VBioTech LLC and VBiotechnology LLC
According to Anthony Viscogliosi, he and his brothers Marc and John, have spent more than a decade scouring the world for the next generation product for osteoinduction. Notably, the VBs specifically chose to not emphasize speed to market, but rather, as Tony described it, “build an overwhelming body of clinical evidence based on high quality pre-clinical evidence that can demonstrate a superior outcome in tissue repair and regeneration”.
In that way, said Tony, the two firms into which these new products and technologies will reside, will be able to deliver to physicians more success in tissue healing, better quality healing and, in the process, be first to market with highly credible next generation bone morphogenic protein products for osteoinduction.
The BMP 2 assets to be acquired from Bioventus will be owned by a subsidiary of the Viscogliosi Brothers, partially owned by outside shareholders—VBioTech LLC. The BMP 7 assets to be acquired from Ember Therapeutics will be owned by VBiotechnology LLC.
As Anthony Viscogliosi described the business plan to OTW, “Our desire and intention is to bring these two businesses together under one umbrella and bring to market the second-generation BMP technology, such that this combination will result in a powerful multi-hundred-million-dollar business that will effectively compete against the only other BMP product on the market—Infuse.”
The Viscogliosi Brother Heritage
The three Viscogliosi Brothers, Anthony, John and Marc, are famous for discovering, nurturing and then bringing to market such ground-breaking technology platforms as total disc arthroplasty, uncemented total ankle joint replacement, small bone repair and osteoarthritis (Knee Creations) and doing so on the strength of vast multi-center, Level 1, prospective randomized and expensive clinical studies.
That approach is, in fact, a Viscogliosi Brother heritage.
At a time when most orthopedic products come to market via the 510(k) pathway (since 2008 the FDA has received more than 20,000 510(k) submissions but barely 220 PMA submissions—for all medical devices) the Viscogliosi Brothers insist on bringing products to market through the most rigorous FDA approval pathway – the Pre-Market Application (PMA).
For example, even though the coflex product had been used in more than 10,000 patients in Europe, the VBs insisted on a full prospective, Level 1 PMA spine study which collected healthcare economic data in addition to clinical, radiographic and safety data for spinal stenosis.
Their commitment to doing the hard work resulted in a 95% follow-up rate through two years—the highest ever for a PMA spinal implant (91% follow-up at 5-years!).
The VBs even committed to a head-to-head comparison with lumbar pedicle screw fusion following surgical decompression. Finally, they made sure to include Medicare-aged patients in the study.
The study resulted in tens of thousands of pages of clinical data.
And clinical credibility.
In an earlier time, that same decision with the Pro-Disc arthroplasty system established that product as the market leader—which has endured all these years later.
For the recently acquired BMP assets the VBs are planning a series of multi-center studies to measure clinical safety, quality of the bone healing and the rate at which bone will heal.
