given ReVivo Medical’s “next generation design anterior cervical plate and interbody cages used in anterior cervical discectomy and fusion procedures.”
OTW spoke with ReVivo Medical Co-Founder Eric Ledet, Ph.D., a biomedical engineer, about the upcoming year. Dr. Ledet told OTW, “ReVivo Medical is about to initiate a first in human use IDE [investigational device exemption] clinical trial for our anterior cervical plate and cage. After many years in development and very encouraging pre-clinical data, we are eager to work with the talented surgeons at the Cleveland Clinic and the Albany Medical Center Hospital to initiate the 50 patient clinical trial. Results from the IDE trial will support applications for clearance in the U.S. for both the plate and cage.”
Dr. Ledet continued, “ReVivo Medical is currently fundraising for the clinical trial and to support the continued development [of] our product pipeline. ReVivo’s Medical’s devices are all investigational and none are currently cleared for use in the United States.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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